Legal

These General Terms and Conditions of Use of the Platform (hereinafter the “GTCU Platform”) are those of the company Safety Observer registered in the Lons-le-Saunier Trade and Companies Register under number 798 692 018, having its registered office at Hameau de Vaucluse in Saint-Claude (39200), represented by Mr. Thierry Hamard (hereinafter “SAFETY OBSERVER”).

Phone: +33 676 23 20 48
Email: contact@safetyobserver.com
SAFETY OBSERVER operates a monthly regulatory intelligence report intended to Pharmacovigilance and Drug Safety professionals.
These reports (hereinafter “Reports”) are sold in the form of quarterly or annual subscriptions which are made available on a dedicated Reading Platform (hereinafter the “Platform“).
These reports (hereinafter the “Reports”) are sold in the form of quarterly or annual subscriptions which can be purchased by SAFETY OBSERVER’s professional clients (hereinafter the “Clients“).
SAFETY OBSERVER makes its Reports available on a dedicated Reading Platform (hereinafter the “Platform”) which can be accessed by duly authorised internal users of the Client (hereinafter the “Users”).
These GTCU Platform govern the use of the Platform by Users. They apply between SAFETY OBSERVER and any User who uses the Platform.
Any access to the Platform implies consultation and full, prior and unreserved acceptance of these GTCU Platform.

1. Definitions

Terms with a capital letter in these GTCU Platform have the meaning indicated below. When used without a capital letter, they have the meaning used in everyday language.
“GTCU Platform” means this contract.
“Parties” means SAFETY OBSERVER and a User together.
“Client” means the legal person that has purchased a subscription with SAFETY OBSERVER allowing its Users to access Reports via the Platform.
“Identifiers” means the e-mail address and password chosen by a User to access his User Account.
“Platform” means the Reports reading platform made available to Users by SAFETY OBSERVER as software as a service (SaaS).
“Report” means a regulatory intelligence report produced by SAFETY OBSERVER and made available on the Platform.
“User” means either i) a natural person qualified as a member of the staff of the Client’s company, either ii) or a natural person from outside the Client’s company, and in both cases who is expressly mentioned in the Order placed by the Client and in the tatter case who is expressly authorized by SAFETY OBSERVER. Are considered as a member of the staff of the Client’s company the sole employees and trainees under a training agreement.
“User Account” means a User’s personal account on the Platform, accessible by means of his/her Identifiers, enabling him/her to access the Platform.

2. Purpose

The purpose of these GTCU Platform is to govern the rules for use of the Platform.
Access to and use of the Platform are subject to the User’s prior, full and unreserved reading and acceptance of the GTCU Platform. Any User accessing the Platform is deemed to have accepted the GTCU Platform without reservation.

3. Duration

The GTCU Platform come into force on the first use of the Platform by the User for the duration of the subscription taken out by the Client, unless the User’s User Account is closed under the conditions set out herein.

4. Description of the Platform

The Platform is a web-based reading platform accessible in the form of software as a service (SaaS).
It mainly enables Users to access the Reports and to read them.
It also enables all Users to:
– access to a library of Reports published from 1 January 2023;
– search by keyword throughout the library using a dedicated search bar;
– modify their profile information and choose the devices on which they wish to access the Platform (up to a maximum of 2 devices).

5. Access to the Platform

5.1. Rights of access and use

SAFETY OBSERVER grants the User, for the whole world, a personal, non-exclusive and non-transferable right of remote access and use of the Platform for the duration of the GTCU Platform and for the sole purpose of using its functionalities in accordance with the present.
Any interruption, suspension or termination of the Client’s subscription may result in the interruption, suspension or termination of the right of access and use granted to the User.

5.2. Mode of access

Users access the Platform via the Internet, by logging into their User Account on the Platform, from their own computer environment.
The User is solely responsible, at his/her sole expense, for acquiring, installing, maintaining and connecting the various configuration elements and telecommunications resources required to
access the Platform.

