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License Agreement

Services Agreement

This Services Agreement (this “Agreement”) is made and entered into by and between CELLCARTA and the person or entity agreeing to these terms (“Customer” or “you”).

This Agreement is effective as of the date that Customer clicks to accept the Agreement (the “Effective Date”). If you are accepting on behalf of Customer, you represent and warrant that: (i) you have read and understand this Agreement; and (ii) you agree, on behalf of Customer, to this Agreement. This Agreement governs Customer’s access to and use of the Service.

  1. 1. Defined Terms.

    “Account” means Customer’s CellEngine account.

    “Affiliate” means any entity that directly or indirectly Controls, is Controlled by, or is under common Control with a party.

    “Allegation” means an unaffiliated third party’s allegation.

    “Alpha” means a limited-availability test stage for features before they are cleared for widespread use. All significant design elements have been resolved and we are in the process of verifying functionality. Alpha releases may not be feature complete, may not have SLAs and do not have technical support obligations.

    “Ancillary IP” means any software and other Intellectual Property (including without limitation rendered HTML pages and API client libraries) provided by CELLCARTA for use in connection with the Hosted Services.

    “API” means an application program interface.

    “Applicable Law” means all applicable laws, rules, regulations, rulings, judgments, declarations, decrees, directives, statutes, or other enactments, orders, mandates or resolutions of any governmental authority in any country or jurisdiction, as may be amended or otherwise revised from time to time.

    “Services” means all services made available by CELLCARTA or CELLCARTA affiliates in connection with CellEngine, including without limitation all Hosted Services, Documentation and Ancillary IP. Services do not include third-party content.

    “Beta” means a test stage for features that are available for any customer to use. Beta releases may have open outstanding issues, may not have SLAs and do not have technical support obligations.

    “Brand Features” means the trade names, trademarks, service marks, logos, domain names, and other distinctive brand features of each party, respectively, as secured by such party from time to time.

    “Business Associate” has the meaning set forth in the Health Insurance Portability and Accountability Act of 1996.

    “Confidential Information” means information that one party discloses to the other party under this Agreement, and which is marked as confidential or would normally under the circumstances be considered confidential information. It does not include information that is independently developed by the recipient, is rightfully given to the recipient by a third party without confidentiality obligations, or becomes public through no fault of the recipient. Subject to the preceding sentence, Customer Data is considered Customer’s Confidential Information.

    “Control” means control of greater than fifty percent of the voting rights or equity interests of a party.

    “Covered Entity” has the meaning set forth in the Health Insurance Portability and Accountability Act of 1996.

    “Customer Data” means content provided to CELLCARTA by Customer (or at its direction) via the Services.

    “Customer End Users” means the individuals whom Customer permits to use the Application.

    “Documentation” means the CELLCARTA documentation (as may be updated from time to time) located at https://docs.cellengine.com (and any successor or related locations designated by us).

    “Early Access” means a limited-availability test stage for features before they are cleared for widespread use. To use these Services, you may be required to sign a confidentiality agreement. These features may be unstable, changed in backward-incompatible ways and are not guaranteed to be released.

    “Feedback” means feedback or suggestions about the Services provided to CELLCARTA by Customer, in any medium.

    “GDPR” means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).

    “HIPAA” means the Health Insurance Portability and Accountability Act of 1996 as it may be amended from time to time, and any regulations issued under it.

    “Hosted Services” means the CellEngine software platform, APIs or other functions and/or infrastructure made available for access and use on a remote, hosted and/or software as a service basis.

    “Indemnified Liabilities” means any (i) settlement amounts approved by the indemnifying party; and (ii) damages and costs finally awarded against the indemnified party and its Affiliates by a court of competent jurisdiction.

    “Intellectual Property Rights” means any and all interest, whether registered or unregistered, under Applicable Law in (a) trademarks, service marks, trade names, trade dress and Internet domain names, together with all goodwill and common law rights associated therewith; (b) patents; (c) copyrights; (d) registrations and applications for registration of any of the foregoing in (a)-(c); (e) rights in trade secrets; and (f) rights of privacy and/or publicity; with all tangible and intangible embodiments thereof to the extent governed by (a)-(f) collectively meaning “Intellectual Property.”

    “Suppliers” means agencies and service providers employed by CELLCARTA to deliver the Services, including our Web hosting provider.

    “Term” has the meaning set forth in section 6.1 of the Agreement.

    “Terms URL” means the URL set forth here: https://docs.cellengine.com/licenseagreement.

    “Third-Party Legal Proceeding” means any formal legal proceeding filed by an unaffiliated third party before a court or government tribunal (including any appellate proceeding).

