ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE

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 L D I R E T T O R E G E N E R A L E

N. 77 del 27/02/2020

OGGETTO: Approvazione dello schema di contratto c.d. ``Biological Material Transfer Agreement for research purposes`` tra l`IZSVe, quale Laboratorio di referenza OIE per la Salmonellosi e Animal & Plant Health Agency per la cessione di ceppi di salmonella kentucky

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 DEL DIRETTORE GENERALE

OGGETTO: Approvazione dello schema di contratto c.d. ``Biological Material Transfer Agreement for research purposes`` tra l`IZSVe, quale Laboratorio di referenza OIE per la Salmonellosi e Animal & Plant Health Agency per la cessione di ceppi di salmonella kentucky

Si sottopone al Direttore generale f.f. la seguente relazione del Responsabile della SS Affari Generali, Anticorruzione e Trasparenza.

Si premette che:

- ai sensi dell’art. 1, comma 6, del D.Lgs. n. 270/1993 e dell’art. 9, comma 2, del D.Lgs. n. 106/2012 “Gli Istituti, in relazione allo svolgimento delle loro competenze, possono 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 […]”;

- l’Istituto Zooprofilattico Sperimentale delle Venezie, nel quadro dei propri compiti istituzionali – di cui all’art. 3, dell’Accordo sulla gestione dell’IZSVe 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 – provvede all’effettuazione di ricerche di base e finalizzate per lo sviluppo delle conoscenze nell’igiene e sanità veterinaria, nella sicurezza alimentare e nutrizione, secondo programmi e anche mediante convenzioni con università e istituti di ricerca italiani e stranieri, nonché su richiesta dello Stato, delle Regioni, delle Province autonome e di enti pubblici e privati;

- presso l’IZSVe è attivo il “Centro di Referenza Nazionale per le Salmonellosi” che è stato istituito con decreto del Ministero della Salute del 4 ottobre 1999; dal 2006 è stato designato anche come “Laboratorio nazionale di riferimento per la salmonellosi” e dal

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X.X.X.Xx – Deliberazione del DIRETTORE GENERALE

2007, è stato inoltre riconosciuto dall’Organizzazione mondiale della Sanità Animale (OIE) come “Laboratorio di referenza OIE per le salmonellosi”. In tale ambito il laboratorio fornisce supporto diagnostico, consulenza, attività di formazione ai paesi membri dell’OIE.

Nell’ambito delle suddette funzioni, con nota del 22.1.2020, acquisita a ns. prot. n. 1024 del 24.1.2020, the Secretary of State for Environment Food and Rural Affaires of Nobel House tramite Animal Plant Health Agency (APHA) con sede in Addlestone (United Kingdom), ha richiesto di addivenire alla stipula di un contratto per il trasferimento di isolati di Salmonella Kentucky conservati presso la ceppoteca del Centro di Referenza Nazionale IZSVe da utilizzare per finalità di ricerca.

Il Ministero della Salute – Direzione generale della sanità animale e de farmaci veterinari, con nota prot. n. 4227 del 21.02.2020 trasmessa a mezzo PEC e acquisita a ns. prot. n. 2062 di pari data, ha autorizzato l’invio del materiale in parola.

Pertanto, al fine di formalizzare il rapporto, l’IZSVe e Animal Plant Health Agency hanno concordato lo schema di contratto in lingua inglese cd “Biological Material Trasfer Agreement for research purposes” per la fornitura del materiale biologico specificatamente descritto nelle premesse del predetto accordo che si allega al presente provvedimento quale parte integrante e sostanziale (allegato n. 1).

Con ticket intranet n. 141481, la Dott.ssa Xxxx Xxxxx, Dirigente Veterinario, Direttore della “SCS1 – Analisi del Rischio e Sorveglianza in Sanità Pubblica” dell’IZSVe ha richiesto a questa Struttura di procedere con gli adempimenti necessari alla sottoscrizione del contratto in parola.

