Code of Ethics

I. Definitions

• CODE: this Code of Ethics in its current version and any annexes;
• SUBJECTS: persons to whom the provisions of the CODE apply, including COMPANY OFFICERS, EMPLOYEES, COLLABORATORS (including AGENTS and CONSULTANTS) as well as persons who, having relations with MASTELLI SRL, undertake to comply with the CODE;
• COMPANY OFFICERS: the Chairman and the members of the Board of Directors, the Auditor, as well as any other person in an executive position, by which is meant any person who performs functions of representation, administration or management for MASTELLI SRL or of one of its units or divisions, endowed with financial and operational autonomy;
• EMPLOYEES: persons that have a subordinate employment relationship with MASTELLI SRL, of any degree or nature, including temporary workers and those in a placement or apprenticeship programmes, or those with part-time contracts, as well as workers on assignment or in force with para-subordinate work contracts (employment contracts);
• COLLABORATORS: persons or entities that have a relationship with MASTELLI SRL: (i) project work relationships; (ii) agency relationships and other relationships resulting in the provision of coordinated and continuous work, predominantly personal, of a non-subordinate nature; (iii) occasional collaboration relationships (e.g. consultancy), as well as persons subject to the direction or supervision of a COMPANY OFFICER, even if they are not EMPLOYEES;
• SUPPLIERS: entities that supply MASTELLI SRL with goods and services;
• BoD Board of Directors
• PA Public Administration
• ETHICS COMMITTEE: Committee composed of: Chairman of the Board of Directors, CEO, Auditor, HR Manager, Legal Support or Regulatory Affairs Manager appointed ad hoc by the BoD in order to supervise the application of the CODE, receive and manage reports, and apply sanctions.

II. MASTELLI S.R.L. and its corporate mission

MASTELLI S.R.L. was founded in 1952 in Sanremo, in the province of Imperia, as a pharmaceutical production company.

It is mainly present in the following therapeutic areas: Dermatology, Wound Care, Aesthetic Medicine, Gynaecology, Paediatrics and, more recently, Orthopaedics and Physiatrics and it markets its products in Italy and abroad.

The mission of MASTELLI SRL, in the context of an enterprise logic and fair competition, is to dedicate itself to personal care, placing the patient and their well-being at the centre of all its activities.

This is why, over the years, Mastelli has focused on research and development, the production and marketing of pharmaceuticals, medical devices and dermo-cosmetics, and has only marketed dietary supplements.

At the same time, through the fulfilment of its mission, MASTELLI S.R.L. also intends to contribute to the economic, technological and cultural progress of the countries in which it operates.

III. Purpose and scope of the CODE of ethics

In order to define the set of values by which it intends to orient its activity to achieve its business objectives, MASTELLI S.R.L., by means of this CODE, establishes the general principles of behaviour, by which to guide the professional commitment of each of MASTELLI SRL’s collaborators and employees.

With the adoption of the CODE, MASTELLI SRL intends to confirm and consolidate the values and ethical responsibilities that must guide COMPANY OFFICERS, EMPLOYEES and COLLABORATORS, and in general all those who operate in the name and/or on behalf of MASTELLI S.R.L. (the SUBJECTS), in Italy and abroad, to behave appropriately and carry out proper conduct, in their business life, towards all internal, external and institutional stakeholders.

Through specific reference to the CODE OF ETHICS contained in the contractual clauses, MASTELLI SRL intends to align its relations with third parties to the principles and provisions of the CODE: in this way, suppliers and contractual partners of MASTELLI S.R.L. are required to comply with same.

The CODE is inspired by the Code of Ethics of FARMINDUSTRIA – ASSOCIAZIONE NAZIONALE DELL’INDUSTRIA FARMACEUTICA (National Association of the Pharmaceutical Industry) and by the Code of Ethics of CONFINDUSTRIA DISPOSITIVI MEDICI – associations of which MASTELLI S.R.L. is a member, as well as by the Guidelines of FARMINDUSTRIA for the certification of procedures related to the activity of scientific information.

MASTELLI SRL recognises that compliance with the CODE by all SUBJECTS is of the utmost importance, as well as being a condition for safeguarding and promoting its reputation.

All SUBJECTS are required to comply with the indications formalised in the CODE, each one within the scope of their own responsibilities and duties: any conduct carried out in violation of the CODE by the aforesaid persons in the performance of the various activities constitutes an offence for disciplinary purposes.

The CODE shall be applied with reference to all activities of MASTELLI S.R.L. and shall be a constant reference for all procedures, policies, guidelines and contractual relationships with MASTELLI SRL.

Where there is conflict between the provisions of the CODE and the instructions given by the internal hierarchical organisation and procedures, the provisions of the CODE shall prevail.

In no case may the belief of the SUBJECTS that they are pursuing the interest of MASTELLI SRL legitimise non-compliance with the provisions of the CODE or behaviour contrary to the regulatory provisions.

EMPLOYEES are obliged to comply with the CODE according to Art. 2104 of the Civil Code

The SUBJECTS are obliged to observe the CODE both in their internal relations and in their relations with third parties (known as external relations). The SUBJECTS shall in fact inform the latter of the obligations set forth in the CODE and enforce their compliance. In this sense, MASTELLI S.R.L. makes the provisions of the CODE legally binding with appropriate acts and legal agreements (e.g. contractual clauses).

