ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE

L E G N A R O (PD)

D E L I B E R A Z I O N E

D E LLA D I R E T T R I C E G E N E R A L E

N. 266 del 30/08/2024

OGGETTO: Approvazione dello schema di ``Service Agreement`` tra l`Istituto Zooprofilattico Sperimentale delle Venezie e University Health Network con sede in Toronto, Canada.

Atto sottoscritto digitalmente ai sensi del D.Lgs. 82/2005 s.m.i. e norme collegate e sostituisce il documento cartaceo e la firma autografa

ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE

L E G N A R O (PD)

DELIBERAZIONE DELLA DIRETTRICE GENERALE

OGGETTO: Approvazione dello schema di ``Service Agreement`` tra l`Istituto Zooprofilattico Sperimentale delle Venezie e University Health Network con sede in Toronto, Canada.

Si sottopone alla Direttrice generale la seguente relazione del Responsabile della S.S. Affari Generali, Anticorruzione e Trasparenza.

Si premette che:

- l’articolo 1, comma 6, del Decreto Legislativo n. 270/1993, confermato dall’art. 9, comma 2, del Decreto Legislativo n. 106/2012, consente agli Istituti Zooprofilattici Sperimentali di “[…] stipulare convenzioni o contratti di consulenza per la fornitura di servizi e per l’erogazione di prestazioni ad enti, associazioni, organizzazioni pubbliche e private, sulla base di disposizioni regionali, fatte salve le competenze delle unità sanitarie locali”;

- l’articolo 5, comma 1 – rubricato “Attività verso terzi” – dell’Accordo per la gestione dell’Istituto Zooprofilattico Sperimentale delle Venezie approvato dalla Regione del Veneto, dalla Regione Autonoma Friuli Venezia Giulia e dalle Province Autonome di Trento e Bolzano, rispettivamente, con Leggi n. 5/2015, n. 9/2015, n. 5/2015 e n. 5/2015, prevede del pari che “Fermo restando l’assolvimento dei propri compiti istituzionali, l'istituto può fornire prestazioni a terzi a titolo oneroso, stipulando convenzioni o contratti di consulenza per la fornitura di servizi e per l'erogazione di prestazioni a enti, associazioni, organizzazioni pubbliche e private sulla base di disposizioni regionali, fatte salve le competenze delle aziende unità sanitarie locali. […]”;

- con riferimento a tali prescrizioni, l’art. 5, comma 1, dello Statuto dell’Istituto – adottato con DCA n. 12 del 24.05.2021 e approvato con DGRV n. 1308 del 28.09.2021 – prevede che l’Istituto “[…]può fornire prestazioni a terzi a titolo oneroso, stipulando convenzioni o contratti di consulenza per la fornitura di servizi e per l'erogazione di prestazioni a

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soggetti privati, ad imprese, enti, associazioni, organizzazioni pubbliche e private sulla base di disposizioni degli enti cogerenti […]”; il comma 2 del citato art. 5 stabilisce che “Nelle more delle disposizioni di cui al punto precedente, l’Istituto continua ad applicare le modalità in atto”;

- l’art. 6, comma 2, lett. e) del D. Lgs. n. 270/1993, ripreso dall’art. 3, comma 2, lett. e) della Legge della Regione Veneto n. 5 del 18.03.2015, prevede che il finanziamento degli Istituti Zooprofilattici Sperimentali sia, inoltre, assicurato “dagli introiti per la fornitura di servizi e per l’erogazione di prestazioni a pagamento”;

- i vigenti documenti di programmazione dell’IZSVe prevedono – tra gli indirizzi approvati

– la promozione e l’incentivazione di attività progettuali finanziate da soggetti terzi ad integrazione del finanziamento istituzionale;

- con DDG n. 317 del 26/06/2013 è stato approvato il nuovo “Regolamento per la prestazione di attività e servizi aggiuntivi in favore di soggetti privati tramite la stipula di contratti e convenzioni” e con nota prot. n. 10134/2013 è stata diffusa la relativa circolare interpretativa a firma del Direttore generale;

- quest’ultima prevede che le attività non-istituzionali cd. semplici, così come enucleate e definite all’interno della citata circolare, deroghino dall’ambito di applicazione del vigente Regolamento e pertanto dall’iter procedurale di approvazione del contratto ivi stabilita.

Presso l’University Health Network – organizzazione di assistenza sanitaria e ricerca medica con sede a Toronto (Canada) – è attivo un gruppo di ricerca che sta sviluppando un sistema di spettrometria di massa per la caratterizzazione rapida di tessuti biologici. Al fine di indagare l’efficacia di tale metodo, l’Università in parola ha richiesto all’IZSVe di addivenire alla stipula di un contratto di servizi avente ad oggetto l’esecuzione di analisi del profilo spettroscopico di tessuti tumorali, da condurre presso la sede della citata Università mediante l’impiego di uno spettrometro “Raman” portatile, di proprietà dell’Istituto.

Al fine di formalizzare il rapporto e regolare gli aspetti giuridici ed economici, le Parti hanno concordato, per le vie brevi, lo schema di “Service Agreement” unitamente al relativo “Technical Annex”, documento che si allega al presente provvedimento quale parte integrante e sostanziale (allegato n. 1).

In conformità alle soprarichiamate disposizioni, la dott.ssa Xxxxxxxxxx Xxxx, ricercatore chimico presso la “SCS8 - Valorizzazione delle produzioni alimentari”, ha inserito, in qualità di referente scientifico, la richiesta intranet n. 219645/2024, allegando il quadro economico – che riporta sinteticamente i costi a carico dell’Istituto per le attività da svolgere – nonché la dichiarazione, datata 23.05.2024, per la stipula del contratto con la sopracitata Università comprensiva della dichiarazione di insussistenza di conflitti di interesse, documenti conservati agli atti presso questa Struttura.

