Delibera del Direttore Generale n. 590 del 22-11-2023

AZIENDA OSPEDALIERO UNIVERSITARIA XXXXX

Delibera del Direttore Generale n. 590 del 22-11-2023

Proposta n. 1070 del 2023

Oggetto: ACCORDO DI RISERVATEZZA CON BRISTOL-XXXXX SQUIBB COMPANY PRELIMINARE A POSSIBILE FUTURO STUDIO CLINICO – APPROVAZIONE SCHEMA DI ACCORDO

Dirigente: XXXXXXXX XXXXXXXX

Struttura Dirigente: RESP. XXXXX CHILDREN'S RESEARCH INSTITUTE

Delibera del Direttore Generale n. 590 firmata digitalmente il 22-11-2023

AZIENDA OSPEDALIERA UNIVERSITARIA XXXXX I.R.C.C.S.

Istituto di Ricovero e Cura a Carattere Scientifico Xxxxx Xxxxxxxxxx, 00 - 00000 XXXXXXX

C.F. P.Iva 02175680483

DELIBERAZIONE DEL DIRETTORE GENERALE

Oggetto	Sperimentazione clinica
Contenuto	ACCORDO DI RISERVATEZZA CON BRISTOL-XXXXX SQUIBB COMPANY PRELIMINARE A POSSIBILE FUTURO STUDIO CLINICO – APPROVAZIONE SCHEMA DI ACCORDO

Area Tecnico Xxx.xx	AREA TECNICO AMMINISTRATIVA
Coord. Area Tecnico Xxx.xx	XXXX XXXXX
Struttura	MEYER CHILDREN’S RESEARCH INSTITUTE
Direttore della Xxxxxxxxx	XXXXXXXX XXXXXXXX
Responsabile del procedimento	XXXXXXXX XXXXXXX
Immediatamente Esecutiva	SI

Spesa prevista Conto Economico Codice Conto Anno Bilancio

Estremi relativi ai principali documenti contenuti nel fascicolo
Allegato	N° di pag.	Oggetto
1	6	Confidentiality Agreement

“documento firmato digitalmente”

Richiamati:

IL DIRETTORE GENERALE

Dr. Xxxxx Xxxxxxx Xxxxxxxx (D.P.G.R.T. n. 149 del 28 agosto 2023)

- il Decreto Legislativo n. 502 del 30.12.1992 e successive modifiche ed integrazioni, recante “Riordino della disciplina in materia sanitaria, a norma dell’art.1 della legge 23 ottobre 1992, n. 421”;

- il Decreto Legge n. 75 del 22 .06.2023, così come modificato dalla Legge n. 112 del 10.08.2023, recante “Disposizioni urgenti in materia di organizzazione delle pubbliche amministrazioni, di agricoltura, di sport, di lavoro e per l’organizzazione del Giubileo della Chiesa cattolica per l’anno 2025” ed in particolare l’art. 8-bis, contenente “Disposizioni in materia di dirigenza sanitaria, amministrativa, professionale e tecnica del Servizio sanitario nazionale”;

- la Legge Regionale Toscana n. 40 del 24.02.2005 e successive modifiche ed integrazioni, di “Disciplina del Servizio Sanitario Regionale”;

- la Legge Regionale Toscana n. 12 del 16.03.2023 e successive modifiche ed integrazioni “Disposizioni in materia di istituti di ricovero e cura a carattere scientifico pubblici. Modifiche alla l.r. 40/2005” con la quale si è proceduto alla disciplina degli istituti di ricovero e cura a carattere scientifico di diritto pubblico ed in particolare l’art. 13 con il quale sono state dettate le “Disposizioni transitorie per il passaggio da Azienda Ospedaliero Universitaria Xxxxx ad Azienda Ospedaliera Universitaria Xxxxx IRCCS…”;

Visto il Decreto del Presidente della Giunta Regionale n. 149 del 28.08.2023 con il quale il Dr. Xxxxx Xxxxxxx Xxxxxxxx è stato nominato Direttore Generale dell’Azienda Ospedaliera Universitaria Xxxxx IRCCS;

Dato atto che:

