Slovenská asociácia farmaceutických spoločností

•

Statutes of the Slovak Association of Research Based Pharmaceutical Companies

I.
BASIC PROVISIONS

ARTICLE 1. Formation of a Special Interest Association.
A Special Interest Association (hereinafter the ”Association”), pursuant to Sections 20f-20j of the Slovak Civil Code, has been founded according to the minutes of the meeting signed by all members at the first constituent members’ meeting on 13th March 1997.

ARTICLE 2. Name.
The name of the association is:

In Slovak :	Slovenská asociácia farmaceutických spoločností orientovaných na výskum a vývoj
In English :	Slovak Association of Research Based Pharmaceutical Companies

ARTICLE 3. Seat.

The seat of the Association is Ružová dolina 6, 821 08 Bratislava.

ARTICLE 4. Duration.

The association is established for an indefinite period of time.
ARTICLE 5. Purpose.

The main purpose of the Association is to uphold and promote the financial, legal and professional interests of its members, to provide services to the purpose of the Association and to promote the understanding of issues and opportunities connected with innovative international drug research.
In addition to the above, the Association may:
(i) promote relevant scientific institutions, institutes, persons and publications;
(ii) support publications that promote the development of chemical-pharmaceutical research or the economic development of pharmaceutical companies in the Slovak Republic;

establish and operate databases using all available methods, including electronic media, in full compliance with Act. No. 256/1992 Coll., Act on the Protection of Personal Data in Information Systems;
organize conferences and speeches within the scope of interest of pharmaceutical companies;
train and examine professional and trade groups within pharmaceutical enterprises, to the extent permitted under Slovak law;
cooperate with other relevant organizations in Slovak Republic and abroad, including exchange of information and eventual membership in such organizations;
cooperate with other relevant institutions and public authorities, and to make known to them the proposal and decisions of the Association;
establish contact with relevant enterprises, public authorities, other business associations and interested persons;

(ix) contribute to the adherence of ethical behaviors by its members;
(x) participate in the planning and safeguard of medical supplydistribution in the Slovak Republic, particularly in the case of a crisis.
The activities of the Association are not intended to generate profits.
The Association has no intention whatsoever to create or promote cartels or gentlemen’s agreements. The Association does not engage in trade, commercial transactions or political activities.

ARTICLE 6. Liability.
The Association’s liability is limited to the amount of its assets. Any liability of individual members is excluded.

ARTICLE 7. Assets.
The assets of the Association are administered by the Board of Directors. A member has no right to demand any assets of the Association.
In case of dissolution of the Association, the General Meeting shall decide, with a simple majority, on the use of any remaining assets after coverage of all liabilities by the liquidator, if such assets have not been dedicated for a specific purpose.

ARTICLE 8. Business Year.
The business year shall be the calendar year. The first business year begins on the day of the registration of the Association and ends on 31 December 1997.

II.
MEMBERSHIP

ARTICLE 9. Members.
Membership in the Association is voluntary.

Any pharmaceutical company - legal entity active in discovery and development of newly invented chemical and biological entities, therapeutic treatment procedures and/or their producing or importing may become a member of the Association.
Membership begins upon admission to the Association and ends with the withdrawal of the member, dissolution, liquidation or bankruptcy of the Association, or the expulsion of the member. Any legal person who desires to become a member of the Association must present a written request to the Board of Directors. The Board of Directors shall decide, with sole discretion, upon admission of a new member to the Association. There is no legal right to admission. The Board of Directors shall notify the applicant by registered mail.
With the decision on the membership of the Board of Directors, the new member automatically adheres to the Code of Ethics which is inseparable part of the by-laws of the Association and to its next amendments in the future adopted by the Council of I.F.P.M.A. and formally approved by the General Meeting of the I.F.P.M.A.. The applicant may appeal against the refusal, within two weeks upon receipt of the notification, to the seat of the Association. In case of appeal, the following General Meeting shall decide on admission of the applicant, with the admission approved by a 2/3 (two-thirds) majority of all members of the Association.
The admission to the Association must always comply with the applicable antitrust law of the Slovak Republic and implies acknowledgment of these statutes.
A majority may by expelled upon decision of the General Meeting, with a simple majority of all members of the Association. In a vote regarding the expulsion of a member, the abstention of any member from voting shall be counted as a negative vote.
The Executive Director shall keep the list of members of the Association. Upon the member’s request the Executive Director may issue a written certificate of membership in the Association and of the term of its membership duration.

ARTICLE 10. Power to Vote.
Each member is entitled to one vote at the General Meeting. Members organized as legal persons exercise their voting rights either through a person or persons authorized by law to act on their behalf or subject to a written power of attorney issued by such person (persons).

