Legal

These General Conditions (hereinafter the “Contract”) 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 and made available on the website www.safetyobserver.com (hereinafter the “Website”).

This Contract applies :

• to the visits of the present Website by any visitor,
• to any sale of regulatory intelligence reports published by SAFETY OBERVER (hereinafter “Reports”) made through the Website.

This Contract is made available to all visitors on the Website. It constitutes the sole basis of the trade negotiation and prevail on the general contractual terms and conditions of the other contracting party, unless otherwise formally accepted in writing by SAFETY OBSERVER. However, special conditions may be granted.

SAFETY OBSERVER may change the Contract at any time. It is advised to any visitor or client to refer regularly to the latest version of the Contract. In the event of any change, the applicable General Conditions are those in force on the day of the visit of the Website by the visitor or on the day of the order confirmation by the client.

When a client previously placed an order, the modifications of the Contract will be notified to him by SAFETY OBSERVER. He will be able to refuse them within 7 days from the notification. In case of refusal, the Client will remain contractually bound to SAFETY OBSERVER under the version of the general conditions in force at the time he placed his Order. In the absence of refusal within 7 days, the modifications will be considered accepted by the client.

Any use of the Website or any order made through it entails full acceptance of this Contract.

1. Definitions

Each term beginning with a capital letter and used in both the singular and plural in this contract shall have the meaning indicated in its definition given in this article, identical terms used without capital letters being considered in their current meaning.

“Account” means the personalized account created on the Website by a Client at the time of registration, accessible by means of his Identifiers, and allowing him to place Orders.

“Client” means any user registered on the Website to purchase Products.

“Identifiers” means the email address and password chosen by the Client to access his Account. The Identifiers must be kept confidential by the Client.

“Order” means any order for one or more Reports placed by a Client on the Website and subject to this Contract.

“Report” means a regulatory intelligence report offered for sale by SAFETY OBSERVER on the Website.

“Subscription Plan” means an offer to sell that includes several Reports.

“User” means a person under the responsibility of the Client who is expressly authorized to have access to the Reports in accordance with the Order placed by the Client.

“Visitor” means any person who visits the Website whether or not he as an Account.

“Website” refers to the online sales Website www.safetyobserver.com owned by SAFETY OBSERVER and on which the Client can create an Account and purchase Reports.

2. Information on the Reports and Subscription Plans

2.1.      Content of the Reports

The Reports are produced in English only. It presents information collected on the internet from Regulatory Authorities, News Agencies and Professional Organisations, as deemed relevant to the operation of a Pharmacovigilance System for companies involved in the development and/or marketing of Human Medicinal Products.

The content of the Reports is the result of the active monitoring of identified sources publishing their content in English or French. The list of sources screened on a systematic basis by SAFETY OBSERVER includes without limitation:

• International sources: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Council for International Organizations of Medical Sciences (CIOMS), Pharmaceutical Inspection Co-operation Scheme (PIC/S).
• European sources: European Medicines Agency (EMA), European Commission (EU), European Co-ordination Group for Mutual Recognition and Decentralised procedures – Human (CMDh).
• National Authorities: US Food and Drug Administration (FDA), UK Medicines & Healthcare products Regulatory Agency (MHRA), Australian Therapeutic Goods Administration (TGA), Health Canada, and the French National Agency (ANSM).
• Other sources: Professional Associations, Service Providers and Law Firms.

The Reports produced by SAFETY OBSERVER may contain information from other sources and countries, but only when such information is identified through the monitoring of secondary sources, including News Agencies and Service Providers.

SAFETY OBSERVER issues eleven Regulatory Intelligence Reports per year, i.e. on a monthly basis except in August. A double issue is produced in September to cover the information released in July and August.

2.2. Description of the Subscription Plans

The Subscription Plans offered for sale are the following:

• 1 year Subscription Plan : 11 consecutive Reports, starting with the next release (includes a double issue for July/August)
• 3 months Subscription Plan : 3 consecutive Reports, starting with the next release

It is also possible to buy Reports available in the SAFETY OBSERVER library by the unit.

3. Order

3.1. Website registration

To place an Order, the Client must be regularly registered on the Website.

To register, the Client must complete the registration form available on the Website to create an Account on the Website.

The Client agrees that the information he provides on this occasion is accurate, sincere and complete, and to update it on his Account in the event of a change.

The Client who is regularly registered can access his Account using his Identifiers.

The Client is solely responsible for the confidentiality and security of his Identifiers. The Identifiers are confidential, personal and non-transferable. Also, any action carried out on the Website via the Client’s Account is deemed to have been carried out by the Client.

