ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE

L E G N A R O (PD)

N. 184 del 26/05/2023

OGGETTO: Approvazione dello schema di ``Biological Material Transfer Agreement`` tra l`IZSVe e l`Universita` degli Studi di Ferrara per la fornitura di materiale biologico, nell`ambito del progetto di ricerca europeo H2020 ``European Virus Archive GLOBAL - XXX XXXXX L``.

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 ``Biological Material Transfer Agreement`` tra l`IZSVe e l`Universita` degli Studi di Ferrara per la fornitura di materiale biologico, nell`ambito del progetto di ricerca europeo H2020 ``European Virus Archive GLOBAL - XXX XXXXX L``.

Si sottopone al Direttore 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 all’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 disposizioni, 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

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convenzioni o contratti di consulenza per la fornitura di servizi e per l'erogazione di prestazioni a 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, confermato all’art. 3, comma 2, lett. e) della Legge della Regione del Veneto n. 5 del 18.3.2015, 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”;

- l’IZSVe è partner del progetto di ricerca europeo denominato H2020 “European Virus Archive Global – EVA GLOBAL”, iniziativa scientifica che si prefigge l’obiettivo di creare e mobilitare una rete internazionale di centri di alto livello per condividere risorse e informazioni fondamentali per la lotta alle malattie infettive virali dell’uomo, degli animali e delle piante;

- l’Università degli Studi di Ferrara, al fine di indagare i possibili effetti del West Nile Virus in correlazione a malattie neurodegenerative, ha rilevato la necessità di avvalersi di ceppi virali richiedendone la disponibilità all’IZSVe tramite il portale “EVA-g – European Virus Archive Global”;

- di conseguenza, l’Università degli Studi di Ferrara, in data 28.04.2023, ha inserito nel citato portale l’“Order ref 10196” per l’acquisto di n. 1 ceppo di West Nile Virus.

Al fine di formalizzare il rapporto con particolare riferimento ai diritti e obblighi delle Parti, le parti hanno condiviso, per le vie brevi, lo schema di “Biological Material Transfer Agreement”, documento che si allega al presente provvedimento quale parte integrante e sostanziale (allegato n. 1), unitamente ai relativi allegati “Technical Annex” e “Order ref 10196”.

Con ticket intranet n. 199505/2023, il “Laboratorio Virologia Diagnostica” afferente la “SCT3 – Padova, Vicenza e Rovigo” ha richiesto alla scrivente Struttura di procedere con gli adempimenti necessari alla stipula dell’Accordo citato.

Con la sottoscrizione del predetto Accordo – efficace dalla data di ultima sottoscrizione fino alla fornitura del materiale e al pagamento del corrispettivo – a fronte della cessione del materiale biologico specificamente indicato negli allegati “Technical Annex” e “Order ref 10196”, l’Università degli Studi di Ferrara si impegna a corrispondere all’IZSVe un corrispettivo di € 1.500,00 oltre IVA e spese di spedizione, subordinatamente all’emissione di regolare fattura.

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

1. di approvare lo schema di “Biological Material Transfer Agreement”, da sottoscrivere tra l’Istituto Zooprofilattico Sperimentale delle Venezie, rappresentato dal Direttore Generale e legale rappresentante pro tempore, dott.ssa Xxxxxxx Xxxxx, e l’Università degli Studi di Ferrara, rappresentata dal Direttore del Dipartimento di Scienze Chimiche, Farmaceutiche ed Agrarie, Xxxx. Xxxxxxx Xxxxxxxxx, per la fornitura di materiale biologico, documento che si allega al presente provvedimento quale parte integrante e sostanziale (allegato n. 1);

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2. di procedere, per l’effetto, alla sottoscrizione dell’accordo 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, a fronte della cessione del materiale biologico specificamente indicato nel “Technical Annex”, nonché nel citato “Order ref 10196”, allegati all’Accordo, l’Università degli Studi di Ferrara si impegna a corrispondere all’IZSVe un corrispettivo di € 1.500,00 oltre IVA e spese di spedizione, subordinatamente all’emissione di regolare fattura;

4. di rilevare il ricavo derivante dal presente provvedimento al sottoconto 620010951 “Ricavi per prestaz. Sanitarie ad altri soggetti pubblici – Antigeni, reagenti e altro” del Bilancio d’esercizio 2023.

IL DIRETTORE GENERALE

ESAMINATA la proposta di deliberazione del Responsabile della S.S. 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.

