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Registry no. 227.019
Collection no. 72.615
DEED OF INCORPORATION

"C.E.R. - ROMAN ETHICS COMMITTEE"

ITALIAN REPUBLIC

The year two thousand seventeen, the day three of the month of April
(April 3, 2017)

in Rome, in my office at Via Giambattista Vico no. 1.
Before me, Doctor Claudio CERINI, Notary in Rome, enrolled in the Roll of the United Notarial Districts of Rome, Velletri and Civitavecchia,

are present

• Ammirati Cinzia, born in Castrovillari, province of Cosenza, on October 18, 1966, domiciled in Rome, Via Tor Di Nona 26, Lawyer, Tax Code: MMR CNZ 66R58 C34Q; founding member
• Danilo Nuccetelli, born in Scurcola Marsicana, on May 19, 1951, domiciled in Rome Via Giovanni Lanza 120, Primary Care Physician, Tax Code: NCC DNL 51E19 I553J; founding member

The appearing parties, Italian citizens, whose personal identity I, Notary, am certain of, with this deed agree and stipulate the following:

ART. 1
It is constituted among Mr./Ms. Ammirati Cinzia, Danilo Nuccetelli, and the Ethics Committee, pursuant to art. 36 of the Civil Code,
named:
"C.E.R. - ROMAN ETHICS COMMITTEE"

ART. 2
The Association has its registered office in Rome, via Fulcieri Paulucci Di Calboli no. 60.

ART. 3
The purpose, rules on administration, and any other regulations regarding the functioning of the Association are set out in the Association’s Statute which, composed of twenty-nine articles, is transcribed below.

ART. 4
The undersigned Mr./Ms. Ammirati Cinzia, Danilo Nuccetelli, in order to provide the Ethics Committee with financial means to start its activity, deposit in the Association’s funds the sum of euros
each; therefore the initial assets of the Association amount to euros
The undersigned delegate to the Board of Directors the determination of the annual membership fee.

ART. 5
The undersigned determine the number of 3 (three) members of the Board of Directors, to serve until revocation, among the following individuals, appointed pursuant to article four of the Statute, to their respective offices:
Ammirati Cinzia President
Danilo Nuccetelli Vice President,
Secretary
to be appointed Councillor/Treasurer

ART. 6
The duration of the Association is set for an unlimited time.

ART. 7
The undersigned state that the first fiscal year closes on December 31, 2017.

ART. 8
The expenses of this deed, related and consequent, are borne by the Ethics Committee.

ART. 9
The rules concerning the functioning of the Ethics Committee are transcribed below:

ART. 9
STATUTE "C.E.R. ROMAN ETHICS COMMITTEE"

ART. 1
The "ROMAN ETHICS COMMITTEE" is established.

ART. 2
The Ethics Committee has its office in Rome, via Fulcieri Paolucci Di Calboli no. 60.

ART. 3
The Ethics Committee is an independent body, responsible for guaranteeing the protection of the welfare of subjects involved in any clinical study, diagnostic methods, non-pharmacological therapies, or observational study, providing public assurance of such protection.
The Ethics Committee operates with reference to the fundamental ethical and deontological principles of the medical profession as well as applying the current legislation in the matter: its opinion is binding for the execution of any clinical study.
The Ethics Committee is composed of members designated based on the evaluation of professionalism, documented knowledge, and experience necessary to assess the ethical, scientific, and methodological aspects of proposed studies as well as to express opinions in other matters within the competence of the Ethics Committee.
Members are appointed by the Board of Directors.
The Ethics Committee must include at least:

• a territorial general practitioner;
• a pediatrician;
• a biostatistician;
• a pharmacologist;
• regarding the study of new technical, diagnostic, and therapeutic procedures: a clinical expert in the field;

The members of the Ethics Committee serve for three years and may not delegate others in their place. The mandate is renewable consecutively only once, for a total of six years.
Members of the Ethics Committee who do not participate in more than 3 consecutive meetings without justification or 50% of the sessions in a year, are declared lapsed by the administrative body that appointed them. Resignation of a member becomes effective upon acceptance with effects on the formation of majorities.

Members of the Ethics Committee, even if employed by the related healthcare structures, are not subject to hierarchical subordination within the scope of their duties.
Members of the Ethics Committee and the staff of the Secretariat Office, as per art. 5, are bound by official secrecy.
The Ethics Committee may consult external experts with experience in specific areas not covered by members.
External experts, if applicable, may also attend meetings without voting rights, with the same obligations as members regarding confidentiality and conflict of interest.
Staff participating in the study may provide the Ethics Committee with information on any aspect of the study but may not participate in decisions, the formulation of opinions, or voting of the Ethics Committee.

