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. 354 del 06/10/2020
OGGETTO: Approvazione dello schema di ``Master Service Agreement`` tra questo Istituto e Anixa Biosciences Inc. con sede in California (USA)
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 ``Master Service Agreement`` tra questo Istituto e Anixa Biosciences Inc. con sede in California (USA)
Si sottopone al Direttore generale la seguente relazione del Responsabile della SS 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. 16 del 3.8.2015 e approvato con DGRV n. 1320 del 9.10.2015 – prevede che l’Istituto “può fornire prestazioni a terzi a titolo oneroso, stipulando convenzioni o contratti di consulenza per la fornitura di servizi e per l'erogazione di prestazioni a soggetti privati, ad imprese, enti, associazioni, organizzazioni pubbliche e private sulla
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X.X.X.Xx – Deliberazione del DIRETTORE GENERALE
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”;
- i vigenti documenti di programmazione di IZSVe prevedono – tra gli indirizzi approvati – la promozione e l’incentivazione di attività progettuali finanziate da soggetti terzi ad integrazione del finanziamento istituzionale.
Anixa Biosciences di seguito denominata “Anixa”, con sede in Xxx Xxxx, Xxxxxxxxxx (XXX) società di biotecnologia che sviluppa una serie di programmi per affrontare il cancro e le malattie infettive, con nota acquisita a ns. protocollo n. 7963 del 02.09.2020, ha richiesto di addivenire alla stipula di un Accordo c.d. “Master Services Agreement”, per la fornitura di servizi riguardanti la valutazione di campioni per lo studio di parametri relativi al Covid-19.
Con ticket intranet n. 151759/2020 il Xxxx. Xxxxxxxxx Xxxxxxxx, Dirigente Veterinario in servizio presso la “SCS6 – Virologia speciale e sperimentazione”, ha richiesto a questa Struttura di procedere con l’iter amministrativo per la conclusione dell’Accordo con Anixa, allegando, tra i documenti, la propria dichiarazione per la stipula del contratto con la suindicata organizzazione.
Al fine di formalizzare il rapporto, l’IZSVe e Anixa hanno concordato lo schema di Accordo denominato “Master Services Agreement” (MSA) documento che, unitamente agli allegati n. 1 “Sub- Service Agreement Form” n. 2 “Description of sub-service Agreement activities” e n. 3 “Change of Order Form”, si allega al presente provvedimento quale parte integrante e sostanziale (allegato n. 1);
In base all’art. 1 del suddetto documento, durante la vigenza contrattuale, Anixa potrà richiedere all’IZSVe determinati servizi, per i quali verrà inviato – di volta in volta – un preventivo del servizio richiesto e a fronte del quale sarà stipulato lo specifico “ Sub Service Agreeemnt ”. Nel contratto in parola sarà dettagliata la tipologia di prestazione e i relativi aspetti economici, nel rispetto dei termini e delle condizioni previste nel “Master Service Agreement” ed in conformità all’allegato n. 1 allo stesso.
Eventuali modifiche ai servizi relativi ad un Ordine di lavoro, potranno essere apportate solo previo consenso scritto di Anixa. Per le modifiche con un probabile impatto su costi, qualità o scadenze, sarà necessario l'utilizzo del modulo “Change Order Form” di cui all’allegato n. 3 del MSA.
Il “Master Service Agreement” non comporta oneri economici a carico delle parti.