The Client 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 Client must change them without delay. If the password is forgotten, the Website provides the possibility to obtain a new password by e-mail.

The Client is free to unsubscribe from the Website at any time by email to the address indicated at the top of this Contract. Unsubscribing has no effect on the current Orders and on the obligations of the Parties relating thereto.

3.2. Placing an Order

To place an Order on the Website, the Client must:

1. choose the Report or Subscription Plan he wishes to order and the number of Users in their company/organisation, check the adequacy of the Report or Subscription Plan to his needs on the basis of the description and the conditions of sale indicated, and click on the dedicated button to add it to the shopping cart.
2. access his shopping cart,
3. check a box certifying his acceptance of this Contract,
4. validate his Order by clicking on the button provided for this purpose,
5. connect to his Account:

• if he already has an Account, he must identify himself by means of his Identifiers,
• if he does not have an Account, he must create one by following the registration procedure provided on the Website,

6. choose his means of payment and fill his payment information ;
7. check the details of his Order that are displayed, especially the Report or Subscription Plan included in his shopping cart, the price, any applicable fees and terms and conditions (the Client can also correct possible errors);
8. confirm his Order and payment by clicking on the button provided for this purpose.

This confirmation results in the conclusion of the sales contract and acceptance of the present general contractual terms and conditions in force at the date of the order, recognition of complete comprehension and a disclaimer with regards to other contractual conditions.

3.3. Confirmation and processing of the Order  

Once the Order has been confirmed, SAFETY OBSERVER communicates without delay the confirmation of the Order, via an e-mail sent to the address given by the Client when creating his Account. This confirmation of Order details the information communicated by the Client in its entirety.

The Order shall only be processed once the Client has confirmed the Order on the Website and has paid the full price of the Order and any related costs.

In any event, SAFETY OBSERVER reserves the right not to process the Order for any legitimate reason, in particular:

• if the Client has not paid the total price of the Order, including any additional costs, or if the Client’s payment has been rejected by the organization managing his means of payment,
• when, at the time of processing the Order, SAFETY OBSERVER becomes aware of:

• • a material error between the posted price and the actual price, in accordance with Article 4.1, or
  • a material error on the displayed price making the price derisory within the meaning of article 1169 of the French Civil code.

3.4. Modification of the Order

Any change of the Order made by the Client after confirming his Order is subject to acceptance by SAFETY OBSERVER. For any question concerning the order, the client can call +33 676 23 20 48.

3.5. Renewal of Subscription Plans

The Client has the possibility to renew his Subscription Plan from the Website at any time. SAFETY OBSERVER will inform the Client immediately after the distribution of the last Report of the Subscription Plan concerned. The Client will therefore have approximately one month to renew his Subscription Plan in order to avoid any interruption of service.

4. Payment

4.1. Prices

The Client undertakes to pay the full price of any Order placed on the Website.

Reports and Subscription Plans are sold at the price in force at the time of the Order, which is indicated in Euros. SAFETY OBSERVER reserves the right to modify its prices at any time but commits to applying the prices in force at the date of the Order.

The prices are firm and cannot be revised by SAFETY OBSERVER during the Order process. The Order process extends from the addition of a Report or Subscription Plan to the shopping cart to the payment of the Order.

In the event of a material error between the price displayed on the Website and the actual price charged by SAFETY OBSERVER, SAFETY OBSERVER may, after confirmation of the Order, contact the Client to:

• in the event of an actual price lower than the price displayed, inform the Client that the price to be paid is in fact lower and that it will be invoiced at the lower price;
• in the event that the actual price is higher than the displayed price, inform the Client that the price to be paid is in fact higher and ask the Client whether he agrees to pay the actual price or whether he prefers to cancel his Order in whole or in part.

In any event, if the material error on the price of a Report or a Subscription Plan makes its price derisory, either Party may claim the cancellation of the relevant Order.

4.2. Taxes

SAFETY OBSERVER is a Service Provider based in France and subject to applicable tax regulations in France and the European Union (EU), which will be reflected on the invoice.

Value Added Tax (VAT) may apply depending on the country where the Client is established, as defined in EU Directive 2006/112/EC on the common system of Value Added Tax (articles 44 and 196) and in the French Tax Code (Code Général des Impôts – CGI article 259 and 283-2).

