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Statutes of the
Association of Drug and Health Device Suppliers

New version effective from May 18 2016

The new version of the Statutes of ADL was adopted at the congress of delegates dated February 17, 2016 and subsequently amended and approved by members of ADL, and submitted by the President of ADL:

Article 1

The Association of Drug and Health Device Suppliers (hereinafter „ADL“) is an association of legal entities established under Section 20f and the following Sections of the Civil Code.

Article 2

These Statutes provide the organizational structure of ADL, its bodies and the scope of authority of its bodies, as well as the rights and obligations of members of ADL.

Article 3
Name of the association

In the Slovak language: Asociácia dodávateľov liekov a zdravotníckych pomôcok
In the English language: Association of Drug and Health Device Suppliers
Abbreviated name: ADL

Article 4
Registered office

The registered office of ADL is at Metodova 204/7, 821 08 Bratislava, Slovak Republic.

Article 5
Subject of activity

ADL carries out the following activities:

1. Organizes cooperation in carrying out ADL members' activities in the provision of health services in the field of drugs and health devices and laboratory medicine.
2. Creates the conditions for improving the knowledge and professional standards of ADL members.
3. Represents, protects and promotes the legitimate interests of ADL members.
4. Comments on draft legislation relating to the activities of ADL members, cooperates with ministries and other governmental bodies in developing new legislation in relation to the activities of its members.
5. Cooperates in the advertising-promotional activities of ADL and its members and creates the technical-organizational conditions for their provision.
6. Rents advertising spaces during ADL professional activities and mediates the renting of advertising spaces for ADL members.
7. Provides information, consultation and advisory services for ADL members.
8. Creates opportunities for mutual meetings and coordinates the mutual communication of ADL members with the authorities of the Slovak Republic.
9. Cooperates in the publishing of professional periodical and non-periodical publications in the field of drugs and health care.
10. Creates opportunities for cooperation and cooperates with printed, radio and visual media.
11. Cooperates with experts in expert broadcasts on radio and on television.

Article 6
Members

ADL consists of:

1. Pharmaceutical companies, drug manufacturers, suppliers of drugs and health devices, and pharmaceutical care providers in the Slovak Republic.
2. ADL is divided into sections according to the subject of activity.

Article 7
Creation of membership

1. Membership in ADL is voluntary and it is divided into regular and associated.
2. Membership in ADL is created on the day of entry into the list of ADL members on the basis of submission of a written application, the decision of the Presidium on accepting a member and payment of a set membership fee for the relevant calendar year.
3. The list of ADL members is maintained by the ADL office, and each member is also a member of the relevant section according to its business activity.
4. Associated members may be legal entities which do not have pharmaceutical and marketing activity in the drug market field as their business activity. An associated member has the right to participate in the activities of ADL without having voting rights.
5. Each member is obliged to specify a current e-mail address, which is a communication and delivery channel for ADL activities under the Statutes.

Article 8
Expiration of membership

1. Membership in ADL may be renounced by a written submission addressed to ADL. Membership expires on the day specified in the written submission, which will be confirmed in writing by an ADL manager. The paid membership fee shall not be refunded.
2. The Presidium shall cancel the membership of an ADL member if:
   1. the member fails to fulfil its obligation resulting from Article 10 of these Statutes, despite receiving a written notice and given a reasonable period for remedy;
   2. the member ended its activities or the member's license to carry out its business has been cancelled;
   3. the member's actions endangered or damaged the reputation of ADL or any of its members.

Article 9
Rights of members

1. A member of ADL has the right to:
   1. elect and be elected into the bodies of ADL;
   2. make decisions by voting in the relevant bodies of ADL;
   3. participate in ADL activities, make proposals and request reports on activities of its bodies; point out errors and shortcomings in its activities and demand their remedy;
   4. publicize its membership in ADL in its official communications;
   5. require protection of its interests in line with ADL activities in all justified cases;
   6. have access to all information and services that the ADL office provides for them.

Article 10
Duties of members

The basic duties of ADL members include:

1. To comply with the Statutes and resolutions of ADL bodies.
2. Protect the legitimate interests and property of ADL.
3. Pay the set membership fees.
4. Follow the principles of the ADL code of ethics.

Article 11
Bodies

1. The bodies of ADL are:
   1. the congress of delegates
   2. the Presidium
   3. the sections
   4. the chairman of a section
2. The activities of the bodies are ensured by the ADL office pursuant to Article 16.

