STPP SIEF Agreement Contract
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DRAFT Consortium Agreement for the REACH Registration of Sodium Tri Poly Phosphate (STPP) pursuant to requirements of the European REACH Regulation TABLE OF CONTENTS Members ............................................................................................................................. 3 Preamble ............................................................................................................................ 4 Copyright ........................................................................................................................... 4 I) Definitions ............................................................................................................. 5 II) The purpose .......................................................................................................... 7 II. 1) REACH Registration preparation ........................................................................... 7 II. 2) Management of access to the REACH Registration Dossier ................................ 8 III) Membership .......................................................................................................... 8 III. 1) Admission of new Members to the Consortium ..................................................... 8 III. 2) Transfer of membership ........................................................................................ 9 III. 3) Termination of Membership ................................................................................. 10 III. 4) Exclusion ............................................................................................................. 10 III. 5) Common provisions on termination and exclusion .............................................. 11 IV) Confidentiality ...................................................................................................... 11 V) Ownership of data ................................................................................................ 12 V. 1) Obligation to make available data ....................................................................... 12 V. 2) Ownership rights and uses of Information ........................................................... 13 V. 3) Third party access to Information ........................................................................ 14 VI) VI. Organisation .................................................................................................... 15 VI. 1) Legal personality .................................................................................................. 15 VI. 2) Organisation ........................................................................................................ 15 VI. 3) Governing Committee .......................................................................................... 15 VI. 4) Not applicable ...................................................................................................... 16 VI. 5) Technical Committee ........................................................................................... 16 VI. 6) Not applicable ...................................................................................................... 17 VI. 7) The Secretariat .................................................................................................... 17 VI. 8) Delegations of powers and representation to third parties .................................. 18 VI. 9) Working language. ............................................................................................... 19 VI. 10) Rules on voting, quorum and meeting organisation ........................................ 19 VII) Lead Company ..................................................................................................... 21 VIII) Individual obligations .......................................................................................... 21 IX) Competition law compliance ............................................................................... 22 X) Definition of costs and cost allocation .............................................................. 22 X. 1) Valuation of Studies ............................................................................................. 22 X. 2) Cost sharing principles ........................................................................................ 22 XI) Administration & Reporting of costs .................................................................. 23 XII) Limitation of liability ............................................................................................ 23 XIII) Duration, termination, modification .................................................................... 24 XIV) Dispute resolution and applicable law ............................................................... 24 Sodium Tri Poly Phosphate REACH Consortium Agreement version 28-3-08 page 1 / 47 pages XV) Signatures ................................................................................................................. 25 Annex 1 - Substance identification ................................................................................ 26 1. The Substance ......................................................................................................... 26 2. Impurities: ................................................................................................................ 26 Annex 2 – Identified Uses ............................................................................................... 27 1. Non confidential uses .............................................................................................. 27 2. Confidential uses ..................................................................................................... 28 3. Identification of “confidential” uses .......................................................................... 28 Annex 3 – Not applicable - company information ........................................................ 28 Annex 4 – Affiliates of Members .................................................................................... 29 Annex 5 – Existing Studies ............................................................................................ 30 Annex 6 – Specified external experts ............................................................................ 33 Annex 7 – Typical current costs of Studies and tests ................................................. 33 Annex 8 – Valuation and access to information ........................................................... 34 1. Scientific evaluation ................................................................................................. 34 2. Calculation of value ................................................................................................. 35 3. Indicative summary table: Rules of access ............................................................. 36 Annex 9 – Financial rules ............................................................................................... 37 1a. General financial rules ........................................................................................... 37 1b. Indicative summary table : Payments due for Membership and/or Dossier access 39 2. Administration Fee ................................................................................................... 40 3. Advantage Compensation Payment: ....................................................................... 40 4. Consortium Entry Fee: ............................................................................................. 40 5A). Pro Rata Share: ................................................................................................... 41 5B). Cost sharing mechanism: one Member = one share ........................................... 41 5C). Costs included in Pro Rata Share costs .............................................................. 42 5D). Rules for company costs ..................................................................................... 42 6. Dossier Contribution Costs: ..................................................................................... 42 7. Financial contributions in case of leaving the Consortium ...................................... 43 8. Consortium accounting system and payments ........................................................ 43 Annex 10A – Model Letter of Access (for Members) ................................................... 45 Annex 10B – Model Letter of Access (Non Members) ................................................. 46 Annex 11 – Consortium preparatory work costs ......................................................... 47 Sodium Tri Poly Phosphate REACH Consortium Agreement version 28-3-08 page 2 / 47 pages Sodium Tri Polyphosphate Consortium Agreement This Agreement is signed between the following Members: Note: conform to §I below (“Definitions”), one “Member” may cover a number of legal entities which are separate REACH Registrants (each paying its own Registration Fee), if and only if each of these legal entities is an “Affiliate” (see Definitions) of this Member, and in this case this Member is treated as a single unit in all aspects of this Agreement: one vote, one share in cost sharing, etc … Affiliates of Members as at the date of Entry into Force are listed in Annex 4. Members At the date of Entry into Force of this Agreement 1) BK Giulini GmbH, a company with limited liability under German law (Gesellschaft mit beschraenkter Haftung), whose registered