5.3. User Account – Identifiers

SAFETY OBSERVER provides the User with a User Account enabling him/her to benefit from personalised access to the Platform and to use its functionalities.
The User Account is reserved exclusively for the User, to the exclusion of any other person.
The User is solely responsible for his/her own actions on the Platform and, more generally, for the way in which the Platform made available to him/her is used. In this respect, any operation carried out after having authenticated himself with his Identifiers on the Platform is deemed to have been carried out by himself.
The User must inform SAFETY OBSERVER immediately in the event of use or suspicion of unauthorised use of his/her User Account.
Access to the User Account is by means of Identifiers provided by SAFETY OBSERVER. The Identifiers are unique, personal and strictly confidential and enable the User to benefit from a specific and confidential access to the Platform.
The User is solely responsible for the confidentiality of his Identifiers.
The User can modify his Identifiers online at any time. The change of his Identifiers will invalidate his prior Identifiers automatically. If his Identifiers are lost, stolen or accidentally divulged, the User must change them without delay on the Platform.

5.4. Authorised devices

Each User is only authorised to access the Platform using 2 devices (for example: computer and smartphone). The User can choose these 2 devices on the Platform via his User Account.
The User can modify his/her authorised devices at any time by following the dedicated procedure on the Platform (validation by a unique code sent to the user’s e-mail address). Authorisation of a new device is subject to removal of one of the 2 devices already authorised.
The User is expressly informed that SAFETY OBSERVER monitors the number of devices with which the Platform is used.
In this respect, if the User authorises a new device in addition to the 2 authorised devices more than 3 times during a period of 30 days, he will receive an email inviting him to cease. Failing this, SAFETY OBSERVER reserves the right to close the User Account of the User concerned.

6. Availability – Hosting

The Platform is not hosted by SAFETY OBSERVER but by a third-party provider, a professional host specially chosen for its know-how, its reputation and its commitments in terms of data security. SAFETY OBSERVER remains free to use any other service provider of its choice at any time.
SAFETY OBSERVER uses its best efforts to offer an availability of the Platform approaching as much as possible an availability 24 hours on 24 and 7 days on 7. This is only an obligation of means for SAFETY OBSERVER so that the Platform may experience periods of temporary unavailability, at any time of day.
SAFETY OBSERVER draws the attention of the User to the fact that:
– access to or use of the Platform may be interrupted or slowed down for any reason beyond SAFETY OBSERVER’s control, in particular in the event of regional or global saturation of the Internet network, or of the server centre of the hosting provider;
– occasional interventions for the maintenance of the Platform and the correction of anomalies may lead to momentary interruptions.
SAFETY OBSERVER also reserves the right to suspend or interrupt access to the Platform in the event of suspicious or abnormal use thereof by a User.
By suspicious or abnormal use, the Parties mean in particular:
– any multiple or failed connection attempts, any abnormal activity with regard to the User’s current or usual activities (or those of other SAFETY OBSERVER Users) ;
– any activity indicating that the User is sharing his User Account in violation of these GTCU Platform;
– any hacking attempt, any multiple requests sent to the Platform.

7. Changes to the Platform – Updates

SAFETY OBSERVER may develop the functionalities of the Platform or carry out updates of the latter at any time.
SAFETY OBSERVER will, in particular, develop its Platform to adapt to developments in the technologies and standards used on the Internet network. These developments may require Users to update their web browser.
SAFETY OBSERVER will proceed directly to the updates or will provide Users with the necessary means and assistance to implement them if they require an intervention from them.
SAFETY OBSERVER may not be held responsible in the event of malfunction, unavailability, or non-conformity of the Platform resulting from a refusal or failure to implement an update required by SAFETY OBSERVER.

8. Hypertext links

The Platform and the Reports may contain hypertext links to other websites. To the extent SAFETY OBSERVER has no influence on the content of these websites, it cannot be held liable for the availability of these resources, neither for their accessibility or their content.