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 “Master Services Agreement” tra Anixa Biosciences Inc., con sede in San Xxxx, California (USA), rappresentato dall’amministratore delegato, Xxxx. Xxxx Xxxxx, e l’Istituto Zooprofilattico Sperimentale delle Venezie, nella persona del Direttore generale e legale rappresentante pro tempore Dott.ssa Xxxxxxx Xxxxx, per la fornitura di servizi riguardanti la valutazione di campioni per lo studio di parametri relativi al Covid-19, documento che - unitamente agli allegati n. 1 “Sub- Service Agreement Form” n. 2 “Description of sub-service Agreement activities” e n. 3 “Change of Order Form”- viene allegato al presente provvedimento quale parte integrante e sostanziale (allegato n. 1);
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X.X.X.Xx – Deliberazione del DIRETTORE GENERALE
2. di procedere, per l’effetto, alla sottoscrizione del contratto di cui al punto che precede, ai sensi degli artt. 15 e 16 del vigente Accordo interregionale sulla gestione dell’Istituto Zooprofilattico Sperimentale delle Venezie;
3. di dare atto che l’Accordo costituirà la base per i successivi “Sub- Service Agreement Form” che definiranno nello specifico - e caso per caso - le attività richieste da Anixa e gli aspetti economici, nel rispetto dei termini e delle condizioni previste nel “Master Services Agreement” e in conformità ai modelli allegati allo stesso;
4. di assegnare al Xxxx. Xxxxxxxxx Xxxxxxxx la responsabilità scientifica per la realizzazione delle attività di cui il presente Accordo e degli specifici “Sub- Service Agreement”;
5. di imputare gli introiti per la fornitura dei servizi, di volta in volta dettagliati negli specifici “Sub- Service Agreement”, al sottoconto 620011003 “Ricavi per prestazioni sanitarie erogate a soggetti privati - Altre convenzioni forfettarie” del Bilancio Economico Preventivo 2020 e futuri (centro di costo da individuare);
6. di prendere atto che l’Accordo di cui al punto 1, non prevede oneri economici a carico delle parti.
Tutto ciò premesso, sulla base degli elementi riportati dal referente dell’istruttoria, si propone al Direttore generale quanto segue:
ESAMINATA la proposta di deliberazione del Responsabile della SS Affari Generali Anticorruzione e Trasparenza che attesta la regolarità della stessa in ordine ai contenuti sostanziali, formali e di legittimità dell’atto, attestazione allegata al presente provvedimento.
VISTA l’attestazione di copertura della spesa, ove prevista, allegata al presente provvedimento.
VISTO il decreto del Presidente della Giunta regionale del Veneto n. 102 del 22 settembre 2020 con il quale è stabilito di nominare 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.
DATO ATTO che è in corso la nomina del Direttore sanitario.
ACQUISITO il parere favorevole del Direttore amministrativo per quanto di competenza, espresso ai sensi dell’art. 15, comma 3, dello Statuto dell’Istituto, adottato con DCA n. 16 del 3 agosto 2015 e approvato con DGRV n. 1320 del 9 ottobre 2015.
VISTO l’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 “Master Services Agreement” tra Anixa Biosciences Inc., con sede in San Xxxx, California (USA), rappresentato dall’amministratore delegato, Xxxx. Xxxx Xxxxx, e l’Istituto Zooprofilattico Sperimentale delle Venezie, nella persona del Direttore generale e legale rappresentante pro tempore Dott.ssa Xxxxxxx Xxxxx, per la fornitura di servizi riguardanti la valutazione di campioni per lo studio di parametri relativi al Covid-19, documento che - unitamente agli allegati n. 1 “Sub- Service Agreement Form” n. 2 “Description of sub-service Agreement activities” e n. 3 “Change of Order Form”- viene allegato 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 dare atto che l’Accordo costituirà la base per i successivi “Sub- Service Agreement Form” che definiranno nello specifico - e caso per caso - le attività richieste da Anixa e gli aspetti economici, nel rispetto dei termini e delle condizioni previste nel “Master Services Agreement” e in conformità ai modelli allegati allo stesso;
4. di assegnare al Xxxx. Xxxxxxxxx Xxxxxxxx la responsabilità scientifica per la realizzazione delle attività di cui il presente Accordo e degli specifici “ Sub- Service Agreement” ;
5. di imputare gli introiti per la fornitura dei servizi, di volta in volta dettagliati negli specifici “Sub- Service Agreement”, al sottoconto 620011003 “Ricavi per prestazioni sanitarie erogate a soggetti privati - Altre convenzioni forfettarie” del Bilancio Economico Preventivo 2020 e futuri (centro di costo da individuare);
6. di prendere atto che l’Accordo di cui al punto 1, non prevede oneri economici a carico delle parti.