ARTICLE 11. Rights and Duties of Members.
Members are entitled to participate in regular and extraordinary General Meetings or any other meetings or events of the Association. Members are also entitled to use the facilities and services of the Association according the guidelines issued by the Board of Directors.
Members are obliged to promote the interests of the Association and to refrain from anything that could damage the image or purpose of the Association. In particular, members are obliged to respect these Statutes and the decisions of the General Meeting and the Board of Directors and the provisions of the Code of Ethics.
Each member will abide by this Code and the complaints procedure attached to the Code and not to take any legal actions against the Association or individual members of the Association for any consequences resulting from the assessment of complaints by the ethics committee of the Association. Each member undertakes to inform its employees of the Code of Ethics and will remedy any failure by any employee to observe this code.
In addition, members shall keep confidential all facts, proceedings, decisions and documents of the Association designated as confidential with respect to third parties. Upon proposal by the Board of Directors, the General Meeting may decide about amount and payment of membership fees.
Members shall pay a membership fee to the Association. The amount of such membership fee shall be determined by the General Meeting upon proposal by the Board of Directors. Members are obliged to pay the membership fee within 30 calendar days after the day of the General Meeting that decided on membership fee.

III.
ORGANIZATION

ARTICLE 12. Bodies of the Association.
The bodies of the Association are:
(i) the General Meeting
(ii) the Board of Directors (with the assistance of the Association’s office)

IV.
GENERAL MEETING

ARTICLE 13. Supreme Governing Body.
The General Meeting (or ”Members’ Meeting”) is the supreme governing body of the Association. The General Meeting shall be convened by the Board of Directors. The Board of Directors shall convene an ordinary General Meeting by the end of March of each year, at the latest. The regular General Meeting shall resolve, without limitation, the following matters:

(i)  consideration and approval of the annual report of the Board of Directors;
(ii) consideration and approval of the annual financial statement;

(iii) appointment and dismissal of the Directors constituting the Board of   Directors and the Auditor;
(iv) approval of the protocol of the proceeding General Meeting;
(v) approval of the budget and determination of the annual membership fee or any extraordinary fee;
(vi) approval of amendments to these Statutes;
(vii) expulsion of members and decision regarding admission of members in cases of appeal against the denial of admission by the Board of Directors;
(viii) winding-up of the Association; and
(ix)  decision on any other issues reserved for resolution by the General Meeting.

ARTICLE 14. Extraordinary General Meeting.
The Board of Directors may, at its convenience, convene an extraordinary General Meeting. An extraordinary General Meeting must be convened by the Board of Directors through an invitation issued, pursuant to Article 15, within 5 days of receipt of a written request signed by 1/5 (one fifth) of the members, and with indication of the reason for such extraordinary General Meeting.

ARTICLE 15. Invitation.
The Board of Directors shall call each General Meeting in writing no later than 20 business days before the date of each such General Meeting.
The notice for each General Meeting shall specify the time, place, and agenda of the business to be transacted. In case of amendment to the Statutes, the notice shall contain the proposed language of the amendment.
The General Meeting may only decide on issues contained in the agenda. For decision on issues not in the agenda, consent must be given by all members of the Association.

ARTICLE 16. Execution.
The Chairman of the Board of Directors or the Vice Chairman shall preside as chairman of the General Meeting.
A properly convened General Meeting shall form a quorum if at least over 1/2 of all members are present. In case a quorum is not formed in the time specified in the invitation for the opening of the General Meeting, 30 minutes after the planned opening of the General Meeting the General Meeting shall constitute a quorum, if at least nine (9) members are present.

In case a quorum is not formed, the Board of Directors shall convene a second General Meeting within a week of the original date. Such second General Meeting shall constitute a quorum, if at least 1/3 of all members are present. In case a quorum of such second General Meeting is not formed within 30 minutes, the Meeting shall constitute a quorum, if at least 3 members are present.
A member represented by proxy shall be considered as present. The General Meeting may adopt resolutions regarding only matters that have been on the agenda. Unless these Statutes provide otherwise, all decisions shall be made by simple majority of the members present at the General Meeting my decide on a secret vote.

