Merck-Approved DLA template for K-REACH
No Sub-licensing
Approved: July 2022

DATA LICENSE AGREEMENT
ACCORDING TO THE ACT ON THE REGISTRATION AND EVALUATION OF CHEMICALS (AREC), KNOWN AS KOREA REACH¹

¹The Act on the Registration and Evaluation of Chemicals (known as Korea REACH) passed the plenary session of the National Assembly in Korea on April 30, 2013 and came into force on Jan 1, 2015.DATA LICENSE AGREEMENT FOR REGISTRATION UNDER KOREA REACH

This Data License Agreement for Registration under Korea REACH (the "Agreementâ”¬Ã¶) is concluded between

ReachCentrum SA, a company established under the laws of Belgium, having its registered office at Cantersteen 47, 1000 Brussels, Belgium, represented by Magdalena Selerowska, General Manager (hereinafter referred to as 'ReachCentrum'), acting on behalf and for the account of the Data Owner

(hereinafter referred to as the "Data Owner(s)â”¬Ã¶)

and

[Grantee_Details]

(hereinafter referred to as "the Grantee(s)â”¬Ã¶)

Hereinafter referred to individually as a "Partyâ”¬Ã¶ and collectively as the "Partiesâ”¬Ã¶.

PREAMBLE

WHEREAS, the Data Owner holds rights on certain Studies relating to the Substance and has the authority to grant rights to refer to, use and copy the Studies;
WHEREAS, the Grantee considers that the Studies of the Data Owner may be of use for the preparation of its registration dossier on the Substance to be submitted to the Regulatory Authority for the compliance with the requirements of the Act on the Registration and Evaluation of Chemicals (AREC) (as amended from time to time) ("Korea REACHâ”¬Ã¶);
WHEREAS, the Grantee desires to refer to the full study reports and where applicable, to use the (robust) study summaries owned by the Data Owner, solely for the purpose of complying with the requirements of Korea REACH;
WHEREAS, ReachCentrum is entitled to duly represent the Data Owner for the purposes of this Agreement;
WHEREAS, the Data Owner is willing to provide the Grantee with a License as defined under Article 2 below, upon receipt of a compensation determined in a fair, transparent and non-discriminatory manner, in accordance with the terms and conditions of this Agreement;
WHEREAS, for the purpose of this Agreement, the Parties shall not exchange competitive or market information including, by way of example and without limitation, prices, identity of customers, raw material costs, manufacturing costs, marketing or sales plans, business plans and profit margins.

NOW, THEREFORE, in consideration of mutual promises, the Data Owner and the Grantee agree as follows:

Article I. Definitions

Terms starting with capital letters are defined in the Preamble above, in this Article 1 or in other parts of this Agreement.


Agreement:	This agreement including its Annexes 1 and 2.
Affiliate:	Any legal entity controlling, controlled by, or under common control with, either directly or indirectly, a Party. For purposes hereof, the term "controlâ”¬Ã¶ means (i) the possession, directly or indirectly, of the power to direct the general management or policies of an entity, whether through the ownership of voting rights, by contract or otherwise; or (ii) the ownership, directly or indirectly, of fifty per cent (50%) or more of the voting rights or other ownership interest of an entity.
Annex:	An attachment to this Agreement that makes integral part of this Agreement.
Appendix:	An enclosure to an Annex.
Effective Date:	The date upon which the last of the Parties signs this Agreement.
EU REACH:	Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
Letter of Access:	A document signed by ReachCentrum (representing the Data Owner) and addressed to the Regulatory Authority allowing it to rely on the Studies for the benefit of the Grantee, in the format as set out in Annex 1.
License:	Any reference to, and/or reliance on the Studies which the Grantee requires to make a submission to the Regulatory Authority for the purpose of compliance with Korea REACH as described under Article 2.
Regulatory Authority:	National Institute of Environmental Research ("NIERâ”¬Ã¶).
Studies:	Study or studies listed in Annex 2, and if applicable, copy or copies of the study summaries and/or robust study summaries, as listed in Annex 2.
Substance:	sodium 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonate [CAS 75277-39-3; EC 278-169-7].
Third Party:	Any party that is not a Data Owner or a Party to this Agreement.