Con la sottoscrizione del Contratto in parola – efficace dalla data di ultima sottoscrizione per un periodo di 24 mesi o, in ogni caso, fino al completamento dei servizi da parte di IZSVe e al pagamento del corrispettivo da parte della citata Università – l’Istituto si impegna a prestare i servizi di cui all’art. 3 del Contratto, come dettagliati nel relativo “Technical Annex”, a fronte dei quali l’Università si impegna a corrispondere, subordinatamente alla presentazione di regolare fattura, un importo di € 5.000,00 (IVA esclusa), oltre al rimborso delle spese di

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trasferta e di quanto sostenuto per la spedizione dello strumento “Raman”, secondo le modalità previste all’art. 4 del Contratto.

Tutto ciò premesso, sulla base degli elementi riportati dal referente dell’istruttoria, si propone alla Direttrice generale quanto segue:

1. di approvare lo schema di “Service Agreement” tra l’Istituto Zooprofilattico Sperimentale delle Venezie, rappresentato dalla Direttrice Generale e legale rappresentante pro tempore, dott.ssa Xxxxxxx Xxxxx, e University Health Network, rappresentata dal Vice-Presidente Esecutivo, xxxx. Xxxxxx X. Xxxxxxx, documento che, unitamente al relativo “Technical Annex”, si allega al presente provvedimento quale parte integrante e sostanziale (allegato n. 1);

2. di procedere, per l’effetto, alla sottoscrizione del Contratto di cui al punto che precede ai sensi degli artt. 15 e 16 del vigente Accordo interregionale sulla gestione dell’Istituto Zooprofilattico Sperimentale delle Venezie; sottoscrizione che avverrà con firma digitale ai sensi del D. Lgs. 7 marzo 2005 n. 82;

3. di prendere atto del quadro economico – che riporta sinteticamente i costi a carico dell’IZSVe per le attività da svolgere – e della dichiarazione del 23.05.2024 per la stipula del Contratto, nella quale è contenuta la dichiarazione di insussistenza di conflitti di interesse, documenti allegati alla richiesta intranet n. 219645/2024 e conservati agli atti di questa Struttura;

4. di prendere atto, altresì, che con la sottoscrizione del Contratto in parola, l’IZSVe si impegna a prestare i servizi di cui all’art. 3 dello stesso, come dettagliati nel relativo “Technical Annex”, a fronte dei quali l’Università si impegna a corrispondere, subordinatamente alla presentazione di regolare fattura, un importo di € 5.000,00 (IVA esclusa), oltre al rimborso delle spese di trasferta e di quanto sostenuto per la spedizione dello strumento “Raman”, secondo le modalità previste all’art. 4 del Contratto;

5. di dare atto che il Contratto in parola decorre dalla data di ultima sottoscrizione per un periodo di 24 mesi o, in ogni caso, fino al completamento dei servizi da parte dell’IZSVe e al pagamento del corrispettivo da parte dell’Università;

6. di assegnare la responsabilità scientifica delle attività previste dal Contratto alla dott.ssa Xxxxxxxxxx Xxxx, ricercatore chimico presso la “SCS8 – Valorizzazione delle produzioni alimentari”;

7. di rilevare, per l’effetto, il ricavo derivante dal presente provvedimento al sottoconto 620011003 “Ricavi per prestaz. sanitarie erogate a soggetti privati – Altre convenzioni” attribuito pro quota a ciascun esercizio finanziario secondo il criterio di competenza economica.

LA DIRETTRICE GENERALE

ESAMINATA la proposta di deliberazione del Responsabile della S.S. Affari Generali, Anticorruzione e Trasparenza.

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PRESO ATTO che il Responsabile della S.S. Affari Generali, Anticorruzione e Trasparenza nel proporre il presente atto attesta la regolarità tecnica ed amministrativa, la legittimità e congruenza dell’atto con le finalità istituzionali dell’Istituto, l’assenza di conflitto di interessi, stante anche l’istruttoria effettuata a cura del suddetto Dirigente.

VISTO il decreto del Presidente della Giunta regionale del Veneto n. 102 del 22 settembre 2020 con il quale è stata nominata la dott.ssa Xxxxxxx Xxxxx quale Direttore generale dell’Istituto Zooprofilattico Sperimentale delle Venezie.

VISTA la DDG n. 141 del 19 aprile 2023 con la quale il xxxx. Xxxxxxxx Xxxxxxx è stato nominato Direttore sanitario dell’Istituto.

VISTA la DDG n. 101 del 10 marzo 2021 con la quale il xxxx. Xxxxxxx Xxxxxx è stato nominato Direttore amministrativo dell’Istituto.

ACQUISITO il parere favorevole del Direttore amministrativo e del Direttore sanitario per quanto di competenza, espresso ai sensi dell’art. 15 dello Statuto dell’Istituto, adottato con delibera del CdA n. 12 del 24 maggio 2021 e approvato con delibera della Giunta regionale del Veneto n. 1308 del 28 settembre 2021.

VISTO l’Accordo per la gestione dell’Istituto Zooprofilattico Sperimentale delle Venezie tra la Regione del Veneto, la Regione Autonoma Friuli Venezia Giulia e le Province Autonome di Trento e Bolzano, approvato dai suddetti Enti, rispettivamente, con leggi n. 5/2015, n. 9/2015, n. 5/2015 e n. 5/2015.

D E L I B E R A

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Il presente provvedimento non è soggetto al controllo previsto dall’Accordo per la gestione dell’Istituto Zooprofilattico Sperimentale delle Venezie approvato dagli Enti cogerenti con le leggi regionali e provinciali citate nelle premesse.

