These General Conditions of Supply (hereinafter the “Conditions”) lay down rules to be applied to relationships for the supply of products, goods, services, tangible or intangible assets, completion of projects, works, including intellectual activities, consultancy, collaborations established between the Supplier and Roche S.p.A. - sole-shareholder company (hereinafter “Roche”) as a result of a purchase order issued by the latter.

Any contractual conditions prepared and proposed by the Supplier that differ from these Conditions will have no value with reference to the collaboration relationship between Roche and the Supplier referred to in the purchase order. It is understood that, if a specific contract to regulate the Supplier’s provision of goods, works or services is formalised between Roche and the Supplier, the conditions contained in the contract must be considered prevailing with respect to the rules contained in the General Conditions of Purchase.

The Supplier undertakes to act upon, and execute, what is specified in the purchase order received from Roche without violating any of the regulatory requirements referred to in (i) Legislative Decree No. 219/2006; (ii) the Farmindustria Code of Conduct, as well as (iii) legislation governing relations with healthcare professionals and public officials; (iv) Legislative Decree No. 165/2001, (v) Presidential Decree No. 62/2013, (vi) Legislative Decree No. 81/2008 (Consolidated Law on occupational health and safety), (vii) the current legislation and regulations on the prevention of corruption and on conflict of interest pursuant to Law No. 190/2012, as amended, and regulations, where applicable, on the prevention of corruption issued by Autorità Nazionale Anti-corruzione (ANAC, Italian National Anti-Corruption Authority).

The Supplier declares that it is aware of, and undertakes to comply with, the rules contained in the Code of Ethics and in the Organisation Policy adopted by Roche under Legislative Decree No. 231/2001 (viewable on the Internet site, and any procedures and guidelines of the Roche Group agreed upon from time to time.

“Supplier”: any natural or legal person, any organisation (public, private or third sector, including “non-profit” organisations) or grouping of such persons and/or organisations that could validly maintain commercial or collaboration or partnership relationships with Roche, respectively offering, on the market, the completion of projects, works and/or activities, production or marketing of goods, supply of products or provision of services.

“Order”, “Purchase Order”, “PO”: legally binding written instrument treated as a contract whereby Roche, as a customer or purchaser, formalises its intention to the Supplier, who accepts, to act upon a business transaction concerning one or more services or obligations already defined in all their fundamental elements as a result of prior negotiations concluded successfully between Roche and the Supplier itself (hereinafter, jointly, the “Parties”).

Contract”: a legally relevant relationship that is created between the Parties as a result of the issue of an Order by Roche and acceptance thereof by the Supplier in light of the prior acceptance of these General Conditions.

Product”: any service, work or tangible activity, intangible or intellectual service that may be the subject of a business transaction, as specified in the purchase order.

The Supplier acknowledges that the prior, full and unconditional acceptance of these General Conditions is a pre-requisite for the purpose of accreditation in the supplier registry of Roche S.p.A. and that Roche S.p.A. may at any time verify, or appoint third parties to verify, whether the Supplier actually and continuously meets the requirements referred to in these Conditions for the purpose of permanence in the supplier registry.

It is understood, and the Supplier takes note thereof, that the mere accreditation in the supplier registry of Roche will not, in itself, constitute a sufficient condition to entertain expectations to successfully conclude business transactions with Roche, nor will it give the Supplier or third parties any right to mention Roche among their referrals.

Orders from Roche may reach the Supplier either cumulatively or, alternatively at the sole discretion of Roche, by courier, postal service, email, purchasing electronic platforms (if accredited) or hand delivery, and must always be signed, including by electronic signature, if any, by two duly empowered company attorneys, being the Supplier required to accept the form and procedure chosen by Roche from time to time.

Pursuant to Article 1326 of the Italian Civil Code, including without the formal signature of a document, acceptance by the Supplier of the order will constitute a contractual event implying intent, to which these General Conditions apply.

Pursuant to Article 1327 of the Italian Civil Code, at the time of commencement of the fulfilment of its contractual obligation, the Supplier will accept these Roche General Conditions of Supply in full and without reservations. It is understood that Roche reserves the right to revoke a Purchase Order, by notice in writing and providing reasonable grounds to the Supplier, in case of force majeure or changes in its business programs, reimbursing the Supplier only for the amount equal to any documented costs incurred until the purchase order was revoked.