- con deliberazione del Direttore Generale n. 54 del 01.02.2021 è stato approvato il nuovo Atto Aziendale dell’A.O.U. Xxxxx, ai sensi dell’art. 6 del Protocollo d’intesa del 22.04.2002 fra Regione Toscana e Università degli Studi di Firenze, Siena e Pisa, con decorrenza dal 01.02.2021;

- con deliberazione del Direttore Generale n. 55 del 01.02.2021 sono stati assunti i primi provvedimenti attuativi in relazione alla conferma/riassetto delle strutture complesse e semplici dotate di autonomia ed al conferimento dei relativi incarichi di direzione;

- con deliberazione del Direttore Generale n. 56 del 01.02.2021 sono state assunte determinazioni attuative del nuovo Atto aziendale in relazione alla conferma/riassetto delle strutture Dipartimentali e/o a valenza dipartimentale, delle Aree Funzionali Omogenee, dell’Area Servizi dell’Ospedale, dell’Area dei Diritti del Bambino, dell’Area Tecnico Amministrativa ed al conferimento di relativi incarichi di direzione;

- con successiva deliberazione del Direttore Generale n. 92 del 15.02.2021 si è provveduto ad assumere ulteriori disposizioni attuative relative all’organizzazione dell’A.O.U. Xxxxx in ordine alle Strutture semplici Intrasoc, Unità Professionali, Uffici e Incarichi professionali;

- con deliberazione del Direttore Generale n. 443 del 23.09.2022 l’A.O.U. Xxxxx ha disposto la presa d'atto del Decreto del Ministero della Salute del 02.08.2022, pubblicato nella Gazzetta Ufficiale n. 200 del 27.08.2022, con cui l’Azienda Ospedaliero Universitaria Xxxxx è

stata riconosciuta Istituto di Ricovero e Cura a Carattere Scientifico (I.R.C.C.S.), per la disciplina di pediatria;

Su proposta del Responsabile del Meyer Children’s Research Institute, Dr.ssa Xxxxxxxx XxXxxxxx, la quale, con riferimento alla presente procedura, ne attesta la regolarità amministrativa e la legittimità dell’atto;

Ricordato che questa Azienda, tra le proprie finalità istituzionali, promuove la ricerca scientifica con lo scopo di raggiungere risultati di eccellenza nella cura in campo pediatrico e che taluni progetti di ricerca, prima del loro avvio, necessitano di una fase preliminare atta ad esplorarne la fattibilità presso le proprie strutture;

Considerato che la società farmaceutica Bristol-Xxxxx Squibb Company ha manifestato il proprio interesse a condurre una sperimentazione clinica nel campo delle malattie cardiologiche che vede coinvolto il Xxxx. Xxxxxx Xxxxxxxx in qualità di sperimentatore;

Evidenziato che è nell’interesse dell’AOU Xxxxx IRCCS esplorare la possibilità di condurre la su citata sperimentazione e garantire la valorizzazione della ricerca in pediatria;

Stabilito, pertanto, che è nelle intenzioni di questa Azienda scambiare con la suddetta società, attraverso apposito Accordo di riservatezza, talune informazioni riservate necessarie per esaminare l’opportunità e la realizzabilità di uno studio clinico;

Verificato che dall’Accordo di cui sopra non derivano oneri economici per l’AOU Xxxxx IRCCS;

Ritenuto pertanto di stipulare l’Accordo di riservatezza con Bristol-Xxxxx Squibb Company per la disciplina delle condizioni normative ed operative per la tutela delle informazioni confidenziali scambiate tra le parti dell’Accordo;

Rilevata l’opportunità di dichiarare il presente atto immediatamente eseguibile per consentire che le informazioni confidenziali siano oggetto di reciproco scambio in tempi congrui con le esigenze di confronto, nel breve periodo, sulla fattibilità di uno studio clinico da eseguire nelle strutture dell’AOU Xxxxx IRCSS;

Considerato che il Responsabile del Procedimento, individuato ai sensi della Legge n. 241/1990 nella persona del Dr. Xxxxxxx Xxxxxxxx, sottoscrivendo l’atto attesta che lo stesso, a seguito dell’istruttoria effettuata, nella forma e nella sostanza è legittimo;

