ETHICAL CODE

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Industria Farmaceutica Galenica Senese S.r.l.

ETHICAL CODE

pursuant to Legislative Decree 231/2001

Approved by the Sole Administrator on 17/06/2020

SUMMARY

PREMISE

CHAPTER I - GENERAL PRINCIPLES

  • PURPOSE AND CONTENTS OF THE ETHICAL CODE
  • GENERAL PRINCIPLES
  • RECIPIENTS AND DIFFUSION OF THE CODE
  • EFFECTIVENESS OF THE CODE

CHAPTER III - PRINCIPLES AND VALUES - ETHICS AND VALUES

  • ADOPTION AND ENTRY INTO FORCE
  • INTERPRETATION
  • SUPERVISION, VIOLATIONS AND SANCTIONS
  • CONTRACTUAL VALUE OF THE CODE
  • CODE UPDATE

CHAPTER III - PRINCIPLES AND VALUES - ETHICS AND VALUES

  • LEGALITY
  • CORRECTNESS
  • NON-DISCRIMINATION
  • ENHANCEMENT AND RESPONSIBILITY OF HUMAN RESOURCES
  • BUSINESS HONESTY
  • CONFIDENTIALITY
  • DILIGENCE AND ACCURACY
  • PROFESSIONALISM
  • PROTECTION OF THE PERSON
  • ECONOMIC-FINANCIAL TRANSPARENCY
  • ENVIRONMENTAL PROTECTION
  • PARTICIPATION AND RECIPROCITY
  • DATA PROTECTION AND COMPUTER SYSTEMS

CHAPTER IV – GOVERNANCE

  • SHAREHOLDER STRUCTURE
  • ADMINISTRATIVE BODY
  • BOARD OF AUDITORS

CHAPTER V - HUMAN RESOURCES AND EMPLOYEES

  • STAFF SELECTION AND RECRUITMENT
  • MANAGEMENT OF RELATIONS
  • PROHIBITION TO ACCEPT GIFTS AND / OR OTHER UTILITIES
  • CONFLICT OF INTERESTS

CHAPTER VI - EXTERNAL RELATIONS

  • RELATIONS WITH THE PUBLIC ADMINISTRATION
  • RELATIONS WITH CUSTOMERS
  • RELATIONS WITH AGENTS, PARTNERS, SUPPLIERS AND COMPETITORS
  • ACCOUNTING AND FINANCIAL MANAGEMENT

CHAPTER VII - PENALTY SYSTEM

  • REPORTING VIOLATIONS TO THE ETHICAL CODE
  • VIOLATIONS AND SANCTIONS

The Industria Farmaceutica Galenica Senese was born in Siena in 1949 thanks to the desire and commitment of two pharmacists who thought of industrializing the production process of galenic infusion solutions, which was still artisanal at the time, by creating a small production site within the ancient city walls of Siena. In the 1980s the company, which in the meantime had grown, was moved to the countryside in Monteroni d'Arbia, near the spring of Monte Amiata (called Vivo D'Orcia) whose water is known for its particular microbiological properties, which make it perfect in terms of concentration of mineral salts, pH and hardness.

The company is still there and works with the same spring water, although in the meantime it has seen its size grow and has changed owners. In 1985 it was acquired and incorporated into the SVAS group, owned by a Neapolitan family headed by Mr. Francesco Fausto Perillo - founder of the group in 1972. SVAS, now SVAS BIOSANA, is a company specialized in the production of medical devices, medications, solutions for incontinence, cotton wool, and markets over 20,000 products including medical devices, electro-medical equipment, surgical instruments and specialist products. Now Francesco Fausto Perillo is gone, last year his beloved wife Claudia Scala-Perillo also passed away. The children Umberto and Danila Antonia currently lead the group.

Dr. Danila Antonia Perillo is the CEO of Galenica Senese.