It is understood that any exclusive rights are expressly excluded.

The Supplier undertakes to perform what is requested in the purchase order according to the highest standards of the relevant business sector and with the utmost diligence and expertise. Roche reserves the right to verify the progress and accurate execution of the work commissioned, including through visits and audits at the Supplier’s premises, implemented at the discretion of its personnel.

The total fees negotiated in relation to the Order will be understood as fixed and invariable, and, unless otherwise specified, inclusive of all expenses that are instrumental for delivery. Unless otherwise specified by Roche, with instructions to be issued in writing, payment terms will not be less than 60 days from the end of the month from the invoice date, with payment by bank transfer. No bank charges will be accepted. Pursuant to and in accordance with regulations on electronic billing in force since 2019, this is to inform those concerned that the “Codice Univoco Ufficio” (electronic office billing code) of Roche S.p.A. to be specified in their electronic invoices is SN4CSRI. If the electronic billing system has not been adopted, invoices must be submitted in paper form to the address specified in the Purchase Order, or in electronic format to the email address: [email protected]. Invoices should not be issued with a date prior to the date of delivery of the related goods and should refer to the Order number and to the Documento di Trasporto (DDT, transport document) and must contain a description of the products, works or services in the same sequence as listed therein. In case of partial delivery, the invoice will specify whether the delivery is a partial or final delivery. In any case, Roche reserves the right to reject any goods or invoices in the event of non-compliance with these rules and all costs and charges will be borne by the Supplier. The Supplier will not be permitted to assign its credit with Roche to any third parties, pursuant to Article 1260, 2nd paragraph, of the Italian Civil Code.

Roche will have the right to refuse a late execution or delivery with respect to the agreed deadline, without the need for further clarification to the Supplier. Any shipments whose cost is borne by Roche will be performed by the Supplier, unless otherwise specified, at prices and conditions that offer a comprehensive shipping rate that is the most beneficial to Roche. Executions or deliveries to Roche locations will be performed during normal opening hours of the same, being the Supplier required to verify / agree on the same in advance. For shipments requested by Roche, the Supplier must use nationally and/or internationally recognised approved couriers and must take out suitable insurance for the transported goods, sending a copy of the relevant shipping documents to Roche. In case of special needs / risks in activities / shipments, due to the characteristics of the order, the Supplier undertakes, at the request of Roche, to take out the necessary additional insurance to guarantee delivery, showing a copy of a valid policy to Roche upon simple request. The related cost and methods will be defined and agreed between the parties from time to time. Any stoppages, delays and other expenses due to the Supplier’s document deficiencies will be charged to the same. For shipments from abroad, the Supplier will be required to send, before the arrival of the goods, a certificate of origin and a copy of the customs bill in four specimens. Deliveries must be made within the specified deadline. In the event of a foreseeable delay, the Supplier is required to give prompt notice to Roche in advance. Roche will have the right to procure the service from third parties, cancelling the order or the part thereof that has been hampered by the delay, with a further right to claim any damages resulting therefrom. Unless otherwise stated in the order, delivery will be understood as C.l.P. (Incoterms 2000) up to the place of delivery specified in the order; all products will be delivered by using appropriate means of transport and will be marked according to regulations in force. It is in any case agreed that any liabilities and risks relating to the loss of the goods or products will rest with the Supplier until the time when Roche obtains full possession of such goods or products, certified by the signature of the transport document at the premises of Roche, or, alternatively, at any other premises agreed in writing. With reference to packaging, if not included in the price, the Supplier will, upon shipment of the material, be required to give accurate instructions for its return, it being understood that, in the absence of such instructions, the Supplier intends to abandon such packaging, which will not be billed to Roche for any reason. No minimum order will be set.

Transport documents (DDT) must specify the order number, the identification code (if assigned), and the relevant description and quantity of the product to which they refer. In case of partial delivery, it must be specified whether the delivery is partial or final; in case of replacement of defective products, the DDT details issued by Roche must be included.

The Supplier declares that, regardless of any approval or preliminary control by Roche, the work completed or service delivered will be free from obvious or hidden original or manufacturing defects and will be in full compliance with the instructions contained in the order. For orders that expressly include testing sessions, the acceptance of the supply will be subject to the successful outcome of such testing. In case of non-acceptance of the supply due to defects in the scope of the service or in its execution, the work delivered will be replaced at the expense of the Supplier in the terms specified by Roche. In any case, the right of Roche to cancel all or part of the supply, and to be indemnified for the damage suffered, will remain without prejudice. Any testing of products or works must be performed in a workmanlike manner and must be documented in writing.

