General Purchasing Conditions

These general purchasing conditions (hereafter “the General Purchasing Conditions”) govern the contractual provisions to be complied with by the Supplier of products, works or services, receiving the purchase order (hereafter “the Supplier”) from the Issuer Company Roche Diagnostics S.p.A. – a sole shareholder company (hereafter “Roche”). Any contractual condition other than these that may be issued by the Supplier shall only be valid if expressly and specifically accepted in writing by two duly authorised Roche attorneys.

It is understood that in case of a specific agreement being formalised between Roche and the Supplier with the aim of governing the supply of goods, works or services by the same Supplier, the conditions contained in the agreement must prevail over the provisions of the General Purchasing Conditions.

1. ACCEPTANCE OF THE GENERAL PURCHASING CONDITIONS: Roche’s orders can be made to the Supplier, alternatively or cumulatively, at Roche’s exclusive discretion, via courier, mail, email, telefax or in person, and must be signed, also via electronic signature, by two duly authorised corporate attorneys, with the Supplier being bound to accept the form and methods determined by Roche from time to time. Pursuant to art. 1327 of the Italian Civil Code, by commencing fulfilment of its contractual obligations, the Supplier tacitly accepts Roche’s General Purchasing Conditions. It is understood that Roche reserves the right to revoke the purchase order with written and motivated communication given to the Supplier, in case of force majeure or change in its own company schedule, paying the Supplier only the amounts equal to the expenses incurred and documented until the revocation of the purchase order.

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2. DILIGENCE: the Supplier undertakes to perform the services/works/supplies that are the subject of this purchase order with the utmost diligence and expertise. Roche reserves the right to check the progress and good execution of the supplies related to the issued orders, via visits and checks made at the discretion of its personnel at the Supplier’s premises.

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3. PRICES, INVOICING AND PAYMENT CONDITIONS: the prices set for this supply are fixed, unchangeable and, unless otherwise specified, inclusive of packaging for shipment. Unless otherwise specified by Roche in writing, the payment conditions shall not provide for a term shorter than 60 days from the end of the month of the invoice date, via bank transfer; the debiting of bank charges shall not be accepted. The invoices related to the orders shall be sent as hardcopy to the address reported in the purchase order or alternatively in electronic form to the address monza.contabilita-fornitori@roche.com. These invoices shall not be issued with a date prior to the date of delivery of the relative goods and shall make reference to the order number, the shipping document and indicate, in the same sequence, the products, works or services listed in said document; in the event of partial delivery, the invoice shall indicate whether said delivery is the initial delivery or the balance. In any case Roche shall be entitled to refuse the goods or the invoices in the event of breach of these conditions and all costs and charges shall be borne by the Supplier. The Supplier’s credit towards Roche is not transferable to third parties pursuant to art. 1260, 2nd par. of the Italian Civil Code.

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4. TERMS AND METHODS OF DELIVERY, PACKAGING AND MARKINGS: Roche shall have the right to refuse the products that are delivered late compared to the agreed terms, without any need for additional clarifications with the Supplier. The deliveries on Roche's account shall be made by the Supplier, unless otherwise instructed, at the prices and conditions that offer the cheapest overall transport tariff. Deliveries to Roche facilities must be made during normal business hours, which the Supplier is asked to check beforehand. For the deliveries requested by Roche, the Supplier must use authorised couriers recognised nationally and/or internationally, possessing suitable insurance for the transported goods, and must forward Roche a copy of the relevant delivery documents. In case of special requirements/risks regarding the deliveries due to the characteristics of the transported goods, the Supplier undertakes to stipulate, upon Roche’s request, the necessary supplementary insurance in order to guarantee the delivery. The relevant cost and methods shall be defined and agreed between the parties from time to time. Any break, deadlock and other expenses due to the Supplier’s missing documents shall be charged to the same Supplier. For deliveries abroad, the Supplier is obliged to send, before the arrival of the goods, the certificate of origin and four copies of the invoice for the customs office. Deliveries must be made in the set terms. In the event of a foreseeable delay, the Supplier must give prompt communication in advance. Roche shall be entitled to procurement from third parties, cancelling the order or the part of it that is delayed, reserving the right to claim consequential damages. Unless otherwise stipulated in the order, delivery shall be C.I.P. (Incoterms 2000) up to the place of delivery indicated in the order. All products shall be delivered using appropriate means of transport and shall be marked in accordance with the laws currently in force. It is, however, agreed that the Supplier shall continue to be liable for risk of loss of product up to such time as Roche shall have full availability of same, having signed the shipping document, at Roche premises or, subordinately, at different places agreed in writing. If the cost of the packaging is not included in the price, the Supplier shall, at the time of shipment of the material, impart precise instructions for its collection; in the absence of said instructions, it is understood that the Supplier intends to abandon the packaging in question, which must not be billed to Roche for any reason whatsoever.