PREMISE

The Industria Farmaceutica Galenica Senese S.r.l. (hereinafter, for brevity, "Galenica Senese" or the "Company") was born in Siena in 1949 thanks to the desire and commitment of two pharmacists who thought of industrializing the production process of galenic infusion solutions, which was still artisanal at the time, by creating a small production site within the ancient city walls of Siena. In the 1980s the company, which in the meantime had grown, was moved to the countryside in Monteroni d'Arbia, near the spring of Monte Amiata (called Vivo D'Orcia) whose water is known for its particular microbiological properties, which make it perfect in terms of concentration of mineral salts, pH and hardness.
The company is still there and works with the same spring water, although in the meantime it has seen its size grow and has changed owners. In 1985 it was acquired and incorporated into the SVAS group, owned by a Neapolitan family headed by Mr. Francesco Fausto Perillo - founder of the group in 1972. SVAS, now SVAS BIOSANA, is a company specialized in the production of medical devices, medications, solutions for incontinence, cotton wool, and markets over 20,000 products including medical devices, electro-medical equipment, surgical instruments and specialist products. Now Francesco Fausto Perillo is gone, last year his beloved wife Claudia Scala-Perillo also passed away. The children Umberto and Danila Antonia currently lead the group.

Dr. Danila Antonia Perillo is the CEO of Galenica Senese.

Galenica Senese is a company specialized in the production of infusion (and injectable) drugs, loco-regional anesthetics, saline infusion solutions, glucose, electrolytic, ringer, mannitol, glycerol, sodium bicarbonate to restore the hydro-saline and energy balance of hospitalized patients, amino acid solutions, infusion solutions for pain therapy such as paracetamol, iopamidol and contrast media for radiology, cardioplegic solutions in bags, antibiotics in bags, veterinary solutions, life-saving drugs such as adrenaline and noradrenaline, fluids for dialysis.

These are only some of the many formulations that the company is able to produce.

Thanks to the commitment of its management, the company has grown progressively and, in just a few years, has become an important point of reference in Italy and abroad for the healthcare sector.

Through the enhancement of the production lines and the expansion of its technical skills (through the continuous search for innovative techniques and the utmost attention to quality), GALENICA has been able to develop third party production also for Italian and foreign companies.

Galenica Senese is equipped with a modern and efficient establishment and above all particularly careful to quality. The chemical and microbiological analysis laboratories are also well equipped with modern equipment. The Company produces some medical devices in plastic bags, bottles and vials. Research and technology, high quality and experience, safety and speed in responses represent the Company's commitment to the varied clientele, both Italian and foreign, consisting of Italian hospitals, pharmacies, pharmaceutical wholesalers and distributors, Italian and multinational industries.

The manufacturing plant, in continuous renewal, has several production lines, a Quality Control laboratory, a small Research and Development laboratory, two large warehouses, one for raw materials and another one for the finished product from which products destined for the Italian and abroad market depart. The commercial and administrative offices are also located in Monteroni D 'Arbia. The company is currently able to produce large volumes and large numbers of infusion solutions thanks to the constant technical and structural updating of the plant and the inclusion of new production and packaging systems.

The company's chemical and microbiological laboratory has technologically advanced equipment (HPLC, gas chromatograph) in order to be able to perform all the checks required by European and international GMPs.

Close by to Galenica Senese is the University of Siena for more selective and refined methodologies and techniques. In the company's laboratories, chemical-physical and microbiological analysis are performed on raw materials, packaging materials, semi-finished products, finished products as well as all the countless analytical activities required for the preparation of dossiers and for compliance with GMPs.

GALENICA's target market are Italian hospitals, pharmacies and nursing homes. The technicians and laboratories are constantly engaged in the development of new products, which are also the result of the constant research studies done in the Universities of Siena, Florence and other universities, including foreign ones. The foreign sales office offers GALENICA’s products to sell all over the world, assisting customers both from a regulatory point of view and in drafting the dossier also in foreign language. The company is structured in compliance with GMP standards, both for drugs for human and veterinary use and having contacts with customers from all over the world, the quality system has integrated the GMP quality system with the various WHO, PIC/S and ICH. The company is also authorized to produce medical devices by CE 0373 and has ISO 13485 certification.

The Company has also implemented voluntarily the following certification systems:

  • ISO 9001
  • ISO 14001
  • BS OHSAS 18001

ISO 14001 is a voluntary international standard, applicable to any type of public or private organization, which specifies the requirements of an environmental management system. For the implementation of this management system, an in-depth environmental analysis was carried out, all the information of technical, scientific and legislative nature useful for highlighting the current environmental characteristics of the company's activities, products and services was collected. In fact, the certified environmental management system allows:

  • Control and maintenance of legislative compliance and monitoring of environmental performance.
  • Reduction of waste (water consumption, energy resources, etc.).
  • Support in investment or technological change decisions.
  • Guarantee of a systematic and premeditated approach to environmental emergencies.
  • Improvement of the company’s image.

