ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE
ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE
L E G N A R O (PD)
D E L D I R E T T O R E G E N E R A L E
N. 196 del 05/06/2023
OGGETTO: Approvazione dello schema di ``Biological Material Transfer Agreement for research activities`` per la fornitura di materiale biologico, tra l`Istituto Zooprofilattico Sperimentale delle Venezie e ZOETIS BELGIUM S.A.
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 for research activities`` per la fornitura di materiale biologico, tra l`Istituto Zooprofilattico Sperimentale delle Venezie e ZOETIS BELGIUM S.A.
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 convenzioni o contratti di consulenza per la fornitura di servizi e per l'erogazione di
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X.X.X.Xx – Deliberazione del DIRETTORE GENERALE
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 ha sviluppato negli anni diverse metodiche per la diagnosi delle micoplasmosi, istituendo l’“U.O. Micoplasmi” presso la sezione territoriale “SCT1 – Verona”. Tale laboratorio svolge attività diagnostica e di ricerca sui micoplasmi animali, raccoglie ceppi di micoplasmi e funge da laboratorio di riferimento WOAH per la micoplasmosi aviaria.
ZOETIS BELGIUM S.A., azienda con sede in Belgio avente esperienza e competenza nello sviluppo di prodotti per la salute animale, con e-mail del 21.07.2022, ha richiesto all’IZSVe di addivenire alla stipula di un accordo avente ad oggetto la fornitura di n. 4 ceppi di Mycoplasma hyopneumoniae per attività di ricerca.
Con ticket intranet n. 200586/2023, la “SCT1 – Verona”, ha richiesto a questa Struttura di procedere con gli adempimenti necessari alla stipula dell’accordo.
Acquisita, pertanto, l’autorizzazione del Direttore Generale, al fine di definire i diritti e gli obblighi delle Parti rispetto al Materiale, le Parti hanno condiviso, per le vie brevi, lo schema di “Biological Material Transfer Agreement for research activities”, documento che si allega al presente provvedimento quale parte integrante e sostanziale (allegato n. 1).
Con la sottoscrizione del predetto accordo – efficace dalla data di ultima sottoscrizione per un periodo di 12 mesi o, in ogni caso, fino alla fornitura del materiale e al pagamento del corrispettivo – a fronte della cessione del materiale biologico specificamente indicato all’art. 1 dell’accordo, ZOETIS si impegna a corrispondere all’IZSVe un corrispettivo pari a € 5.000,00 per ogni ceppo, per un totale di € 20.000,00 – oltre IVA, se applicabile, e spese di spedizione – subordinatamente all’emissione di regolare fattura, secondo le modalità indicate all’art. 3 dell’accordo.
Ai sensi dell’Agreement in parola, eventuali ceppi non inclusi nell’accordo potranno essere richiesti all'IZSVe da ZOETIS ed i relativi termini per la cessione dell’ulteriore materiale saranno concordati tra le Parti per iscritto come “Amendment” all’accordo.
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 fo research activities”, da sottoscrivere tra l’Istituto Zooprofilattico Sperimentale delle Venezie, rappresentato dal Direttore Generale e legale rappresentante pro tempore, dott.ssa Xxxxxxx Xxxxx, e ZOETIS BELGIUM S.A., rappresentata dall’Executive Director, dr. Xxxxxxx Xxxxxxxxx, per la fornitura di n. 4 ceppi di Mycoplasma hyopneumoniae, 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 dell’accordo di cui al punto che precede – efficace dalla data di ultima sottoscrizione per un periodo di 12 mesi o, in ogni caso, fino alla fornitura del materiale e al pagamento del corrispettivo – ai sensi degli artt. 15 e 16 del vigente Accordo interregionale sulla gestione dell’Istituto Zooprofilattico Sperimentale delle Venezie, sottoscrizione che avverrà con firma digitale, ai sensi dell’art. 15, comma 2-bis della L. n. 241/1990, come modificato dall’art. 6, comma 5, del D.L. n. 145/2013, convertito, con modificazioni, dalla Legge n. 9/2014;
3. di prendere atto che, a fronte della cessione del materiale biologico specificamente indicato nell’art. 1 dell’accordo, ZOETIS BELGIUM S.A. si impegna a corrispondere all’IZSVe un corrispettivo pari a € 5.000,00 per ogni ceppo, per un totale di € 20.000,00
– oltre IVA, se applicabile, e spese di spedizione – subordinatamente all’emissione di regolare fattura, secondo le modalità indicate all’art. 3 dell’accordo;
4. di rilevare il ricavo, derivante dal presente provvedimento, al sottoconto 620010950 “Ricavi per prest. sanitarie a privati – Antigeni, reagenti e altro” del Bilancio d’esercizio 2023;
5. di prendere, infine, atto che, ai sensi dell’Agreement in parola, eventuali ceppi non inclusi nell’accordo potranno essere richiesti all'IZSVe da ZOETIS e che i relativi termini per la cessione dell’ulteriore materiale saranno concordati tra le Parti per iscritto come “Amendment” all’accordo.
