Terms and Conditions

I. General aspects

The content of the web platform MICS Immunowell JCV Portal (hereinafter referred to as the “Web Portal”) is designed by Sandoz AG (“Sandoz”) and developed, implemented and hosted by its Data Processor - Medicover Integrated Clinical Services Romania S.R.L (herewith “MICS)

The use of the Web Portal, as defined below, is conditional upon reading, understanding and agreeing to the hereby Terms and Conditions (hereinafter referred to as the "T&C").

If you decide to access the Web Portal, the hereby T&C represent the agreement and shall govern the relationship between the Sandoz and you. Access to the Web Portal shall be possible only after reading, understanding and accepting these T&C. If you do not agree with the hereby T&C, you may not use the Web Portal.

Your personal data shall be processed in accordance with the Privacy Policy

II. The acceptance of the Terms and Conditions

By accessing and using the Web Portal, you irrevocably confirm and give your express acceptance that you agree to comply with the terms and conditions as presented herein in their entirety, as well as with any revisions/amendments that may be operated in the future.

We recommend reading the hereby T&C carefully! If you do not agree to the T&C, do not use the Web Portal!

These T&C may be reviewed at intervals as decided by the Sandoz without its obligation to send a notification to the Web Portal users. Continued use of the Web Portal after changes to the T&C represents your acceptance of the changes operated. We recommend users to periodically visit this page to familiarize themselves with and read the T&C, in order to ensure the use of the Web Portal in an informed manner and in compliance with the obligations of any person who is interested in the functionalities and options of the Web Portal as a user.

Acceptance of the hereby T&C constitutes your voluntary consent to the terms of use regarding the Web Portals’ usage and to the information available on it. The hereby T&C set out the minimum mandatory rules to be followed, the legal terms and conditions under which you can use the Web Portal, which are complemented by the legal provisions in force.

The access to the Web Portal, related services and the Web Portal’s content are made available to users free of charge on the condition that you accept, without any reservation, the provisions of these T&C in their entirety. If you do not accept the hereby T&C, you are unable to use the Web Portal and all the services that are operated through it.

The Web Portal’s users are the Healthcare Services Providers (hereinafter referred to as “HCPs”) (including their personnel), as well as the testing laboratories, the logistic team, admins and support users responsible for viewing and approving the collection of samples collected from patients within the Program (as described below) and for preparation and coordination of their related shipment, administrative operations and HCP support.

III. Web Portal description and purpose

The Web Portal is a platform designed for a project desired to increase safety for patients by enabling JCV testing in blood samples collected from patients at Healthcare Professionals to support treatment decisions. This project has been enabled by Sandoz (herein referred to as the “Project Enabler”) and MICS has been engaged to perform the related patient testing services, portal development and maintenance at Sandoz’s request, and other services as agreed between the parties. The project is therefore designed as an ELISA Testing Program of patients with Multiple Sclerosis to guide treatment decisions for therapy with natalizumab biosimilar Tyruko, including the services as described above, as delivered by the MICS on behalf of Sandoz, the project being hereinafter referred to as the “Program”.

The Web Portal shall collect and integrate information from various sources into a single user interface in order to support HCP in conducting the Program, also serving as interface between the HCPs, MICS and the testing laboratory involved in the performance of the Program.

The Web Portal facilitates the completion of the following activities by all parties involved in the Program:

  • For HCPs: (i) Self-register authentication on the Web Portal and registration of their patients; (ii) Order and confirm the receipt of collection materials used for the sample collection from patients; (iii) Register the patient; (iv) Order sample pickup by the courier; (v) Create and cancel the JCV testing orders for collected sample(s) from the respective patient(s); (vi) View and download the test results of their patients; (vii) Manage additional HCP users – only applicable to HCP Super User(s) as described within chapter IV below; (viii) Access the frequently asked questions and answers related to the Program; (ix) Manage users profiles and their account passwords.
  • For Lab users (from testing laboratory): (i) View orders of the JCV testing; (ii) Receive/ update receipt of the samples and cancel test orders in LIS (as described below); (iii) View received samples; (iv) View cancelled test orders; (iv) Provide /view test results; (v) View test reports; Note* The Web Portal, is integrated with a Lab Information System which allows us to receive JCV testing order details, send updated test order statuses, send request of the cancelled test orders and send test results to the Web Portal.
  • For Sample Coordinator: (i) View all JCV testing orders; (ii) Enter sample receipt data and time (i.e. confirm the receipt of samples); (iii) Enter any results of the parcel integrity QC; iv) Cancel JCV test orders (and adding a reason) for samples not being received;
  • For Logistics Coordinator: (i) Receive/view the orders of collection materials placed by the HCPs and related details; (ii) Update the status of the collection materials to indicate the shipment details and view the related status; (iii) View any comments from the HCPs related to the collection materials order/delivery; (iv) View the JCV testing orders placed by HCPs; (v) Provide the parcel information and update the status of sample pickup order and view the related statuses; (vi) View delivery status of the samples; (v) View the necessary information about HCPs for logistics arrangement including name, address, , contact person, phone number.
  • For Support Users: (i) View the orders of collection materials placed by the HCPs and related details ; (ii) View the orders of sample pickup placed by the HCPs and related details; (iii) View the JCV testing orders (without patient personal information) placed by HCPs and related statuses; (iv) View the HCPs profiles; (v) View all of the information in the Web Portal (without patient personal information) to conduct root cause analysis in case of queries.