L’IZSVe con il predetto contratto, la cui efficacia decorrerà dalla data di sottoscrizione e fino al completamento delle attività di ricerca, si impegna a fornire il suddetto materiale biologico a titolo gratuito, salvo il costo per le spese di spedizione che saranno sostenute dall’Agenzia.

Tutto ciò premesso, sulla base degli elementi riportati dal referente dell’istruttoria, si propone al Direttore generale f.f. quanto segue:

1. di approvare lo schema di contratto in lingua inglese, cd “Biological Material Transfer Agreement for research purposes” da sottoscrivere tra l’IZSVe, nella persona del Direttore generale e legale rappresentante pro tempore, dr.ssa Xxxxxxx Xxxxx, e the Secretary of State for Environment Food and Rural Affaires of Nobel House tramite Animal Plant Health Agency nella persona del dr. Xxxxxxx Xxxxxx, head of Business Development, documento che 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;

3. di prendere atto che l’IZSVe con il predetto contratto, con efficacia decorrente dalla data di sottoscrizione e fino a completamento delle attività di ricerca da parte di APHA, si impegna a fornire alla controparte il materiale biologico indicato all’art. 1 del predetto contratto a titolo gratuito, salvo il costo per le spese di spedizione che saranno a carico del ricevente.

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

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X.X.X.Xx – Deliberazione del DIRETTORE GENERALE

IL DIRETTORE GENERALE F.F.

ESAMINATA la proposta di deliberazione del Responsabile della SS Affari Generali Anticorruzione e Trasparenza che attesta la regolarità della stessa in ordine ai contenuti sostanziali, formali e di legittimità dell’atto, attestazione allegata al presente provvedimento.

VISTA l’attestazione di copertura della spesa, ove prevista, allegata al presente provvedimento.

VISTA la DDG n. 164 del 27 marzo 2018 con la quale la dott.ssa Xxxxxxx Xxxxx è stata nominata Direttore sanitario dell’Istituto.

VISTA la DDG n. 166 del 11 aprile 2019 avente ad oggetto “Applicazione dell’art. 3, comma 6, del D.Lgs. 502/1992 e s.m.i. e dell’art. 16, comma 5, dell’Accordo per la gestione dell’Istituto tra la Regione Veneto, la Regione Autonoma Friuli-Venezia Giulia, la Provincia Autonoma di Bolzano e la Provincia Autonoma di Trento, approvato con atto normativo degli Enti cogerenti. Presa d’atto” con la quale si prende atto che, a decorrere dal 13 aprile 2019, le funzioni di Direttore generale sono svolte dal Direttore sanitario ai sensi delle sopracitate disposizioni.

VISTA la DDG n. 332 del 22 luglio 2016 con la quale il Xxxx. Xxxxx Xxxxxxxx è stato nominato Direttore amministrativo dell’Istituto.

ACQUISITO il parere favorevole del Direttore amministrativo per quanto di competenza, espresso ai sensi dell’art. 15, comma 3, dello Statuto dell’Istituto, adottato con DCA n. 16 del 3 agosto 2015 e approvato con DGRV n. 1320 del 9 ottobre 2015.

VISTO l’art. 15 del D.Lgs. n. 106 del 28 giugno 2012 il quale, al primo comma, dispone che “… Gli organi degli Istituti in carica alla data di entrata in vigore del presente decreto sono prorogati sino all’insediamento dei nuovi organi”.

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

1. di approvare lo schema di contratto in lingua inglese, cd “Biological Material Transfer Agreement for research purposes” da sottoscrivere tra l’IZSVe, nella persona del Direttore generale e legale rappresentante pro tempore, dr.ssa Xxxxxxx Xxxxx, e the Secretary of State for Environment Food and Rural Affaires of Nobel House tramite Animal Plant Health Agency nella persona del dr. Xxxxxxx Xxxxxx, head of Business Development, documento che si allega al presente provvedimento quale parte integrante e sostanziale (allegato n.1);

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X.X.X.Xx – Deliberazione del DIRETTORE GENERALE

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;

3. di prendere atto che l’IZSVe con il predetto contratto, con efficacia decorrente dalla data di sottoscrizione e fino a completamento delle attività di ricerca da parte di APHA, si impegna a fornire alla controparte il materiale biologico indicato all’art. 1 del predetto contratto a titolo gratuito, salvo il costo per le spese di spedizione che saranno a carico del ricevente.

