Common use of REACH Clause in Contracts

REACH. Upon receipt of payment, the Lead Registrant will issue the Non-Lead Member which has complied with its obligations under Article VI.4, VI.5 or VI.6 as applicable, with a revised Letter of Access listing the expanded study list and summaries, for which rights to refer are granted. 7. If it becomes apparent that before the submission of the Joint Registration Dossier the actual costs are higher than the payment set out under paragraph 4 above, the Lead Registrant has the right to adjust the payments by requiring additional payment from the Non-Lead Member. 8. If the SIEF comprises various Affiliates of the Non-Lead Member, only one of these Affiliates within the SIEF shall be subject to the obligation to compensate the Joint Registration Dossier. Such single Joint Registration Compensation will be calculated on the basis of the highest tonnage band of all these Affiliates. Accordingly, the Affiliates of the compensating Non-Lead Member, or the Affiliates of the non-EU established companies represented by an Only Representatives being a Non-Lead Member, shall also have the right to refer to the Joint Registration Dossier under the same conditions without additional payment. In that case, the Non-Lead Member that has paid the compensation is responsible for compliance of its Affiliates or their Only Representative (as the case may be) with the rights and obligations pursuant to the Agreement, including the confidentiality obligations under Title I, Article II of the Agreement. 9. If an Only Representative represents more than one non-EU entity within the SIEF, 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. 10. If a Third Party Representative represents more than one entity within the SIEF, 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. 11. 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. 12. 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.

REACH. Upon receipt of payment, the Lead Registrant will issue the Non-Lead Member which has complied with its obligations under Article VI.4, VI.5 or VI.6 as applicable, with a revised Letter of Access listing the expanded study list and summaries, for which rights to refer are granted. 7. If it becomes apparent that before the submission of the Joint Registration Dossier the actual costs are higher than the payment set out under paragraph 4 above, the Lead Registrant has the right to adjust the payments by requiring additional payment from the Non-Lead Member. 8. If the SIEF comprises various Affiliates of the Non-Lead Member, only each one of these Affiliates within the SIEF shall be subject to the obligation to compensate the Joint Registration Dossier. Such single Joint Registration Compensation will be calculated on the basis of the highest tonnage band of all these Affiliates. Accordingly, the Affiliates of the compensating Non-Lead Member, or the Affiliates of the non-EU established companies represented by an Only Representatives being a Non-Lead Member, shall also have the right to refer to the Joint Registration Dossier under the same conditions without additional payment. In that case, the Non-Lead Member that has paid the compensation is responsible for compliance of its Affiliates or their Only Representative (as the case may be) with the rights and obligations pursuant to the Agreement, including the confidentiality obligations under Title I, Article II of the Agreement. 9. If an Only Representative represents more than one non-EU entity within the SIEF, 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. 10. If a Third Party Representative represents more than one entity within the SIEF, 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. 11. 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. 12. 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.