IV. Registration/Authentication to the Web Portal

Depending on the quality of the user / your status as a user, there are the following ways of connecting within the Web Portal:

  • 1. HCP users

    Selected HCPs can register as a Super User within the Web Portal through self-registration, accessing the web link and following the authentication steps, namely: (i) (i) Confirms the T&C; (ii) Confirms the reading and understanding of the Privacy Policy; (iii) Submits the requested data/information about the related Standard and Light User(s). Afterwards, an email with a url and default password shall be sent to the HCP to log in to the Web Portal.

    Note* Standard and Light Users that are added by Super Users are not required to perform steps (i) and (ii).

    After registration, the HCPs can perform the activities based on their role as described within chapter III above and summary below:

    • Super User : Can perform all of the activities enumerated within chapter III above;
    • Standard User : Can perform all of the activities enumerated within chapter III above, except the ability to manage other HCP users and modify institute-level information;
    • Light User : Can perform all of the activities enumerated within chapter III above, except the ability to manage other HCP users, view test results and modify institute-level information.

  • 2. Lab User, Sample Coordinator, Logistics Coordinator, Support Users and Admin Users

    The registration of the Lab User, Sample Coordinator, Logistics Coordinator, Support Users and Admin Users within the Web Portal is performed by the portal developer on behalf of Sandoz.

    The registration of the Lab User, Sample Coordinator, Logistics Coordinator, Support Users and Admin Users receive an email notification with the web link along with default password in order to log in to the Web Portal.

V. Accessing the results

The JCV testing order may be cancelled by the testing laboratory in Laboratory Information System if the samples in question are not compliant in terms of volume for the related test. Consequently, the status “Cancelled at Lab” is automatically updated within the Web Portal using the integration with the LIS. In terms of quality, the sample will be accepted by the laboratory “as is”, regardless of its quality status, upon request of the Program Enabler. The testing laboratory has been required to deviate from their defined “sample acceptance criteria”.

After the testing, the results are validated by the testing laboratory in the LIS and the status “Results Ready” will be updated automatically within the Web Portal. HCP users shall receive an email notification containing the details of JCV testing order (excluding test results and any patient personal information) for which the results are ready.

The Web Portal generates a related test report, in the language preferred by the HCP user, and can be viewed /downloaded by the HCP user.

VI. Confidentiality and security of personal data

Through the Web Portal are processed personal data in accordance with the principles and applicable legislation on the protection of personal data. The personal data of data subjects shall be processed for the purpose of performing the laboratory tests requested within the Program and for enabling other aspect of the Program (collection materials ordering, sample pickup arrangements, user support, etc.)

Appropriate technical and organizational measures were implemented to safeguard the information provided on the Web Portal by all the users, including all reasonable security measures for the information within the Web Portal to remain confidential.

You are solely responsible for maintaining the confidentiality of your username and password, as well as your information available within the Web Portal. Any distribution of information available within the Web Portal by you or a third party is made solely at your own risk.

We warn you that you are fully responsible in the event that your account is used by a third party, regardless of whether there is your consent for this use or not. Whenever you find that an unauthorized use of your account has occurred, you have the obligation to immediately notify us at the e-mail address:helpdesk@immunowell-jcv-portal.com

Nor Sandoz, neither MICS are and will be legally responsible in any case and for any inadvertence or erroneous description of the information that you submit on the site.

For more information about processing of personal data, please consult the Privacy Policy and for any questions in a matter related to data protection, you can contact us at the e-mail address sandoz_global.dpo@sandoz.com.

VII. Intellectual property

Content of the Web Portal may be protected by copyright laws. You should assume that all product names appearing on this Site, whether appearing in large print or with the trademark symbol are trademarks of Sandoz, its affiliates or its licensors, partners and/or other parties. This Site may also contain or reference patents, proprietary information, technologies, products, processes or other proprietary rights of Sandoz and/or other parties. No license to or right in any such trademarks, patents, copyright, trade secrets, technologies, products, processes and any other proprietary rights and intellectual property of Sandoz and/or other parties is granted to or conferred upon you.

All text, graphics, photographs, videos, logos, sounds, music, artwork user and visual interfaces, computer code ("Materials"), including but not limited to the design, structure, selection, coordination, expression, "look and feel" and arrangement of such Materials, contained on this website is owned or licensed by Sandoz and/or other parties, and is protected by intellectual property rights and unfair competition laws. Except as expressly provided in these Terms and Conditions, no part of the Site and no Material may be copied, reproduced, republished, uploaded, posted, publicly displayed, encoded, translated, transmitted or distributed in any way to any other computer, server, website or other medium for publication or distribution or for any commercial enterprise, without Sandoz’s express prior written consent.