• Business-to-Business (B2B) transactions:

Most Clients of SAFETY OBSERVER services are Business Customers and the following rules apply depending on whether the Client is established in France, another EU country, or outside the EU:

Client Company is established in:	VAT rule:
France	French VAT (20%) applies. It will be collected and paid by SAFETY OBSERVER.
Other EU Country	Businesses established in EU Member States (other than France) are required to provide their EU VAT identification Number and must pay the corresponding VAT in their respective countries (reverse charge procedure).
Country outside the EU	Businesses established outside of the EU must pay applicable VAT or sale tax equivalent in their country.

• Business-to-Consumer (B2C) transactions:

In the event that the Order is placed by a private individual (i.e. a non-Business Customer), the following rules apply depending on whether the Client resides in France, another EU country, or outside the EU:

Customer resides in:	VAT rule:
France	French VAT (20%) applies. It will be collected and paid by SAFETY OBSERVER.
Other EU Country	French VAT (20%) applies. It will be collected and paid by SAFETY OBSERVER.
Country outside the EU	Clients residing outside of the EU must pay applicable VAT or sale tax equivalent in their country.

4.3. Terms of payment

Any purchase made on the Website is payable by credit card or bank transfer at the choice of the Client, in a single payment at the time of the Order.

In case of payment by bank transfer, SAFETY OBSERVER will be able exceptionally and at its sole discretion to accept that the payment intervenes within 30 days of the date of invoice. In this case, we require the client to pay for all banking fees associated to the bank transfer.

Online payment is made through a secure system allowing to encrypt the banking data transmission. The Client must enter his banking details in the relevant fields and confirm the entry. SAFETY OBSERVER reserves the right to verify the data communicated by the Client and adopt all the necessary measures for this verification. SAFETY OBSERVER may give formal notice to the Client to justify his identity. The failure by the client to answer this request within three calendar days will automatically result in the cancellation of the sale.

4.4. Invoices

Once payment has been made, the Client will receive an invoice with his name detailing his Order.

The Client accepts that the invoices will be sent to him in electronic format, by sending an e-mail.

The invoice shall include any discounts and rebates granted to the Client.

4.5. Payment delays or failure

Pursuant to Article L.441-6 of the French Commercial Code, any amount not paid at its due date will result automatically in the application of penalties of an amount equal to ten times the legal interest rate and a fixed allowance for recovery costs of an amount of 40 €.

In the event of payment failure, the Contract shall be either suspended or terminated, at SAFETY OBSERVER’s discretion, under the conditions provided in Article 8.

5. Availability of the Reports

The Reports ordered are sent to the Client by e-mail in PDF format, to the address given on his Account.

The information provided by the Client bind him: in the event of an error in the wording of his contact details or incomplete information, SAFETY OBSERVER shall not be held responsible for the impossibility of sending the Reports.

Concerning the Subscription Plans, SAFETY OBSERVER uses its best efforts to send its Reports at the latest on the 10th of each month. However, this is only a mere indication and non-compliance will not in any case engage the liability of SAFETY OBSERVER or justify a modification or a cancellation of an Order.

6. Rules for the use of Reports

The use of the Reports is strictly reserved to the number of Users indicated by the Client when placing the Order. In case of a multi-Users Order, the Client is responsible for the distribution to the authorised Users.

It is strictly prohibited to communicate a copy 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 Client :

• 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, and for a period of 12 months following the end of the Contract, regardless of the cause of the latter.

In case of violation of any of the above prohibitions by the Client, the Contract shall be either suspended or terminated, at SAFETY OBSERVER’s discretion, under the conditions provided in Article 8.

The Parties further expressly agree that in case of use of the Reports by persons other than the expressly authorised Users, the Client shall pay to SAFETY OBSERVER a penalty calculated as follows:

• 60 € (excluding tax) X number of Reports used in fraud X number of unauthorized persons having had access to them

7. Use of the Website 

7.1. Website Access

The Website is accessible free of charge to any Visitor having internet access. The costs arising from the equipment (computer, telephone, software, means of telecommunication …) allowing the Website access are payable only by the Visitor, as well as the telecommunication costs arising from their use.

The Visitors are solely responsible for the good functioning of their computer equipment as well as their internet access.

7.2. Availability of the Website

The Website 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 without this being considered as a modification of the conditions of execution of this Contract.

SAFETY OBSERVER uses its best efforts to offer an availability of the Website approaching as much as possible an availability 24 hours on 24 and 7 days on 7. Any Visitor acknowledges and accepts that this is only an obligation of means for SAFETY OBSERVER so that the Website may experience periods of temporary unavailability, at any time of day.

