Data Sharing Agreement for Registration Under REACH
5October2009
Model Data Sharing Agreement
according to REACH Regulation (EC) No 1907/2006[1]
The present data sharing agreement has been elaborated by the Cefic Legal Aspects of REACH Issue Team on the basis of REACH requirements, the available guidance, in particular the Guidance on data sharing and the European Law in force.
Please note that this model is by no means intended to be mandatory or prescriptive. It should rather serve primarily as basis for discussion in order to ensure that all interested parties address a range of aspects when considering legal framework for their cooperation.
The passages in italic in this Agreement identified as “options” are binding on the Parties only if they have been specifically retained in each case. Ultimately, it is for the Parties to assess the appropriateness of the provisions on a case-by case basis and decide what elements they wish to adopt and at what level but when making any decisions it is recommended that these issues should be taken in consideration[2].
Companies are to apply this model at their own risk and Cefic will not accept any warranties resulting from the use of or reliance on this document and its application.
For Cefic and its members: for further clarifications and questions, contact Vincent Navez, Cefic Legal Counsellor. Tel. +32 2 792 75 10 - E-mail:
Data sharing agreement under REACH[v1]
Between
“[______add name and address”]
(hereinafter referred to as "Data Owner")
and
Optional:
-[______add name and address of Lead Company], as Lead Company of [the Consortium ____ (add name of Consortium)] / [of other form of cooperation ___ (add name of the cooperation)]
-[xxx,acting on its own name and for account of the members of the [xxx consortium/other form of cooperation] [v2]
(hereinafter referred to as "the Grantee”)
Hereinafter referred individuallyto as “the Party” or collectively to as “the Parties”.
1.Preamble
Whereas the Data Owner holds rights oncertain Studiesrelatingto the Substance(s) and has the authority to grant rights to refer to, use and copy the Studies;
Whereas the Studiesof the Data Owner may be of use for preparing theREACH Joint Registration Dossier on the Substance(s) for submission to the European Chemicals Agency (“ECHA”) as required by Regulation (EC) N° 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals ("REACH");
Whereas the Granteedesires to (optional[v3]:refer to the full study reports and to use the (robust) studies summaries and) enable SIEF Participants to refer to the full study reports and to use the (robust) studies summaries, only for purposes of REACH requirements, via a right to use or refer tothe Studies of the Data Owner as required by article 10 of REACH;
Whereas the Data Owner is willing to provide suchrightson the Studies in accordance with the terms and conditions of this Agreement (hereinafter the “Purpose”).
THE PARTIES HAVE AGREED UPON THE FOLLOWING:
Article I. Definitions
Terms written in capital letters are defined in the Preamble above, in this Article 1 or in other parts of this Agreement. To the extent not otherwise defined in this Agreement, any definition specified in REACH, in particular in Article 3, shall apply to this Agreement:
Affiliate: Any legal entity controlling, controlled by, or under common control with, either directly or indirectly, a Party or in case of an only representative, the affiliate of the non-EU manufacturer or in case of a third representative, the affiliate of the legal entity represented. For these purposes, “control” shall refer to: (i) the possession, directly or indirectly, of the power to direct the management or policies of a person, whether through the ownership of voting rights, by contract or otherwise; or (ii) the ownership, directly or indirectly, of 50 % or more of the voting rights or other ownership interest of a person.
Studies: the study/ies and information listed in Annex 2, copy/ies of the study summary/ies and/or robust study summary/ies which have been provided by the Data Owner.
Substance(s): [designation of the name(s) and EINECS#/CAS# or other descriptor], as defined in Annex 3.
Article II. License and sub-license
1. The Data Owner grants to the Grantee a non-exclusive andnon-terminableright (license) to refer to the full study reports and to use the (robust) studies summaries [optional: and provides the Grantee with a copy of the study summaries and robust study summaries [as well as the full study reports].
2.The Data Owner further grants the Granteethe right to sub-license such rights only toSIEF participants under obligation to register the Substance(s) under REACH[v4].
3. The license and rights to sub-license hereunder granted are limited for the sole purpose of compliance with REACHrequirements.
4. Within [xx] days of receipt of payment of the compensation stipulated in article III.2, and upon Grantee request the Data Owner shall issue a “Letter of Access” in the form attached hereto as Annex 1.