  2. 2. Provision of the Services.
    1. 2.1. Hosted Services and Documentation Use. Subject to this Agreement, during the Term, Customer may (i) access and use the Hosted Services in a limited, non-exclusive, non-transferable manner, solely by Customer End Users and solely for Customer’s internal use, and (ii) use, display, reproduce, and distribute any Documentation to any Customer End Users of the Hosted Services.
    2. 2.2. No Sublicense or Transfer. Customer may not sublicense or transfer any rights provided for or granted under this section 1 except as permitted under the Assignment section of the Agreement.
    3. 2.3. Data Location and International Users. CELLCARTA may process and store the Customer Data anywhere CELLCARTA or its Suppliers maintain facilities. By using the Services, Customer consents to this processing and storage of Customer Data. If and to the extent that, in processing the Customer Data, CELLCARTA will be processing personal data (as defined under the GDPR) of data subjects (as defined under the GDPR) on behalf of Customer, the parties will have the rights and obligations set out in Attachment 1. Users who access or use the Services from other jurisdictions do so at their own volition and are responsible for compliance with local law.
    4. 2.4. Accounts. Customer must have an Account to use the Services, and is responsible for the information it provides to create the Account, the security of access credentials and its passwords for the Account, and for any use of its Account and the access credentials. If Customer becomes aware of any unauthorized use of its password or its Account, Customer will notify CELLCARTA as promptly as possible. By registering, Customer agrees that all information provided in the registration data is true and accurate and that Customer will maintain and update this information as required in order to keep it current, complete, and accurate. Customer may not share their Account or password with anyone. If your account is discontinued by CELLCARTA due to your violation of any portion of the Terms, then you agree that you shall not attempt to create another Account.
    5. 2.5. New Applications and Services.
      1. 2.5.1. CELLCARTA may, in its sole discretion: (i) make new applications, tools, features or functionality available from time to time through the Services and (ii) add new services to the “Services” definition from time to time (collectively, “New Applications and Services”), the use of which may be contingent upon Customer’s agreement to additional terms.
      2. 2.5.2. New Applications and Services may be launched in Early Access, Alpha and Beta stages, during which time (i) no validity, accuracy, stability or availability provisions apply unless specified in the Documentation; (ii) no technical support obligations apply; (iii) significant, backward-incompatible changes may be made by CELLCARTA to the New Applications and Services. Additionally, Early Access, Alpha and Beta New Applications and Services may be provided confidentially, in which case Customer may not disclose any information regarding the Early Access, Alpha or Beta New Applications and Services to anyone outside of CELLCARTA.
    6. 2.6. Modifications.
      1. 2.6.1. To the Services. CELLCARTA may make commercially reasonable updates to the Services from time to time in its sole discretion. If CELLCARTA makes a material change to the Services, CELLCARTA will inform Customer, provided that Customer has subscribed with CELLCARTA to be informed about such change.
      2. 2.6.2. To the Agreement. CELLCARTA may make changes to this Agreement, including pricing and any linked documents from time to time, in its sole discretion. Unless otherwise noted by CELLCARTA, material changes to the Agreement will become effective 30 days after they are posted, except if the changes apply to new functionality in which case they will be effective immediately. If Customer does not agree to the revised Agreement, Customer shall terminate this Agreement in accordance with section 8.5 of this Agreement. CELLCARTA will post any modification to this Agreement to the Terms URL.
  3. 3. Customer Obligations.
    1. 3.1. Privacy. Customer will obtain and maintain any required consents, and provide all notices required by Applicable Law and necessary to permit the processing of Customer Data under this Agreement.
    2. 3.2. HIPAA and other health information laws. Unless otherwise specified in writing by CELLCARTA, CELLCARTA does not intend uses of the Services to create obligations under HIPAA, and makes no representations that the Services satisfy HIPAA requirements. If Customer is (or becomes) a Covered Entity or Business Associate, a health information custodian or trustee, as defined in HIPAA or other health information laws as applicable, Customer will not use the Services for any purpose or in any manner involving Protected Health Information or personal health information (as defined in HIPAA or other health information laws as applicable) unless Customer has received prior written consent to such use from CELLCARTA.
