MOG Rev.0

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ORGANIZATION AND MANAGEMENT MODEL

of

Industria Farmaceutica Galenica Senese s.r.l.

pursuant to Legislative Decree 231/2001

REV.0: May 15th, 2020

Approved by the Sole Admnistrator on 17/06/2020

GENERAL PART

SEZIONE PRIMA

LEGISLATIVE DECREE No. 231/2001

1.1 THE ADMINISTRATIVE RESPONSIBILITY OF INSTITUTIONS
1.2 PERSONS SUBJECT TO LEGISLATIVE DECREE No. 231/01
1.3 THE CRIMES PROVIDED FOR BY THE DECREE
1.4 THE SANCTIONS IMPOSED BY THE DECREE
1.5 LIMITATION CONDITIONS OF ADMINISTRATIVE RESPONSIBILITY
1.7 CRIMES COMMITTED ABROAD
1.6 ATTEMPTED CRIMES
1.7 'GUIDELINES' OF FARMAINDUSTRIA

SECTION TWO

THE ORGANIZATION, MANAGEMENT AND CONTROL MODEL OF GALENICA SENESE SRL

2.1 THE MODEL OF GALENICA SENESE SRL
    2.1.1 THE OBJECTIVES OF THE MODEL
    2.1.2 THE CONSTRUCTION OF THE MODEL
    2.1.3 THE CONCEPT OF ACCEPTABLE RISK
    2.1.4 THE STRUCTURE OF THE MODEL AND THE RELEVANT OFFENCES
    2.1.5 ADOPTION OF THE MODEL
    2.1.6 RECIPIENTS
2.2 DOCUMENTS RELATED TO THE MODEL
2.3 MANAGEMENT OF FINANCIAL RESOURCES

SECTION THREE

ELEMENTS OF THE GOVERNANCE MODEL AND THE GENERAL ORGANIZATIONAL STRUCTURE OF GALENICA SENESE SRL

3.1 THE GOVERNANCE MODEL OF GALENICA SENESE SRL
3-2 GENERAL PRINCIPLES OF CONTROL

SECTION FOUR

SUPERVISORY BODY

4.1 CHARACTERISTICS OF THE SUPERVISORY BODY
4.2 IDENTIFICATION OF THE SUPERVISORY BODY
4.3 DURATION OF THE ROLE AND CAUSES FOR TERMINATION
4.4 CASES OF INELIGIBILITY AND FORFEITURE
4.5 FUNCTIONS, TASKS AND POWERS OF THE BODY
4.6 RESOURCES OF THE BODY
4.7 INFORMATION FLOWS OF THE SUPERVISORY BODY
     4.7.1 INFORMATION FLOWS TO THE BODY
     4.7.2 COMMUNICATION FLOWS OF THE BODY

SECTION FIVE

PENALTY SYSTEM

5.1 GENERAL PRINCIPLES
5.2 DEFINITION OF "VIOLATION" SUBSEQUENT TO OPERATION OF THIS SYSTEM
5.3 PENALTIES FOR EMPLOYEES
5.4 PENALTIES FOR EMPLOYED PERSONS WITH THE STATUS OF MANAGERS
5.5 MEASURES TOWARDS ADMINISTRATOR
5.6 MEASURES TOWARDS MAYORS
5.7 MEASURES AGAINST SENIOR POSITIONS
5.8 MEASURES AGAINST EXTERNAL PARTNERS
5.9 REGISTER

SECTION SIX

DIFFUSION OF THE MODEL

6.1 RECIPIENTS
6.2 TRAINING AND INFORMATION FOR PERSONNEL
6.3 INFORMATION TO THIRD PARTIES AND DIFFUSION OF THE MODEL

SECTION SEVEN

ADOPTION AND UPDATE OF THE MODEL

 

SECTION ONE

Legislative Decree of June 8 2001 No. 231

1.1 The Administrative Responsibility of The Institutions

The Legislative Decree of June 8 2001, n. 231 and subsequent amendments, due to the Delegated Law of September 29 2000, n. 300, introduced in Italy the "Discipline of administrative responsibility of legal persons, companies and associations even without legal personality" (hereafter, for brevity, also "D. Lgs. No. 231 of 2001" or the "Decree"), that is, in accordance with what is provided for in the Community, the administrative responsibility of institutions, where "entities" means commercial, capital and personal companies, and associations, even without legal personality.

This regulatory intervention also aimed to adapt the internal legislation on the liability of legal entities to some international conventions to which the Italian Republic had already long adhered, and in particular:

  • the Brussels Convention of July 26 1995 on the protection of financial interests of the European Communities;
  • the Brussels Convention of May 26 1997 on fighting against corruption of officials of the European Community or of the Member States;
  • the OECD Convention of December 17 1997 on fighting against Public corruption
  • Foreign officers in economic and international operations

 

This new form of responsibility, although defined as "administrative" by the legislator, has the characteristics of criminal responsibility, since it is left to the competent criminal court to ascertain the crimes from which it is derived, and since the same guarantees of criminal proceedings are extended to the institution.

The administrative responsibility of the institution derives from the fulfillment of crimes committed, expressly indicated in D. Lgs. 231/2001, in the interest or for the benefit of the institution itself, by natural persons who represent, administer or manage the institution or its organizational unit with financial and functional autonomy, or who exercise, even in actual fact, its management and control (the so-called "senior subjects"), or who are subject to the management or supervision of one of the above subjects (the so-called "submitted subjects"). On the contrary, the existence of an exclusive advantage on the part of the person who commits the crime excludes the responsibility of the Company, which is in this way found in a situation of absolute non-involvement from the crime committed.

In addition to the existence of the requirements described above, D. Lgs. 231/2001 also requires the determination of the guilt of the institution, in order to be able to assert its responsibility. This requirement is attributable to an "organization's fault", to be understood as the failure of the institution to adopt appropriate preventive measures to prevent the commission of the crimes listed in the next paragraph, by the subjects identified in the Decree.

If the institution is able to demonstrate that it has adopted and effectively implemented a suitable organization to avoid the commission of such crimes, through the adoption of the model of organization, management and control provided for by D. Lgs. 231/2001, the latter will not answer for the administrative responsibility.

It should be pointed out that the administrative responsibility of the legal person is added to the criminal responsibility, but does not cancel, the responsibility of the natural person who materially committed the crime; both of these responsibilities are investigated in front of the criminal court.

The responsibility of the company may also be claimed if the pre-imposed crime appears in the form of an attempt (pursuant to Art. 26 of D. Lgs. 231/01), that is, when the subject performs suitable acts in an unequivocal way to commit the crime and the action does not take place or the event does not occur.

1.2 Persons subject to Legislative Decree No. 231 of 2001

Those who commit a crime in the interest or for the benefit of the Company, may determine their responsibility as listed below:

(i) natural persons in top positions (representation, administration or management of the Company or its organisational unit with financial and functional autonomy or persons exercising, in short, the "Senior Subjects"),

(ii) natural persons subject to management or supervision by one of the Senior Subjects (hereafter, for brevity, the "Subjected Persons").

In this regard, it should be noted that it is not necessary for the Subjected Persons to have an employment relationship with the Company, it must also include in that concept "those workers who, although not <employees> of the company, have a relationship with it such as to suggest that there is an obligation of supervision by the top management of the institution: for example, agents, partners in joint ventures operations, so-called parasubordinates in general, distributors, suppliers, consultants, collaborators"1.

In fact, according to the prevailing doctrine, those situations in which a particular task is entrusted to external collaborators, required to perform it under the direction or control of Senior Subjects, assume relevance for the administrative responsibility of the company.

However, it should be reaffirmed that the Company does not respond, by express legislative provision (Article 5, paragraph 2, of the Decree), if the aforementioned subjects have acted in the exclusive interest of themselves or of third parties. In any case, their behavior must refer to that "organic" relationship for which the acts of the natural person can be imputed to the Company.

 

1.3 The crimes provided for by the decree

The crimes, from which the administrative responsibility of the company is derived, are those expressly and strictly referred to by D. Lgs. 231/2001 and subsequent amendments and additions.

