AZIENDA OSPEDALIERO UNIVERSITARIA MEYER
AZIENDA OSPEDALIERO UNIVERSITARIA XXXXX
Delibera del Direttore Generale n. 380 del 04-08-2022
Proposta n. 733 del 2022
Oggetto: ACCORDO DI RISERVATEZZA RECIPROCA DA SOTTOSCRIVERE CON GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LIMITED 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. 380 firmata digitalmente il 04-08-2022
AZIENDA OSPEDALIERO UNIVERSITARIA XXXXX
(Art. 33 L.R.T. 24 febbraio 2005 n. 40)
Xxxxx Xxxxxxxxxx, 00 - 00000 XXXXXXX
C.F. P.Iva 02175680483
DELIBERAZIONE DEL DIRETTORE GENERALE
Oggetto | Progetto |
Contenuto | ACCORDO DI RISERVATEZZA RECIPROCA DA SOTTOSCRIVERE CON GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LIMITED 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 | XXXXX CHILDREN’S RESEARCH INSTITUTE |
Direttore della Xxxxxxxxx | XXXXXXXX XXXXXXXX |
Responsabile del procedimento | XXXXXXX XXXXXXXX |
Immediatamente Esecutiva | SI |
Conti Economici | |||
Spesa prevista | Conto Economico | Codice Conto | Anno Bilancio |
Estremi relativi ai principali documenti contenuti nel fascicolo | ||
Allegato | N° di pag. | Oggetto |
1 | 5 | Mutual Confidential Disclosure Agreement |
“documento firmato digitalmente”
IL DIRETTORE GENERALE
Dr. Xxxxxxx Xxxxxxxx (D.P.G.R.T. n. 99 del 30 luglio 2020)
Visto il D. Lgs.vo 30/12/1992 n. 502 e sue successive modifiche ed integrazioni e la L. R. Toscana n. 40 del 24/02/2005 e s.m.i. di disciplina del Servizio Sanitario Regionale;
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 1.2.2021;
- che con deliberazione del Direttore Generale n. 55 del 1.02.2021 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;
- che con deliberazione del Direttore Generale n. 56 del 1.02.2021 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;
- che con successiva deliberazione del Direttore Generale n.92 del 15.02.2021 si è provveduto ad assumere ulteriori disposizioni attuative relative all’organizzazione dell’AOU Xxxxx in ordine alle Strutture semplici Intrasoc, Unità Professionali, Uffici e Incarichi professionali;
Dato atto altresì che con deliberazione del Direttore Generale n. 106 del 2.03.2017 avente ad oggetto “Sistematizzazione delle deleghe allo svolgimento delle funzioni vicarie del Direttore Sanitario, del Direttore Amministrativo, del Coordinatore dell’Area Tecnico Amministrativa e dei Dirigenti Responsabili delle Strutture Organizzative dell’Area Tecnico Amministrativa” è stato disposto, tra l’altro, che le funzioni vicarie del Direttore Sanitario siano svolte dal Dr. Xxxxxxx Xxxxx, Direttore del Dipartimento Specialistico Interdisciplinare;
Su proposta del Direttore Operativo 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;
Premesso che questa Azienda, tra le proprie finalità istituzionali, promuove la ricerca scientifica con lo scopo di raggiungere risultati di eccellenza nella cura in pediatria e che talune proposte di ricerca, prima del loro avvio, necessitano di una fase preliminare per esplorarne la fattibilità presso le proprie strutture;
Posto che il Xxxx. Xxxxxxx Xxxxxx ha sottomesso a GlaxoSmithKline Research and Development Limited, un’azienda farmaceutica con sede in Gran Bretagna, una richiesta di finanziamento per un progetto di ricerca su una malattia rara e che l’AOU Meyer, nel caso di accettazione della domanda di finanziamento, sarà il promotore del correlato studio clinico che verrà eseguito nell’ambito del progetto medesimo;
Considerato che GlaxoSmithKline Research and Development Limited ha manifestato l’interesse nel progetto proposto dal Xxxx. Xxxxxxx Xxxxxx e che è nelle intenzioni di questa Azienda condurre il relativo studio clinico presso le proprie strutture;