In particular:

a) the COMPANY OFFICERS, within the scope of their duties, will conform their conduct to the provisions of the CODE, both within MASTELLI SRL and towards third parties in contact with MASTELLI SRL;

b) the managers of the departments and offices of MASTELLI SRL demand compliance with the CODE by both EMPLOYEES and COLLABORATORS and supervise their behaviour in order to prevent violations thereof. More specifically, each manager is obliged to:

• inform its EMPLOYEES and COLLABORATORS in a clear, precise and complete manner about their obligations, including vis-à-vis compliance with the CODE, by clearly informing them that any breach of the CODE is reprimandable and may constitute a contractual breach or disciplinary offence;
• promptly report any breach of the CODE, whether directly ascertained or learned of by others, to the Ethics Committee;
• within the scope of the assigned duties, implement or promote the adoption of appropriate measures to avoid violations of the CODE and their repetition, preventing retaliation against any SUBJECT who has reported alleged violations to a manager of which he or she has become aware;
• select EMPLOYEES and COLLABORATORS carefully, on the basis of their personal aptitudes and willingness to comply with this CODE.

IV.  Structure of the Code of Ethics

This CODE consists of four sections:

1. the first regulates the general principles of reference in the management of MASTELLI SRL;
2. the second sets out the principles of conduct towards the SUBJECTS of the CODE and the Internal, External and Institutional Stakeholders considered relevant for MASTELLI SRL, namely: Staff, Customers, Suppliers, Consultants, Agents, Public Administration, Judiciary and Public Supervisory Authorities, Health Care Professionals, Competitors and Trade Associations, Political Parties, Trade Unions and Environmental Organisations;
3. the third defines the procedures for implementing the CODE, including the dissemination and communication activities relating to the CODE and the tools available to report behaviour that is not in line with the provisions of the CODE;
4. the fourth section is devoted to informing the SUBJECTS about sanctions in case of non-compliance with the contents of the CODE.

1. General principles of conduct in business management

1.1. Compliance with the law and ethical principles and values

MASTELLI SRL has, as an essential principle, respect for the law, regulations and rules of self-discipline, as well as the values and principles of ethics in force in Italy and in all the countries in which it operates, and consequently it will not initiate or continue any relationship with those who do not intend to adopt and respect these principles.

1.2. Transparency and correctness of information and accounting

MASTELLI SRL condemns any behaviour, by anyone, aimed at altering the correctness and truthfulness of the data and information contained in financial statements, reports or other company communications required by law.

All persons involved in the preparation of the aforementioned documents are required to verify, with due diligence, the correctness of the data and information that will then be incorporated into such documents for their drafting.

All operations must be documented and the original documents (or certified copies) must be retained, in accordance with the law, so that it is always possible to identify the individual actions performed at the various stages, who performed them and, where known, the reasons.

The auditor must have unfettered access to all data, documents and other information necessary to perform their duties.

All SUBJECTS shall promptly report both the existence of errors or omissions in the accounting process, as well as conduct that is not in line with the provisions of this article.

All SUBJECTS must ensure the utmost truthfulness, transparency and completeness of the information, whether verbal and documentary (paper and digital), produced in the course of the performance of the activities, each one for the part within their own area of competence and responsibility. All persons involved in the preparation of the data contained in financial statements, company reports and all corporate communications required by law, must comply with these principles and diligently verify the accuracy of the information.

1.3. Conflict of interest and the principle of transparency

The SUBJECTS must always act in order to avoid situations where the parties involved in the transactions are, or may even only appear to be, in a conflict of interest; meaning, generically, all situations in which the pursuit of one’s own interest is in conflict with the interests and mission of MASTELLI SRL. Furthermore, situations through which a SUBJECT may derive an undue advantage and/or profit from opportunities known in the course of their business shall be avoided.

In the event that MASTELLI SRL nevertheless finds itself operating in situations of conflict of interest, it not only complies with the regulations governing the case in hand, but also with the principle of transparency, undertaken prior to the conflict and with the subsequent communication of the essential terms of the operation, as well as the justification of the decision taken. Without prejudice in this regard to the external and self-regulation rules, situations of conflict of interest must always be disclosed and adequately managed, in order to avoid prejudice to customers, counterparties or MASTELLI SRL.

When the conflict situation affects the interests of customers or MASTELLI SRL, it shall in any case remain mandatory for the SUBJECT to abstain from the activity of non-corporate interest.

1.4. Impartiality and the principle of non-discrimination

In relations with its internal, external and institutional interlocutors in general, MASTELLI SRL avoids any discrimination on the basis of age, gender, sexuality, state of health, race, nationality, political opinions and religious beliefs of its interlocutors.

In the conviction that gender differences can be a resource and should be recognised and valued for business development, special attention is paid to equal opportunities and the development of women, pursuing the objectives of increasing the involvement of women in staff development plans and adopting a specific strategy to ensure the strengthening of female gender representation in middle management positions, in maximum compliance with the UNI/PdR 125:2022 reference practice.

1.5. Respect for the person

SUBJECTS are required to respect the dignity of persons and their privacy, both in internal and external relations. Harassment or offence of any kind is not tolerated.

All SUBJECTS must personally contribute to building and maintaining a climate of mutual respect, showing attention to colleagues and to each other’s sensitivities, in an atmosphere of cooperation and help.

1.6. Environmental protection

The environment is a primary asset that MASTELLI SRL is committed to safeguarding. To this end, MASTELLI SRL develops its business with the utmost respect for current environmental regulations, taking into account also, the development of scientific research and the best experiences in the field, so as to seek compatibility between economic initiative and environmental needs.

MASTELLI SRL promotes behaviour and activities aimed at reducing its environmental impacts and is actively engaged in the constant adaptation of its production sites to the best reference practices, including specifying the correct disposal methods for the various packaging components.

1.7. Respect for privacy

MASTELLI SRL undertakes to treat personal data and confidential information collected and managed within the scope of its activity in the manner established by the laws on confidentiality in force.

To this end, the SUBJECTS are required to act in accordance with the Corporate Data Security Policy prepared by MASTELLI SRL for the management of data in line with privacy regulations.

1.8. External information and confidentiality

Information and communication to the outside world must be truthful, accurate, complete, clear, transparent and comprehensible, so as to enable the SUBJECTS to make informed decisions.

