Data Protection & Privacy Notice

Unilabs a.s. (henceforth also referred to as “Unilabs”, “we”, “our” or “us”) provides and operates https://stratifyjcv.unilabsweb.com/ (henceforth also referred to as “Website”). Unilabs’ processing ensures security, integrity, and confidentiality in adherence with EU data protection and privacy law. This privacy notice (henceforth referred to as “Notice”) sets out the basis on which any data, including any personal data, we collect from you, or you provide to us, will be processed by us.

You may contact dpo@unilabs.com if you have specific questions concerning the protection of your personal data and privacy.

Data collection – what do we collect and how?

For the services

We collect personal data to provide our services for healthcare professionals (henceforth also referred to as “you” or “Institution”). This includes registration for a new account to access services; to fulfill the requests for our services as defined in our Terms of Use section 2, and to analyze how registered Institutions utilize the Website, or as otherwise set forth in this Notice. We collect the following types of information you provide to us:

• Full name,
• Telephone number,
• Email address,
• Address of hospital / clinic / private practice
• Patient’s full name
• Patient’s gender
• Patient’s date of birth

For the website (cookies)

Whenever you interact with our Website, we automatically receive and record information on our server logs from your browser including your IP address, ‘cookie’ information, and the page you requested. ‘Cookies’ are data files we transfer to your terminal (e.g. PC, smartphone, or tablet). You may be able to change the preferences on your browser and device to prevent or limit your device’s acceptance of cookies. This may impact the functioning of the Website. For more on our use of cookies and the types of cookies used see our Cookie Notice.

Legal basis of the data processing

The legal basis for our processing of personal data is:

• Article 6 (1) of the General Data Protection Regulation
• Section 6 (1) of the Danish Data Protection Act

The nature of our services requires the processing of special categories of personal data. The legal basis for processing of such special categories of personal data is:

• Article 9(2)(h)
• Section 7(3) of the Danish Data Protection Act

Data sharing

We may anonymize personal data so that no one person can be individually identified, and it does not constitute personal data and share that information with our partners at Biogen International GmbH. The data being shared may include, but is not limited to, non-personally identifiable information, aggregated data, statistical information, or any other data that does not constitute personal data under provisions of the General Data Protection Regulation. When we collect and share Website usage information, we only use this data in aggregate form, and not in a manner that would identify your patients, as per the statement in section 9(b) of the Terms of Use.

How do we store your data?

We will keep your data for as long as we register activity on your account. If inactivity is registered during a time period of 24 months, we will promptly delete your data and all data related to your account.

Your rights

Unilabs is subject to the General Data Protection Regulation. As the data subject, you are given rights related to the processing of information about you. If you want to exercise your rights (described below), you must contact us at helpdesk@unilabs.com

The rights are:

• Right to see information (right of access)
  You have a right to gain access to the information that we process about you and some further information.
• Right to rectification (correction)
  You have a right to have rectified incorrect information about you.
• Right to erasure
  You have the right to have erased information about you before the time of our ordinary general erasure.
• Right to restriction of processing
  In certain cases, you have a right to have restricted the processing of your personal data. If you have a right to have the processing restricted, in the future we may only process the information - except for storage - with your consent or for the purpose of determining, relying on or defending a legal claim or to protect a person or vital public interests. In that connection it is noted that archiving purposes are considered vital public interests.
• Right to objections
  In certain cases, you have a right to object to our otherwise lawful processing of your personal data.

Contact

Feedback, complaints, and questions related to this Website and its services can be filed in writing and sent to our registered office or emailed to helpdesk@unilabs.com

---

Terms of Use

Unilabs A/S (Company ID 29458219), is a legal entity organised under the laws of Denmark, with its registered address at Nygaardsvej 32, DK-2100 Copenhagen, Denmark (henceforth also referred to as “Unilabs”, “we”, “Our” or “us”) provides and operates the website https://stratifyjcv.unilabsweb.com/ (henceforth also referred to as “Website”).

This page contains the terms and conditions for use of the Website (henceforth also referred to as “Terms”) and request for services related hereto. The Terms serve as an agreement between Unilabs and the Institution using the Website (henceforth also referred to as “you” or “Institution”). We ask that you read carefully.

1 – Background

Unilabs StratifyJCV service offer the Institution a digital platform to be able to request StratifyJCV test, fully funded by Biogen, for Multiple Sclerosis (“MS”) patients considering or prescribed Tysabri^TM (natalizumab-Biogen), to use in conjunction with the PML Risk Estimates Table (Ho PR., et al 2017) for the individualized annual prediction of risk of progressive multifocal leukoencephalopathy (PML), and CSF JCV DNA testing for the confirmation of PML diagnosis for MS patients prescribed Tysabri.