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
xxxx. Xxxxx Xxxxxxxx
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X.X.X.Xx – Deliberazione del DIRETTORE GENERALE
ATTESTAZIONI ALLEGATE ALLA DELIBERAZIONE DEL DIRETTORE GENERALE
Il Responsabile della Struttura proponente attesta la regolarità della proposta di deliberazione, presentata per l’adozione, in ordine ai contenuti sostanziali, formali e di legittimità dell’atto e che la stessa:
Comporta spesa su Finanziamento istituzionale
Finanziamento vincolato
Altri finanziamenti
Non comporta spesa x
ATTESTAZIONE DI COPERTURA ECONOMICA DELLA SPESA
Il Responsabile del Budget attesta l’avvenuto controllo sulla disponibilità di budget
Evidenziato infine che il responsabile della Struttura proponente, con la sottoscrizione della proposta di cui al presente atto, dichiara, sotto la propria responsabilità ed ai sensi e agli effetti degli artt. 47 e 76 del dPR 28 dicembre 2000, n. 445, che, in relazione alla presente procedura, non si trova in condizioni di incompatibilità di cui all’art. 35 bis del d.lgs. n. 165/2001, né sussistono conflitti di interesse di cui all’art. 6 bis della legge n. 241/1990 e agli artt. 6, 7 e 14 del dPR n. 62/2013.
dott.ssa Giulia Ferriani
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ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE
Viale dell’Università 10 – 00000 XXXXXXX (XX)
DELIBERAZIONE DEL DIRETTORE GENERALE N. 354 del 06/10/2020
OGGETTO: Approvazione dello schema di ``Master Service Agreement`` tra questo Istituto e Anixa Biosciences Inc. con sede in California (USA)
Pubblicata dal 07/10/2020 al 22/10/2020 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 Xxxxxxx Xxxxx - Direzione Generale Xxxxx Xxxxxxx - - Gestione Atti
MASTER SERVICES AGREEMENT
(the “Agreement”) entered into by and between
Istituto Zooprofilattico Sperimentale delle Venezie
Viale dell’Università 10
35020 Legnaro (Padua) Italy
VAT-ID No.: 00206200289
(hereinafter referred to as “Provider” or “IZSVe”)
and
Anixa Biosciences, Inc.
0000 Xxxxxxx Xxxxxxxxxx, Xxxxx 000 Xxx Xxxx, Xxxxxxxxxx 00000
XXX
(hereinafter referred to as “Anixa” or the “Company”) (severally as “Party” and jointly as “Parties”)
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WHEREAS Anixa is a U.S. entity, duly incorporated in the State of Delaware and existing under U.S. laws, and wishes to procure certain services from Provider regarding biological testing.
WHEREAS Provider is an Italian entity, duly incorporated and existing under Italian law, has knowledge and experience in the performance of such services and has represented that it is willing and able to perform these services under the terms and conditions as set forth below;
NOW, THEREFORE, in consideration of the mutual covenants contained herein, the Parties agree as follows:
1. Purpose of the Agreement
1.1 During the term of this Agreement, Anixa may request and Provider shall perform certain work in the field of in vitro and in vivo testing (the “Service(s)”) under the terms and conditions of this Agreement.
1.2 The Parties agree on the following procedure for requesting the Services:
As per request of Anixa to perform a Service to be detailed on a case-by-case basis, the Provider shall submit a written service estimate with the description of the requested Services to Anixa (“Service Estimate”). Such Service Estimate shall describe in detail the work-package, timelines, deliverables, costs and payment schedule and a coordinating person appointed by Provider. If Anixa agrees with such Service Estimate then Anixa will issue a Sub-Service Agreement in accordance with the template in Appendix I for signature by both Parties. More than one Sub-Service Agreement may be included under the terms and conditions of this Agreement, each subsequent to the preceding Sub-Service Agreement and subject to the achieved results, thus requested to continue the services.
1.3 No obligations for the rendering of Services or costs shall be incurred by either Party hereto unless and until a Sub-Service Agreement has been signed by both Parties in accordance with this Agreement. All Sub-Service Agreements shall reference and be subject to the terms and conditions set forth in this Agreement unless expressly stated otherwise in the respective Sub-Service Agreement by reference to the respective Section in this Agreement and agreed upon by the Parties in writing prior to its execution.
