AZIENDA OSPEDALIERA UNIVERSITARIA MEYER IRCCS

AZIENDA OSPEDALIERA UNIVERSITARIA XXXXX IRCCS

Delibera del Direttore Generale n. 549 del 27-09-2024

Proposta n. 1006 del 2024

Oggetto: ACCORDO DI RISERVATEZZA CON BIOMX LTD. PER POSSIBILE FUTURO STUDIO CLINICO – APPROVAZIONE SCHEMA DI ACCORDO

Dirigente: XXXXXXXX XXXXX

Struttura Dirigente: DIRETTORE SCIENTIFICO

Delibera del Direttore Generale n. 549 firmata digitalmente il 27-09-2024

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	Studio clinico
Contenuto	ACCORDO DI RISERVATEZZA CON BIOMX LTD. PER POSSIBILE FUTURO STUDIO CLINICO – APPROVAZIONE SCHEMA DI ACCORDO

Struttura	Direzione Scientifica
Dirigente Proponente	Xxxx. Xxxxx Xxxxxxxx
Responsabile del procedimento	Xxxxxxx Xxxxxxxx
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	4	Mutual 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. 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;

- con deliberazione del Direttore Generale n. 286 del 09.05.2024 è stato adottato ai sensi dell’art. 50 novies comma 3 della L.R.T. 40/2005 e s.m.i., a seguito dei pareri favorevoli della Giunta Regionale e del Ministero della Salute, il Regolamento di organizzazione e funzionamento dell’A.O.U. Xxxxx I.R.C.C.S.;

- con deliberazione del Direttore Generale n. 296 del 10.05.2024 è stato approvato il nuovo assetto organizzativo dell'A.O.U. Xxxxx I.R.C.C.S. il cui organigramma ha decorrenza dal 01.07.2024;

Su proposta del Direttore Scientifico f.f. Xxxx. Xxxxx Xxxxxxxx, il quale, con riferimento alla presente procedura, attesta la regolarità amministrativa e la legittimità dell’atto;

Ricordato che questa Azienda, tra le proprie finalità istituzionali, promuove la ricerca biomedica e sanitaria 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 BiomX Ltd., un’azienda farmaceutica con sede in Israele, ha manifestato il proprio interesse a condurre uno studio clinico nel campo pediatrico che vede coinvolto il Dr. Xxxxxxxx Xxxxxxxx in qualità di sperimentatore;

Evidenziato che è nell’interesse dell’AOU Xxxxx IRCCS esplorare la possibilità di condurre il su citato studio 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 un possibile futuro 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 BiomX Ltd. per la disciplina delle condizioni normative ed operative per la tutela delle informazioni confidenziali scambiate con la predetta società che, allegato N. 1 al presente atto, ne forma parte integrante e sostanziale;

Rilevata l’opportunità di dichiarare il presente atto immediatamente eseguibile per consentire che le informazioni confidenziali siano oggetto di trasmissione 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 Xxxx. Xxxxxxx Xxxxxxxx, sottoscrivendo l’atto attesta che lo stesso, a seguito dell’istruttoria effettuata, nella forma e nella sostanza è legittimo;

Acquisiti i pareri favorevoli del Direttore Amministrativo, del Direttore Sanitario e del Direttore Scientifico;

DELIBERA

Per quanto esposto in narrativa che espressamente si richiama,

1) Di approvare lo schema di Accordo di riservatezza da stipulare con BiomX 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 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 AMMINISTRATIVO	IL DIRETTORE SANITARIO	IL DIRETTORE SCIENTIFICO f.f.
Xxxx. Xxxxxxx Xxxxxxx	Dr. Xxxxxxxx Xxxx	Xxxx. Xxxxx Xxxxxxxx
IL DIRETTORE GENERALE Dr. Xxxxx Xxxxxxx Xxxxxxxx

MUTUAL CONFIDENTIALITY AGREEMENT

This Mutual Confidentiality Agreement (the “Agreement”) is entered into as of the last date of signature herein by and between BiomX Ltd., an Israeli company with offices at 00 Xxxxxxxx Xx., Xxxx Xxxxx, Xxxxxx (“BiomX”), and Xxxxx Children’s Hospital IRCCS, with registered office at Xxxxx Xxxxxxx Xxxxxxxxxx, 00000 Xxxxxxx, Xxxxx (the “Institution” and, together with BiomX, the “Parties” and each a “Party”).