The following are the "violation categories" currently included in the scope of D. Lgs 231/2001:

  1. Crimes against the Public Administration (Articles 24 and 25);
  2. Computer crimes and illegal data processing, introduced by Law 48/2008 (art.24-bis);
  3. Crimes of organized criminality, introduced by Law 94/2009 (Art. 24-ter);
  4. Crimes in the field of counterfeiting coins, public credit cards, stamp values and instruments or signs of recognition, introduced by Law 409/2001 and amended by Law 99/2009 (art. 25-bis);
  5. Crimes against industry and commerce, introduced by Law 99/2009 (Art. 25-bis 1);
  6. Corporate crimes, introduced by D. Lgs. 61/2002 and amended by Law 262/2005 (Art. 25-ter), Law 190/2012 and Law 69/2015;
  7. Crimes with the purpose of terrorism or insurgency of the democratic order, introduced by Law 7/2003 (Art. 25c)
  8. Practices of mutilation of female genital organs, introduced by Law 7/2006 (Art. 25- c. 1);
  9. Crimes against individual personality, introduced by Law 228/2003 and amended by Law 38/2006 and Legislative Decree 39/2014 (art. 25 quinquies);
  10. Market abuses, introduced by Law 62/2005 and amended by Law 262/2005 (Art. 25-sexies);
  11. Transnational crimes, introduced by Law 146/2006;
  12. Unintentional crimes committed in violation of accident prevention legislation and on the protection of hygiene and health at work, introduced by Law 123/2007 (art. 25-septies);
  13. Crimes commited in the field of receiving, laundering and use of money of illicit origin introduced by D. Lgs. 231/2007, as well as self-laundering (Art. 25-octies);
  14. Crimes in the field of copyright infringement, introduced by Law 99/2009 (Art. 25-novies);
  15. Crime of induction of not making statements or to make false statements to the judicial authority, introduced by Law 116/2009 (art. 25-decies);
  16. Environmental crimes, introduced by D. Lgs. 121/2011 and amended by Law 68/2015 (art. 25- undecies);
  17. Crime of employment of third-country nationals with irregular residency permit, introduced in the Decree by D. Lgs. 109/2012 (art. 25-duodecies);

Racism and Xenophobia (Art. 25 terdecies).

1.4 The sanctions imposed by the Decree

Legislative Decree no. 231 of 2001 provides for the following types of sanctions applicable to the entities recipients of the legislation:

  1. administrative fines;
  2. interdictive sanctions;
  3. confiscation of the price or profit of the crime;
  4. publication of the sentence.

 

(a) The monetary administrative penalty, governed by Articles 10 and following articles of the Decree, constitutes the "basic" sanction of necessary application, the payment of which is the company's responsibility with its assets or with the common fund.

The Legislator has adopted an innovative criterion for measuring the sanction, giving the Judge the obligation to proceed with two different and subsequent operations of appreciation. This implies a greater adjustment of the penalty to the seriousness of the crime and to the economic conditions of the Company.

The first evaluation requires the Judge to determine the number of shares (in any case not less than one hundred, nor more than a thousand)2 taking into account:

  • of the seriousness of the committed act;
  • the degree of responsibility of the Company;
  • the work carried out to eliminate or mitigate the consequences of the event and to prevent further wrongdoing.

During the second assessment, the Judge determines, within the predetermined minimum and maximum values in relation to the penalties sanctioned, the value of each share. The amount is fixed "on the basis of the economic and financial conditions of the institution in order to ensure the effectiveness of the sanction" (Articles 10 and 11, paragraph 2, D. Lgs. no. 231 of 2001).

As stated in point 5.1. of the Report of the Decree, "As for the methods of ascertaining the economic and financial conditions of the institution, the judge may make use of the financial statements or other records in any case suitable to describe these conditions. In some cases, the test may also be obtained taking into account the size of the institution and its market position. (...) The court will have to, with the help of consultants, merge into the reality of the company, where it will also be able to draw on the information relating to the state of economic, financial and capital solidity of the institution".

The Legislative Decree No. 231 of 2001 foresees a series of cases in which the financial penalty is reduced. They are summarized in the following table, indicating the reduction made and the conditions for the application of the reduction itself.

 Reduction   Requirements

1/2

(and cannot be higher than Euro 103,291.00)
.......
  • The offender committed the crime in the main interest of himself or of third parties and the Company did not get an advantage or obtained a minimum advantage from it;

that is,

  • the damage caused to the assets is of particular tenuousness
from 1/3 to 1/2    

[Before the declaration of initiation of the first instance hearing]

  • The Company has fully compensated the damage and has eliminated the harmful or dangerous consequences of the crime or has in any case effectively worked towards it;

that is,

  • an organisational model has been implemented and made operational to prevent crimes of the kind that have occurred.
da 1/2 a 2/3  

[Before the declaration of initiation of the first instance hearing]

  • The Company has fully compensated the damage and has eliminated the harmful or dangerous consequences of the crime or has in any case effectively worked towards it;

and,

  • an organisational model has been implemented and made operational to prevent crimes of the kind that have occurred.

 

(b) The following interdictive sanctions are provided for by the Decree and apply only in relation to crimes for which they are expressly foreseen:

  • interdition of exercing the company's activity;
  • suspension or withdrawal of authorisations, licenses or concessions functional to the commission of the offence;
  • prohibition to bargain with the Public Administration, except to obtain the services of a public service;
  • exclusion from benefits, financing, contributions and subsidies, and/or the withdrawal those already granted;
  • prohibition on advertising goods or services.

In order for interdictive sanctions to be imposed, it is necessary to maintain at least one of the conditions reported in Article 13, D. Lgs. No. 231 of 2001, namely:

  • "the company has made a significant profit from the crime and the crime was committed by subjects in a senior position or by subjected persons to the direction of others when, in this case, the commission of the crime was determined or facilitated by serious organizational deficiencies"; that is,
  • "in the event of recurrence of wrongdoing" 3.

In addition, interdictive sanctions can also be requested by the Public Minister and applied to the Company by the Judge as a precautionary measure, when:

  • there are serious indications to believe that the Company is responsible for an administrative offence dependent on a crime;
  • there are well-founded and specific elements which suggest that there is a real danger that offences of the same nature as those for which they are carried out will be committed;
  • the Company has made a significant profit.

In any case, no interdictive sanctions are applied when the crime has been committed in the main interest of the author of the crime or of third parties and the Company has obtained a minimum or zero advantage, or the property damage caused is of particular tenuousness.

The application of the interdictive sanctions is also excluded from the fact that the Company has put in place the restorative conduct provided for in Article 17, D. Lgs. No. 231 of 2001 and, more precisely, when the following conditions are met:

  • "the company has fully compensated the damage and eliminated the harmful or dangerous consequences of the crime or has effectively worked towards it";
  • "the company has eliminated the organisational deficiencies that have led to the crime through the adoption and implementation of organisational models suitable to prevent crimes of the same kind that have occurred";
  • "the company has made available the profit obtained for confiscation".

The interdictive sanctions have a duration of not less than three months and not more than two years and the choice of the measure to be applied and its duration is made by the Judge on the basis of the criteria previously indicated for the measurement of the financial penalty, "taking into account the suitability of individual sanctions to prevent offences of the type committed" (Art. 14, D. Lgs. No. 231 of 2001).

The Legislator has then pointed out that the interdition of the activity is of residual nature in relation to the other interdictive sanctions.

Legislative Decree 231/2001 also provides that, where the conditions are in place for the application of an interditive sanction providing for the interruption of the company's activity, the Judge may, in place of the application of that specific sanction, order the continuation of the activity by a judicial commissioner (Article 15) appointed for a period equal to the duration of the penalty that would have been applied, if at least one of the following conditions applies:

  • the company carries out a public service or service of public utility whose interruption may cause serious harm to the community;
  • the interruption of activity may have a significant impact on employment, taking into account the size of the company and the economic conditions of the territory in which it is situated.

(c) In accordance with Article 19, Lgs. 231 of 2001, it is always ordered, with the sentence of conviction, the confiscation - also by equivalent - of the price (money or other economic utility given or promised to induce or determine another person to commit the crime) or of the profit (immediate economic utility obtained) of the crime, except for the part that can be returned to the damaged party and without prejudice to the rights acquired by third parties in good faith.