The Supplier warrants that the service provided and/or work completed in execution of the order meets and will continue to meet the characteristics set out and requested therein, and warrants for its compliance with all applicable regulations in Italy and in the European Union and for the good operation thereof for a period of 365 days from the date of final acceptance and, for services and activities where no delivery takes place, for a period of 365 days of continuous service. Roche will notify the Supplier of any defects found within 60 days of delivery in the case of obvious defects, and within 60 days of discovery in the case of hidden defects. Defects that may have been discovered at the time of unpacking will also be considered as hidden defects. The obligation to report the defect within the above period will not apply if the Supplier has acknowledged the existence of the defect or has concealed it. If a product defect is assessed within the warranty period - and is notified to the Supplier within the above period - the Supplier will promptly arrange for its repair or replacement at its own expense; conversely, Roche will have the right to eliminate the defect directly or through third parties by charging the Supplier for all related costs. In any case, the Supplier’s liability for any defects in the supplied product and for any damages deriving therefrom to Roche or to third parties will, in compliance with national and EU regulations, remain without prejudice. During the warranty period, the same will be automatically renewed for the same period - for all parts replaced, repaired or modified - starting from the date on which they became operational again. It is understood that any repairs, replacements or modifications that may become necessary in view of the warranty for good operation will be borne by the Supplier, without prejudice to the right to compensation for damages.

The Supplier warrants that the products, works or services, and related documentation, provided to Roche, do not violate any patent, trademark, software, copyright or other right concerning the intellectual or industrial property of third parties, either nationally or internationally, and that no legal action for patent infringement or violation of the rights referred to above is pending in any jurisdiction; conversely, the Supplier will be required to give written notice thereof to Roche. The Supplier undertakes to keep Roche harmless from any damage resulting from claims brought by third parties alleging such infringement or violation. Roche reserves the right to use the documentation relating to products, works or services free of charge, to reproduce, translate and modify it in order to insert it into its documentation and to transmit it to its foreign associated companies.

In the event that the order is executed for the purpose of performing specific instructions, technical solutions, know-how communicated by Roche, the Supplier will not use the same for supplies to third parties without written authorisation from Roche. Upon Roche’s request, the Supplier will be required to immediately return all documents provided, including all copies or reproductions.

In the event that the order concerns the performance of sponsorship activities, the Supplier, depending on the type of activity / service, undertakes to use the Roche trademark in the formats and sizes that will be provided by Roche:

  • inserting it in all the printed material distributed during the activities;

  • displaying together with the sentence referred to in the previous point on the website;

  • undertaking, within the framework of the organised event, to inform the participants that the event is sponsored by Roche.

The trademark must be published in strict compliance with the graphic standards specified by Roche. The Contract will not constitute a trademark license and will not give the Supplier any right to use the trademark other than as provided for. Accordingly, the Supplier undertakes to refrain from any further, direct or indirect, use of the trademark, as well as from any sub-licensing to third parties, except with the prior written consent of Roche.

Pursuant to Legislative Decree No. 152/2006, as amended, the Supplier undertakes to remove, hold and dispose of the waste generated by work activities, retaining the entire responsibility for the management thereof and holding Roche harmless from any liabilities that may derive to it in this regard. If required by applicable regulations on the matter or fulfilling an express request, the Supplier must send to Roche a copy of the documents proving successful disposal.

In case of delivery of machinery or equipment, the Supplier warrants that the product supplied is compliant with EC Directives and national transposing legislation, is fully functional and was built in compliance with applicable regulations on plant safety and occupational health and safety. Roche reserves the right to request the Supplier to take out an insurance policy to ensure its correct operation, as well as to cover third-party liability.