    3. 3.3. Third-Party Components. Third-party components (which may include open source software) of the Services may be subject to separate license agreements. To the limited extent a third-party license expressly supersedes this Agreement, that third-party license governs Customer’s use of that third-party component.
    4. 3.4. Documentation. CELLCARTA may provide Documentation for Customer’s use of the Services. The Documentation may specify restrictions on how the Services may be used and Customer will comply with any such restrictions specified.
    5. 3.5. Restrictions and Acceptable Use. Without CELLCARTA’s written consent, customer shall not, and shall not to allow third parties to, (a) make the Services available to, or use the Services for the benefit of, any third party, (b) sell, resell, license, sublicense, host, reproduce, distribute, rent or lease the Services, or include the Services in a timeshare, service bureau or outsourcing offering, (c) use the Services for any unlawful, invasive, infringing, defamatory or fraudulent purpose, to store, transmit or distribute infringing, libelous or otherwise unlawful or tortious material, or to store, transmit or distribute material in violation of third-party privacy rights, (d) generate, distribute, publish or facilitate unsolicited email, promotions, advertisements or other commercial electronic messages, (e) use the Services to store, transmit or distribute malicious code, (f) disable, interfere with or disrupt the integrity or performance of the Services, the equipment used to provide the Services or third-party data or content contained therein, (g) interfere with the use of the Services by customers, authorized resellers, or other authorized users, (h) attempt to gain unauthorized access to the Services or related systems or networks, (i) modify, translate, or create derivative works based on the Services, (j) copy the Services or any part, feature, function or user interface thereof except as permitted herein, (k) use the Services, or any interfaces provided with the Services, to access any other CELLCARTA product or service in a manner that violates the terms of service of such other CELLCARTA product or service, (l) frame or mirror any part of the Services, (m) remove any proprietary notices or labels, (n) reverse engineer, decompile, disassemble or otherwise attempt to discover the source code, object code or underlying structure, ideas, know-how or algorithms relevant to the Services or any software, documentation or data related to the Services, (o) access the Services in order to (i) build a similar or competitive product or service or (ii) copy any features, functions or graphics of the Services, (p) create multiple Accounts to simulate or act as a single Account or otherwise access the Services in a manner intended to avoid incurring Fees, or (q) process or store any Customer Data that is subject to the International Traffic in Arms Regulations maintained by the United States Department of State.
  4. 4. Privacy Policy. To the extent that CELLCARTA collects personal information of Customer, the collection, use and disclosure of such information will be in subject to the Privacy Policy available at https://docs.cellengine.com/privacy (“Privacy Policy”).
  5. 5. Ownership and Intellectual Property Rights; Customer Data; Feedback.
    1. 5.1. No Grant. Except as expressly set forth in this Agreement, this Agreement does not grant either party any rights, title or interest, implied or otherwise, to the other’s content or any of the other’s Intellectual Property.
    2. 5.2. Ownership; Intellectual Property Rights. As between the parties, CELLCARTA is the sole and exclusive owner of the Services and all Intellectual Property Rights therein.,
    3. 5.3. Customer Data. Customer owns all Intellectual Property Rights in Customer Data. CELLCARTA will not access or use Customer Data, except as necessary to provide the Services to Customer or as provided in the Privacy Policy. Without limiting the generality of the foregoing, Customer acknowledges and agrees that CELLCARTA may access Customer Data on a limited basis for troubleshooting, remediation, service improvement or in case of legal obligations.
    4. 5.4. Customer Feedback. If Customer provides CELLCARTA with Feedback about the Services, then CELLCARTA may use that information without obligation to Customer, and Customer hereby irrevocably assigns to CELLCARTA all right, title, and interest in that Feedback and waives all moral rights Customer may have therein.
  6. 6. Technical Support Services. Unless otherwise agreed, technical support services are provided by CELLCARTA on a best-effort basis.
  7. 7. Deprecation of Services. CELLCARTA may discontinue any Services or any portion or feature for any reason at any time without liability to Customer. CELLCARTA will use commercially reasonable efforts to continue to operate all Service versions and features without change for at least one year after announcing deprecation, unless required by law or third-party relationship, or unless doing so could create a security risk or substantial economic or material technical burden.
  8. 8. Term and Termination.
    1. 8.1. Agreement Term. The “Term” of this Agreement will begin on the Effective Date and continue until the Agreement is terminated as set forth in this Agreement.