Article III. Compensation
1.In consideration for the licenses granted under Article II, the Grantee will compensate the Data Owner.
2. The compensation for these licenses and the rights to sub-license will be effective by the payment tothe Data Owner of the relevant lump-sump of … €. Payment is due within [1 (one)] month after receipt of an invoice issued by the Data Owner.[v5]
3. All payments due hereunder shall be net payments, i.e. free of any bank or transfer charges or similar charges and without deduction of any taxes, levies or other dues payable If payer is required to withhold any tax or to make any other deduction from any such payments, then the said payments shall be increased to the extent necessary to ensure that, after making of the required deduction or withholding, payee receives and retains (free from any liability in respect of any such deduction or withholding) a net sum equal to the sum which it would have received and so retained had no such deduction or withholding been made or required to be made (gross-up amount). If upon application of the beneficiary any withholding tax can be reduced, or refunded, or an exemption from withholding tax is granted, payer shall file on behalf of payee for such reduction, refund or exemption.Data Ownershall render any assistance to the Granteeto obtain such withholding tax reduction, refund or exemption. The Granteeshall be entitled to any refund of withholding taxes.
4. Indirect taxes, including but not limited to Value Added Tax (VAT), Goods and Service Tax (GST), service tax, business tax, as applicable pursuant to the relevant tax law, shall be borne by the Grantee. However, Lead Registrantis entitled to withhold any payment of indirect taxes unless payee has provided payer with a sufficient invoice for purposes of indirect taxation.
Article IV. Representations
The Data Owner represents that he is the owner of the Studies, and/or has authority to grant the rights granted or referred to under Article II.
2.Article V. Ownership of Information
1. This Agreement does not grant any ownership rights or change existing ownership rights to any of the Studies provided under this Agreement, on whatever form and whenever, by the Data Owner.
2. Neither this Agreement nor any disclosure of Studies shall vest any present or future rights in any patents, trade secrets or property rights and no license(s) other than the(se) specified under article II are granted.
Article VI. Term & Termination
1. This Agreement and the license granted hereunder will have no expiration, except as providedunder Paragraphs 2 and 3.
2. This Agreement and the license provided hereunder shall expire once the Studies are no longer protected and may be used without restrictions under the applicable law. The Parties acknowledge that the period of protection under the REACH Regulation currently is twelve years after the first submission to the European Chemicals Agency.
3. Either Party may terminate this Agreement and the licenses granted under this Agreement, if the other Party is in material breach of any representation, warranty, covenant, or agreement contained in this Agreement, after providing written notice to the other Party of such intent and reason for termination. This termination will be effective thirty (30) calendar days after the date of sending the notice, unless before the end of that period the other Party cured the breach identified in the notice. If the breach is cured in the specified period and the breaching Party receives written acknowledgement from the non-breaching Party that the breach has been cured, then the notice of termination will be void and of no effect.
4.Upon termination of this Agreement under the paragraph 3 due to the Grantee’ breach:
(a) All Studiesin whatever form will be immediately returned by the Granteeto the Data Owner;
(b) The Granteewill withdraw any Letter of Access for the Studiesthat wassubmitted to any regulatory agency;
(c) All rights granted to the Granteeand the subsequent rights granted by the Grantee to any third partywill immediately revert to the Data Owner; and
(d) The Granteewill have no claim against the Data Owner, for compensation of loss of business or goodwill for any other damages that may result from such termination of this Agreement.
5.Upon termination of this Agreement under Paragraph 3 due to the Data Owner’s breach, any compensation received by the Data Owner, under Article IIIwill be returned to the Granteewithin forty-five (45) calendar days of the effective date of such termination.
3.Article VII. Legal entity change
The consent of the other Party shall not be required in case a Party assigns, transfers or delegates its rights and obligations under this Agreement to any of its Affiliates or to a legal successor in ownership by sale, division, merger or consolidation of all or substantially the whole of the business relevant to the Substance referred to in this Agreement, subject to acceptance by the assignee of the terms of this Agreement, to be notified in written to the other Party without undue delay.
Article VIII. Liabilities
1. It is the individual responsibility of the Grantee to critically assess the Studies that is made available. The Grantee assumes the full responsibility for its own use of the Studiesso received. The Data Owner gives no warranty for acceptance by the ECHA of the Joint Registration Dossier or any data it contains.
