Joint Submission Agreement for Substance {{$jsfData->cas_name}}


This Agreement (hereinafter the “Agreement”) is entered into by and between:

AND

Hereinafter collectively referred to as “the Parties”

Preamble

Whereas the REACH Regulation imposes on manufacturers and importers as well as on only representatives the obligation to register the Substance (as defined below) within the prescribed deadlines;

Whereas the Parties and/or their Affiliates wants to register the Substance {{$jsfData->cas_name}}(EC {{$jsfData->ec_no}}, CAS {{$jsfData->cas_no}}) *(hereinafter referred to as ‘the Substance’) and have agreed on the identity and the sameness of the Substance;

Whereas the REACH Regulation requires, subject to certain exceptions, multiple registrants of the same substance to share certain data and jointly submit through a Lead Registrant part of the information required for the registration relating to the Substance to the European Chemicals Agency (“Agency”);

Whereas the Lead Registrant prepared the Joint Submission Dossier and submitted the latter to the Agency, the Parties are aware that they and/or their Affiliates have co-operation and data sharing obligations with other co-registrants;

Whereas the Non-Lead Member has the intention to register the Substance and he is willing to appoint the Lead Registrant in order to enable him to submit the Joint Registration Dossier.

Whereas the European Commission adopted the Implementing Regulation 2016/09 on joint submission and data-sharing (the “Implementing Regulation 2016/9”), which entered into force on 26 January 2016, that inter alia defines more clearly what the terms ‘fair, transparent and non-discriminatory" mean for data and cost sharing obligations within the REACH legislation.

Whereas the Agency states in its REACH Guidance on data sharing of January 2017 that the members of the Joint Submission have to agree in writing certain operational rules concerning data sharing, rights on the developed information and sharing of costs, including a reimbursement mechanism, in accordance with the aforementioned criteria of fairness, transparency and non-discrimination.

Therefore, with a view to fulfilling their regulatory obligations under the REACH Regulation in respect to the Substance, the Parties hereto have decided to pursue the following objectives (hereinafter the “Purpose”):

  1. to agree on the operating rules governing the exchanges of information between the potential registrants of the substance (Title I);

  1. to agree on the rules regarding the rights to participate in the joint submission of data, to use the (robust) study summaries and to refer to the relevant full study reports in the Joint Registration Dossier developed by the Lead Registrant (Title II);

under the terms and conditions set forth in this Agreement.

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 hereunder, any definition specified in the REACH Regulation, in particular its Article 3, shall apply:

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 Party 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.

Data Owner: Any entity holding rights to use Information on the Substance.

Information: studies, other scientific, statistical, or technical data, including but not limited to composition, characteristics, properties and processes and applications, and any information in any form made available by a Party or generated by the Parties jointly, pursuant to or in the course of this Agreement.

Joint Registration Dossier: The data that the Parties are required to submit jointly to the Agency in order to register the Substance, pursuant to Article 11 (1), paragraph 2 and 4 or Art. 19 (1) paragraph 2 of the REACH Regulation.

Only Representative: A natural or legal person established in the EU appointed by a non-EU manufacturer to fulfil the obligations applicable to importers under the REACH Regulation, as permitted by Article 8 of the REACH Regulation.

Party/Parties: the signing parties to this Agreement, having the quality of either:

  1. Lead Registrant: a Member of the Joint Submission who is subject to the registration requirements under the REACH Regulation, which the Co-Registrant agrees hereto to appoint acting as Lead Registrant as defined under Article 11 (1) of the REACH Regulation.

  2. Co-registrant: a Memberof the Joint Submission being neither a Lead Registrant nor a data holder (article 28 (7) of the REACH Regulation) and that agrees to rely on the Joint Registration Dossier prepared and/or made available by the Lead Registrant, on his own behalf, for its Affiliates, and/or on behalf of the represented potential registrants in case he is an Only Representative and/or a Third Party

Substance:

Name: {{$jsfData->cas_name}}

(CAS no:{{$jsfData->cas_no}}, EC No:{{$jsfData->ec_no}})

Title I: OPERATING RULES

Article II. Confidentiality

  1. The Parties shall:

    1. treat all Information as confidential and not disclose it to third parties, unless regulatory disclosure requirements Each Party shall advise immediately the other Parties in writing of any disclosure or misuse by any Party or a third party of Information, as well as of any request by competent authorities relating to the disclosure of that Information.
      Disclosure of Information as required for legal and/or regulatory purposes including the REACH Regulation, shall only take place by the Parties in a form (for example short summaries where possible) reflecting the minimum information required to be disclosed. This restriction does not apply to the Party who has provided the Information.