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.
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X.X.X.Xx – Deliberazione del DIRETTORE GENERALE
1. di approvare lo schema di “Biological Material Transfer Agreement fo research activities”, da sottoscrivere tra l’Istituto Zooprofilattico Sperimentale delle Venezie, rappresentato dal Direttore Generale e legale rappresentante pro tempore, dott.ssa Xxxxxxx Xxxxx, e ZOETIS BELGIUM S.A., rappresentata dall’Executive Director, dr. Xxxxxxx Xxxxxxxxx, per la fornitura di n. 4 ceppi di Mycoplasma hyopneumoniae, documento che si allega al presente provvedimento quale parte integrante e sostanziale (allegato n. 1);
2. di procedere, per l’effetto, alla sottoscrizione dell’accordo di cui al punto che precede – efficace dalla data di ultima sottoscrizione per un periodo di 12 mesi o, in ogni caso, fino alla fornitura del materiale e al pagamento del corrispettivo – ai sensi degli artt. 15 e 16 del vigente Accordo interregionale sulla gestione dell’Istituto Zooprofilattico Sperimentale delle Venezie, sottoscrizione che avverrà con firma digitale, ai sensi dell’art. 15, comma 2-bis della L. n. 241/1990, come modificato dall’art. 6, comma 5, del D.L. n. 145/2013, convertito, con modificazioni, dalla Legge n. 9/2014;
3. di prendere atto che, a fronte della cessione del materiale biologico specificamente indicato nell’art. 1 dell’accordo, ZOETIS BELGIUM S.A. si impegna a corrispondere all’IZSVe un corrispettivo pari a € 5.000,00 per ogni ceppo, per un totale di € 20.000,00
– oltre IVA, se applicabile, e spese di spedizione – subordinatamente all’emissione di regolare fattura, secondo le modalità indicate all’art. 3 dell’accordo;
4. di rilevare il ricavo, derivante dal presente provvedimento, al sottoconto 620010950 “Ricavi per prest. sanitarie a privati – Antigeni, reagenti e altro” del Bilancio d’esercizio 2023;
5. di prendere, infine, atto che, ai sensi dell’Agreement in parola, eventuali ceppi non inclusi nell’accordo potranno essere richiesti all'IZSVe da ZOETIS e che i relativi termini per la cessione dell’ulteriore materiale saranno concordati tra le Parti per iscritto come “Amendment” all’accordo.
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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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 Xxxxxx Xxxxxxxx
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ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE
Viale dell’Università 10 – 00000 XXXXXXX (XX)
DELIBERAZIONE DEL DIRETTORE GENERALE N. 196 del 05/06/2023
OGGETTO: Approvazione dello schema di ``Biological Material Transfer Agreement for research activities`` per la fornitura di materiale biologico, tra l`Istituto Zooprofilattico Sperimentale delle Venezie e ZOETIS BELGIUM S.A.