SAFETY OBSERVER draws the attention of the Visitor to the fact that :

• access to or use of the Website 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 Website and the correction of anomalies may lead to momentary interruptions.

The maintenance operations may be made without prior notice to the Visitors.

7.3. Obligations regarding the use of the Website  

Any Visitor undertakes to access the Website and to use the services and functionalities it contains, in particular via its Account if he has one, in accordance with their purpose and any applicable regulations and in compliance with this Contract and any rules of use communicated or made accessible by SAFETY OBSERVER, in particular by way of posting, publication or notification on the Website.

In particular, the Visitor shall refrain from:

• copy, reproduce, modify, create derivative works from, distribute or disclose to the public any content of the Website without the express prior written consent of SAFETY OBSERVER or, where appropriate, that of the third parties concerned;
• disrupt or attempt to disrupt the proper functioning of the Website or the activities that take place on it;
• circumvent the protocols of exclusion of robots or any other measure used to prevent or limit access to the Website;
• visit or use the Website if he’s not legally capable of entering into contracts, are under the age of 18, or if their access has been denied or suspended temporarily or indefinitely;
• distribute viruses or other technologies that may harm SAFETY OBSERVER or the interests or property of other Clients or any third party;
• copy, modify or distribute content from the Website, SAFETY OBSERVER’s copyrights and trademarks;
• collect in any way whatsoever information about other Clients, including e-mail addresses, without their consent;
• use bots, spiders, scrapers or any other automated process to access the Website for any purpose without the express prior written consent of SAFETY OBSERVER;
• to conduct data mining on the Website without the prior written consent of SAFETY OBSERVER.

Any visitor who fails to comply with any of the above obligations shall be solely responsible for any resulting harmful consequences.

In case of violation of any of the above obligations by the Client, the Contract shall be either suspended or terminated, at SAFETY OBSERVER’s discretion, under the conditions provided in Article 8.

7.4. Hypertext links

The Website and the Reports may contains 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.

8. Cancellation of an Order – Termination

All Orders are final from the date of their confirmation by the Client on the Website.

However, an Order may be cancelled and the Contract terminated in the event of a serious breach or repeated breaches of one or more obligations of the Contract or in the event of a breach of an obligation considered essential between the Parties.

The Parties agree to consider the following obligations as essential:

• obligation to pay under the terms of Article 4;
• obligation to make Reports available under the terms of Article 5;
• obligation to respect the rules of use of the Reports under the terms of Article 6;
• obligations set forth in Article 3.

The termination will take effect as of right within fifteen days following a formal notice sent by e-mail, without prejudice to the damages to which the injured party could be entitled.

In the event of termination due to Client’s fault, Client shall be liable for payment of the Order in full. The Client shall immediately pay any outstanding amounts to SAFETY OBSERVER and shall not be entitled to any refund of amounts already paid.

In case of cancellation due to SAFETY OBSERVER’s fault, the Client shall be bound to the payment of his Order only in proportion to the number of Reports he has received. In such a case, SAFETY OBSERVER will reimburse the Client the sums corresponding to the Reports not received by the latter.

9. Liability

9.1. General limitation

The obligations of SAFETY OBSERVER are obligations of means.

SAFETY OBSERVER’s liability can only be engaged for the foreseeable damages of which it is directly at the origin, to the exclusion of any indirect damage, material or immaterial damage, consecutive or not, any operating loss, production loss, loss of profit, loss of contract, image damage, immobilization of personnel or equipment, and this without any joint and several liability with the third parties having contributed to the damage.

In any case, in the hypothesis that the responsibility of SAFETY OBSERVER would be retained for any reason whatsoever, the total amount of the indemnities that SAFETY OBSERVER could be brought to pay to the Client cannot exceed, all sums and all damages combined :

• the amount (excluding tax) actually paid by the Client for the Order concerned, if the dispute concerns a given Order;
• the amount (excluding tax) actually received by SAFETY OBSERVER from the person concerned during the last 6 months for any other dispute;
• and this, whatever the legal basis of the complaint and the procedure used to make it succeed.

No claim and/or action, for whatever reason, can be formulated and/or engaged against SAFETY OBSERVER after a period of twelve (12) months after the occurrence of the fact on which it is based.

9.2. Specific limitations

SAFETY OBSERVER commits to collecting and compiling very carefully the information presented in the Reports but cannot be held responsible for any error, omission or inaccuracy contained in the documents or websites used to make this compilation.