The Supplier warrants that it complies with all applicable regulations on occupational health and safety (Legislative Decree No. 81/2008), taking all responsibility for the correct fulfilment of contractual, social security and insurance obligations relating to its personnel, and also taking all responsibility for any damage or injury caused to the same personnel in the execution of orders or instructions. In particular, the Supplier will, within the statutory period, be required to pay any withholding taxes on employment income and to pay any social security contributions and mandatory insurance contributions for accidents in the workplace and occupational illnesses of employees, without prejudice to the right of Roche to verify the fulfilment of such obligations by requesting a copy of the relevant documentation (for example: Documento Unico di Regolarità Contributiva, DURC, [i.e. single certificate of good standing in the payment of contributions]).

Roche therefore reserves the right to suspend payment of any fees due until the Supplier has submitted the above documentation upon request. Therefore, the Supplier undertakes to:

  • a) ensure its personnel a regulatory and salary treatment not lower than the treatment established by contractual rules in force for the category to which they belong;

  • b) take out insurance relating to accidents in the workplace, third-party liability relating to persons or property with a suitable maximum ceiling and with companies of primary importance, for health and social security assistance, and to abide by all applicable legal provisions on labour legislation;

  • c) adopt any and all arrangements, devices and measures to prevent the occurrence of injuries to persons or damage to property;

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

Regardless of the separate conclusion of the appropriate non-disclosure agreement, the Supplier undertakes to treat as confidential all the information received from Roche in negotiations held for the purpose of preparing and drafting any specifications, or otherwise acquired for the purpose of executing the order, and not to disclose to third parties, or to use, for any purposes other than the execution of the order without the prior written consent of Roche, any technical and business information, including documents, drawings, sketches, models, moulds, samples and components supplied by Roche for the execution of such order or in any case acquired during the execution of such order. The scope of this rule will be prospective, i.e. binding on the Supplier and its assignees including after termination of the relationship with Roche for a period of five years, including in case of a change in the Supplier’s business name or ownership structure. In the event of a violation, Roche may take action to obtain compensation for damages, without prejudice to the right to seek prosecution of the Supplier pursuant to Articles 621, 622 and 623 of the Italian Criminal Code. The Supplier will not be permitted to make any reference to Roche or to the purchase order in any of its product items, press statements or other forms of advertising, without prior authorisation in writing from Roche.

The sub-contracting of services / works / contributions / supplies commissioned by Roche to the Supplier is prohibited.

Notwithstanding the general subcontracting prohibition set forth herein, the Supplier, before starting any related or preparatory activity regarding the order and in due advance, may formally and from time to time request Roche to give a reasoned authorisation to subcontract the partial execution of services / works / contributions / supplies to third parties in an amount not exceeding thirty per cent of the total value of the order, specifying any details relating to the subcontract in the estimate.

It should be noted that, pursuant to applicable regulatory provisions, the Supplier will be jointly and severally liable with the subcontractor for the calculation and payment of withholding taxes on employment income and for the payment of mandatory social security contributions and insurance contributions for accidents in the workplace and employees’ occupational diseases that the subcontractor is required to make. Such joint and several liability may only cease if the Supplier, after acquiring the related documentation before payment of the fee, has verified that the obligations specified above in connection with the performance of employment work concerning the works, supplies or services entrusted have been correctly fulfilled by the subcontractor, without prejudice to Roche’s right to suspend payment of the fee until the subcontractor has submitted the relevant documentation (for example, DURC). The Supplier will be required to select, and will have the responsibility for selecting, any subcontractors after successfully verifying that the same meet all requirements relating to organisational departments, personnel, skills and suitable experience accrued in the field, in compliance with regulations and obligations applicable to the activity and services covered by the subcontract. In any case, the Supplier will remain solely and exclusively liable towards Roche, including in relation to any subcontracted works. The right of Roche to request the Supplier to interrupt the relationship with a subcontractor for objective and not unreasonable grounds, at any time, replacing the same with another subcontractor approved by Roche will in any case remain without prejudice.

The Supplier warrants that it is aware of its obligations deriving from anti-corruption legislation.

The Supplier declares that it has verified that there is no conflict of interest, including potential and/or apparent, which may compromise the establishment of a business relationship with Roche.

The Supplier declares that it has verified, including with regard to all of its employees, that there are no restrictions whatsoever to cooperation, and undertakes to verify and declare that there are no irregularities regarding applicable laws and regulations relating to anti-corruption and transparency, where required and applicable, either national, adopted by the competent (Italian) Regional authorities or relating to the relevant industrial sector, including implementation guidelines adopted by Autorità Nazionale Anticorruzione (ANAC, Italian national anti-corruption authority).