    2. use the Information only for the Purpose or otherwise as permitted under or in accordance with this Agreement.

    3. disclose the Information to their employees, Affiliates, external experts and/or consultants and if the Lead Registrant is an Only Representative or a Third Party Representative, the non-EU manufacturer(s) or the legal entity(ies) represented by any of them, only on a need to know basis and only to the extent absolutely necessary for the Purpose or otherwise as permitted under or in accordance with this Agreement. Each Party shall have in place policies and procedures to ensure the confidentiality of Information, and require that its external experts and/or consultants also have such policies and procedures in place to ensure their compliance with these confidentiality.

  2. The obligations specified in Article 1 above shall not apply to Information for which the receiving Party can reasonably demonstrate that such Information:

    1. wasknown to the receiving Party on a non-confidential basis prior to its disclosure pursuant to this Agreement;

    2. ispublicly known at the time of disclosure or thereafter becomes publicly known without breach of the terms of this Agreement on the part of the receiving Party;

    3. becomesknown to the receiving Party through disclosure by sources other than the disclosing Party, having a right to disclose such Information,

    4. wasindependently developed by the receiving Party without access to the disclosing Party’s Information, as evidenced by documentary

    Specific items of Information shall not fall within any exception merely because they are combined with more general Information falling within any exception. Likewise, any combination of specific items of Information shall not fall within any exception merely because the specific items fall within any exception, but only if the combination itself, and its principles of operation, fall within any exception.

  3. With regard to studies, the obligations specified in this Article shall remain in effect for a period of twelve (12) years following the initial submission to the authorities

  4. The Co-registranth as the right to terminate the present Agreement subject to a prior three (3) months written notice to the Lead Registrant. The termination shall be effective at the end of the aforementioned notice period. No reimbursement shall be due and all the rights deriving from this Agreement will be withdrawn ex nunc. Notwithstanding the above, the Co-registrant shall continue to fulfil its own individual obligations deriving from REACH.

Article III. Competition Law compliance

  1. The Parties acknowledge that any activities carried out under this Agreement have to be carried out in full compliance with EU competition law, in particular but not limited to Articles 101 and 102 TFEU as well as any applicable national The Parties explicitly agree to observe Cefic REACH competition law compliance guidance attached as Annex 1 to this Agreement.

  2. Should it become apparent at any time that any provision of this Agreement, or any activity or decision of the Parties, can have a potentially restrictive effect on open and fair competition, in breach of any statutory provision, each Party to this agreement shall take immediate steps to remedy that

Article IV. Legal personality

This Agreement or the cooperation contemplated herein shall not constitute or be deemed to constitute a legal entity or partnership between the Parties.

Article V. Regular report of the preparation of the Joint Registration Dossier

  1. The Lead Registrant undertakes to inform the Non-LeadMember regularly on the development of the Joint Registration Dossier.

  2. In particular, in case the Chemical Safety Reportis included in the Joint Registration Dossier, the Lead Registrant undertakes to inform the Non-LeadMember on the list of uses to be covered in that Chemical Safety Report without undue delay.

  3. The Non-Lead Member undertakes to make all best efforts to check proactively and regularly all up-dated Information that is made available by the Lead Registrant on the development of the Joint Registration Dossier.

  4. The Parties agree that such communication may be channelled via the use of electronic communications and/or the relevant the joint submission object in REACH-IT as mentioned under Article VIII paragraph 1 of the present Agreement.

TITLE II: DATA SHARING AND JOINT SUBMISSION OF THE DOSSIER

Article VI. Participation in the joint submission of data by multiple registrants

  1. Inaccordance with Article 11 (1) or 19 (1) of the REACH Regulation, the Parties hereto agree to have the Joint Registration Dossier for the Substance submitted by the Lead Registrant on behalf of the Non-Lead Member having fulfilled its obligations under Article IX to this Agreement. Upon demand of the Agency, within the requested deadline and to the extent necessary, the Lead Registrant agrees to complete the Joint Registration Dossier.

  2. Notwithstanding anything to the contrary under this Agreement, the Parties remain individually responsible to comply with the REACH Regulation, in particular, but not limited to, in relation to the individual submission of the information required under Article 11(1) or 19 (1) of the REACH Regulation.

  3. Theparticipation in the Joint Registration Dossier may deviate per requesting Non-Lead Member according to its tonnage band or possible opt-outs for certain endpoints.