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5. SHIPPING DOCUMENTS (S.D.): the shipping documents (S.D.) shall indicate the order number, the identification code (if any), the relative description and the quantity of the product to which they refer. In the event of partial delivery, the S.D. shall indicate whether the delivery is an initial delivery or a delivery of the balance; in the event of replacement of faulty products, the details of the S.D. issued by Roche shall be given.

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6. ACCEPTANCE AND TESTING OF THE SUPPLY: With regard to the goods to be supplied, an excess of not more than that agreed on or that is customary shall be tolerated. In the event that the quantity of goods delivered exceeds this tolerance, the Supplier undertakes to recall the excess quantity at its own expense. Any increase in the products, works or services compared to the amounts stated in the initial order can take place only through a subsequent purchase order. The Supplier declares and warrants that, irrespective of any consent or preliminary check on the part of Roche, the goods delivered are free from all forms of patent or latent defects of origin or manufacture and fully conform to the prescriptions of this order. In the case of orders that explicitly specify acceptance tests, acceptance shall be subject to a favourable outcome of same. In the event of failure to accept the supply for defects in terms of performance or execution, the Supplier shall replace what was delivered at its expense and according to the terms indicated by Roche. All this without prejudice to Roche’s right to cancel the order, wholly or partially, and to be indemnified for the damage suffered. Any testing of the products and works must be performed with good workmanship and documented in writing.

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7. WARRANTY: The Supplier guarantees that the goods delivered shall maintain the technical characteristics established and shall be in good working order. Unless otherwise agreed in writing due to the peculiarities of the product, the supply is covered by warranty by the Supplier for a period of 365 days from the delivery date.

Roche must notify to the Supplier any defects found within 60 days from the delivery in case of patent defects, and within 60 days from their discovery in case of latent defects. The defects discovered when unpacking are considered as latent defects. The obligation to report the defect by the terms above does not apply if the Supplier recognised the existence of the defect or hid it.

If a defect is found in the product by the warranty period, and communication is given to the Supplier by the abovementioned terms, the Supplier must promptly repair or replace it at its expense; otherwise Roche shall be entitled to eliminate the effects directly or through third parties, charging the Supplier the related costs. In any case the Supplier remains responsible for the defects found in the product supplied and for any damage caused by it to Roche or third parties, in compliance with national and community regulations. For all parts replaced, repaired or modified, this warranty period is automatically renewed for the same period starting from the date of restart-up. It is understood that any repair, replacement or modification that proves to be necessary under the warranty shall be borne by the Supplier, without prejudice to the right to compensation for damages.

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8. INTELLECTUAL AND INDUSTRIAL PROPERTY RIGHTS: the Supplier guarantees that the products, works or services and the relative documentation supplied to Roche do not infringe any patent, trademark, software, copyright or other intellectual and industrial property right of any third party, at national or international level, and that no legal action for infringement of patent or breach of the rights referred to above is pending before any whatsoever court; if this is not the case, the Supplier has an obligation to inform Roche in writing. The Supplier shall hold Roche harmless against all claims of third parties asserting infringement or breach. Roche shall have the right, free of charge, to utilise the product, work or service documentation, reproduce, translate and modify the same to include it in its own documentation and supply it to its associated companies abroad.

