ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE

L E G N A R O (PD)

N. 7 del 13/01/2021

OGGETTO: Approvazione dello schema di ``Biological Material Transfer Agreement`` tra il Xxxxxx Xxxx-Institut e l`Istituto Zooprofilattico Sperimentale delle Venezie, nell`ambito del Progetto di ricerca europeo denominato H2020 ``European Virus Archive GLOBAL - EVAg`` - Grant Agreement number 871029 - EVA-GLOBAL.

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 il Xxxxxx Xxxx-Institut e l`Istituto Zooprofilattico Sperimentale delle Venezie, nell`ambito del Progetto di ricerca europeo denominato H2020 ``European Virus Archive GLOBAL - EVAg`` - Grant Agreement number 871029 - EVA-GLOBAL.

Si sottopone al Direttore generale la seguente relazione del Responsabile della S.S. 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;

- l’IZSVe è partner, al pari del “Xxxxxx Xxxx-Institut” – organizzazione facente parte del Ministero federale della Salute tedesco, con sede a Berlino – del progetto di ricerca europeo denominato H2020 “European Virus Archive Global - EVAg”, iniziativa

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

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;

- con DDG n. 41/2020 è stato preso atto della stipula del “Grant Agreement number 871029 – Eva-Global” relativo ai diritti e agli obblighi in capo alle parti derivanti dal suddetto progetto ed è stata autorizzata la successiva stipula del Consortium Agreement, atto diretto a definire i rapporti interni tra i partner coinvolti nel progetto;

- la “SCT3 – Padova e Rovigo – Diagnostica in sanità animale” dell’IZSVe, ai fini della realizzazione del progetto di ricerca relativo alle zoonosi emergenti in cani e gatti nei canili, ha rilevato la necessità di avvalersi di ceppi virali di DNA da utilizzare per lo sviluppo e la convalida di test diagnostici molecolari, richiedendone la disponibilità al Xxxxxx Xxxx-Institut tramite il portale “Eva-g – European Virus Archive Global”.

Al fine di formalizzare il trasferimento del materiale biologico, il Xxxxxx Xxxx-Institut con e-mail del 25.11.2020, ha trasmesso lo schema di contratto in lingua inglese cd. “Biological Material Transfer Agreement”, documento redatto secondo il fac-simile allegato al Consortium Agreement, che si allega al presente provvedimento quale parte integrante e sostanziale (allegato n.1).

Con ticket intranet n. 156130/2021, la “SCT3 – Padova e Rovigo – Diagnostica in sanità animale”, ha richiesto a questa Struttura di procedere con gli adempimenti necessari alla stipula del contratto in parola.

Il Xxxxxx Xxxx-Institut, con il predetto contratto, la cui efficacia decorrerà dalla data di sottoscrizione fino al completamento delle attività di ricerca, poste sotto la responsabilità della dott.ssa Xxxx Xxxxxx, direttore della “SCT3 – Padova e Rovigo – Diagnostica in sanità animale”, si impegna a fornire all’IZSVe, a titolo gratuito, il materiale biologico, specificato nel Technical Annex del contratto, salvo il costo delle spese di spedizione che saranno sostenute dall’IZSVe.

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 contratto in lingua inglese, cd. “Biological Material Transfer Agreement”, da sottoscrivere tra il Xxxxxx Xxxx-Institut, nella persona del rappresentante legale, Dr. Xxxxxx Xxxxxxx, e l’Istituto Zooprofilattico Sperimentale delle Venezie, nella persona del Direttore Generale e legale rappresentante pro tempore, dott.ssa Xxxxxxx Xxxxx, 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 il Xxxxxx Xxxx-Institut con il predetto contratto, efficace a decorrere dalla data di sottoscrizione e fino al completamento delle attività di ricerca da parte dell’IZSVe, si impegna a fornire a titolo gratuito il materiale biologico descritto nel Technical Annex dell’Agreement, e che le spese di spedizione saranno sostenute dall’IZSVe.

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

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.

VISTA l’attestazione di copertura della spesa, ove prevista, 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 DDG n. 332 del 22 luglio 2016 con la quale il xxxx. Xxxxx Xxxxxxxx è stato nominato Direttore amministrativo dell’Istituto.

VISTA la DDG n. 372 del 14.10.2020 con la quale la dott.ssa Gioia Capelli è stata nominata Direttore sanitario dell’Istituto.

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

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

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.

