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CAS 68919-40-4 | Data Package 10 - 100 t/a

Price: POA
All endpoints used in the EU REACH dossier and needed in the Turkey REACH dossier.

Product Features:

  • CAS 68919-40-4

  • EC 272-897-9

  • Cocoamphodipropionic Acid

  • Imidazolium compounds, 1-[2-(2-carboxyethoxy)ethyl]-1(or 3)-(2-carboxyethyl)-4,5-dihydro-2-norcoco alkyl

Includes:

Study name Short Description Data Owner
Phys-Chem | Appearance/physical state/colour Robust Study Summary -- Title: Physicochemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Appearance/physical state/colour Right to refer to study -- Title: Physicochemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Melting point/freezing point Robust Study Summary -- Title: Physicochemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Guideline: 102 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Melting point/freezing point Right to refer to study -- Title: Physicochemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Guideline: 102 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Boiling point Robust Study Summary -- Title: Physicochemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Guideline: 103 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Boiling point Right to refer to study -- Title: Physicochemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Guideline: 103 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Density Robust Study Summary -- Title: Physicochemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol,4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Guideline: 109 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Density Right to refer to study -- Title: Physicochemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol,4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Guideline: 109 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Vapour pressure Robust Study Summary -- Title: Physicochemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole- 1-ethanol, 4,5-dihydro, 2- (C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Guideline: 104 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Vapour pressure Right to refer to study -- Title: Physicochemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole- 1-ethanol, 4,5-dihydro, 2- (C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Guideline: 104 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Partition coefficient Robust Study Summary -- Title: n-Octanol/Water Partition Coefficient of MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid / Slow stirring method | Author: Ricau, H | Year: 2019 | Guideline: 123 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Partition coefficient Right to refer to study -- Title: n-Octanol/Water Partition Coefficient of MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid / Slow stirring method | Author: Ricau, H | Year: 2019 | Guideline: 123 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Water solubility Robust Study Summary -- Title: Solubility in water of MIRANOL C2M AA / Reaction product of 1HImidazole-1- ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Ricau, H | Year: 2019 | Guideline: 105 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Water solubility Right to refer to study -- Title: Solubility in water of MIRANOL C2M AA / Reaction product of 1HImidazole-1- ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Ricau, H | Year: 2019 | Guideline: 105 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Water solubility Robust Study Summary -- Title: Physicochemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Water solubility Right to refer to study -- Title: Physicochemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Solubility in organic solvents/fat solubility Robust Study Summary -- Title: Solubility in n-octanol of MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Ricau | Year: 2019 | Guideline: 105 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Solubility in organic solvents/fat solubility Right to refer to study -- Title: Solubility in n-octanol of MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Ricau | Year: 2019 | Guideline: 105 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Surface tension Robust Study Summary -- Title: Physicochemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Guideline: 115 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Surface tension Right to refer to study -- Title: Physicochemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Guideline: 115 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Flash point Robust Study Summary -- Title: Security physico-chemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Flash point Right to refer to study -- Title: Security physico-chemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole-1-ethanol, 4,5-dihydro, 2-(C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Auto-ignition temperature Robust Study Summary -- Title: Security physico-chemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole- 1-ethanol, 4,5-dihydro, 2- (C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Auto-ignition temperature Right to refer to study -- Title: Security physico-chemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole- 1-ethanol, 4,5-dihydro, 2- (C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Flammability Robust Study Summary -- Title: Security physico-chemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole- 1-ethanol, 4,5-dihydro, 2- (C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Flammability Right to refer to study -- Title: Security physico-chemical tests on MIRANOL C2M AA / Reaction product of 1HImidazole- 1-ethanol, 4,5-dihydro, 2- (C11-17 and C17 unsatd. alkyl) derivs. and acrylic acid | Author: Demangel, B. | Year: 2019 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Environmental | Biodegradation in water: screening tests Robust Study Summary -- Title: Biodegredability of MIRANOL C2M AA / Reaction product of 1HImidazole- 1- ethanol, 4,5-dihydro, 2- (C11-17 and C17 unsatd. alkyl) derivs. | Author: Flach F. | Year: 2018 | Guideline: 301B | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Environmental | Biodegradation in water: screening tests Right to refer to study -- Title: Biodegredability of MIRANOL C2M AA / Reaction product of 1HImidazole- 1- ethanol, 4,5-dihydro, 2- (C11-17 and C17 unsatd. alkyl) derivs. | Author: Flach F. | Year: 2018 | Guideline: 301B | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Eco-Tox | Short-term toxicity to aquatic invertebrates Robust Study Summary -- Title: Miranol C2M AA: A Study on the Acute Toxicity to Daphnia magna | Author: Egeler, P. & Lang, A. | Year: 2019 | Guideline: 202 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Eco-Tox | Short-term toxicity to aquatic invertebrates Right to refer to study -- Title: Miranol C2M AA: A Study on the Acute Toxicity to Daphnia magna | Author: Egeler, P. & Lang, A. | Year: 2019 | Guideline: 202 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Eco-Tox | Toxicity to aquatic algae and cyanobacteria Robust Study Summary -- Title: Miranol C2M AA: A Study on the Toxicity to Freshwater Green Algae (Raphidocelis subcapitata) | Author: Gilbert, D. & Lang, A. | Year: 2019 | Guideline: 201 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Eco-Tox | Toxicity to aquatic algae and cyanobacteria Right to refer to study -- Title: Miranol C2M AA: A Study on the Toxicity to Freshwater Green Algae (Raphidocelis subcapitata) | Author: Gilbert, D. & Lang, A. | Year: 2019 | Guideline: 201 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Toxicological | Acute toxicity: oral Robust Study Summary -- Title: Miranol C2M Anhydrous Acid - Acute toxicity in mice | Author: I. Levenstein | Year: 1978 | Guideline: 401 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. -
Toxicological | Acute toxicity: oral Right to refer to study -- Title: Miranol C2M Anhydrous Acid - Acute toxicity in mice | Author: I. Levenstein | Year: 1978 | Guideline: 401 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. -
Toxicological | Skin irritation / corrosion Robust Study Summary -- Title: Miranol C2M Anhydrous Acid: Skin irritation in rabbit | Author: I. Levenstein | Year: 1978 | Guideline: 404 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. -
Toxicological | Skin irritation / corrosion Right to refer to study -- Title: Miranol C2M Anhydrous Acid: Skin irritation in rabbit | Author: I. Levenstein | Year: 1978 | Guideline: 404 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. -
Toxicological | Eye irritation Robust Study Summary -- Title: The effect of Miranol C2M Conc Anhydrous Acid 8803149 on the eye mucosa of New Zealand Albino rabbits | Author: Y. Terrell | Year: 1988 | Guideline: 405 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. -
Toxicological | Eye irritation Right to refer to study -- Title: The effect of Miranol C2M Conc Anhydrous Acid 8803149 on the eye mucosa of New Zealand Albino rabbits | Author: Y. Terrell | Year: 1988 | Guideline: 405 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study. -
Toxicological | Eye irritation Robust Study Summary -- Title: Effect of Miranol C2M Anhydrous Acid on rabbits' eyes. | Author: I. Levenstein | Year: 1978 | Guideline: 405 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. -
Toxicological | Eye irritation Right to refer to study -- Title: Effect of Miranol C2M Anhydrous Acid on rabbits' eyes. | Author: I. Levenstein | Year: 1978 | Guideline: 405 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. -
Toxicological | Skin sensitisation Robust Study Summary -- Title: Miranol C2M AA: In Chemico Skin sensitisation: Direct Peptide Reactivity Assay (DPRA) | Author: C. Michel | Year: 2018 | Guideline: 442C | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Toxicological | Skin sensitisation Right to refer to study -- Title: Miranol C2M AA: In Chemico Skin sensitisation: Direct Peptide Reactivity Assay (DPRA) | Author: C. Michel | Year: 2018 | Guideline: 442C | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Toxicological | Skin sensitisation Robust Study Summary -- Title: Miranol C2M AA: KERATINOSENS TEST AN IN VITRO SKIN SENSITISATION ASSAY | Author: C. Michel | Year: 2019 | Guideline: 442D | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Toxicological | Skin sensitisation Right to refer to study -- Title: Miranol C2M AA: KERATINOSENS TEST AN IN VITRO SKIN SENSITISATION ASSAY | Author: C. Michel | Year: 2019 | Guideline: 442D | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Toxicological | Skin sensitisation Robust Study Summary -- Title: Miranol C2M AA: ASSESSMENT OF THE SKIN SENSITIZATION POTENTIAL USING THE HUMAN-CELL LINE ACTIVATION TEST (h-CLAT) | Author: Alizée Aubert | Year: 2019 | Guideline: 442E | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Toxicological | Skin sensitisation Right to refer to study -- Title: Miranol C2M AA: ASSESSMENT OF THE SKIN SENSITIZATION POTENTIAL USING THE HUMAN-CELL LINE ACTIVATION TEST (h-CLAT) | Author: Alizée Aubert | Year: 2019 | Guideline: 442E | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Toxicological | in vitro gene mutation study in bacteria (Ames) Robust Study Summary -- Title: Miranol C2M AA: Bacterial reverse mutation test | Author: K. Privat | Year: 2018 | Guideline: 471 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Toxicological | in vitro gene mutation study in bacteria (Ames) Right to refer to study -- Title: Miranol C2M AA: Bacterial reverse mutation test | Author: K. Privat | Year: 2018 | Guideline: 471 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study. -
Phys-Chem | Particle size distribution (Granulometry)/Fibre length and diameter distribution Waiver -
Phys-Chem | Explosive properties Waiver -
Phys-Chem | Oxidising properties Waiver -
RSS and access rights to the underlying studies. The price offered gives restricted access for registration purposes under Turkey REACH only.
The offer does not include the right for sublicensing.
For publicly available studies, no access costs have been included and the buyer needs to ensure that they fulfil the requirements for the use of the publication.
Rhodia Operations-Approved DLA Standard template for KKDIK
No Sub-licensing
Approval: 13-Dec 2021
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DATA LICENSE AGREEMENT
FOR REGISTRATION UNDER TURKEY REACH1