Pubblicata dal 06/06/2023 al 21/06/2023 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
BIOLOGICAL MATERIAL TRANSFER AGREEMENT FOR RESEARCH ACTIVITIES
Istituto Zooprofilattico Sperimentale delle Venezie, is a public veterinary Institute with offices at Xxxxx xxxx’Xxxxxxxxxx 00, 00000 Xxxxxxx (XX), Xxxxx, fiscal code and VAT n. 00206200289, acting by Dr. Xxxxxxx Xxxxx, in her capacity as Director General, hereinafter referred to as “IZSVe” or “Provider”
and
ZOETIS BELGIUM SA, company number BE0401.953.350, RPM Nivelles, a company incorporated in Belgium whose registered office is at Xxx Xxxx Xxxxxx 0 (Xxxx Scientifique Xxxxxxx), 1348 Louvain-La-Neuve, Belgium and its Affiliates, represented by Dr Xxxxxxx Xxxxxxxxx, in his capacity as Executive Director, hereinafter referred to as “Zoetis” or “Recipient or Receiving Party”
and severally as “Party” 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 subject to the terms and conditions of this Agreement.
WHEREAS:
• The mission of the IZSVe is to monitor and preserve animal welfare and to control the animal and plant origin food-production chain; it is also involved in experimental research projects embracing the veterinary field;
• The IZSVe is involved in current research projects in collaboration with national and international organizations that aim at strengthening the existing knowledge in the field of veterinary hygiene and animal welfare, food safety and nutrition;
• Zoetis has extensive experience and expertise in the development, manufacturing and commercialization of animal health pharmaceuticals, vaccines, and diagnostics, and desires to acquire certain Materials available at IZSVe for research and development activities;
• IZSVe agrees to transfer to Recipient the following biological material in compliance with the clauses of the present Agreement.
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
For purposes of this Agreement, the following definitions shall be applicable:
“Effective date”: the date as of which the Agreement enters into force.
“Commercial Purposes”: the application of patents, the sale of products or services containing or incorporating the Materials, lease, license, or other transfer of the Material for any commercial purpose or for the direct benefit of any for-profit entity, including use of the Material by any organization, including the Recipient, to screen compounds, to produce or manufacture products for general sale.
“Confidential Information”: Information of any nature protected or not by an intellectual property right (for example 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:
a) is a part of the public domain at the date of this Agreement or became available following the aforementioned acquisition by act or behavior not prohibited by the Receiving Party;
b) is known or can be demonstrated that it was known by the Receiving Party at the time of transmission;
c) is disclosed to the Receiving Party and explicitly defined as non-confidential;
d) have been independently developed by the Receiving Party without using any of the confidential information;
e) is revealed to the Recipient Party by someone other than the Revealing Party that has no obligation to secrecy under the terms and conditions of the present Agreement; or else, information which becomes
available or is disclosed to the Recipient Party by any other means not ascribable to the present Agreement;
f) 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;
g) have been previously agreed upon in written form by the Provider of such information.
“Original Material”: the Material to be delivered from IZSVe to the Recipient under the term of this Agreement is as below specified.
Microorganism | Isolate ID Sample type | Year of isolation/S ample Collection date | Species | Substrate of Isolation | Comments | Quantity |
Mycoplasma hyopneumoniae | IZSVe/2016/1501 /9filfriisw/oinhibit ors | 2016 | Pig | bronchus | 1 | |
Mycoplasma hyopneumoniae | IZSVe/2021/1979 /2filfriis | 2021 | Pig | bronchus | 1 | |
Mycoplasma hyopneumoniae | IZSVe/2022/1436 /13filfriis | 2022 | Pig | bronchus | 1 | |
Mycoplasma hyopneumoniae | IZSVe/2022/9858 /3ldilfriis | 2022 | Pig | bronchus | 1 |
“Material”: Original Material, Progeny, Unmodified Derivatives.
“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, such as homologous recombination products, germ line transmission products, crossover products, novel varieties, cell fusion, sub-clonation products, genetic modification, attenuation, etc.
“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.
“Affiliates”: with respect to each party, the legal entities that control, are controlled by, or under common control with, such party.
“Provider's Scientist”: the employees of IZSVe.
“Recipient’s scientist”: the employees of the Recipient.
ART. 2. MATERIAL TRANSFER AND USE OF MATERIAL
IZSVe shall supply Zoetis the Material within sixty (60) days after this Agreement has been signed and dated by both Parties.
The Recipient will contact IZSVe, in particular the Provider’s scientist (Dr. Xxxxx Xxxxxxxxxx), to arrange the date(s) of shipment. IZSVe will ship the Material identified above in compliance with the applicable law and rules to the aforementioned address of the Recipient.