LA DIRETTRICE GENERALE

Xxxxxxx Xxxxx

Sul presente atto deliberativo ha espresso parere favorevole

Il Direttore amministrativo Il Direttore sanitario Xxxxxxx Xxxxxx Xxxxxxxx Xxxxxxx

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ATTESTAZIONI ALLEGATE ALLA DELIBERAZIONE DELLA DIRETTRICE GENERALE

Il Responsabile della Struttura proponente attesta la regolarità della proposta di deliberazione, presentata per l’adozione, in ordine ai contenuti sostanziali, formali e di legittimità dell’atto e che la stessa:

Comporta spesa 🞏 su Finanziamento istituzionale 🞏

Finanziamento vincolato 🞏

Altri finanziamenti 🞏

Non comporta spesa ⌧

ATTESTAZIONE DI COPERTURA ECONOMICA DELLA SPESA

Il Responsabile del Budget attesta l’avvenuto controllo sulla disponibilità di budget

Evidenziato infine che il responsabile della Struttura proponente, con la sottoscrizione della proposta di cui al presente atto, dichiara, sotto la propria responsabilità ed ai sensi e agli effetti degli artt. 47 e 76 del dPR 28 dicembre 2000, n. 445, che, in relazione alla presente procedura, non si trova in condizioni di incompatibilità di cui all’art. 35 bis del d.lgs. n. 165/2001, né sussistono conflitti di interesse di cui all’art. 6 bis della legge n. 241/1990 e agli artt. 6, 7 e 14 del dPR n. 62/2013.

La Dirigente della S.S. Affari Generali, Anticorruzione e Trasparenza

Xxxxxx Xxxxxxxx

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ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE

Xxxxx xxxx’Xxxxxxxxxx 00 – 00000 XXXXXXX (XX)

DELIBERAZIONE DELLA DIRETTRICE GENERALE N. 266 del 30/08/2024‌

OGGETTO: Approvazione dello schema di ``Service Agreement`` tra l`Istituto Zooprofilattico Sperimentale delle Venezie e University Health Network con sede in Toronto, Canada.

Pubblicata dal 30/08/2024 al 14/09/2024 Atto immediatamente esecutivo

Il Responsabile della Pubblicazione Xxxxxxxxx Xxxxxxxxx

Elenco firmatari

Questo documento è stato firmato da:

Dott.ssa Xxxxxx Xxxxxxxx - Servizio Affari generali, anticorruzione e trasparenza Xxxxxxx Xxxxxx - Direzione Amministrativa

Xxxxxxxx Xxxxxxx - Direzione Sanitaria Xxxxxxx Xxxxx - Direzione Generale Xxxxxxxxx Xxxxxxxxx - Gestione Atti

SERVICE AGREEMENT

BY AND BETWEEN

Istituto Zooprofilattico Sperimentale delle Venezie, an Italian governmental institution, with offices at Xxxxx xxxx’Xxxxxxxxxx 00, 00000 Xxxxxxx (XX), Xxxxx, fiscal code and VAT n. 00206200289, represented by Dr. Xxxxxxx Xxxxx, Director General and Legal Representative,

(hereinafter referred to as “IZSVe”)

and

University Health Network, a health care and medical research non-share share corporation having a registered office at X. Xxxxxx Xxxxxx Xxxxxxxx, 0xx Xxxxx, 000 Xxxxxxxxx Xx., Xxxxxxx XX, Xxxxxx, fiscal code and VAT n. 119259505-RR, Represented by Dr. Xxxxxx X. Xxxxxxx, EVP Science & Research

(hereinafter referred to as “UHN” or “Customer”)

(and severally as “Party” and jointly as “ Parties”)

WHEREAS

- IZSVe is involved in providing diagnosis and research on infectious livestock diseases and zoonosis, quality control of foods of animal origin for human consumption, control of animal feed, epidemiologic surveillance and monitoring, planning of animal health programs, training of veterinary service personnel;

- IZSVe pursuant to art. 1, paragraph 6, of Legislative Decree n. 270/1993, and art. 5, paragraph 1 of the Agreement regulating the management of the IZSVe executed among the Veneto Region, the Autonomous Region of Friuli-Venezia Giulia, the Autonomous Region of Bolzano and the Autonomous Province of Trento as approved by the Regional Law of the Veneto Region n. 5/2015, is authorized to execute service agreements with public entities, associations, public or private organizations and entities;

- the Zarrine-Afsar Laboratory at UHN is developing a laser-based mass spectrometry system for rapid characterization of biological tissues and has secured institutional approvals to compare the efficacy of the lase mass spectrometry method to competing Raman spectrometry method using biobanked human specimen of lung and brain cancers;

- the IZSVe possess a portable Raman spectrometer (RDA 9723, no. 028944) and has expertise in its operation, data collection and analysis;

- the Customer requires IZSVe to perform certain services regarding spectroscopic profiling analysis, using a portable Raman spectrometer, the associated statistical analysis, services to be carried out at the Customer’s premises;

- IZSVe is interested in performing the services requested by the Customer in compliance with the rules in force regarding the management of the IZSVe;

NOW, THEREFORE,

in consideration of the covenants and obligations hereinafter set forth, the Parties hereto, individually and by their respective agents and representatives, hereby agree as follows:

ART 1 RECITALS

The recitals and annexes of the Agreement are an integral and substantial part of it and bind its interpretation and implementation.

ART 2 DEFINITIONS

Unless specifically set forth to the contrary under this Agreement, the following terms, whether used in the singular or plural, shall have the respective meanings set forth below.

