1.1. The Association is a legal person established in accordance with Act no. 83/1990 Coll., on the association of citizens (hereinafter referred to as „Association Act“).
1.2. The Association is a non-governmental non-profit organization.
1.3. The Association is founded in accordance with the stipulations of s. 6 par. 1 of the Association Act.
Name and Registered Office of the Association
2.1. The Association’s name is ACRO – CZ (hereinafter referred to as „Association“).
2.2. The Association’s registered office is at Prague 1, Týnská 12, postal code 110 00.
The Objective of the Association’s Activities
3.1. The Association’s objective is to associate subjects, who are engaged in clinical research and development in the area of human medicines, on the basis of common professional interests. These subjects are understood mainly as contractual research organizations (hereinafter referred to as „CRO“).
3.2. The Association’s activities are consistent with its objective, specified in par. 3.1., namely:
- representing CRO in conceptual communication and negotiations with state bodies in the given area, as well as institutions issuing special norms and rules directly or indirectly connected to the activities of the CRO;
- strengthening and consolidating the position and possibilities of Association members on the domestic as well as on the international scale;
- actively contributing to discussions during the conception and amendment of legal regulations, rules and norms pertaining mainly to clinical research of human medicines;
- counseling in the area of clinical evaluation of humane medicines;
- determining and preparing CRO code books, including their alterations and amendments; as well as supervision of their observance;
- creating suitable conditions for the education of Association members or their co-workers and, within this context, organizing conferences, schooling and lectures on the problematic of clinical evaluation of humane medicines or related issues;
- supporting the highest standard of research and development of humane pharmaceuticals and publishing information on these facts;
- initiating and supporting cooperation with non-governmental non-profit organizations in the Czech republic and abroad, whose activities are directly or indirectly related to the objectives of the Association;
- initiating and facilitating regular contacts and exchange of information between subjects engaged in activities similar to those of the Association;
- initiating and maintaining stable contacts with state administrative bodies, national and multinational professional organizations in the area of clinical evaluation of humane medicines for the purposes of attaining the objectives of the Association, as well as with namely producers of humane medicines, scientists, medical establishments and physicians;
- actively functioning as a member within the framework of international organizations with the same or similar focus of activity.
Membership in the Association
4.1. Any subject, whose objectives or focus of activities correspond to the objectives of the Association, as specified in article III. hereof, may become a member of the Association. The subject has to prove this fact by submitting the trade license or any other license to activity according to article III., paragraph 3.1. of the Articles of Association.
4.2. Legal persons may become members of the Association.
4.3. A legal person with interest in becoming a member of the Association (hereinafter referred to as “applicant”) expresses his interest by sending a duly completed record card to the address of the Association’s office. The Association is entitled to request additional supplementary information from the applicant pertaining to the requisites for becoming a member.
4.4. Membership begins on the date on which the executive committee adopts a resolution to accept an applicant as a member of the Association.
Cessation of Membership
5.1. Membership in the Association ends:
- When a member secedes from the Association;
- By expulsion of a member of the Association on the basis of a resolution of the executive committee according to the stipulations of par. 5.3. hereof;
- Dissolution of Association.
5.2. In the case given in par. 5.1. letter a) hereof the date of cessation of membership is the date on which the Association receives the pertinent written notification from a member.
5.3. The executive committee may resolve on the expulsion of a member of the Association in case the member:
- no longer fulfils the qualifications for membership according to the Articles;
- breached the Association’s Articles;
- acts in conflict with the objectives of the Association or its strategy;
- did not, although notified in writing and accorded an extra term of payment, pay his membership fee, if a fee is set.
Rights and Obligations of Association Members
6.1. A member of the Association is entitled to:
- take part in members meetings;
- take part in events organized by the Association;
- vote and stand as candidate for the Association’s executive bodies;
- assert his opinions and standpoints in connection with the Association’s objectives;
- present his proposals for changes and amendments to the Articles and other documents of the Association,
- present his proposals for the acceptance or annulment of a member’s membership;
- request information from the Association regarding activities and economic management of the Association.
6.2. A member of the Association is obliged to:
- observe the Articles of the Association, resolutions of members meetings, decisions of the executive committee and expert’s sections;
- pay membership fees, if set, within the term decided on at a members meeting;
- provide the Association’s executive bodies all information necessary for attaining the purposes and objectives as well as performing the activities of the Association;
- enforce and clarify the Association’s standpoints externally, if entitled to act on behalf of the Association;
- fully respect all agreements with third parties.