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.

IL DIRETTORE GENERALE F.F.

Dott.ssa Xxxxxxx Xxxxx

Sul presente atto deliberativo ha espresso parere favorevole Il Direttore amministrativo

xxxx. Xxxxx Xxxxxxxx

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X.X.X.Xx – Deliberazione del DIRETTORE GENERALE

ATTESTAZIONI ALLEGATE ALLA DELIBERAZIONE DEL DIRETTORE 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 x

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.

Dott.ssa Xxxxxx Xxxxxxxx

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ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE

Viale dell’Università 10 – 00000 XXXXXXX (XX)

DELIBERAZIONE DEL DIRETTORE GENERALE N. 77 del 27/02/2020‌

OGGETTO: Approvazione dello schema di contratto c.d. ``Biological Material Transfer Agreement for research purposes`` tra l`IZSVe, quale Laboratorio di referenza OIE per la Salmonellosi e Animal & Plant Health Agency per la cessione di ceppi di salmonella kentucky

Pubblicata dal 28/02/2020 al 14/03/2020 Atto immediatamente esecutivo

Il Responsabile della Pubblicazione Xxxxx Xxxxxxx

Elenco firmatari

Questo documento è stato firmato da:

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

Dott.ssa Xxxxxxx Xxxxx - Direzione Generale Xxxxx Xxxxxxx - - Gestione Atti

BIOLOGICAL MATERIAL TRANSFER AGREEMENT FOR RESEARCH PURPOSES

Istituto Zooprofilattico Sperimentale delle Venezie, with offices at Xxxxx xxxx’Xxxxxxxxxx 00, 00000 Xxxxxxx (XX), Xxxxx, fiscal code and VAT n. 00206200289, PEC: xxxxxxxxxx@xxxxxxxxx.xxx, represented by Dr. Xxxxxxx Xxxxx, in her capacity as Acting Director General (Direttore Generale), fiscal personal code n. RCCNTN67B42G224Ereinafter referred to as “IZSVe” or “Provider”

and

The Secretary of State for Environment, Food and Rural Affairs of Nobel House, 00 Xxxxx Xxxxxx, Xxxxxx XX0X 0XX (“the Secretary of State”) acting through the Animal and Plant Health Agency, Addlestone, Surrey, United Kingdom represented by dr. Xxxxxxx Xxxxxx, in his capacity as acting Head of Business Development

herein referred to as “Recipient” and jointly as “ Parties”

This Agreement sets out the understanding of the Parties with respect to the provision of certain biological material to the Recipient, which wishes to use the material for non- commercial evaluation purposes only subject to the terms and conditions of this Agreement.

WHEREAS:

• IZSVe is a public veterinary Institute which conducts prevention, control and research activities in three main areas: animal health and welfare, food safety, and environmental protection;

• Animal and Plant Health Agency is engaged in safeguarding animal and plant health for the benefit of people, the environment and the economy.

• IZSVe agrees to transfer to Recipient the following biological material;

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. DEFINITIONS

The above mentioned words have the following meanings in this Agreement:

“Effective data”: the date as of which the Agreement enters into force.