2. None of the Parties shall be held liable for any direct, indirect or consequential loss or damage incurred by any Party in connection with the activities contemplated in this Agreement, unless caused by gross negligence or wilful misconduct.
3. Nothing in this Agreement will be deemed to be a representation or warranty by the Data Ownerof the accuracy, safety, or usefulness for any purpose of any technical information, techniques, or practices at any time made available by the Data Ownerto the Grantee. The Data Ownerwill have no liability whatsoever should any part of the Studies be questioned in any manner or considered inaccurate, incomplete or insufficient for the purposes of inclusion in any REACH registration.
Article IX. Dispute resolution and applicable law
1. The Parties shall first attempt to settle amicably any dispute arising out of this Agreement. Any dispute shall be resolved by arbitration, ousting jurisdiction by ordinary courts, by a panel of three arbitrators. Each party to the dispute will nominate one arbitrator. These two arbitrators will then designate a third arbitrator who will also act as chairman. The arbitration decision shall be binding on the parties. The arbitration rules of the [e.g. CEPANI, ICC] shall be applicable. The place of any hearing shall be Brussels and the language of the arbitration shall be English.
Each Party may at any time request from any competent judicial authority any interim or conservatory measure.
2. This Agreement shall be governed by the laws of [e.g. Belgium], without regard to any principle of conflict or choice of laws that would cause the application of the laws of any other jurisdiction.
3. If at any time any provision of this Agreement is or becomes invalid or illegal in any respect, this shall have no effect on the validity of the remaining contractual provisions. The invalid provisions are to be replaced, backdated to the time of their becoming ineffective, by provisions which come closest to achieving their objective
The Parties by their duly authorized representatives, sign this Agreement in duplicate; with each Party receiving one of the signed originals hereof.
For: The Grantee For: the Data Owner
Represented by: Represented by:
Name: Name:
Title:______Title:
Date: Date:
Annex 1 - Letter of Access to Data for REACH Registration
Subject:Letter of Access for the registration of the substance(s) as listed in Annex 1 under Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning inter aliathe Registration, Evaluation, Authorisation and Restriction of Chemicals (“REACH”)[3]
Dear Sirs,
Subject to the terms and in consideration of the compensations set forth in the Data SharingAgreementfor Registration under REACH dated [xx/xx/xx] between the xxxand the Data Owner, by this letter, the Data Owner, grants the Grantee thelicense to refer to the below Studies, solely for the purpose of preparing a REACH registration dossier onthe below Substances for submission to the European Chemicals Agency:
GRANTEE:xxx
SUBSTANCE(S): The substance(s) specified in Appendix 1
STUDIES: The data and summaries specified in Appendix 2.
Sincerely,
For: The Data Owner
Signature:
Name:
Title:
Date:
Appendix 1: [list substances, by chemical name, CAS number, and EINECS number]
Appendix 2: [list relevant studies and insert description of the data, studies, summaries, waiving arguments, testing proposals and/or assessments, insofar as relevant]
Annex 2 - STUDIES
(readily identifiable listing of data, studies and summaries(e.g. title of data/study/summary) per Substance, financial valuation and financial contribution per entity, date, etc).
Annex 3 – SUBSTANCE(S)
(to be completed)
Annex 4
Cefic guidance on competition compliance
REACH data sharing agreement_05.10.09
[1] Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), OJ L 136 of 29.5.2007
[2] Adjustments may be necessary in order to comply with the national law applicable according to the Article IX.
[3]Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC; OJ 2006, L 396/1.
[v1]In case of exchange of confidential information, a separate non-disclosure agreement is recommended between the Parties (e.g. to cover the previous studies evaluation process by the Grantee)
[v2]Situation of an external service provider contracting on its own behalf and for account of the consortium/other form of cooperation between Lead Members
[v3]When the Grantee is the Lead Company for example
[v4]That covers the other Lead Members and the Non-Lead Members
[v5]In view of a practical approach, in order to postpone the payment of the compensation to the Data owner after the registration deadline and after the collection of the payments of the Joint Registration compensations by the SIEF members, as alternative provision:This amount is due within xx days from the first registration deadline under the REACH Regulation (i.e. 1 December 2010).