Stabilito che è, altresì, nell’interesse di questa Azienda garantire la valorizzazione della ricerca pediatrica e, pertanto, scambiare con la società sopra citata, attraverso apposito Accordo di riservatezza reciproca,
talune informazioni riservate necessarie per esaminare con maggior dettaglio l’opportunità e la realizzabilità di eseguire uno studio clinico presso le proprie strutture;
Vista la bozza di Accordo che è unita quale allegato N. 1 al presente provvedimento a formarne parte integrante e sostanziale;
Verificato che dall’Accordo di cui sopra non derivano oneri economici a carico dell’AOU Xxxxx;
Ritenuto pertanto di stipulare l’Accordo di riservatezza reciproca con GlaxoSmithKline Research and Development Limited, allegato N. 1 al presente atto a formarne parte integrante e sostanziale, per la disciplina delle condizioni normative ed operative per la tutela delle informazioni confidenziali scambiate tra le parti dell’Accordo per esplorare la fattibilità di uno studio clinico;
Rilevata l’opportunità di dichiarare il presente atto immediatamente eseguibile in considerazione della necessità di scambiare in tempi brevi le informazioni riservate di cui all’Accordo in oggetto per valutare la fattibilità di eseguire uno studio clinico presso l’AOU Xxxxx;
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 Coordinatore dell’Area Tecnico Amministrativa, Dr.ssa Xxxxx Xxxx, 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 GlaxoSmithKline Research and Development Limited che, allegato N. 1 al presente atto, ne forma parte integrante e sostanziale.
2. Di precisare che dal presente atto non derivano oneri economici a carico dell’AOU Xxxxx.
3. Di dichiarare il presente provvedimento 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 con lo scambio di informazioni riservate così da valutare la fattibilità di condurre uno studio clinico presso l’AOU Meyer.
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.
IL DIRETTORE GENERALE | |
(Dr. Xxxxxxx Xxxxxxxx) | |
IL DIRETTORE SANITARIO | IL DIRETTORE AMMINISTRATIVO |
(Dr.ssa Xxxxxxxxx Xxxxxxx) | (Dr. Xxxx Xxxxx) |
MUTUAL CONFIDENTIAL DISCLOSURE AGREEMENT
Incoming and Outgoing Information
THIS CONFIDENTIAL DISCLOSURE AGREEMENT (“Agreement”) is effective as of the last date of signature (“Effective Date”) by and between GlaxoSmithKline Research and Development Limited, with an office and place of business at 000 Xxxxx Xxxx Xxxx, Xxxxxxxxx, Xxxxxxxxx, XX0 0XX, Xxxxxx Xxxxxxx (“GSK”), and Xxxxx Children’s University Hospital, having their principal place of business at 24 Xxxxx Xxxxxxx Xxxxxxxxxx, 00000 Xxxxxxx XX, Xxxxx (“AOU Meyer” or “SPONSOR”), collectively referred to as “Parties” or individually as “Party,” under the following terms and conditions:
1. Definitions
For the purposes of this Agreement, the following terms shall be defined as follows:
“Affiliates” means any corporation or other entity which controls, is controlled by, or is under common control with a Party to this Agreement or any successor entity. A corporation or other entity shall be deemed to control another corporation or entity if it (i) owns, directly or indirectly, greater than fifty percent (50%) of the voting shares or other interest, (ii) has the power to elect more than half the directors of such other corporation or entity, or (iii) has the ability, via contract or otherwise to direct the affairs of such other corporation or entity.
“Agreed Purpose” means the limited purpose of discussions that will support the development of the protocol and supporting documentation for an investigator-sponsored clinical study.
“Agreement” means this agreement comprising the clauses, amendments, schedules, appendices and attachments to it, if any.