Sandoz and/or other parties involved in the web portal design, development and maintenance will enforce its intellectual property rights to the fullest extent of the law.

VIII. Users’ responsibilities

By accepting the hereby T&C we inform you that, you have acknowledged and fully agree that Sandoz and/or other parties involved in the web portal design, development and maintenance are not and will not be liable for any direct, indirect, accidental, or special damages that could result from:

  • (i) the use or impossibility of using the Web Portal due to causes not attributable to Sandoz and/or other parties involved in the web portal design, development and maintenance;
  • (ii) loss of access data (username and password) for reasons attributable to you;
  • (iii) any statements or actions made by third parties in relation to the Web Portal, for which Sandoz and/or other parties involved in the web portal design, development and maintenance are not obliged to respond, under the law;
  • (iv) any other problem related to the services and information presented through the Web Portal for which the Sandoz and/or other parties involved in the web portal design, development and maintenance are not held liable, under the law.

Sandoz and/or other parties involved in the web portal design, development and maintenance expressly declines any responsibility for the actions or omissions of users or third parties in connection with the Web Portal, regardless of their action or inaction, and the entire risk arising out of your use of the Web Portal in violation of these T&C is yours.

As a user you understand and agree that the Sandoz and/or other parties involved in the web portal design, development and maintenance does not guarantee that the Web Portal will be available continuously, uninterrupted, secure or error-free.

IX. Liability limits

Sandoz and/or other parties involved in the web portal design, development and maintenance is not responsible in any way for the content provided by third parties within the Web Portal.

Sandoz reserve the right to suspend, modify, add or delete at any time, portions of the content of the Web Portal and to restrict users' access to the Web Portal.

Sandoz reserves the right to suspend or delete the access to the Web Portal for the Users that do not comply in accordance with the requirements outlined in the Privacy Policy or descried herein.

It is forbidden to copy, distribute or publish the information on the Web Portal, regardless of the form they take.

Users may use the content of the Web Portal only for the Programs’ use, subject to the purposes and conditions highlighted in this document and none of the actions described below are permitted without the prior written consent of Sandoz:

  • Removal or alteration of the content or signs that identify the copyright of Sandoz and/or other parties over the content;
  • Reproducing or storing the content, as well as sending this content to any other website, server or any other means of storing information.

The User acknowledges that Sandoz and/or other parties involved in the web portal design, development and maintenance cannot be held liable, in any way whatsoever, and for any reason whatsoever, for any direct (in particular immaterial) and/or indirect damage (in particular any commercial damage, loss of customers, loss of order, commercial trouble, loss of profit, loss of brand image), relating to the use of the Web Portal (in particular content, access...) by the User, the latter remaining solely responsible in this respect.

Without prejudice to the other cases of limitation of liability provided for in these T&C, Sandoz and/or other parties involved in the web portal design, development and maintenance cannot be held liable, directly or indirectly, for damage suffered by the User or its equipment related to an interruption of the Web Portal, a computer bug and the unauthorized intrusion of a third party into the Host's computer system resulting in the dissemination of malicious code, in particular through its available applications and widgets download.

Any action or attempt likely to violate the above provisions will legitimize Sandoz and/or other parties involved in the web portal design, development and maintenance to exercise the right to apply to the courts legally competent to sanction such an act.

The limits of the liability as set forth in this section IX are essential elements of the relationship between Sandoz and the users, and the latter expressly agree to the provisions regarding the liability limits set forth herein.

X. Cookies

The Web Portal uses cookies, these being data stored on the user's hard drive, containing information about it. The use of the cookie mechanism is an advantage for the benefit of users. It allows the storage of navigation options on the Web Portal, such as the type of filters that apply to the display of certain pages, as appropriate.

For more details on the cookies used, access the Cookies Policy.

By agreeing to the hereby T&Cs, users fully assume any risks derived from the inappropriate use of the Web Portal.

XI. Notifications

All notices and/or any communication with Sandoz, including those relating to these T&C, as well as complaints and/or requests or suggestions regarding the way of accessing the Web Portal, shall be submitted to in writing, via e-mail, at the following e-mail address: helpdesk@immunowell-jcv-portal.com

Any queries in matter related to data protection shall be submitted at the e-mail address: sandoz_global.dpo@sandoz.com

XII. Disputes and Applicable Law

These T&C shall be governed by and construed in accordance with laws of Switzerland. Any dispute arising between Sandoz and any of the users shall be resolved amicably. If an amicable solution is not possible, Sandoz and/or the users shall address the competent courts in Switzerland.

XIII. Generalities

If, through recognized procedural methods, one or more clauses of the hereby T&C is/are cancelled or declared null and void by a competent court, the effects of this nullity shall not affect in any way the validity of the other provisions which, being in accordance with the legal regulations, shall remain fully applicable in the future.

Sandoz is the only one entitled to amend the conditions of use of the Web Portal, without sending any notification and without needing to request your consent in advance. Any amendment of the conditions is immediately implemented within the Web Portal and gives you the right to find out the latest version of these conditions by simply accessing the page.