The ISO 9001 standard, recognized worldwide, represents the reference for the certification of the quality management system of organizations of all production sectors and of all sizes. The management system focuses its attention on the effectiveness of the quality management system in order to meet customer requirements.

The international standard BS OHSAS 18001 is related to the management system for health and safety in the workplace.

In order to clearly define the reference values ​​and responsibilities, this Ethical Code (hereinafter the "Code") has been formalized, the observance of which by the Shareholders, the Management Bodies of the company, the Board of Auditors, the personnel, as well as by all those who work for the achievement of the company’s objectives, each within the scope of their functions and responsibilities, is of fundamental importance for the efficiency, reliability and reputation of the Company.

With particular reference to Legislative Decree 231/2001, the purpose of the Code is, moreover, the definition of legal obligations, the clarification of the conduct resulting from the aforementioned obligations, and the identification of the responsibilities of each person who collaborates in any title with Galenica Senese.

For all those who work in favor of Galenica and for all third parties, adherence to the ethical principles in the Code is a necessary condition for the continuation of the relationship with the company itself:

The Code is an integral part of every signed contract.

This Code therefore represents the fundamental text in which Galenica Senese enunciates the general ethical principles to which all business practices must be related, specifies the behavioral rules which are recognized to have a positive ethical value, defines the methods of implementation and control of the Ethical Code itself.

In addition to the enunciation of behavioral standards, the principles set out in the Code aim to increase the efficiency of the organization, directing the recipients towards positive objectives capable of generating benefit both for those directly concerned and for the general reference environment in its complex, strengthening the cohesion and consistency of the system, through the improvement of internal relations and attention to good reputation.

The adoption of the Ethical Code represents a public declaration of Galenica Senese's commitment to pursuing the highest levels of ethics in achieving corporate objectives.

Industria Farmaceutica Galenica Senese is committed to the promotion of knowledge, to respect and to enforce the general principles and ethical standards indicated in the Code, since this respect, as well as fundamental moral purposes, corresponds to a greater protection of the same corporate interest, also from an economic point of view.

The Company monitors on the compliance with the Code, providing adequate prevention and control tools and procedures to ensure the transparency of the activities and behaviors adopted, intervening with continuous improvement actions.

The Code does not replace and does not overlap with the laws and other regulatory sources such as the Collective Labor Agreement, the Company Bylaws, and all the systems/models already approved and operating in the Company.

Instead, it is a document that is placed at a different level from the purely legal one and integrates and strengthens the principles contained in these sources, with specific reference to the ethical profile of the company’s behavior and the reputation of the company itself.

CHAPTER I- GENERAL PRINCIPLES

Purpose and contents of the Ethical Code

The Ethical Code is a self-regulatory tool aimed at making company activity transparent and ethically directing its performance, even beyond what is established by current regulations and by the Employment Contracts to which the Company adheres.

The Code aims to identify the principles and specific rules of conduct that must inspire the behavior of GALENICA SENESE towards all stakeholders, internal and external, and which are at the basis of the relationships between them. The Code governs, through the introduction of a set of behavioral rules, the conduct of: Shareholders, Administrative Bodies, Board of Auditors, employees, suppliers, agents, partners and customers of the Company and of all those who work for the achievement of the objectives of the company, for any reason, directly or indirectly, permanently or temporarily.

Compliance with the Code is an essential condition for achieving the corporate mission of Galenica Senese.

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General principles

Ethical integrity and fairness in relationships between people are fundamental values for GALENICA SENESE and the principle of fairness constitutes the ethical foundation of the relationships that the Company intends to establish with all its stakeholders.

To this end, with this Code, GALENICA SENESE undertakes to bind its corporate governance system.

In particular, GALENICA SENESE, in following its ethical principles, undertakes to:

  • manage business relationships in compliance with all laws and regulations in force;
  • always act in mutual respect;
  • abide to its own moral and social obligations;
  • comply with all regulations regarding the protection, health and safety of people;
  • never make decisions based on personal gain;
  • contribute to the development of the local communities in which the COMPANY operates, adopting a code of ethics capable of ensuring commitment, honesty, safety and compliance with the rules.

Furthermore, all behaviors put in place by the people of GALENICA SENESE in carrying out their work must be inspired by the maximum correctness, completeness and transparency of information, legitimacy under the formal and substantial aspect and the clarity and truthfulness of the accounting documents, according to the law and internal procedures.

The activities of GALENICA SENESE must be carried out with commitment and professionalism, in compliance with the business objectives and with the aim of creating value and well-being for all stakeholders, while protecting the prestige and reputation acquired by the Company.