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

IL DIRETTORE GENERALE

dott.ssa Xxxxxxx Xxxxx

Sul presente atto deliberativo ha espresso parere favorevole

Il Direttore amministrativo Il Direttore sanitario xxxx. Xxxxx Xxxxxxxx dott.ssa Gioia Capelli

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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 

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 Giulia Ferriani

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ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE

Viale dell’Università 10 – 00000 XXXXXXX (XX)

DELIBERAZIONE DEL DIRETTORE GENERALE

N. 7 del 13/01/2021

OGGETTO: Approvazione dello schema di ``Biological Material Transfer Agreement`` tra il Xxxxxx Xxxx-Institut e l`Istituto Zooprofilattico Sperimentale delle Venezie, nell`ambito del Progetto di ricerca europeo denominato H2020 ``European Virus Archive GLOBAL - EVAg`` - Grant Agreement number 871029 - EVA- GLOBAL.

Pubblicata dal 14/01/2021 al 29/01/2021 Atto immediatamente esecutivo

Il Responsabile della Pubblicazione Xxxxx Xxxxxxx

Elenco firmatari

Questo documento è stato firmato da:

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

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

European Virus Archive

Supported by Horizon 2020 Programme Grant Agreement No. 653316

BIOLOGICAL MATERIAL TRANSFER AGREEMENT

BETWEEN

EVAG PARTNER (contracting party)

Organization: Xxxxxx Xxxx-Institut (RKI) Xxxxxxx Xxxxxxxx 00, 00000 Xxxxxx Xxxxxxx: Germany

Sender Scientist (for information)

Name and Title: Dr. Xxxxxxx Xxxxxxx

Organization: RKI, Centre for Biological Threats and special Pathogens (ZBS-1) Address: Xxxxxxxxx 00, 00000 Xxxxxx, Xxxxxxx

Representing the European Virus Archive goes Global (EVAg) hereinafter referred to as EVAg PARTNER

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AND

RECIPIENT (contracting party)

Organization: IZSVe Address:

xxxxx xxxx'Xxxxxxxxxx, 00

00000 Xxxxxxx (Xxxxxx) Xxxxx

Recipient Scientist (for information)

Name and Title: Dr. Xxxx Xxxxxx

Organization: IZSVe

Address: xxxxx xxxx'Xxxxxxxxxx, 00 00000 Xxxxxxx (Xxxxxx)

Xxxxx

Hereinafter referred to as RECIPIENT

IT IS PRELIMINARILY STATED THAT:

1. Whereas EVAg PARTNER is in possession of [Cowpox DNA, strain HumBer 07/1] (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 EVAg PARTNER in order to perform a Diagnosis of suspected cases as described in the Technical Annex (hereinafter referred to as “RESEARCH PROJECT”);

EVAg PARTNER and the RECIPIENT mutually desire to formalize their understanding and agreement as to the terms and conditions under which the MATERIAL has been transferred and will be transferred in the future as follows:

I. Definitions:

1. EVAg PARTNER:

Organization(s) providing the ORIGINAL MATERIAL. The names and addresses of this Party 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.

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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 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 EVAg 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. EFFECTIVE DATE:

The date of final signature of this Agreement:

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II. Terms and Conditions of this Agreement:

A/ Ownership

1. The EVAg 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 EVAg 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.

B/ Non commercial use

The MATERIAL will be used for non-commercial research purpose and academic research purposes only. 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 EVAg PARTNER.

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 EVAg PARTNER and the RECIPIENT.

However, both the RECIPIENT and EVAG 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 EVAG PARTNER. For the avoidance of doubt, the EVAG PARTNER is not obliged to agree upon any commercial use. No rights are given, implied or intended by this Agreement or the material transfer other than those explicitly stated in this Agreement.

C/ Distribution to third parties

This MATERIAL should be considered a property of the EVAg 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 EVAg PARTNER any request for the MATERIAL from anyone other than those persons working under the RECIPIENT SCIENTIST's direct supervision. EVAg 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 EVAg 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 EVAG PARTNER.

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D/ Confidentiality

The RECIPIENT agrees to treat the MATERIALS as it would treat its own confidential and proprietary information and at least 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 EVAg PARTNER agrees to keep confidential that the RECIPIENT is using the MATERIAL. Section 10 of EVAg Consortium Agreement is applicable (Annex 1).

E/ 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 to the EVAg partner (Xxxxxx Xxxx Institute) as 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. Section 8.4 of EVAg Consortium agreement is applicable (Annex 2).

F/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 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 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.