“Agreement” shall mean this service Agreement and the Annex attached thereto.

“Technical Annex”, at Annex A, contains the detailed description of the Services (as defined in art. 3 below).

“Compensation” shall mean the payment due to IZSVe set forth in art. 4 herein for the Services.

"Confidential Information" includes any information, documentation, material, tool, knowledge, data, found, patented or patentable, know-how and, in general, any news, of a technical, economic, commercial or administrative nature, as well as any drawing, document, magnetic medium or sample and material or product even if not marked "private" or "confidential" or otherwise identified as such by the Party transmitting it (i.e. the disclosing Party) to the "receiving Party" during the term of the Agreement;

“Final Report” shall mean the report in writing, arising from the performance of the Services, containing experimental results including statistical analysis and modeling results.

“Legal Interest” shall mean the interest paid by the Customer to IZSVe for the delay in payment of the Consideration (as detailed in art. 4), in full or in part, at the rate set forth by Legislative Decree n. 231/2002. “Personnel” shall mean the personnel of the IZSVe involved in the Services.

“UHN Proprietary Materials” shall mean (a) any de-identified clinical information that is furnished by UHN to Personnel or IZSVe, and (b) any tangible chemical, biological, or physical material, molecules, compounds, samples of any kind; in each case of the foregoing that the Customer provides to IZSVe or Personnel: i) to be used solely in the provision of the Services; ii) to be tested; or iii) in relation to which an analytical method is required to be developed and/or validated, and/or iv) as the Customer considers necessary for conducting the Services. UHN Proprietary Materials are detailed without limitation at Annex A.

“Background” shall mean all inventions, works of authorship, designs, topographies, software, formulae, algorithms, techniques, instructions, processes, flow charts, logic diagrams, manuals, specifications, instructions, knowledge, information as well as any intangible asset, protected and not protected under national, EU and international intellectual and industrial property laws, of which one Party is the owner before the start of the activity of this Agreement.

“Sideground” shall mean all inventions, works of authorship, designs, topographies, software, formulae, algorithms, techniques, instructions, processes, flow charts, logic diagrams, manuals, specifications, instructions, knowledge, information as well as any intangible good that is protectable under national, EU and international intellectual and industrial property laws and regulation, created or otherwise achieved by a Party during the period of effectiveness of this Agreement but not in its execution nor connected to the objective of the activity to be performed, even if it is in the same technical or scientific field of the subject matter of the Agreement. “Foreground” shall mean all inventions, works of authorship, designs, topographies, software, formulae, algorithms, techniques, instructions, processes, flow charts, logic diagrams, manuals, specifications, instructions, knowledge, information as well as any intangible property that is eligible for protection under national EU and international intellectual and industrial property laws, created or otherwise achieved pursuant to the Agreement and the Services.

“Results” shall mean all data, knowledge, information, matter, or deliverable, as well as any intangible property created or otherwise achieved from the performance of the Services and pursuant to the Agreement and the Services, but not protected under national, EU and international intellectual and industrial property laws.

ART 3 OBJECT OF THE AGREEMENT

3.1 The Customer requests and IZSVe shall perform certain services regarding spectroscopic profiling analysis using a portable Raman spectrometer and the associated statistical analysis, to be carried out by IZSVe Personnel at the Customer’s premises (hereinafter referred to as “Services”) on the terms and conditions of this Agreement and in accordance with the attached Technical Annex (“Annex A”), that is an integral and essential part of it. No changes to the activities as described in Annex A shall be made without the prior written consent of the Parties. In case any such changes result in substantial differences in the cost of the Services, the final budget will be adjusted by an amount mutually agreed by the Parties in writing. In case of disagreement on the adjusted budget, the Parties may terminate the Agreement pursuant to art. 12 of this Agreement.

Any amendments must clearly specify the modifications requested both from a technical, scientific and economic point of view.

3.2 The Customer undertakes to supply IZSVe with UHN Proprietary Materials, as defined without limitation in Annex A, and for the entire duration of the Agreement and in the quantities necessary and sufficient for the execution of the Services. In the event that IZSVe considers UHN Proprietary Materials not suitable for the execution of the Services, it will promptly send a notice to obtain replacements thereof.

The IZSVe acknowledges and agrees (i) not to provide or disclose to any third Party, nor any person or entity other than Personnel who require the UHN Proprietary Materials to fulfill the Services and are obligated to maintain their confidential nature, the UHN Proprietary Materials without the Customer’s prior written consent;

(ii) not to use UHN Proprietary Materials to re-identify or contact any individual; and (iii) not to use any UHN Proprietary Materials in humans.

The IZSVe: (i) shall use UHN Proprietary Materials only to perform the Services in accordance with the Agreement; (ii) shall not chemically, physically, or otherwise modify UHN Proprietary Materials, except if specifically required in Annex A; (iii) shall handle, store, and dispose of UHN Proprietary Materials in compliance with all applicable local, state, laws, rules, and regulations including, but not limited to, those governing hazardous substances; (iv) shall not link, match, or combine UHN Proprietary Materials with any other information (including information that is available from third party sources) except if specifically required in Annex A; and (v) shall not make any attempts (whether directly or indirectly) to reverse engineer UHN Proprietary Materials, except if specifically required in Annex A.

3.3 Upon request of the Customer, the IZSVe shall communicate in writing the working progress of the Services rendered pursuant to this Agreement.

During the term of this Agreement, the Parties may meet periodically in order to check and/or clarify and/or update the Services’ working progress. The meetings will be held by videoconference or in any other convenient place as agreed by the Parties and they will be attended by the Personnel involved in the Services.