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Recipients and diffusion of the code

The provisions of the Code are addressed to all the people of GALENICA SENESE: Members, Administrative Bodies, Board of Auditors, employees, Third Parties as well as to all those who work for the achievement of the Company's objectives, each within the scope of their functions and responsibilities.

In particular, this Code is addressed to:

  • The partners;
  • the Corporate Bodies (the administrative body, the board of auditors and the Auditing business)
  • the Company's Personnel (i.e. employees, etc.);
  • Third parties (i.e. agents, consultants and suppliers of goods and services, including professionals, and anyone who carries out activities in the name and on behalf of the Company or under its control).

Specifically: agents, suppliers, consultants and partners who operate within the so-called sensitive areas of activity on behalf or in the interest of the Company.

The Company undertakes to promote the knowledge of the Code by the people working in the organization and by the other stakeholders so that the prescribed principles and behaviors constitute the bases of a business culture inspired by sustainable development and guide daily the company’s conduct.

GALENICA SENESE, in compliance with Legislative Decree 231/01, disseminates the Code in particular:

  • to internal staff at the time of hiring, by posting at the workplace as well as during specific training sessions, to promote awareness and practice on the behaviors indicated therein;
  • to external collaborators, suppliers and other third parties who carry out activities in the name and on behalf of GALENICA SENESE, by means of an appropriate and clear informative communication, on paper and/or electronic, so as to enable the Recipient to fully understand its content and to sign it consciously.

To obtain maximum dissemination of the Code, it is published on the website

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Effectiveness of the Code

The principles contained in the Code integrate, from an ethical point of view, the conduct relevant to the complete and correct fulfillment of the obligations of loyalty, diligence and good faith expected by the staff and by each person who is involved in any title in the activities of Galenica Senese.

Failure to comply with the rules contained in this Code will be proportionally sanctioned by resorting to disciplinary action and, where necessary, by legal, civil or criminal law. Third parties involved in the activities of GALENICA SENENSE are made aware of the commitments imposed by the Code and, in the event of non-compliance, appropriate internal and, if admissible and within the remit of GALENICA SENESE, external initiatives will be adopted.

CHAPTER II - APPLICATION OF THE CODE

Adoption and entry into force

The Code comes into force from its approval by the Company's Administrative Body.

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Interpretation

Any conflicts of interpretation between the principles and contents of the Company's procedures and the Code must be considered favorably resolved in favor of the latter.

In any case, the Administrative Bodies and the Control Bodies (i.e., Supervisory Body) take care of the definition of every problem regarding the interpretative and application aspects of the Code.

This Code cancels and completely replaces any pre-existing deed.

Supervision, violations and sanctions. The supervisory function on the observance and functioning of the Code and the Organization, Management and Control Model referred to in Legislative Decree no. 231/2001 is remitted to the Supervisory Body (hereinafter, the "SB").

This body detects any violations of the rules of the Code, reports them to the Administrative Bodies that contest them against the offenders, imposing them the sanctions provided for by the disciplinary system adopted, according to the type of offender. In particular, with regards to subordinate workers, the sanctions will be imposed in compliance with art. 2103, 2106, 2118 of the Civil Code, of art. 7 of the Workers' Statute L. n. 300/1970, as well as the current legislation on dismissals and the procedures provided for by the National Collective Labor Agreement applied.

In cases of an organic relationship, the detected and contested violation by the Administrative Body and/or the Board of Statutory Auditors will be assessed according to its gravity and may even result in the revocation for "right cause" of the appointment, resolved by the Shareholders.

In contractual relationships, depending on the severity of the violation, the signed contract may be considered terminated due to non-fulfillment, attributable pursuant to art. 1453 and 1455 of the Civil Code.

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Contractual value of the Code

Compliance with the rules of the Ethical Code must be considered an essential part of the contractual obligations of all those who operate in the interest of the company, in accordance with and for the properties of the applicable law.

Violation of the contents of the Ethical Code may constitute non-compliance with the obligations of the employment relationship or disciplinary offence, with any legal consequence, also concerning the preservation of the employment relationship and compensation for any damage caused.

The aforementioned recipients of the Code are obliged to observe and respect its principles and to comply with its behavioral rules.

Knowledge and adaptation to the requirements of the Code represent an indispensable requirement for the establishment and maintenance of collaborative relationships with third parties, to which the Company undertakes to disseminate all related information, in a context of absolute transparency.