The Supplier also declares that its own internal evaluation bodies responsible for the prevention of corruption, if any, have raised no objections in regard of the signature of this Contract under the terms set forth and agreed herein, and declares that the Contract is not in conflict in any way with the principles contained, where applicable, in its Corruption Prevention Plan (or similar regulations).

The Supplier undertakes not to perform, or attempt to perform, any actions that may result in a violation of the Code of Ethics by an employee of the Roche group or that may cause a violation by any group company of laws regarding fraud prevention, corruption, racketeering, money laundering or terrorism.

The Supplier will not be permitted, either directly or indirectly or by attempt, to pay, promise or authorise the payment of money, nor promise, give or authorise the granting of any valuable items to any person or entity, including professional operators working in the healthcare world at the governmental level or personnel belonging to any healthcare facility, for the purpose of attempting to gain an undue advantage for any company in the Roche group. The Supplier also warrants that it will not, either directly or indirectly, receive or request sums of money or valuable items from any person or entity, to obtain an undue advantage.

The Supplier declares that in the 24 months prior to receipt of the order from Roche, it has not made, solicited, authorised or received any payments, promises or gifts of the type described in the preceding paragraph.

In any case, both Parties undertake to fulfil all obligations arising from the order and from acceptance of these Conditions in compliance with applicable legislation and regulations concerning the prevention and repression of corruption, racketeering, money laundering or terrorism.

The Supplier declares that:

  • It is aware of applicable legislation on the administrative liability of corporations and, in particular, of the provisions of Legislative Decree No. 231/2001, and that it complies with the same fully and on an ongoing basis;

  • It is aware of the adoption and implementation by Roche of an “Organisation, Management and Control Policy” prepared in compliance with the provisions of Legislative Decree No. 231/2001 (hereinafter the “Policy”), whose principles the Supplier fully shares without any exception whatsoever.

The Supplier undertakes not to engage in - and will ensure that its directors, employees and/or collaborators do not engage in - acts or conduct such as to determine the violation of the Policy Roche and, more generally, the commission, including attempted commission, of the offenses referred to in Legislative Decree No. 231/2001.

The Supplier warrants that it has properly trained, or undertakes to train, its personnel on the provisions of Legislative Decree No. 231/2001 and has established or put in place supervisory and control mechanisms over such personnel in order to prevent the commission of offenses, in particular with reference to environmental offenses.

It is understood that the Supplier’s non-compliance with the rules laid down in Legislative Decree No. 231/2001 and in the Policy will be considered by Roche a serious breach and grounds for termination due to breach pursuant to Article 1456 of the Italian Civil Code with immediate effect.

During its interactions with Roche, the Supplier undertakes to promptly inform Roche of any event (including, but not limited to: commencement of proceedings pursuant to Legislative Decree No. 231/2001 against it; investigation reports or news published in major newspapers; etc.) potentially concerning the Supplier’s corporate structure, in regard of the cases contemplated by Legislative Decree No. 231/2001. For the purposes of this paragraph, “promptly” will be understood as notifying Roche no later than two business days after the Supplier has become aware of the event.

Without prejudice to any other remedies granted to Roche, including the right to compensation for damages, Roche will have the right to revoke a purchase order in writing, in whole or in part, and to declare the relationship terminated with effect from the date of receipt of the notice sent by Roche to the Supplier, pursuant to Article 1456 of the Italian Civil Code, in the event that:

  • the Supplier is in breach of the obligations contained in these General Conditions of Purchase, in particular but not exclusively with reference to Articles 14 and 15 or the Supplier’s conduct may in any way harm the reputation of Roche or of Roche Group affiliated companies, without prejudice to the right to compensation for any damages suffered;

  • the Supplier fails to fulfil an obligation deriving from the purchase order relating to delivery dates (where essential) and quantities, discrepancies, confidentiality or other specific mandatory obligations;

  • the Supplier suffers a substantial change in the ownership of its own shares or quotas, as a result of which the person that has the majority required for the election of Directors is modified, or suffers the transfer of a substantial part of its own company to a third party (e.g. in case of extraordinary corporate transactions);

  • the Supplier contravenes the “Safety regulations for the prevention of accidents in the workplace” and/or the internal safety regulations of Roche;

  • the scope of the order provides for shipping dangerous or toxic and harmful substances and the Supplier has failed to obtain the appropriate national or Regional authorisations.