Acquisito il parere del Dr.ssa Xxxxx Xxxx, Coordinatore dell’Area Tecnico Amministrativa, espresso mediante sottoscrizione del presente atto;

Vista la sottoscrizione del Direttore Sanitario e del Direttore Amministrativo, per quanto di competenza, ai sensi dell’art. 3 del Decreto Legislativo n. 229/99;

DELIBERA

Per quanto esposto in narrativa che espressamente si richiama,

1) Di approvare lo schema di Accordo di riservatezza da stipulare con Bristol-Xxxxx Squibb Company che, allegato N. 1 al presente atto, ne forma parte integrante e sostanziale.

2) Di dare atto che dall’Accordo di cui sopra non derivano oneri economici a carico dell’AOU Xxxxx IRCCS.

3) Di dichiarare il presente atto immediatamente eseguibile ai sensi dell’art. 42, comma 4 della L.R.

T. n. 40/2005 in considerazione della necessità di procedere in tempi brevi alla sottoscrizione del su citato Accordo e consentire così nell’immediato la discussione reciproca tra le parti relativamente alla fattibilità di uno studio clinico da eseguirsi presso l’AOU Xxxxx IRCCS.

4) Di trasmettere il presente atto al Collegio Sindacale ai sensi dell’art. 42, comma 2, della L.R.T. n. 40/2005 contemporaneamente all’inoltro all’albo di pubblicità degli atti di questa A.O.U. Xxxxx I.R.C.C.S.

IL DIRETTORE GENERALE
(Dr. Xxxxx Xxxxxxx Xxxxxxxx)
IL DIRETTORE SANITARIO	IL DIRETTORE AMMINISTRATIVO
(Dr. Xxxxxxxx Xxxx)	(Dr. Xxxxxxx Xxxxxxx)

CONFIDENTIALITY AGREEMENT

Basic Information About This Agreement
Effective Date:	Last date of below signature
BMS:	Bristol-Xxxxx Squibb Company Xx. 000 & Xxxxxxxx Xxxx Xxxx Xxxxxxxxx, XX 00000 XXX
INSTITUTION:	Xxxxx Children’s Hospital IRCCS Xxxxx Xxxxxxx Xxxxxxxxxx 00, 00000 Xxxxxxx, Xxxxx
PRINCIPAL INVESTIGATOR	Xxxx. Xxxxxx Xxxxxxxx
Permitted Purpose:	Mutual consideration of INSTITUTION’s and Prinicpal Investigator’s participation in the following clinical study/ies (either interventional or non-interventional): CV027-010
Expiration Date:	The two-year anniversary of the Effective Date
Confidentiality Obligation Period:	Until the Expiration Date and for a period of ten (10) years thereafter
CRO:	Fortrea Development Ltd Xxx Xxxxxxx Xxxxxxxxxx 00 Xxxxxx (XX) CAP 20146

This Confidentiality Agreement (this “Agreement”) is entered into on the Effective Date by and between BMS and INSTITUTION and, for acceptance and acknowledgement, by PRINCIPAL INVESTIGATOR.

PRELIMINARY STATEMENTS

A. CRO has been engaged by BMS in connection with Protocol # CV027-010. XXX is acting as an independent contractor on behalf of BMS.

B. Each of BMS and INSTITUTION and PRINCIPAL INVESTIGATOR owns or controls information that they consider confidential and proprietary, defined below as Confidential Information.

C. BMS desires to disclose certain of its Confidential Information to INSTITUTION and PRINCIPAL INVESTIGATOR solely for the Permitted Purpose indicated above.

D. CRO is authorized to disclose BMS’ Confidential Information to INSTITUTION and PRINCIPAL INVESTIGATOR on BMS’ behalf.

E. INSTITUTION and PRINCIPAL INVESTIGATOR desires to disclose certain of its Confidential Information to BMS solely for the Permitted Purpose indicated above.

F. CRO is authorized to receive INSTITUTION and PRINCIPAL INVESTIGATOR’s Confidential Information on BMS’ behalf and is bound by confidentiality obligations at least as restrictive as those within this Agreement.