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Update of the Code

The content of the Code can be modified and supplemented on the basis of the suggestions, indications and proposals that will be formulated by the Supervisory Body provided for by Legislative Decree 231/01.

CHAPTER III – PRINCIPLES AND VALUES – ETHICS AND VALUES

The Company inspires its choices and rules of conduct to the ethical and value principles summarized below, which constitute the company's policy.

Legality

GALENICA SENESE recognizes legality as a founding principle for the conduct of any activity, and urges its collaborators to comply with this Code, with the law, with the current legislation and specific company regulations and/or procedures.

GALENICA SENESE does not justify any contrary behaviour, even if motivated by the pursuit of an interest of the Company itself, and sanctions such conduct according to the provisions of its Disciplinary System.

GALENICA SENESE prevents, with specific controls, the establishment and maintenance of any form of relationship with subjects whose behavior is not based on principles of verified legality.

Correctness

The Company in business relations is inspired by the principles of loyalty, fairness, transparency, efficiency and openness to the market. All the actions and operations carried out and the conduct held by each of the subjects, employees of the Company, in carrying out the activities are inspired by legality from a formal and substantive point of view, according to current rules and internal procedures, as well as correctness. The pursuit of the Company's interest can never justify a conduct that is contrary to the principles of fairness and honesty, as well as to the laws and regulations in force.

Non-discrimination

In its internal relationships and in its relations with all third parties, the Company avoids any discrimination based on age, racial and ethnic origin, nationality, political opinions, religious beliefs, sex, sexuality or state of health of its interlocutors.

Development and responsibility of human resources

All Galenica Senese employees contribute to defining, maintaining and improving the company's image and the quality of the products supplied. For this reason, the Company continuously promotes the value of its human resources, stimulating collaboration and teamwork and supporting training sessions.

GALENICA SENESE enhances its human resources through the protection of their physical and moral integrity, favoring a continuous increase in technical and professional skills. The management and enhancement of human resources is based on respect of personality and professionalism of each of them in the general context of society.

GALENICA SENESE stimulates honest, open and constructive interaction, participation and collaboration, sharing of information and knowledge.

GALENICA SENESE offers all employees the same opportunities for professional growth, making sure that everyone can enjoy fair treatment, based on merit criteria, without any discrimination in order to:

  • adopt merit criteria, competence and in any case strictly professional for any decision relating to an employee;
  • select, hire, train, pay and manage employees without discrimination;
  • create a working environment in which personal characteristics cannot give rise to discrimination.

Each employee must work actively to maintain a climate of mutual respect for the dignity and reputation of each one.

The recipients of this Code are also required to follow the most reserved appropriate processing for personal data, which they encounter during their work, in order to protect the confidentiality, image and dignity of people.

Business honesty

The Company's staff must adopt a correct and honest attitude, both in the performance of their duties and in relations with the other members of the Company, avoiding pursuing illicit or illegitimate purposes, or generating hypotheses of conflict of interest in order to obtain an undeserved advantage, own or third party. Under no circumstances may the interest or benefit of the Company induce and/or justify dishonest behaviour.

Confidentiality

GALENICA SENESE's activities constantly require the acquisition, storage, processing, communication and dissemination of news, documents and other data related to negotiations (contracts, acts, etc.) that, for contractual agreements, cannot be disclosed externally, or whose inappropriate or untimely disclosure could cause damage to corporate interests.

Considering the transparency of the activities carried out and the information obligations imposed by the current provisions, it is an obligation for all those who collaborate with GALENICA SENESE to ensure the confidentiality required by the circumstances for each news learned due to their work function.

The information, knowledge and data acquired or processed during the work activities belong to GALENICA SENESE and cannot be used, communicated or disclosed without specific authorization of the superior in a managerial position, in compliance with specific procedures.

Diligence and accuracy

The Company ensures that its staff fulfills their duties with the necessary diligence and accuracy, in compliance with shared directives and, in general, with company quality standards.

Professionalism

The subjects operating within the Company, also those to whom the Company entrusts the performance of certain services, are endowed with proven requirements of competence, professionalism and experience.

Protection of the person

In compliance with the law to protect physical and moral integrity, the Company ensures its staff respectable working conditions, in safe and healthy working environments.

The Company considers the principle of health protection as a primary objective, in line with the business activity and the economic initiatives that descend from it.

GALENICA SENESE's activities are conducted in accordance with the laws and regulations relating to the protection of the health and the safety of workers, the environment and public safety.