(d) The publication of the sentence in one or more newspapers, by extract or in full, may be ordered by the Judge, together with the posting in the municipality where the body has its head office, when an interditive sanction is applied. The publication is carried out by the Chancellor’s office of the competent court and at the expenses of the Company.

1.5 Limitation conditions of administrative responsibility

Articles 6 and 7 of D. Lgs. No. 231 of 2001 provide for specific forms of exemption from the administrative responsibility of the Company for crimes committed in the interest or for the benefit of the same both by Senior Subjects and by Subjected Persons (as defined in paragraph 1.2 reported above)

In particular, in case of crimes committed by Senior Subjects, Article 6 of the Decree foresees the exemption if the Company itself proves that:

  1. the governing body has adopted and effectively implemented, before the commission of the fact, a model of organization and management suitable to prevent crimes of the kind that occurred (hereafter, for brevity, the "Model");
  2. the task of supervising the operation and observance of the Model and of taking care of its updating has been entrusted to a body of the Company (hereafter, for brevity, the "Supervisory Body" or the "SB"), with autonomous powers of initiative and control;
  3. the people who committed the crime acted by fraudulently circumventing the Model;
  4. there has been no failure or insufficient supervision by the Supervisory Body.

With regard to the Subjected Persons, Article 7 of the Decree provides for the exemption of responsibility in the event that the Body has adopted and effectively implemented, before the commission of the crime, a Model suitable to prevent crimes of the kind that occurred.

The exemption of the responsibility of the Company is not, however, determined by the mere adoption of the Model, but by its effective implementation to be carried out through the implementation of all the protocols and controls necessary to limit the risk of commission of the crimes that the Company intends to avoid. In particular, with reference to the characteristics of the Model, the Decree expressly provides, in Article 6, paragraph 2, the following preparatory phases for the correct implementation of the Model itself:

  • identification of activities in which there is a possibility of committing the crimes;
  • prevision of specific protocols aimed at planning the training and implementation of the decisions of the Company in relation to the crimes to be prevented;
  • identification of how financial resources are to be allocated to prevent the commission of such crimes;
  • prevision of obligatoty information towards the Supervisory Body;
  • introduction of a disciplinary system suitable to sanction the non-compliance of the measures indicated in the Model.

With reference to the effective application of the organization, management and control model, the D. Lgs.  231/2001 requires:

  • periodic verification, and, in the event that significant violations of the requirements imposed by the model or changes in the organisation, in the activity of the company or legislative changes, the modification of the organization, management and control model;
  • the imposed sanctions in case of violation of the requirements imposed by the model organization, management and control.

1.6 Crimes committed abroad

Under Article 4 of the Decree, the company may be held responsible, in Italy, for the commission of certain crimes outside national borders. In particular, Article 4 of the Directive provides that entities having their head office in the territory of the State also respond in relation to crimes committed abroad in the cases and under the conditions provided for in Articles 7 to 10 of the Penal Code, provided that the State of the place where the fact was committed does not proceed against them.

Therefore, the institution is punishable when:

  • it has its headquarters in Italy, that is, the actual place where administrative and management activities take place, possibly also different from that in which the company or registered office is located (entities with legal personality), or the place where the activity is carried out continuously (entities without legal personality);
  • the State where the jurisdiction has been committed is not proceeding against the company;
  • the request of the Minister of Justice, to whom the criminality may be subject, is also referred to the body itself.

These rules cover crimes committed entirely abroad by senior subjects or subjected persons. For criminal conduct that have taken place even in part in Italy, the principle of territoriality is applied ex art. Article 6 of the Penal Code, according to which "the crime shall be deemed to have been committed in the territory of the State, where the action or omission, which constitutes it, has taken place there in whole or in part, or where the event which is the consequence of the action or omission has occurred there".

1.7 Attempted crimes

In cases of commission, in the forms of the attempt, of the crimes assumed by the Decree, the financial penalties (in terms of amount) and the interdictive sanctions (in terms of time) are reduced from a third to half, while the imposing of sanctions is excluded in cases where the Company voluntarily prevents the completion of the action or the realization of the event (Article 26 of the Decree).

1.8 The Guidelines

Following expressed indication of the delegated Legislator, the Models can be adopted on the basis of codes of conduct drawn up by representative associations that have been communicated to the Ministry of Justice which, in agreement with the competent Ministries, can make observations within 30 days on the suitability of the models to prevent crimes.

The preparation of this Model is inspired by the Guidelines for the construction of the Management, Organization and Control models ex D. Lgs. no. 231 of 2001, updated by Farmindustria in 2014.

Consequently, Galenica's Organization and Management Model refers to the provisions and indications provided by the Farmindustria guidelines that are therefore an integral part of it, in particular with regards to risk–crime analysis contained in the special part of the guidelines and risk prevention measures.

The path indicated by the Guidelines for the elaboration of the Model can be summarized according to the following fundamental points:

  • identification of areas at risk, aimed at verifying in which areas/sectors of the company it is possible to carry out crimes;
  • preparation of a control system able to reduce risks through the adoption of special protocols. To support this, there is a need of coordinated set of organizational structures, activities and operating rules applied - on the recommendation of the senior positions - by management and consultants, aimed at providing reasonable security regarding the achievement of the objectives falling within a good internal control system.

The most relevant components of the preventive control system proposed by the Confindustria Guidelines are, with regards to the prevention of fraudulent crimes:

  • the Ethical Code;
  • the organisational system;
  • manual and IT procedures;
  • authorization and signature powers;
  • the control and management system;
  • communication to employees and their training.

With regards to unintentional crimes (crimes in the field of health and safety at work and - although subsequent to the emission of the Guidelines - most environmental crimes), the most relevant identified components are:

  • the Ethical Code (or conduct) with reference to the considered crimes;
  • the organizational structure,
  • formation and training,
  • communication and involvement,
  • operational management,
  • the security monitoring system.

The control system must be informed of the following principles:

  • verifiability, traceability, consistency and congruence of each operation;
  • separation of functions (no one can manage all phases of a process independently);
  • documentation of controls;
  • introduction of an adequate sanction system for violations of the rules and protocols provided for in the Model;
  • identification of a Supervisory Body whose main requirements are:
  • autonomy and independence,
  • professionalism,
  • continuity of action;

obligation, by the company’s functions, and in particular those identified mostly as "at risk of crime", to provide information to the Supervisory Body, both on a structured basis (periodic information in implementation of the Model itself), and to report anomalies or atypicality found in the context of the available information.

SECTION TWO

THE ORGANIZATION, MANAGEMENT AND CONTROL MODEL OF GALENICA SENESE SRL

2.1 The Model of Galenica Senese

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, 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, at the present date it has separated. Doctor Danila Antonia Perillo, at first President of Board of Directors and Chief Executive Officer of Galenica Senese, is today the Sole Administrator of the company.

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.

All three management systems listed above constitute the internal control system present in the Company, whose documentation, procedures, operational instructions and forms are transposed and integrated into the Organization, Management and Control Model ex D. Lgs. 231/01, constituting some of the control mechanisms.

In order to guarantee conditions of legality, correctness and transparency in carrying out its activity, Galenica Senese has decided to implement its own Organization, Management and Control Model pursuant to Decree 231.

The Model, therefore, is addressed to all those who work with the Company, who are required to know and comply with the provisions contained in the Model.

2.1.1 The objectives of the Model

The Model prepared by the Company on the basis of the identification of areas of possible risk in the company activity within which the possibility of committing crimes is considered higher, aims to:

prepare a system of prevention and control aimed at reducing the risk of committing crimes related to the company's activity;

make all those who operate in the name and on behalf of Galenica Senese, and in particular those engaged in "risk activity areas", aware that they can incur, in case of violation of the provisions reported in the Model, an offence liable to sanctions, at criminal and administrative level, not only against them but also against the company;

  • inform all those who work with the Company that the violation of the requirements contained in the Model will result in the application of appropriate sanctions or the termination of the contractual relationship;
  • confirm that Galenica Senese does not tolerate unlawful conduct, of any kind
  • and regardless of any purpose and that, in any case, such conduct (even if the Company is apparently in a position to take advantage of it) are in any case contrary to the principles on which the Company's entrepreneurial activity is inspired;
  • spread a corporate culture based on legality, in the awareness of the express disapproval by the Company of any conduct contrary to the law, regulations, internal provisions and, in particular, the provisions contained in this Model;
  • realize a balanced and efficient organisational structure, with particular regard to the clear allocation of powers, the formation of decisions and their transparency and motivation, controls, estimates and subsequent checks, acts and activities, as well as correctness.