1.4 All Services shall begin immediately after execution of the respective Sub-Service Agreement and shall be finalised upon receipt and written approval of the deliverables set forth in the respective Sub-Service Agreement by Anixa pursuant to Section 3.2 below.
1.5 Any changes of the Services under a Sub-Service Agreement shall only be made with the prior written consent of Anixa. For changes with a likely effect on either costs, quality or timelines for the rendering of the Services, the use of a Change Order Form (Appendix III) is mandatory. Such form shall be sent by the Provider to Anixa and if the same is accepted by Anixa, it shall sign it and return it to the Provider for the changes to become effective.
1.6 Notwithstanding the provisions in Section 1.5, Provider shall immediately inform Anixa with regard to expected changes regarding the rendering of the Services.
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1.7 Provider may not sub-contract or assign its obligations under this Agreement without the prior written consent of Anixa.
1.8 Provider shall also perform the Services in benefit of an Affiliate of Anixa pursuant to this Agreement, provided that such Affiliate issues a Sub-Service Agreement (as defined in Section1.2) for Services making reference to this Agreement and agreeing to be bound by the terms of this Agreement. The term "Affiliate" shall mean any company or business entity which controls, is controlled by, or is under common control with Anixa. For purposes of this definition, "control" shall mean the possession, directly or indirectly or the power to direct or cause the direction of the management and policies of an entity (other than a natural person), whether through the majority ownership of voting capital stock, by contract or otherwise.
1.9 In case of a Sub-Service Agreement executed between an Affiliate and Provider, notwithstanding what is provided in Article 8 of this Agreement, any rights and obligations resulting from such Sub-Service Agreement and this Agreement shall exist between the Provider and the respective Affiliate only.
2. Representations and Warranties.
2.1 General Representations – Each Party represents and warrants that it is a duly organized entity in good standing and has power and authority to perform its obligations under this Agreement, and that this Agreement does not conflict with or violate any agreement with a third party and that in the conduct of its business and performance of its obligations hereunder, Anixa and IZSVe represent that they will observe and comply with all applicable laws, rules and regulations. Each Party hereby further represents that, as of the date of execution of this Agreement, the rights granted to the other hereunder do not conflict with the rights of any third party under any agreement with the Party making the representation or any of its Affiliates.
2.2 Except as otherwise explicitly set forth herein, each Party expressly disclaims to the other Party any express or implied warranty related to: (1) the performance or non- performance of this agreement; (2) the implied warranties of merchantability and fitness for a particular purpose; (3) any implied warranty arising out of a course of dealing, custom or usage of trade; (4) any representation or warranty of non-infringement of third party intellectual property rights; or (5) any other matter or subject arising out of this agreement.
3. Obligations of Provider
3.1 Provider shall keep Anixa informed of the progress of the work under a Sub-Service Agreement(s) on a regular basis as agreed upon in the Sub-Service Agreement.
3.2 Provider shall provide Anixa with the complete and detailed deliverables and a final report (“Report”) agreed upon in the respective Sub-Service Agreement for Anixa’s review and approval. Upon written request from Anixa, Provider shall make any reasonable modifications in such deliverables within ten (10) business days after receipt of Anixa’s written request.
3.3 Provider represents and warrants that:
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(i) it will use its commercially reasonable best efforts to carry out the Services within the times agreed upon and set forth in the Sub-Service Agreement and with all reasonable care and skill in accordance with all applicable laws and all provisions of this Agreement;
(ii) it shall devote the efforts of suitably qualified and trained employees capable of carrying out the Services in a professional manner and complying with work safety regulations and shall provide all necessary facilities therefor;
(iii) the services to be provided to Anixa shall be in accordance with the Sub-Service Agreement and best scientific practice;
(iv) it is entitled to transfer the rights according to Article 6 to Anixa, and that it has taken all appropriate measures therefore under all applicable local laws and regulations (including the claim of any inventions made by its employees, if necessary).