    2. 8.2. Termination after Free Trial. This Agreement is immediately terminated upon expiration of the Customer’s free trial of the Services. For clarity and notwithstanding the foregoing, if Customer purchases a subscription for the Services, this Agreement will also apply to use under such subscription.
    3. 8.3. Termination for Breach. Either party may terminate this Agreement for breach if: (i) the other party is in material breach of the Agreement and fails to cure that breach within thirty days after receipt of written notice; (ii) the other party ceases its business operations or becomes subject to insolvency proceedings and the proceedings are not dismissed within ninety days; or (iii) the other party is in material breach of this Agreement more than two times notwithstanding any cure of such breaches. In addition, CELLCARTA may terminate any, all, or any portion of the Services, if Customer meets any of these conditions.
    4. 8.4. Termination for Inactivity. CELLCARTA reserves the right to terminate the Services for inactivity, if, for a period exceeding 180 days, Customer: (a) has failed to access the Services; and (b) no electronic bills are being generated.
    5. 8.5. Termination for Convenience. Customer may stop using the Services at any time. Customer may terminate this Agreement for its convenience at any time on prior written notice and upon termination, must cease use of the applicable Services. CELLCARTA may terminate this Agreement for its convenience at any time without liability to Customer.
    6. 8.6. Effect of Termination. If the Agreement is terminated, then: (i) the rights granted by one party to the other will immediately cease; (ii) all Fees owed by Customer to CELLCARTA are immediately due upon receipt of the final electronic bill; (iii) Customer will have 60 days from the date of such termination to retrieve any data that Customer wishes to retain before deletion by CELLCARTA; and (iv) upon request, each party will use commercially reasonable efforts to return or destroy all Confidential Information of the other party.
  9. 9. Representations and Warranties. Each party represents and warrants that: (a) it has full power and authority to enter into the Agreement; and (b) it will comply with all laws and regulations applicable to its provision, or use, of the Services, as applicable. CELLCARTA warrants that it will provide the Services in accordance with the applicable service level agreement separately concluded with Customer, if any.
  10. 10. Disclaimer. EXCEPT AS EXPRESSLY PROVIDED FOR IN THIS AGREEMENT, TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, CELLCARTA AND ITS SUPPLIERS DO NOT MAKE ANY WARRANTY OF ANY KIND, WHETHER EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR USE AND NONINFRINGEMENT. CELLCARTA AND ITS SUPPLIERS ARE NOT RESPONSIBLE OR LIABLE FOR THE DELETION OF OR FAILURE TO STORE ANY CUSTOMER DATA AND OTHER COMMUNICATIONS MAINTAINED OR TRANSMITTED THROUGH USE OF THE SERVICES. NEITHER CELLCARTA NOR ITS SUPPLIERS WARRANT THAT (A) THE OPERATION OF THE SOFTWARE OR THE SERVICES WILL BE ERROR-FREE, SECURE OR UNINTERRUPTED, (B) THAT THE RESULTS THAT MAY BE OBTAINED FROM THE USE OF THE SERVICES OR MATERIALS WILL BE EFFECTIVE, ACCURATE OR RELIABLE, OR (C) THE QUALITY OF ANY PRODUCTS, SERVICES, OR INFORMATION PURCHASED OR OBTAINED BY YOU FROM THE SITE FROM US OR OUR AFFILIATES WILL MEET YOUR EXPECTATIONS OR BE FREE FROM MISTAKES, ERRORS OR DEFECTS. NEITHER THE SOFTWARE NOR THE SERVICES ARE DESIGNED, MANUFACTURED, OR INTENDED FOR HIGH-RISK ACTIVITIES. THE SERVICES ARE PROVIDED FOR INFORMATIONAL PURPOSES ONLY. AS ALL SERVICES PROVIDED ARE BASED UPON THE INFORMATION PROVIDED TO CELLCARTA BY YOU, YOU ACKNOWLEDGE AND AGREE THAT THE OUTPUTS PROVIDED TO YOU VIA THE SERVICE ARE WHOLLY DEPENDENT UPON THE ACTIONS, INSTRUCTIONS AND INPUTS TAKEN OR PROVIDED BY YOU.
  11. 11. Limitation of Liability.
    1. 11.1. Limitation on Indirect Liability. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, NEITHER PARTY, NOR CELLCARTA’S SUPPLIERS OR AFFILIATES, WILL BE LIABLE UNDER THIS AGREEMENT FOR LOST REVENUES OR INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY, OR PUNITIVE DAMAGES, EVEN IF THE PARTY KNEW OR SHOULD HAVE KNOWN THAT SUCH DAMAGES WERE POSSIBLE AND EVEN IF DIRECT DAMAGES DO NOT SATISFY A REMEDY.
    2. 11.2. Limitation on Amount of Liability. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, NEITHER PARTY, NOR CELLCARTA’S SUPPLIERS OR AFFILIATES, MAY BE HELD LIABLE UNDER THIS AGREEMENT FOR MORE THAN THE AMOUNT PAID BY CUSTOMER TO CELLCARTA UNDER THIS AGREEMENT DURING THE SIX (6) MONTHS PRIOR TO THE EVENT GIVING RISE TO LIABILITY.
    3. 11.3. Exceptions to Limitations. These limitations of liability do not apply to breaches of confidentiality obligations, violations of a party’s Intellectual Property Rights by the other party, indemnification obligations, or Customer’s payment obligations.
  12. 12. Indemnification.
