Intraocular Lenses 3

The tenderer must declare whether it or its representatives have relevant final convictions within the previous five years, or are still subject to an exclusion period, for participation in a criminal organisation, corruption, fraud, terrorism-related offences, money laundering or terrorist financing, child labour or human trafficking. It must also declare whether it has outstanding tax or social security payment obligations. In Estonia, tax debts below EUR 100 are not treated as requiring a tax-debt certificate, and a debt whose payment has been rescheduled is also treated accordingly; foreign tenderers are assessed under the rules of their country of establishment. Other grounds include bankruptcy, insolvency, liquidation, an arrangement with creditors, a comparable situation under national law, administration of assets by a liquidator or court, or suspended business activity; serious professional misconduct; competition-distorting agreements; an unmanageable conflict of interest; involvement in preparing the procurement that creates an advantage which cannot otherwise be neutralised; and significant or repeated failures under previous public contracts resulting in early termination, damages, a price reduction or a penalty. Grounds also include breaches of environmental, social or labour obligations; false or misleading information, withholding information, failure to provide requested supporting documents, or seeking confidential information to gain an improper advantage; enabling the unlawful employment of a foreign national; contracting with a person or entity in breach of an international or Estonian government sanction; and convictions for tax offences. Where permitted, the tenderer may provide evidence of measures taken to restore its reliability.

The tenderer must have supplied intraocular lenses or comparable ophthalmic implants to healthcare providers under at least one contract during the 36 months before the procurement began. The contract may be completed or ongoing and must have a total value of at least EUR 50,000 excluding VAT. The tenderer must provide the contract value, period and customer; the contracting authority may request evidence of the references and proper performance. The tenderer must submit the completed participation form, the prescribed pricing spreadsheet and the completed technical description and offer form. The total tender price must be stated excluding VAT in the required format and according to the specified pricing form. Conditional tenders are not permitted, and submission confirms acceptance of the procurement document requirements. For each product offered, provide manufacturer-issued technical information in Estonian or English, a declaration of conformity, instructions for use and package labelling, and an EC certificate where applicable. For products from the same manufacturer that differ only in size, package labelling for one selected size is sufficient. The tenderer must also provide evidence of compliance and a manufacturer-issued document or copy proving that it is an official representative and/or authorised reseller of the offered products. Each offered intraocular lens must have been in clinical use for at least five years before the tender submission deadline. Where an equivalent product is offered, explain the equivalence and provide supporting evidence. The tenderer must confirm that the offered goods are not subject to international sanctions and do not originate from sanctioned regions. For contracts within the scope of the relevant EU sanctions regulation, the tenderer must also confirm that subcontractors and suppliers covered by the Russian sanctions restrictions will not perform more than 10% of the contract value. Joint tenderers must appoint an authorised representative and submit their power of attorney. Any information claimed as a trade secret must be identified and the claim justified; tender prices and other specified assessment figures may not be designated as trade secrets.