ARTICLE 17. Adopting Decisions out of the General Meeting:

Members of the Association may adopt decisions falling under the authority of the General Meeting outside the General Meeting either, by so-called per rollam voting. When members of the Association are adopting decision outside the General Meeting, the Board of Directors or the Secretary of the Association shall send to each member of the Association a draft of the decision to be adopted including all its enclosures (if any) in writing (by mail/courier/e-mail/fax/telegraph). Enclosed to the draft an instruction must be sent to the members specifying the form of their expected statement to the draft (by mail, e-mail, fax, personal delivery), a time period in which their statements must be at the latest delivered and a contact person to whom the statement shall be delivered. The aforesaid time period must not be shorter than five (5) and longer than fifteen (15) days and shall start to lapse from the day of submitting the draft for delivery. The statement must be undersigned, in the event of e-mail communication sent, by a person authorised to act on behalf of a member either by law or subject to a written power of attorney issued by such an authorised person. Should the member fail to deliver its statement to the draft in the stated time period, it shall be presumed that it abstained from the voting. The Board of Directors or the Secretary of the Association shall announce results of per rollam voting to each member of the Association within three (3) working days from expiration of the time period for delivery of the statements by mail/courier/e-mail/fax/telegraph. The decision shall be considered adopted if approved by members in per rollam voting by simple majority of votes of all members of the Association. If the member’s statements to the draft is not expressly affirmative or expressly dissenting (i.e. approval or disapproval), namely if it contains any comments, proposals or additional conditions, such a statement shall be considered as disapproval to the draft. Decisions adopted by per rollam voting must not be consequently approved by the next General Meeting of the Association.

V.
BOARD OF DIRECTORS

ARTICLE 18. Rights and Duties.
The Board of Directors is the executive body of the Association. The Board of Directors shall decide on all matters of the Association, unless they fall under the authority of the General Meeting, in compliance with these Statutes, or are reserved for resolution by the General Meeting itself. The duties of the Board of Directors include, without limitation, the following:
(i) appointment of a Chairman, Vice-Chairman, Secretary and
Treasurer from its members within 14 days after the election of the Board of Directors or after the Chairman or Vice-Chairman leave office. The members shall be notified in writing within four weeks after such appointment. The first Chairman and Vice-Chairman shall be appointed by the Constituting Members’ Meeting;
(ii) recall of the Chairman and Vice-Chairman;
(iii) establishment of a budget for the business year and preparation of the annual report and annual financial statement of the Association;
(iv) preparation for and convening of General Meetings (Members’ Meetings);
(v) administration of the Association’s assets;
(vi) decisions on admissions of new members;
(vii) decisions on the establishment of committees for specific tasks; and
(viii) decisions regarding the employment of necessary personnel and regarding necessary facilities, infrastructure and organization for the day-to-day operation of the Association.

The Chairman with another member of the Board of Directors or Executive Director shall represent the Association, in particular with respect to public authorities and third parties.Representatives of Association are obliged to follow the bylaws, decisions of the General Meeting and the Board of Directors and respective laws. The Chairman shall preside as the Chairman of the General Meeting (the Members’ Meeting) and the meeting of the Board of Directors. The Chairman further manages and supervises the activities of the Association. He may retain necessary personnel to assist him in this function.
In case of imminent damage to the interests of the Association, the Chairman may act independently and on his own responsibility, even in areas that are the authority of the General Meeting or the Board of Directors. Such actions shall be subsequently approved by the respective body of the Association.
Members of the Board of Directors and all employees of the Association, if any, must maintain the secrecy in respect of all materials and information of which they have or will learn when performing their activities and shall not use any of such confidential information for other purposes than discharging their duties. Members of the Board of Directors shall resign to their office if they cease to be active in the pharmaceutical industry or if they terminate their employment with the pharmaceutical company operating in the Slovak Republic or in the event of their joining other employer and remaining active in the pharmaceutical industry.