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 delibera del Direttore generale n. 372 del 14 ottobre 2020 con la quale la dott.ssa Xxxxx Xxxxxxx è stata nominata Direttore sanitario dell’Istituto.

VISTA la delibera del Direttore generale 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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materiale biologico, documento che si allega al presente provvedimento quale parte integrante e sostanziale (allegato n. 1);

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

dott.ssa Xxxxxxx Xxxxx

Sul presente atto deliberativo ha espresso parere favorevole

Il Direttore amministrativo Il Direttore sanitario

xxxx. Xxxxxxx Xxxxxx dott.ssa Xxxxx Xxxxxxx

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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 ⌧

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. 184 del 26/05/2023‌

OGGETTO: Approvazione dello schema di ``Biological Material Transfer Agreement`` tra l`IZSVe e l`Universita` degli Studi di Ferrara per la fornitura di materiale biologico, nell`ambito del progetto di ricerca europeo H2020 ``European Virus Archive GLOBAL - EVA GLOBAL``.

Pubblicata dal 26/05/2023 al 10/06/2023 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. Xxxxxxx Xxxxxx - Direzione Amministrativa

Dott.ssa Gioia Capelli - Direzione Sanitaria Dott.ssa Xxxxxxx Xxxxx - Direzione Generale Xxxxx Xxxxxxx - Xxxxxxxx Atti

European Virus Archive GLOBAL

Supported by Horizon 2020 Programme Grant Agreement No. 871029

BIOLOGICAL MATERIAL TRANSFER AGREEMENT

BETWEEN

EVA-GLOBAL PARTNER (contracting party)

Organization: Istituto Zooprofilattico Sperimentale delle Venezie (IZSVe)

Address Xxxxx xxxx’Xxxxxxxxxx, 00 00000 Xxxxxxx (Xxxxxx)

Country: ITALY

SENDER SCIENTIST (for information)

Name and Title: Dr. Xxxxxxxxx Xxxxxxxx Veterinarian

Organization: Istituto Zooprofilattico Sperimentale delle Venezie (IZSVe)

Address: Xxxxx xxxx’Xxxxxxxxxx, 00 00000 Xxxxxxx (Xxxxxx)

hereinafter referred to as EVA-GLOBAL PARTNER or PARTY

AND

RECIPIENT (contracting party)

Organization: University of Ferrara

Address: Xxx X. Xxxxxxx, 00 - 00000 Xxxxxxx

Country: ITALY

on behalf of Xxxx. Xxxxxxx Xxxxxxxxx, Head of Department of Chemical, Pharmaceutical and Agricultural Sciences - DOCPAS

RECIPIENT SCIENTIST (for information)

Name and Title: Xxxx. Xxxxxxx Xxxxx (full professor in Microbiology and Clinical Microbiology) Organization: University of Ferrara

Address: Xxx X. Xxxxxxx, 00 – 00000 Xxxxxxx

Hereinafter referred to as RECIPIENT or PARTY

XXX-GLOBAL PARTNER and RECIPIENT hereinafter collectively referred to as PARTIES

IT IS PRELIMINARILY STATED THAT:

1. Whereas EVA-GLOBAL PARTNER is in possession of West Nile virus/Italy/2022/Padova/22VIR7363 (hereinafter referred to as “ORIGINAL MATERIAL”), and is the owner of these certain substances/compounds, know-how and/or intellectual property rights relating thereto;

2. Whereas the RECIPIENT requested to receive the ORIGINAL MATERIAL from EVA-GLOBAL PARTNER in order to perform a research entitled [ ] as described in the Technical Annex (hereinafter referred to as “RESEARCH PROJECT”).

Whereas EVA-GLOBAL PARTNER and the RECIPIENT mutually desire to formalize their understanding and agreement as to the terms and conditions under which the ORIGINAL MATERIAL or MATERIAL can be transferred;

I. Definitions:

1. EVA-GLOBAL PARTNER:

Organization(s) providing the ORIGINAL MATERIAL. The names and addresses of this PARTY are specified on the first page of this MTA.

2. SENDER SCIENTIST:

Name and address are specified on the first page of this MTA.

3. RECIPIENT:

Organization receiving the ORIGINAL MATERIAL. The name and address of this PARTY is specified on the second page of this MTA.

4. RECIPIENT SCIENTIST:

Name and address are specified on the second page of this MTA.