“Commercial Purposes”: the sale of products or services, lease, license, or other transfer of the Material or Modifications for any commercial purpose or for the direct benefit of any for- profit entity, including use of the Material or Modifications by any organization, including Recipient, to perform research for third parties who obtain rights in research results, to screen compounds, to produce or manufacture products for general sale, or to conduct any research activities that result in any sale, lease, license, or transfer of the Material or Modifications to a for-profit entity.‌

“Confidential Information”: Information of any nature protected or not by an intellectual property right (data, documents, methods, know-how, etc.) whatever their subject, transmission mode, origin, communicated within the frame of this Agreement. The Material is Confidential Information. Confidential information does not include information that:

i. is already known by the Party to which it is disclosed;‌

ii. is or becomes part of the public domain without breach of this Agreement;

iii. is obtained from third parties that have no obligation to keep confidential to the parties to this Agreement;

iv. is independently developed by the receiving party or its parent corporation or their respective subsidiaries and/or affiliates without the aid, application or use of the Confidential Information (and such independent development can be properly demonstrated by the receiving party); or,

v. is required by law, regulation, rule, act or order of any governmental authority or agency to be disclosed by the receiving party, provided, however, that such receiving party

(A) gives the disclosing party sufficient advance written notice to permit it to seek a protective order or other similar order with respect to such Confidential Information and (B) thereafter discloses only the minimum information required to be disclosed in order to comply, whether or not a protective order or other similar order is obtained by such disclosing party.

“Original Material”: the Material to be delivered from IZSVe to the Recipient under the term of this Agreement is as below specified.

S/N	CODE	STATE OF ORIGIN	TYPE OF SAMPLE	Number.	Serotype
1	OG 70 WR2	OGUN	WATER	34	S.KENTUCKY
2	OG 79 FAT4	OGUN	FEACAL	96	S.KENTUCKY
3	OG59 WT2	OGUN	WATER	99	S.KENTUCKY
4	OG 68 FAT4	OGUN	FEACAL	272	S.KENTUCKY
5	OG 79 BST4	OGUN	BOOTSWABS	274	S.KENTUCKY
6	OG 68 BST4	OGUN	BOOTSWABS	275	S.KENTUCKY
7	OG 95 BST4	OGUN	BOOTSWABS	277	S.KENTUCKY
8	OG 35 DT2	OGUN	DUST	281	S.KENTUCKY
9	OG 67 DR2	OGUN	DUST	287	S.KENTUCKY
10	OG 67 FAT2	OGUN	FEACAL	290	S.KENTUCKY
11	OG 86 BST3	OGUN	BOOTSWABA	407	S.KENTUCKY
12	OG 54 FAT3	OGUN	FEACAL	408	S.KENTUCKY
13	OG 38 WR1	OGUN	WATER	412	S.KENTUCKY
14	OG 54 FAT 4	OGUN	FEACAL	414	S.KENTUCKY
15	EN 7 FAT4	ENUGU	FEACAL	425	S.KENTUCKY
16	EN 4 DT3	ENUGU	DUST	428	S.KENTUCKY
17	EN 4 FER2	ENUGU	FEED	429	S.KENTUCKY
18	EN 3 FAR4	ENUGU	FEACAL	430	S.KENTUCKY
19	EN 3 FER4	ENUGU	FEED	431	S.KENTUCKY
20	EN 32 DT3	ENUGU	DUST	437	S.KENTUCKY
21	EN 38 FET3	ENUGU	FEED	441	S.KENTUCKY
22	RV 17 FET4	RIVERS	FEED	478	S.KENTUCKY
23	PL 80 WT2	PLATEAU	WATER	2459	S.KENTUCKY
00	XX 00 XXX0	XXXXXXX	XXXXXX	2542	S.KENTUCKY
25	PL 19 D3	PLATEAU	DUST	2544	X.XXXXXXXX
00	XX 00 DR2	PLATEAU	DUST	2548	X.XXXXXXXX
00	XX 00 FER2	PLATEAU	FEED	2550	S.KENTUCKY
28	PL 80 BST3	PLATEAU	BOOT SWAB	2554	S.KENTUCKY
29	PL 25 DR3	PLATEAU	DUST	2555	S.KENTUCKY
30	PL 72 WR2	PLATEAU	WATER	2557	S.KENTUCKY
31	PL 81 BSR3	PLATEAU	BOOT SWAB	2558	X.XXXXXXXX
00	XXX. XX 80 FET3	NIGERIA	AVIAN SOURCES	14SAL/2037	X.XXXXXXXX
00	XXX. XX 22 FER	NIGERIA	AVIAN SOURCES	14SAL/2514	S.KENTUCKY
00	XXX. XX 00 XXX0	XXXXXXX	AVIAN SOURCES	14SAL/2515	X.XXXXXXXX
00	XXX. XX 55 FAR	NIGERIA	AVIAN SOURCES	14SAL/2546	S.KENTUCKY
36	RIF. GM 1	NIGERIA	AVIAN	14SAL/2550	X.XXXXXXXX