2 - Description of services

The Website offers access to a variety of services (henceforth collectively referred to as “Services”). These Services include:

1. Registering with Unilabs for the use of the services
2. Ordering blood sample collection material
3. Delivery and collection by courier
4. StratifyJCV and CSF JCV DNA testing of samples performed in Unilabs laboratories.
5. Reporting of test results,
6. Assistance related to sampling and shipping procedures via email or phone via Unilabs’ internal helpdesk service.

3 - Acceptance of Terms of Use

By accessing or using or submitting information on the Website or downloading or registering or placing orders or engaging in any way which signify engagement and affirmative acceptance of the Terms, you hereby represent that:

• You have the authority to represent the Institution when using the Website.
• You have read, understood, and agreed to the Terms and any updates and additions to these Terms which may occur in the future.
• You agree and commit to make only true and not misleading statements and declarations when using the Website functions and Services.
• You understand and acknowledge that the undue use of the Services may cause the deactivation of access to the Website and its Services at Unilabs’ sole discretion.
• Your account has not been previously disabled because of violation of the law or breaching the Terms in the past.
• You are able to request Stratify-JCV, for a maximum of 3 times per patient prescribed Tysabri within a 12 months period of time.
• You are able to request StratifyJCV, for a maximum of 3 times per patient considering Tysabri.

You acknowledge and accept that the provision of StratifyJCV funded by Biogen is contingent upon Biogen being a provider of Tysabri to the Institution. The Institution also acknowledges that it will utilize Biogen funded Services only if Tysabri is available to be prescribed and patients are able to receive Tysabri. The provision of StratifyJCV outside of this use will not be funded by Biogen.

4 - Account Creation and Registration

You acknowledge that an order for the Services presented on the Website is conditioned by the registration and creation of an Institution-specific account (henceforth referred to as “Account”) on the Website. Access to the Account is secured by the following credentials:

• Username
• Password

The Institution is responsible for maintaining the confidentiality of the Account login information and is fully responsible for all activities that occur under the Account. You agree to immediately notify Unilabs of any unauthorized use or suspected unauthorized use of your Account or any other breach of security. Unilabs cannot and will not be liable for any loss or damage arising from your failure to comply with the above requirements.

5 – The Institution’s obligations

5 (a) – Conduct

You agree to not engage in any illegal, harmful, or unauthorized activities and to use the Website and Services in compliance with all applicable laws and regulations.

5 (b) – Management of rights

The Account can be assigned by multiple users at any time (henceforth “User”). Users can be delegated specific rights that impact their access on the Website and the Account. Types of Users and their respective rights are listed below:

1. Administrator user: An “administrator” has the rights to add additional account users and control their user rights.
2. Normal user: A “normal” user has the rights to view test results and order blood sampling kits but does not have the right to add additional users.

The Institution is responsible for the delegation of rights and selection of type of Users on the Account. The Institution is also responsible for the deletion of a User on the Account.

5 (c) – Patient registration

As you register a StratifyJCV blood sample for testing, you accept that provision of the patient’s personal data (patient date of birth, sex, patient id and / or first name, last name), sampling of biological material, preparation of such sampled biological material, transport of the sample to Unilabs laboratory, and delivery of test results to you, are inseparable and necessary steps of Services.

6 - Account Termination and Deletion

You may at any time make a request for the termination of the Account by following the designated process. Upon termination, we will delete all data related to the Account, including patient data, in accordance with our data retention policy as laid down in the Privacy Policy and in accordance with the Data Processing Agreement between Unilabs and the Institution.

If there is no activity registered on the Account within a time period of 24 months, we will terminate the Account. Unilabs reserves the right to also suspend or terminate the Account in accordance with these Terms. All personal data related to the account will be deleted.

The Institution also acknowledges that it will utilize Biogen funded diagnostics services only if Biogen has been awarded the tender to supply Tysabri to the Institution. The provision of StratifyJCV outside of this use will not be funded by Biogen.  If the Institution does not comply with any of the requirements set hereby to use the Services, Unilabs reserves the rights to suspend or terminate the Institution’s funded services account at its own discretion.  

7 - Data Security and Confidentiality

Unilabs take measures to protect the Institution’s data from unauthorized access, disclosure, or alteration. However, no data transmission over the internet can be entirely secure, and the Institution use our Website and Services at its own risk.

8 – Data Protection and Privacy

We collect and process personal data as part of the account registration process and the provision of the Services. Our Data Protection and Privacy Notice outlines how we handle personal data and is an inseparable part of this Agreement. By using the Website, you consent to the collection, use, and disclosure of your personal data as described in the Data Protection and Privacy Notice,  and you agree to provide Unilabs with the necessary information to enter into the a valid Data Processing Agreement and to ensure legal transfer of personal data

9 - Third parties

The Institution agrees to allow certain data to be shared with Biogen International GmbH. It is explicitly acknowledged and agreed that the data being shared does not contain any personal data as defined by applicable data protection laws and regulations. The data being shared may include, but is not limited to, non-personally identifiable information, aggregated data, statistical information, or any other data that does not constitute personal data.