3.4 IZSVe agrees that (a) legal title to UHN Proprietary Materials will be unaffected by this Agreement or any provision of the foregoing to Personnel hereunder; and (b) the provision of UHN Proprietary Materials to Personnel does not grant IZSVe any additional rights in the foregoing other than as specifically set forth in this Agreement.

ART 4 CONSIDERATION

4.1 The Customer shall pay to IZSVe for all Services rendered pursuant to this Agreement a lump sum of Euro 5.000,00 (VAT excluded), plus reimbursement of travel/board expenses and shipping costs for the Raman instrument, against presentation of regular invoice.

The payment shall be made, upon completion of the requested Services, by bank transfer using the following bank details:

Beneficiary bank – Intesa San Paolo

Bank account – IBAN XX00X0000000000000000000000

BIC or SWIFT code – XXXXXXXX.

The Customer undertakes to make all payments due under this Agreement within 45 days after the receipt of the invoice by IZSVe.

All payments by the Customer shall constitute admission by the Customer as to the performance by IZSVe of its obligations under this Agreement.

In case the delay of payment exceeds one hundred and eighty (180) days, the IZSVe may terminate this Agreement pursuant to art.12 of this Agreement, without prejudice to its right to claim for further damages, if any.

4.2 In case laboratory/instrumental test and/or additional services/activities not included in the foreseen and agreed compensation fee are deemed necessary to perform the Services, the Parties may integrate this Agreement with an amendment that sets an increase of the agreed fee.

4.3 Expense for the shipment of the Raman instrument, as well as travel/board expenses for Personnel connected with the performance of the Services covered by this Agreement, shall be reimbursed by the Customer to IZSVe subject to the presentation of the related documentation.

ART 5 TERM

This Agreement shall be effective upon its execution and shall remain in force for 24 months, or in any case, until

i) the IZSVe completes the requested Services and ii) the Customer settles the corresponding compensation. Any variation of the duration of this Agreement, including its renewal or extension, shall be agreed upon by the Parties in writing, subject to the approval by their competent bodies.

ART 6 PRINCIPAL INVESTIGATOR

IZSVe hereby appoints dr. Xxxxxxxxxx Xxxx as its Principal Investigator. UHN appoints dr. Xxxxx Xxxxxxx-Xxxxx as its Principal Investigator.

If for any reason the appointed responsible is unable to continue to serve as Principal investigator, the name of the substitute shall be communicated to the other Party.

ART 7 WARRANTIES AND LIABILITY

7.1 Each Party represents and warrants that it is a duly organized entity and has power and authority to perform its obligations under this Agreement, and that this Agreement does not conflict with or violate any agreement with a third Party.

Customer and IZSVe declare that they will observe and comply with all applicable laws, rules and regulations. The Parties warrant that their entry into and performance under the terms of this Agreement will not knowingly infringe the rights of any third party or knowingly cause it to be in breach of any obligations to a third party.

7.2 The Customer acknowledges that the Services, the Results and the Foreground that may be achieved or in any case obtained are experimental and supplied without any explicit or implicit guarantee, such as, for example, guarantees of merchantability, suitability for a particular purpose.

Within the limits of Art. 1229 of the Italian Civil Code, if the Customer, under the Agreement or subsequent agreements, uses the Results, any Foreground or part of them in economic activities or, in any case, commercializes them directly or indirectly, the Customer – including third Parties entitled by the Customer itself

– shall be solely liable for any damages, direct or indirect, for any reason whatsoever, arising from such use or commercialization, the IZSVe being unassailable by any such liability claim. For such purpose, the Customer undertakes to substantially and procedurally indemnify, defend, and hold harmless the IZSVe against any and all losses, damages, liabilities, costs or expenses, including legal costs, arising from or in any way connected to claims, licenses or disputes by third Parties, relating to the use in economic activities or, in any case, to the commercialization of the Results, any Foreground or parts of them.

ART 8 TREATMENT OF CONFIDENTIAL INFORMATION

8.1 During the term of this Agreement and for a period of 60 months following its expiration (or upon termination of the Agreement) the IZSVe and the Customer agree also on behalf of their employees and/or agents:

a) to keep the utmost confidentiality and secrecy regarding any Confidential Information that such Party may become directly or indirectly aware of in connection with this Agreement, and not to disclose or communicate such information, in any manner whatsoever, to third Parties, without the prior written consent of the Disclosing Party;

b) to take all the precautions and employ any and all acts or activities reasonably necessary to ensure that Confidential Information is not freely accessible to third Parties;

c) to take any appropriate measure to ensure the protection and integrity of the Confidential Information (including but not limited to taking any reasonable measure to prevent and protect Confidential Information against theft, copy or reproduction or any unauthorized use, disclosure or dissemination);

d) not to use the Confidential Information for any purpose other than the Services without the prior written consent of the Disclosing Party;

e) to limit the communication of Confidential Information only to those members of its staff who need to have access thereto in order to properly perform the Services (and provided however that they are bound by the same confidentiality obligation in this Agreement). The Receiving Party is responsible to ensure that such staff comply with such confidentiality and non-disclosure obligations;

The Parties expressly agree that Confidential Information is relevant, essential and confidential and its disclosure would seriously affect the effectiveness and success of the Services, and that any breach of this clause constitutes a material breach of this Agreement.

In the event of termination of this Agreement for any reason and at any time, upon request of the Disclosing Party, the Receiving Party shall return to the Disclosing Party or destroy all documents and media containing the Confidential Information, as well as all originals, copies, extracts and summaries of documentary material and other manifestations of Confidential Information except for one (1) copy which may be retained in the legal files for evidentiary purposes only. Such retained copy shall remain subject to the confidentiality provisions in this Agreement despite its termination or earlier expiration. If not provided to the Disclosing Party, the aforementioned Confidential Information must be destroyed.