The parties agree as follows:

1 Definitions

1.1 "Affiliate(s)" means a business entity which directly or indirectly Controls, is under the Control of or under common Control with the party.

1.2 "Control" means the possession, directly or indirectly, of the power to direct or cause the direction of the management of such business entity, whether through ownership of voting securities or otherwise.

1.3 "Disclosing Party" means the party disclosing Confidential Information, directly or indirectly through its Affiliates or designee(s), to the Receiving Party under this Agreement.

1.4 "Receiving Party" means the party receiving Confidential Information, directly or indirectly through its Affiliates or designee(s), from the Disclosing Party under this Agreement.

1.5 “Confidential Information" means information that is owned or controlled by the Disclosing Party or its Affiliate(s) and is directly or indirectly disclosed or otherwise made available hereunder by or on behalf of the Disclosing Party or its Affiliates (including by their designee(s)) . Confidential Information includes, without limitation, investigator brochure(s), protocol(s), newsletter(s), clinical and preclinical data, and business plans.

Confidential Information does not include information to the extent that:

1.5 (a) it is now in the public domain or subsequently enters the public domain through no breach of this Agreement;

1.5 (b) the Receiving Party lawfully receives it from any third party without restriction as to use or confidentiality as shown by written or other tangible evidence;

1.5 (c) it is independently developed by or for the Receiving Party by persons without access to the Confidential Information; or

1.5 (d) it was already known by the Receiving Party at the time of its disclosure under this Agreement as shown by written or other tangible evidence.

2 Use of Confidential Information. Receiving Party shall use Confidential Information solely for the Permitted Purpose. Receiving Party will hold the Disclosing Party’s Confidential Information in strict confidence, will not use the Confidential Information, in whole or in part, for any purpose other than the Permitted Purpose without first entering into an agreement with Disclosing Party covering the use thereof, and will not use, provide or disclose the Confidential Information to any other person or entity other than Receiving

Party’s employees or agents who need to know same in connection with the Permitted Purpose. Receiving Party shall be responsible for any actions of such employees or agents which are not in accordance with the terms of this Agreement. Receiving Party’s right to use Confidential Information shall terminate upon the completion of the Permitted Purpose. Receiving Party will use best efforts to safeguard such Confidential Information, and will take appropriate steps to ensure that its employees and agents understand the confidential nature of the Confidential Information and are bound to Receiving Party to a like obligation of confidentiality.

3 Required Disclosures. If Receiving Party receives a subpoena or other validly issued administrative or judicial process or order from a governmental authority demanding Confidential Information (“Order”), Receiving Party will (a) promptly inform the party or entity issuing such Order or other government process of the existence of this Agreement;

(b) unless prohibited by law, promptly notify the Disclosing Party of the disclosure requirement (which will include a copy of any applicable Order); (c) unless prohibited by law, afford the Disclosing Party a reasonable opportunity to oppose, limit or secure confidential treatment for the required disclosure; and (d) not oppose any effort by the Disclosing Party to quash any such Order. If the Disclosing Party fails to intervene after being given notice and a reasonable opportunity to do so, or if such motion is denied by a court of competent jurisdiction or an order from a governmental authority, the Receiving Party will disclose only that portion of the Confidential Information that the Receiving Party is legally required to disclose. In the event that any Confidential Information is ordered to be produced in an action or proceeding, it will not lose its confidential status through such use, and Receiving Party will take all reasonable and necessary steps, unless prohibited by law, to protect its confidentiality.

4 Permitted Disclosures. Receiving Party agrees that it will not disclose Confidential Information to any third party without prior written consent of Disclosing Party. Notwithstanding the foregoing, Receiving Party may disclose Confidential Information to an agent or third party performing services to the Receiving Party to the extent that (a) such disclosure is related to the Permitted Purpose; (b) the agent’s or third party’s duties justify the need to know the Confidential Information; and (c) provided that such agent or third party is under obligations of confidentiality and non-use at least as restrictive as those within this Agreement.