Although the adoption of the Model does not constitute an obligation imposed by the Decree, but an optional choice left to each individual institution, for the reasons mentioned above, the Company has decided to comply with the provisions of the Decree, starting with a project of analysis of its organizational, management and control tools, aimed at verifying the correspondence of the behavioral principles and control mechanisms already adopted for the purposes provided for by the Decree and, if necessary, to the integration of the current system.

Aware of the need to keep the Model updated so that it is suitable for the prevention of committing the crimes, the Company has therefore approved the present version of the Model, which incorporates the company evaluation with respect to the organizational changes and the applicability to the operational context of Galenica Senese of the new crimes that have recently been introduced.

2.1.2 The construction of the Model

On the basis of the indications contained in the Reference Guidelines, the construction of the Model (and the subsequent drafting of this document) has been divided into the following phases:

(i) preliminary examination of the business context through the analysis of the relevant corporate documentation and the conduction of interviews with Galenica Senese managers informed on the structure and activities of the company, in order to define the organization and activities carried out by the various organizational/functional units, as well as the business processes in which the activities are articulated and their concrete and effective implementation takes place;

(ii) mapping of areas of activity and business processes "at risk" for crime commission D. Lgs. 231, carried out on the basis of the aforementioned preliminary examination of the business context;

(iii) definition in the hypothesis of the main possible methods of commissioning Crimes Assumption within the individual Areas at Risk of Crime commission;

(iv) Following the mapping of business activities/processes and the analysis of The Assumption Crimes, risk identification was carried out.

(v) the adoption of a sanction system aimed at ensuring the effective implementation of the Model and containing the disciplinary measures applicable in the event of a violation of the requirements contained in the Model;

(vi) the carrying out of an information and training activity on the contents of this Model.

 

2.1.3 The concept of acceptable risk

In the preparation of an Organization and Management Model, such as the present Model, the concept of acceptable risk cannot be disregarded. It is, in fact, essential to establish, in order to comply with the provisions introduced by D. Lgs. No. 231 of 2001, a threshold that allows to limit the quantity and quality of the prevention tools that must be adopted in order to prevent the commission of the crime. With specific reference to the sanctioning mechanism introduced by the Decree, the threshold of acceptability is represented by the effective implementation of an adequate preventive system that is such that it cannot be circumvented except intentionally, or, for the purposes of the exclusion of administrative responsibility of the institution, the people who committed the crime acted by fraudulently evading the Model and the controls adopted by the Company.

2.1.4 The structure of the Model and the Relevant Offences

The Company prepared a Model that took into account its particular company reality, in line with its system of governance and able to enhance controls and existing organisms.

The Model, therefore, represents a coherent set of principles, rules and provisions that:

  • affect the internal functioning of the Company and the way in which it is related to the outside world;
  • regulate the diligent management of a control system of areas at risk of crime, aimed at preventing the commission, or the attempted commission, of the crimes referred to by the Decree.

In particular, the Model of Galenica Senese consists of a "General Part", which contains the cardinal principles of the Model and a "Special Part", in turn divided into Sections in relation to the different categories of crimes provided for by D. Lgs. no. 231 of 2001.

The Special Part contains - for each category of alleged crimes - a brief description of the offences that may be the source of an administrative responsibility of the Company, the indication of the Areas at Risk of Crime identified and the description of the main rules of conduct implemented by the Company, to which the Recipients of the Model (as defined below) must comply in order to prevent the commission of such crimes.

Also taking in consideration the number of criminal cases that currently constitute a prerequisite for the administrative responsibility of the Entities pursuant to the Decree, some of them have not been considered relevant for the construction of this Model, as it has been considered that the risk related to the commission of such crimes was only abstract and not concretely conceivable. In particular, following a careful evaluation of the concrete activity carried out by Galenica Senese and its history, the following cases were considered irrelevant and unfeasible:

  • (i) crimes with the purpose of terrorism or the subversion of the democratic order, introduced by Law No. 7 of January 14 2003, which inserted Article 25-quater in D. Lgs. bo. 231 of 2001;
  • (ii) practices of mutilation of female genital organs, introduced by Law No. 7 of January 9 2006, which inserted in D. Lgs. no. 231 of 2001 art. 25-quater.1;
  • (iii) crimes against individual personality, introduced by Law No. 228 of August 11 2003, which inserted Article 25-quinquies in D. Lgs. no. 231 of 2001;
  • (iv) crimes of market abuse, provided for by Law No. 62 of April 18 2005, which included in D. Lgs. no. 231 of 2001 Article 25-sexies and, within the TUF, Article 187-quinquies "Liability of the institution":
  • (v) crime of employment of irregular residents, introduced by Legislative Decree no. 109 of July 16 2012 implementing Directive 2009/52/EC introducing minimum standards for sanctions and measures against employers employing third-country nationals whose stay is irregular", which included article 25-duodecies in D. Lgs. no. 231 of 2001.
  • (vi) Racism and xenophobia (Art. 25 terdecies)

In any case, the ethical principles on which the Company Model and its governance structure are based on are aimed at generally preventing even those cases of crime that, due to their irrelevance, do not find specific discipline in the Special Part of this Model.

2.1.5 Adoption of the Model

The adoption of this Model is delegated by the Decree itself to the competence of the governing body and in particular to the Administrative Body, which is also assigned the task of integrating this Model with additional Sections of the Special Part relating to other types of Crimes Assumption newly introduced in Legislative Decree no. 231 of 2001.

2.1.6 Recipients

The provisions of the present Model are binding on the members of the corporate bodies, management and employees of Galenica Senese, as well as all those who work to achieve the purpose and objectives of the Company (hereafter the "Recipients").

2.2. Documents related to the Model

The following documents are an integral and substantial part of the Model:

  • ethical code containing all Galenica Senese's rights, duties and responsibilities towards the recipients of the Model itself (hereafter, for brevity, the "Ethical Code");
  • disciplinary system and related sanctioning mechanism to be applied in case of violation of the Model (below, for brevity, the "Sanction System");
  • system of delegations and powers of attorney, as well as all documents aimed at describing and assigning responsibilities and /or tasks to those who operate within the Institution in areas at risk of crime (i.e. organization charts, service orders, job descriptions, function charts, etc.);
  • system of procedures, protocols and internal controls aimed at ensuring adequate transparency and knowledge of decision-making and financial processes, as well as of the behaviors that must be held by the recipients of this Model operating in the Areas at Risk of Crime. (Hereafter, for the sake of brevity, the system of delegations and powers of attorney, the procedures, protocols and internal controls mentioned above will be cumulatively defined as the "Procedures")

It follows that with the term Model not only this document must be identified, but also all further documents and procedures that will be subsequently adopted in accordance with the provisions of the Model and that will pursue the purposes indicated therein.

2.2 Management of financial resources

Without prejudice to the above, taking into account that pursuant to Article 6, letter (c) of Legislative Decree No. 231 of 2001 among the needs to be answered by the Model there is also the identification of the methods of management of financial resources suitable to prevent the commission of crimes, the Company has adopted specific protocols containing the principles and behaviors to be followed in the management of such resources.

SECTION THREE

ELEMENTS OF THE GOVERANCE MODEL AND THE ORGANIZATIONAL STRUCTURE OF GALENICA SENESE SRL

3.1. Galenica Senese's governance Model

Galenica Senese is a limited liability company managed by a Sole Administrator.

The Administrator has been appointed to office indefinitely.

The Sole Administrator has all the widest powers for the ordinary and extraordinary management of the Company, without any exception, with all the powers for the implementation and achievement of social purposes, except as established by the Civil Code

The Sole Administrator can therefore contract any kind of obligation and perform any act of capital provision without limitations of any kind, since everything is not expressly reserved for the deliberations of the Shareholders' Meeting.

The Legal Representation of the Company is the responsibility of the Sole Administrator.