Article II. License

Within thirty (30) days of receipt of payment of the compensation stipulated in Article 3 below, the Data Owner will grant to the Grantee a one-time, non-exclusive and non-transferable right (License) to refer to the Studies, and if applicable, to use the (robust) study summaries. Such right (License) will be implemented by a Letter of Access in the form set forth under Annex 1 to this Agreement.
If requested by the Grantee and accepted by the Data Owner and where applicable, the Data Owner will also provide the Grantee with (robust) study summaries in the form of an electronic file, based on the entries in the EU REACH joint registration dossier of the Data Owner, as it has been prepared by the Data Owner for EU REACH purposes. When provided, (robust) study summaries will be listed in Annex 2.
If requested by the Regulatory Authority, as evidenced to the Data Owner by the Regulatory Authority or by the Grantee in writing, the Data Owner or ReachCentrum, upon receiving an express written instruction from the Data Owner, will make the copy or copies of the full study reports available to the Regulatory Authority.
The License granted hereunder is limited for the sole purpose of compliance with Korea REACH requirements for the Substance. No sub-licensing is permitted. The Grantee 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.
The Parties recognise and agree that the Studies remain the exclusive property of the Data Owner and that intellectual property rights and any other protection rights connected with the Studies, including, but not limited to, patents and trademarks, are and shall continue to be the exclusive property of the Data Owner.
For the sake of clarity, this Agreement does not grant any ownership rights or change existing ownership rights to any of the Studies provided under this Agreement. Neither this Agreement nor any disclosure regarding the Studies shall vest any present or future rights in any patents, trade secrets or property rights and no license(s) other than those specified hereunder.
In case the Grantee is the lead registrant for the Substance, by signing this Agreement, the Grantee is bound by the obligation to inform Third Party co-registrants of the same Substance about the need to obtain right to refer (license) to the Studies for the fulfilment of Korea REACH requirements. Upon signature of the present Agreement, the Grantee shall provide ReachCentrum with the relevant contact details and tonnage bands information of such Third Parties.
Where applicable, the (robust) study summaries will be made available to the Grantee in English. It is the full responsibility of the Grantee to comply with the requirements of Korea REACH relating to translation and/or formatting thereof (if and when needed). The Data Owner and/or ReachCentrum shall not assume any direct or indirect responsibility or liability for the accuracy or correctness of the translation and/or formatting.

Article III. Compensation

In consideration of the License granted under Article 2 above, the Grantee will compensate the Data Owner.
The compensation for the License will be effective by the payment to ReachCentrum of the relevant amount of EUR [Bundle amount] in addition to ReachCentrum's handling fee of EUR [Handling Fee amount]. Payment is due within thirty (30) days after receipt of a pro-forma invoice issued by ReachCentrum. On receipt of payment, ReachCentrum will issue a tax invoice.
All payments due pursuant to this Agreement 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. Furthermore, should the Grantee be required under any applicable law or regulation to withhold or deduct any portion of the payment due to the Data Owner, then the sum payable to ReachCentrum will be increased by the amount necessary to yield to the Data Owner an amount equal to the sum it would have received had no withholdings or deductions been made.
If the Grantee fails to withhold or deduct an amount as required under any applicable law or regulation (i) any amounts under-withheld and any penalty or interest paid by the Grantee for failing to withhold, shall not be recovered from the Data Owner or ReachCentrum; and (ii) the Grantee shall indemnify the Data Owner and ReachCentrum for any claims made against the Data Owner and/or ReachCentrum in respect of the amounts under-withheld by the Grantee and any associated penalties and interest.
The compensation mentioned under this Agreement excludes any indirect taxes, including but not limited to Value Added Tax (VAT), Goods and Service Tax (GST), service tax, business tax, as applicable under the applicable laws or regulations. If any indirect taxes are payable under this Agreement, the Grantee will pay to the Data Owner or the relevant tax authority an amount equal to the indirect tax payable, subject to the Grantee receiving a valid tax invoice as required under the applicable law or regulation.