ART. 4 – Organization
The appointments of the president and vice president are decided by the majority of members at the first available meeting and are effective for the three-year term of the appointed persons.
The President:

•  coordinates the activity of the Ethics Committee;
• convenes Ethics Committee meetings, setting the agenda;
• in case of urgency, convenes the Ethics Committee with the communication methods provided by art. 6;
• provides appropriate information on initiatives undertaken and ensures dissemination of the proposals and reports of the Ethics Committee;
• represents the Ethics Committee.

The President, in performing their functions, uses, as applicable, the technical-scientific Secretariat of the Ethics Committee.
The Vice President replaces the President in case of absence or impediment.
If, due to justified absence or conflict of interest, neither the President nor the Vice President can preside over a meeting of the Ethics Committee, the members present, after verifying the quorum, appoint a Deputy Vice President to temporarily preside over the work of that session.
Additionally, the Ethics Committee may designate among the members a Liaison Officer for communication with the Technical-Scientific Secretariat Office.

ART. 5 - Technical-Scientific Secretariat Office
The Ethics Committee makes use, in its administrative and technical-scientific functions, of a Secretariat Office that handles applications, prepares meeting minutes, manages convocations, maintains contacts with regulatory bodies, oversees publication of acts, and keeps archives. It ensures connection with national and international databases and the electronic submission of opinions.
The Secretariat staff is bound to confidentiality regarding the content and conduct of work.

ART. 6 - Convening and decisions
The Ethics Committee meets at least monthly, according to a calendar prepared annually, together with the deadlines for submission of opinion requests.
The meeting is valid with the presence of the majority plus one of the members required for that session, determined based on the type of studies on the agenda.
The convocation is sent by email at least 5 days before the meeting date. It is accompanied, normally, by significant material regarding the agenda items.
Ethics Committee meetings are not public and are held at the association’s office. The Ethics Committee expresses its opinion by simple majority of those present. At the request of at least 1/3 of them, voting by secret ballot may be requested. Divergent opinions are, on request, recorded and transcribed in the meeting minutes.
Decisions are motivated and communicated to the requesting parties.
The convocation is accompanied by the relevant documentation and a summary report by a clinical member of the Ethics Committee or the Technical-Scientific Secretariat.
The President and members express their opinion by email within 48 hours of convocation.

Art. 7 – Investigative Activities of the Ethics Committee
Within the Ethics Committee, operational meetings, working subgroups, or commissions can be organized to explore specific topics in preparation for their discussion in a plenary session. The Ethics Committee, for the purpose of streamlining its activities, may also appoint, within its own structure and within the Technical-Scientific Secretariat, a variable number of members to handle requests for opinions and to prepare reports on them for plenary sessions.

Art. 8 – Criteria for Evaluating Clinical Studies and Opinions
When formulating decisions on requests for opinions, the Ethics Committee adheres to the regulations governing the conduct of studies.
The Ethics Committee may issue the following opinions:

• Suspension of the decision
• Favorable opinion subject to conditions (minor modifications/integrations, receipt of the single opinion from the Ethics Committee of the coordinating center, changes to the informed consent form and patient information sheet, insurance renewals)
• Unfavorable opinion
• Favorable opinion

In the case of a suspension of the decision, the Ethics Committee Secretariat sends the relevant request for clarifications/integrations to the sponsor and the responsible investigator via email. Upon receipt of the requested information, the Ethics Committee expresses its opinion during a collegial meeting.

In the case of a favorable opinion subject to conditions, the Ethics Committee Secretariat sends the relevant request for modifications/integrations to the sponsor and the responsible investigator via email, except when the favorable opinion is conditioned only on the receipt of the single opinion from the Ethics Committee of the coordinating center.

Upon receipt of the requested information, the Technical-Scientific Secretariat (with, if necessary, the collaboration of the competent member) verifies compliance with the conditions required by the Ethics Committee in formulating the opinion and/or analyzes the single opinion from the coordinating center’s Ethics Committee and, if appropriate, resolves any reservations and confirms the favorable opinion previously expressed. For subsequent actions, reference is made to the "favorable opinion" section.

The Technical-Scientific Secretariat (if the requests of the Ethics Committee have not been fulfilled or if new information emerges that could affect the previously expressed opinion, or new elements arise from the single opinion of the coordinating center’s Ethics Committee) may refer the final opinion back to the Ethics Committee during a collegial meeting.

In the case of an unfavorable opinion, the Ethics Committee Secretariat sends the relevant motivated opinion to the responsible clinician. The opinion is also transmitted to the Legal Representative of the healthcare facility involved.

In the case of a favorable opinion, the Ethics Committee Secretariat sends the opinion to the sponsor, the responsible investigator, and the Legal Representative of the healthcare facility involved for study authorization.