Zoetis agrees that the Material:
- will be used solely in connection with performing the above-mentioned research and development activity.
- shall not be incorporated into any product for sale, and in particular not be used for commercial vaccine production.
- will not be used in human subjects, in human clinical trials, or for diagnostic purposes involving human subjects without the Provider/s prior written consent.
Zoetis undertakes not to sell, disclose, transfer, give away or distribute the Material to any third party.
In no case will Zoetis start a patent application solely and directly related to the Strains and unmodified Derivatives.
Recipient shall use, and shall cause its researchers to use, the Materials in compliance with all applicable laws, regulations, guidelines and recommendations issued by national and international bodies, applicable to the Material, according to the terms and conditions set out in this agreement. In particular, Recipient shall use the Material in compliance with ethical laws, the research shall be conducted in accordance with the national and international ethical guidelines related to the use of animals in research.
The Material may be used on animals only if such use is explicitly approved by an Ethics Committee or by the legislation on the treatment of laboratory animals.
The Recipient shall ensure that the Recipient's employees and agents using the Material agree to be bound by the terms of this Agreement.
The Parties hereby agree that any Modifications created by Recipient shall be the sole property of Recipient and shall not be submitted to the non-use restrictions imposed to the Material under this Agreement.
ART. 3. CONSIDERATION
Zoetis shall pay an amount of € 5.000,00 (five thousand Euros) plus VAT, if applicable, per each strain, against presentation of regular invoice, for a total amount of € 20,000.00 (twenty thousand Euros) plus VAT, if applicable.
The four broth cultures containing each one of the bacterial strains included in this contract will be divided into two aliquots: one aliquot of 15 ml and another one of 30-35 ml. The Provider will send these aliquots to two different destinations as requested by the Recipient:
15mL Frozen material to Xxxxxx Xxxxxxx. Xxxx. Xx Xxxxxxxxx, x/x, 00000 X’Xxxxxxxxx xx Xxxxxx, Xxxxxx,Xxxxxx.
30-35mL Refrigerated material (Contact: xxxx.xxxxxxxx@xxxxxxxxxx.xxx + provide him shipment tracking number) to: PathoSense, Faculty of Veterinary Medicine, Xxxxxxxxxxxxx 000, X-0000 Xxxxxxxxx, Xxxxxxx.
Additional strains not included in this Agreement, may be requested from IZSVE by Zoetis, and the transfer price will be agreed between the Parties in writing as an amendment to this Agreement.
IZSVe will ship the samples identified above in compliance with the applicable law and rules. Organisation and shipping costs via dedicated courier company will be charged to Zoetis.
The payment shall be made by bank transfer using the following bank details:
Beneficiary bank – Intesa San Paolo
Bank account – IBAN XX00X0000000000000000000000 BIC or SWIFT code – XXXXXXXX.
Zoetis undertakes to make all payments due under this Agreement within 60 days after receipt of a properly set up invoice.
All payments made by Zoetis shall constitute admission by Zoetis as to the performance by IZSVe of its obligations under this Agreement.
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.
The Parties agree that this Agreement is subject to VAT according to Italian law (D.P.R. n. 633/1972 and its amendments) that is conform to EU single market rules. The registration fee is due just in the event of judicial or administrative use, as set forth in Italian law (D.P.R. n. 131/1986) and costs and expenses will be borne by the requesting Party. The Parties will contribute in equal measure to the other tax duties related to this agreement, stamp duty included.
ART. 4. INTELLECTUAL PROPERTY
Except as provided herein, all intellectual property rights resulting from the development of products for which Zoetis or Zoetis’ affiliate has used the Material as research materials shall be the sole property of Zoetis and Zoetis shall have the right at its own discretion to apply for patents in its own name and at its own expense.
IZSVe is the owner and has all the rights on the Material. The transfer does not grant or imply the ownership of the Material, or any intellectual and industrial property rights to the Recipient.
ART. 5. LIABILITY
All Material provided within the framework of the present Agreement are experimental.