	XXX0		XXXXXXX
00	XXX. XX 00 XXX0	XXXXXXX	AVIAN SOURCES	14SAL/2907	X.XXXXXXXX
00	XXX. XX 0 XXX0	XXXXXXX	AVIAN SOURCES	14SAL/2909	S.KENTUCKY
39	RIF. BA 6 WR2	NIGERIA	AVIAN SOURCES	14SAL/2922	X.XXXXXXXX
00	XXX. XX 0 XXX0	XXXXXXX	AVIAN SOURCES	14SAL/2923	X.XXXXXXXX
00	XXX. XX 0 XXX0	XXXXXXX	AVIAN SOURCES	14SAL/2944	X.XXXXXXXX
00	XXX. XX 0X XXX0	XXXXXXX	AVIAN SOURCES	14SAL/2945	X.XXXXXXXX
00	XXX. XX 0 XXX0	XXXXXXX	AVIAN SOURCES	14SAL/3083	X.XXXXXXXX
00	XXX. XX 0 XXX0	XXXXXXX	AVIAN SOURCES	14SAL/3088	X.XXXXXXXX
00	XXX. XX 00 XXX0	XXXXXXX	AVIAN SOURCES	14SAL/3097	S.KENTUCKY
46	RIF. KT 4 BST2	NIGERIA	AVIAN SOURCES	14SAL/3110	S.KENTUCKY
47	RIF. KD 64 WT4	NIGERIA	AVIAN SOURCES	14SAL/3480	S.KENTUCKY
48	RIF. KD 37 BST3	NIGERIA	AVIAN SOURCES	14SAL/3482	X.XXXXXXXX
00	XXX. XX 0 XXX0	XXXXXXX	AVIAN SOURCES	14SAL/3485	X.XXXXXXXX
00	XXX. XX 000 XX0	XXXXXXX	AVIAN SOURCES	14SAL/3490	X.XXXXXXXX
00	XXX. XX 00 XX0	XXXXXXX	AVIAN SOURCES	14SAL/3497	X.XXXXXXXX
00	XXX. XX 00 XXX0	XXXXXXX	AVIAN SOURCES	14SAL/3498	X.XXXXXXXX
00	XXX. XX 00 XX0	XXXXXXX	AVIAN SOURCES	14SAL/3503	S.KENTUCKY
54	RIF. KD 4 DR2	NIGERIA	AVIAN SOURCES	14SAL/3523	X.XXXXXXXX
00	XXX. XX 00 XX0	XXXXXXX	AVIAN SOURCES	14SAL/3667	X.XXXXXXXX
00	XXX. XX 00 XXX0	XXXXXXX	AVIAN SOURCES	14SAL/3683	S.KENTUCKY
57	RIF. KD 109 FAT3	NIGERIA	AVIAN SOURCES	14SAL/3685	X.XXXXXXXX
00	XXX. XX 0 XXX0	XXXXXXX	AVIAN SOURCES	14SAL/3691	X.XXXXXXXX
00	XXX. XX 00 XXX0	XXXXXXX	AVIAN SOURCES	14SAL/3708	S.KENTUCKY
60	RIF. KN 22 DR3	NIGERIA	AVIAN SOURCES	14SAL/4075	X.XXXXXXXX
00	XXX. XX 00	XXXXXXX	AVIAN	14SAL/4078	S.KENTUCKY