For communications, updates, or non-substantial amendments for which current regulations only require notification, the Ethics Committee does not issue any formal acknowledgment. In accordance with D.M. 21/12/07, the documentation is recorded and filed by the Secretariat.

By delegation of the Chair, the opinions of the Ethics Committee may be signed by the Vice-Chair and the Secretariat.

Art. 9 – Procedures for Requesting an Opinion from the Ethics Committee
Requests for opinions must be submitted to the Secretariat Office of the Ethics Committee. They must be received by the dates indicated in the meeting calendar. The documentation to be presented, depending on the type of research, as well as the forms to be used, are listed in the specific operational instructions.
The requested documentation must be submitted in a single package, except for the Single Opinion issued by another Ethics Committee, which must be transmitted as soon as available and, in any case, before the Ethics Committee meeting.
In the event of an excess of requests, the order of completion of the documentation will be respected. Priority will also be given to studies whose opinions were previously suspended.

Art. 10 – Transparency and Final Provisions
This regulation, as well as the operational procedures adopted by the Ethics Committee, will be publicly available, along with the list of names and qualifications of the appointed members, through a dedicated section on the website.

ART. 11
The assets consist of:

• movable and immovable property, which will become the property of the Ethics Committee;
• any reserve funds established from budget surpluses;
• any grants, donations, contributions, or bequests.

The income of the Ethics Committee consists of:

• initial and annual membership fees;
• funding from public and private entities;
• income from training activities and the organization of events of any kind, the proceeds of which will partly contribute to the Committee’s income and partly cover, according to the applicable rates, reimbursements;
• expenses for members with appropriate qualifications or for members of the Board of Directors tasked with designing and implementing the activities provided for by these statutes;
• reimbursements;
• any other revenue contributing to the growth of the Committee’s assets.

The Board of Directors annually establishes the minimum payment to be made at the time of joining the Ethics Committee for those intending to become members, as well as the annual membership fee.
Payments to the Ethics Committee’s Fund are, in any case, non-refundable, non-reappraisable, and non-recoverable under any circumstance. Therefore, in the event of the dissolution of the Ethics Committee, death, extinction, withdrawal, or exclusion from the Ethics Committee, no reimbursement of contributions can be claimed.

ART. 12
All natural and legal persons, entities, and associations of proven integrity and morality who are interested in the institutional purposes, share the objectives of the Ethics Committee, and commit to achieving them may become members of the Ethics Committee.
The initial membership fee for each ordinary member and the annual fee will be determined by the Board of Directors.
Membership in the Ethics Committee is indefinite and cannot be limited to a specific period, without prejudice to the right of withdrawal. For memberships following the founding act, the President must maintain a dedicated Register in which to record the active members of the Ethics Committee. Notarial extracts from this Register shall serve as full proof of the status of the members listed therein.

ART. 13
Within the Ethics Committee, members are classified as founding members, honorary members, ordinary members, and meritorious members.

• Founding members are those who participated in the constitutive meeting of the Ethics Committee.
• Ordinary, honorary, and meritorious members acquire membership status in the Ethics Committee upon submitting an application for admission to the Board of Directors. Once the eligibility requirements are verified, they join the Ethics Committee and commit to paying an annual membership fee, which is non-transferable and non-refundable.

Specifically:

• Honorary members pay an annual membership fee, which is non-transferable and non-refundable, have no voting rights, and cannot be elected to office.
• Ordinary members pay an annual membership fee, which is non-transferable and non-refundable, have voting rights, and can be elected to office.
• Meritorious members acquire their status by contributing an amount equal to at least three times the annual fee established by the Board of Directors for the current year, on the occasion of voluntary extraordinary contributions potentially approved by the Assembly. They have no voting rights and cannot be elected to office.

ART. 14
Membership may be lost due to death, resignation, or a bankruptcy ruling, as well as due to delinquency, unworthiness, or exclusion. Delinquency, defined as non-payment of fees or other amounts owed to the Ethics Committee for more than one year, will be declared by the Board of Directors. Unworthiness will be determined by the Assembly of members if a member engages in conduct that is not in accordance with the statutes.

ART. 15
The organs of the Ethics Committee are:

• the General Assembly of members;
•  the Board of Directors;
• the President;
• the Secretary/Treasurer.

ART. 16
The Ethics Committee has its sovereign body in the General Assembly.
It may be ordinary or extraordinary.
Founding and ordinary members who are up to date with their membership fees have the right to attend the Assembly and to vote.
Each member may represent another member if properly authorized by a written proxy.

The Assembly deliberates on the preliminary and final budgets, the general guidelines and directives of the Ethics Committee, the appointment of the Board members, any temporary interest-free advances requested from members if necessary, amendments to the articles of association and statutes, and any other matters assigned by law or statute.