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9. ROCHE’S KNOW HOW: if the subject of the orders is created in execution of moulds, specifications, indications, technical solutions or know how communicated by Roche, the Supplier cannot use them in third party supplies unless authorised to do so by Roche in writing. Upon Roche’s request, the Supplier undertakes to immediately return all the documents provided to it, including any copies or reproductions.

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10. WASTE DISPOSAL: Pursuant to Leg. Decree 152/2006 and subsequent amendments and integrations, the Supplier undertakes to remove, keep and dispose of the waste generated by the processing activities, being entirely responsible for managing it and exempting and keeping harmless Roche from any responsibility which may derive in this sense. When provided for by the applicable regulations in force or following an expressed request, the Supplier shall forward to Roche copies of the documents proving the disposal.

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11. MACHINERY AND EQUIPMENT: in case of supply of machinery or equipment, the Supplier guarantees that the product being supplied complies with EC Directives and national implementing regulations, is in good working order and was made in accordance with applicable regulations on the safety of the plants and hygiene and safety in the workplace. Roche reserves the right to request the Supplier to enter into an insurance policy that guarantees the correct operation as well as covering third party civil liability.

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12. SAFETY AT WORK; WELFARE AND CONTRIBUTION OBLIGATIONS: the Supplier guarantees to comply with all the regulations in force on health and safety in the workplace (Leg. Decree no. 81/2008), assuming any responsibility regarding the due fulfilment of contractual, welfare and insurance obligations towards its personnel, being also liable for any damage or accident caused to the same personnel in performing the service. The Supplier shall in particular be obliged to pay the withholding taxes on the income of employees and the compulsory welfare and insurance contributions set by law for accidents at work and occupational diseases of the employees, notwithstanding Roche’s right to verify the fulfilment of these obligations, requesting a copy of the relevant documentation (by way of example: DURC – Single Insurance Contribution Payment Certificate).

Therefore Roche reserves the right to suspend the payment of the due consideration until the Supplier produces the documentation above, once requested.

Thus the Supplier undertakes to:

a) guarantee its personnel a regulatory and remuneration treatment that is not lower than the one established by the contractual regulations in force for the relevant category;

b) provide insurance coverage for accidents at work, third party civil liability regarding people or objects with a suitable ceiling, stipulated with leading insurance companies, for social security and health treatment, and observe all the provisions in force regarding employment laws;

c) adopt all the measures, devices and procedures aimed at avoiding the occurrence of accidents and damage to people or objects;

d) strictly comply with applicable regulations on environmental protection and waste management.

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13. CONFIDENTIALITY: the Supplier undertakes to consider all the information received by Roche or in any case acquired while executing the order, as confidential and not to disclose to third parties or use for purposes other than the execution of the order, without Roche’s prior written consent, technical and commercial information, including drawings, outlines, designs, moulds, samples and components, supplied by Roche for the execution of the order or in any case acquired while executing the same order. This prohibition must be considered as binding for the Supplier and its assignees also after the termination of the contractual relationship with Roche for a period of five years, and shall be binding also in case of change in the company name and ownership structure of the Supplier. In case of breach Roche may intervene for damage compensation, notwithstanding the right to prosecute the Supplier pursuant to articles 621, 622 and 623 of the Italian Criminal Code. The Supplier shall not make reference to Roche or to the purchasing order in any of its press releases or other forms of advertising unless authorised by Roche beforehand in writing.

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14. PROHIBITION TO SUBCONTRACT: sub-contracting the services/works/supplies commissioned by Roche to the Supplier is forbidden. Deviating from this prohibition, the Supplier may subcontract to third parties the execution of all or part of the services/works/supplies, indicating in the quote all the details of the subcontract. Issuing the orders by Roche equates to accepting the subcontract, as indicated in the quote by the Supplier.