1KKDIK - the Turkish implementation of the European Union's (EU) REACH in Turkey (also known as Turkey REACH) was published by the Ministry of Environment and Urbanisation (MoEU) on June 23, 2017 and came into force on Dec 23, 2017.
DATA LICENSE AGREEMENT FOR REGISTRATION UNDER TURKEY REACH


This Data License Agreement (the "Agreement") is effective as of [Order Date], (the "Effective Date") 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 Solvay-Rhodia Operations based 52 rue de la Haie Coq 93300 Aubervilliers, France (hereinafter referred to as the 'Data Owner')

(hereinafter referred to as the "Data Owner(s)")

and

[Grantee_Details]

(hereinafter referred to as "the Grantee(s)")


Hereinafter referred to individually as a "Party" and collectively as the "Parties".

PREAMBLE

  1. 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;
  2. 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 Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDIK) (as amended from time to time) ("Turkey REACH");
  3. WHEREAS, the Grantee desires to refer to the full study reports and where applicable, to use the (robust) study summaries and/or the CSR owned by the Data Owner, solely for the purpose of complying with the requirements of Turkey REACH;
  4. WHEREAS, ReachCentrum is entitled to duly represent the Data Owner for the purposes of this Agreement;
  5. 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;
  6. 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 "control" 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 exclusively to make a submission to the Regulatory Authority for the purpose of compliance with Turkey REACH as described under Article 2.
Regulatory Authority:Ministry of Environment and Urbanization.
Studies:Study or studies listed in Annex 2, and if applicable, copy or copies of the study summaries and/or robust study summaries, and/or if applicable, chemical safety report ("CSR") as listed in Annex 2.
Substance:Imidazolium compounds, 1-[2-(2-carboxyethoxy)ethyl]-1(or 3)-(2-carboxyethyl)-4,5-dihydro-2-norcoco alkyl [CAS 68919-40-4; EC 272-897-9].
Third Party:Any party that is not a Data Owner or a Party to this Agreement.