    1. 12.1. By Customer. Unless prohibited by applicable law, Customer will defend and indemnify CELLCARTA and its Affiliates against Indemnified Liabilities in any Third-Party Legal Proceeding to the extent arising from Customer’s (a) violation of this Agreement; or (b) violation of any Applicable Laws. CELLCARTA reserves the right, at its own cost, to assume the exclusive defense and control of any matter otherwise subject to indemnification by you, in which event you will fully cooperate with CELLCARTA in asserting any available defenses. You agree that the provisions in this section will survive any termination of your Account, this Agreement or your access to the Services.
    2. 12.2. By CELLCARTA. CELLCARTA will indemnify, defend and hold you harmless from any Third-Party Legal Proceeding that alleges that your use of the Services in accordance with the terms herein, infringes such third party’s U.S. or Canadian copyrights, trade secrets or trademarks, and CELLCARTA will pay all damages, judgments and/or settlements incurred by you in connection with such suit.
    3. 12.3. Exclusions. This Section 12 will not apply to the extent the underlying Allegation arises from:
      1. 12.3.1. the indemnified party’s breach of this Agreement;
      2. 12.3.2. modifications to the indemnifying party’s technology or Brand Features by anyone other than the indemnifying party;
      3. 12.3.3. combination of the indemnifying party’s technology or Brand Features with materials not provided by the indemnifying party; or
      4. 12.3.4. use of non-current or unsupported versions of the Services or Brand Features.
    4. 12.4. Violations. If CELLCARTA becomes aware of any possible violations by Customer of this Agreement, CELLCARTA reserves the right to investigate such violations. If, as a result of the investigation, CELLCARTA believes that criminal activity has occurred, CELLCARTA reserves the right to refer the matter to, and to cooperate with, any and all applicable legal authorities. CELLCARTA is entitled, except to the extent prohibited by applicable law, to disclose any information or materials in CELLCARTA’s possession in connection with your use of the Services, to (1) comply with applicable laws, legal process or governmental request; (2) enforce the Terms, (3) respond to your requests for customer service, or (4) protect the rights, property or personal safety of CELLCARTA, its Users or the public, and all enforcement or other government officials, as CELLCARTA in its sole discretion believes to be necessary or appropriate.
    5. 12.5. U.S. Federal Agency Users. The Services may have been developed in part with U.S. Federal Government funding and are commercial computer software and related documentation within the meaning of the applicable Federal Acquisition Regulations and their agency supplements.
  13. 13. Miscellaneous.
    1. 13.1. Notices. All notices must be in writing and addressed to the other party’s legal department and primary point of contact. The email address for notices being sent to CELLCARTA’s Legal Department is . Notice will be treated as given on receipt as verified by written or automated receipt or by electronic log (as applicable).
    2. 13.2. Assignment. This Agreement, and your rights and obligations hereunder, may not be assigned, subcontracted, delegated or otherwise transferred by you without CELLCARTA’s prior written consent, and any attempted assignment, subcontract, delegation, or transfer in violation of the foregoing will be null and void.
    3. 13.3. Force Majeure. CELLCARTA shall not be liable for any delay or failure to perform resulting from causes outside its reasonable control, including, but not limited to, acts of God, war, terrorism, riots, embargoes, acts of civil or military authorities, fire, floods, accidents, strikes or shortages of transportation facilities, fuel, energy, labor or materials.
    4. 13.4. No Waiver. Any waiver or failure to enforce any provision of this Agreement on one occasion will not be deemed a waiver of any other provision or of such provision on any other occasion.
    5. 13.5. Severability. If any provision of this Agreement is, for any reason, held to be invalid or unenforceable, the other provisions of this Agreement will remain enforceable, and the invalid or unenforceable provision will be deemed modified so that it is valid and enforceable to the maximum extent permitted by law.
    6. 13.6. U.S. Governing Law. this Agreement and any action related thereto will be governed and interpreted by and under the laws of the State of Delaware, without giving effect to any principles that provide for the application of the law of another jurisdiction. The United Nations Convention on Contracts for the International Sale of Goods does not apply to this Agreement.
    7. 13.7. Entire Agreement. This Agreement sets out all terms agreed between the parties and supersedes all other agreements between the parties relating to its subject matter. The terms located at a URL referenced in this Agreement and the Documentation are incorporated by reference into the Agreement. After the Effective Date, CELLCARTA may provide an updated URL in place of any URL referenced in this Agreement.
    8. 13.8. Conflicting Terms. If there is a conflict between the documents that make up this Agreement, the documents will control in the following order: the Agreement, and the terms at the applicable URL.