“Confidential Information” includes but is not limited to any and all proprietary or confidential scientific, technical, financial business or personal data (if any) information disclosed or provided to the Receiving Party by or on behalf of the Disclosing Party before, on or after the Effective Date of this Agreement whether communicated in tangible or intangible form and including, without limitation, all copies, excerpts, modifications, translations, enhancements and adaptations of all the foregoing, whether made by the Receiving Party or otherwise.
“Disclosing Party” means the Party and or its Affiliates that releases, exchanges, shares, discloses Confidential Information.
“Investigator” means Xxxx. Xxxxxxx Xxxxxx who is directly involved in receiving or disclosing Confidential Information.
“Laws” means all laws, regulations, statutes or ordinances applicable to the Receiving Party’s performance of its obligations under this Agreement.
“Receiving Party” means the Party(ies) that receives, obtains or retains the Disclosing Party’s Confidential Information. “Security Breach” means any actual or suspected unauthorised disclosure, loss or theft of Confidential Information.
2. Maintenance of Confidentiality; Non-Use Obligations
Each Party shall hold the Confidential Information disclosed to it in confidence, shall use the Confidential Information only for the Agreed Purpose and shall not disclose said Confidential Information except to such of its officers, employees, Affiliates, agents and consultants to whom disclosure is necessary for the Agreed Purpose and who are bound by confidentiality obligations substantially similar to those contained in this Agreement.
The Disclosing Party will use reasonable efforts to mark its Confidential Information as “Confidential.” In the event Confidential Information is disclosed and not so marked, the Receiving Party agrees to treat such information as confidential to the extent that a reasonable person would consider such information to be confidential given the content and circumstances of the disclosure.
The Receiving Party shall protect the Confidential Information of the Disclosing Party in the same manner that it protects its own confidential information of a similar nature, which shall be at least a reasonable standard of care.
The Receiving Party shall implement and maintain reasonable safeguards (i.e. physical protection) including, on request, encryption to protect the Disclosing Party’s Confidential Information from accidental loss, damage, alteration, disclosure or destruction.
3. Excluded Information
Confidentiality and non-use obligations shall not apply to the following as established by reasonable, written proof:
i) information which at the time of disclosure is in the public domain; or
ii) information which, after its disclosure, becomes part of the public domain by publication or otherwise, except by breach of this Agreement; or
iii) information which the Receiving Party can establish was in its possession prior to disclosure or was subsequently and independently developed by employees of or on behalf of the Receiving Party without use, direct or indirect, of information required to be held confidential hereunder, or who had no knowledge of the Confidential Information disclosed; or
iv) information which the Receiving Party shall receive from a third party, provided however that the third party has the legal right to disclose the information to the Receiving Party, free of any confidentiality obligation.
4. Acknowledgement of Independent Activities
The Disclosing Party understands and acknowledges that the Receiving Party and/or its Affiliates may have in the past (including prior to the Effective Date), currently do, or may in the future, either internally or with a third party, engage in research, development and commercialisation activities relating to the subject matter of the Disclosing Party’s Confidential Information (“Independent Activities”). Accordingly, the Disclosing Party acknowledges and agrees that nothing in this Agreement will be construed by implication or otherwise as preventing the Receiving Party or its Affiliates, during the term of this Agreement or thereafter, from engaging in such Independent Activities, provided, that the Receiving Party does not reference and does not use the Disclosing Party’s Confidential Information disclosed under this Agreement in connection therewith.
5. Notification of Mandatory Disclosure
Notwithstanding any provision to the contrary, if the Receiving Party becomes obligated by Law or by a court having competent jurisdiction or regulatory body to disclose any of the Disclosing Party’s Confidential Information to a third party, the Receiving Party shall immediately, to the extent legally permissible, notify the Disclosing Party of such a requirement so that the Disclosing Party may seek an appropriate protective order or other remedy, at the Disclosing Party’s expense, to narrow the scope of such requirement and/or waive the Receiving Party’s compliance with the provisions of this Agreement.