It is specified that, pursuant to the regulatory provisions in force, the Supplier is responsible with the subcontractor jointly and severally for the application and payment of the withholding taxes on the income and the compulsory welfare and insurance contributions set by law for accidents at work and occupational diseases of the employees to which the subcontractor is obliged.

This joint and several responsibility may cease to apply only when the Supplier finds, by acquiring the related documentation prior to paying the consideration, that the obligations stated above and connected to the employment performance concerning the entrusted work, supply or service, have been correctly carried out by the subcontractor, notwithstanding Roche’s right to suspend the payment of the consideration until subcontractor produces the related documentation (by way of example, DURC). It is understood that the Supplier is obliged to carry out a substantial selection of the subcontractor based on an in-depth assessment of the requirements in terms of organisational structure, personnel, skills and expertise in the industry, compliance with regulations and the obligations applicable to the activity and services that are the subject of the subcontract. In any case, the Supplier shall remain the only responsible party towards Roche, also in relation to the subcontracted works.

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15. COMPLIANCE WITH ANTI-CORRUPTION REGULATIONS: the Supplier declares to know and to comply with the provisions of Leg. Decree no. 219/2006, of the Farmindustria Code of Professional Conduct, Roche’s Code of Ethics, published on the website http://www.roche.it. The Supplier shall not undertake any action that may determine a breach of the Code of Ethics by a Roche employee or which may result, always by any company of the Roche Group, in a breach of the laws concerning the prevention of frauds, corruption, racketeering, money laundering or terrorism. The Supplier must not either directly or indirectly pay, promise or authorise the payment of cash, or promise or authorise the concession of any valuable asset to any person or body, including professionals operating in the healthcare industry or public official, or personnel of any healthcare facility, to attempt to obtain an undue advantage for any company of the Roche Group. The Supplier declares that in the 24 months prior to this contractual relationship it has not made, solicited, authorised or received any payment, promise or perk related to the description in the paragraph above.

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16. COMPLIANCE WITH LEG. DECREE 231/2001: the Supplier guarantees to have adopted and implemented organization and management models that are suitable to prevent crimes from being committed pursuant to the regulation on the administrative responsibility of companies under Leg. Decree 231/01, to have duly trained its personnel concerning the provision of Leg. Decree 231/01 and to have set up surveillance and control mechanisms for the same personnel in order to prevent crimes from being committed.

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17. EXPRESSED TERMINATION: with no obligation for the termination and with no prejudice for any other remedy connected to Roche, including the right to compensation for damages, Roche shall have the right to revoke the purchase orders in writing, fully or partially, and therefore declare the contract relationship terminated pursuant to art. 1456 of the Italian Civil Code in the case in which:

 

  • the Supplier has not fulfilled the obligations under the General Purchasing Conditions, with particular but not exclusive reference to articles 15 and 16, i.e. should the conduct of the Supplier be in some way harmful to Roche’s reputation or the reputation of one of the affiliates of the group, notwithstanding the right to compensation for the damages suffered;
  • the Supplier is subject to bankruptcy, receivership proceedings or other insolvency procedure pursuant to Royal Decree no. 267 of 16 March 1942 and subsequent amendments and integrations, or becomes in any case insolvent or unable to correctly manage its affairs;
  • the Supplier does not fulfil its obligation deriving from the purchase order and relating to: delivery dates and quantities, deviations, confidentiality or other specific obligations;
  • in case of merger or incorporation of the Supplier into another company or body or in case of substantial change in the corporate ownership of the Supplier pursuant art. 2359 of the Italian Civil Code;
  • the Supplier breaches the “Safety regulations for the prevention of accidents in the workplace” and/or Roche’s internal safety regulations;
  • the subject of the order includes the transportation of hazardous or harmful or toxic substances, the Supplier does not have the appropriate national or regional authorisations.