By requesting the Material and signing this Agreement, the Recipient accepts responsibility for the proper handling and testing of the Material and Modifications 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 accepts that the Material and any Progeny classified as Risk Group 2(as defined by EU Regulations on such matters) includes known pathogens and that any other Material, differently identified, may be pathogenic under certain conditions.
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, except in the case of IZSVe’s negligence or willful misconduct.
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, except in the case of IZSVe’s negligence or willful misconduct.
the Provider won’t take the responsibility or guarantee that the use of the Material does not violate any patent, trademark or any other property right of any Third party.
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.
Neither the execution and delivery of this Agreement nor the granting of rights by IZSVe to Zoetis herein requires IZSVe to obtain any permits, authorizations or consents from any Governmental Authority (except for any export authorization released by the Italian Ministry of Health) or from any other person, firm or corporation, and such execution and granting of rights will not result in the breach of or give rise to any termination of any agreement or contract to which IZSVe may be a party which relates to the Materials, except that may reasonably not be expected to adversely affect the ability to perform its obligations under this Agreement.
ART. 7. TERM AND TERMINATION
This Agreement shall be effective upon the execution and shall remain in force for a period of 12 months, or, in any case, until the completion of the supply by IZSVe and payment by Zoetis of the corresponding compensation.
Each Party has the right to withdraw from this Agreement at any time, by giving 60 days’ notice in writing. The termination will not affect the obligations already performed by the Parties or whose performance is in progress at the time of termination. The withdrawal must be communicated to the other Party in pursuit of Art 8 – Notices.
If either Recipient or IZSVe materially breaches or materially defaults in the performance or observance of any of the provisions of this Agreement, and such breach or default is not cured within sixty (60) days after the giving of notice by the other Party specifying such breach or default, the other Party shall have the right to terminate this Agreement forthwith, such termination to be effective upon the expiration of such sixty-day notice period.
ART. 8. MISCELLANEOUS
Confidential information: The Recipient may share the Materials with its parent corporations, affiliates, subsidiaries and subcontractors as reasonably necessary for the performance of Recipient’s permitted uses of the Material. The Recipient shall not give, sell, share, release, convey, or otherwise distribute the Material and/or any accompanying Confidential Information to any other third parties not directly engaged by the recipient or acting on behalf of the Recipient in the performance of Recipient’s permitted uses of the Material without the prior written permission of IZSVe. The Recipient will refer any requests for the Material from anyone other than Recipient’s parent corporations, affiliates, subsidiaries and subcontractors to the Provider's Scientist. The Recipient acknowledges that IZSVe may withhold its consent for any reason it deems necessary and is not obliged to give the reason thereof.
Both Parties have already signed on July 8th, 2022 (rif. prot. IZSVe n. 6520/2022) a Mutual Confidentiality Agreement (“Mutual CDA”), whose content is a substantial integral Part of the present Material Transfer Agreement as far as applicable.
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, subsidiaries and subcontractors and subcontractors, only as strictly necessary for the performance of Recipient’s activities and permitted uses hereunder; provided, however, that such parent corporations, affiliates, subsidiaries and subcontractors and subcontractors must 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 Recipient shares the Material or Confidential Information with subcontractors, Recipient shall ensure that the Material and Confidential Information will only be used for the specific research and development purpose agreed between Recipient and its subcontractors, provided that such uses comply with the permitted uses herein, and that the Material and Confidential Information are returned to Recipient or destroyed after the specific research and development activity is completed by the subcontractor.
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.
Default. A Party will be considered in default of its obligations under this Agreement if such party should fail to observe, to comply with, or to perform any term, condition, or covenant contained in this Agreement and such failure continues for thirty (30) days after the non-defaulting party gives the defaulting party written notice thereof. In the event of default, the non-defaulting party, upon written notice to the defaulting party, may terminate this Agreement as of the date specified in the notice, and may seek such other and further relief as may be provided by law.
Force Majeure: The IZSVe will not be held responsible for the failure, the inaccurate or delayed fulfillment of the obligations of this Agreement, where the same has been caused, directly or indirectly, by unforeseeable circumstances, force majeure or any other cause not attributable to the same.
In the event of such force majeure, IZSVe thereby shall promptly notify the other Party in writing. If the force majeure lasts more than ninety (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.