WHEREAS:

A) This Agreement will confirm the mutual understanding of the basis on which each Party (a “Discloser”) may disclose to the other Party (a “Recipient”) information relating to a research project or operations of their respective businesses for purposes of the Parties cooperating for the possibility of conducting a project research or discussions with respect to such possibility (the “Purpose”); and

B) Dr. Xxxxxxxx Xxxxxxxx, head of the Institution’s Cystic Fibrosis Department, is the Institution’s reference person for receiving Confidential Information (as defined below).

NOW, THEREFORE, in consideration of the covenants and promises contained herein, the Parties agree as follows

Each Party is willing to disclose this information to the other for the Purpose only, on the following terms:

1. “Confidential Information” shall mean all information relating to the assets, business or operations of Discloser or its Affiliates disclosed by Discloser to Recipient either directly or indirectly, whether from observation, from materials submitted, or from disclosures made orally, including, but not limited to, research and development activities related to the development of drug candidates, medical devices, and other products (the “Products”) indications and potential indications of the Products, regulatory approval process relating to the Product including without limitation the United States and elsewhere around the world, reimbursement strategy and actions with respect to the Products, processes, manufacturing techniques, business and marketing information and plans, financial information, information relating to pricing, production information, formulations, know how, other trade secrets and any other intellectual property rights owned or used by or licensed to Discloser, as well as the fact that the parties have or may have an interest or business relationship with each other regarding the subject matter of this Agreement.

2. “Affiliates” shall mean, with respect to any party, any person, corporation or other entity that directly or indirectly, by itself or through one or more intermediaries, controls or is controlled by, or is under common Control with, such party. The term “Control” means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ability to vote fifty percent (50%) or more of voting securities or otherwise.

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3. Recipient agrees that:

(a) it will hold in confidence all Confidential Information;

(b) it will restrict the disclosure of Confidential Information within its own organization and to any of its auditors, agents, accountants, counsel or other fiduciaries of Recipient (the “Representatives”) who need to know the Confidential Information for the Purpose, provided, however, that (i) each such Representative has been informed of Recipient’s obligations under this Agreement, (ii) each Representative is bound by contractual or ethical obligations towards Recipient with respect to the Confidential Information that are at least as strict as the confidentiality obligations under this Agreement, and (iii) that Recipient shall be liable for any breach or violation of this Agreement by a Representative;

(c) it will not disclose Confidential Information to any third party without the prior written consent of Discloser;

(d) it will make no copies of any Confidential Information without the prior written approval of Discloser, other than copies necessary for those Representatives who require the information for the performance of duties pursuant to this Agreement and the business relationship between Discloser and Recipient; and

(e) it will not use Confidential Information except for the Purpose.

4. Confidential Information shall not include, and the obligations of Recipient set forth above shall not apply, to information which Recipient can demonstrate by non-testimonial evidence that such Confidential Information:

(a) was known to Recipient prior to any disclosure by Discloser; or

(b) was publicly available prior to any disclosure by Discloser, or subsequently becomes public information through no breach of this Agreement; or

(c) was received by the Recipient without restriction from a third party known to the Recipient that was lawfully in possession of such information and was not in breach of any agreement or confidential relationship with the Discloser.

(d) is required to be disclosed pursuant to a court or governmental authority order or governmental rule or law, provided that (i) Recipient promptly, if legally permitted, notifies Discloser of the required disclosure and (ii) Recipient shall only disclose such portion of the Confidential Information that is required to be disclosed by such order or governmental rule.

5. Confidential Information shall remain the property of Discloser, and Recipient shall return to Discloser, immediately upon request or upon the termination or expiration of this Agreement, all Confidential Information submitted to it by Discloser in written form,

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including all copies thereof, and all documents (including documents created by Recipient) that contain Confidential Information; provided, however, that (i) Recipient may keep one

(1) copy for legal, regulatory, audit and compliance purposes or to comply with any bona fide records retention policy, and (ii) the obligations set forth in this Section 5 shall not apply to electronic copies made as part of any disaster recovery policy, and, provided further, that (x) the Recipient or any of its Representatives shall make no use of such retained Confidential Information and (y) the confidentiality undertakings set forth herein shall continue to apply to such retained Confidential Information so long as it is retained, regardless of the term and survival provisions set under Section 12.