5. ORIGINAL MATERIAL:

The description of the material being transferred is specified in the preliminary statement.

6. MATERIAL:

MATERIAL: ORIGINAL MATERIAL, PROGENY, and UNMODIFIED DERIVATIVES.

MATERIAL does not include: a) MODIFICATIONS or b) other substances created by the RECIPIENT through the use of the MATERIAL.

7. PROGENY:

Unmodified descendant from the ORIGINAL MATERIAL, such as, but not limited to: micro-organism from micro-organism and/or recombinant DNA from recombinant DNA.

8. UNMODIFIED DERIVATIVES:

Substances created by the RECIPIENT which constitute an unmodified functional subunit or product expressed by the ORIGINAL MATERIAL, such as, but not limited to: cloned/sub cloned ORIGINAL MATERIAL, purified or fractionated subsets of the ORIGINAL MATERIAL, and proteins expressed from DNA/RNA supplied by the EVA-GLOBAL PARTNER.

9. MODIFICATIONS:

Substances created by the RECIPIENT which contain/incorporate the MATERIAL.

10. COMMERCIAL PURPOSES:

The application of patent, sale, lease, license, or other transfer of the MATERIAL or MODIFICATIONS to a for-profit organization. COMMERCIAL PURPOSES shall also include uses of the MATERIAL or MODIFICATIONS by any organization, including RECIPIENT, to perform non-academic contract research, to produce or manufacture products for general sale, or to conduct research activities that result in any patent, or in sale, lease, license, or transfer of the MATERIAL or MODIFICATIONS to a for-profit organization. However, industrially sponsored academic research shall not be considered as a use of the MATERIAL or MODIFICATIONS for COMMERCIAL PURPOSES per se, unless any of the above conditions of this definition are met.

11. NON FOR-PROFIT ORGANIZATION(S):

A university or any other institution of higher education or an organization exempt from taxation or any non for profit scientific or educational organization. As used herein, the term also includes government agencies.

12. AFFILIATES:

Affiliates being defined as with respect to an entity that controls, is controlled by, or is under common control with such first entity. For the purposes of this definition only, control means (a) to possess, directly or indirectly the power to direct the management of policies of an entity, whether through ownership of voting securities or by contract relating to voting rights or corporate governance, or (b) to own, directly or indirectly, more than 50% of the outstanding voting securities or other ownership interest of such entity and not capable of assignment other than to RECIPIENT’s Affiliates.

13. EFFECTIVE DATE:

[The date of final signature of this Agreement]

14. RESEARCH PROJECT

The description of the envisaged research with the ORIGINAL MATERIAL or MATERIAL specified in the preliminary statement and the technical annex.

II. Terms and Conditions of this Agreement:

A/ Ownership

1. The EVA-GLOBAL PARTNER retains ownership of the MATERIAL, including any MATERIAL contained or incorporated in MODIFICATIONS.

2. The RECIPIENT retains ownership of:

(a) MODIFICATIONS (except that, the EVA-GLOBAL PARTNER retains ownership rights to the MATERIAL included therein), and

(b) those substances created through the use of the MATERIAL or MODIFICATIONS, but which are not PROGENY, UNMODIFIED DERIVATIVES or MODIFICATIONS (i.e., do not contain the ORIGINAL MATERIAL, PROGENY, UNMODIFIED DERIVATIVES). If either 2(a) or 2(b) results from the collaborative effect, joint ownership shall be negotiated.

Ownership of the results, inventions, discoveries or know-how generated by the RECIPIENT using the MATERIAL shall rest with the RECIPIENT. Nevertheless, any results, inventions, discoveries or know-how which contain/incorporate the MATERIAL, generated by the RECIPIENT using the MATERIAL (“MODIFICATIONS”) shall be jointly owned by the EVA-GLOBAL PARTNER and the RECIPIENT.

B/ Non commercial use

The MATERIAL will be used for the sole RESEARCH PROJECT. In this Agreement, non-commercial research purpose and academic research purposes mean that the MATERIAL cannot be used for COMMERCIAL PURPOSES, and the RECIPIENT may not exploit commercially results, inventions, discoveries or know-how which incorporates the MATERIALS for its own benefit nor for a third party, without the consent of the EVA-GLOBAL PARTNER.