The Assembly also approves any regulations governing the activities of the Ethics Committee, decides on its dissolution and liquidation, and on the allocation of its assets.

• The ordinary Assembly is valid in first call when at least half of the non-delinquent members are present directly or by proxy; in second call, it is valid regardless of the number of non-delinquent members present.
• The extraordinary Assembly is valid in first call with the presence, directly or by proxy, of two-thirds of non-delinquent members; in second call, it is valid with the presence of the majority of non-delinquent members.

In both ordinary and extraordinary Assemblies, resolutions are valid with a majority of members present.

ART. 17
Members are convened to the ordinary Assembly by the Board at least once a year by December 31, through written notice sent to each member and posting on the Ethics Committee’s notice board, or by email, at least 5 days before the scheduled meeting.
The Assembly must also be convened upon a motivated request signed by at least one-tenth of the members.
The Assembly must take place in Rome, even outside the official headquarters.
The Assembly is chaired by the President of the Board; in their absence, by the Vice President; if both are absent, the Assembly elects its own President.
The President of the Assembly appoints a Secretary, and if necessary, two tellers.
The President of the Assembly verifies the validity of proxies and the right of members to participate.
Minutes of the Assembly are drawn up and signed by the President and Secretary, and, if applicable, the tellers.

ART. 18
The Association is managed by a Board of Directors composed of a minimum of two and a maximum of three members elected unanimously by the Assembly, who remain in office until revoked or resigned.
In the event of resignation or death of a Board member, the Board shall appoint a replacement at its next meeting, subject to confirmation at the next annual Assembly.

ART. 19
The Board of Directors is vested with full powers for the ordinary and extraordinary management of the Ethics Committee. It may request extraordinary contributions, temporary interest-free financing, or co-participation of third parties in the Committee’s projects. The Board may also, as necessary, appoint employees or consultants and determine their remuneration, which must be ratified by the Assembly, in compliance with applicable law.

The Board’s functions also include:

• managing the Ethics Committee in all aspects according to the directives of the Assembly;
• appointing the Secretary from among the elected Board members;
• admitting new members to the Ethics Committee;
• preparing the annual preliminary and final budgets;
• publishing and disseminating programs and regulations of events;
• proposing amendments to the Statutes.

ART. 20
The President of the Ethics Committee holds the legal signature and representation of the Committee, and in their absence, the Vice President.
The President is responsible for the ordinary administration of the Committee according to the directives of the Assembly and Board.

ART. 21
The Board elects from among its members a President and Vice President if these positions have not been filled by the Assembly.
No remuneration is due to Board members.

ART. 22
The Board meets whenever the President deems necessary or when requested by a member, and at least once a year to approve the preliminary and final budgets and determine the membership fee.
For resolutions to be valid, a majority of Board members must be present, and a majority of those present must vote in favor; in the event of a tie, the President’s vote prevails.
The Board is chaired by the President, or in their absence, by the Vice President.
Minutes of Board meetings are recorded in a dedicated book and signed by the President and Secretary.

ART. 23
The Board has the broadest powers for ordinary and extraordinary management of the Ethics Committee, without limitation.
It also prepares the preliminary and final budgets for submission to the Assembly, appoints employees and staff, determines their remuneration, and drafts the internal regulations governing the Committee’s functioning, which are binding for all members.

ART. 24
The President, or in their absence the Vice President, legally represents the Ethics Committee towards third parties and in court, ensures the execution of Assembly and Board resolutions, and in urgent cases may exercise the powers of the Board, subject to ratification at the next meeting.

ART. 25
The Treasurer manages the Committee’s finances, keeps the accounts up to date according to the Board’s instructions and applicable regulations, safeguards accounting books, collects payments and makes disbursements, prepares preliminary and final budgets for the Assembly’s approval, and prepares the annual financial statement for the Board’s approval.
The Treasurer is granted legal representation for all activities related to these duties and participates in Board meetings and the Assembly.

ART. 26
The dissolution of the Ethics Committee is resolved by the Assembly in accordance with the last paragraph of Article 21 of the Civil Code, which shall appoint one or more liquidators and decide on the allocation of the Committee’s assets.

ART. 27
Any disputes between members, or between members and the Ethics Committee or its bodies, will, wherever not prohibited by law and excluding any other jurisdiction, be submitted to a panel of three Arbitrators appointed by the Assembly. They shall judge ex bono et aequo without formal procedures. Their award shall be final and unappealable.

ART. 28
Specific rules regarding the functioning and implementation of this statute may be established by internal regulations drafted by the President and approved by the Assembly.

ART. 29
For matters not expressly provided for in this statute, reference shall be made to the applicable laws.
As requested by the Notary, I drafted this act, read it to the appearing parties, and all, having been questioned by me, declare it conforms to their will and sign it in the margin and at the bottom with me, the Notary.