Attachment 1: Standard Contractual Clauses

SECTION I

Clause 1: Purpose and scope

  1. (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)1 for the transfer of personal data to a third country.
  2. (b) The Parties:
    1. (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
    2. (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’).
  3. (c) These Clauses apply with respect to the transfer of personal data as specified in Annex I.B.
  4. (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

  1. (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.
  2. (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

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

Clause 4: Interpretation

  1. (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.
  2. (b) These Clauses shall be read and interpreted in the light of the provisions of Regulation (EU) 2016/679.
  3. (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 – Optional: Docking clause

  1. (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.
  2. (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.
  3. (c) The acceding entity shall have no rights or obligations arising under these Clauses from the period prior to becoming a Party.

SECTION II – OBLIGATIONS OF THE PARTIES

Clause 8: Data protection safeguards

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

8.1 Instructions

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

8.2 Purpose limitation

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

8.3 Transparency

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

8.4 Accuracy

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

8.5 Duration of processing and erasure or return of data

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

8.6 Security of processing

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

8.7 Sensitive data

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

8.8 Onward transfers

The data importer shall only disclose the personal data to a third party on documented instructions from the data exporter. In addition, the data may only be disclosed to a third party located outside the European Union2 (in the same country as the data importer or in another third country, hereinafter ‘onward transfer’) if the third party is or agrees to be bound by these Clauses, under the appropriate Module, or if:

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

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

8.9 Documentation and compliance

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

Clause 9: Use of sub-processors

  1. (a) The data importer has the data exporter’s general authorisation for the engagement of sub-processor(s) from an agreed list. The data importer shall specifically inform the data exporter in writing of any intended changes to that list through the addition or replacement of sub-processors at least 30 days in advance, thereby giving the data exporter sufficient time to be able to object to such changes prior to the engagement of the sub-processor(s). The data importer shall provide the data exporter with the information necessary to enable the data exporter to exercise its right to object.
  2. (b) Where the data importer engages a sub-processor to carry out specific processing activities (on behalf of the data exporter), it shall do so by way of a written contract that provides for, in substance, the same data protection obligations as those binding the data importer under these Clauses, including in terms of third-party beneficiary rights for data subjects3. The Parties agree that, by complying with this Clause, the data importer fulfils its obligations under Clause 8.8. The data importer shall ensure that the sub-processor complies with the obligations to which the data importer is subject pursuant to these Clauses.
  3. (c) The data importer shall provide, at the data exporter’s request, a copy of such a sub-processor agreement and any subsequent amendments to the data exporter. To the extent necessary to protect business secrets or other confidential information, including personal data, the data importer may redact the text of the agreement prior to sharing a copy.
  4. (d) The data importer shall remain fully responsible to the data exporter for the performance of the sub-processor’s obligations under its contract with the data importer. The data importer shall notify the data exporter of any failure by the sub-processor to fulfil its obligations under that contract.
  5. (e) The data importer shall agree a third-party beneficiary clause with the sub-processor whereby – in the event the data importer has factually disappeared, ceased to exist in law or has become insolvent – the data exporter shall have the right to terminate the sub-processor contract and to instruct the sub-processor to erase or return the personal data.

Clause 10: Data subject rights

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

Clause 11: Redress

  1. (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.

    The data importer agrees that data subjects may also lodge a complaint with an independent dispute resolution body4 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.

  2. (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.
  3. (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:
    1. (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;
    2. (ii) refer the dispute to the competent courts within the meaning of Clause 18.
  4. (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.
  5. (e) The data importer shall abide by a decision that is binding under the applicable EU or Member State law.
  6. (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

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

Clause 13: Supervision

  1. (a)

    [Where the data exporter is established in an EU Member State:] The supervisory authority with responsibility for ensuring compliance by the data exporter with Regulation (EU) 2016/679 as regards the data transfer, as indicated in Annex I.C, shall act as competent supervisory authority.

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

    [Where the data exporter is not established in an EU Member State, but falls within the territorial scope of application of Regulation (EU) 2016/679 in accordance with its Article 3(2) without however having to appoint a representative pursuant to Article 27(2) of Regulation (EU) 2016/679:] The supervisory authority of one of the Member States in which the data subjects whose personal data is transferred under these Clauses in relation to the offering of goods or services to them, or whose behaviour is monitored, are located, as indicated in Annex I.C, shall act as competent supervisory authority.

  2. (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

  1. (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.
  2. (b) The Parties declare that in providing the warranty in paragraph (a), they have taken due account in particular of the following elements:
    1. (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;
    2. (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 safeguards5;
    3. (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.
  3. (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.
  4. (d) The Parties agree to document the assessment under paragraph (b) and make it available to the competent supervisory authority on request.
  5. (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).
  6. (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

  1. (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:
    1. (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
    2. (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.
  2. (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.
  3. (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.).
  4. (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.
  5. (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

  1. (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).
  2. (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.
  3. (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

  1. (a) The data importer shall promptly inform the data exporter if it is unable to comply with these Clauses, for whatever reason.
  2. (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).
  3. (c) The data exporter shall be entitled to terminate the contract, insofar as it concerns the processing of personal data under these Clauses, where:
    1. (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;
    2. (ii) the data importer is in substantial or persistent breach of these Clauses; or
    3. (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.
  4. (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.
  5. (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 Belgium.