Governing Law: The Parties shall attempt in good faith to resolve any dispute arising out of or relating to this Agreement promptly by negotiation. Any Party may give the other Party written notice of any dispute not resolved in the normal course of business. Within 15 days after delivery of the notice, the receiving Party shall
submit to the other a written response. In the event of continuing disagreement, the Parties shall refer the dispute to the courts of the general place of jurisdiction of the defending Party.
Entire Agreement: This Agreement and the Mutual CDA 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.
Assignment: 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.
Notices: All notices and other correspondence related to this Agreement shall be in writing and shall be effective when delivered by: (i) certified mail with return receipt, or (ii) hand delivery with signature or delivery receipt provided by a third party courier service (such as FedEx, UPS, DHL etc.), to the designated representative of the party as indicated below. A Party may change its designated representative for notice purposes at any time by written notice to the other Party:
If to IZSVe:
IZSVe
Attn: Xxxxxxx Xxxxxxxxx Xxxxxxx Xxx Xxxxxxxx 0/X
00000 - Xxxxxxxxxxx (XX) Xxxxxx
If to the Recipient:
Zoetis Belgium SA Attn: Xxxxxxx Xxxxxx Xxxxxxxxxxxxxxx 00
0000 Xxxxxxxx, Xxxxxxx
Email: xxxxxxx.xxxxxx@xxxxxx.xxx
With a copy to:
Zoetis
Attn: Xxxxx Xxxxxx, VP and Chief Counsel 000 Xxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Email: XxxxxXxxxxxx@xxxxxx.xxx
Copy to: XXXXXXXxxxxxxxXxxxxxxxxx@xxxxxx.xxx
ART. 9. ANTI-BRIBERY
a) Provider represents and warrants that:
i. Provider is licensed, registered, or qualified under local law, regulations, policies, and administrative requirements to do business and, to the extent required by applicable law, Provider has obtained licenses, consents, authorizations or completed such registrations or made such notifications as may be necessary or required by law to provide the goods or services encompassed herein; and Provider’s provision of such goods or services in this Agreement is not inconsistent with any other obligation of Provider.
ii. Provider shall comply with all local, national, and other globally applicable laws (such as the U.S. Foreign Corrupt Practices Act and the U.K. Bribery Act) regulating bribery and corruption (the “ABAC Laws”), and Zoetis’ Anti-Corruption and Anti-Bribery principles, attached hereto as Appendix A, and will take no action to cause Zoetis, or any of its subsidiaries, affiliates, partners, or representatives to violate these laws.
iii. Provider has not and will not directly or indirectly make, promise, pay, offer, or authorize the payment of money, or anything else of value, to improperly or corruptly influence any government official or any other person or entity in order to gain an improper business advantage, and, has not accepted, and will not accept in the future, such a payment.
iv. If applicable, all information provided by Provider during Xxxxxx’ pre-contractual due diligence, including all information provided in the Due Diligence Questionnaire, is complete, truthful and accurate, and Provider undertakes to update this information if (during the performance of this Agreement) Provider or any of the employees or individuals who will be primarily responsible for performing under this Agreement, or a familial relative of such an employee or individual, becomes a government official.
b) Provider hereby permits Zoetis to take reasonable steps to ensure that funds provided pursuant to this Agreement are properly used, including: (i) Providing periodic invoices stating, in detail, the supply of material; (ii) In the event Provider learns or has reason to know of any offer, promise, payment approval, or transfer of money, or anything else of value, that would violate the ABAC Laws, Provider will notify Zoetis immediately.
c) In addition to the rights and obligations set forth in Section 7, the parties may terminate this Agreement in good faith: (a) if Provider/Recipient breaches any terms set forth in this Section; (b) if Zoetis/IZSVe learns
(i) that improper payments are being or have been made to government officials or any other person or entity by Provider/Recipient, or (ii) that Provider/Recipient or those acting on behalf of Provider/Recipient with respect to the Agreement has accepted any payment, or anything else of value, as an improper inducement to award, obtain, or retain business or otherwise gain or grant an improper business advantage from or to any other person or entity.