Unilabs and the Institution affirm that they have taken reasonable measures to ensure that no personal data is included in the shared data and will continue to exercise due diligence in maintaining the data's integrity throughout the duration of this agreement.

If any personal data is inadvertently discovered within the shared data, the receiving party shall immediately inform the disclosing party, and the necessary steps shall be taken to address the situation in accordance with applicable data protection laws. This clause shall remain in effect for the duration of the data sharing arrangement and any subsequent extensions or renewals unless explicitly amended in writing by both Unilabs and the institution.

10 – Intellectual Property Rights

The Website and its content and Services shall remain the sole property of Unilabs. The use of or access to this Website shall not in any way transfer or assign to you any ownership or other proprietary rights in or to this Website or any content published by Unilabs or our licensors or third parties. This Website, Services, and its contents, including but not limited to the trademark, logo, copyright, design, layout, typography, underlying HTML, Java scripts, text, audio clips, video clips and graphics, and in the expression of the information contained herein, whether as a compilation or otherwise is protected by relevant IP laws, rules and regulations. Trademarks, trade names and designs appearing on this Website are the exclusive property of or are licensed to Unilabs and are protected. No use of a trademark, trade dress, trade name or design appearing on this Website may be made without the prior, written permission of Unilabs.

11 – Liabilities

We hereby exclude liability from the following matters to the extent permitted by law:

Liability for direct or indirect loss or damage that has incurred by any User or representative of the Institution in connection with the Website. This includes the inability to use the Website, the use of linked websites or the use of material on the Website. It also excludes liability for loss or damages caused by viruses or other technologically harmful material.

Liability is, without limitation, excluded for loss of income, loss of business, loss of profits or contracts, loss of anticipated savings, loss of data, loss of goodwill, wasted management or office time and for other losses or damages of any kind. It does not matter if it is caused by tort, a breach of contract or otherwise and it includes negligence and foreseeable damages.

The limitation of liability does not affect any liability which cannot be excluded under applicable law.

We shall perform the Services to the best of our effort to ensure the accuracy and complete results of the tests or clinical data and in compliance with the law. However, Unilabs shall not be liable for any inaccurate or incomplete test results if such inaccuracy or incompleteness was caused by various demonstrable reasons beyond our control.

We shall be exempt from liability for partial or total failure to fulfil obligations and duties under the Terms if such failure is caused by circumstances caused independently of the our will and which prevent us from fulfilling our obligations, and if with regards to all the circumstances, and it is logical to assume these circumstances or their consequences could not have been averted or overcome, nor foreseen, by us upon the conclusion of these Terms. Should circumstances which exempt Unilabs from liability occur, the period to fulfil our obligations pursuant to the Terms shall be extended by the duration of such circumstances.

12 - Modification of Terms

We reserve the right to modify the Terms at any time. We will notify the Institution of any material changes to the Terms. Continued use of our Website and Services after such modifications constitutes the Institution’s acceptance of the updates to the Terms.

13 - Cookies

Unilabs may use cookies and tracking technologies to enhance your experience on the Website. By using the Website, the Institution consents to the use of these technologies as described in our Data Protection and Privacy Notice

14 – Contact

Unilabs must ensure compliance with all applicable quality standards and requirements based on the type and nature of the requested test. The quality of the Services shall mean the performance of the test and the result sent to the Institution according to these Terms.

Feedback, complaints, and questions can be filed in writing and sent to our registered office or emailed to helpdesk@unilabs.com

15 - Indemnification

You agree to indemnify and hold Unilabs harmless from any claims, losses, or liabilities arising from the Institution’s use of the Website and Services or any violation of the Terms.

16 - Legal Action

If you are found to be degrading, tarnishing, maligning the image, goodwill or reputation of Unilabs, by spreading hate, false information, fake reviews or engaging in mala fide actions against the Website or against any other of Unilabs affiliates, we will pursue legal actions immediately.

17- Legal Disclaimer

Unilabs may decide at any time at its sole discretion to cease making available certain features of the services. Under no circumstances will Unilabs or its affiliates, suppliers, partners or agents be held liable for any damages due to such interruptions or lack of availability of such features.

Unilabs is not responsible for delay or failure of our performance of any of the services caused by events beyond our reasonable control, including but not limited to natural disasters, electrical, internet or telecommunication outage, government restrictions including lockdowns, etc.

18 - Governing Law and Jurisdiction

This Agreement shall be governed by and construed and enforced in accordance with Danish law and both Unilabs and the Institution submit to the jurisdiction of the courts of Denmark.