(v) it has obtained all authorizations and approvals and has notified all authorities necessary for the conduct of animal experiments and it will strictly comply with all laws, regulations and guidelines for the handling, treatment, welfare and ethical treatment of animals in research.
4. Considerations
4.1 In consideration of the Services to be conducted by Provider under a Sub-Service Agreement, Anixa shall pay the Provider the amount set forth in the respective Sub- Service Agreement, in accordance with the payment schedule detailed in the respective Sub-Service Agreement. The price set forth in a Sub-Service Agreement also includes any costs and expenses of Provider incurred in connection with the performance of the respective Services, including but not limited to the purchase of equipment, the costs of personnel and the costs for auditing.
4.2 Anixa undertakes to make all payments due under a Sub-Service Agreement within sixty
(60) days of receipt of an invoice by Provider. 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.
All payments shall constitute admission by Anixa as to the performance by IZSVe of its obligations under this Agreement.
In case the of payment’s delay exceeds one hundred and eighty (180) days, IZSVe may terminate this Agreement, without prejudice to its right to claim for further damages, if any.
The present Agreement does not involve travel and accommodation costs at the expense of IZSVe for the performance of the Services. Both Parties will follow their ordinary and internal policy which regulates terms and conditions of national and international missions, should these be considered necessary. Each Party shall bear its own expenses.
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The registration fee is due just in the event of judicial or administrative use, as set forth in Italian law (DPR n. 131/1986) and costs and expenses not exceeding EUR 200 will be borne by the requesting Party.
5. Confidentiality
6. Intellectual property rights, publicity and publication
The Parties agree that the intellectual property rights related to the results arising out of the performance of the Services (the “Results”) shall reside in Anixa. Anixa will evaluate the possibility of authorizing IZSVe to use the results for medical publications in the understanding that IZSVe shall request authorization in writing at least 30 days before the date of publication.
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The Parties acknowledge and agree that all intellectual property rights related to the logo will remain exclusive property of the owning Party; particularly, with no limitation, the usage of the logo of a Party by the other Party will not transfer to the using Party any rights or titles related to the logo.
7. Term and Termination
7.1 This Agreement shall be effective upon the execution and shall remain in force n. 60 months, or in any case, until the completion of the Services by IZSVe and payment by Anixa of the corresponding compensation.
7.2 This Agreement may be terminated at once by written notice by either Party if (i) the other Party breaches this Agreement in any material manner and shall have failed to remedy such default within sixty (60) days after written notice thereof from the terminating Party or (ii) the other Party by voluntary or involuntary action goes into liquidation or receivership; or dissolves or files a petition for bankruptcy or reorganisation or for suspension of payments or is adjudicated as bankrupt, becomes insolvent or assigns or makes any composition of its assets for the benefit of credit.
7.3 Notice of termination must in all cases be given in writing.
8. Effects of Expiration and/or Termination
8.1 Termination of this Agreement for any reason shall be without prejudice to the rights which expressly survive the termination in accordance with the terms of this Agreement and applicable laws, including without limitation, the rights and obligations of the Parties regarding to Intellectual Property Rights, Publicity and Publication, samples and materials. Termination pursuant to Section 7.2 shall not affect any running Sub-Service Agreements which shall be finalised according to the terms of this Agreement and the respective Sub-Service Agreement, subject to early termination pursuant to Section 7.2.
8.2 In the event of a termination pursuant to Section 7.2 in case Anixa is the defaulting Party, Anixa shall bear all Services-related costs incurred by Provider in accordance with the Sub-Service Agreement until the date of termination (including actual costs resulting from non-cancellable commitments entered into by Provider, provided, that
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Provider has used its best efforts to minimise such costs) but at maximum the price set forth in the respective Sub-Service Agreement.
8.3 The respective rights and obligations of the Parties under Articles 2, 5, 6, 9, 12, and 14 shall survive the expiration or termination of this Agreement for a period of five (5) years.
9. Miscellaneous
The delay or failure of either Party to enforce at any time or for any period of time any of the provisions of this Agreement shall not be construed as a waiver of such provisions or of the right of the Party to thereafter seek their enforcement.