Notwithstanding the return or disposal of the Confidential Information, each Party will continue to be bound by its non-disclosure and confidentiality obligations and other obligations hereunder.

8.2 However, Confidential Information shall not be considered as such in case:

a) it is in the public domain prior to the disclosure by the Disclosing Party, or becomes public subsequently, without breach of this agreement;

b) it was known or used by the Receiving Party at the time or prior to its disclosure by the Disclosing Party to the Receiving Party, as evidenced by the Receiving Party's written records;

c) it is rightfully acquired by the Receiving Party from a Third Party not subject to confidential obligations towards the Disclosing Party and without restriction or violation of the Agreement;

d) is developed independently of the Receiving Party without use of or reference to the Disclosing Party's Confidential Information, as evidenced by the documents or other evidence in the Receiving Party's possession.

e) a Party is required to disclose the Confidential Information to the Judicial or Administrative Authorities by reason of an obligation under law or regulations, or by the Judicial or Administrative Authorities themselves;

in such case, the Party receiving the obligation shall promptly inform the other Party in writing prior to disclosure as to the timing and manner of such disclosure; if such prior notice is objectively impossible, notice shall be given immediately thereafter in order to limit disclosure as much as possible.

8.3 For the purposes of application of this article, Third Parties shall mean all the individuals other than the Parties who are not representatives, employees, collaborators or consultants of the Parties themselves. In any case, in relation to the individual Confidential Information that may be relevant from time to time, Third Parties shall also include the subjects indicated above in cases when, due to the nature of their relationship with the Parties, they have no reason or need to know one or more Confidential Information, or where the Party entitled to such information has expressly forbidden the communication of Confidential Information to their address.

ART 9. ACCESS RIGHTS TO KNOWLEDGE

9.1 Each Party is the owner of the intellectual and industrial property rights pertaining to its own Background and Sideground. The Parties mutually acknowledge that nothing in this Agreement shall be construed to directly or indirectly imply the transfer of any right on the Parties’ Background and/or Sideground.

The Parties, for the duration of this Agreement, mutually acknowledge the gratuitous and non-exclusive right, revocable and non-transferable to use their respective Backgrounds in the implementation of this Agreement, insofar as such use is necessary for the execution of the Services. Sub-licensing or transfer to third Parties under any title whatsoever of such Background is expressly forbidden.

On the other hand, the Sideground pertaining each Party may not be used by the other Party without the express authorization, in writing, of the holder thereof.

ART 10. UTILIZATION AND PUBLICATION OF RESULTS AND FOREGROUND

10.1 The Parties agree that the Results arising out of the performance of the Services shall be the sole and exclusive property of the Customer. Customer hereby grants IZSVe a non-exclusive and royalty-free license to Results for use for internal education and non-commercial research purposes. Should the Customer publish any Results in their entirety, Customer shall (a) identify IZSVe and all individuals designated by IZSVe in any such publication in accordance with scientific custom, and (b) share such publication with IZSVe.

10.2 The Parties agree that all Foreground shall be the sole and exclusive property of the Customer, and any copyrights in such Foreground shall be deemed “works made for hire”. To ensure compliance with this section, upon request by the Customer, IZSVe shall execute all such things (as may be required and on behalf of all employees, contractors, and agents working on behalf of IZSVe) to vest in the Customer all right, title, and interest in and to all Foreground.

10.3 The IZSVe warrants and represents that the use or exploitation by the Customer of any Results will not infringe any intellectual property rights of which a third Party is the proprietor including, in particular but without limitation, any patents, copyrights, registered designs or rights of confidence. The IZSVe undertakes not to oppose any of its prior intellectual property rights to the use and/or exploitation of the Results.

ART 11. USE OF TRADEMARKS

Neither Party shall use the name or the logo of the other Party, of its Principal Investigator or its employees in any publicity, new release, publication or advertising without the express prior written approval of the Party. The Parties acknowledge and agree that all intellectual property rights related to the logo will remain exclusive property of the owning Party; particularly, with no limitation, the usage of the logo of a Party by the other Party will not transfer to the using Party any rights or titles related to the logo.

ART 12. TERMINATION CLAUSE

12.1 The Parties expressly agree that this Agreement shall be deemed to be terminated by right pursuant to Article 1456 of the Italian Civil Code in the event of non-payment of the consideration, after 180 days from the date of receipt of the invoice, or if the Customer is subject to bankruptcy proceedings which are incompatible with the continuation of its business activity, pursuant to the current legislation. In this case, the termination shall occur as of right when the IZSVe, by registered mail with return receipt (A/R) declares to the Customer that it intends to avail itself of this clause.

12.2 In the hypothesis referred to in the preceding paragraph, the IZSVe reserves the right to take action to claim compensation for damages suffered for breach of Agreement.

12.3 Without prejudice to the provisions of this Agreement, either Party may terminate this Agreement for non- performance, pursuant to and in accordance with Article 1454 of the Italian Civil Code, by sending a written notice at least 30 (thirty) days in advance, if the other Party fails to comply with the obligations set forth in Articles 3 (subject matter), 7 (right of access to knowledge) 6 (treatment of confidential information) 9 (use of trademarks), which the Parties recognize as essential. The termination shall be effective upon receipt of the

notice. A Party's performance pending receipt of the notice of termination remedies the non-performance, but is without prejudice to the other Party's right to damages.

12.4 The termination of this Agreement for any reason whatsoever shall not affect any obligations already performed by the Parties nor any rights that expressly survive termination in accordance with the terms of this Agreement and applicable laws, including, without limitation, the Parties' rights and obligations regarding confidentiality, intellectual property rights, Results, and UHN Proprietary Materials.