ARTICLE 19. Composition of the Board of Directors, Nomination of Candidates and Appointment Procedure.
The Board of Directors shall be formed of no more than five members (individual persons). The Members of the Board of Directors perform their activities in office without remuneration. They shall be elected for a period of two years and re-election shall be permitted.
If a member of the Board of Directors resigns to his/her position in the Board of Directors during the term of his/her office, or if he/she ceases to comply with all requirements for the discharge of the office of the member of the Board of Directors, the new Member of the Board of Director will be elected by the following General Meeting and his/her office will last until the following Annual General Meeting when he/she can be re-elected.
No later than 60 days prior to the General Meeting, on which the new members of the Board of Directors will be appointed, the Chairman of the Board of Directors or Executive Director shall invite by e-mail all Members to deliver no later than 10 days prior to the General Meeting to the Chairman of the Board of Directors or the Executive Director by e-mail their nominations of candidates for the Board of Directors member. Each Member may nominate one or more candidates, stating their full name and specifying the Member whom the candidate shall represent. The nomination must be equipped by a written consent of a person nominated as the candidate for the Board of Directors member with his/her authentic signature attached thereto; the written consent can be sent as an electronic document (scan). If the nomination is send by the very candidate or by the statutory representative of the Member employing the candidate from his/her e-mail address, the written consent shall not be required.
The candidate may be discarded from the list only subject to his/her resignation received no later than one day prior the General Meeting, on which the new members of the Board of Directors will be appointed, is to be held sent by the very candidate or the statutory representative of the Member employing the candidate from his/her e-mail address. The candidate may resign to his/her nomination directly at the General Meeting, on which the new members of the Board of Directors will be appointed, only if he/she is personally attending this General Meeting; the statutory or the authorized representative of the Member employing the candidate may submit the resignation on the candidate’s behalf, however, also only if such statutory or authorized representative is personally attending this General Meeting.
Directly at the General Meeting, on which the new members of the Board of Directors will be appointed, the Members may nominate additional candidates for the Board of Directors member. Such nominees, however, can only be the persons personally attending this General Meeting or the persons whose written consent with their nomination, having their authentic signature attached thereto, has been submitted to the General Meeting.
Each of the candidates for the Board of Directors member shall be allowed to personally present his/her appointment speech before the appointment procedure opens not exceeding 2 minutes.
After finishing all appointment speeches, the chairman of the General Meeting shall put each candidate individually to the vote.The voting is secret and shall be made by ballot. After finishing the voting, the chairman of the General Meeting shall acquaint the General Meeting with the results, including the number of votes gained by the respective candidates.
If, in cases of appointment of new members of the Board of Directors, a tie is sustained in two consecutive votings in respect of some of the candidates and it is not possible, for any reason whatsoever, to use the decisive the vote of the Chairman of the Board of Directors, the new member of the Board of Directors shall be selected (consensually) from the candidates who obtained the equal number of votes by already elected members of the Board of Directors. If they will not reach an agreement within thirty minutes from the last voting, the new member of the Board of Directors shall be selected by drawing. The drawing shall be executed after expiration of the aforementioned time period either by the Chairman of the Board of Directors or the Executive Director.

ARTICLE 20. Organization.
Unless provided otherwise in these Statutes, the Board of Directors shall determine its own organization and establish its own order. The Chairman and Vice-Chairman of the first Board of Directors shall be appointed by the Constituting Members’ Meeting and shall remain in office until the first regular General Meeting. The first Directors may be elected.

ARTICLE 21. Committees.
The Board of Directors may establish committees for specific tasks and may elect persons to these committees that are not members of the Board of Directors.

ARTICLE 22. Meetings.
The meetings of the Board of Directors shall be convened by the Chairman of the Board, who is obliged to convene a meeting, if at least 2 members of the Board of Directors request it. To form a quorum, at least 2/3 of all Directors constituting the Board of Directors must be present. In case a quorum is not formed, the Chairman of the Board shall convene a new meeting within a week of the original date. Such second meeting shall constitute a quorum, if over one half of all members are present. All decisions shall be made by simple majority of the Directors present at the Board of Directors meeting. In case of parity votes, the Chairman will have the deciding vote. The Board of Directors must provide minutes of its meetings.

ARTICLE 23. Signatures.
The Association shall be represented by the joint signature of the Chairman and the Vice-Chairman of the Board of Directors or by the joint signature of any of the aforementioned persons and the Executive Director.The Board of Directors may appoint, at its convenience, additional Directors that may be entitled to sign on behalf of the Association, whereby the additional Directors shall be registered in the relevant Association’s Register. The Board of Directors must introduce limitations on representation.

VI.
SECRETARIAT AND OFFICE OF THE ASSOCIATION.

ARTICLE 24. Day-to-Day Operations.
The Board of Directors may provide for the necessary facilities,
infrastructure and organization to safeguard the day-to-day operation of the Association, such as employment of necessary personnel or secretaries.

VII.
AUDITOR.

ARTICLE 25. Auditor.
The General Meeting may appoint an Auditor. The Auditor shall audit the financial statements of the Association upon conclusion of each business year. Upon completion of the audit, the Auditor shall present a written report to the Board of Directors and to the General Meeting.

VIII.
FINAL PROVISIONS.

ARTICLE 26. Winding-up of the Association.
The Association may be wound-up by resolution of an General Meeting, convened for the purpose of rendering a decision on the dissolution and liquidation of the Association, including the appointment of a liquidator. Such resolution requires a 2/3 majority of all members of such General Meeting.
The Association terminates upon its deletion from the Association’s Register held at the respective District Authority.
If the assets of the Association are not transferred to its legal successor, a liquidation of the Association shall take place. A liquidation surplus shall be distributed among the members of the Association, determined by duration of membership in the Association. The liquidation shall be performed in a manner determined by the Commercial Code.

ARTICLE 27. Approvals.
The present Statutes have been duly authorized and approved by the Members’ Meeting of the Association of January 21th, 2010 at Bratislava and on this day the Statutes come into effect.