In accordance with the provisions of the law, MASTELLI SRL protects the confidential nature of the information in its possession, respecting the confidentiality of the persons and the obligations of confidentiality set forth in the CODE itself.

Information may only be disclosed by the expressly delegated corporate departments.

SUBJECTS are prohibited from using confidential information for purposes not strictly related to the exercise of their professional activity.

1.9. Know-How of MASTELLI SRL Information processing and confidentiality obligation

The scientific, productive and commercial know-how of MASTELLI SRL constitutes a fundamental resource and asset. Confidentiality is an essential requirement for the protection of the industrial and intellectual property of MASTELLI SRL. Violation of the duty of confidentiality may cause irreparable damage to MASTELLI SRL.

Each employee or collaborator is bound by the utmost confidentiality, and undertakes not to disclose to unauthorised persons, and in any case to persons outside the company, the information that constitutes the know-how of MASTELLI SRL, including, by way of example and without any limitation, all that concerning: research projects; patent applications; techniques and technologies; productions; strategies; negotiations; trademarks; contracts; launches, promotions and commercial actions, lawsuits and legal actions; except in the cases and obligations strictly and expressly provided for by law.

1.10. Confidential information

Confidential information is understood as data and knowledge not accessible to the public, in any way processed or recorded, pertaining to the organisation of MASTELLI SRL, company assets, commercial and financial operations planned or initiated by MASTELLI SRL, customer relations and judicial and administrative proceedings and other institutional counterparts.

Confidential information known to MASTELLI SRL in the performance or occasion of the various activities, cannot be used, communicated to third parties or disseminated, except within the limits of the requirements imposed by a correct working activity and, in any case, never for purposes other than institutional ones.

Considering the delicacy of the information known to MASTELLI SRL and the consequences of its disclosure, the communication of news not yet public, concerning the activity of MASTELLI SRL, and the drafting and circulation of prospectuses, reports and communications to the market constitute the confidential and exclusive task of the departments expressly delegated for this purpose.

Persons who, according to internal regulations, have knowledge of confidential information, or occasionally come to know of it, are bound to respect the confidentiality constraints established by MASTELLI SRL and its Internal Regulations.

SUBJECTS are required to comply strictly with the provisions of laws, regulations, self-regulatory rules and specific confidentiality agreements concerning the acquisition, disclosure and management of inside information.

SUBJECTS are required to comply with all further requirements set forth by the competent corporate bodies concerning the circulation and dissemination of information.

1.11. Respect for real market conditions, free trade, fair competition and industrial property Respect for copyright

MASTELLI SRL undertakes to respect the legitimate exercise of another industry or trade, and to operate according to the principles of fair competition, without prejudice to its general objective of maximizing profits in compliance with the law.

MASTELLI SRL therefore undertakes to implement all forms of control to avoid the sale or circulation of industrial products with counterfeit or altered names, trademarks or distinctive signs, or the sale and circulation of industrial products with misleading signs, as well as the manufacture or trade of goods made by patent infringement or through misappropriating other industrial property titles.

With reference to non-patented confidential know-how received from third parties on the basis of secrecy or other agreements, MASTELLI SRL guarantees that communication can only be made internally on a need-to-know basis (need-to-know principle) by qualified persons who are actually involved in the development and/or use of such know-how.

MASTELLI SRL is committed to complying with current copyright legislation and ensures that the dissemination of scientific or other publications, and of extracts or copies thereof, may only be ordered by the relevant corporate department after verification by the Legal Department that the current copyright regulations are complied with.

1.12. Gifts and gratuities

It is forbidden for any SUBJECT to promise or offer to third parties, as well as to accept the promise to receive from third parties, directly or indirectly, even in simulated forms, gifts, benefits or other utilities, unless they comply with the relevant laws and code of association. Their nature and value must not be, or appear to be aimed at obtaining favourable treatment and, in any case, must be such as not to compromise the image of MASTELLI SRL.

The foregoing prohibition shall allow exceptions for goods or services of low value whose offer is in the ordinary course of business, provided that they have not been solicited by the SUBJECT and are not such as to create the impression that their offer involves undue advantages for the recipient or for others.

SUBJECTS who, in spite of themselves, receive goods, services or other benefits in a manner contrary to the foregoing, shall promptly inform the Ethics Committee of the situation.

1.13. Charitable contributions and donations

Donations of money and/or equipment must be handled in accordance with company procedures and applicable regulations.

Donations may only be made to University Institutes, Hospitals, NGOs, Associations and Foundations in compliance with the administrative procedures of MASTELLI SRL.

 Donations are prohibited if they involve any possible conflict of interest vis-à-vis the SUBJECTS or if such donations are linked to a commercial interest of MASTELLI SRL.

1.14. Research

In addition to the development of new drugs and medical devices, MASTELLI’s research structure also focuses on the development of new knowledge and new ways of using drugs and medical devices already on the market. The aim of MASTELLI’s research activity is, in the context of a logic of enterprise and fair competition, to discover increasingly effective and safe drugs and medical devices, with the aim not only of improving the health of patients, but also of guaranteeing them a better quality and longer life.

1.15. Clinical trials

At any stage, whether before or after the granting of the marketing authorisation for medicinal products and medical devices, only clinical trials authorised in accordance with the applicable regulations are permitted. Clinical studies of any kind, including post-marketing studies, must be conducted for scientific purposes.

The conduct of non-interventional (observational) clinical studies is subject to compliance with the applicable regulatory provisions and must always be regulated by a specific agreement between MASTELLI SRL and the Ethics Committees involved.

1.16. Corporate governance

MASTELLI SRL adopts a corporate governance system that complies with the provisions of the law and industry regulations applicable thereto.

1.17. Internal control

MASTELLI SRL must provide for a system of internal controls, entrusted to appropriate departments in terms of structure and training, in compliance with the requirements of the law, supervisory regulations and self-regulatory standards.