G/ Misuse/ Dual use/ Biosafety/ Use in humans

RECIPIENT accepts full responsibility for the safety of the RESEARCH and warrants that the RESEARCH will be performed in accordance with all local or national laws, rules and regulations. In particular this MATERIAL will only be used for Research purposes 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.

H/ Termination of Agreement

The EVAG PARTNER reserves the right to terminate this Agreement by notice to the RECIPIENT for an important reason for which the EVAG PARTNER cannot reasonably be expected to continue the Agreement. Such reasons may include but are not limited to: breach of the RECIPIENT’s obligations under this Agreement, change of control of the RECIPIENT, new information about possible hazardous uses of the MATERIAL.

In the case of termination, RECIPIENT will discontinue its use of the MATERIAL and will, upon direction of the EVAg PARTNER, return or destroy any remaining MATERIAL. The cost of return will be taken in charge 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.

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I/ Dispute and Jurisdiction

This agreement shall be governed by and construed in accordance with the law of the EVAg PARTNER’s country of domicile.

Any proceedings relating to any claim or matter arising under or in connection with this Agreement or the legal relationships established by this Agreement shall be brought in the courts of the EVAg PARTNER’s country of domicile.

J/ 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 both Parties.

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PAGE of SIGNATURES

EVAg PARTNER

Organization: Xxxxxx Xxxx-Institut

Address: Xxxxxxxx 00

00000 Xxxxxx Xxxxxxx

Signature Date

Sender Scientist

Name and Title: Dr. Xxxxxxx Xxxxxxx

Organization: Xxxxxx Xxxx-Institute, Centre for Biological Threats and Special Pathogens, highly Pathogenic Viruses Unit (ZBS-1)

Address: Xxxxxxxxx 00,

00000 Xxxxxx Xxxxxxx

Signature Date

RECIPIENT

Organization: IZSVe

Address: xxxxx xxxx'Xxxxxxxxxx, 00 00000 Xxxxxxx (Xxxxxx)

Xxxxx

Signature Date

Recipient Scientist

Name and Title: Dr. Xxxx Xxxxxx Organization: IZSVe

Address: xxxxx xxxx'Xxxxxxxxxx, 00 00000 Xxxxxxx (Xxxxxx)

Xxxxx

Signature Date

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Technical Annex

Nature of the transferred material: Cowpox DNA, strain HumBer 07/1

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

□Cellular biology, virus-cell interactions

x Development and validation of molecular diagnostic assays Detailed description (maximum 1 page):

In the context of a project regarding emerging zoonoses of cats and dogs in kennels, the cowpox DNA strain humber-071 will be used as positive control for a Real Time PCR for the screening of pet samples.

Annex 1

Section 10 of EVAg Consortium agreement: Non-disclosure of information

10.1 All information in whatever form or mode of communication, which is disclosed by a Party (the “Disclosing Party”) to any other Party (the “Recipient”) in connection with the Project during its

implementation and which has been explicitly marked as “confidential” at the time of disclosure, or when disclosed orally has been identified as confidential at the time of disclosure and has been confirmed and designated in writing (letter or email) within fifteen (15) calendar days from oral disclosure at the latest as confidential information by the Disclosing Party, is “Confidential

Information”.

10.2 The Recipients hereby undertake in addition and without prejudice to any commitment of non- disclosure under the Grant Agreement, for a period of 4 years after the end of the Project:

- not to use Confidential Information otherwise than for the purpose for which it was disclosed;

- not to disclose Confidential Information to any third party without the prior written consent by the Disclosing Party;

- to ensure that internal distribution of Confidential Information by a Recipient shall take place on a strict need-to-know basis; and

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- to return to the Disclosing Party on demand all Confidential Information which has been supplied to or acquired by the Recipients including all copies thereof and to delete all information stored in a machine readable form. The Recipients may keep a copy to the extent it is required to keep, archive or store such Confidential Information because of compliance with applicable laws and regulations or for the proof of on-going obligations.

10.3 The Recipients shall be responsible for the fulfilment of the above obligations on the part of their employees or third parties involved in the Project and its Affiliated Entities listed in Attachment 4 and shall ensure that they remain so obliged, as far as legally possible, during and after the end of the Project and/or after the termination of the contractual relationship with the employee or third party.