The Supplier warrants that it will grant Roche, any auditing firm it may appoint and any regulatory authority, the right to gain access to its premises, as well as the right to gain access to, and directly examine, any documentation that exclusively refers to the execution of the order and to the obligations to be fulfilled by the Supplier under these general contractual conditions (“Audits”). Within the framework of an Audit, Roche will be given access to commercially sensitive information of the Supplier, of its affiliates or of any of its contractors and subcontractors involved in the execution of the order or instruction; if such Audit is carried out by an auditing firm appointed by Roche, the same will only report relevant information to Roche to inform it of compliance with the provisions of the General Conditions of Purchase. It is understood that, if Roche uses an auditing firm, it undertakes to ensure that such firm signs a confidentiality agreement. During the Audit, the Supplier undertakes to provide all reasonably requested cooperation and assistance during normal office hours, it being understood that Roche undertakes to ensure that any auditor or other person to whom access is granted for the Audit causes the least disturbance to the Supplier’s activities and observes safety regulations. Roche will directly bear any Auditing and monitoring costs arising from the actions set forth herein.

Roche has procedures in place to monitor and review the performance of its Suppliers in order to pursue a continuous improvement of its purchases. The Supplier undertakes to cooperate with Roche in relation to such monitoring and reviews and undertakes to provide Roche with all the information requested by it (or by its auditors in case of sensitive information) linked to the contractual relationship regulated by the order.

Pursuant to the provisions of Regulation (EU) 2016/679 (“GDPR”) and Legislative Decree No. 101/2018, on the “protection of natural persons with regard to the processing of personal data and on the free movement of such data”, with reference to the processing of personal data relevant for the purposes of the Contract as part of the execution of the order, the Parties declare that they have communicated to each other the information required by Articles 13 and 14 of the GDPR concerning the aims pursued, the legal basis of the processing, the methods and tools used, as well as the rights and methods to exercise the same.

The Parties declare that the personal data provided are correct and true, holding each other harmless from any liabilities for material errors in filling out any forms or for errors deriving from an inaccurate attribution of such data in their electronic and paper archives.

Roche and the Supplier undertake to process any personal data relating to the Order and its execution in compliance with the principles set forth in the GDPR. In particular, such data will be: a) processed in a lawful, fair and transparent manner; b) collected and processed for specific, explicit and legitimate purposes; c) adequate, relevant and limited to what is necessary with respect to the purposes for which they are processed; d) accurate and, if necessary, updated; e) retained in a form that permits the identification of data subjects for a period not exceeding the achievement of the purposes for which they are processed; f) processed in such a manner as to ensure adequate security.

Both Roche and the Supplier undertake to comply with the requirements of the GDPR and to adopt the appropriate security measures pursuant to Article 32 of the GDPR.

The Supplier agrees to appoint any staff members in its employ who may have access to data of which Roche is the Controller as “Processors on its behalf” imparting suitable instructions to ensure compliance with the rules enshrined in the Code regarding the protection of personal data and with the regulations applicable by each party involved.

With particular reference to any sensitive data that may be processed during service performance, the Supplier undertakes to abide by, and will ensure that its employees abide by, the regulations in force applicable to the processing of such data and to comply with the specific instructions given to it by the Data Controller in this regard.

If the Supplier finds a personal data breach, as defined in the GDPR, or otherwise finds that it is unable to comply with the instructions received from the Data Controller, including due to unforeseeable circumstances or force majeure (damage, malfunction of protection and access control devices, etc.), the same must implement all possible and reasonable safeguards and must immediately notify the incident to Roche and agree on any further protective measures.

Should the Supplier receive any communications from data subjects relating to the exercise of their rights pursuant to Articles 15-22 of the GDPR, and should this communication concern the processing carried out by the Supplier on behalf of Roche, the Supplier undertakes to notify Roche of such an event (in any case no later than 24 hours from receipt of the data subject’s communication).

If, in relation to the services rendered in execution of the order, the Supplier is qualified as Data Processor by Roche, in its capacity as Data Controller, pursuant to Article 28 of Regulation (EU) 2016/679, Roche will proceed to appoint the Supplier by means of a specific written instrument.