GALENICA SENESE ensures continuous alignment with BS OHSAS 18001:2007 standards. Furthermore, Galenica Senese has embarked on a transition path towards the international standard UNI EN ISO 45001.

Economic and financial transparency

GALENICA SENESE observes the rules of correct, complete and transparent accounting, according to the criteria indicated by Law and national and international accounting standards; the Company also operates social communications (financial statements, notes, reports and other documents) in compliance with the articles of the Civil Code.

Keeping this in mind, any economic and financial transaction must be correctly registered, authorized, verifiable, legitimate, consistent and reasonable, as well as verifiable through paper and/or computer media with an indication, where possible, of its author. It must be properly accounted for and stored.

The Company prohibits any action that may be an obstacle to the activity of public supervisory authorities.

In particular, in the management of the drafting of accounting and corporate documents and in social communications, the employee acts in compliance with the principle of diligence and fidelity.

Diligence means all the precautions and attention to be observed in the performance of the service.

The obligation of fidelity consists instead in the prohibition to disclose news related to the organization and operating methods and to make use of the acquired knowledge in such a way as not to harm the Company.

Protection of the environment

GALENICA SENESE produces and works with a wide vision: respect for the limited resources of the planet and awareness of the delicate balance between technology and nature, have led the Company to always search for new production processes that are more compatible with the environment.

GALENICA SENESE is therefore very careful to environmental issues as a tool for corporate enhancement. With respect to this, a responsible and scrupulous behaviour in the field of environmental protection is of fundamental importance.

The Company prohibits any activity that causes the pollution of water, soil and subsoil, and is committed to ensuring that the maintenance activities of the plants and the management of waste are carried out with the utmost respect for the environment.

GALENICA SENESE also guarantees continuous alignment with ISO 14001 standards.

Participation and Reciprocity

GALENICA SENESE recognizes in the observations and suggestions coming from its Stakeholders an important participatory and engaging tool useful to improve and to satisfy the interested parties.

For this reason, it disseminates internally and externally a policy of extreme openness to dialogue and confrontation, promoting and facilitating the achievement of balanced solutions and limiting the onset of inconvenience and conflict.

With this participatory perspective, the Company considers the sharing of the principles of the Code, an essential requirement so that any relationship with stakeholders can take place and be maintained.

Data protection and computer systems

GALENICA SENESE protects the secrecy and confidentiality of information and data, belonging to employees, collaborators or third parties, collected in reason of or due to the work activity, and every employee and worker is required to comply with these principles; the management of the processing of personal data is in full agreement with current legislation on the subject. The Recipients ensure maximum confidentiality on the news and information constituting Galenica Senese's corporate assets in compliance with current legislation.

GALENICA SENESE prohibits any practice that may violate the confidentiality of its own computer systems and third parties or otherwise cause harm, or aimed at falsifying a public computer document and/or having probative effect.

CHAPTER IV – GOVERNANCE

Shareholders

Shareholders are among the first recipients of the Code and, therefore, undertake to respect its precepts by promoting their sharing and knowledge.

The Company ensures that the Shareholders do not oppose to social interests, pursuing interests of their own or of third parties, foreign or contrary to the object of the company, or by adopting partial behavior or operating in an antithetical and conflicting way with the Company.

Administrative Body

The Board of Directors acts and deliberates with awareness of the facts, professionalism, responsibility and independently pursuing the priority objective of maximizing value.

The Administrative Body must be aware of its role and responsibility, as well as sensitivity to its leadership and example function towards those who operate in the Company and must not prevent or hinder the control activities.

It has the responsibility of refraining from carrying out any collateral activity that may harm the interests of the Company, or from pursuing interests of its own or of third parties even if these are considered only potentially conflicting and/or prejudicial to the Company.

In addition to its other competences, the Board of Directors is committed to scrupulously enforcing the values set out in this Code, promoting its sharing and diffusion also towards Third Parties, as well as the behavioral requirements of the Model of Organization, Management and Control assumed by the Company.

Board of Auditors

The members of the Board of Auditors perform their functions with impartiality, autonomy and independence, in order to guarantee an effective control and constant monitoring of the economic and financial situation of the Company, as well as the compliance and adequacy of the organizational and administrative structure assumed.

CHAPTER V – HUMAN RESOURCES AND EMPLOYEES

Staff selection and recruitment

The Company pays particular attention to the selection and recruitment of employees, ensuring compliance with the values of equal opportunities and equality in line with the relevant legal requirements, with the Workers' Statute and the applied National Collective Labour Agreement.