Executive Bodies of the Association
The Association’s executive bodies are:
- members meeting;
- executive committee;
- chairman and vice chairman of the Association;
- expert’s sections.
8.1. The members meeting is the highest executive body of the Association.
8.2. A members meeting is constituted by all proper members.
8.3. Every member of the Association has one vote. A member of the Association, whose rights and obligations are subject to a vote is not entitled to take part in this vote.
8.4. The members meeting decides on:
- amendments of Articles;
- election of executive committee;
- recalling of executive committee;
- establishment and discontinuation of a expert’s section;
- Association’s membership in other organizations;
- disposal of immovable property;
- disposal of movable property of the Association, whose value exceeds =10 000,- CZK;
- dissolution of the Association and its liquidation.
The members’ meeting approves:
- the framework of expert’s section activities;
- annual Association budget and changes to it;
- annual report of the Association;
- the Association’s strategy.
8.5. A proper members meeting is called by the executive committee, usually two times in a year, but minimally once a year.
8.6. An extraordinary members meeting is called by the executive committee:
- at its own initiative, if it is necessary to ensure the due functioning of the Association or
- on the basis of a written request of at least two thirds (2/3) of all Association members, sent by registered mail to the Association’s office address. In case of such a request the executive committee is obliged to call an extraordinary members meeting to be held at latest within two (2) months after the day of delivery of the request for calling an extraordinary members meeting according to this stipulation.
- On the basis of a written request of the auditing commission in compliance with the article X., paragraph 10.6. of the Articles of Association
8.7. Invitations to a members meeting:
- must be delivered to the members by registered mail to the address given in their record card or
- (b) by e-mail to the e-mail address given in their record card and
- (c) publishing of the invitation on the Association’s web page at latest three (3) weeks before the date of the members meeting.
8.8. The members meeting is in quorum if an absolute majority (more than half) of all members is present. If a duly called members meeting is not in quorum, the executive committee shall call a substitute members meeting, to be held at soonest twenty (20) days after the date of the original members meeting. This substitute members meeting is in quorum regardless of the number of members present.
8.9. For a resolution of the members meeting to be valid at least a simple absolute majority of the present members is necessary. This does not apply in case of resolutions given in point 8.4., letters a), d) and l) hereof, when a three fifths (3/5) majority of all Association members is necessary for a valid resolution.
8.10. The executive committee takes the minutes of the members meeting, which must be delivered to the members of the Association at latest within one (1) month of the date when the members meeting was held:
- by e-mail to the e-mail address given in their record card and
- by publishing the minutes on the Association’s web page.
8.11. Until the first members meeting is called, its authority is exercised by the preparatory committee.
9.1. The executive committee is a collective statutory body of the Association, which represents the Association externally.
9.2. The executive committee generally has seven ( 7) members, minimally three ( 3) members. In case there are an equal number of votes, the decisive vote is that of the Association’s chairman, if he is not present personally or through a representative, the decisive vote is than that of the vice chairman.
9.3. All documents are signed on behalf of the executive committee by the chairman or vice chairman of the Association and one member of the executive committee, who attach their signatures to the printed or written name of the Association.
9.4. The executive committee elects the Association’s chairman and vice chairman from among its members. Every member of the executive committee has one vote. A member of the executive committee, whose rights and obligations are subject to a vote, is not entitled to take part in this vote.
9.5. The electoral term of the executive committee is four (4) years. A member of the executive committee may be re-elected.
9.6. The executive committee is voted by the members meeting. The proposal for the composition of the executive committee is placed by the existing executive committee and members of the association. The existing executive committee will state the proposal in the invitation to the members meeting. The members of the association are obliged to hand in their proposals concerning the composition of the new executive committee or proposals of other candidates of the executive committee to the existing executive committee at latest five (5) working days before the members meeting takes place. Until the new executive committee is voted the previous executive committees executes the duties of the executive committee. The first seven (7) members that receive the highest number of votes during the members meeting vote will become the members of the committee. At the same time they agree to become members of the committee. In case the number of voted members will surpass seven (7) by reason of identity in number of votes by one or more candidates the second (2 nd) or another round of the vote will decide. These rounds concern only the candidates that have not been voted yet and have the same number of votes. In case even the 3 rdround does not decide upon the candidates; the membership in the executive committee will be decided by a ballot. The first executive committee is the preparatory committee.