C/ Commercial use

However, both the RECIPIENT and EVA-GLOBAL PARTNER agree that should the RECIPIENT having completed work under this MTA wish to use the MATERIAL or MODIFICATIONS for COMMERCIAL PURPOSES it will be necessary for the RECIPIENT to negotiate the terms of a license agreement with the EVA-GLOBAL PARTNER. No rights are given, implied or intended by this Agreement or the material transfer other than those explicitly stated in this Agreement.

D/Payment

The RECIPIENT shall pay an amount of € 1.500,00, plus VAT, if applicable, for the MATERIAL, as described in the order n. 10196 attached to this Agreement, against presentation of regular invoice.

Shipping costs are not included.

The RECIPIENT undertakes to make the payment within 60 days after receipt of the invoice.

In case of payment’s delay exceeds one hundred and eighty (180) days, default interest shall accrue on the amount due from the original payment date until settlement.

E/ Distribution to third parties

This MATERIAL should be considered a property of the EVA-GLOBAL PARTNER. RECIPIENT therefore agrees to retain control over this MATERIAL, and further agrees not to transfer the MATERIAL to third parties or to personnel of the RECIPIENT not working under the supervision of RECIPIENT SCIENTIST. The RECIPIENT agrees to refer to the EVA-GLOBAL PARTNER any request for the MATERIAL from anyone other than those persons working under the RECIPIENT SCIENTIST's direct supervision. EVA-GLOBAL PARTNER reserves the right to distribute the MATERIAL to others and to use it for its own purposes.

(a) The RECIPIENT shall have the right, without restriction, to distribute substances created by the RECIPIENT through the use of the ORIGINAL MATERIAL only if those substances are not PROGENY, UNMODIFIED DERIVATIVES, or MODIFICATIONS.

(b) Under a separate agreement at least as protective of the EVA-GLOBAL PARTNER's rights, the RECIPIENT may distribute MODIFICATIONS to NON FOR-PROFIT ORGANIZATION(S) for non-commercial research purposes and academic research purposes only, subject to prior written notice to the EVA- GLOBAL PARTNER.

This Agreement is personal to RECIPIENT and its AFFILIATES.

F/ Confidentiality

The RECIPIENT agrees to treat the MATERIAL as it would treat its own confidential and proprietary information and at least with no less than a reasonable degree of care, and to take all reasonable precautions to prevent unauthorized disclosure to any third party of the MATERIAL which it receives hereunder. The EVA-GLOBAL PARTNER agrees to keep confidential that the RECIPIENT is using the MATERIAL.

G/ Publications

This agreement shall not be interpreted to prevent or delay publication of research findings resulting from the use of the MATERIAL or the MODIFICATIONS. The RECIPIENT SCIENTIST agrees to provide appropriate acknowledgement of the source of the MATERIAL in all publications and will make suitable publicity about the support given by the European Community for the MATERIAL provided.

A preferred sentence would be the following: “This publication was supported by the European Virus Archive GLOBAL (EVA-GLOBAL) project that has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 871029”.

H/MATERIAL use liability

The MATERIAL is provided as a service to the research community at large. It is provided without warranty of merchantability or fitness for a particular purpose or any other warranty, express or implied. No indemnification for any damages is intended or provided under this Agreement. Each PARTY shall be responsible for any damages it incurs as a result of its activities under this Agreement. The PARTIES make no express or implied warranty as to any matter whatsoever, including the conditions of the RESEARCH PROJECT or any invention or product, whether tangible or intangible, made, or developed under this Agreement, or the ownership, merchantability, or fitness for a particular purpose of the RESEARCH PROJECT or any Invention or product. The PARTIES further make no warranty that the

use of any invention or other intellectual property or product contributed, made or developed under this Agreement will not infringe any patent or other intellectual property right. In no event will any PARTY be liable to any other PARTY for compensatory, punitive, exemplary or consequential damages.

I/ Misuse/ Dual use/ Biosafety

RECIPIENT accepts full responsibility for the safety of the RESEARCH PROJECT and warrants that the RESEARCH PROJECT will be performed in accordance with all local or national laws, rules and regulations. In particular, this MATERIAL will only be used for purposes of the RESEARCH PROJECT by the RECIPIENT in its laboratory under suitable containment conditions.

Where applicable, each PARTY agrees to abide by all laws, rules, and regulations governing biological select agents and toxins.

Under the terms of this Agreement the MATERIAL may not be used in human beings.