12.5 UHN Proprietary Materials received by the IZSVe prior to receipt of notice of termination, which have not been used, shall be returned to the Customer at the cost and expense of the Party exercising the right to terminate. In the event of such termination, the IZSVe shall notify the Customer of and deliver the Results generated up to the date of termination. In the event of early termination, the Customer shall pay IZSVe a sum, which shall be less than the amount initially agreed, and which shall be agreed in writing between the Parties in proportion to the Services actually carried out by the IZSVe up to the date of termination.

12.6 The IZSVe also reserves the right to terminate this contract if there is a variation and/or change in the type, structure or set-up of the Customer, such as but not limited to mergers, demergers, incorporations, transformations or transfers of Customer branches; in each case of the foregoing that prevent the continuation of the Services.

ART 13. WITHDRAWAL

Each Party has the right to withdraw from this Agreement at any time, by giving twenty (20) days notice in writing, as forth in art. 19. The termination will not affect the obligations already performed by the Parties or whose performance is in progress at the time of termination.

ART 14. FORCE MAJEURE

14.1 A Party shall not be held responsible towards the other for the failure, inaccurate or delayed fulfillment of its obligations established in this Agreement in the event of a direct or indirect unforeseeable circumstance, force majeure or any other cause not attributable to the Party.

14.2 For the purposes of this clause, by way of example and not exhaustive, “Force Majeure event” shall include any event (i) beyond the control of either Party (ii) that may prevent this Party from fulfilling its obligations under this Agreement, (iii) which could not have been reasonably foreseen when the Agreement was executed, and (iv) whose effects cannot be avoided by appropriate measures. For example but not exhaustive: natural disasters, fires, floods, wars (declared or undeclared), civil uprisings, riots, embargoes, sabotage, accidents, labor disputes, strikes, provisions of any public or governmental authority, including applicable laws, ordinances, rules and regulations.

In the event of such Force Majeure, the affected Party shall promptly notify the other Party in writing. If the force majeure lasts more than 90 days, the Party unaffected by the Force Majeure shall have the right to terminate the Agreement; the notice of termination shall be made according to Article 19 of this Agreement.

ART 15. SAFETY HEALTH CARE AND INSURANCE

Except in cases of willful misconduct or gross negligence, the Parties mutually release and hold harmless each other from any liability for any harmful event that may occur to the personnel of one Party during their stay at the other Party’s premises.

ART 16. TREATMENT OF PERSONAL DATA

16.1 In compliance with the conditions set forth in the EU General Data Protection Regulation 2016/679 (GDPR), the Parties mutually undertake to process and, if necessary, to communicate to third Parties the personal data contained in this Agreement, or in any case acquired during its execution, for the sole purpose of fulfilling the commitments undertaken thereunder or for the fulfilment of the obligations connected therewith.

The data provided by the Parties shall be collected and processed by manual, paper and computerised means, by means of their inclusion in paper and/or computer files.

By signing this deed, the Parties express their consent to the processing and communication of their personal data in the manner and for the purposes described above.

16.2 Each Party may exercise its rights of access, rectification and cancellation, opposition and right to limit the processing of personal data collected by the other Party.

The IZSVe may exercise its rights by contacting xxxxxxx@xxx.xx .

The Customer may exercise its rights by contacting xxx@xxxxxxxxxx.xx .

16.3 In the event a Party becomes aware of an actual or potential breach of security (including, without limitation, any destruction, loss, accidental or intentional alteration, unauthorised disclosure of, or access to,

personal data) involving the other Party's premises, networks, or systems or those of any of its employees, agents, representatives, and/or consultants and any affiliates that may be affected by this Agreement, that Party

(a) shall immediately inform the other Party of its knowledge of the breach;

(b) shall assist the other Party in investigating, remediating, and taking any action that the Parties deem necessary with respect to the breach and the affected personal data.

ART 17. GOVERNING LAW AND DISPUTE RESOLUTION

The Parties shall attempt in good faith to resolve any dispute arising out of or relating to this Agreement promptly by negotiation. Any Party may give the other Party written notice of any dispute not resolved in the normal course of business. Within 15 days after delivery of the notice, the receiving Party shall submit to the other a written response. In the event of continuing disagreement, any proceedings relating to any claim or matter arising under or in connection with this Agreement or the legal relationship established by this Agreement instituted against the Customer by IZSVe shall be brought in the courts of the Province of Ontario, Canada (and the courts competent to hear any appeal therefrom), and any such proceedings against IZSVe by the Customer shall be brought in the courts of the IZSVe country of domicile.

ART 18. ANTI- CORRUPTION AND CODE OF CONDUCT

18.1 The Customer declares that it has read the Code of Ethics and Conduct of the IZSVe, approved by DCA No. 12/2017, to adhere to the principles contained therein and to observe, to the extent compatible, the rules set forth therein.

18.2 The Parties undertake to comply with the national legislation on the prevention of corruption (Law n. 190/2012 and subsequent amendments) and mutually undertake to immediately inform the other Party of any possible violation of this article and will make available all information and documentation for any appropriate verification

18.3 Any violation of this article by the IZSVe or the Customer constitutes a breach of the Agreement and will allow IZSVe and the Customer to terminate the agreement with immediate effect, pursuant art. 12.

IZSVe reserves the right, at its sole discretion, not to proceed or to suspend this Agreement if:

- It believes that a conflict of interest may arise between public and private activities;

- It recognizes a possible prejudice or damage to the image or to its initiatives or activities.

The Customer must not in any way cause prejudice or harm the ethic of the primary institutional public function of the IZSVe and must not expose it to the risk of appearing unduly influenced by private interests of an advertising and commercial nature.