The Parties claim that all rights that allow the signing and performance of this Agreement and that allows the other Party to perform the obligations set forth herein, belong to them. Each Party claims that the signing and performance of this agreement and the rights set forth herein do not compromise any third party rights.
If one or more of the provisions of this Agreement should be or become invalid or impracticable, the validity of the remaining provisions shall not be affected. The Parties shall in good faith make any efforts to replace the invalid or impracticable provision by an effective provision which must closely approximate to the purpose of this Agreement.
IZSVe and Anixa will act all times as independent contractors. Nothing contained herein shall be construed or applied so as to create the relationship of principal and agent or of employer and employee between IZSVe and Anixa or any partnership or joint-venture. Neither Party shall make any commitment or incur any charge or expense in the name of the other Party.
This Agreement may be amended, modified, superseded or canceled, only by a written instrument executed by each Party’s duly authorized representatives.
All notices and communications related to this agreement shall be made by registered or certified letter, return receipt requested, tele copier, email or electronic transmission confirmed in writing by register letter and shall be addressed as follows (or to other address as may hereafter be designed by written notice):
If to IZSVe: Att. Xxxxxxxxx Xxxxxxxx
Istituto Zooprofilattico Sperimentale delle Venezie Viale dell’Università 10
00000 - Xxxxxxx (XX) XXXXX
e-mail xxxxxxxxx@xxxxxxxxxx.xx
Support secretarial office: Xxxxxxxxx Xxxxxx – xxxxxxx@xxxxxxxxxx.xx
If to Anixa: Att. Xxxx Xxxxx Anixa Biosciences, Inc.
0000 Xxxxxxx Xxxxxxxxxx, Xxxxx 000 Xxx Xxxx, XX 00000
XXX
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10. WITHDRAWAL
10.1 Each Party has the right to withdraw from this Agreement at any time, by giving a six (6) months’ prior 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. These obligations are governed by Sections 8.1 and 8.3 as applicable of this Agreement.
10.2 In the event of a withdrawal pursuant to Section 10.1, Anixa shall bear all Services- related costs incurred by Provider in accordance with the Sub-Service Agreement until the date of termination (including actual costs resulting from non-cancellable commitments entered into by Provider, provided, that Provider has used its commercially reasonable best efforts to minimise such costs) but at the maximum the price set forth in the respective Sub-Service Agreement.
11. FORCE MAJEURE
IZSVe shall not be liable for failure of or delay in performing obligations set forth in this Agreement, or for having incorrectly performed them, and shall not be deemed in breach of its obligations, if such failure, delay or incorrect performance is due to natural disasters or any causes beyond its reasonable control including, without limitation, any act of God, any civil commotion or strike. In the event of such force majeure, the Party affected thereby shall promptly notify the other Party in writing. If the force majeure lasts more than 90 days, the Party shall have the right to terminate the Agreement; the notice of termination shall be made according to Article 9.
12. SAFETY HEALTH CARE AND INSURANCE
IZSVe acknowledges and agrees to respect and to enforce, within its premises, national law and internal regulations related to workers’ safety and health care. In case Anixa’s employees or consultants shall perform any kind of activities within IZSVe premises, visits and inspections included, Anixa acknowledges and agrees to enforce on its personnel the said laws and regulations, provided that such activities, visits and inspections, shall be scheduled in advance in writing by the Parties.
In case Anixa’s employees or consultants shall perform any kind of activities within IZSVe premises, visits and inspections included, Anixa shall have adequate insurance policies covering the damages, third party civil liability and accidents which may be caused by or issued from its personnel.
13. COMPLIANCE
13.1 IZSVe represents, warrants and covenants that it and its affiliates, owners, officers, directors, employees, agents, subcontractors, consultants and representatives (collectively referred to as “Representatives”) will perform all of IZVe’s obligations under this Agreement in compliance with all local, state, national, and international statutes, rulings, regulations, ordinances, and governmental directives, including , without limitation, those pertaining to anti-bribery, money laundering, competition, regulation of trade, the environment, transportation, safety, health, and employment (collectively referred to as the “Applicable Laws”) that apply to Anixa, IZSVe, either Party’s business, and the IZSVe services to which this Agreement relates. IZSVe further represents and warrants
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that neither it nor its Representatives will take any action that might cause Anixa to violate any Applicable Law. IZSVe will advise Anixa immediately if it learns, or has any reason to know, of: (i) any violation of any Applicable Law by IZSVe or its Representatives that occurred or may have occurred in performing IZSVe’s obligations under this Agreement; or (ii) any failure of IZSVe or any of its Representatives to comply with IZSVe’s obligations under this article.