J/ Convention on Biological Diversity

If the MATERIAL is considered a genetic resource within the meaning of the Convention on Biological Diversity (CBD), then, PROVIDER and RECIPIENT wish to comply with the terms of the CBD, in particular its regulations on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits as laid out in the Nagoya Protocol. Both Parties shall endeavour to ensure the realisation of the rules and procedures laid down in the Nagoya Protocol with regard to the specific legislation of the country of origin of the Material. This legislation might as well be applicable for the non-commercial use of the MATERIAL.

Therefore, the RECIPIENT shall ensure that it complies with the relevant access and benefit sharing regulation of the country where the MATERIAL originated. The EVA-GLOBAL PARTNER shall supply the RECIPIENT with information about the MATERIAL that is required under the access and benefit sharing legislation, including at minimum the country or origin, date the MATERIAL was accessed and any restriction the EVA-GLOBAL PARTNER is aware of.

K/ Termination of Agreement

The term of this Agreement shall be from the EFFECTIVE DATE until the supply of the MATERIAL and payment of the price. At the end of this term, the Agreement shall automatically terminate. Upon the effective date of termination, or if requested, the deferred effective date of termination, RECIPIENT will discontinue its use of the MATERIAL and will, upon direction of the EVA-GLOBAL PARTNER, return or destroy any remaining MATERIAL. The costs of return shall be borne by the RECIPIENT. The RECIPIENT, at its discretion, will also either destroy the MODIFICATIONS or remain bound by the terms of this Agreement as they apply to MODIFICATIONS. If these MODIFICATIONS are co-owned, the Parties shall agree whether the modifications are destroyed or split between the Parties.

L/ Dispute

Any proceedings relating to any claim or matter arising under or in connection with this Agreement or the legal relationships established by this Agreement instituted against the RECIPIENT by the EVA- GLOBAL PARTNER shall be brought in the courts of the RECIPIENT’s country of domicile and any such proceedings against the EVA-GLOBAL PARTNER by the RECIPIENT shall be brought in the courts of the EVA-GLOBAL PARTNER’s country of domicile.

M/ Miscellaneous

This Agreement may not be modified, in whole or in part, except by the written consent of both PARTIES. If any provision of this Agreement is held to be unenforceable or void, the remaining provisions

shall remain in effect. This Agreement may be signed in counterpart, and by the PARTIES hereto or separate counterparts, each of which shall be deemed an original.

This MTA is effective when signed by all PARTIES. The PARTIES executing it certify that their respective organizations have accepted the terms and regulations of this Agreement, and further agree to be bound by the terms, for the transfer specified above.

PAGE of SIGNATURES

EVA-GLOBAL PARTNER

Organization: Istituto Zooprofilattico Sperimentale delle Venezie (IZSVe)

Address: Xxxxx xxxx’Xxxxxxxxxx 00 00000 Xxxxxxx (Xxxxxx)

Country: ITALY

Signature:

Name and Title: Dr. Xxxxxxx Xxxxx, Director General and Legal Representative

Date

SENDER SCIENTIST

Name and Title: Dr. Xxxxxxxxx Xxxxxxxx Veterinarian

Organization: Istituto Zooprofilattico Sperimentale delle Venezie (IZSVe)

Address: Viale dell’Università 10 35020 Legnaro (Padova)

ITALY

Signature Date

RECIPIENT

Organization: University of Ferrara

Address: Xxx X. Xxxxxxx, 00 – 44121 Ferrara

Country: ITALY

Signature:

Name and Title: Xxxx. Xxxxxxx Xxxxxxxxx, Head of the Department of Chemical, Pharmaceutical and Agricultural Sciences – DOCPAS

Date

RECIPIENT SCIENTIST

Name and Title: Xxxx. Xxxxxxx Xxxxx (Full professor in Microbiology and Clinical Microbiology)

Organization: University of Ferrara

Address: Xxx X. Xxxxxxx, 00 – 00000 Xxxxxxx XXXXX

Signature Date

Technical Annex

Nature of the transferred material:

Infectious cell culture supernatant containing West Nile virus passage 1 (West Nile virus/Italy/2022/Padova/22VIR7363. This virus is preserved under Viral Storage Medium -80C. The product risk group is RG3 and biosafety restrictions are BSL3. Production cell line was Vero E6. The geographical origin was Italy. The product was isolated under the following conditions: 7 days, 37°C, 5% CO2. The cell culture used to replicate this virus was confirmed mycoplasm free. The genome sequence is known.