Article 12
Congress of delegates

1. The highest body of ADL is the congress of delegates. Every member of ADL has the right to participate in the congress of delegates.
2. A statutory representative of a member participates in the meeting of the congress of delegates personally or through a representative authorized in writing.
3. Every member has one vote.
4. The congress of delegates is convened by the ADL manager as necessary, at least once a year. The manager shall always convene an extraordinary congress of delegates within 30 days, if requested by at least 1/3rd of ADL members.
5. The congress of delegates shall primarily
   1. approve the Statutes and decide on their amendments;
   2. approve the budget;
   3. approve the ADL code of ethics and the basic internal regulations of ADL;
   4. discuss and approve reports on the activities and management of ADL for the previous period and the annual financial statements;
   5. cancel and change the resolutions of the Presidium;
   6. make resolutions on other matters that it reserves for itself;
   7. establish and dissolve relevant sections.

Article 13
Presidium

1. The Presidium is the highest executive body of ADL between the congresses of delegates.
2. The Presidium consists of at least 4 and at most 8 members.
3. Each member of the Presidium has only one vote in the decision making (voting) of the Presidium; the member of the Presidium, who is the President, has two votes.
4. The Presidium carries out the tasks that arise from the resolutions of the congress of delegates and is responsible for its activities to the congress of delegates.
5. The Presidium is elected for a period of 24 months from the day of election.
6. The Presidium consists of the following:
   • 3 members – chairmen of sections
   • at least 1 and at most 3 members elected by the manufacturer section
   • at most 1 member elected by the distributor section
   • at most 1 member elected by the pharmaceutical section
7. The Presidium elects the President from its members.
8. The President is the highest professional representative of ADL, presides over the meetings of the Presidium, proposes solutions, assigns tasks to the manager of ADL, defends the interests of ADL and represents ADL externally.
9. The Presidium delegates tasks and responsibilities to the manager of ADL for the purpose of execution and completion of tasks.

Article 13a
Manager of ADL

1. The manager of ADL
   1. is a statutory representative of ADL
   2. acts as a proxy for, negotiates, represents, and defends the interests and reputation of, ADL externally
   3. carries out all other activities and decides on other ADL matters
   4. establishes and maintains contacts with third parties in carrying out ADL activities
   5. is responsible for the condition, and increasing of the membership base, of ADL, takes care of the renewal and extension of memberships of existing members and the recruiting of new members
   6. is responsible for the preparation and implementation of the program activities and professional goals of ADL, proposes the primary areas of interest and the focus of individual projects and events of ADL; is responsible for their preparation, coordination and compliance
   7. is responsible for the administration and management of ADL finances and property, manages and carries out financial operations, prepares an annual report on the economic management of ADL and the budget for the next period
   8. provides information and reports to the Presidium or to the President of ADL
   9. carries out other tasks assigned by the Presidium or the President
   10. carries out employer's rights towards ADL employees
2. The manager of ADL is elected and appointed by the Presidium and is accountable for his activities to the Presidium and the President.
3. The term of office of the manager of ADL begins on the date of appointment of the Presidium for an indefinite period and expires when the Presidium removes him from his office for any reason.
4. The manager carries out his office for remuneration. The amount of remuneration is decided upon by the Presidium and the contract with the manager is concluded by the President.
5. The manager may be one of the members of the Presidium, a representative of one of the members of the association, or a third party.
6. The manager is entitled to participate in meetings of the Presidium.
7. The performance of the office of ADL manager is incompatible with membership in other associations, the activities of which have a competitive nature to ADL activities. The performance of the office of ADL manager is also incompatible with the performance of activities in a legal entity, the activities of which have a competitive nature to ADL activities.
8. The manager may choose a deputy, by written authorization with the prior approval of the Presidium. The provisions of paragraph 7 of this Article shall correspondingly apply to the deputy. In the event that the office of ADL manager becomes vacant, all rights and duties shall be transferred to the President of ADL.
9. The manager shall be obliged to settle the financial obligations incurred during the normal and regular activity of ADL according to the approved budget. Expenses beyond the frame of regular activity and the approved budget shall be settled by the manager only with the approval of the Presidium.