Article II. License

  1. 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 and the CSR. For the avoidance of doubt, the License shall not allow the Grantee to sub-licence any rights granted thereunder to other potential further registrants under Turkey REACH, as set out in Article II.7 below. Such right (License) will be implemented by a Letter of Access in the form set forth under Annex 1 to this Agreement.
  2. 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 and/or with the CSR, as it has been prepared by the Data Owner for EU REACH purposes. For the avoidance of doubt, the Data Owner will not provide the full study reports of the Studies. When provided, the (robust) study summaries and the CSR will be listed in Annex 2.
  3. 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 only to the Regulatory Authority.
  4. The License granted hereunder is limited for the sole purpose of compliance with Turkey 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.
  5. 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.
  6. 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.
  7. 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 the right to refer (license) to the Studies for the fulfilment of Turkey 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.
  8. Where applicable, the (robust) study summaries and the CSR will be made available to the Grantee in English. It is the full responsibility of the Grantee to comply with the requirements of Turkey 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

  1. In consideration of the License granted under Article 2 above, the Grantee will compensate the Data Owner.
  2. 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.
  3. 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.
  4. 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.
  5. 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

  1. 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 Turkey 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.
  2. 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 Turkey REACH, the Grantee will immediately inform ReachCentrum in writing.
  3. The provisions of this Article 4 shall survive the termination or expiry of this Agreement.

Article V. Term & Termination

  1. This Agreement takes effect on the Effective Date.
  2. This Agreement and the License granted hereunder will have no expiration, except as provided under Article 5.3 and Article 5.4 below.
  3. This Agreement and the License provided hereunder shall expire once the Studies are no longer protected. The Parties acknowledge the data protection period under Turkey REACH.
  4. 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.
  5. Upon termination of this Agreement pursuant to Article 5.4 above due to the Grantee'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.
  6. Upon termination of this Agreement pursuant to Article V.4 above, no sums paid under this Agreement shall be refunded.

Article VI. Liability

  1. The Parties shall undertake their obligations in good faith and according to all applicable laws and regulations.
  2. 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.
  3. 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.
  4. 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 Turkey REACH.
  5. 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 particular but not limited to the CSR) in the format provided by the Data Owner.
  6. 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 and/or the CSR, where applicable, the Grantee shall obtain all necessary referral rights from Third Party data owners, and without such referral rights, those (robust) study summaries and data in the CSR cannot be used or referred to.

Article VII. Legal entity change

  1. The Grantee shall not 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

  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 of the Treaty on the Functioning of the European Union as well as any applicable national laws.
  2. 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

  1. 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.
  2. This Agreement may be amended by mutual agreement between the Parties in writing.

Article X. Dispute resolution and applicable law

  1. 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.
  2. 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 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 CEPANI shall be applicable. The place of any hearing shall be Brussels and the language of the arbitration shall be English.
    10.2.Notwithstanding the above, each Party, at its own expenses, may at any time request from any competent judicial authority any interim or conservatory measure.
  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.

Article XI. Notices & Miscellaneous

  1. 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.
  2. 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.
  3. 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, 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 Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDIK) also known as "Turkey REACH"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 Turkey REACH dated [Order Date] 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 Turkey REACH registration dossier on the below mentioned Substance for submission to the Ministry of Environment and Urbanization:


GRANTEE:[Grantee_Details]
SUBSTANCE:Imidazolium compounds, 1-[2-(2-carboxyethoxy)ethyl]-1(or 3)-(2-carboxyethyl)-4,5-dihydro-2-norcoco alkyl [CAS 68919-40-4; EC 272-897-9]
STUDIES:as per Annex 2.

This Letter of Access does not under any circumstances authorise the Ministry of Environment and Urbanization 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 Turkey 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-à-vis all unauthorised third parties at all times. The relevant Studies can only be viewed by designated personnel within the relevant department of the Ministry of Environment and Urbanization. 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:_____________


1KKDIK - the Turkish implementation of the European Union's (EU) REACH in Turkey (also known as Turkey REACH) was published by the Ministry of Environment and Urbanisation (MoEU) on June 23, 2017 and came into force on Dec 23, 2017.

Appendix 1

CAS 68919-40-4 | Data Package [...] t/a


[List of Studies]

Annex 2 - Studies

CAS 68919-40-4 | Data Package [...] t/a

[List of Studies with Access Value]