13.2 Compliance Awareness and Training. IZSVe ensures that it and its Representatives involved in the performance of IZSVe’s obligations under this Agreement are knowledgeable about what is permissible and prohibited conduct under this article. If requested by Anixa or IZSVe, IZSVe and its Representatives will receive specific training.
13.3 IZSVe Records. IZSVe will maintain Records that accurately, fairly, and in reasonable detail, reflect all transactions and disposition of funds under this Agreement for the time period of 5 (five) years. IZSVe will maintain a system of internal financial and accounting controls and procedures sufficient to provide reasonable assurances that transactions and disposition of funds are properly recorded and authorized.
14. GOVERNING LAW AND DISPUTE RESOLUTION
This Agreement shall be subject to, governed by and construed in accordance with the laws of Italy (without regard to the conflicts of law rules, which might result in the application of the laws of any other jurisdiction). All disputes, controversies or differences which may arise between the Parties out of or in connection with this agreement, its interpretation or performance, shall be submitted to the exclusive jurisdiction of the Court of Padua, Italy.
15. TREATMENT OF PERSONAL DATA
According to and in compliance with the General Data Protection Regulation UE 2016/679 (GDPR), and in compliance with applicable U.S. regulations, the Parties acknowledge and agree to use, process and communicate to any third party the personal data contained herein, or acquired in any other form during the performance of this Agreement, solely and exclusively in order to carry out the purposes set forth in the agreement itself or to accomplish the fulfillments connected to it. Each Party authorizes the process of its data solely and exclusively in order to manage the agreement according to the terms and conditions set forth in the said law.
This Agreement has been freely negotiated between the Parties hereto and represent their willingness as duly and clearly shown in the content hereof and properly considered.
IN WITNESS WHEREOF, the Parties have caused this agreement to be executed by their duly authorized representatives.
This agreement is made at the date and place of the last signature.
IZSVe Anixa
Acting General Manager Chief Executive Officer
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Dr. Xxxxxxx Xxxxx Dr. Xxxx Xxxxx
Date Date
Appendix I: Sub-Service Agreement Form
Appendix II: Description of Sub-Service Agreement activities Appendix III: Change of Order Form
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Appendix I
Sub-Service Agreement
BY AND BETWEEN
Istituto Zooprofilattico Sperimentale delle Venezie, an Italian governmental institution, with offices at Xxxxx xxxx’Xxxxxxxxxx 00, 00000 Xxxxxxx (XX), Xxxxx, fiscal code and VAT n. 00206200289, PEC: xxxxxxxxxx@xxxxxxxxx.xx, represented by Dr. Xxxxxxx Xxxxx, Acting Director General,
(hereinafter referred to as “IZSVe” or
“Supplier”)
and
Anixa Biosciences, Inc. a U.S. entity organized under the laws of the State of Delaware, having its registered office at 0000 Xxxxxxx Xxxxxxxxxx, Xxxxx 000, Xxx Xxxx, XX 00000, XXX, represented by Dr. Xxxx Xxxxx, Chief Executive Officer
(hereinafter referred to as the “ Company” or
“Customer”
and severally as “Party” and jointly as “ Parties”)
In consideration of the covenants and obligations hereinafter set forth, and in compliance with the General terms and conditions of the present Master Service Agreement, the Parties hereto, individually and by their respective agents and representatives, hereby agree as follows:
1. SERVICES
Company requests and IZSVe shall perform certain services regarding in vitro testing (hereinafter referred to as “Services”) on the terms and conditions of this Master Service Agreement. A brief description of activities are outlined in Appendix II.