These general conditions of purchase and the related contractual relationship are governed by the Italian Law. Any dispute arising from the interpretation or adoption thereof will be referred to the exclusive jurisdiction of the Court of Milan.

The adoption of these Conditions will commence from the time of acceptance of the order by the Supplier until the actual completion of activities provided for therein; any renewal due to silence and/or automatic renewal of the relationship is expressly excluded.

In the event of total or partial failure by the Supplier to act upon the instructions contained in the order, Roche will be authorised to suspend any payments that may have accrued for the Supplier’s services, including if prior and if performed under a different capacity.

The Supplier will be liable to Roche and will hold the same harmless from any direct or indirect damages, as well as any costs that the same may suffer and/or incur as a result of its breach.

In case of a delay in the execution or delivery of what is specified in the order, Roche reserves the right to apply a 15 % (fifteen percent) penalty on the total amount of the order, for each calendar day of delay.

The penalty will not be applied only in case of delays with respect to deadlines due to reasons not attributable to the Supplier.

Roche may withdraw from the contract pursuant to Article 1373 of the Italian Civil Code at any time by simple written notice to be sent to the Supplier by written communication with r/r. In this case, the Supplier will be entitled to any fees actually accrued at the effective date of withdrawal, being any further compensation and/or indemnification excluded.

If, during the performance of the services commissioned by Roche, the Supplier becomes aware of suspicious adverse events, special situations, other cases or complaints related to the use of a Roche medicinal product, it undertakes to report them to the Roche Pharmacovigilance department within one business day from the date on which it received such information, to the following contact details, also giving notice to the reporting party, if possible.

Contact information: Roche - Department of Pharmacovigilance: email: [email protected] - Fax: 039-2475088

Employment relationships between Roche and the Supplier’s employees will be excluded in accordance with Legislative Decree No. 276/2003. The Supplier will be the sole responsible party for the classification, performance and termination of the relationship between the Supplier and any self-employed or subordinated collaborators appointed by the same.

The Supplier will be the sole responsible party for salaries, contributions or any other kind of payable amounts, related to, associated with or originating from the relationship between the Supplier and any self-employed or subordinate collaborators of the same appointed for the purpose of executing the order received from Roche.

The Supplier also declares that its employees and/or third parties it uses are appropriately covered by insurance with the social security and welfare institutions required by law.

The Supplier warrants that it will fulfil all obligations towards its employees and/or collaborators it uses under any applicable legal provisions and regulations concerning labour, accident prevention, health and safety, recruitment and remuneration, social security and assistance, bearing all the related charges on its own account. To this end, the Supplier undertakes to provide Roche at any time, at the latter’s request, all the documentation proving the fulfilment of the above obligations (for example: DURC).

The Supplier hereby undertakes to indemnify and/or otherwise hold Roche harmless from any claims that may be made against the latter by the above collaborators and/or personnel of the Supplier concerning claims of any nature, classification, performance and termination of any existing or past relationships between the same and the Supplier.

The Supplier hereby undertakes to indemnify and/or otherwise hold Roche harmless from any damage caused by the Supplier to third parties in the performance of activities related to the execution of the order.

The Supplier undertakes to promptly notify Roche of any disputes and/or claims from its employees or former employees in relation to the execution of the order, in any case no later than 5 (five) business days from the date the same has become aware of such disputes and/or claims.

The Supplier declares that it has an insurance contract in place with a primary insurance company for civil liability towards its employees (EL), third-party liability (TPL) including machinery, plants and building structures, whose maximum ceilings are in line with the highest market levels in its business sector. The Supplier warrants that it may submit to Roche a copy of the valid policy referred to herein upon simple request of the same.

The Supplier must also warrant that it will maintain the aforementioned insurance contracts in place throughout the entire duration of the relationship with Roche.

Should any extraordinary and unforeseen events occur due to force majeure which prevent or delay the Supplier’s execution of the Order (such as epidemics, wars, coups, earthquakes, fires, floods, natural disasters), the terms for the fulfilment of the obligations arising from the order will be considered to be extended for the duration of said events and the effects thereof.

The party to the detriment of whom the force majeure event has occurred will be required to promptly notify the other party in writing of the occurrence and ceasing of such an event, taking all suitable measures to limit its effects.

If the above force majeure event persists for a period greater than three months, either party will be entitled to terminate the agreement and the instructions contained in the order by simple written notice sent to the other party to that effect.