These Terms and Conditions for Purchases of Goods and Services (“T&C”) govern the supply of the goods or the performance of the services described and quoted in the relevant purchase order (“Order”) by the company indicated therein as supplier / provider (“Company”) for A. Menarini Manufacturing Logistics and Services S.r.l., having its registered office at Via Rosolino Pilo 4, Florence, Italy (“Menarini”).
The present T&C and the Order hereinafter jointly referred to as “Agreement”. Company and Menarini hereinafter individually referred to as “Party” and collectively as “Parties”.
1. Object
1.1. Company shall supply the goods or perform the services described in the Order, according to the terms and conditions set forth in such Order and - to the extent applicable - in the present T&C, to any applicable laws and regulations in force from time to time.
1.2. Company represents and warrants to have full right and authority to enter into this Agreement and to have knowledge, expertise, facilities and personnel necessary to properly supply the goods or perform the services.
1.3. (If applicable) Company’s Use of Artificial Intelligence Systems. To the extent Company uses any artificial intelligence system as tool or component (“AI”) for the provision of the services or the generation of the Results (as hereinafter defined), Company shall be fully liable against Menarini for the compliance of the AI with the applicable laws and regulations and for the quality, accuracy and reliability of any outputs generated by Company’s interactions with the AI that may be used in relation to or for the services and/or the Results. Company shall remain liable to Menarini for the security of any Menarini’s Confidential Information (as hereinafter defined) that may be used within, or uploaded to, the AI, in compliance with Section 3 below. In no event shall Company use any AI that: (i) uses Menarini’s Confidential Information uploaded to the AI to improve the AI itself, unless otherwise expressly authorized in writing by Menarini; (ii) may jeopardize Menarini’s intellectual property rights.
2. Consideration
2.1. In return for the supply of the goods or the performance of the services, Menarini shall pay Company the consideration set forth in the Order, under the payment terms detailed thereto.
3. Confidentiality
3.1. Company shall consider this Agreement and any and all information disclosed by Menarini in connection with this Agreement (collectively “Confidential Information”) as strictly confidential. Company shall not disclose the Confidential Information to any third party, with the only exception of its directors, officers and employees involved in the performance of this Agreement (collectively “Representatives”), only to the extent strictly necessary for the performance of this Agreement, subject to confidentiality and non-use obligations consistent with those set forth hereunder and remaining liable towards Menarini for any unauthorized use or disclosure of Confidential Information made by its Representatives.
Menarini shall be entitled to disclose the existence and the content of this Agreement, as well as any information possibly obtained from Company, to its affiliates and its and their partners and contractors.
3.2. The obligations of confidentiality and non-use set forth in this Agreement shall not apply to the Confidential Information which Company can prove: (i) at the time of disclosure is generally known to the public; (ii) after disclosure becomes public knowledge, except by breach of this Agreement by Company; (iii) was in Company possession at the time of disclosure by Menarini and was not obtained, directly or indirectly, from Menarini; and (iv) was received from a third party having the legal right to disclose such Confidential Information to Menarini, provided, however, that such Confidential Information was not obtained by said third party, directly or indirectly, from Menarini.
3.3. Upon expiration or termination of this Agreement, Company shall promptly destroy or return to Menarini any and all Confidential Information, without retaining any copy.
3.4. The obligations of confidentiality and non-use set forth in this Section 3 shall remain in full force and effect during the term of this Agreement and until each piece of Confidential Information becomes subject to any of the exceptions set forth in Section 3.2 above.