10.4 The above shall not apply for disclosure or use of Confidential Information, if and in so far as the Recipient can show that:

- the Confidential Information becomes publicly available by means other than a breach of the Recipient’s confidentiality obligations;

- the Disclosing Party subsequently informs the Recipient that the Confidential Information is no longer confidential;

- the Confidential Information is communicated to the Recipient without any obligation of confidence by a third party who is to the best knowledge of the Recipient in lawful possession thereof and under no obligation of confidence to the Disclosing Party;

- the disclosure or communication of the Confidential Information is foreseen by provisions of the Grant Agreement;

- the Confidential Information, at any time, was developed by the Recipient completely independently of any such disclosure by the Disclosing Party; or

- the Confidential Information was already known to the Recipient prior to disclosure or

- the Recipient is required to disclose the Confidential Information in order to comply with applicable laws or regulations or with a court or administrative order, subject to the provision Section 10.7 hereunder.

10.5 The Recipient shall apply the same degree of care with regard to the Confidential Information disclosed within the scope of the Project as with its own confidential and/or proprietary information, but in no case less than reasonable care.

10.6 Each Party shall promptly advise the other Party in writing (letter or email) of any unauthorized disclosure, misappropriation or misuse of Confidential Information after it becomes aware of such unauthorized disclosure, misappropriation or misuse.

10.7 If any Party becomes aware that it will be required, or is likely to be required, to disclose Confidential Information in order to comply with applicable laws or regulations or with a court or administrative order, it shall, to the extent it is lawfully able to do so, prior to any such disclosure

- notify the Disclosing Party, and

- comply with the Disclosing Party’s reasonable instructions to protect the confidentiality of the information.

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Annex 2

8.4 Dissemination

8.4.1 Dissemination of own Results

8.4.1.1 During the Project and for a period of one (1) year after the end of the Project, the dissemination of own Results by one or several Parties including but not restricted to publications and presentations, shall be governed by the procedure of Article 29.1 of the Grant Agreement subject to the following provisions.

Prior notice of any submission of publication or communication to an editor shall be given to the other Parties at least forty-five (45) calendar days before the publication. Any objection to the planned publication shall be made in accordance with the Grant Agreement in writing (letter or email) to the Project Coordinator and to the Party or Parties proposing the dissemination within 30 calendar days after receipt of the notice. If no objection is made within the time limit stated above, the publication is permitted.

8.4.1.2 An objection is justified if

(a) the protection of the objecting Party's Results or Background would be adversely affected

(b) the objecting Party's legitimate academic or commercial interests in relation to the Results or Background would be significantly harmed.

The objection has to include a precise request for necessary modifications.

8.4.1.3 If an objection has been raised the involved Parties shall discuss how to overcome the justified grounds for the objection on a timely basis (for example by amendment to the planned publication and/or by protecting information before publication) and the objecting Party shall not unreasonably continue the opposition if appropriate measures are taken following the discussion.

The objecting Party can request a publication delay of not more than 90 calendar days from the time it raises such an objection. After 90 calendar days the publication is permitted, provided that Confidential Information of the objecting Party has been removed from the Publication as indicated by the objecting Party.

8.4.1.4 In accordance with practices in the scientific Community, the Party’s contributions will be expressly reflected in all written or oral public disclosures concerning Results by acknowledgment or co-authorship, as appropriate. Unless Funding Authority requests or agrees otherwise or unless it is impossible, any dissemination of results (in any form, including electronic) must:

(a) display the EU emblem and

(b) include the following text:

‘This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement N°653316.

8.4.2 Dissemination of another Party’s unpublished Results or Background

A Party shall not include in any dissemination activity another Party's Results or Background without obtaining the owning Party's prior written approval, unless they are already published.

For the avoidance of doubt, the mere absence of an objection according to 8.3.1 is not considered as an approval.

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8.4.3 Cooperation obligations

The Parties undertake to cooperate to allow the timely submission, examination, publication and defence of any dissertation or thesis for a degree which includes their Results or Background subject to the confidentiality and publication provisions agreed in this Consortium Agreement.

8.4.4 Use of names, logos or trademarks

Nothing in this Consortium Agreement shall be construed as conferring rights to use in advertising, publicity or otherwise the name of the Parties or any of their logos or trademarks and/or associated personnel without their prior written approval.

Nothing contained in the section 8 shall prevent:

- the submission of a thesis to examiners in accordance with the normal regulations and practice of the Public bodies subject where appropriate to such examiners being bound by confidentiality provisions in no less terms than those outlined in Section 10;

- the obligation of a Party to issue a scientific activity report for the State or administrative organisation it belongs to. This communication shall not constitute a public disclosure, but will be an internal communication to the Party.

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ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE

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