ART. 10. ANTI-CORRUPTION AND CODE OF CONDUCT
The Company declares that it has read the:
- Code of Ethics and Behavior of the IZSVe, approved with DCA n. 12/2017, available in the “Transparent Administration/General Provisions” section of the Institute/website at the following link xxxx://xxx.xxxxxxxxxx.xx/xxxxxxxxxxxxxxx-xxxxxxxxxxx/XX00/xxxxxxxxxx.xxx and to adhere to the principles contained therein and to observe, if compliant, the rules provided for by the same Codes;
- Three-year plan for the prevention of corruption and transparency of the IZSVe, now “PIAO (Integrated Activity and Organisation Plan) Section II.3 - Corruption risks and transparency”, published on the institutional website xxxxx://xxx.xxxxxxxxxx.xx/xxxxxxxxxxxxxxx-xxxxxxxxxxx/XX00/xxxxxxxxxxxxxxx.xxx
The Parties also undertake to comply with the national legislation on the prevention of corruption (Law n. 190/2012 and subsequent amendments) and mutually undertake to immediately inform the other party of any possible violation of this article and will make available all information and documentation for any appropriate verification.
Any violation of this article by IZSVe or the Recipient constitutes a breach of the Agreement and will allow IZSVe and the Recipient to terminate the agreement with immediate effect.
IZSVe reserves the right, at its sole discretion, not to proceed or to suspend this Agreement if:
- believes that a conflict of interest may arise between public and private activities;
- recognizes a possible prejudice or damage to the image or to its initiatives or activities.
The Recipient must not in any way cause prejudice or harm the ethic of the primary institutional public function of the IZSVe and must not expose it to the risk of appearing unduly influenced by private interests of an advertising and commercial nature.
ART. 11. TREATMENT OF PERSONAL DATA
Both Parties undertake and agree to process the other party personal data in compliance with the General Data Protection Regulation EU 2016/679 within the execution of the present Agreement.
a) If a Party processes any personal data from the other Party behalf (“Personal Data”), the Party will do so in accordance with the other Party instructions and will take all appropriate technical and organizational measures to prevent unauthorized or unlawful processing or accidental loss or destruction of or damage to such data. Each Party shall preserve the accuracy and integrity of Personal Data. Each Party shall update, amend, correct or delete Personal Data that is inaccurate or incomplete at the request of the other Party or the data subject. To the extent that a security issue or data breach in relation to the Personal Data is identified by or made known to the Party. Each Party shall immediately notify the other Party in writing within 24 hours and, within ten (10) business days thereafter, either remediate such security issue or data breach.
b) To the extent that a Party provides data to the other Party which could be considered personal data requiring data privacy protections, each Party consents to the Personal Data being processed and used for the purposes of the administration of the parties contractual relationship (including without limitation the transfer of this Personal Data to other members of the Zoetis group of companies, to representatives and contractors working on behalf of Zoetis group and to veterinary regulatory authorities both within and outside the European Economic Area (EEA) (including the United States and Australia), both in connection with the Work and Xxxxxx’ subsequent activities). In addition, IZSVe’s Personal Data will be held on one or more databases for the purposes of determining IZSVe’s potential involvement in future research activities and for regulatory requirements.
IZSVe shall send any request for access to Personal Data to xxxxxxx@xxxxxx.xxx. Zoetis shall send any request for access to Personal Data to xxx@xxxxxxxxxx.xx. The personal data will be retained for the period of this agreement and for additional period as required by law.
ART. 12. 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 by their duly authorised representatives.
This Agreement is made at the date and place of the last signature.
Zoetis Belgium SA Istituto Zooprofilattico Sperimentale delle Venezie
Dr.Xxxxxxx Xxxxxxxxx, Executive Director Dr. Xxxxxxx Xxxxx, Acting Director General
APPENDIX A
GLOBAL ANTI-BRIBERY AND ANTI-CORRUPTION PRINCIPLES
Zoetis has a corporate policy that prohibits colleagues or anyone acting on our behalf from providing any payment or benefit to any person or entity in order to improperly influence a government official or other third party or to gain an unfair business advantage. Zoetis is committed to acting ethically and legally in accordance with all applicable laws and regulations. We expect the same commitment from the consultants, agents, representatives or other companies and individuals acting on our behalf (“Providers”), as well as those acting on behalf of Providers, in connection with work for Zoetis.