3.5. Company shall manage the risks posed to the security of network and information systems used in the performance of the services and shall prevent or minimize the impact of incidents on the services and/or the Results. With respect to Menarini’s Confidential Information disclosed hereunder, Company represents and warrants to have in place, as of the effective date, and agrees to maintain in force until Menarini’s Confidential Information is retained:
(a) an information security management system (including, without limitation, encryption in transit and at rest) and associated control and monitoring processes to ensure information security is managed in accordance thereto;
(b) appropriate measures to protect the security of physical and electronic Confidential Information (including, without limitation, fire and water protection, prevention of extreme temperatures, emergency power supply for relevant areas, and access protection - for physical Confidential Information - and virus protection, interface protection, attack detection, data backup and logging - for electronic Confidential Information);
(c) a security incident management process; and
(d) a comprehensive disaster recovery plan to ensure, inter alia, the continuity of the services. This plan shall include: (i) regular and secure backups of all Menarini’s Confidential Information, including Confidential Information (if any) related to Menarini’s use of the services or the Results; (ii) the ability to promptly recover and restore said Confidential Information in the event of a security incident, significant interruption, or impairment of the services; (iii) measures to prevent any loss, deletion, corruption, or alteration of Menarini’s Confidential Information, including information related to Menarini’s use of the services or the Results, and (iv) periodic testing, at least annually, to validate the effectiveness of the disaster recovery plan. Company shall provide Menarini with a copy of these test results upon request.
Upon Menarini’s request, Company shall provide Menarini with copies of the aforementioned systems, measures, processes, and plans.
Company represents and warrants that its Representatives have appropriate skills and experience, and are adequately trained to comply with this Agreement and the security requirements set forth herein. Company shall take appropriate measures to manage supply chain risks related to the provision of the services and/or the use of the Results by Menarini, including risks concerning the relationships with its suppliers, third party providers or subcontractors. Without undue delay upon knowledge and in accordance with any incident reporting requirements of the network and information security laws and regulations (including, but not limited to, Directive NIS2) applicable to Menarini, Company shall inform Menarini in writing of any potential or actual information security incidents which is or may be relevant to Menarini’s Confidential Information or the services. Such notice shall include all relevant details and documentation available at the time, including any potential cross-border impact. Company shall provide any further information concerning the incident, as reasonably requested by Menarini.
For the purpose of this Section 3.5, “information security” and “security” mean confidentiality of Confidential Information as well as integrity, availability and authenticity of any information, including Confidential Information.
4. Property of goods, results of the services and intellectual property rights
4.1. In case of supply of goods by Company the goods shall become the sole and exclusive property of Menarini.
4.2. In case of performance of services by Company, any and all results, ideas, inventions, data, information, documentation, analysis, solutions - whether patentable or not - arising out from the performance of the services (collectively “Results”) shall be the sole and exclusive property of Menarini. Such Results shall be considered Confidential Information and shall be treated in accordance with Section 3 above. Company shall assign any right, title and interest in the Results to Menarini.
4.3. By means of the present Agreement, neither Party sells, licenses or otherwise transfers to the other Party any intellectual property right developed, conceived or reduced to practice before the effective date of this Agreement or outside and independently of the scope of this Agreement.
5. Defective goods and services
5.1. The goods supplied to Menarini and the services performed by Company hereunder shall comply with the specifications set out in the Order and shall be free of defects.
5.2. Menarini shall notify Company of any defect of the goods or any error, omission or default in the performance of the services within sixty (60) days from Menarini’s knowledge. In such event, Company shall be obliged, at Menarini’s sole option - without prejudice to any other remedy to which Menarini may be entitled to and without limiting Company’s liability hereunder - either to: (i) replace or repair the goods, or correct or repeat the defective part of the services, at Company’s own cost; or (ii) refund to Menarini the consideration paid for the defective goods or services.
6. Indemnification
6.1. Company shall defend, indemnify and hold Menarini and its affiliates harmless against any and all third party’s claims, demands, proceedings, losses, damages, liabilities, deficiencies and costs to the extent arising out of: (i) any negligence or wilful misconduct of Company; (ii) any breach of this Agreement by Company; and/or (iii) any infringement of third party intellectual property rights deriving from the goods supplied or the services performed hereunder.
6.2. Menarini shall defend, indemnify and hold Company and its affiliates harmless against any and all third party’s claims, demands, proceedings, losses, damages, liabilities, deficiencies and costs to the extent arising out of: (i) any negligence or wilful misconduct of Menarini; and/or (ii) any breach of this Agreement by Menarini.
7. Term and termination
7.1. This Agreement shall enter into full force and effect upon the date of last signature and shall remain in effect until the full supply of the goods or the completion of the performance of the services hereunder.
