Delibera del Direttore Generale n. 690 del 21-12-2023
AZIENDA OSPEDALIERO UNIVERSITARIA XXXXX
Delibera del Direttore Generale n. 690 del 21-12-2023
Proposta n. 1227 del 2023
Oggetto: ACCORDO DI RISERVATEZZA CON ENTERPRISE THERAPEUTICS LTD PRELIMINARE A POSSIBILI FUTURI STUDI CLINICI – APPROVAZIONE SCHEMA DI ACCORDO
Dirigente: XXXXXXXX XXXXXXXX
Struttura Dirigente: RESP. MEYER CHILDREN'S RESEARCH INSTITUTE
Delibera del Direttore Generale n. 690 firmata digitalmente il 21-12-2023
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 ENTERPRISE THERAPEUTICS LTD PRELIMINARE A POSSIBILI FUTURI STUDI CLINICI – 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 | Mutual Secrecy 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 Xxxxx 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 Enterprise Therapeutics Ltd, con sede in Inghilterra, ha manifestato il proprio interesse a condurre sperimentazioni cliniche nel campo della fibrosi cistica che vedono coinvolto il Dr. Xxxxxxxx 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 possibili futuri studi clinici;
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 Enterprise Therapeutics Ltd 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 studi clinici 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 Enterprise Therapeutics Ltd 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) |
THIS AGREEMENT is made as of the last date of signature hereto (“Effective Date”)
BETWEEN:
A. ENTERPRISE THERAPEUTICS LTD a company registered in England, with Registration Number 09022750 and having its registered office at Sussex Innovation Centre, University of Sussex, Science Xxxx Xxxxxx, Xxxxxx, Xxxxxxxx XX0 0XX (“ENTERPRISE”); and
X. XXXXX CHILDREN’S HOSPITAL IRCCS, a public hospital of the Italian health service registered in Italy, with VAT/tax code 02175680483, and having its registered office at Xxxxx Xxxxxxx Xxxxxxxxxx 00, 00000 Xxxxxxx, Xxxxx (“INSTITUTION”)
WHEREAS:
ENTERPRISE possesses valuable proprietary information, know-how, experience and expertise, which it believes to be confidential relating development of new treatments for respiratory diseases (“ENTERPRISE Expertise”); and,
INSTITUTION possesses valuable proprietary information, know-how, experience and expertise, which it believes to be confidential relating to clinical trials in people with Cystic Fibrosis (“INSTITUTION EXPERTISE”); and,
Dr Xxxxxxxx Xxxxxxxx, head of the Cystic Fibrosis Dept. at the INSTITUTION, is the person responsible for receiving the confidential and proprietary information disclosed by ENTERPRISE;
ENTERPRISE and INSTITUTION wish to enter into discussions for the purpose of feasibility and execution of clinical trials in people with CF (“Purpose”). In order to facilitate those discussions and the Purpose, each Party is willing to disclose its respective Confidential Information (as defined hereunder), know-how, experience and expertise to the other Party on the terms and conditions set out in this Agreement.
NOW IT IS HEREBY AGREED as follows:
1. In this Agreement "Confidential Information" means all know-how, technical information, data, analyses, compilations, studies, structures, formulae, processes, designs, specifications, plans, prototypes, models, drawings, computer software, visual demonstrations, and samples, and any other materials bearing or incorporating any information relating to the ENTERPRISE Expertise or the INSTITUTION Expertise in whatever form, supplied to one party (the "Receiving Party") by or on behalf of the other party (the "Disclosing Party") or in relation to the operations or business of the Disclosing Party or any part thereof or any other matter of a valuable and confidential nature supplied to the Receiving Party.
2. In consideration of the disclosure to the Receiving Party of the Confidential Information the Receiving Party hereby undertakes to the Disclosing Party to keep strictly confidential and not to disclose to any third party any Confidential Information so disclosed to it without the prior written consent of the Disclosing Party and the Receiving Party further undertakes that the Confidential Information so received by it shall be used solely for the Purpose and that should written permission be given for disclosure to third parties, such disclosure shall not be made until the Disclosing Party has approved such disclosure and the third party has signed a confidentiality agreement containing at least equivalent provisions of confidentiality as contained herein.
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3. The Receiving Party shall initiate a system for the safe custody of the Confidential Information and for the control of the making of such copies of the Confidential Information as may strictly be required for the Purpose. Visitors to any premises occupied by the Receiving Party where the Confidential Information is in use by the Receiving Party will have access to the Confidential Information restricted by the Receiving Party so far as is necessary to prevent disclosure of the Confidential Information. In addition to these specific obligations, the Receiving Party shall protect and safeguard the Confidential Information with at least the same degree of care with which it protects and safeguards its own confidential information.
4. Notwithstanding Clauses 2 and 3 above, the Receiving Party shall have the right to communicate to such of its employees such part of the Confidential Information as is essential to achieve the Purpose, provided that it shall procure that each such "need to know" employees having access to the Confidential Information is made aware of the obligations of secrecy attached thereto and shall instruct each such employee that the Confidential Information be treated as secret and kept in safe custody, shall prohibit them from retaining copies of it and shall procure that any of its employees to whom disclosure of the Confidential Information is made in accordance herewith shall adhere to the terms of this Agreement as if it were a party hereto.