  4. If the Co-registrant requests the submission of the Joint Registration Dossier on behalf of an Affiliate, the Co-registrant shall notify the Lead Registrant with its name, address and other relevant data documenting such status of Affiliate. Upon receipt of such information, the Lead Registrant shall submit the Joint Registration Dossier also on behalf of such Affiliate.

  5. If the Co-registrantis an Only Representative and requests the submission of the Joint Registration Dossier on behalf of a legal entity represented by him in the Joint Submission, the Non-Lead Member shall notify the Lead Registrant under confidentiality obligations with the name, address and other relevant data of the represented legal entity. Upon receipt of such information, the Lead Registrant shall submit the Joint Registration Dossier also on behalf of such legal entity.

  6. If Co-registrant is a Third Party Representative and requests the membership to the Joint Registration Dossier on behalf of a legal entity represented by him in the Joint Submission, the Co-registrant may notify the Lead Registrant, under appropriate confidentiality obligations, with the name, address and other relevant data of the represented legal entity within 4 months before the registration due date. Upon receipt of such information, the Lead Registrant shall submit the Joint Registration Dossier also on behalf of such legal entity.

  7. The Lead Registrant shall open a joint submission object in REACH-IT and, in accordance to Article 11 (4) of the REACH Regulation, shall pay the registration fee as invoiced by the Agency for the submission of the Joint Registration Dossier without undue delay.

  8. The Lead Registrant shall make available the data referred to in Article 11 (1) paragraph 2 or Article 19 (1) paragraph 2 of the REACH Regulation that have been submitted in the Joint Submissionand when applicable the CSR as defined according to Article I of this Agreement, to the Co-registrant and/or Co-registrant’s Affiliate notified under Article VI.4 of this Agreement, provided the Co-registrant and/or the Co-registarnt’s Affiliate has/have fulfilled the relevant obligations under Article IX of this Agreement.

Article VII. Grant of right to use the (robust) studies summaries in the Joint Registration Dossier and to refer to the full study reports.

  1. Subject to the payment of the Joint Registration Compensation as specified under Article IX of this Agreement, the Lead Registrant grants the Co-registrant the non-exclusive, non-transferable and non-terminable right:

    1. to use the (robust) studies summaries and other Information used in the Joint Registration Dossier within the applicable tonnage band and for which no opt-out has been claimed by the Co-registrant;

    2. to refer to the full study reports on which basis the (robust) studies summaries have been developed(for the avoidance of doubt, copies of the full study reports will not be provided); and

    3. to grant the rights referred to under (a) and (b) hereabove to the Co-registrant’s Affiliates notified under Article VI.4, with the right to sub-license such rights only to their Only Representatives.

  2. Not with standing the foregoing, if the Co-registrantis a Third Party Representative or Only Representative, he is granted only with the rights specified under (a) and (b) here above, and only for the purpose to pass them to the legal entities represented by him in the Joint Submission and notified to the Lead Registrant under Article VI.5.

  3. The rights granted under this Article can be exercised only for the purpose of compliance with the REACH Regulation. The Parties shall abstain from any other use, whether commercial or non-commercial. For the avoidance of doubt, any further use of the studies shall be subject to an additional written agreement.

  4. In case, the Joint Registration Dossier includes data owned by Data Owner(s), the respective parts of the Joint Registration Dossier can only be submitted on behalf of the Co-registrant if either

    1. the Lead Registrant is entitled to pass on usage rights to the respective data; or

    2. the Co-Registrant has acquired usage rights directly from the Data Owner(s).

Based on the above, the Lead Registrant shall inform the Co-registrant of data which require separate third party(ies) (i.e. Data Owner(s)) approval for usage rights and may demand confirmation from the Co-registrant that he will acquire the relevant usage rights directly from the Data Owner(s).

Article VIII. Information on the submission of the Joint Registration Dossier

  1. Provided the Co-registrant has fulfilled its obligations under Article IX, the Lead Registrant shall inform immediately the Co-registrant of the creation of the joint submission object in REACH-IT and shall provide the valid security token number and the name of the joint submission.

  2. The Lead Registrant shall inform immediately the Co-registrant of the submission of the Joint Registration Dossier to the Agency and provide documentation of the same. For the avoidance of any doubt, the term documentation includes, but it is not limited to, the relevant IUCLID file.

  3. The Lead Registrant shall further communicate the confirmation that the joint registration has been successful and shall inform the Co-registrant of the reception of the relevant registration number that has been obtained from the Agency without undue delay.