Clause 18: Choice of forum and jurisdiction

  1. (a) Any dispute arising from these Clauses shall be resolved by the courts of an EU Member State.
  2. (b) The Parties agree that those shall be the courts of Belgium.
  3. (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.
  4. (d) The Parties agree to submit themselves to the jurisdiction of such courts.

Annex 1 to the Standard Contractual Clauses

A. LIST OF PARTIES

Data exporter(s): Customer is the data exporter and controller.

Data importer(s): CELLCARTA

B. DESCRIPTION OF TRANSFER

  1. Data subjects

    The personal data transferred concern the following categories of data subjects:

    • Customers (for the purpose of billing, account management, technical support and other similar activities).
    • Research subjects as selected by Customer (for the purpose of scientific data analysis). This may include patients and volunteer test subjects.

  2. Categories of Data

    The personal data transferred concern the following categories of data:

    • About customers: administrative information, such as names, email addresses, contact details and IP addresses.
    • About research subjects: pseudonymized data potentially including race, ethnicity, health data and genetic data. The extent and exact types of data are determined by the Customer, but must be pseudonymized before uploading to CellEngine.

  3. Special categories of data / sensitive personal data

    The personal data transferred concern the following special categories of data:

    • About customers: none.
    • About research subjects: as determined by the Customer, but potentially including data revealing racial or ethnic origin, genetic data, data concerning health, data concerning a person’s sex life and/or data concerning a person’s sexual orientation.

  4. Processing operations

    The personal data transferred will be subject to the following basic processing activities: In order to provide cytometry analysis services, CELLCARTA will host, maintain and support a system holding Customer’s customer data. CELLCARTA will grant Customer’s authorized users electronic access to this system.

C. COMPETENT SUPERVISORY AUTHORITY

Varies by location of data exporter (customer) per Clause 13.

Annex 2 to the Standard Contractual Clauses

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

Data importer (CELLCARTA) agrees and warrants that it has implemented and will maintain technical and organisational measures appropriate to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorized disclosure or access, in particular where the processing involves the transmission of data over a network, and against all other unlawful forms of processing. These measures ensure a level of security appropriate to the risks presented by the processing and the nature, scope, context and purposes of the processing, having regard to the state of the art and the cost of their implementation, including as appropriate: (i) the pseudonymisation and encryption of Client Personal Data; (ii) the ability to ensure the ongoing confidentiality, integrity, availability and resilience of processing systems and services; (iii) the ability to restore the availability and access to Client Personal Data in a timely manner in the event of a physical or technical incident; and (iv) a process for regularly testing, assessing and evaluating the effectiveness of technical and organisational measures for ensuring the security of the processing. The measures data importer has taken include, as appropriate and without limitation:

  1. Implementation of and compliance with a written information security program consistent with established industry standards and including administrative, technical, and physical safeguards appropriate to the nature of personal data and designed to protect such information from: unauthorized access, destruction, use, modification, or disclosure; unauthorized access to or use that could result in substantial harm or inconvenience to the data exporter, its customers or employees; and any anticipated threats or hazards to the confidentiality, security, availability or integrity of such information.
  2. Adopting and implementing appropriate policies and standards related to security;
  3. Assigning responsibility for information security management;
  4. Devoting adequate personnel resources to information security;
  5. Carrying out verification checks on permanent staff who will have access to personal data;
  6. Conducting appropriate background checks and requiring employees, vendors and others with access to the personal data to enter into written confidentiality agreements;
  7. Conducting training to make employees and others with access to personal data aware of information security risks and to enhance compliance with data importer’s policies and standards related to data protection;

  8. Preventing unauthorized access to the personal data through the use, as appropriate, of physical and logical (passwords) entry controls, secure areas for data processing, procedures for monitoring the use of data processing facilities, built-in system audit trails, use of secure passwords, network intrusion detection technology, encryption and authentication technology, secure log-on procedures, and virus protection, monitoring compliance with data importer’s policies and standards related to data protection on an ongoing basis. In particular, data importer has implemented and complies with, as appropriate and without limitation:

    1. Confidentiality
      1. Physical access control measures to prevent unauthorized access to data processing systems (e.g., access ID cards, card readers, desk officers, alarm systems, motion detectors, burglar alarms, video surveillance and exterior security);
      2. Denial-of-use control measures to prevent unauthorized use of data protection systems (e.g., automatically enforced password complexity and change requirements, firewalls, etc.);
      3. Requirements-driven authorization scheme and access rights, and monitoring and logging of system access to ensure that persons entitled to use a data processing system have access only to the data to which they have a right of access, and that personal data cannot be read, copied, modified or removed without authorization (virtual access controls);
    2. Integrity
      1. Data transmission control measures to ensure that personal data cannot be read, copied, modified or removed without authorization during electronic transmission, transport or storage on data media, and transfer and receipt of records. In particular, data importer’s information security program shall be designed (transfer control):
        1. To encrypt in storage any data sets in data importer’s possession, including sensitive personal data.
        2. To ensure that any sensitive personal data transmitted electronically (other than by facsimile) to a person outside data importer’s IT system or transmitted over a wireless network is encrypted to protect the security of the transmission.
      2. Data Entry control measures to ensure data importer can check and establish whether and by whom personal data has been input into data processing systems, modified, or removed (input control);

    3. Availability and resilience

      Availability control includes measures to ensure that personal data are protected against accidental destruction and loss.

    4. A process for regularly testing, assessing and evaluating

      1. Organizational control
      2. Privacy by default
      3. Subcontractor supervision measures to ensure that, in the case data importer is permitted to use sub-processors, the data is processed strictly in accordance with the controller’s instructions including, as appropriate and without limitation;
        1. Measures to ensure that personal data is protected from accidental destruction or loss including, as appropriate and without limitation, data backup, retention and secure destruction policies; secure offsite storage of data sufficient for disaster recovery; uninterrupted power supply, and disaster recovery programs;
        2. Measures to ensure that data collected for different purposes can be processed separately including, as appropriate and without limitation, physical or adequate logical separation of client data.
    5. Taking such other steps as may be appropriate under the circumstances.

Annex 3: List of Sub-Processors

Name of entity conducting the data processing Address Description of processing activity
1. CellCarta Fremont LLC Fremont, California Provision of the Services and ancillary activities such as technical support and billing.
2. Mosaic Laboratories LLC (a CellCarta Company) Lake Forest, California
3. CellCarta NV Antwerp, Belgium
4. CellCarta Biosciences SA Gosselies, Belgium
5. CellCarta China Ltd Jining, China
6. CellCarta Pty Ltd Sydney, Australia
7. Google Cloud Platform and its subprocessors listed at https://cloud.google.com/terms/subprocessors (See link) Cloud hosting services

1Where the data exporter is a processor subject to Regulation (EU) 2016/679 acting on behalf of a Union institution or body as controller, reliance on these Clauses when engaging another processor (sub-processing) not subject to Regulation (EU) 2016/679 also ensures compliance with Article 29(4) of Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39), to the extent these Clauses and the data protection obligations as set out in the contract or other legal act between the controller and the processor pursuant to Article 29(3) of Regulation (EU) 2018/1725 are aligned. This will in particular be the case where the controller and processor rely on the standard contractual clauses included in Decision 2021/915.

2The Agreement on the European Economic Area (EEA Agreement) provides for the extension of the European Union’s internal market to the three EEA States Iceland, Liechtenstein and Norway. The Union data protection legislation, including Regulation (EU) 2016/679, is covered by the EEA Agreement and has been incorporated into Annex XI thereto. Therefore, any disclosure by the data importer to a third party located in the EEA does not qualify as an onward transfer for the purpose of these Clauses.

3This requirement may be satisfied by the sub-processor acceding to these Clauses under the appropriate Module, in accordance with Clause 7.

4The data importer may offer independent dispute resolution through an arbitration body only if it is established in a country that has ratified the New York Convention on Enforcement of Arbitration Awards.

5As regards the impact of such laws and practices on compliance with these Clauses, different elements may be considered as part of an overall assessment. Such elements may include relevant and documented practical experience with prior instances of requests for disclosure from public authorities, or the absence of such requests, covering a sufficiently representative time-frame. This refers in particular to internal records or other documentation, drawn up on a continuous basis in accordance with due diligence and certified at senior management level, provided that this information can be lawfully shared with third parties. Where this practical experience is relied upon to conclude that the data importer will not be prevented from complying with these Clauses, it needs to be supported by other relevant, objective elements, and it is for the Parties to consider carefully whether these elements together carry sufficient weight, in terms of their reliability and representativeness, to support this conclusion. In particular, the Parties have to take into account whether their practical experience is corroborated and not contradicted by publicly available or otherwise accessible, reliable information on the existence or absence of requests within the same sector and/or the application of the law in practice, such as case law and reports by independent oversight bodies.