ART 19. MISCELLANEOUS

19.1 The delay or failure of either Party to enforce at any time or for any period of time any of the provisions of this Agreement shall not be construed as a waiver of such provisions or of the right of the Party to thereafter seek their enforcement.

19.2 The Parties claim that, to their knowledge, all rights that allow the signing and performance of this agreement and that allow the other Party to perform the obligations set forth herein belong to them. The Parties warrant that their entry into and performance under the terms of this Agreement will not knowingly infringe the rights of any third party or knowingly cause it to be in breach of any obligations to a third party.

19.3 With regard to the real purpose pursued by the Parties, if, after the conclusion of this Agreement, one or more clauses should prove to be invalid or void, in whole or in part, the Agreement shall remain valid and the clauses found to be invalid or void shall be replaced by fully valid and effective provisions, unless such clauses are of an essential nature.

19.4 IZSVe and the Customer will act all times as independent contractors. Nothing contained herein shall be construed or applied so as to create the relationship of principal and agent or of employer and employee between IZSVe and the Customer or any partnership or joint-venture. Except as expressly provided under this Agreement, neither Party shall make any commitment or incur any charge or expense in the name of the other Party.

19.5 This Agreement and the rights and duties set forth herein may not be assigned, transferred, delegated or sub-contracted by either Party without the written consent of the other Party. Any such assignment or transfer shall be null and void.

19.6 This Agreement may be amended, modified, superseded or canceled, only by a written instrument executed by each Party’s duly authorized representatives.

19.7 All notices and communications related to this agreement shall be made by registered letter, return receipt requested, telecopier or electronic transmission confirmed in writing by register letter and shall be addressed as follows (or to other address as may hereafter be designed by written notice):

If to IZSVe: Att. Servizio Affari generali Anticorruzione e Trasparenza Istituto Zooprofilattico Sperimentale delle Venezie

e-mail: xxxxxxxxxx@xxxxxxxxxx.xx

If to the Customer: Att. UHN Research Procurement e-mail: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx@xxx.xx

ART 20. VAT, REGISTRATION FEE AND TAX DUTIES

The services covered by this Agreement are subject to VAT according to Italian law (D.P.R. n. 633/1972 and its amendments) in compliance with the EU single market rules. The registration fee is due just in the event of judicial or administrative use, as set forth in Italian law (D.P.R. n. 131/1986) and costs and expenses will be borne by the requesting Party.

This Agreement is signed with a digital signature pursuant to Article 24 of Legislative Decree No. 82 of 7 March 2005, with an advanced electronic signature pursuant to Article 1, paragraph 1, letter q-bis) of Legislative Decree No. 82 of 7 March 2005 or with another qualified electronic signature as provided by Law No. 221 of 17.12.2012.

ART 21. NEGOTIATIONS

The Parties expressly declare that this Agreement has been negotiated in its entirety and in each and every part. Therefore, Articles 1341 and 1342 of the Italian Civil Code shall not apply.

This deed, for the use of IZSVe and the Customer, is read, confirmed and signed.

[SIGNATURE PAGE TO FOLLOW]

IN WITNESS WHEREOF, the Parties have caused this agreement to be executed by their duly authorized representatives.

This agreement is made at the date and place of the last signature.

IZSVe University Health Network

Director General Executive Vice President, Science & Research

Dr. Xxxxxxx Xxxxx Dr. Xxxxxx X. Xxxxxxx

Technical Annex – Annex A

Statement of work (Service Agreement)

On site data collection and data analysis services

Between University Health Network (Zarrine-Afsar group) and Istituto ZooprofilatticoSperimentale delle Venezie.

Scientific goals:

1. The Zarrine-Afsar laboratory at University Health Network (UHN) is developing a laser-based mass spectrometry system for rapid characterization and discrimination of cancerous human tissues.

2. Zarrine-Afsar laboratory has obtained institutional ethics approvals to compare the performance of the laser mass spectrometry method to Raman spectrometry using human specimens of lung and brain cancers (under institutional approvals UHN REB 22-5954.4 and 21-5929.8, anonymized specimens wherein for each only the histological subclass/type of cancer is known).

3. The Istituto Zooprofilattico Sperimentale delle Venezie is a fee-for-service entity that possesses a portable Raman spectrometer with additional expertise in hardware operation, data collection and Raman data analysis.

Resources:

(A) Istituto Zooprofilattico Sperimentale delle Venezie will send a scientific associate alongside the portable Raman spectrometer instrument (Bravo handheld Raman spectrometer by Bruker) to UHN for data collection alongside the data collection (Opus by Xxxxxx) and the data analysis software (R package).

(B) The Zarrine-afsar group grants access to 100 human lung and brain cancer specimens, gloves, laboratory coats and a functional biological safety cabinet (BSC) for the collection of Raman data from risk-group level 2 human specimens approved in UHN REB 22-5954.4 and 21-5929.8.

Activities:

(D) The Zarrine-Afsar laboratory will obtain the necessary ethics approval for animal work as well as ensures approvals for human tissue work above remain valid and in place.

(E) The scientific associate will optimize the Raman method on site at UHN and will collect Raman data from both human and xenograft tissues.

(F) The data will be visualized on site using the Opus software.

(G) The generated data will be analyzed by Istituto Zooprofilattico Sperimentale delle Venezie staff with a custom R data analysis package remotely via TeamViewer without being transported off UHN for modeling and statistical analysis. As such, the generated Raman data does not leave UHN and is only viewed remotely by said staff.

(H) The Istituto Zooprofilattico Sperimentale delle Venezie will transfer the statistical analysis and modeling results to UHN in the form of a final report.

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ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE

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