Indicate the intended use of the MATERIAL supplied, by ticking the box(es) that concern(s) the activity, and provide a technical description in the section below the ticked box(es):

□ Establish a virus collection

□ Genomics and evolution

□ Structural genomics related to viral proteins

□ Recombinant viral protein expression and purification

□ Animal modeling

□ Immunological reagents production for diagnostic applications

□ Vaccine development

⌧Research on antivirals (screening)

⌧ Investigation of immunological mechanisms

⌧ Virus-cell interactions

□ Development and validation of molecular diagnostic assays

Detailed description (maximum 1 page):

Neuroinvasive WNV viral infection may be linked epidemiologically and mechanistically to neurodegeneration, associated with a significant prevalence of sequelae such as memory loss, confusion, and fatigue years later. Focusing on the recently discovered antimicrobial roles of amyloid beta (Xxxxxxxxxx et al., 2019), we connected WNV late pathology to overlapping features encountered in neurodegenerative diseases such as Alzheimer’s disease.

Xxxx. Xxxxxxx Xxxxx, the PI of the proposal, aims to investigate the possible effect of WNV on neurodegenerative and dysfunctional biomarkers (e.g. amyloid beta (Aβ), total and phosphorylated tau protein (p-tau), alpha-synuclein (α-syn), transactive response (TAR) NA-binding protein 43 (TDP-43), prion protein (PrPSc), neurofilament light chains (NFL)) expression in neuronal cells (neurons, oligodendrocytes, and microglia), to clarify the mechanism underlying the CNS sequelae associated to WNV infection.

Methods: WNV will be propagated and titrated on Vero cells in the BSL-3 facility of the University of Ferrara for further experiments. 2D cultures and 3D neuronal models will be obtained with iPS (Induced Pluripotent Stem) cells and infected with WNV in the BSL3 facility of the University of Ferrara. The mRNA and proteomic profiles will be evaluated by molecular biology (Real-Time PCR) and ELISA systems. Viral RNA will be extracted from cells and/or supernatants by Viral RNA purification Kits and quantified by TaqMan qPCR after reverse transcription. Infective particles will be also evaluated by plaque forming assay on Vero cells.

Espected results: Our results would clarify the possible role of WNV infection on CNS neurodegenerative process by altering Aβ expression, suggesting a novel pathogenetic role.

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Order details on Friday 28 April 2023

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West Nile virus/Italy/2022/Padova/22VIR7363 (025V-04960)

IZSVe 1 500,00 € 1.00 1 500,00 €

Order total 1 500,00 €

Xxxxxxxxx Xxxxxxx Università di Ferrara Xxx X. Xxxxxxx, 00 00000

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Xxxxxxxxx Xxxxxxx Università di Ferrara Xxx X. Xxxxxxx, 00 00000

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Background: In recent years, the North-Est region of Italy, particularly Veneto and Xxxxxx- Romagna (Riccò M. et al., 2022), has been characterized by a significant increase of West Nile Virus (WNV) infection rate. Neuroinvasive WNV viral infection may be linked epidemiologically and mechanistically to neurodegeneration, associated with a significant prevalence of sequelae such as memory loss, confusion, and fatigue years later. Focusing on the recently discovered antimicrobial roles of amyloid beta (Xxxxxxxxxx et al., 2019), we connected WNV late pathology to overlapping features encountered in neurodegenerative diseases such as Alzheimer’s disease.

Aims: Xxxx. Xxxxxxx Xxxxx, the PI of the proposal, aims to investigate the possible effect of WNV on neurodegenerative and dysfunctional biomarkers (e.g. amyloid beta (Aβ), total and phosphorylated tau protein (p-tau), alpha-synuclein (α-syn), transactive response (TAR) DNA-binding protein 43 (TDP-43), prion protein (PrPSc), neurofilament light chains (NFL)) expression in neuronal cells (neurons, oligodendrocytes, and microglia), to clarify the mechanism underlying the CNS sequelae associated to WNV infection.

Espected results: Our results would clarify the possible role of WNV infection on CNS neurodegenerative process by altering Aβ expression, suggesting a novel pathogenetic role.

Do you have the containment facilities and end-user qualification to handle the product(s) of interest?:

Yes

H2020 - grant agreement n871029 - EVA-G Page 1 of 2

Intended use: Investigation of immunological mechanisms Research on antivirals (screening)

Virus-cell interactions

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H2020 - grant agreement n871029 - EVA-G Page 2 of 2

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ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE

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