  4. The Co-registrantshall inform mutatis mutandis the Lead Registrant about any changes in tonnage band registration and information requirements that could have an impact on the joint submission and the data and cost sharing rules mentioned under the present Agreement. The changes above shall become effective and operational vis-à-vis the Lead Registrant and the other members of the Joint Submission.

Article IX. Financial compensation for the Joint Registration Dossier

  1. The Co-registrant shall compensate in a fair, transparentand non-discriminatory way the Lead Registrant with a “Joint Registration Compensation” for the development and submission of the Joint Registration Dossier and the rights granted under Article VII above.

  2. The Joint Registration Compensationisset out in Annex 3 and will comprise the following elements:

    1. Administrative costs reasonably incurred bythe Lead Members and the Lead Registrant including but not limited to, secretarial services, management of confidential data and costs of external experts and provided that they are justified appropriately irrespective of their nature.

    2. Costs to acquire rights to use existing studies of an individual Lead Member and costs for studies jointly developed by the Data Owner(s)according to Annexes VI, VII, VIII, IX and X of the REACH Regulation.

    3. c) Costs for rights to use studies from Data Owners, if the Lead Registrant is authorized by Data Owners to transfer to Co-registrant the rights specified under Article VII. paragraph 1.

    4. When applicable costsfor the CSR which is made available by the Lead registrant to Co-registrant on an individual request.

    5. Costs for preparing the Technical Dossier including preparatory work like literature search, assessment of available data and writing (robust) study summaries.

  3. Both the study and administrative costs referred to above shall be allocated according to Annex 3 to this Agreement, in a transparent, fair and non-discriminatory wayand in full compliance with the Implementing Regulation 2016/9, to all Members of the Joint Submission with the intent to register the Substance, taking into account the following exceptions:

    1. Where a Co-registrant registers the Substance in a tonnage band lower than the one covered by the Joint Registration Dossier, it shall only be requested to compensate for those parts of the Registration Dossier that it is included in and for those studies it receives a right to refer for.

    2. Where the Co-registrant decides, based on Article 11 (3) of the REACH Regulation, to opt-out from the Joint Submission or some parts of the Joint Registration Dossier and submit the relevant information separately, it shall only be requested to compensate for those parts of the Joint Registration Dossier that are submitted jointly.

  4. Based on the above, the Lead Registrant will send an invoice to the Co-registrant for the sharing of the costs mentioned above after the request to join the joint submission. The Non-Lead Members will only receive a valid security token number after payment of the invoice. Payment is due within 1 (one) month after receipt of the invoice issued by the Lead Registrant or any legal entity acting on his behalf.

  5. In case new studies have to be purchased or performed or other dossier preparation, administrative or other cost have to be engaged after conclusion of this Agreement, the resulting cost will be divided in accordance with Annex 3 to this Agreement between all Members of the Joint Submissionwho are required to incorporate the results of these new studies into their registration dossiers, unless they claim to opt out in accordance with Article 11 (3) REACH. The Co-registrant will be granted on these new studies the same rights as referred to under Article VII.1 (a) and (b) of this Agreement.

  6. Upon signature of the present Agreement, the Parties agree to be bound by the cost sharing mechanism mentioned under Annex 2 herein. Furthermore, the cost sharing mechanism shall be based on the criteria of fairness, transparency and non-discrimination, and shall take into account, inter alia, the following factors: (i) the variable number of registrants potentially joining the Joint Submission; (ii) any additional information requirements for the successful submission of the Joint Registration Dossier; (iii) futurecosts including, but not limited to, the costs arising from a decision adopted by the Agency in accordance with Title VI of the REACH Regulation.

  7. Parties hereby agree to be bound by the recalculation of the study and non-study costs related to registration made by the Lead Registrant after the 2018 registration deadline and successively on a regular basis at the discretion of the Lead Registrant, and to share subsequently the aforementioned costs in a fair, transparent and non-discriminatory manner.

  8. When cost and income estimations related to the Joint Registration Dossier change, additional payments or refunds respectively may be initiated by the Lead Registrant. For both payments and refunds a threshold of 1.000 € per joint registrant is applicable.

  9. If the SIEF comprises various Affiliates of the Non-Lead members, each affiliate shall be subject to the obligation to compensate the Joint Registration Dossier in accordance with the Guidance on Data Sharing (v.3.1, 13/01/17):“In case of companies with various affiliates which are separate legal entities each of them must fulfil its registration obligations separately. Accordingly, each separate legal entity is obliged to fulfil its data and cost sharing obligations.”