	BST2		SOURCES
62	RIF. KN 11 DR3	NIGERIA	AVIAN SOURCES	14SAL/4095	S.KENTUCKY
63	RIF. KN 11 DR4	NIGERIA	AVIAN SOURCES	14SAL/4101	X.XXXXXXXX
00	XXX. XX 00 XX0	XXXXXXX	AVIAN SOURCES	14SAL/4109	S.KENTUCKY

“Material”: Original Material, Progeny and Unmodified Derivatives, but does not include Modifications or other substances created by the Recipient through the use of the Material. “Progeny”: an unmodified descendant from the Material, such as virus from virus, cell from cell, or organism from organism.‌

“Unmodified Derivatives”: substances created by the Recipient which constitute an unmodified functional subunit or product expressed by the Original Material (for example subclones of unmodified cell lines, purified or fractionated subsets of the Original Material, proteins expressed by DNA/RNA supplied by the Provider, or monoclonal antibodies secreted by a hybridoma cell line).

“Modifications”: substances created by the Recipient which contain or incorporate the Material.

“Patent Rights”: any patents, patent applications, trade secrets or other proprietary rights of the Provider having claims relating to the Original Material, including any altered forms of the Material made by the Provider, and any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates or the like, or provisional applications of any such patents and patent applications, or foreign equivalents thereof.

“Provider's Scientist”: the employees of IZSVe.

“Recipient’s scientist”: the employees of the Recipient.

“Research activities”: (described in Annex 1) description of the experiments planned with the Material.

ART. 2. MATERIAL TRANSFER

IZSVe shall supply the Recipient the Original Material within thirty (30) days after the execution of this Agreement by both Parties and received by IZSVe.

The Recipient will contact IZSVe, in particular the contact specified at the end of this agreement, to arrange the date(s) of shipment.

Subject to the terms and conditions herein, the Provider grants to the Recipient a royalty-free, non exclusive license to use the Material solely in performance of the Research activities described in Annex 1 – Description of activities. The Recipient agrees that the Material:

a) will not be used for Commercial Purposes; any commercial use of the Material is strictly forbidden. The Recipient undertakes not to sell, disclose, transfer, give or distribute the Material to any third party.

b) will not be used in human subjects, in clinical trials, or for diagnostic purposes involving human subjects without the Provider's prior written consent;

c) will be used only at the Recipient organization and only in the Researcher's laboratories under the direction of the Researcher or others working under his or her direct supervision.

d) will not be further transferred without the Provider's prior written consent.

The Recipient will refer any request for the Material from anyone other than those persons working under the Researcher's direct supervision to the Provider's Scientist.

Upon request, the Recipient will provide to IZSVe with a summary of the Research Activities obtained with the Material.

The Recipient will use the Material and Modifications in compliance with all English laws and governmental regulations and guidelines applicable to the Material and Modifications.

The Recipient shall ensure that the Recipient's employees, students and agents using the Material and Modifications agree to be bound by the terms of this Agreement.

ART. 3. FEE AND PAYMENT

The Material for the Research activities is provided for free. Shipping costs will be charged on the Recipient.

ART. 4. USE OF THE MATERIAL AND INTELLECTUAL PROPERTY

The Material is owned by the Provider who maintains the ownership of the Material, including any Material contained or incorporated in Modifications

The Material will be used by the Recipient solely and strictly in connection with performing the Research activities at Recipient’s institutional facilities and under the direction of Recipient’s Scientist only.

No rights are provided to Recipient under any patent applications, trade secrets or other proprietary rights of IZSVe. In particular, no rights are provided to use the Material or Modifications for profit-making or commercial purposes, or provision of a commercial service based upon the Material or Modifications. The Material shall not be incorporated into any service or product for sale, or used for the commercial provision.