3.2 General principles of control in all Areas at Risk of Crime

In addition to the specific controls described in each Section of the Special Part of this Model, the Company has specific general controls applicable in all Areas at Risk of Crime.

In particular, the Company's internal control system is based not only on the behavioral rules provided for in this Model, but also on the following elements:

  1. the Code of Conduct;
  2. hierarchical-functional structure (company organization chart);
  3. the system of delegations and powers of attorney;
  4. the system of the company’s procedures, which also consists of organizational provisions and operating instructions;
  5. informatory systems oriented towards the segregation of functions and the protection of the information contained in them, with reference both to management and accounting systems and to the systems used to support operational activities related to the business.

The general prevention protocols are not the subject of the "Model of Organization and Management – Special Part", but operate in synergy with the protocols of the mentioned model, in fact, they constitute common tools for the prevention and repression of crime hypotheses provided for by Legislative Decree 231/2001 and are addressed to all the Recipients of the Model.

The general prevention protocols, of which Galenica Senese requires compliance, derive from elements of the "Organization and Management Model", already described in the document "Model – General Part" and/or in its annexes.

The following is a list of these protocols:

  • Statute;
  • Ethical Code;
  • Disciplinary system;
  • Organization chart
  • Process of updating the Organization and Management Model ex D.Lgs. 231/01;
  • System of power of attorney;
  • Applicable voluntary standards (ISO 9001; ISO 14001; OHSAS 18001)
  • Criteria for the management of the processing of personal data;
  • Criteria for the management of relationships with third parties;
  • Criteria for the management of Financial Resources for the prevention of crimes;
  • Policies for storing documentation and tracking operations;
  • the system of the company’s procedures, for each Company, also consisting of organizational provisions and operational instructions;
  • information systems oriented to the segregation of functions and the protection of the information contained in them, with reference both to management and accounting systems and to the systems used to support operational activities related to the business.

The Company is also certified:

  • ISO 9001 Quality Management Systems – Requirements
  • ISO 14001 Environmental Management Systems - Requirements and Guide for Use
  • OHSAS 18001 Management Systems for Health and Safety at Work – Requirements
  • ISO 13485

In addition, the periodic flow of information that must reach the Supervisory Body constitute general prevention protocols.

The control system involves every sector of the Company's activity through the distinction of operational and control tasks, reasonably reducing any possible conflict of interest.

The company's current internal control system, seen as a process implemented in order to manage and monitor the main risks and allow a healthy and correct business management, is able to guarantee the achievement of the following objectives:

  1. "every operation, transaction, action must be verifiable, documented, consistent and appropriate": each operation must be supported by adequate documentation on which the responsible persons of the company can proceed at any time to carry out checks that attest to the characteristics and motivations of the operation and identify those who authorized, carried out, registered and verified the operation itself.
  2. "no one can manage an entire process independently": the control system operating in the company must ensure the application of the principle of separation of functions, so that the authorization to carry out an operation must be under the responsibility of a person other than the person who accounts, executes operationally or controls the transaction. In addition, the system provides that: (i) no one is given unlimited powers; (ii) powers and responsibilities are clearly defined and known within the organisation; (iii) the authorisation and signature powers are consistent with the organisational responsibilities assigned.
  3. "documentation of the controls": the control process carried out must always be documented (possibly through the drafting of reports).

The Company has identified a number of elements that make up the preventive control system, in order to ensure the effectiveness of the Model in compliance with the following "control principles":

  • Transparency: every operation/transaction/action must be justifiable, verifiable, consistent and appropriate;
  • Separation of functions/powers: no one can manage an entire process independently and can be endowed with unlimited powers; authorisation and signature powers must be defined in a manner consistent with the organisational responsibilities assigned;
  • Adequacy of internal rules: all company regulations must be consistent with the operations carried out and the level of organizational complexity and such as to guarantee the controls necessary to prevent the commission of crimes provided for by the Decree;

Traceability/Documentability: Every operation/transaction/action, as well as its verification and control activity, must be documented and the documentation must be properly archived.

SECTION FOUR

THE SUPERVISORY BODY

4.1 Characteristics of the Supervisory Body

Article 6, paragraph 1 of D. Lgs. 231/2001 requests as a condition to benefit from the administrative responsibility, that the task of supervising the observance and functioning of the Model, taking care of its updating, is entrusted to a Supervisory Body within the Company that, endowed with autonomous powers of initiative and control, continuously exercises the tasks entrusted to it.

Therefore, the Supervisory Body performs its functions outside the Operational Processes of the Company, periodically reporting to the Board of Directors, free from any hierarchical relationship with the Administration itself and with the individual responsible people in the Management.

In accordance with the requirements of D. Lgs. 231/2001, Galenica Senese intends to establish the Supervisory Body with a collegiate structure of three components.

According to the provisions of G. Lgs. no. 231 of 2001 (Articles 6 and 7), as well as the indications contained in the Reference Guidelines, the characteristics of the Supervisory Body, such as to ensure effective and effective implementation of the Model, must be:

  1. autonomy and independence;
  2. professionalism;
  3. continuity of action.

Autonomy and independence

The requisites of autonomy and independence are fundamental so that the SB is not directly involved in the management activities that are the subject of its control activity and, therefore, does not suffer conditioning or interference by the management body.

These requisites can be obtained by guaranteeing the Supervisory Body the highest possible hierarchical position, and by providing for a reporting activity to the highest charge of the company, that is to the Board of Directors as a whole. For the sake of independence, it is also essential that the SB is not assigned operational tasks, which would compromise its objectivity with regard to checks on the behaviour and effectiveness of the Model. The highest hierarchical position of the SB can be appropriately guaranteed by the appointment, as its component, of an internal member of the company, of proven experience, authority and autonomy, which acts as a glue between the SB itself and the Administrative Body and that is able to ensure the in-depth knowledge of the organizational and management profiles of the institution and the continuity of action required by the standard and practice.

Professionalism

The SB must possess technical and professional skills adapted to the functions it is called to perform. These characteristics, combined with independence, guarantee the objectivity of judgment4.

Continuity of action

The Supervisory Body must:

  • carry out in a continuous way the activities necessary for the supervision of the Model with adequate commitment and with the necessary investigative powers;
  • be a structure related to the Company, in order to ensure due continuity in the supervisory activity.

In order to ensure the effective existence of the requirements described above, it is appropriate that these subjects have, in addition to the professional skills described, the formal subjective requirements that further guarantee the autonomy and independence required by the task (e.g. good reputation, absence of conflicts of interest and relatives with the social bodies and with the top management positions, etc.).

4.2. Identification of the Supervisory Body

The Sole Administrator has appointed as the Supervisory Body of the Company a multi-subjective body composed of 3 (three) members identified among subjects with specific and proven skills and experience in corporate matters and in inspective activities

This configuration guarantees the autonomy of the control initiative from any form of interference and/or conditioning by any component of the organization, while ensuring sufficient continuity of action and, overall, allows to meet the requirement of professionalism in relation to the different categories of Crime Assumption.


4 This refers, among other things, to: risk analysis and assessment techniques; measures to contain them (organizational procedures, mechanisms for opposing tasks, etc.); flow charting of procedures and processes for the identification of weaknesses, interviewing techniques and questionnaire processing; methodologies for the detection of fraud; etc. the Supervisory Body must have inspection powers (to ascertain how a crime of the species in question and of those who committed it could have been verified); consulting powers (to adopt – at the time of the design of the Model and subsequent changes – the most appropriate measures to prevent, with reasonable certainty, the commission of the crimes themselves) or, again, currently to verify that daily behaviors actually respect those codified) and legal competences. Legislative Decree No. 231 of 2001 is a criminal discipline and, having the Supervisory Body the aim of preventing the realization of crimes is therefore essential to have the knowledge of the structure and methods of implementation of crimes (which can be ensured through company resources or external advice).

By the same resolution, the Chief Executive Officer appoints the SB, and fixes the remuneration due to that body for the task assigned to it.

Once established, the Supervisory Body provides its own rules of procedure, as well as to establish and update the plan of activities to be carried out.

4.3 Duration of position and causes for termination

4.3 Duration of position and causes for termination

The Supervisory Body remains in charge for the duration indicated in the act of designation and may be renewed.