6. Term of Obligations
This Agreement is made effective on the Effective Date and shall remain in effect for a period of two (2) years thereafter. This Agreement’s confidentiality and non-use obligations shall survive for ten (10) years from expiry or earlier termination of this Agreement.
7. Ownership
All Confidential Information is and shall remain the property of the Disclosing Party. Neither this Agreement nor any disclosure hereunder shall be deemed to vest in the Receiving Party any license or ownership rights to the Disclosing Party’s Confidential Information or under any Confidential Information or inventions, patents, know-how, trade secrets, trademarks or copyrights owned or controlled by the Disclosing Party or its Affiliates.
8. Compliance with Applicable Law
The Receiving Party shall comply with all Laws applicable to the performance of its obligations under this Agreement. To the extent not prohibited by Law, the Receiving Party will promptly notify the Disclosing Party in writing of any investigation or inquiry into whether the Receiving Party may have failed to comply with the Laws in relation to its performance under this Agreement.
9. Return or Destruction of the Confidential Information
Upon completion of the Agreed Purpose, the Receiving Party shall cease all use of the Disclosing Party’s Confidential Information, and shall upon written request promptly return to the Disclosing Party all of the Confidential Information (including copies thereof), which is in tangible form (including electronic imaging), or certify that all such Confidential Information has been destroyed, except that the Receiving Party shall be permitted to retain one (1) copy of the Disclosing Party’s Confidential Information so that any continuing obligations may be determined or to the extent otherwise required by any Laws or legal or judicial process, provided that the confidentiality and non-use obligations hereunder shall continue to apply to any retained Confidential Information. The obligation to return or destroy the Disclosing Party’s Confidential
Information shall not apply to any backup copies made pursuant to the Receiving Party’s routine information technology backup procedures.
10. Use of Parties’ Names
Neither Party shall make nor permit any person to make any public announcement (oral or written) concerning this Agreement or its prospective interests in the Agreed Purpose without the other Party’s prior written consent (such consent not to be unreasonably withheld or delayed). Neither Party may use the other Party’s or its Affiliate’s name(s), trademarks or in any other way identify the other Party without the other Party’s prior written consent.
11. No Other Obligation
Nothing in this Agreement or the disclosure of Confidential Information shall be construed, by implication or otherwise, as an obligation to enter into any further agreement.
12. Representations and Warranties
12.1 Each Party represents and warrants to the other Party that: (a) it has the rights in and to its Confidential Information and/or it has the right to disclose such Confidential Information to the other Party; and (b) by entering into this Agreement it is not breaching any obligation in any agreement to any third party.
12.2 Except as expressly stated in this Agreement, the Disclosing Party makes no express or implied warranty or representation concerning its Confidential Information, including the accuracy or completeness of its Confidential Information.
13. Privacy
The Parties agree that it is not their intention to share personal data under this Agreement. To the extent Confidential Information does include incidental personal data, the Parties agree that each Party shall, in addition to the confidentiality obligations set out in this Agreement, comply with obligations under all applicable data laws.
14. Notices and Security Breach Notices
Security Breach. Upon the discovery of any event that could reasonably be expected to compromise the security of a Party’s Confidential Information or upon discovering any suspected or actual Security Breach of any Party’s Confidential Information, the discovering Party will promptly e-mail the affected Party. Upon any occurrence or compromise, the discovering Party shall e-mail for GSK at xxxx@xxx.xxx and for AOU Meyer at xxxxxxxxxxxxxxxxxxx@xxxxx.xx and xxxxxxx.xxxxxx@xxxxx.xx. For Security Breaches involving personal data, notice must be given within seventy-two (72) hours (to AOU Meyer, to the following email: xxxxxxx.xxx@xxxxx.xx). Each Party shall work with the other in good faith to identify a root cause and remediate any Security Breach.