Taking into account the above principles, in the selection of the employees the following points must be ensured:

  • compliance with transparent and impartial selection criteria;
  • verification of the correspondence between the profiles of the candidates and the needs of the Company;
  • the application of regular forms of work;
  • respect the employees’ rights to working conditions based on the dignity of the person.

Without prejudice to the above principles and criteria, the recruitment of the selected candidate presumes the regular signing, between the Company and the candidate, of the applicable employment contract, which must indicate all the fundamental elements of the relationship established.

Management of relations

The employment relationships that the Company establishes are conform to principles of mutual respect, fair treatment and meritocracy. In this sense, the Company hinders all forms of favoritism, nepotism or discrimination.

Prohibition to accept gifts and/or other benefits

GALENICA SENESE’s employees are not authorized to offer, accept or promise, for themselves or for others, any form of gift, compensation, utility or service, of any kind, even if not of an economic nature, aimed at influencing or otherwise carrying out favor treatments during the performance of their duties.

If, despite this prohibition, a member of the Company should receive – even regardless of his will – promises of gifts and/or other benefits from third parties, he/she must promptly inform the Board of Directors as well as the Supervisory Body.

Conflict of interests

Employees may not pursue interests that are in conflict, even if only potential or partial, with those indicated in the corporate’s purpose or in any way in the Company, nor can they carry out, directly or indirectly, collateral activities that may conflict, in any way, with the Activities and Interests of the Company.

In the event that a member of the Company other than the corporate bodies finds him/her self in a potential conflict, he/she has the obligation to refrain from participating in the operation and must promptly inform the Administrative Body, as well as the Supervisory Body.

CHAPTER VI – EXTERNAL RELATIONS

Relations with the Public Administration

The Company's relations with public officials, in charge of public services, public employees are based on transparency, loyalty and fairness.

With particular reference to participation in tenders announced by the Public Administration, the Company maintains professional and transparent relationships, complying with the requirements, regulatory and address provisions, remaining subject to the control of the Client and other public bodies.

Facilitations, pressure, or other forms of privilege by all those who operate in the name and on behalf of the Company in the management and relations with the Public Administration are prohibited in order to induce it to take favorable attitudes or decisions in favor of the Company in an unlawful manner and contrary to the principles of this Code.

The assumption of obligations towards the Public Administration and Public Institutions is reserved exclusively for the authorized and designated company functions.

Employees and external collaborators, whose actions may refer to GALENICA SENESE, must keep during the relations with the Public Administration behaviors characterized by fairness, transparency and traceability.

With regard to employees of the Public Administration or officials acting on behalf of the Public Administration, the following applies:

  • active or passive corruption practices or collusive behaviour of any kind or in any form are not allowed. Acts of corruption are considered to be both unlawful payments to institutions or their employees and unlawful payments made through persons acting on behalf of such entities;
  • it is not allowed to offer money or perform acts of commercial courtesy (such as gifts) to managers, officials or employees of the Public Administration or their relatives, except in the case of material goods of modest commercial value. In any case, these acts must not be used as a means of exerting pressure to obtain illegitimate favours;
  • it is also forbidden to promise advantages or other benefits to public officials and representatives of the Public Administration;
  • during business negotiations or relations with the Public Administration, the employees in charge must not seek to improperly influence the decisions of the other party, including those of the officials who deal with decisions on behalf of the Public Administration;
  • any informal contacts with representatives of the Public Administration involved in the tendering procedures or in the procedures for granting and/or authorization request, must be specifically motivated and traced;
  • A consultant or a third party must not represent GALENICA SENESE, towards the Public Administration, when conflicts of interest may arise.

Any action that conflicts with the correctness in relation to the Public Administration must be promptly reported to the competent internal functions, in the manner defined by the specific procedure.

In complying with the above principles, GALENICA SENESE bases its relations with the Supervisory and Control Authorities - of the Public Administration or of Bodies authorized by it - to the maximum collaboration in full respect of their institutional role, committing itself to implementing their requirements promptly.

With particular reference to the management of legal proceedings GALENICA SENESE takes care of its documents until their storage in particular to avoid the crime of falsification of computer documents having probative effect.

Management also ensures that no one is convinced not to make statements or to make false statements to the judicial authority, both in Italy and abroad.

Finally, the Company prohibits any conduct that may unlawfully influence the outcome of legal proceedings.