Article 14
Sections

1. A section is made of members according to the matching subject of their activities.
2. ADL is made of three sections:
   1. manufacturer section
   2. pharmaceutical section
   3. distributor section
3. A section elects its chairman from its members.
4. A section decides on matters within its competence at its congress.
5. A section congress is convened by the chairman of the section as necessary.
6. A section congress shall primarily:
   1. decide on the subjects of activity of the section
   2. approve major matters of the section, which are affecting the activities of the section or have been delegated by the congress of delegates or the Presidium,
   3. approve the work plan of the section
   4. approve the budget of the section
   5. elect the chairman of the section

Article 15
Section chairman

1. A section chairman is elected by the members of the section and is the supreme body of the section between congresses of the section.
2. A section chairman shall convene a section congress as necessary or if requested by 1/3rd of the section members.
3. A section chairman organizes section activities and is also a member of the Presidium.
4. A section chairman gives the Presidium a proposal for convening an extraordinary congress of delegates.
5. A section chairman fulfils the tasks that arise from the resolutions of the congress of delegates and decisions of the Presidium and resolutions of the congress of the section, while
   1. managing the activity of the relevant ADL section,
   2. submits reports on his/her activity to the congress of delegates, the Presidium and the section congress, as well as other proposals that are subject to approval,
   3. creates working groups for specific problems.

Article 16
The Office

1. The ADL office supports the activities of ADL, the Presidium and sections in technical-organizational, administrative and economic terms.
2. The office fulfils the tasks assigned by the Presidium, the manager and sections. It prepares the meetings of bodies, ensures and prepares materials for the meetings of bodies, and sends invitations for the meetings of bodies.
3. The office is accountable for its activities to the manager of ADL.

Article 17
Meetings and voting of ADL bodies

1. A meeting of an ADL body is convened by invitations sent to the e-mail addresses of members of the body, at least 7 working days in advance. The invitation primarily contains: place, date and hour of the meeting of the body, and the agenda of the meeting.
2. Non-attendance at the meeting must be excused in advance at the ADL office in writing or by electronic communication.
3. The meeting of the congress of delegates and the Presidium of ADL is chaired by the President of ADL or the manager of ADL, the meeting of a section congress is chaired by its chairman. In the case of non-attendance, the meeting can be chaired by the President / ADL manager / deputy authorized by the chairman chosen from members („the chair“).
4. Each ADL body can hold a meeting if an absolute majority of its members is in attendance (the quorum).
5. The chair shall open the meeting at the designated hour. If a sufficient number of members of the body fail to meet in one hour from the time designated as the start of the meeting, the chair shall convene a new meeting of the body in 14 days. If the quorum fails to convene at the repeated meeting within 30 minutes from its start, the body has a quorum if more than 1/3rd of its members are in attendance.
6. At the beginning of the meeting the chair announces the number of attending members, submits the meeting's agenda for approval and a nomination of minutes verified for approval. It is possible to deviate from the agenda with a proposal for amendment or a change to the agenda made by a member of the body, if approved by a majority of the attending members of the quorum body.
7. The meeting of the body is directed towards the adoption of resolutions for items on the agenda. The submitter of the material or an authorized person will justify the material for the purpose of hearing.
8. Members can sign up for the discussion by a written request in advance or by raising a hand. The chair gives the floor to speakers and sets the time limit for discussion. Attendees of the meeting may not interrupt the speaker during a speech, if he/she has been given the floor. The chair has the right to interrupt the speaker only if the speaker is not addressing the discussed issue. If the discussion includes a significant inaccuracy or error, a member has the right to make a factual comment or respond to it. The chair shall give the floor to this member after the speaker, during the speech of whom the delegate raised the comment into the discussion. The factual comment is signalled by raised hands joined into the shape of the letter „T“, and the duration of the factual comment may not exceed 1 minute. When all members that signed into the discussion have had their say, the chair shall end the discussion. After the end of the discussion, the chair shall give the floor to the submitter of the material, who may give it up. The submitter may withdraw their material from the meeting of the congress until the start of the vote on the proposal of its resolution.
9. After the end of the discussion the resolution is proposed. The resolution of a body primarily decides upon the discussed issues, it imposes obligations or draws conclusions. It is formulated briefly, with the specified names of task solvers and a deadline for fulfilment. Resolutions, which contain permanent, long-term or repeated tasks, shall also include the deadline for inspection of the fulfilment of the resolution. If the proposal for resolution includes tabling amendments, a vote shall be made on these first in the order in which they were submitted. If an adopted amendment eliminates further ones, these are not voted on.
10. Decisions are made by voting. The resolution of a body shall be adopted if at least 2/3rds of the attending members of the body with a quorum vote for it. The resolution shall be binding for all the members of the body.
11. The method of decision making is public, performed by the raising of hands or, if adopted by members of the body in a resolution, secret, through anonymous ballots.
12. The meeting of the body can be suspended by its resolution. Its continuation shall be decided by the body directly at this meeting, by setting the date of continuation of the meeting.
13. After completing the agenda of the meeting of the body, the chair shall conclude the meeting. Minutes of the meeting shall be drafted, and signed by the chair and the elected verifier. The minutes shall be drafted no later than in 7 working days and the office shall subsequently send them to the members of the body. The minutes primarily include information on the chair of the meeting, the number of attending and excused members, the contents of the meeting and the resolutions of the meeting. All materials from the meetings shall be archived by the office.
14. The Presidium may suspend a resolution of another body if it considers that it does not correspond to valid generally binding legal regulations, the Statutes of ADL, or is disadvantageous for ADL. The Presidium shall submit the suspended resolution for the decision of the congress of delegates. The ADL manager shall convene an extraordinary congress of the delegates for this purpose no later than in 30 days from the day of adoption of the decision of the Presidium to suspend the resolution of another body. Suspension of a resolution shall be carried out by the manager of the office announcing the suspension of the resolution to those members whose rights and duties are affected by the resolution and to all recipients that received the resolution.
15. The task solvers are responsible for the timely fulfilment of the content of resolutions. The office shall inspect and monitor the fulfilment of resolutions. The manager of the office shall provide information on the fulfilment of a resolution at the body's meeting.