All other notices given under this Agreement shall be given in writing, by registered mail or commercial courier, to the Party’s address below. Notice shall be effective upon receipt.
A Party may change its address details for receipt of notices by notice to the other Party.
A notice given under this Agreement is not valid if sent by e-mail with the exception of notices for Security Breaches. However, this is not intended to prohibit the use of e-mail for day-to-day operational communications between the Parties and/or their Affiliates.
i) All notices shall be sent to the following address:
If to GSK: | If to AOU Meyer: |
Xxxxxxx Xxxxx | Contact Name: Alessio Fabbiano |
GlaxoSmithKline Research & Development Limited | Azienda Ospedaliero-Universitaria Xxxxx |
000 Xxxxx Xxxx Xxxx, Xxxxxxxxx, Xxxxxxxxx | Xxxxx Xxxxxxx Xxxxxxxxxx |
XX0 0XX, Xxxxxx Xxxxxxx | 0000000 Xxxxxxx Xxxxx |
15. Remedies for Breach
The Parties agree that, should this Agreement be breached, money damages may be an inadequate remedy. Accordingly, the non-breaching Party shall be entitled to seek, and a court of competent jurisdiction may grant, specific performance and injunctive or other equitable relief as a remedy for any such breach. Such remedy shall be in addition to all other remedies available to the non-breaching Party at law or in equity.
16. Assignment
This Agreement shall not be assigned by any Party without the prior written consent of the other Party, which consent may be withheld in the other Party’s sole discretion. Any assignment without such consent shall be void; provided, however, that any Party may without such consent assign this Agreement to an Affiliate; and provided further, that either Party may without such consent assign this Agreement in connection with the sale or transfer of all or substantially all of its business related to the subject matter of the Agreed Purpose or in connection with a merger or other consolidation with another entity upon giving written notice to the other Party.
17. Amendment and Variation
This Agreement may not be amended, modified, or released except in writing signed by each of the Parties.
18. Third Party Rights
Except for Affiliates, a person who is not a Party to this Agreement has no right to enforce any of its terms. Each Party’s Affiliates shall have the right to enforce any obligations under this Agreement, but their consent shall not be required to make any amendment or terminate this Agreement.
19. Severability
If any provision(s) of this Agreement should be illegal or unenforceable in any respect, the legality and enforceability of the remaining provisions contained in it shall not be affected and the Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be maintained.
20. Entire Agreement
This Agreement contains the full and complete understanding of the Parties with respect to the subject matter of this Agreement and supersedes all prior representations and understandings, whether oral or written. No course of dealing or usage of trade shall be used to modify the terms of this Agreement.
21. Waiver
Any delay in enforcing a Party’s rights under this Agreement or any notice of waiver (only effective if in writing and signed) as to a particular default or other matter shall not constitute a waiver of such Party’s rights with regard to the future enforcement of its rights under this Agreement.
22. Governing Law and Jurisdiction
This Agreement shall be governed by and construed in accordance with the Laws of Italy without reference to conflict of law principles. Any, matter, dispute or legal action arising out of or in connection with this Agreement, whether contractual or non-contractual, shall be brought in a court having jurisdiction in Italy.
23. Counterparts and Signatures
This Agreement may be signed (including electronic signatures) in counterparts, each executed by at least one or more of the Parties. Each counterpart will be an original and all counterparts taken together will constitute one (1) instrument.
An executed counterpart of this Agreement (the entire Agreement, not just a signature page) may be delivered by e-mail (in PDF or another agreed format).
SIGNATURES TO FOLLOW
This Agreement has been entered into:
For and on behalf of GlaxoSmithKline Research and Development Limited by:
Signature: Name:
Title:
Email:
Date:
For and on behalf of Azienda Ospedaliero-Universitaria Xxxxx by:
Signature: Name: Xxxxxxx Xxxxxxxx
Title: CEO
Email: xxxxxxxxx.xxxxxxxx@xxxxx.xx