 

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18. CONTROL AND AUDIT: the Supplier grants Roche and any auditing company possibly appointed by it as well as any regulatory authority, the right to access its premises and directly access and examine any document that exclusively refers to the service/work/supply and the obligations borne by the same Supplier under these general agreement conditions ("Audit"). As part of the Audit, Roche may have access to commercially sensitive information of the Supplier, its affiliates or any of its contractors and sub-contractors involved in the execution of the service/work/supply; should this Audit be carried out by auditing companies appointed by Roche, these shall report to Roche only the pertinent information to inform it on the compliance with the provisions and content of the General Purchasing Conditions. It is understood that, should an auditing company be used, Roche undertakes to guarantee that the same company signs a confidentiality agreement. During the Audit, the Supplier undertakes to provide all the cooperation and assistance reasonably requested during normal office hours, it being understood that Roche undertakes to guarantee that any auditor or other person who is given access for the Audit causes the minimum disturbance to the activities of the Supplier and that they observe the safety regulations. Roche shall incur individually the Audit and surveillance costs according to the content of this article.

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19. ACTIVITY MONITORING: Roche has implemented procedures to monitor and review the performance of its suppliers in order to continuously improve its purchases. The Supplier undertakes to cooperate with Roche in relation to this monitoring and review activities and to provide Roche with all the information requested by it (or its auditors in case of sensitive information), linked to the contractual relationship determined by the order.

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20. INFORMATION PURSUANT TO ARTICLE 13, LEGISLATIVE DECREE 196/2003:Pursuant to Art. 13 of Leg. Dec. 196/2003, “Personal data protection code”, the Supplier is informed that the personal data provided to Roche or otherwise acquired by it in execution of the purchase order, shall be processed.

The personal data that is processed shall be utilised solely for the following purposes:

 

  • supplier administration;
  • fulfilment of contractual obligations;
  • management of contracts, orders, deliveries and invoices;
  • fulfilment of legal obligations, including tax and accounting obligations;
  • defensive needs.

 

The personal data shall be processed using instruments capable of guaranteeing data security and confidentiality, utilising manual, computer and electronic instruments with logics strictly correlated to the purposes listed above.

The Supplier’s data shall be processed by Roche’s employees and/or collaborators duly appointed to carry out the processing tasks.

Provision of the Supplier’s personal data is voluntary but necessary for the performance and the management of the contractual relationship and obligatory for fulfilling the company’s legal obligations. Accordingly, refusal to provide the data shall make it impossible for the company to execute or perform the relative contracts.

The Supplier is also informed that in relation to the purposes specified above, its personal data may be communicated exclusively to parent companies, subsidiaries and associated companies of the Roche Group, banks and credit institutions, service and consultancy companies, consultants, professionals, trade and employers’ associations and the competent authorities for compliance with the law.

The Supplier’s personal data may be transferred abroad, including to countries that are not members of the European Union, always and exclusively for the purposes indicated herein and for technical and IT-related reasons.

Legislative Decree 196/2003 provides certain instruments for the protection of these rights, listed in Art. 7 of same. In particular, the data subject has the right to obtain confirmation of the existence of personal data that concern him/her at any time, and to learn the content and origin of this data, verify its correctness and request additions, update, or rectification. Pursuant to the same article the data subject has the right to request cancellation of the data, transformation into anonymous form or the blocking of data processed unlawfully and to object, in all cases, for legitimate reasons, to the processing.

The Supplier may exercise these rights at any time, by contacting the Data Controller, Roche S.p.A. (registered and administrative offices in V.le G.B. Stucchi 110, 20900 Monza) or the Data Processor being the Manager of the Purchasing Department domiciled for his office in Monza, V.le G.B. Stucchi 110 or may send an e-mail to the following address:

monza.privacy@roche.com

An updated list of the data processors concerned can be consulted on the site: www.roche.it.

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21. APPLICABLE LAW AND COURT OF JURISDICTION: these general purchasing conditions and the relevant contractual relationships are governed by the laws of Italy and any dispute that may arise on its interpretation or application shall be referred exclusively to the Court of Milan.

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