Article 18
Electronic communication and electronic voting

1. Electronic communication shall be carried out by sending the information/de­livery to the recipient's valid e-mail address or via the Intranet. The delivery shall be deemed received on the next working day following the sending of mail / publishing on the Intranet, even if the recipient did not learn of the receipt thereof (hereinafter referred to as „Electronic communication“).
2. Electronic communication has the character of written communication within the ADL association with the exception of expiration of membership and written representation.
3. The ADL office maintains a list of valid e-mail addresses of individual ADL members and members of ADL bodies. An e-mail address shall be considered valid until the user announces a different e-mail address to the ADL office.
4. Each ADL body may adopt decisions within its scope of authority also outside its meeting, by so-called electronic voting. A decision made via electronic voting has the same effects as a decision made at the meeting of the corresponding body.
5. Electronic voting is carried out via Electronic communication.
6. The ADL body shall send the agenda of its meeting via Electronic communication via the ADL office, or a proposal of resolution on which the voting is being carried out along with the deadline for carrying out the voting. The deadline for voting may not be less than 10 working days, except in urgent matters, in which the deadline may not be less than 3 working days.
7. Electronic voting is carried out in a manner where a member of the body via Electronic communication within the deadline for carrying out the voting expresses his/her approval or disapproval or decides to not participate in the vote. Only unequivocal approval without comments is considered as an approval vote.
8. Electronic voting shall be valid if the necessary quorum participates in the voting.
9. The results of a vote shall be evaluated similarly to a vote at the meeting of the corresponding body.
10. The office shall draft the minutes of electronic voting within 7 working days at the latest with the content similar to the minutes of voting at a meeting of the body, with the specification of votes of individual members of the body and the result of the voting.
11. The office shall immediately send the minutes of electronic voting to all members of the corresponding body.

Article 19
Economic management

1. ADL manages its property, the source of which are primarily
   1. yearly membership fee of ADL, the amount of which is decided upon by the congress of delegates on the proposal of the Presidium,
   2. additional membership fee pursuant to the decision of the Presidium,
   3. gifts and other performances from natural and legal persons.
2. ADL conducts its economic management based on the approved budget proposed by the Presidium and approved by the congress of delegates.
3. In justified cases the Presidium has the right to decide on the extraordinary use of funds obtained beyond the scope of achieved income.
4. ADL is liable for its obligations to the fullest extent of its assets. Any asset liability of individual members for ADL obligations is excluded.
5. The financial year is the calendar year.
6. The ADL office is required to submit to the members an annual Report on the auditing of ADL accounts (hereinafter „the Report“) performed by an accounting firm for the previous financial year.

Article 20
Dissolution

1. ADL shall be dissolved by a decision of the congress of delegates or by a decision of the body responsible for registration.
2. After its dissolution the association shall be liquidated, if the capital will not pass to a legal successor.
3. Each member of the association has the right to a share of the liquidation balance in proportion to the size of his/her annual contribution.

Article 21
The previously effective Statutes are repealed.

Voting and meeting regulations of ADL are repealed.
Calculation of time limits and other actions are governed by the Civil Code.

PhamDr. Koloman Gachall
President of ADL