7.2. Menarini shall be entitled to unilaterally terminate this Agreement at any time, with a thirty (30) - day prior written notice to Company, at its own and incontestable discretion.
7.3. Without prejudice to any other right and remedy hereunder, either Party shall have the right to terminate this Agreement with immediate effect by written notice to the other Party in case of breach by the other Party of any of the obligations set forth in this Agreement, provided that the breaching Party does not cure its breach within thirty (30) days from the notification of such breach by the non-breaching Party.
7.4. In any case of termination of this Agreement, except in case of termination attributable to Company, Menarini shall pay Company for the goods actually supplied and for the services actually performed up to the termination date. In any case of termination of this Agreement, if applicable, Menarini shall be entitled to receive from Company all Results connected to, or arising out from, the performance of the services.
8. Force majeure
Neither Party shall be liable to the other Party for any delay or non-performance of its obligations under this Agreement arising from any cause beyond the reasonable control of the affected Party, which could not be reasonably planned for or avoided - including, without limitation, any epidemic, pandemic, act of God, governmental act, war, fire, flood, explosion and civil commotion - (“Force Majeure Event”); provided however that the affected Party shall: (i) promptly notify the other Party in writing the existence and the likely duration of the Force Majeure Event; and (ii) use its best endeavours to remove such Force Majeure Event, to limit the effect of delay or non-performance on the other Party and to resume the execution of its obligations under this Agreement as soon as possible.
9. Assignment and sub-contract
Neither Party may assign or sub-contract any right or obligation hereunder without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed. Notwithstanding the foregoing, Menarini shall be entitled to perform its obligations and exploit its rights under this Agreement through its affiliates.
10. Privacy
10.1. The Parties recognise that the performance of this Agreement does not involve any personal data processing under Regulation (EU) 2016/679 (“Regulation”). Subject to the foregoing, should, at any time, the performance of this Agreement involve data processing under the Regulation, the Parties recognise that acting in full compliance with the privacy laws in force (i.e. the Regulation and the applicable orders of the supervisory authority) and, in particular, proper implementation of security measures protecting personal data is essential in the performance of the present Agreement. The Parties also undertake that, in such event, they will specify in detail their respective obligations to fully comply with the privacy laws, including appropriately classifying the respective privacy roles of the Parties under the Regulation.
10.2. Each Party agrees that the personal data (e.g. names, e-mail addresses and company phone numbers) of its employees, collaborators and contact persons in any way involved in the negotiation, execution or performance of this Agreement (collectively “Data Subjects”) will be processed by the other Party as Data Controller, for the purposes strictly necessary for the negotiation, execution or performance of this Agreement, in accordance with the provisions laid down in the respective Information Notice pursuant to Articles 13 and 14 of the Regulation, where applicable. Menarini’s Information Notice is published on the website www.menarini.com - Privacy Section and Company undertakes to forward Menarini’s Information Notice to its Data Subjects. This Section 10.2 shall apply regardless of whether the performance of this Agreement involves the processing of personal data or not.
11. Compliance with laws and regulations
11.1. In the performance of this Agreement, Company shall comply with any applicable laws and regulations, including the following:
(a) (Anticorruption Laws and Ethical Principles) Company represents and warrants to Menarini that any activity performed, directly and indirectly, under this Agreement shall be conducted in accordance with the principles of any applicable anti-corruption law (“Anticorruption Laws”).
Company represents and warrants to have adopted and effectively implemented a code of ethics (“Code of Ethics”) and to comply with it in the performance of this Agreement.
(b) (Trade Laws) Company shall comply with all applicable national and international trade laws and regulations, including those governing imports and (re-)exports or relating to trade sanctions and embargoes, such as the United Nations resolutions, the European Union regulations, the laws of the United Kingdom and the laws of the United States of America (“Trade Laws”).
(c) (Network and Information Security Laws) Company acknowledges that the services provided under this Agreement may fall within the scope of any laws and regulations concerning network and information security, including, but not limited to, the Directive (EU) 2022/2555 (NIS2) (“Network and Information Security Laws”). To the extent applicable, Company shall comply with all the requirements of those Network and Information Security Laws, as amended and implemented from time to time.