No changes to the activities as described in Appendix II shall be made without the prior written consent of the Parties. In case any such changes result in substantial differences in the cost of the Services , the final budget will be adjusted by a mutually amount agreed by the Parties in writing. Deliverables and timelines will be agreed upon by the Parties and the material and samples relating to the Services (hereinafter referred to as “Material”) are provided by Company to IZSVe.
During the term of this Sub-Service Agreement, the Parties may also communicate periodically in order to check and/or clarify and/or up to date the Services’ working progress.
2. CONSIDERATION
Company shall pay to IZSVe for all Services rendered pursuant to this Agreement the sum of Euro …………………… ( taxes and pension fund included but VAT excluded) against presentation of regular invoice, according to the following terms:
- a first installment equal to 50% of the Consideration (i.e. Euro ………….. taxes and pension fund included but VAT excluded) at the execution of this Sub-Service Agreement;
- a final balance equal to 50% of the Consideration (i.e. Euro taxes and
pension fund included but VAT excluded) upon the termination of this Sub-Service Agreement;
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Invoices may be sent by regular mail or e-mail.
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.
Company undertakes to make all payments due under this Sub-Service Agreement within 60 days after the receipt of invoice by IZSVe.
All payments by Company shall constitute admission by Company as to the performance by IZSVe of its obligations under this Sub-Service Agreement.
In case the of payment’s delay exceeds one hundred and eighty (180) days, IZSVe may terminate this Sub-Service Agreement, without prejudice to its right to claim for further damages, if any.
3. TERM
This Sub-Service Agreement shall be effective upon the execution and shall remain in force until the completion of the Services by IZSVe and payment by Company of the corresponding compensation.
IZSVe Principal Investigator(s):
Company Principal Investigator(s):
In the understanding that payments are only due within sixty (60) days of receipt by Company of the corresponding invoice issued by Provider.
Acknowledged and agreed by Anixa Biosciences, Inc.
…………………………………………… Date…………………
Acknowledged and agreed by ISTITUTO ZOOPROFILATTICO SPERIMENTALE DELLE VENEZIE
……………………………………………………………………………………………… Date…………………………..
Warranties and liability, treatment of confidential information, intellectual property rights, publicity and publication, termination clause, withdrawal and force majeure clauses, safety health care and insurance, treatment of personal data, governing law and dispute resolution will be in compliance with what has been set forth in the Master Service Agreement
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Appendix II
Brief description of the requested activities
Anixa’s affiliate will provide 10 compounds which we are requesting to be tested as follows:
1) Pre-screening of 10 compounds by PRA on Caco-2 cells; using the concentration range: 30
– 10 – 3.33 – 1.11 – 0.37 – 0.123 µM. Option of additional compounds to be pre-screened; such additional tests will be fixed by amendment(s); 110 € per test item.
2) The 2 most effective compounds in PRA (considering antiviral IC50 and if necessary toxicity issues) will be subsequently tested in VYRA (2 MOIs) on Caco-2 cells. By doing so,
(A) supernatants will be tested by RT-qPCR, and (B) FFA (titrating supernatants' infectivity after dialysis) will be done by using Vero-E6 cells, yielding in IC50 determinations. Option of additional compounds to be tested; such additional tests will be fixed by amendment(s); each additional test item in VYRA will cost 2,539.20 €.
In case that we will have a higher number of interesting compounds to be testet, in PRA and/or VYRA, we would like to handle it short-termed and flexible by amendments.
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Appendix III
Appendix III
Change of Order-Form
CONTRACT BETWEEN: | EFFECTIVE DATE: |
DATE OF THE ORDER: | ORDER NUMBER: |
DESCRIPTION OF THE WORK ORDER REQUEST: | |
REASONS FOR ISSUING A CHANGE OF WORK ORDER: | |
INVOLVED CHANGES OF BUDGET (ESTIMATE), IF ANY: | |
OTHER EFFECTS ON THE SERVICES (TIMELINE, QUALITY, ETC.): | |
AGREED BY XXXXXXX (SIGNATURE AND DATE) | AGREED BY THE PROVIDER (SIGNATURE AND DATE) |
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