The office of the SB may be terminated in one of the following cases:

  • end of the assignment;
  • suspension of the Body by the Administrative Board;
  • waiver of a component, formalized by means of a special written communication sent to the administrative body;
  • one of the causes of forfeiture

The suspension of the SB can only be ordered for just cause for the following hypotheses:

  • the case in which the component is involved in a criminal trial concerning the commission of a crime;
  • the event that the breach of the confidentiality obligations of the SB is found;
  • serious negligence in the performance of the tasks related to the assignment;

the possible involvement of the Company in a procedure, criminal or civil, that is connected to a failure or insufficient supervision, even negligent.

The revocation is ordered by resolution of the Board of Directors, after binding opinion of the Board of Statutory Auditors of the Company.

In the event of expiry, revocation or waiver, the Board of Directors appoints the new member of the SB without delay, while the outgoing member remains in office until his replacement.

4.4 Cases of ineligibility and forfeiture

The following points constitute thr reasons for the ineligibility and/or forfeiture of the component of the SB:

  • the disability, incapacity, bankruptcy or, in any case, the criminal conviction, even if not final, for one of the crimes provided for by the Decree or, in any case, to a penalty that involves the suspension, even temporary, from public offices or the inability to exercise management offices;
  • the existence of relatives, spouse or affinity relatves within the fourth degree with the members of the Representative Body or the Board of Statutory Auditors of the Company, or with the external subjects in charge of the revision;
  • the existence of capital relationships between the component and the Company such as to compromise the independence of the component itself.

If, during the assignment, a cause of forfeiture occurs, the member of the Supervisory Body is required to inform the administrative body immediately.

4.5 Functions, tasks and powers of the Supervisory Body

In accordance with the indications provided by the Decree and the Guidelines, the function of the Supervisory Body consists, in general, in:

  • Supervise the dissemination within the Society of Knowledge, Understanding and Observance of the Model;
  • Supervise the effective application of the Model in relation to the different types of crimes taken into account by the same;
  • verify the effectiveness and adequacy of the Model and its real ability to prevent the commission of the crimes in question;
  • report to the Board of Directors the opportunity for updates and changes of the Model itself in relation to the changed legislation or the changed needs or conditions of the company;
  • verify that the updating and modification proposals formulated by the Board of Directors have actually been included in the Model.

Within the framework of the function described above, the SB has the following tasks:

  • periodically verify the map of the Areas at Risk of Crime and the adequacy of the control points in order to allow their adaptation to changes in the activity and/or company structure. For this purpose, the recipients of the Model, as best described in the special parts of the model, must report to the SB any situation capable of exposing Galenica Senese to the risk of crime. All communications must be written and transmitted to the appropriate e-mail address activated by the SB;
  • periodically, on the basis of the SB's business plan established, targeted checks and inspections on certain specific operations or act carried out within the Areas at Risk of Crime;
  • collect, process and retain the relevant information (including the reports referred to in the next paragraph) regarding compliance with the Model, as well as update the list of information that must be transmitted to the same SB;
  • investigate the reports received to verify whether violations of the Code of Conduct and/or the Model are intact and to ascertain their validity, reporting, on the outcome of the investigations conducted, to the competent Function or the Administrative Body, depending on the corporate role of the perpetrator of the violation, the opportunity to initiate disciplinary proceedings or to take appropriate sanctions against the author himself;
  • verify that the elements provided for in the Model for the different types of crimes (standard clauses, procedures and related controls, system of delegations, etc.) are actually adopted and implemented and are meeting the needs of compliance with Legislative Decree no. 231 of 2001, providing, if not adopted, corrective actions and updates of the Model.

For the performance of the above functions and tasks, the following powers shall be conferred to the SB:

  • wide access to the various company documents and, in particular, to those concerning contractual relationships not established by the Company with third parties;
  • use of support and cooperation of the various company structures and corporate bodies that may be interested, or otherwise involved, in control activities;

specific consultancy and assistance assignments to professionals also outside the Company.

4.6 Resources of the Supervisory Body

The Administrative Body assigns to the SB the human and financial resources deemed appropriate for the performance of the assigned task. In particular, the Supervisory Body is granted autonomous spending powers, as well as the right to conclude, modify and/or resolve professional assignments to third parties with the specific skills necessary for the best execution of the task.

4.7 Information flows of the Supervisory Body

4.7.1 Information obligations towards the Supervisory Body

In order to facilitate the supervision of the effectiveness of the Model, the SB must be informed, through special reports by the Recipients (and, where appropriate, by third parties) about events that could involve the responsibility of Galenica Senese pursuant to Legislative Decree no. 231 of 2001.

Information flows to the SB are distinguished by general information and mandatory specific information.

In the first case, the following information must be communicated to the Supervisory Body:

  • on a periodic basis, the information, data, news and documents that constitute derogations and /or exceptions with respect to the company procedure, previously identified by the Supervisory Body and formally requested by the individual Directorates/Functions (so-called information flows), according to the methods and timing defined by the Body itself;
  • as part of the supervisory body's verification activities, any information, data, news and document deemed useful and/or necessary for the carrying out of these checks, previously identified by the Body and formally requested from the individual Directorates/Functions;
  • on an occasional basis, any other information, of any kind, relating to the implementation of the Model and/or the Code of Conduct in the areas of risk-crime activity, as well as compliance with the provisions of the Decree, which may be useful for the performance of the Body's tasks (reports).


In regards to this:

  • recipients are required to report to the SB the information relating to the commission, or the reasonable belief of commission, of crimes or practices not in line with the procedures and rules of conduct issued or that will be issued by Galenica Senese
  • third parties are required to make reports relating to the commission, or to the reasonable conviction of the commission, of the crimes within the limits and in accordance with the ones provided in the contract
  • Third parties are required to make any reports directly to the SB.

The Supervisory Body will evaluate the reports received, and may summon, if it deems it appropriate, both the whistleblower to obtain more information, and the alleged perpetrator of the violation, also giving rise to all the investigations that are necessary to ascertain the validity of the report.

Reports without any substantial elements to support them, excessively vague or unsubstantiated or of obvious defamatory or libelous content, will not be taken into account. Once the validity of the report has been established, the Body:

  • for violations carried out by the employees, immediately communicates them in writing to the Competent Function for the initiation of the consequent disciplinary actions;
  • for violations of the Model and/or the Code of Conduct, deemed well founded, by the Director of the Company, immediately communicates it to the Board of Directors and the Board of Statutory Auditors;
  • for violations of the Model and/or the Code of Conduct, considered founded, by senior figures of the Company, immediately communicates it to the Board of Directors.

In addition to the reports relating to violations of a general nature described above, information concerning:

  • measures and/or news from judicial police bodies, or any other authority, relating to the conduct of investigations involving the Company or the members of the corporate bodies;
  • any reports prepared by the managers of other bodies (for example, Board of Statutory Auditors) as part of their control activity and from which facts, acts, events or omissions with critical profiles with respect to compliance with Legislative Decree no. 231 of 2001 could emerge;
  • news relating to disciplinary proceedings as well as any sanctions imposed or measures to close such proceedings with the related reasons, if they are linked to the commission of crimes or violation of the rules of conduct or procedure of the Model;
  • committees of inquiry or internal relations/communications from which the responsibility for the crime hypotheses referred to in Legislative Decree No. 231 of 2001 emerges;
  • changes in the system of powers of attorney and powers of attorney, as well as amendments to the statutory or corporate organization chart;
  • requests for legal assistance submitted by the apical functions and/or employees in the event of the initiation of legal proceedings for the crimes included in Legislative Decree 231/2001.
  • any communications of the Board of Statutory Auditors regarding aspects that may indicate shortcomings in the system of internal controls, objectionable facts, comments on the Company's financial statements;
  • the declaration of truthfulness and completeness of the information contained in social communications;
  • the results of any actions taken following written notification by the Supervisory Body of ascertained violation of the Model, the imposed disciplinary sanctions for violation of the Model, as well as the storage measures with the related reasons for reporting serious injuries (involuntary manslaughter or serious or very serious manslaughter, in any case any accident with prognosis exceeding 30 days) occurred to employees, collaborators of the Company, and more generally to all those who have access to the Company's facilities;
  • changes in roles and responsibilities within workplace safety management systems (such as appointment to employer, delegation of function ex Art. 16 Legislative Decree 81/2008, appointment to RSPP) and environment (such as prosecutors and delegations in environmental matters).