SAFETY OBSERVER’s liability is also expressly excluded for any damage :

• resulting from a breach by the Client, or by a mere Visitor, of any of the obligations of this Contract, and in particular the obligations contained in article 6 and 7.3 hereof;
• resulting from the provision by the Client of false, erroneous or insincere information or from the failure to spontaneously update this information on his Account;
• resulting from a security defect (hardware or software) in the connection terminal (computer, cell phone, tablet, etc.) with which the Client or Visitor accesses the Website;
• suffered by the technical environment of the Client or the Visitor and in particular, his computers, software, network equipment (modems, telephones…) and any equipment used to access the Website;
• resulting from the inaccessibility, unavailability, suspension, interruption or slowdown of the Website;
• resulting from modification, intrusion, alteration, unavailability of the Website operated by a third party (person, virus, etc.);

The Client acknowledges that the limitations of liability stipulated above operate between the Parties a reasonable distribution of risks and responsibilities with regard to the context and the conditions, in particular financial, of the present.

10. Force majeure

Neither of the Parties shall be held liable to the other for non-performance or delays in performance of an obligation hereunder that would be due to the occurrence of a case of force majeure as usually recognized by French case law and courts, or to an external cause, such as, without this list being exhaustive: total or partial strikes, internal or external to the company, bad weather, epidemics, water damage, fires, attacks, natural disasters, social conflicts, intervention by civil or military authorities, governmental or legal restrictions, interruption of the electrical or telecommunication networks, DOS, DDOS, scheduled interventions or seizures by the courts.

In such a case, the obligations arising hereunder will be suspended.

If such a case of force majeure, fortuitous event or external cause continues for more than one (1) month, the Order shall be cancelled and shall give rise, where applicable, to the reimbursement of the sums paid by the Client corresponding to the Reports not received by the latter.

11. Personal data

SAFETY OBSERVER is led to collect and process personal data concerning the Clients within the framework of the sales carried out on the Website and concerning all Visitors within the framework of the operation of the Website.

These processing operations are carried out in accordance with the applicable legislation and in particular the 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) and the French law of 6 January 1978 “Informatique et Libertés”.

These processing operations are explained in the SAFETY OBSERVER Privacy Policy accessible on the Website.

12. Ownership – Intellectual Property

12.1. Concerning the Website

SAFETY OBSERVER is and remains the owner of the Website and of all its constituent elements.

SAFETY OBSERVER is and remains consequently the owner of all intellectual property rights on the Website and on elements which compose it, whatever their nature, as well as of all its savoir-faire as a Website publisher.

These elements are protected by intellectual property laws and others, including copyright.

The access to the Website does not confer any intellectual property right whatsoever to Visitors on the Website or on the elements composing it.

Any use or exploitation of the elements of the Website 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 Website 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.

12.2. 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 the Client who undertakes in any case to use them in accordance with the provisions of the Contract.

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, in any way whatsoever, to unauthorized third parties constitutes a breach of contract and may constitute infringement and/or unfair competition.

12.3. Concerning trademarks and distinctive signs

Any commercial use by the Client 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 authorization of SAFETY OBSERVER.

13. Client service – Claim

The Client may contact SAFETY OBSERVER via the Contact Form on the Website or at the e-mail address indicated at the top of this Contract for any information on a Report or Subscription Plan or for any claim relating to an Order placed. SAFETY OBSERVER’s Client service is open from 09:00 a.m. to 5:00 p.m. (Central European Time) from Monday to Friday.

14. Proof agreement

Each of the Parties undertakes to recognize a probative value equivalent to that of a paper document to any electronic document or any information exchanged between them through their electronic correspondence or communication tools made available to them on the Website as well as to any computerized data stored, accessible or generated by the Website and relating to their contractual and pre-contractual relationship.

The Parties waive, except in the case of proven computer fraud on the information systems used or deliberate human falsification, to invoke any unenforceability, inadmissibility or nullity of any evidence that would be reported by means of the aforementioned documents or information.

15. Waiver

The fact that either of the Parties does not claim the application of any clause of the Contract 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.

16. Partial nullity

Cancellation or invalidation of one of the provisions of the Contract shall not generate cancellation or invalidation of the whole Contract, 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 Contract.

17. Jurisdiction attribution and applicable law

Any dispute which may arise between the Parties concerning the use of the Website or any contract made and entered into through this Website, whether it concerns the validity, the interpretation, the performance or the termination of the said contract, will be under the jurisdiction of the Court where the head office of SAFETY OBSERVER is located. Any dispute will be governed by the French law.