Article IV. Confidentiality

The Grantee agrees to:
1. Treat all information contained in the Studies as confidential and to use the Studies only for the purpose specified in, and according to the terms of, this Agreement;
2. Advise immediately ReachCentrum in writing of any disclosure or misuse by a Third Party of the Studies as well as of any request by the Regulatory Authority or any competent authority relating to the disclosure of confidential information;
3. Make all reasonable efforts to ensure that disclosure of the Studies, as required for the compliance with Korea REACH purposes, shall only take place in a form reflecting the minimum information required to be disclosed (e.g. short summaries where possible);
4. Make the confidential information available only to those employees, Affiliates (including their employees) or external consultants (including their employees) who need to have access to the Studies for the purpose specified in this Agreement and who are contractually or otherwise obligated to keep the latter confidential. The Grantee shall be responsible and accountable for the compliance of its Affiliates (including their employees) or its external consultants (including their employees) with the obligations of this Article 4.
In the event the Grantee is requested to disclose the Studies due to a governmental and/or judicial obligation or order other than for the requirements under Korea REACH, the Grantee will immediately inform ReachCentrum in writing.
The provisions of this Article 4 shall survive the termination or expiry of this Agreement.

Article V. Term & Termination

This Agreement takes effect on the Effective Date.
This Agreement and the License granted hereunder will have no expiration, except as provided under Article 5.3 and Article 5.4 below.
This Agreement and the License provided hereunder shall expire once the Studies are no longer protected. The Parties acknowledge the data protection period under Korea REACH.
Any Party may terminate this Agreement and the License granted hereunder, 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) 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.
Upon termination of this Agreement pursuant to Article 5.4 above due to the Granteeâ”¬Ã†s breach:
1. All Studies in whatever form will be immediately returned by the Grantee to the Data Owner;
2. The Grantee will withdraw any Letter of Access for the Studies that was submitted to the Regulatory Authority;
3. All rights granted to the Grantee will immediately revert to the Data Owner; and
4. The Grantee will have no claim against the Data Owner and/or ReachCentrum, for compensation of loss of business or goodwill for any other damages that may result from termination of this Agreement.
No sums paid under this Agreement shall be refunded.

Article VI. Liability

The Parties shall undertake their obligations in good faith and according to all applicable laws and regulations.
The Grantee acknowledges that in no event shall the Data Owner and/or ReachCentrum be liable to the Grantee for any damage of any kind, whether direct or indirect (including, but not limited to, consequential damages, lost profits and trading losses), that may result from reliance on the Studies by the Grantee, unless caused by gross negligence or wilful misconduct.
The Data Owner and/or ReachCentrum do not provide any express or implied warranty regarding the quality of the Studies. No warranty is provided for the acceptance by the Regulatory Authority of the Studies in the format provided.
The Grantee has satisfied itself as to the relevancy of the Studies. The Data Owner and/or ReachCentrum will have no liability should the Studies or any part of the Studies be questioned in any manner or considered inaccurate, incomplete or insufficient for the purposes of compliance with Korea REACH.
The Grantee represents and warrants that it shall not try to alter, modify or amend the Studies and shall solely use and/or refer to the Studies in the format provided by the Data Owner.
The Grantee further represents that it fulfils and shall fulfil any applicable national and international legal requirement, including but not limited to intellectual property rights, related to the referral rights on publicly available studies that are necessary for the effective reference to the full study reports and (robust) study summaries mentioned under Article 2 above. Similarly, in case of (robust) study summaries, where applicable, the Grantee shall obtain all necessary referral rights from Third Party data owners, and without such referral rights, those (robust) study summaries cannot be used or referred to.

Article VII. Legal entity change

Neither Party shall have the right to assign this Agreement, nor any of its rights hereunder, nor delegate any of its obligations hereunder, without the prior written consent of the other Party, which shall not be unreasonably withheld.

Article VIII. Compliance with competition law

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 of the Treaty on the Functioning of the European Union as well as any applicable national laws.
Should it become apparent at any time that this Agreement, any provision of this Agreement, or any activity or decision of the Parties, could 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 situation.