BMS may disclose the Confidential Information of INSTITUTION and PRINCIPAL INVESTIGATOR to any entity with which BMS co-develops, co-promotes or otherwise collaborates on certain unapproved or approved (by regulatory authorities) pharmaceutical and/or biological products (a “Collaboration Partner”), but only to the extent (i) such disclosure is directly related to the Permitted Purpose; and (ii) the Collaboration Partner needs to know such Confidential Information for the Permitted Purpose; and (iii) the Collaboration Partner is under obligations of confidentiality and non- use at least as restrictive as those within this Agreement.

Receiving Party will be liable for unauthorized use and/or disclosure of Confidential Information by it, its Affiliates and its/their officers, employees, agents and Collaboration Partner(s).

5 Return of Confidential Information. Upon the termination or expiration of this Agreement, or at any other time upon the written request of Disclosing Party, Receiving Party will promptly return to Disclosing Party all Confidential Information in Receiving Party’s possession or control, together with all copies, summaries and analyses, regardless of the format in which the information exists or is stored. At the Disclosing Party’s request, the Receiving Party will promptly destroy all such information instead of returning it. In case of destruction, Receiving Party will promptly send a written certification that destruction has been accomplished to the Disclosing Party. However, Receiving Party is entitled to retain one copy of Confidential Information for the sole purpose of determining its obligations under this Agreement. With regard to Confidential Information stored electronically on backup tapes, servers or other electronic media, the parties agree to make reasonable efforts to destroy such Confidential Information without undue expense or business interruption; however, Confidential Information so stored is subject to the obligations of confidentiality and non-use contained in this Agreement for as long as it is stored.

6 Term and Duration of Confidentiality. This Agreement is effective as of the Effective Date and expires on the Expiration Date (as defined above). The obligations of confidentiality survive expiration or earlier termination of this Agreement for the duration of the Confidentiality Obligation Period (as defined above).

7 Rights to Confidential Information. Nothing in this Agreement is intended to grant or create any right or license to the Receiving Party or its Affiliates with respect to any patent rights, copyrights, trademarks or other intellectual property rights owned or controlled by the Disclosing Party or its Affiliates, except as necessary for the Permitted Purpose.

8 Future Agreements. Nothing in this Agreement is intended to be construed as a commitment by either party or their respective Affiliates to enter into any additional agreement(s) or from preventing either party from entering into similar discussions with any third party.

9 Assignment of Agreement. This Agreement may not be assigned in whole or in part by either party without prior written consent of the other party, which consent will not be unreasonably withheld or delayed. Any assignment by either party without such consent shall be null and void and of no force or effect.

10 Governing Law . This Agreement and any claim, controversy or dispute arising under or related to this Agreement, the relationship of the parties, or the enforcement of the rights and obligations of the parties will be governed by the laws of Italy and shall be construed and governed under and in accordance with the laws of Italy without regard to the provisions governing conflict of laws.

11 Entire Agreement, Severability. Each party agrees that this Agreement embodies the entire agreement of the parties and supersedes all prior agreements and understandings relating to its subject matter. In the event that the parties mutually decide to pursue the clinical study/ies contemplated by the Permitted Purpose and execute a definitive agreement relating to the same (“Definitive Agreement”), the terms and conditions of such Definitive Agreement shall supersede the terms and conditions of this Agreement. This Agreement is intended to be severable, and the invalidity and/or unenforceability of any

clause of this Agreement, or part thereof, shall not affect the validity and or enforceability of any other clause or part thereof to the extent not invalidated or held unenforceable.

12 Signatures; Counterparts. The parties are agreeing that they may use electronic signatures, and by doing so agree to being subject to the relevant provisions of applicable laws.This Agreement may be signed in counterparts, each of which shall be deemed to be an original, and all such counterparts shall together constitute one and the same Agreement.

[SIGNATURES ON NEXT PAGE]

In order to demonstrate their agreement, the parties have caused this Confidentiality Agreement to be executed by their duly authorized representatives as of the Effective Date.

Bristol-Xxxxx Squibb Company	Xxxxx Children’s Hospital IRCCS
By:	By:
Name:	Name: Xxxxx Xxxxxxx Xxxxxxxx
Title:	Title: CEO
Date:	Date:

For acceptance and acknowledgement

The Principal Investigator

Xxxx. Xxxxxx Xxxxxxxx Date: