Explanatory note on the Cefic model data sharing agreement
Introduction:
According to SIEF categorisation, the Lead Members (members of SIEF category 1) usually represent the main owners of existing data and the collection of their data probably fulfilsasignificant part of the REACH registration dossier, if not all. However, following the compilation of the data of the Lead Members, it may occur that some data required by the REACH regulation may still be missing in order to complete the REACH registration dossier.
In case these existing studies are out of the SIEF Leadership Team and in accordance with the requirement of “legitimate possession or right to refer” for each registrant (Art 10 REACH),the Lead Members should seek contractual arrangements with the respective data owners.
The rights on these data may be owned either by data owners that are in the SIEF (either a potential registrant or a Data Holderas defined by Article 28.7 REACH) or data owners that are not participants in the SIEF (e.g. universities, EU and non-EU institutes or associations, etc).
For the purpose of the present model, the term “data owner” differs from the legal term “Data Holder” (limited to a SIEF participant in accordance withArticle 28.7 REACH) since data ownersthat could be party to the data sharing agreement may also not be SIEF participants.
Purpose:Centralisation of rights on data by the Lead Registrant
In order to simplify the SIEF process by avoiding multiple and different data sharing agreements by all the SIEF participants, with a view tothe completion of the data compilation, the Lead Registrant(LR) should preferably conclude a bilateral data sharing agreement with the data owners non-member of the SIEF Leadership team, with a right for the LR to sub-license these rights to the SIEF participants. Consequently, the SIEF participants would not need to also look for specific contractual arrangements with the data owners.
That is the purpose of the present model.
Combined with the rights on data owned by the members of the SIEF Leadership Team, therefore, the Lead Registrantwill be entitled to sub-license all the rights on data to all SIEF members via the SIEF agreement.
See pictures of the situation below:
Data owned by a data owner: data sharing between the Lead Registrant and the data owner, ascovered by the present model data sharing agreement.
Data owned by Lead Members: data sharing between the Lead Registrantand the other Lead Members is already covered by the consortium agreement or the cooperation agreement between Lead Members:
In addition to the new data generated jointly by the Lead Members, the combination of the contractual arrangements between Lead Members (consortium/cooperation agreement) and of the data sharing agreement(s) allows the Lead Registrant to provide to the SIEF participants via the SIEF agreement the rights on all the data that are part of the Joint Registration Dossier:
Whenthe data owner is a SIEF participant with intention to register, the data sharing with the Lead Registrant should preferably be covered by the present model bilateral data sharing agreement (instead of adapting the SIEF agreement with specific data sharing provisions).
Scope of the data sharing agreement:
The data sharing agreement covers:
-the licence: The data owner grants to the Lead Registrant aright to refer to the full study reports and a right to use the (robust) studies summaries.
-the right to sub-licence: The data owner grants the Lead Registrant the right to grant himself the required rights on data to the respective SIEF participants, in order to also legitimately grantthese SIEF participants the required rights in accordance with the requirements of Article 10 REACH. These SIEF participants are the other Lead Members and the other SIEF Participants (registrants with 2010, 2013 and 2018 deadline).
It is not recommended to set up a data sharing agreement that does not cover also the right for the Lead Registrant to sub-license to the SIEF participants.
Parties to the data sharing agreement:
The SIEF agreement is a bilateral contractthat should be preferably agreed between:
-the data owner and
-the Lead Registrantor an external service provider (called “Grantee” in the model).
When the cooperation between Lead Members, either governed by a consortium agreement or by a cooperation agreement, is coordinated and managed by an external service provider, said service provider may be indeed the contractual party to the data sharing agreement, acting on its own behalf and on behalf of all the Lead Members.
Options in the data sharing agreement:
Very few points in the model data sharing agreement are optional and should be assessed before their insertion: governing law, arbitration body, etc.
Consideration was given to the practical need for brief and simple provisions. Consequently, in a case-by-case approach, a review should be conducted to assess whether the provisions of the relevant model agreement are appropriate and whether other conceivable provisions may be required and suitable.
Fixation of the cost compensation:
The most simple and practical option regarding the amount of the compensation consists in making the best possible estimate at the moment of the agreement of the number of SIEF members that will get the rightson the studies and based on that estimate, a lump-sum is agreed as global cost compensation. The compensation will not be the perfect and exact reflection of the final number of sub-licences but such option is preferred as the most practical.
It’s a one-time operation, compared to other options with systems for example of regular flows of compensation based on the actual numbers of the SIEF participants that will be provided rights on the studies (in 2010, 2013 and 2018).
The timing of the payment of the compensation may be differentiated from the moment of the data sharing agreement. In particular, it may be indicated that the Lead Registrant or the external service providerwill proceed to effect payment of the agreed lump-sum after the first registration deadline, once the Lead Registrant has collected all the revenues from the 2010 registrants.
Process of adoption and signature of the cooperation agreement
When to set up the data sharing agreement?
Once the data owner has been identified by the Lead Members and after the parties have negotiated and agreed on the studies covered and on the compensation to be paid.
The initial studiesevaluation phase (when the Lead Members evaluate the quality, reliability and relevance of the studies of the data owner) is not covered by the model data sharing agreement: existing “classical” non-disclosure agreements are valid, when needed in that regard.
Who is signatory to the data sharing agreement?
The data owner and the Lead Registrant or the external service provider
The Cefic model data sharing agreement has been developed by the Cefic Legal Aspects of REACH Issue Team where more than 50 legal experts from companies participate.
For Cefic and its members: for further clarifications and questions, contact Vincent Navez, Cefic Legal Counsellor. Tel. +32 2 792 75 10 - E-mail:
The information contained in this document is intended for guidance only and whilst the information is provided in utmost good faith and has been based on the best information currently available, it is to be relied upon at the user’s own risk. No representations or warranties are made with regard to its completeness or accuracy and no liability will be accepted for damages of any nature whatsoever resulting from the use of or reliance on that document and itsapplication.
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