9. Rules for using the Platform – Prohibited behaviour

The User undertakes to use the Platform:
– in a normal, reasonable, non-fraudulent manner and in accordance with its intended purpose;
– in compliance with the provisions hereof and any rules of use made available by SAFETY OBSERVER, in particular by way of display, publication or notification on the Platform;
– in compliance with the intellectual property rights of third parties and those of SAFETY OBSERVER, and all regulations in force.
In particular, the User undertakes not to:
– distribute, disclose to the public, copy, reproduce, modify, create derivative works, disassemble, decompile, in particular by reverse engineering, any content or element of the Platform without the express, written and prior consent of SAFETY OBSERVER;
– allow unauthorised third parties to access the Platform by any means whatsoever (transfer of accounts, disclosure of identifiers) without the express, written and prior consent of SAFETY OBSERVER;
– use the Platform on another device than the 2 authorised devices to access it;
– to disrupt or attempt to disrupt the proper functioning of the Platform in whole or in part;
– distribute viruses or other technologies likely to harm SAFETY OBSERVER or the interests of third parties;
– to circumvent robot exclusion protocols or any other measure used to prevent or limit access to the Platform or certain uses of it;
– data mining on the Platform without the express, written and prior consent of SAFETY OBSERVER;
– use bots, spiders, scrapers or any other automated process to access the Platform for any purpose whatsoever, without the express prior written consent of SAFETY OBSERVER;
– extract and/or re-use a qualitatively or quantitatively substantial part of SAFETY OBSERVER’s databases;
– to extract and/or re-use in a repeated and systematic way all or part of the SAFETY OBSERVER databases.
Any breach by a User of any of these obligations may justify the suspension or permanent closure of his/her User Account, without prejudice to any damages to which SAFETY OBSERVER may be entitled.
The User is also informed that the violation of these obligations may lead to the termination of the contract concluded between SAFETY OBSERVOR and the Client, and that the latter may be held personally liable for any breaches committed.

10. Rules for the use of Reports

Use of the reports is strictly limited to Users and to the number of Users specified in the client’s subscription.
It is strictly prohibited to broadcast the Reports or to communicate a copy of the Reports or parts of the Reports, whatever the medium used, to a person other than the authorised Users and SAFETY OBSERVER reserves the right to track access to its Reports and verify compliance with these terms.
It is also strictly forbidden to the Users:
– to market the Reports in any way whatsoever;
– to produce or market, in any form whatsoever, regulatory intelligence reports that compete with or are similar to those marketed by SAFETY OBSERVER during the entire term of the contract concluded between SAFETY OBSERVER and the Client, and for a period of 12 months following the end of the said contract, regardless of the cause of the latter.
In case of violation of any of the above prohibitions by the User, SAFETY OBSERVER reserves the right to suspend or definitively close his/her access to the Platform, in whole or in part, without prior notice, without prejudice to any damages to which SAFETY OBSERVER may be entitled.
The User is also informed that the violation of these obligations may lead to the payment of penalties by the Client and to the termination of the contract concluded between SAFETY OBSERVOR and the Client, and that the latter may be held personally liable for any breaches committed.

11. Intellectual property

11.1. Concerning the Platform

SAFETY OBSERVER is and remains the owner of the Platform and of all its constituent elements.
SAFETY OBSERVER is and remains consequently the owner of all intellectual property rights on the Platform and on elements which compose it, whatever their nature, as well as of all its savoir-faire as a software publisher.
These elements are protected by intellectual property laws and others, including copyright.
The access to the Platform does not confer any intellectual property right whatsoever to Users on the Platform or on the elements composing it.
Any use or exploitation of the elements of the Platform made in contravention of this Contract may give rise to the exercise of any appropriate action at the initiative of SAFETY OBSERVER, including the exercise of an infringement action.
Any total or partial reproduction of the Platform and/or elements thereof by any means whatsoever, without the express permission of SAFETY OBSERVER is therefore prohibited and would constitute an infringement punishable by articles L. 335-2 and following of the French Intellectual Property Code.