Bribery of government officials
Most countries have laws that forbid making, offering or promising any payment or anything of value (directly or indirectly) to a government official when the payment is intended to influence an official act or decision to award or retain business. It is Zoetis policy to broadly interpret “government official” to include: (i) any elected or appointed government official; (ii) any employee or person acting for or on behalf of a government official, agency, or enterprise performing a governmental function; (iii) any political party, candidate for public office, officer, employee, or person acting for or on behalf of a political party or candidate for public office; or (iv) an employee or person acting for or on behalf of a public international organization. “Government” is meant to include all levels and subdivisions of governments (i.e., local, regional, or national and administrative, legislative, or executive).
Anti-bribery and anti-corruption principles governing interactions with governments and government officials
A Provider must communicate and abide by the following principles with regard to their interactions with governments and government officials:
• Providers, and those acting on their behalf in connection with work for Zoetis, may not directly or indirectly make, promise, or authorize the making of a corrupt payment or provide anything of value to any government official as an improper inducement for such government official to make any governmental act or decision to help Zoetis obtain or retain business or otherwise improperly benefit Zoetis’ business activities.
• Providers, and those acting on their behalf in connection with work for Zoetis, need to understand whether local laws, regulations, or operating procedures impose any limits, restrictions, or disclosure requirements on compensation, financial support, donations, or gifts that may be provided to government officials. Providers, and those acting on their behalf in connection with work for Zoetis, must take into account and comply with any applicable restrictions in conducting their Zoetis-related activities. If a Provider is uncertain as to the meaning or applicability of any identified limits, restrictions, or disclosure requirements with respect to interactions with government officials, that Provider should consult with his or her primary Zoetis contact before undertaking their activities.
• Providers, and those acting on their behalf in connection with work for Zoetis, are not permitted to offer facilitation payments. A “facilitation payment” is a nominal, unofficial payment to a government official for the purpose of securing or expediting the performance of a routine, non- discretionary governmental action. Examples of facilitation payments include payments to expedite the processing of licenses, permits or visas for which all paperwork is in order. In the event that a Provider, or someone acting on their behalf in connection with work for Zoetis, receives or becomes aware of a request or demand for a facilitation payment or bribe in connection with work for Zoetis, the Provider shall report such request or demand promptly to his or her primary Zoetis contact before taking any further action.
Commercial bribery
Bribery and corruption can also occur in non-government, business to business relationships. Most countries have laws which prohibit offering, promising, giving, requesting, receiving, accepting, or
agreeing to accept money or anything of value in exchange for an improper business advantage. Zoetis colleagues are not permitted to offer, give, solicit or accept bribes, and we expect our Providers, and those acting on their behalf in connection with work for Zoetis, to abide by the same principles.
Anti-bribery and Anti-corruption principles governing interactions with non-governmental parties and Zoetis colleagues
Providers must communicate and abide by the following principles with regard to their interactions with non-governmental parties and Zoetis colleagues:
• Providers, and those acting on their behalf in connection with work for Zoetis, may not directly or indirectly make, promise, or authorize the making of a corrupt payment or provide anything of value to any person to induce that person to provide an unlawful business advantage for Zoetis.
• Providers, and those acting on their behalf in connection with work for Zoetis, may not directly or indirectly, solicit, agree to accept, or receive a payment or anything of value as an improper inducement in connection with their business activities performed for Zoetis.
• Zoetis colleagues are not permitted to receive gifts, services, perks, entertainment, or other items of more than token or nominal monetary value from Providers, and those acting on their behalf in connection with work for Zoetis. Moreover, gifts of nominal value are only permitted if they are received on an infrequent basis and only at appropriate occasions.
Reporting Suspected or Actual Violations
Providers, and those acting on their behalf in connection with work for Zoetis, are expected to raise concerns related to potential violations of these Anti-Bribery and Anti-Corruption Principles or the law. Such reports can be made to a Provider’s primary point of contact at Zoetis, or to the Zoetis Compliance Office by e-mail at Xxxxxxxxxx@Xxxxxx.xxx or by phone at x0 (000) 000-0000.