Article IX. Entire agreement

This Agreement, which incorporates Annexes 1 and 2 represents the entire agreement between the Parties for the purposes of granting/obtaining the License and supersedes any prior agreement (whether oral or written) relating to the subject-matter of this Agreement between the Parties.
This Agreement may be amended by mutual agreement between the Parties in writing.

Article X. Dispute resolution and applicable law

This Agreement shall be governed by the laws of Belgium, without regard to any principle of conflict or choice of laws that would cause the application of the laws of any other jurisdiction.
In case of a dispute arising out of this Agreement, the Parties shall first attempt to find an amicable settlement. Any dispute or claim out of or in connection with the validity, interpretation, execution or termination of this Agreement that cannot be resolved amicably by the Parties within a period of sixty (60) days from the date a Party requested amicable settlement, shall be settled before the Courts of Brussels.
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.

Article XI. Notices & Miscellaneous

Notices under this Agreement shall be given in writing by registered mail to the addresses specified in this Agreement in relation to each undersigning Party.
Notices may also be given under this Agreement by sending an electronic mail to the signatories outlined below, with acknowledgement of receipt then being made by the recipient via electronic mail to the sender.
This Agreement can be executed by means of original signatures, presentation of a scanned version of original signatures or by means of electronic signatures.

IN WITNESS WHEREOF, the undersigned Parties, by their duly authorised officers, have executed and delivered this Agreement.

(SIGNATURE PAGES FOLLOW)
For the Data Owner,
represented by ReachCentrum SA

NAME:	Magdalena Selerowska
TITLE:	General Manager
DATE:	[_______________________]
SIGNATURE:	[_______________________________________]

For the Grantee

NAME:	[_____________________________]
TITLE:	[_______________________________________]
DATE:	[_______________________]
SIGNATURE:	[_______________________________________]

Annex 1
Letter of Access

Subject: Letter of Access for the registration of the Substance under the Act on the Registration and Evaluation of Chemicals (AREC) also known as "Korea REACHâ”¬Ã¶²

To whom it may concern,

Subject to the terms and in consideration of the compensation set forth in the Data License Agreement for Registration under Korea REACH dated _____________ between the Grantee and the Data Owner, by this letter, the Data Owner, grants the Grantee the right (license) to refer to the below mentioned Studies, solely for the purpose of preparing its Korea REACH registration dossier on the below mentioned Substance for submission to the National Institute of Environmental Research ("NIERâ”¬Ã¶):

GRANTEE:	[Grantee_Details]
SUBSTANCE:	sodium 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonate [CAS 75277-39-3; EC 278-169-7]
STUDIES:	as per the Appendix below.

This Letter of Access does not under any circumstances authorise NIER to use, reference or rely upon the Studies listed in the Appendix below in support of other registration applications made by Third parties without written permission of the Data Owner or of ReachCentrum upon receiving an express written instruction from the Data Owner, or for purposes other than those explicitly mentioned under this Letter of Access, including, but not limited to, any use, reference or reliance outside the framework of Korea REACH.

Furthermore, this Letter of Access does not, under any circumstances, authorise the Grantee or any unauthorised Third party to inspect the Studies listed in the Appendix below and/or receive copies thereof, as a whole or in part, in the original form or as a copy.

The Studies listed in the Appendix below must be kept confidential vis-Ã“Â¡Ã‚is all unauthorised Third parties at all times. The relevant Studies can only be viewed by designated personnel within the relevant department of NIER. For the avoidance of any doubt, all data remain the exclusive property of the Data Owner.

Sincerely,

For the Data Owner,

represented by ReachCentrum SA

Signature:	_______________________________
Name:	_______________________________
Title:	____________________________________
Date:	_____________

²The Act on the Registration and Evaluation of Chemicals (known as Korea REACH) passed the plenary session of the National Assembly in Korea on April 30, 2013 and came into force on Jan 1, 2015.

Appendix to the Letter of Access

CAS 75277-39-3 | Data Package [...] t/a

[List of Studies]

Annex 2 - Studies

CAS 75277-39-3 | Data Package [...] t/a

[List of Studies with Access Value]

CAS 75277-39-3 | Data Package 10 - 100 t/a