The tasks of the Internal Control structures are those laid down by law, by the CODE, as well as by other external-regulatory and self-regulatory rules.

Each SUBJECT, within the scope of their assigned duties and tasks, must actively contribute to the proper functioning of the internal control system

1.18. Relations with auditors and other structures

In the relations with the Auditor, each structure or function of MASTELLI SRL as well as each SUBJECT shall also abide by the provisions of the CODE, in compliance with their respective institutional roles.

MASTELLI SRL provides, at all levels, its utmost cooperation to both the Auditor and the Certifying Parties, providing correct and truthful information on the company’s activities, assets and operations, as well as on any reasonable request received from same.

Requests for compliance and documentation must be processed promptly, with clear assumption of responsibility for the truthfulness, completeness and accuracy of the information provided. The requested data and documents are made available in a timely and comprehensive manner. The information thus provided must be accurate, complete, faithful and true, avoiding, and in any case reporting, in the appropriate form and manner, situations of conflict of interest.

Company assets

The use of company assets must always comply with the law, the CODE, internal rules and the requirements of functionality and efficiency.

Each employee and collaborator is required to use company assets diligently, behaving responsibly and protecting such assets. Company assets must be used appropriately and in accordance with the company’s interest, preventing their misuse by third parties. Any exceptions are allowed only if expressly authorised.

Audiovisual, electronic, reprographic or photographic recordings or copying of corporate documents are only allowed for the needs directly related to the performance of the assigned task or duty, within the limits allowed by the law, CODE and internal regulations.

1.20. IT systems, access and information security

The use of the IT systems and databases of MASTELLI SRL is carried out in compliance with current legislation and on the basis of the principles of correctness and honesty.

MASTELLI SRL adopts appropriate protection systems to ensure the security of access to data and programmes stored on the computers of MASTELLI SRL.

Each SUBJECT is responsible for the correct use of the IT resources assigned to them as well as the access codes to the systems themselves. It is prohibited to break into computer systems protected by security measures, as well as to obtain or disseminate access codes to systems and to damage information, data or computer programs.

2. Principles of conduct in relations with internal, external and institutional stakeholders

2.1. Staff

Staff (meaning all EMPLOYEES and COLLABORATORS, including COMPANY OFFICERS who are EMPLOYEES or COLLABORATORS), represent the strategic assets of MASTELLI SRL, which considers them to be a decisive resource in creating the competitive advantage, for achieving entrepreneurial goals and for realising the development of MASTELLI SRL.

MASTELLI SRL is therefore committed to selecting and retaining staff that are particularly well-qualified. This is enhanced by paying special attention to motivational aspects and specific training needs, taking into account individual potential and fostering the conditions for a rewarding and non-conflictual working environment.

It is the primary objective of MASTELLI SRL to maintain a working environment that complies with the provisions of the CODE so as to ensure respect for the individual, in accordance with national laws and international principles on the protection of human rights. All SUBJECTS are required to cooperate in achieving this objective.

MASTELLI SRL recognises the importance of internal company communication, as a tool for sharing institutional information and a motivational vehicle for Staff.

The principles described below guarantee respect for the individual, in accordance with national laws and international principles on the protection of human rights. For this reason, all EMPLOYEES and COLLABORATORS of MASTELLI SRL must strictly adhere to the principles set out below; any violation will be strictly sanctioned.

2.1.1. Staff selection and management

The selection, remuneration, training and career progression of Staff must be based on predetermined and objective criteria inspired by fairness, impartiality and merit. People are recruited on the basis of their experience, aptitude, skills. Staff selection is based exclusively on the combination of expected, required and available profiles.

Professional growth and career advancement have merit as a prerequisite, and are marked by fairness and equal opportunities without discrimination on the grounds of gender, race, age, sexual orientation, religious beliefs and any other factor that is not relevant in terms of professional aptitude.

Recruitment takes place on the basis of a regular employment contract, in compliance with all applicable legal provisions as well as existing collective bargaining agreements, favouring the worker’s integration into the workplace. In particular, the competent Departments of MASTELLI SRL are duty-bound to verifying that the party with whom it is intended to enter into a working relationship, possesses all the requisites required by law for the permanence and undertaking of the requested working activity within the Italian territory.

MASTELLI SRL promotes the professional and personal growth of EMPLOYEES and to this end takes care to involve them in sharing objectives and in assuming responsibilities consistent with the roles held. Each EMPLOYEE has the right to perform duties consistent with those for which they were hired, or which have been assigned to them on the basis of their merits and professionalism.

Decisions concerning STAFF selection, and all decisions concerning the employment relationship, must be justified and documented by the competent department.

Without prejudice to compliance with mandatory rules, as well as trade union regulations and agreements, the remuneration system, at any level, both in terms of cash and benefits must be inspired by predetermined and knowable criteria, implementing the principle that remuneration must be determined solely on the basis of objective assessments relating to educational training, specific professionalism, experience acquired, demonstrable merit and the achievement of assigned objectives.

The criteria established by the company in order to qualify for variable remuneration, must be subject to periodic joint reviews and evaluations of several company structures in order to ensure the necessary internal decision-making balance, and shall be predetermined in a clear, objective manner, and communicated to the interested parties (Directors, Executives, Middle Managers, Area Managers, etc.).

2.1.2. Reward system and incentives

The reward system is geared towards the recognition of skills and merits according to explicit, fair and measurable criteria. The main factors that define meritocracy are: the achievement of pre-established objectives that are achievable and objectively determined, respect for company values and rules, professionalism, empowerment, and the ability to work as part of a team.

The achievement of objectives in full compliance with the applicable regulations, laws and internal provisions is an essential element for a positive evaluation of the performance of STAFF, which must be carried out from a quantitative point of view, i.e. with respect to the results achieved, and from a qualitative point of view, i.e. with respect to their conduct. They must also have maintained a behaviour consistent with MASTELLI SRL’s mission and must have strived to enhance the strengths that characterise the company’s presence on the market.