The Company adopts specific dedicated information channels (dedicated telephone lines or mail boxes created ad hoc) in order to guarantee the above confidentiality and facilitate the flow of reports and information to the Body.

The SB assesses the reports received with discretion and responsibility. To this end, you can listen to the whistleblower and/or the person responsible for the alleged breach, giving written reasons for any independent decision not to proceed. In any case, whistleblowers in good faith will be guaranteed by any form of retaliation or penalty and they will be guaranteed maximum confidentiality, without prejudice to legal obligations and the protection requirements of the Company or persons wrongly or in bad faith.

In the Special Parts, further information requested periodically by the Supervisory Body is indicated, all information, documentation, including the reporting provided for by the Model, and the reports collected by the Supervisory Body and received in the performance of its institutional tasks must be kept by the Body in a special archive established at the Company's headquarters, in compliance with the regulatory provisions on the processing of personal data.

4.7.2 Information obligations specific to the Supervisory Body

Given that the responsibility to adopt and effectively implement the Model remains with the Company's Board of Directors, the SB reports on the implementation of the Model and the occurrence of any critical issues.

In particular, the Supervisory Body is responsible to the Board of Directors for:

  • communicating at the beginning of each exercise, the plan of the activities it intends to carry out in order to carry out the assigned tasks. This plan will be approved by the Board of Directors itself;
  • periodically communicate the progress of the programme together with any changes made to the same;
  • promptly communicate any issues related to the activities, where relevant;
  • report, at least annually, on the implementation of the Model.

The SB will be required to report periodically, in addition to the Board of Directors, also to the Board of Statutory Auditors regarding its activities.

The Body may request to be convened by the aforementioned bodies to report on the functioning of the Model or specific situations. Meetings with the corporate bodies to which the SB refers must be recorded in the minutes. A copy of these minutes will be kept by the SB and the bodies involved from time to time.

Without prejudice to the above, the Supervisory Body may also communicate, evaluating the individual circumstances:

  • the results of its investigations to those responsible for functions and/or processes if the activities give rise to aspects likely to be generated in this case will be necessary for the SB to obtain from the process managers a plan of actions, with relative timing, for the implementation of the activities likely to improve as well as the result of such implementation;
  • report to the Board of Directors and the Board of Statutory Auditors behaviors/actions not in line with the Model in order to:
  1. acquire from the Administrative Board all the elements to make any communications to the structures responsible for the evaluation and application of disciplinary sanctions;
  2. to give indications for the removal of deficiencies in order to avoid a repetition of the occurrence.

Finally, the Body is obliged to inform the Board of Statutory Auditors immediately if the violation concerns the members of the Board of Directors.

 

SECTION FIVE

SYSTEM OF PENALTIES FOR NON-COMPLIANCE WITH THIS MODEL AND THE RULES AND PROVISIONS REFERRED TO THEREIN

5.1 General principles

Galenica Senese takes note and declares that the provision of an adequate sanctionary system for violation of the rules contained in the Model, its Annexes and procedures is an essential condition to ensure the effectiveness of the Model itself.

In this regard, in fact, the same article 6 paragraph 2, point c), of the Decree provides that the models of organization and management must "introduce a disciplinary system suitable to sanction non-compliance with the measures indicated in the model".

The definition of a sanctionatory system, applicable in case of violation of the provisions of this Model, is therefore a necessary condition to ensure the effective implementation of the Model itself, as well as an essential prerequisite to allow the Company to benefit from the administrative responsibility.

The application of disciplinary sanctions is regardless of the outcome of any criminal proceedings, as the rules of conduct imposed by the Model and the Procedures are assumed by the Company in full autonomy and regardless of the type of offences referred to in legislative decree 231 of 2001 that the infringements in question may lead to.

For the purposes of the application of the disciplinary system, it constitutes relevant conduct, which determines the application of any sanctions, any action or behavior, even of an omission, carried out in violation of the rules contained in this Model of Organization, Management and Control.

More precisely, failure to comply with the rules contained in the Model and the Procedures, in fact, in itself violates the trust relationship in place with the Company and involves disciplinary actions regardless of the possible establishment of a criminal judgment in cases where the violation constitutes a crime. This is also in compliance with the principles of timeliness and immediacy of disciplinary challenge and the enforcement of sanctions, in compliance with the rules of law in force.

The application of disciplinary sanctions should be based on the principle of proportionality and graduality and, in particular, the objective and subjective aspects of the relevant conduct are taken into account when identifying the related sanction.

In particular, from the objective point of view and in terms of graduality, account shall be taken of:

  1. breaches of the Model that did not result in exposure to risk or resulted in low exposure to risk;
  2. violations of the Model that have resulted in appreciable or significant exposure to risk;
  3. violations of the Model that have integrated a criminal matter.

The relevant conduct also assumes greater or lesser severity in relation to the circumstances in which the event was committed and in relation to the following subjective aspects:

  1. commission of multiple violations with the same conduct;
  2. recidivism of the agent;
  3. level of hierarchical and/or technical responsibility of the person to whom the contested conduct relates;
  4. sharing responsibility with other competing parties in the violation of the procedure.

The sanctioning procedure is in any case left to the function and/or the competent corporate bodies.

5.2 Definition of "Violation" for the purposes of the operation of the present Sanction System

For a purely general and illustrative reason, the following constitute "Violation" of this Model and its Procedures:

  • the implementation of actions or behaviors, which do not comply with the law and the requirements contained in the Model itself and in the related Procedures, which involve a situation of mere risk of commission of one of the crimes covered by Legislative Decree No. 231 of 2001;
  • the omission of actions or behaviors prescribed in the Model and in the related Procedures that involve a situation of mere risk of commission of one of the crimes covered by Legislative Decree No. 231 of 2001.

5.3 Penalties for employees

5.3.1 Employees in non-managerial positions

The conduct of employees in violation of the rules contained in this Model and in company procedures are defined as disciplinary offences.

With reference to the type of penalties that can be imposed on these employees, they are among those provided for in the national collective agreement of reference.

The violation by the employees may give rise, according to the seriousness of the Infringement itself, to the following measures, which are established in application of the principles of proportionality, as well as the criteria for correlation between infringement sanction and, in any case, in compliance with the form and modalities provided for by current legislation.

The violation of the rules of conduct and procedures indicated in the Model constitutes a disciplinary offence, pursuant to art. 2104, co. 2, c.c.

Without prejudice to the provisions of the CCNL for the application of any disciplinary measures, some relevant conduct is indicated:

  • breach of internal procedures or adoption, in the performance of activities at risk, of a conduct that does not comply with the requirements of the Model itself, having to be seen in such conduct as a non-execution of the orders given by the Company both in written and verbal form (for example, the Worker who does not observe the procedures prescribed, o dare to communicate to the Supervisory Body the prescribed information, o dare to carry out checks, etc.);
  • adoption, in carrying out the activities at risk, of conduct that does not comply with the to the requirements of the Model or violation of the principles of the same, having to be seen in such behavior a non-compliance with the orders given by the Company (for example the Worker who refuses to undergo the health checks referred to in art. 5 of Law No. 300 of 20 May 1970; falsifications and/or other internal or external documents; does not voluntarily apply the provisions given by the Company, in order to benefit itself or the Company itself; is a repeat offender, in any of the shortcomings that have given rise to the application of conservative disciplinary measures).

The Supervisory Body shall forward to the Competent Function a report containing:

  1. the details of the person responsible for the infringement;
  2. the description of the conduct at dispute;
  3. the indication of the model predictions that appear to have been violated;
  4. documents and elements to support the dispute.

Promptly from the acquisition of the report, the Competent Function elaborates a written dispute containing:

  1. a precise indication of the conduct observed;
  2. the forecasts of the violated Model;
  3. the notice of the right to formulate any deductions and /or written justifications within five days of receipt of the communication, being able - in the aforementioned period - to request the intervention of the representative of the trade union association to which the employee adheres or gives a mandate.

The competent function shall take the decision and apply the penalty.