Company shall, without undue delay, support and cooperate with Menarini in preparing any submission to, and fulfilling any request, inspection, control or inquiry by, a competent authority, regulatory body or certifying body, as well as their designee.
11.2. Should Company breach the Anticorruption Laws, the Trade Laws, the Network and Information Security Laws and/or the Code of Ethics in the performance of this Agreement, Menarini shall be entitled to:
a) issue a warning notice to ask Company to strictly abide by the applicable provisions. Such warning notice may contain the request to implement, at Company’s sole cost and responsibility, a remediation plan consisting of those corrective actions necessary to remedy the detected violation;
b) in case the warning notice is not complied with by Company or in case of non-curable or major violations, termination of this Agreement with immediate effect.
12. Disputes and governing law
This Agreement shall be interpreted and construed according to the Italian laws, regardless its principles of choice of laws, and in case of controversies the exclusive jurisdiction of the courts of Florence, Italy is hereby established.
13. Miscellaneous
13.1. (Independent contractors) The Parties are independent contractors and neither Party has any authority to enter into any agreement or assume any obligation for the other Party or make any warranty or representation on behalf of the other Party, unless expressly and previously authorized in writing by such Party. Nothing in this Agreement is intended to create an agency, partnership or joint-venture relationship between the Parties.
13.2. (Entire agreement) This Agreement constitute the entire understanding between the Parties with reference to the subject herein dealt with.
13.3. (Severability) In the event any of the provisions of this Agreement is declared invalid or unenforceable by the relevant authorities, according to the applicable laws, the remaining terms of this Agreement shall not be affected by such declaration and the Parties shall make its best efforts to replace such provision with a valid provision reflecting - to the extent possible - the intent of the original provision.
13.4. (Waiver) No failure by either Party to enforce any of the rights hereunder shall be deemed as a waiver of such right or any of the other rights provided in favour of such Party in this Agreement. No waiver of the rights hereunder provided shall be effective unless made in writing with specific reference to the relevant provision of this Agreement and duly signed by the Party granting the waiver.
13.5. (Conflicts) Should any conflict between this T&C and the Order arise, the terms and conditions of this T&C shall prevail.
13.6. (Modifications) This Agreement may be modified only by written amendments to be jointly agreed and signed by the Parties.
13.7. (Audit) Menarini, directly or through its designee, may, at any time during the term of this Agreement, upon 5 (five) business days’ prior written notice (except in cases of urgent or regulatory inspections where shorter notice or no notice may be provided), inspect and audit Company (including its subcontractors), at its facilities or remotely, for the purpose of evaluating Company’s compliance with this Agreement, as well as any applicable law, regulation, or policy and/or Company’s use of the compensation received under this Agreement. Company shall maintain complete and accurate records documenting its compliance with this Agreement and shall make such records readily available to Menarini upon reasonable request. Company shall respond to Menarini’s requests for information or documentation within five (5) business days, or within one (1) business day in the case of a regulatory submission, inspection, control, or inquiry. Failure to timely respond to such requests constitutes a material breach of this Agreement. If Menarini identifies any deficiencies during an inspection or audit, Company shall promptly take all necessary steps to remediate such deficiencies within a reasonable timeframe agreed with Menarini. Should the deficiencies not be curable or Company fail to remediate the deficiencies within the timeframe agreed with Menarini, Menarini shall be entitled to terminate this Agreement by serving written notice to Company having immediate effect. All information obtained by Menarini during an inspection or audit shall be treated as Company’s confidential information by Menarini.
13.8. (Notices) Any notice to be sent by the Parties in connection with the present Agreement (other than ordinary business and technical correspondence) shall be made in writing by registered letter with acknowledge of receipt to the addresses indicated above or in the relevant Order.
13.9. (Survival) Neither the expiration nor the termination of this Agreement shall relieve the Parties of their obligation incurred prior to such expiration or termination. All provisions that, by their express or implied terms, are meant to survive expiration or termination of this Agreement - in particular Sections 3, 4, 5, 6, 7.4, 11, 12 and 13 - shall continue irrespective of such expiration or termination.