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Regulatory Watches Sunnikan “RIPH” and “GMO” Terms and Conditions

Article 1. – Object

These terms and conditions are intended to clarify the relationship between Sunnikan Consulting and subscriber Sunnikan Regulatory Watches “Research Involving the Human Person, RIPH” or “Genetically Modified Organisms, GMO”, hereinafter entitled “Regulatory Watches Sunnikan” RIPH “and” GMO “.

Article 2. – Validity of the subscription

The subscriber completes, signs and transmits to Sunnikan Consulting the subscription form. Upon receipt of the subscription form, Sunnikan Consulting sends the corresponding invoice to the subscriber, who must pay the payment upon receipt. The newsletters are sent to the subscriber only when Sunnikan Consulting receives the corresponding payment.

Article 3. – Description of the subscription to the Sunnikan Regulatory Watch

The Sunnikan Regulatory Watch is a regulatory watch analyzing the regulatory news of the month, including, if relevant, an impact analysis on the quality system of the subscriber. The subscription, concluded for a period of one year, includes the monthly sending (12 sendings) by electronic mail of a file “pdf” including, if appropriate, addresses of the texts available on Internet. For example, for a subscription covering the news from March, the first issue of the Sunnikan Regulatory Watch will be received in early April and the last issue will be received in early March of the following year.
Texts considered important by Sunnikan Consulting may be sent by email to an alert to the subscriber. Further analysis of the text will be done in the next issue of the Sunnikan Regulatory Watch.

Article 4. – Scope of the Sunnikan Regulatory Watch “RIPH”

The scope of the Sunnikan Regulatory Watch “RIPH” covers Research Involving the Human Person (Interventional and non-interventional research).
Products concerned: medicines, blood derivatives, medical devices, “non-health products”, cosmetics.
Repositories related to research: French legislation, regulations and recommendations, European Union, American (FDA website); international organizations (eg ICH). The field of application for clinical trials of medical devices, cosmetic products, “non-health product” and non-interventional studies is limited to the French and European Union regulations (EMA, European Commission).
Indirectly linked repositories, such as: Protection of personal data, Good Manufacturing Practices for experimental drugs, CNOM …

Article 5. – Scope of the Watch

Regulatory Sunnikan “GMO” The scope of the Sunnikan Regulatory Watch “GMO” covers the specific regulations relating to fundamental research, pre-clinical (manipulation of GMOs, handling of transgenic animals, administration of GMOs to animals) and clinical trials on GMOs.
Products concerned: advanced therapy medicinal products containing or consisting of a GMO.
Repositories related to research: French, EU and international legislation, regulations and recommendations (only ICH, Convention on Biological Diversity and Nagoya Protocol). The field of application is essentially limited to the French and European Union regulations (EMA, European Commission).
Indirectly linked repositories, such as: deliberate release and contained use of GMOs.

Article 6. – Intellectual protection

The information provided by Sunnikan Consulting are works of the mind, as defined by the provisions of the Code of Intellectual Property.
The Subscriber acknowledges that the Sunnikan Regulatory Watch is the intellectual property of Sunnikan Consulting and is protected by copyright. The Subscriber is aware that any use, reproduction or dissemination of the Sunnikan Regulatory Watch that does not conform to the subscribed subscription, whether partial or total, is strictly prohibited. Sunnikan reserves all remedies to protect its product from use, reproduction or distribution that is not the subject of a contract or prior agreement. The Subscriber hereby agrees to comply with the terms of dissemination provided by his subscription to the Regulatory Watch Sunnikan.

Article 7. – Recipient of the subscription

Unless otherwise specified, the “Sunnikan Regulatory Watch” is sent to one or more e-mail addresses depending on the type of subscription subscribed and reserved for a service consisting of a small group of persons (depending on the number of recipients selected by the subscriber), located on a single geographical site. Under no circumstances may the “Sunnikan Regulatory Watch” be broadcast outside the company’s site mentioned on the contract and outside the company to which the subscriber belongs.

Article 8. – Obligations of the subscriber

The subscriber agrees to comply with these terms and conditions of sale. Otherwise, Sunnikan Consulting may terminate this contract. The cancellation will take effect from the receipt by the subscriber of a registered letter with acknowledgment of receipt.

Article 9. – Protection of personal data

As part of the Regulatory Watch, Sunnikan Consulting is responsible for the processing of subscribers’ personal data. The processing of the subscriber’s personal data is carried out in the context of the legitimate interests of the Data Controller (in particular the management of the commercial relationship for the purpose of conducting the monitoring service). The subscriber’s personal data is intended solely for the personnel of Sunnikan Consulting and is used for sending, tracking the subscription and any commercial information related to the subscriber’s functions. These personal data are kept in accordance with the applicable regulations (the General Data Protection Regulation, the Data Protection Act of 6 January 1978 and the simplified standard 48 concerning the management of customer and prospect files (pending updating this simplified standard)). They are kept only for the period of conservation necessary for the management of the commercial relationship. The personal data necessary to establish the proof of a right or a contract, are kept in accordance with the Commercial Code (5 years). Personal data are then archived commercially. At no time will Sunnikan provide the data to other companies for commercial reasons. In case of commercial information, the personal data are used and kept for 3 years following the last contact of the customer. The subscriber has the opportunity to oppose this commercial use of his data free of charge by sending an email to the following address: by mentioning “unsubscription” in the subject line. The subscriber has a right of access, opposition, rectification, limitation and deletion as well as a right of recourse concerning the use of his data. These rights are exercised with Sunnikan Consulting’s Data Protection Department:
Postal address: Sunnikan Consulting Attention: Data Protection Officer
229-231 La Fontaine Street
94120 Fontenay-sous-Bois

Article 10. – Information contained in the Sunnikan Regulatory Watch

The information contained in the Sunnikan Regulatory Watch comes from texts in force or in draft available to the public (especially on the Internet).
Sunnikan Consulting can not be held responsible for a misinterpretation of the texts made by the subscriber.

Version of September 24, 2018