6. It is understood that nothing in this Agreement shall be construed as granting Recipient any right or license with respect to said Confidential Information or other information disclosed pursuant to this Agreement, except as expressly set forth herein. Information or materials developed or produced during or as a result of any activity conducted by Recipient for Discloser shall be deemed “Confidential Information” for all purposes hereof.

7. Nothing in this Agreement shall be deemed to provide any commitment of any kind by either Party to enter into any further agreement with the other Party.

8. In the event that Recipient, a Representative or anyone to whom Recipient transmits Confidential Information becomes legally compelled to disclose any of the Confidential Information, Recipient agrees to provide Discloser, to the extent legally permissible at the advice of Recipient’s legal counsel or office, with prompt written notice so that Discloser may seek a protective order or other appropriate remedy or, if appropriate, waive compliance with the provisions of this Agreement. In the event that such protective order or other remedy is not obtained, or Discloser waives compliance with the provisions of this Agreement, Recipient agrees that it will furnish only that portion of the Confidential Information which Recipient is advised by its legal counsel or office that is legally required to be disclosed. Recipient will exercise reasonable efforts to assist Discloser to obtain protective order or other reliable assurance that confidential treatment will be accorded such Confidential Information.

9. EACH PARTY AGREES THAT NO WARRANTIES ARE MADE BY DISCLOSER IN CONNECTION WITH THE CONFIDENTIAL INFORMATION. CONFIDENTIAL INFORMATION IS PROVIDED ON AN “AS IS” BASIS.

10. Due to the unique nature of the Confidential Information, Recipient understands that Discloser may suffer irreparable harm in the event of any breach of this Agreement and that monetary damages will be inadequate to compensate Discloser for any such breach. Accordingly, Recipient agrees that Discloser will, in addition to any other remedies available at law or in equity, be entitled to seek injunctive relief to enforce the terms of this Agreement.

11. Recipient acknowledges that BiomX is a subsidiary of a publicly traded company, and therefore shall not, and cause its Representatives who are exposed to BiomX’s Confidential Information and to the fact that there is a relationship between Recipient and BiomX, not

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to trade, directly or indirectly (including not tipping third parties, with or without consideration) securities of BiomX’s parent company. This obligation shall terminate six months after the Confidential Information is disclosed to the public unless otherwise agreed by BiomX in writing.

12. The Parties acknowledge and agree that this Agreement, including any and all confidentiality obligations set forth herein, is intended to benefit BiomX and its Affiliates (the “Beneficiaries”). The Beneficiaries shall be third party beneficiaries of this Agreement and shall have the right to enforce any and all provisions of this Agreement, and any breach of this Agreement by the Institution shall be deemed to cause direct harm to the Beneficiaries. The Parties agree that the Beneficiaries have the right to seek all legal and equitable remedies available to them to ensure compliance with this Agreement, including but not limited to injunctive relief and damages.

13. This Agreement shall be governed by and construed in accordance with the laws of the defendant and all disputes arising therefrom shall be adjudicated in the court of proper jurisdiction of the defendant.

14. This Agreement sets forth the entire agreement between the Parties relating to the subject matter hereof. No modification of this Agreement or any of its terms shall be effective unless made in writing and signed by the authorized representatives of both of the Parties. The obligations contained herein shall apply during any period the Parties conduct business together and for five (5) years after the expiration or termination of any relationship between the Parties for any reason whatsoever, except that with respect to trade secrets the obligations set forth above shall continue to apply so long as such are considered trade secrets under applicable law.

IN WITNESS WHEREOF, this Agreement has been executed by the Parties’ duly authorized representatives, as of the date first written above.

BiomX Ltd.	Xxxxx Children’s Hospital IRCCS
By: Xxxxxxxx Xxxxxxx	By: Dr Xxxxx Xxxxxxx Xxxxxxxx
Title: CEO	Title: Managing Director

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