The measure is also communicated to the Supervisory Body.

The disciplinary system is constantly monitored by the Supervisory Body and by the Competent Function.

5.3.2 Managers

In the event of: (a) Violation pursuant to paragraph 5.2 above, or (b) adoption, in the performance of activities in the Areas at Risk of Crime, of conduct that does not comply with the requirements of the aforementioned documents, by managers, the most appropriate disciplinary measures will be applied to the managers in accordance with the provisions of the National Collective Agreement of Reference

5.4 Administrators

Nel caso di Violazione delle regole di cui al precedente paragrafo 5.2. da parte dell’Organo di Amministrazione, l’Organismo di Vigilanza informerà senza indugio il Collegio Sindacale della Società per le opportune valutazioni e provvedimenti.

5.5 Statutory Auditors

In the event of a breach of the rules referred to in paragraph 5.2 above by one or more members of the Board of Statutory Auditors, the Supervisory Body informs the Board of Directors and the Board of Statutory Auditors so that appropriate measures can be taken.

5.6 Third parties: collaborators, agents and external consultants

In the event of a breach of the rules referred to in paragraph 5.2 above by external collaborators, agents or consultants, or, more generally, by Third Parties, the Company, depending on the seriousness of the violation: (i) will call on the interested parties to strictly comply with the provisions provided for therein; or (ii) will be entitled, depending on the different types of contract, to withdraw from the existing relationship for just cause or to terminate the contract for non-compliance with the subjects indicated above.

To this end, Galenica Senese has provided for the inclusion of specific clauses in the same that provide: (a) the disclosure to Third Parties of the adoption of the Model and the Code of Ethics by Galenica Senese of which they declare to have seen, committing to respect its contents and not to engage in behaviors that may lead to a violation of the law, the Model or the commission of any of the Alleged Crimes; (b) the right for the Company to withdraw from the relationship or terminate the contract (with or without the application of penalties), in case of non-compliance with these obligations.

5.7 Register

The Company shall adopt a register in which all persons who have committed a Breach pursuant to paragraph 5.2 must register. Registration in this register shall entail a prohibition on the establishment of new contractual relations with the same persons concerned.

SECTION SIX

6. DISSEMINATION OF THE MODEL

The Company, aware of the importance that the training and information aspects assume from a prevention perspective, defines a communication and training program aimed at ensuring the dissemination to all recipients of the main contents of the Decree and the obligations deriving from it, as well as the requirements provided for in the Model.

Training and communication are central tools in the dissemination of the Model and the Code of Conduct that the company has adopted, consoting an essential vehicle of the regulatory system that all employees are required to know, observe and implement in the performance of their respective functions.

6.1 Recipients

This Model takes into account the particular entrepreneurial reality of Galenica Senese and represents a valid tool for raising awareness and information of apical subjects and subjected persons (below, for brevity, the "Recipients").

All this so that the Recipients follow, in the performance of their activities, correct and transparent behaviors in line with the ethical-social values that the Company is inspired by in the pursuit of its social object and such as to prevent the risk of commission of the crimes provided for by the Decree.

In any case, the competent corporate functions ensure the transposition into the Company's Procedures of the principles and rules of conduct contained in the Model and the Code of Ethics of Galenica Senese.

6.2 Staff training and information

It is the objective of Galenica Senese to ensure a correct knowledge by the Recipients about the content of the Decree and the obligations deriving from it.

For the effective implementation of this Model, the training and information to the Recipients is managed by the Competent Function in close coordination with the Supervisory Body and with the managers of the other company functions from time to time involved in the application of the Model.

The main methods of carrying out the training/information activities necessary also for the purpose of compliance with the provisions contained in the Decree, comply with the specific information at the time of recruitment and the further activities deemed necessary in order to ensure the correct application of the provisions provided for in the Decree. In particular, it is planned to:

  • initial communication. In this regard, the adoption of this Model is communicated to all resources present in the Company. New employees are given the Code of Ethics and the Model - General Part of Galenica Senese. The same are also made to sign a form with which they acknowledge that the Model is available on the company intranet and undertake to observe the contents of the aforementioned legislation. In addition, Apical and/or Subjected Persons operating in the Areas at Risk of Crime, are given information of the Section(s) of the Special Part concerning/not the Reference Area;
  • a specific training activity. This "continuous" training activity is mandatory and developed through IT tools and procedures (update e-mails, company intranet), as well as regular training and updating meetings and seminars. This activity is differentiated, in the contents and methods of delivery, according to the qualification of the Recipients, the level of risk of the area in which they operate, whether or not to have functions of representation of the Company.

In order to ensure the effective dissemination of the Model and the information of the staff with reference to the contents of the Decree and the obligations deriving from the implementation of the same, a specific section of the company intranet is established (in which all the documents that make up the Model are present and available) dedicated to the topic and updated, from time to time, by the internal function of reference in coordination or on the recommendation of the Supervisory Body.

6.3 Information to third parties and dissemination of the Model

Galenica Senese also provides for the dissemination of the Model to persons who have collaboration relationships with the Company without subordination, consultancy relationships, agency reports, commercial representation relationships and other relationships that materialize in a professional service, not of a subordinate nature, both continuous and occasional (including subjects acting for suppliers and partners , also in the form of a temporary association of undertakings, as well as joint ventures) (hereafter, for short, the "Third Parties").

In particular, the company functions, from time to time involved, provide third parties in general and the service companies with which they come into contact, suitable information in relation to galenica Senese's adoption of the Model pursuant to Legislative Decree no. 231 of 2001. The Company also invites Third Parties to view the contents of the Code of Ethics and the General Part of the Model on its website or, in any case, provided in a hard copy.

In the respective contractual texts are inserted specific clauses aimed at informing Third Parties of the adoption of the Model by Galenica Senese, of which they declare that they have seen and have knowledge of the consequences deriving from the non-compliance with the precepts contained in the General Part of the Model, in the Code of Ethics as well as they undertake not to commit and to ensure that their apical or subjected refrain from committing any of the Pre-Compulsory Crimes.

SECTION SEVEN

7. ADOPTION AND UPDATE OF THE MODEL

The adoption and effective implementation of the Model are, by express legislative provision, a responsibility left to the Administrative Body.

It follows that the power to adopt any updates of the Model also belongs to the Administrative Body, which will exercise it by resolution with the procedures provided for its adoption.

The updating activity, seen both as an integration and as a modification, is aimed at ensuring the adequacy and suitability of the Model, evaluated with respect to the preventive function of commission of the crimes provided for by Legislative Decree 231/2001.

On the other hand, it is the responsibility of the Supervisory Body to verify the need or opportunity to proceed with the updating of the Model, promoting this need vis-à-vis the Administrative Board.

The Supervisory Body, within the powers conferred on it in accordance with art. 6, paragraph 1 (.b) and art. 7, paragraph 4 (a) of the Decree, is responsible for formulating proposals to the Administrative Board regarding the updating and adaptation of this Model.

In any case, the Model must be promptly modified and supplemented by the Administrative Board, also on proposal and after consultation with the Supervisory Body, when:

  • variations and eluments of the requirements contained in it that have highlighted their ineffectiveness or inconsistency in the prevention of crimes;
  • significant changes in the company's internal structure and/or the way in which business activities are carried out;
  • regulatory changes.

The following tasks remain in charge to the Supervisory Body:

  • conduct periodic reconnaissance to identify any updates
  • at the end of the company's activity for the purpose of updating the mapping of sensitive activities;
  • coordinate with the department responsible for staff training programmes;
  • interpret the relevant legislation on alleged crimes, as well as any guidelines prepared, also in update to existing ones, and verify the adequacy of the internal control system in relation to the regulatory or guidelines requirements;
  • check the possible model's updates.

The Managers of the Sensitive Areas concerned elaborate and propose to the Competent Functions the changes to be made to the operational procedures for which they are responsible, when such changes appear necessary for the effective implementation of the Model, or if they prove ineffective for the correct implementation of the provisions of the Model.

The competent business functions also take care of the changes or additions to the procedures necessary to implement any revisions of this Model.

Changes, updates and additions to the Model must always be communicated to the Supervisory Body.

Industria Farmaceutica Galenica Senese SRL
Registered Office | Werehouse
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

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