11.2. Concerning the Reports

SAFETY OBSERVER is and remains the owner of the Reports and of all their constituent elements.
The Reports can also contain elements protected by the intellectual property. In this case, SAFETY OBSERVER remains the sole owner of the intellectual property rights on these elements to the exclusion of any User who undertakes in any case to use them in accordance with the provisions of these GTCU Platform.
The Reports constitute a collection of information whose layout and architecture are protected as such by intellectual property law.
Any reproduction, diffusion or distribution of the Reports or parts of the Reports, in any way whatsoever, to unauthorised third-parties constitutes a breach of contract and may constitute infringement and/or unfair competition.

11.3. Concerning trademarks and distinctive signs

Any commercial use of SAFETY OBSERVER’s corporate name, its trading name, its word of figurative marks or any of its distinctive sign is also prohibited, unless prior, express and written authorisation of SAFETY OBSERVER.

12. Personal data

SAFETY OBSERVER is led to collect and process personal data concerning the Users within the framework of the operation of the Platform.
These processing operations are carried out on the instructions of the Client, who acts as data controller within the meaning of European Regulation 2016/679 of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (GDPR).
SAFETY OBSERVER carries out the processing on behalf of the Client as a subcontractor within the meaning of the GDPR.
If the User wishes to obtain more information on the processing carried out or exercise their rights under the GDPR, he/she should contact the Client exclusively.

13. Force majeure

SAFETY OBSERVER shall not be liable if a breach of any of its obligations is the result of a case of force majeure within the meaning of article 1218 of the French Civil Code and the case law of the Cour de cassation.
The Parties agree in particular that the following events, without this list being exhaustive, shall be deemed to be cases of force majeure: acts of war, acts of terrorism, riots, labour disputes, internal and external strikes, lock-outs, natural or health disasters, fire, water damage, lightning, legal or governmental restrictions, acts of administrative, governmental or judicial authorities not attributable to the fault of the defaulting Party, lack of energy supply, partial or total stoppage of the Internet or any communication networks.

14. Suspension of access to the Platform – Account closure

Without prejudice to any damages that SAFETY OBSERVER may seek, SAFETY OBSERVER reserves the right to suspend a User’s access to the Platform, in whole or in part, or to close her/his User Account, without notice or compensation, in the event of non-compliance by the User with these GTCU Platform.

15. Modification of the GTCU Platform

SAFETY OBSERVER may change the GTCU Platform at any time. It is advised to any User to refer regularly to the latest version of the GTCU Platform. In the event of any change, the applicable General Conditions are those in force on the day of the use of the Platform by the User.

16. Waiver

The fact that either of the Parties does not claim the application of any clause of the GTCU Platform or acquiesces to its non-performance, whether permanently or temporarily, would not be interpreted as a waiver by that Party of its rights resulting from the said clause.

17. Partial nullity

Cancellation or invalidation of one of the provisions of the GTCU Platform shall not generate cancellation or invalidation of the whole GTCU Platform, unless the disputed provision can be considered, in the Parties minds, as substantial and decisive, or if the cancellation or invalidation calls into question the general balance of the GTCU Platform.

18. Jurisdiction attribution and applicable law

The GTCU Platform are governed by French law.
Any dispute or litigation arising from the validity, interpretation and/or performance of these GTCU Platform must first be the subject of an attempt at amicable resolution.
If this attempt is unsuccessful within 60 days of the complaint made by a User, then the French courts will be competent to hear the dispute and the provisions of common law arising from the French Code of Civil Procedure will be applicable.
In the event of a dispute between SAFETY OBSERVER and a professional User, acting as such, jurisdiction to hear this dispute is attributed to the competent courts of the place where SAFETY OBSERVER’s head office is located

19. Revision History

The current version was revised on 16-Sep-2024. The detail of all changes made to the previous version from 08-Dec-2023 (Launch date of the Platform) is provided in the attached file: Change History_GTCU Platform