Relations with customers

The Company’s main objective is to increase the degree of satisfaction and approval of its services/products, raising awareness of the needs of customers (even potential) and providing them with a wide and comprehensive preventive information.

With this in mind, GALENICA SENESE, in its relations with its customers, guarantees the correctness and completeness of the information by asking its Employees to define and make communications to customers that are:

  • clear, simple, understandable and complete;
  • comply with current legislation;

GALENICA SENESE also undertakes to communicate promptly to its customers, using the most appropriate and effective means of communication, any contractual changes and technical-economic variations of the product.

Customer relations are always managed according to principles of maximum collaboration, availability, professionalism and transparency.

Relations with Agents, Partners, Suppliers and Competitors

The selection of Agents, Partners and Suppliers and the formulation of the economic conditions of purchase of goods and services is dictated by values and parameters of competition, objectivity, fairness, impartiality, fairness in price and quality of goods and/or services, carefully evaluating the level of assistance and the extent of offers in general.

To this end, it requires its Agents, Partners and Suppliers to accept this code which governs the principles and rules to which Galenica Senese inspires its activity.

With this in mind, non-compliance with this Code is a prerequisite for the non-continuation of the professional/collaborative relationship in place with Galenica Senese and may result in actions for compensation for damages caused by the same violation.

In particular, with reference to the principles to which the choice and selection of the Supplier Company must conform, the management of suppliers must be based on criteria of impartiality, autonomy and independence.

To this end GALENICA SENESE has specific internal procedures and operating instructions that regulate relations with suppliers and in particular their selection, choice and qualification, as well as document management and control activities on the suppliers by the employees that deal with purchases and product quality.

With particular reference to relations with competitors, GALENICA SENESE respects its own and others' industrial and intellectual property rights, including copyrights, patents, trademarks and signs of recognition.

By virtue of compliance with these principles, GALENICA SENESE prohibits unauthorized reproduction of computer programs, documentation or other copyrighted materials and respects the restrictions indicated in the license agreements.

Accounting and financial management

The Company provides a clear, correct and truthful representation of its records, made in accordance with the Civil Code, accounting principles and in compliance with current tax rules, in order to ensure transparency and promptness in verification.

CHAPTER VII – PENALTY SYSTEM

Reporting violations to the Ethical Code

The recipients of the Code are required to report, consequently to a sense of responsibility and loyalty to the Company and in the manner established in the Organization, Management and Control Model 231, any violations of the ethical principles contained in this Code.

Violations and sanctions

The adoption of ethical principles relevant to the prevention of crimes, ex Legislative Decree 231/01, is an essential element of the preventive control system.

To this end, the behavioral rules provided for in the Code constitute a basic reference to which the recipients must adhere when carrying out the sensitive company activities for the purposes of the aforementioned decree and in relations with interlocutors, among which, a prominent importance belongs to the Public Administration, both Italian and foreign, and to public employees.

Any violations of this Ethical Code that damage the trust relationship with the institution and must consequently involve disciplinary actions, regardless of the possible establishment of a criminal judgment in cases where the behavior constitutes a crime.

Any violation of the requirements contained in the Ethical Code may therefore constitute non-compliance with the primary obligations of the employment relationship or disciplinary offence, with the related legal consequences regarding the preservation of the employment relationship and may, if necessary, result in compensation for the damages resulting from the violation itself.

For all violations committed by employees the sanctions provided for in the National Collective Agreement will be applied, commensurate with the seriousness of the violation and the relative objective and subjective circumstances.

All violations committed by Third Parties may determine, depending on the seriousness of the case, the termination of the contractual obligation attributable to art. 1453 and 1455 Civil Code and claim for any damages.

The person responsible for surveillance and monitoring of compliance with the requirements contained in this Code is the Supervisory Body, established in compliance with the requirements contained in Legislative Decree 231/2001.

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Industria Farmaceutica Galenica Senese SRL
Registered Office | Warehouse
Via Cassia Nord 351- 53014 Monteroni D'Arbia
(Siena) - Italy
P.IVA/VAT IT00050110527
Rec: 24454 - SDI: A4707H7

Contacts
Tel. +39 0577 372.800
Fax  +39 0577.374.393
Pec: galenicasenese@pec.it
e-Mail: info@galenicasenese.it

Contact fo urgent call
Pharmacovigilance reaction
Pharmacovigilance for Human products:
Tel. +39 3337336518
Pharmacovigilance for Veterinary products:
Tel. +39 3458717146

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