9.7. The executive committee:
- implements all resolutions of a members meeting;
- decides on all matters, which are not within the exclusive powers of the members meeting;
- calls a members meeting;
- decides on the acceptance of members in the Association or the termination of membership;
- presents proposals for resolution by the members meeting and ensures their implementation;
- elaborates the budget of the Association;
- elaborates the strategy of the Association;
- manages and provides all activities of the Association in periods between members meetings;
- bears responsibility for the Association’s economic management including the keeping of accounts;
- appoints the Association’s liquidator;
- Elaborates projects and grant applications for the purpose of gaining means for the Association’s functioning and its individual activities.
9.8. The executive committee decides by an absolute majority of its members.
9.9. The executive committee meets according to need, but minimally once every six ( 6) weeks.
9.10. The executive committee is called by the chairman of the Association, in his absence the vice chairman of the Association.
10.1. The auditing commission has three (3) members.
10.2. The auditing commission decides upon absolute majority of all its members. The auditing commission meets upon needs; but it has to be at least once in six (6) months.
10.3. The members of the auditing commission are voted by the members meeting; individually – terms of office are four (4) years. The proposal for the composition of he auditing commission can be handed in by the executive committee and members of the association. The executive committee will place the proposal for the composition of the auditing commission in the invitation to the members meeting. The members of the association are obliged to hand in their proposals concerning the composition of the new auditing commission or proposals of individual candidates of the auditing commission to the existing executive committee at latest five (5) working days before the members meeting takes place. Until the new auditing commission is voted the previous auditing commission executes the duties of the auditing commission. The first three (3) members that receive the highest number of votes during the members meeting vote will become the members of the auditing commission. At the same time they agree to become members of the auditing commission. In case the number of voted members will surpass three (3) by reason of identity in number of votes by one or more candidates the second (2 nd) or another round of the vote will decide. These rounds concern only the candidates that have not been voted yet and have the same number of votes. In case even the 3 rdround does not decide upon the candidates; the membership in the auditing commission will be decided by a ballot.
10.4. The auditing commission controls the management of the association. In these questions the auditing commission has the right to require any documents including rendering the meaning concerning the subject of these documents from the executive committee.
10.5. The auditing commission gives regular reports concerning its activities (hereinafter “auditing commission’s reports). These reports are given at latest one (1) month after the meeting of the auditing commission takes place according to the regulation of the paragraph 10.2 of the Articles of Association. The auditing commission’s report must be in the above mentioned one month time limit sent to the executive committee or more precisely to its members and must be further discussed during the following members meeting. The executive committee is obliged to take steps so that the insufficiencies found out by the auditing commission are set right.
10.6. In case that the auditing commission finds out important insufficiencies that endanger the existence of the association or the capability of the association to acquit its financial obligations in the management of the association; the auditing commission is competent to ask the executive committee to call a members meeting. The executive committee is obliged to satisfy this appeal in case that the members meeting should according to the usual terms or the already sent invitation take place later than in two (2) months since the request of the auditing commission concerning the meeting was received.
11.1. The expert’s sections manage the individual professional activities of the Association on the basis of a framework determined by the members meeting.
11.2. The chairman of the expert’s section is appointed by the chairman of the executive committee, in his absence the vice chairman of the executive committee; whereas this appointment is subject to the approval of the absolute majority of the executive committee if this is not the case the chairman/vice chairman has to propose another candidate. The functional term of the chairman of the executive committee is two (2) years, whereat he may be appointed repeatedly.
11.3. The task of the expert’s section is mainly to:
- elaborate expert opinions within the scope of their focus, based on the overall strategy of the Association;
- cooperate with similar organizations and their expert’s sections or their counterparts in the Czech republic and abroad;
- maintain continual contacts with state administrative bodies in the area of their focus;
Economic Management of the Association
12.1. The business year of the Association is the calendar year. The first business year is the period from the date of the Association’s registration by the Czech Ministry of Interior until December 31 st, 2005.
12.2. The Association obtains means for its activities from donations, endowments, grants and membership fees, if membership fees are ordained by the members meeting.
12.3. The Association keeps its accounts in accordance with valid legal regulations. Accounts are kept by the executive committee.
Dissolution of the Association
13.1. The Association is dissolved:
- by a resolution to dissolve passed at the members meeting;
- lawful resolution on its dissolution of a pertinent state administrative body;
- Integration of the Association with another association.
13.2. In case the Association is dissolved with liquidation the eventual liquidation balance, upon defrayment of all liabilities of the Association, is distributed equally among its members.
Prague, March 4 th 2005