In relation to the Pharmaceutical Sales Representative (PSR), the performance evaluation shall also take into account the quality of scientific information through training and verification by the Head of MASTELLI SRL’s Scientific Services.

The mere prospect of increases in remuneration, other advantages or career advancement, in return for carrying out activities that are contrary to the law, the CODE and the internal rules and regulations, even if only in terms of competence, is also prohibited.

2.1.3. Harassment

MASTELLI SRL considers any kind of violence, harassment or undesirable behaviour that violates the dignity of the person towards whom these attitudes are directed, as unacceptable. Any form of sexual harassment, or reference to personal, cultural and religious diversity is therefore prohibited.

2.1.4. Work environment

All employees and collaborators must personally contribute to building and maintaining a climate of mutual respect, showing attention to colleagues and to each other’s sensitivities, in an atmosphere of cooperation and help.

2.1.5. Health and safety

The protection of people’s health and safety is one of the primary objectives of MASTELLI SRL.

The activities of MASTELLI SRL are carried out in full compliance with current legislation on the protection of health and safety in the workplace, as well as specific applicable prevention regulations.

MASTELLI SRL is committed to ensuring safe and healthy working conditions, aimed at protecting the physical and moral integrity of people working at its production sites and offices.

MASTELLI SRL is committed to disseminating and consolidating a culture of safety by developing risk awareness and knowledge of, and compliance with, current prevention and protection regulations, promoting responsible behaviour on the part of all workers.

No EMPLOYEE and no COLLABORATOR shall expose others to risks and dangers that may cause harm to their health and safety, remembering that each worker is responsible for, and must act with the aim of, ensuring the effective management of the health and safety of the working environment.

Everyone must feel involved and called upon to take an active part in constantly improving safety conditions at work.

Within the framework of health protection, MASTELLI SRL disseminates a healthy sports culture, which is against any use of doping substances considered a sports offences, in any form and at any event, adopting a specific “No Doping” company policy, which defines relevant responsibilities, actions and control methods.

2.2. Customers

2.2.1. Customer relations

Customers represent the fundamental asset of MASTELLI SRL.

Relations with customers or potential customers (meaning Local Health Authorities, Hospitals, Pharmacies, Wholesalers, Purchasers and Licensees) must be characterised by the utmost transparency and fairness and always managed in compliance with the applicable law and company procedures.

MASTELLI SRL provides clear and truthful information on each product to enable the customer to make an informed and rational choice; the communication style adopted is based on courtesy, efficiency and collaboration towards each person who has contact with MASTELLI SRL.

In their relationships with customers, the SUBJECTS are required to:

• operate in absolute compliance with the applicable regulations;
• base their activities on fairness and transparency, refraining from any disparaging assessment of competing activities or products;
• avoid claiming that the products produce miraculous effects. The efficacy of reportable products can only be that which is supported by completed, evaluated and published clinical trials.
• specifically facilitate the formation of informed choices by the customer through adequate and accurate information;
• respect the customer’s freedom to negotiate, refraining from inducing them to take decisions that are not properly thought through and independent;
• scrupulously observe the internal procedures for managing customer relations;
• promptly report to the Ethics Committee any customer behaviour that appears to be in conflict with the principles of the CODE.

2.2.2. Quality of products and services

MASTELLI SRL is committed to ensuring the achievement and maintenance of high quality standards in the products and services offered, with the aim of guaranteeing the highest possible satisfaction and protection of its customers.

MASTELLI SRL is committed to ensuring adequate control mechanisms to avoid the product that is delivered to the buyer being different in nature, origin, provenance or quantity from that stated or agreed.

2.3. Suppliers, business partners, consultants and agents

The evaluation and selection of SUPPLIERS and the purchase of goods and services are carried out solely and exclusively by the Company Departments, appointed and trained for this purpose, in such a way as to allow full traceability of the process itself, making it possible to identify the Company subjects who determined and authorised the purchase operations.

The selection of SUPPLIERS is carried out exclusively on the basis of criteria of quality, cost-effectiveness, professionalism and compliance with applicable regulations and price. MASTELLI SRL continues to select contractors without engaging in any discriminatory practices.

No subject of MASTELLI SRL, or party acting on behalf of same, shall have relations with any SUPPLIER if such supplier has an interest, even non-asset related or indirect, in the activity of same.

Relations with the SUPPLIER shall be based on fairness and good faith and must be documented and traceable.

MASTELLI SRL undertakes to contractually commit its SUPPLIERS to comply with the rules of law, as well as to become acquainted with and adhere to the principles enshrined in the CODE.

MASTELLI SRL contractually reserves the right to adopt any suitable measure (including termination of the contract) in the event that the SUPPLIER, in carrying out activities in the name and on behalf of MASTELLI S.R.L., violates the rules of law or the CODE.

Anyone who has relations with the SUPPLIER is required to report significant breaches and non-compliance with the CODE to the head of the department.

The conditions under which the supply is actually carried out must be those contractually agreed upon.

In establishing business relations with new partners and in managing existing ones, it is necessary, taking into account the information available, to avoid any relationship with persons involved in unlawful activities, in particular related to money laundering, organised crime and terrorism, and, in any case, with persons lacking the necessary requisites of seriousness and commercial reliability.

MASTELLI SRL establishes relations only with business partners and contractual counterparties who are reliable and of good reputation and whose business ethics are the same as those of MASTELLI SRL. These relationships are inspired by the following principles, set out in specific procedures:

• MASTELLI SRL and the SUBJECTS shall refrain from entering into agreements that are contrary to law, fraudulent or secret;
• relations with business partners and contractual counterparties in general are conducted in compliance with the CODE;
• the relations in question are held by professionally trained and competent persons, identified according to the internal rules of MASTELLI SRL;
• the SUBJECT shall promptly report to the Ethics Committee any behaviour of the business partner or of the contractual counterparty that appears to be in conflict with the CODE.

MASTELLI SRL is committed to adopting criteria for assigning tasks and mandates to business partners and COLLABORATORS inspired by principles of competence, cost-effectiveness, transparency and fairness, in compliance with applicable internal procedures.

More specifically, the fees and/or sums paid to assignees of professional assignments must be adequately documented and proportionate to the activity performed, and must also take market conditions into consideration.

2.4. Public administration

In its relations with the Public Administration and, in general, with Italian, supranational or foreign public bodies, MASTELLI SRL scrupulously complies with the provisions of the CODE.

The aforementioned relations are maintained only by the competent COMPANY OFFICERS or EMPLOYEES according to the internal rules of MASTELLI SRL or when expressly authorised, with the conferral of appropriate powers. In any case, a person in charge of the procedure is identified, who is entrusted with the task of, among other things, coordinating the persons in charge and supervising compliance with the CODE.

All activities and negotiations conducted by the EMPLOYEES and COLLABORATORS of MASTELLI SRL must be based on the utmost honesty and transparency; their behaviour must demonstrate commitment and professionalism in every situation so as to guarantee and protect the image and reputation of MASTELLI SRL.

EMPLOYEES and COLLABORATORS who, in the performance of their duties, converse or conduct negotiations with Public Administrations, whether Italian or foreign, are required to adopt a clear, correct and transparent attitude, and must not in any way undermine the autonomy of the latter’s representatives or their impartial judgement.

More specifically:

• those who have interests, even if not financial or indirect, that are connected or attributable to bodies of the Public Administrations or with people who are part of same, whatever the reason, cannot hold the aforementioned relationships in the name or on behalf of MASTELLI SRL;
• it is prohibited to promise or pay, for any reason whatsoever, including indirectly or in any fraudulent manner, money or other benefits to persons who are members of the bodies of the Public Administration or to persons connected to them by virtue of family, personal or business relations;
• any person who becomes aware of requests for money or other benefits from persons belonging to the aforementioned bodies shall promptly inform the person in charge of the proceedings and the head of the department;
• in the specific case of carrying out a tender with the Public Administration, one must act in accordance with the law and good business practice;
• it is forbidden, in the production of corporate documents, to put forward untrue representations of facts capable of misleading or altering the analysis and decision-making capacity of the Public Administration;
• it is also forbidden to use contributions, subsidies or funding from the State, other public bodies or the European Community for purposes other than those for which they were granted;
• any conduct aimed at obtaining, from the State, the European Community or any other public body, contributions, financing, subsidised loans or other disbursements by means of false declarations or altered or forged documents, or by means of omitting information, tricks or deception, including those carried out through IT or telematic systems, aimed at misleading the body granting such funds, is prohibited.

2.5. Judicial and public supervisory authorities

Consistent with the provisions of the previous paragraph, MASTELLI SRL’s relations with national, supranational and foreign Supervisory and Control Authorities are inspired by the principles of legality, transparency and loyal cooperation.

MASTELLI SRL, with the help of the expressly authorised departments, fulfils its legal obligations regarding communications and information flows with the competent Authorities, with particular reference to the Supervisory and Control Authorities, guaranteeing the completeness, truthfulness and integrity of the information, the objectivity of the evaluations and the timeliness of reporting.

During audits or inspections by the competent Public Authorities, the SUBJECTS are required to adopt an attitude of helpfulness and cooperation towards the inspection and control bodies and must provide the information requested in a clear and truthful manner.

No SUBJECT shall attempt to persuade others not to provide information or to provide false or misleading information to the competent authorities, nor may they engage in any economic activity, confer any professional task, give or promise any gift, money or other advantage in favour of the person carrying out the investigations and inspections, or in favour of the competent judicial authorities.

those who have interests, even if not financial or indirect, that are connected or attributable to bodies of the Public Administrations, or to the bodies mentioned in the first paragraph, or with people who are part of same, whatever the reason, cannot hold the aforementioned relationships in the name or on behalf of MASTELLI SRL

2.6. Healthcare workers

Relations with all healthcare workers (meaning the various medical figures, pharmacists, medical directors, nursing, technical and administrative staff of public and private healthcare facilities) must be managed in full compliance with applicable laws and with the rules of conduct enshrined in the Code of Ethics of FARMINDUSTRIA and the Code of Ethics of CONFINDUSTRIA DISPOSITIVI MEDICI.

2.6.1. Direct scientific information

The content of the information must always be documented or documentable Exaggerated statements, universal and hyperbolic assertions, and unprovable comparisons lacking a clear objective basis are not permitted.

Pharmaceutical Sales Representatives (PSR) must identify their role when introducing themselves to the health care professional.

The information material prepared by the company on its products, which it uses to inform doctors, must make reference to the official documentation provided to the AIFA – Agenzia Italiana del Farmaco (Italian Medicines Agency) at the time of registration, or must be subsequently approved by said Agency in accordance with the laws in force in that regard. Reference shall also be made to the guidelines prepared by the Ministry of Health and the Medical Devices Regulations.

The training of MASTELLI SRL’s sales representative is carried out with substantial and rigorous criteria and in an exhaustive and detailed manner exclusively by the Scientific Management of MASTELLI SRL, a department appointed for this in compliance with Legislative Decree 219/06.

2.6.2. Promotional material

With specific reference to the activity of information and presentation of medicines carried out with doctors or pharmacists, it is prohibited to grant, offer or promise rewards, pecuniary advantages or benefits in kind.

Promotional material concerning drugs and medical devices and their use shall be of negligible value, be non-fungible and in any case be related to the activity performed by the doctor and the pharmacist. This material must also clearly state the Company and Product being endorsed. All promotional material for doctors and pharmacists is always purchased directly from the company centrally, and must have been submitted for review and approval by the AIFA and/or the Ministry of Health.

In any case, the offer of financial incentives aimed at compensating for the time that health professionals spend away from their normal professional activity at conference events is prohibited.

Information material for scientific consultation or work, not specifically related to the medicine, may only be given free of charge to public health facilities, with the exception of material that has a lower perceived value, i.e. less than 25 euros. This material must be purchased from MASTELLI SRL centrally.

2.6.3. Congresses, conventions and scientific meetings

Participation by MASTELLI SRL in congresses, conventions and meetings as per art. 124, of Legislative Decree 219/06 and subsequent amendments, takes place in compliance with the regulations in force, the Code of Ethics of FARMINDUSTRIA, the Code of Ethics of CONFINDUSTRIA DISPOSITIVI MEDICI and the applicable internal procedures, and must always be inspired by ethical, scientific and economic criteria. Under no circumstances is it permitted to organise scientific initiatives that also have a tourism purpose.

2.6.4. Visits to company laboratories

Visits by healthcare workers to company laboratories are permitted, as long as an adequate training-information area is provided as part of the visit, the visit itself does not exceed the time strictly necessary, the hospitality offered is limited to the period of time between twelve hours prior to the start and twelve hours after the end of the visit, and it does not have characteristics that prevail over the technical purposes of the visit itself.

2.6.5. Advertising in newspapers and magazines

In the context of advertising in newspapers and magazines, a clear separation between information and advertising must be guaranteed, always ensuring that the reader can immediately recognise the promotional message, whatever form it takes, be it editorial or tabular. The institutional and product advertising promotion of MASTELLI SRL respects fundamental ethical values, always maintains truthfulness of content and repudiates the use of vulgar or offensive messages.

MASTELLI SRL edits publications of general interest and maintains institutional websites that are complete, effective and in line with ministerial directives, sector regulations and market expectations.

2.6.6. Scholarships and scientific consultancy

Within the scope of scientific collaboration activities, the applicable regulations, the provisions of the Code of Ethics of FARMINDUSTRIA, the Code of Ethics of CONFINDUSTRIA DISPOSITIVI MEDICI and the applicable company procedures must always be complied with.

Collaboration can also take place through scholarships and scientific consultancy, provided, however, that the appropriateness, adequacy and proof of documentation of the initiative is guaranteed.

However, the decision-making aspect of such initiatives must be reserved for the company’s top management.

2.7. Relations with competitors and trade associations

2.7.1. Fair competition

In carrying out its activity, MASTELLI SRL undertakes, in a context of business logic and fair competition, not to denigrate the image of competing companies and their products and to refrain from any behaviour that violates the principle of fair competition.

2.7.2. Trade associations

Where MASTELLI SRL decides to join trade associations, it undertakes to participate in association activities in full compliance with the rules shared and established by the association itself.

2.8. Relations with trade union, political, social and cultural organisations

MASTELLI SRL engages in dialogue with trade union organisations with a sense of responsibility and in constructive terms, fostering a climate of mutual trust and dialogue, in the continuous search for profitable industrial relations.

In relations with political parties, political and trade union organisations and associations representing collective or category interests, MASTELLI SRL scrupulously complies with the CODE and takes into account its respective roles in social action.

The relations in question are maintained exclusively by the competent COMPANY OFFICERS or EMPLOYEES according to the internal rules of MASTELLI SRL or expressly authorised, with the conferral of appropriate powers.

No one, who has interests, even if not financial or indirect, in any way connected or traceable to the subjects mentioned in the 2nd paragraph of this section, or with persons who are part of same, may hold the aforementioned relations in the name of or on behalf of MASTELLI SRL.

It is always strictly forbidden to promise or pay, for any reason whatsoever, even indirectly, or in any fraudulent manner, money or other benefits to persons who are part of the bodies referred to in paragraph 2, or to persons connected to them by virtue of family, personal or business relations.

Any person who becomes aware of requests for money or other benefits from persons belonging to the bodies referred to in paragraph 2 must promptly inform the person in charge of the proceedings and the head of the department.

MASTELLI SRL does not support events or initiatives that have obvious political aims, and refrains from supporting, with financial or other means, political parties and exponents, trade unions and/or their exponents.

Only in the pursuit of institutional, cultural or social solidarity purposes, may MASTELLI SRL promote or participate, including by contributing money or offering services, in initiatives consistent with the aforementioned purposes. In this case, if circumstances so require, a procedures’ manager is appointed and the participation in the initiative must be adequately justified, including with regard to the appropriateness of the economic commitment and the nature of the initiative and its participants. In particular, MASTELLI SRL may support, with the means available from its current activity, institutions and initiatives of a religious, cultural, artistic, scientific, health, welfare, environmental, sporting and more generally a socially useful nature.

Relations with trade union organisations are inspired, in a context of business logic, by the principles of fairness and respect for the counterpart and are reserved for the Corporate Departments appointed to that end.

Where MASTELLI SRL decides to join trade associations, it undertakes to participate in association activities in full compliance with the rules shared and established by the association itself. 

3. Implementation and control

3.1. Dissemination, training and implementation

MASTELLI SRL informs all the SUBJECTS about the provisions and application of the CODE, and recommends its observance; it takes responsibility for disseminating the Code of Ethics to each EMPLOYEE and in general to all Subjects, with the methods that are most effective and appropriate for the MASTELLI system (transmission by e-mail and/or hand delivery, publication on the website www.mastelli.it)

In particular, within the framework of professional training and updating activities and in the exercise of disciplinary powers, MASTELLI SRL provides, including through the appointment of specific internal functions, the following:

• the promotion, with continuous and effective actions, of the knowledge and respect of the CODE among the SUBJECTS, at each organisational level;
• the verification, through appropriate structures and supervision, of effective compliance;
• the establishment of an appropriate penalty system and its enforcement;
• the adoption of measures related to the removal of the consequences of infringements of the rules contained in the CODE;
• the updating of the provisions of the CODE to ensure its effectiveness and adaptation to the activity of MASTELLI SRL and the relevant legislation. The effectiveness of the CODE in the light of regulatory development and industry best practices, as well as changes in the organisation and activity of MASTELLI SRL, are in fact subject to constant verification. In the event of a violation, a specific verification of the CODE and internal regulations is carried out and, if appropriate, modifications are made to prevent further violations.

Contracts entered into by MASTELLI SRL must include a clause informing third parties of the existence of the Code of Ethics, which shall include the following: “Code of Ethics: this contract is supplemented by the rules of the MASTELLI Code of Ethics (published on the website www.mastelli.it), the breach of which may lead to the termination of the contract”.

3.2. Roles and responsibilities

The Ethics Committee is assigned the responsibility of supervising and controlling the application of the CODE.

In carrying out these activities, the Ethics Committee will be supported by all corporate departments concerned and will have free access to all documentation deemed useful.

3.3. Reports

Any SUBJECT may report breaches of the CODE in the manner provided for by internal procedures. All the SUBJECTS of the CODE are also required to cooperate in internal investigations concerning breaches and behaviours not in line with the CODE, without prejudice to the obligations of anonymity and protection of the reporting party.

Reports are addressed to the Ethics Committee, which carries out further investigations and takes the necessary measures.

All MASTELLI SRL employees and collaborators are required to report any possible or potential violations of the law or of the Code of Ethics that they, in good faith, believe may have occurred or may occur.

The report may be submitted confidentially or in a completely anonymous manner.

The report must be sent as follows:

• by sending it to the dedicated e-mail address: segnalazioni@mastelli.it;
• by post to the address – Ethics Committee – MASTELLI SRL Via Armea 90 18038 Sanremo (IM).

In any case, the reporting and verification of violations are subject to criteria of confidentiality and protection of confidentiality in order to prevent retaliation of any kind against the author of the report.

Reports that fall within the objective and subjective scope of Legislative Decree 24/2023 (Whistleblowing) will be collected and managed by the Reporting Management Committee, according to the procedure that can be viewed in the appropriate section of the website, to which reference is made. 

4. Sanctions

SUBJECTS that engage in conduct that is in breach of MASTELLI SRL’s CODE shall receive a proportionate, effective and dissuasive sanction.

Any violation committed shall be equated with an attempted violation. Sanctions must be predetermined in relation to individual facts.

Observance of the CODE is in fact an integral part of the conditions that regulate working, mandated and commercial relations with MASTELLI SRL. Any violation of this CODE, committed by managers and/or other EMPLOYEES, shall entail disciplinary measures and contractual remedies proportionate to the seriousness or recurrence of the violation, the degree of guilt and the existence of malice, in compliance with the provisions of the law and/or applicable collective agreements. This shall include in any case, as of now, the possible termination of the relationship with immediate effect, without prejudice to compensation for damage caused to MASTELLI SRL.

Sanctions against EMPLOYEES shall be applied in compliance with the provisions of the law and the provisions contained in trade union agreements and contracts and, in particular, with reference to Articles 7 et seq. of Law no. 300 of 20 May 1970 and the provisions contained in the applicable CCNL (National Labour Contract).

For SUBJECTS other than EMPLOYEES, the sanctions for violation of the CODE shall be provided for in the contractual instrument or in the resolution of the corporate bodies regulating the relationship. In particular, the B.o.D. takes appropriate measures against its members who have committed violations of the CODE, except with regard to the compensation of the damage caused to MASTELLI SRL.

Please refer to the annex entitled SANCTIONS SYSTEM. 

ANNEX SANCTIONS SYSTEM

A) REPORTING MANAGEMENT PROCEDURE

The Ethics Committee, upon receipt of the report, meets to share it with all its members, carry out the necessary checks on its veracity and, if the veracity is verified, the Committee shall activate the sanctions system.

B) ACTIVATION OF THE SANCTIONS SYSTEM

Depending on the departments reported, the Sanctions System will be activated by:

• HR manager/Legal Support / Regulatory Affairs Manager, or alternatively a combination thereof, if the reported person is an employee or manager of MASTELLI SRL;
• Board of Directors, if the person reported is the Auditor;
• Auditor, if the person reported is a Director;
• CEO, if the person reported is a third party.

C) SANCTIONS

I. Sanctions against employees and managers:

The deliberate violation of the principles of the Code of Ethics is punishable by a verbal warning.

Repeated and deliberate violation of the principles of the Code of Ethics is punishable by a written warning.

Failure to comply with the obligation to inform the direct superior about incorrect or anomalous behaviour of which you have direct knowledge;

II. Sanctions against managers:

The wilful or deliberate breach of externally relevant procedures and/or fraudulent evasion brought about through conduct unequivocally aimed at committing an offence that is punishable by dismissal without notice; also punishable by dismissal without notice is the wilful or deliberate breach and/or evasion of the control system, i.e. preventing control or access to information and documentation by the persons in charge; failure to comply with the obligation to inform the direct superior about misconduct and/or abnormal and/or irregular conduct of which there is direct and certain evidence.

III. Sanctions against the Chairman of the Board and the Chief Executive Officer:

The deliberate violation of the provisions contained in the Code of Ethics is punishable by written warning.

Serious or repeated violations of the provisions contained in the Code of Ethics are punishable by termination of the appointment and/or office.

IV. Sanctions against external subjects:

Any conduct of a third party that is required to comply with the Code of Ethics, and that is in breach of its provisions shall entail the imposition of the sanctions expressly included in the relevant contracts.

Sanctions against the Auditor:

In the event of violations of the Code of Ethics by the Auditor, the Board of Directors shall activate the Shareholders’ Meeting for the adoption of the most appropriate protective measures.