5. In the event that the Receiving Party becomes aware of any unauthorised disclosure of any information by any of its directors, employees, consultants, suppliers or contractors, it shall promptly notify the Disclosing Party and, if so requested, take all action reasonably necessary to prevent any further unauthorised disclosure.
6. The Receiving Party acknowledges that whilst care has been taken to ensure that the Confidential Information is accurate, the Receiving Party shall not have any claim whatsoever against the Disclosing Party for any loss or damage whatsoever suffered by the Receiving Party arising out of or in respect of the Confidential Information and any representations, conditions or warranties (whether expressed or implied by custom, statute or otherwise) relating to the Confidential Information are hereby excluded by the Disclosing Party to the fullest extent permitted by law.
7. The Receiving Party shall not seek or claim any proprietary rights or any intellectual property rights of any nature whatsoever in, to, or in respect of, or arising out of or in connection with, any of the Confidential Information provided by the Disclosing Party.
8. On the achievement or cancellation of the Purpose the Receiving Party shall forthwith return to the Disclosing Party on request or otherwise destroy all Confidential Information provided to it in any documentary or physical form together with any copies thereof.
9. The obligations contained herein shall not apply to any Confidential Information which it can be clearly demonstrated by existing competent written records maintained in the ordinary course of business:
9.1 is at the time of acquisition by the Receiving Party already in the possession of the Receiving Party and at its free disposal, or in the public domain;
9.2 Enters the public domain at any time hereafter through no fault of the Receiving Party;
9.3 is acquired by the Receiving Party in good faith from third party sources unconnected with and owing no duty of confidentiality to the Disclosing Party; or
9.4 is acquired by the Receiving Party through its own independent research (excluding any research based on any of the Confidential Information).
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10. The Receiving Party may disclose Confidential Information if required to be disclosed by law or order of a governmental authority or court of competent jurisdiction, provided that it notifies the Disclosing Party of the legal requirement and the relevant Confidential Information as soon as the Receiving Party is aware of the same and further provided that the Receiving Party co-operates to take such action as may be available to limit the disclosure and, to the extent permitted by applicable law, provides all reasonable assistance to the Disclosing Party to preserve the confidentiality of the Confidential Information required to be disclosed.
11. Each party agrees to keep the existence and nature of this Agreement and the provisions, terms and conditions hereof confidential and agrees not to use the same or the name of the other party in any publicity, advertisement or other disclosure with regard to this Agreement without the other party’s prior written consent.
12. For the avoidance of doubt nothing herein shall impose any obligation on either party to reveal any Confidential Information to the other party or impose any obligation on any party to proceed with any agreements, arrangements or discussions between the parties.
13. The obligations contained in this Agreement shall except in the occurrence of an event or state referred to in Clause 9 above, last for a period of 5 years from the Effective Date.
14. Each party shall procure that its obligations as a “Receiving Party” under this Agreement are also accepted by and are binding upon and enforceable against any company which is an associated company of that party (“associated” meaning any parent or subsidiary company of the party or any parent or subsidiary of such parent company).
15. All Confidential Information disclosed under this Agreement shall be and remain the property of the Disclosing Party.
16. No delay, omission or forbearance by the Disclosing Party to exercise or enforce any right, power or remedy shall operate as a waiver thereof, and any single or partial exercise or enforcement thereof shall not preclude any other or further exercise or enforcement thereof or the exercise or enforcement of any other right, power or other remedy.
17. This Agreement may not be released, discharged, supplemented, amended, varied or modified except by an instrument in writing signed by a duly authorised representative of each of the parties. The invalidity for any reason whatsoever of any provisions of this Agreement will in no way affect the remainder of this Agreement that will in all other respects remain valid and enforceable.
18. Nothing in this Agreement shall be deemed or construed to constitute a partnership or joint venture or to imply a license between the parties, nor to constitute either party as the agent or the legal representative of the other party for any reason whatsoever. Neither party is granted any right or authority to act for, or to incur, assume or create any obligation, responsibility or liability, express or implied, in the name of or on behalf of the other party or to bind the other party in any manner whatsoever.
19. A person who is not a party to this Agreement pursuant to applicable law shall have no right to enforce any provision of this Agreement but this shall not affect any right that exists or is available apart from this Act.
20. This Agreement shall be governed by and construed in accordance with the law of the Italy. Any dispute arising out of, related or connected to this Agreement, its execution, and construction shall be settled through negotiations between senior executives of the parties hereto; if no settlement is reached, the parties agree to refer the dispute to the competent court of Italy.
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21. This Agreement may be executed in any number of counterparts and by the different parties in different counterparts each of which when executed and delivered is an original but all such counterparts shall be deemed to constitute one and the same instrument. Each party agrees that the delivery of the Agreement by facsimile shall have the same force and effect as delivery of original signatures and that each party may use such facsimile signatures as evidence of the execution and delivery of the Agreement by all parties to the same extent that an original signature could be used.
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IN WITNESS WHEREOF this Agreement has been duly executed by the parties hereto the day and year first before written.
SIGNED BY DATED
Xxxx Xxxx
CEO
Enterprise Therapeutics Limited
SIGNED BY DATED
Xxxxx Xxxxxxx Xxxxxxxx
CEO
Xxxxx Children’s Hospital IRCCS
SIGNED BY DATED
Dr Xxxxxxxx Xxxxxxxx
Head of Cystic Fibrosis Dept. Xxxxx Children’s Hospital IRCCS
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