If Recipient desires to use the Material or Modifications for such profit-making or commercial purposes, Recipient agrees that it must first negotiate a license or other appropriate agreement with IZSVe and third parties as may be required, and it is further understood by Recipient that IZSVe shall have no obligation to enter into such a license or agreement.

The Recipient may distribute substances created by the Recipient through the use of the Original Material only if those substances are not Progeny, Unmodified Derivatives, or Modifications with prior written notice to the Provider.

No patent applications may be filed by the Recipient claiming inventions made by the Recipient through the use of the Materials without written consent of the Provider

Except as provided in this Agreement, no express or implied licenses or other rights are provided to the Recipient under the Patent Rights. In particular, no express or implied licenses or other rights are provided to use the Material, Modifications, or any related patents of the Provider for Commercial Purposes.

Otherwise any results as well as any know-how, discoveries, inventions and other intellectual property generated by the Recipient through the use of the Material permitted by this Agreement, will be owned by the Recipient.‌

The Recipient shall destroy the Material and Modifications after completion of Research purpose.

ART. 5. LIABILITY

By requesting the Material and signing this Agreement, the Recipient accepts responsibility for the proper handling and testing of the Material in accordance with generally accepted international scientific standards, including any disposition and guidelines regarding

biosecurity, biosafety, health and scientific research. The Recipient guarantees that suitable handling and containment conditions are available and will be applied in the Recipient’s laboratory.

The Recipient represents that within its laboratories:

- the access to the Material and to Modifications will be restricted to personnel capable and qualified to safely handle those substances, using appropriate containment;

- the Recipient shall use the utmost precaution to minimise any risk of harm to persons and property and to safeguard them from theft or misuse.

The Recipient assumes all liability for any and all third party damages and claims arising out of or relating to this Agreement, including the receipt, use, handling, storage, conservation of the Material and Modifications.

The Recipient agrees to indemnify, defend and hold harmless IZSVe and its employees from and against any third party claims, losses, costs, expenses and damages, including reasonable attorneys' fees which may incur, suffer or be required to pay resulting from or arising in connection with the use, handling or storage of Material or Modifications by the Recipient or the Recipient’s personnel, or the breach of any obligation of the Recipient hereunder. Such indemnity shall be subject to IZSVe’s prior notification to Recipient of any potential claim and shall exclude any claim resulting from IZSVe’s negligence or willful misconduct.

ART. 6. WARRANTY

The Recipient acknowledges that the Material are supplied to the Recipient with no information on their use, warranties, express or implied, including but not limited to any warranty of fitness for a particular purpose.

However IZSVe represents and warrants to the Recipient that its execution will not result in a breach of any obligation to any third party or infringe or otherwise violate any third party’s rights. There are no express or implied warranties that the Material and/or Modifications will not pose a safety or health risk.‌

If the Material is not available for use or not delivered in sufficient amounts, the Recipient shall send a written notification to IZSVe within ten (10) days after the receipt of the Material (or in case non-delivery of Material, within ten (10) days of the agreed date of shipment). In these cases, IZSVe shall replace the Material only. This warranty is valid if the Recipient ensures that the Material has been stored or processed as indicated in the documents that will accompany it.

Each Party warrants and represents that it has the right to enter into this Agreement.

ART. 7. INTELLECTUAL PROPERTY RIGHTS

IZSVe is the owner and has all the rights on the Material, Progeny and Unmodified Derivatives. The transfer does not grant or imply the ownership of the Material, or any intellectual and industrial property rights to the Recipient.

ART. 8. TERM AND TERMINATION

This Agreement is effective when signed by both parties and terminates on completion of the Recipient’s Research activities using the Material.

Before the Material’s shipping to the Recipient, the Agreement may be terminated on thirty

(30) days written notice by either party to the other. This Agreement may be also terminated immediately by the Provider if the Recipient has not cured a breach of this Agreement within seven (7) days of being notified of such breach.

On termination of this Agreement, Recipient will discontinue the use of the Material and will, upon direction of IZSVe return or destroy any remaining Material, Modifications and Confidential Information. The clauses 4-7 shall survive termination of this Agreement.

ART. 9. MISCELLANEOUS

Confidential information: The Recipient shall not give, sell, share, release, convey, or otherwise distribute the Material and/or any accompanying Confidential Information to any third party without the prior written permission of IZSVe The Recipient acknowledges that IZSVe may withhold its consent for any reason it deems necessary and is not obliged to give the reason thereof.

Confidential Information will be safeguarded and not disclosed to any third parties by the receiving party. The Recipient also undertakes to retain in confidence and not disclose to any third party the Material. The Recipient may disclose the Provider’s Confidential Information to the Recipient’s parent corporations, affiliates and subsidiaries only if such parent corporations, affiliates and subsidiaries agree to be bound by confidentiality and non-use provisions at least as protective of the Provider’s rights as those contained in this Agreement. In the event that the Recipient is requested or required by law or legal process to disclose any of the Confidential Information, the Recipient shall provide IZSVe with prompt written notice before making any disclosure. In addition, Confidential Information may be disclosed to the extent required in the course of inspections or inquiries by EU Federal or State regulatory agencies to whose jurisdiction IZSVe and/or the Recipient is/are subject to and that has/have the legal right to inspect documents containing the Confidential Information. The Recipient shall promptly advise IZSVe upon such disclosure and vice versa.‌

Publication: The Recipient is free to release scientific publications concerning the outcomes of the scientific research carried out with the Material. Every publication referred to the Material and Modification shall acknowledge the source of the Material, giving the due reference to IZSVe

Entire Agreement: This Agreement constitutes the entire understanding of the Parties with respect to the matters contained herein, superseding all prior oral or written understandings or communications between the Parties relating to the present Agreement. This Agreement may be amended, modified, superseded or canceled, only by a written instrument executed by each Party’s duly authorized representatives.

Force Majeure: IZSVe shall not be liable for failure of or delay in supplying Strains set forth in this Agreement, and shall not be deemed in breach of its obligations, if such failure, delay or incorrect performance is due to natural disasters or any causes beyond its reasonable control including, without limitation, any act of God, any civil commotion or strike. In the event of such force majeure, IZSVe thereby shall promptly notify the other Party in writing. If the force majeure lasts more than 90 days, the Party shall have the right to terminate the Agreement; the notice of termination shall be made according to the present article 8.

Assigment: This Agreement and the rights, obligations and duties set forth herein may not be assigned, transferred, delegated or sub-contracted by the Recipient without the prior written consent of the IZSVe.

Governing Law: This Agreement shall be governed interpreted and construed in accordance with the laws of Italy. The Parties shall endeavor to settle any dispute in connection with the interpretation or performance of this agreement by amicable arrangement. In the event of

continuing disagreement, the Parties shall refer the dispute to the courts of the general place of jurisdiction of the defending Party‌

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

If to IZSVe: Att.

Dr. Xxxx Xxxxx

If to the Recipient: Att. Dr. Dr. Xxxxxxxx Card‌

ART. 10. NEGOTIATION

This Agreement has been freely negotiated between the Parties hereto and represents their willingness as duly and clearly shown in the content hereof and properly considered.

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed in duplicate by their duly authorised representatives as of the day and year first above written.

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

, (date) Legnaro, (date)

Animal and Plant Health Agency, Istituto Zooprofilattico Sperimentale‌

delle Venezie

(Dr. Xxxxxxx Xxxxxx acting Head

of Business Development) (Dr. Xxxxxxx Xxxxx, Acting Director General)

Annex 1 – Description of activities

Salmonella strains will be used to investigate the epidemiology of the Kentucky serovar. Strains will be sequenced and results of the analyses will be used to characterize this serovars in terms of its relevance in the Nigerian poultry production chain.