  10. If an only representative represents more than one non-EU entity, such only representative shall compensate the Lead Registrant on account of each non-EU entity it represents by the payment of a separate Joint Registration Compensation per Non-EU entity and its Affiliates.

  11. If a Third Party Representativerepresents more than one entity, such Third Party Representative shall compensate the Lead Registrant on account of each entity it represents by the payment of a separate Joint Registration Compensation per entity and its Affiliates.

  12. Upon signature of the present Agreement, the Co-registrantshall be bound by the obligation to inform the Lead registrant of any changes in their corporate structure that can have an impact on this Agreement. In case the Affiliates companies mentioned above cease to meet the definition of Affiliate set out under Article 1 of this Agreement following changes in their corporate structure, these legal entities shall request separately a Letter of Access to the Lead Registrant and compensate individually and separately the Lead Registrant for any rights granted under this Agreement. These obligations shall be legally binding as from the date of non-fulfilment of the definition set out under Article 1 of this Agreement.

  13. 13. 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. Payee shall render any assistance to payer to obtain such withholding tax reduction, refund or exemption. Payer shall be entitled to any refund of withholding taxes.

  14. 14. 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 payer. However, payer is entitled to withhold any payment of indirect taxes unless payee has provided payer with a sufficient invoice for purposes of indirect taxation.

Article X. Ownership of Information

  1. This Agreement does not grant any ownership rights or change existing ownership rights to any of the Information provided under this Agreement to the Co-registrant, on whatever form and whenever, by the Lead Registrant, including without limitation, the Joint Registration Dossier.

  2. The Information provided by the Lead Registrant to the Co-registrant shall consist in any and all data and/or studies:

    1. Individually developed by one of the Lead Members;

    2. Collectively developed by the Lead Members for which they have acquired valid title or right to use; and

    3. Acquired from Data Owner(s) for which the Lead Members, or the Lead Registrantas the case may be, havebeen granted valid rights.

    4. Neither this Agreement nor any disclosure of Information shall vest any present or future rights in any patents, trade secrets or property rights and no license is granted.

TITLE III: FINAL PROVISIONS

Article XI. Limitation of liability

  1. The Parties shall undertake their Purpose related activities specified hereunder in good faith and according to all applicable laws and regulations, and they shall use all reasonable endeavours to ensure the best possible results based on the evidence, methods and techniques known at the time.

  2. Each Party having provideda study which has been used in the Joint Registration Dossier represents to the others (i)that it is the rightful owner of the study(ies) and/or entitled to grant rights therein or, that he has fulfilled the obligations mentioned under Article VII paragraph 4 above, (ii) that, to the knowledge of this Party, these studies do not infringe on the rights, in particular, but without limitation, intellectual property rights, of any third party and (iii) that this Party has not received a claim or notice of any alleged infringement.

  3. It is the individual responsibility of each Party to critically assess the Information that is generated or that is made available. Each Party assumes the full responsibility for its own use of the Information so developed or received. No warranty for acceptance by the Agency of the Joint Registration Dossieror any data it contains is given.

  4. None of the Parties, including the Lead Registrant, 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. In particular, the Lead Members, including the Lead Registrant,shall not be held responsible and liable for delays in the completion and submission of the Joint Registration Dossier, unless caused by gross negligence or wilful misconduct.

Article XII. Termination

  1. This Agreement shall enter into force as from the date of signing of this Agreement by both Parties. This Agreement shall remain in full force and effect for an indefinite period of time, unless terminated by the Non-Lead member in accordance with paragraph 4 of this Article XII set out below.

  2. This Article and the provisions relating to the protection of confidentiality (Article II),financial compensation for the Joint Registration Dossier (Article IX), ownership of Information (Article X), dispute resolution and applicable law (Article XV) and limitation of the liability (Article XI) shall survive the termination of this Agreement. With regard to the studies, the obligations specified in Article II of this Agreement shall survive for a period of twelve (12) years following the initial submission to the Agency. With regard to all other Information of the Joint Submission, the obligations specified in Article II shall survive for a period of five (5)years after termination.

  3. The Lead Registrant has the right to terminate its functions as lead registrant under the cumulative conditions that:

    1. it has been validly replaced in its functions within the Joint Submission;

    2. its assignee has accepted to be bound by the obligations of the Lead Registrant under this Agreement; and

    3. the Non-LeadMember has been notified about such replacement.

  4. The Co-registranthas the right to terminate the present Agreement subject to a prior