Contract
DELIBERAZIONE N. 927 DEL 31/08/2020 | |
OGGETTO: STIPULA ACCORDO DI COLLABORAZIONE SCIENTIFICA CON UNIVERSI- TA' DI OXFORD E ACCETTAZIONE CONTRIBUTO DI RICERCA DI GBP 34.000,00 PER L'ESECUZIONE DI ATTIVITA' RELATIVE AL PROGETTO DAL TITOLO "TALAZOPARIB AND CHLORAMBUCIL COMBINATION AS A THERAPEUTIC STRATEGY FOR BRCA1/2- DEFICIENT TUMOURS" DA SVOLGERSI SOTTO LA SUPERVISIONE DELLA DR.SSA AN- NAMARIA BIROCCIO | |
Esercizi/o 2020/2021 Conto 401030401 | STRUTTURA PROPONENTE |
Centri/o di costo 3020050 | Servizio Amministrativo della Ricerca |
- Importo presente Atto: € +GBP 34.000,00 (sterline in- glesi) | Il Dirigente Responsabile Xxxxxxxx Xxxxxxx |
- Importo esercizio corrente: € . | |
Budget | |
- Assegnato: € . | |
- Utilizzato: € . | |
- Residuo: € . | |
Autorizzazione n°: . | |
Servizio Risorse Economiche: Xxxxxxxxx Xxxxxxxxx | Responsabile del Procedimento |
Catia Minutiello | |
L’Estensore | |
Catia Minutiello | |
Proposta n° DL-914-2020 | |
PARERE DEL DIRETTORE SANITARIO | PARERE DEL DIRETTORE AMMINISTRATIVO |
Positivo | Positivo |
Data 27/08/2020 | Data 26/08/2020 |
IL DIRETTORE SANITARIO Xxxxxx Xxxxxxx | IL DIRETTORE AMMINISTRATIVO Xxxxx Xxxxxxxxx |
Xxxxxx del Direttore Scientifico IRE Xxxxxxx Xxxxxxxxx data 25/08/2020 Positivo Parere del Direttore Scientifico ISG Xxxx Xxxxxxx data 26/08/2020 Positivo | |
La presente deliberazione si compone di n° 6 pagine e dei seguenti allegati che ne formano parte integrante e sostanziale: - Accordo di Collaborazione | |
Il Dirigente della Servizio Amministrativo della Ricerca
Visto il decreto legislativo 30 dicembre 1992, n. 502 e successive modificazioni ed in- tegrazioni;
il decreto legislativo 16 ottobre 2003, n. 288;
la legge regionale del 23 gennaio 2006, n. 2;
il D.M. del Ministero della Salute dell’8 maggio 2020 di conferma del ricono- scimento del carattere scientifico dell’IRCCS di diritto pubblico a Istituti Fisio- terapici Ospitalieri (IFO) relativamente alla disciplina di “Oncologia” per l’Isti- tuto Nazionale Tumori Regina Xxxxx (IRCCS IRE);
Premesso che l’art. 7 del decreto legislativo 16 ottobre 2003 n. 288, contempla le diverse tipologie di ricavi degli IRCCS;
che in data 9 Dicembre 2019 la Dr.ssa Xxxxxxxx Xxxxxxxxx, Professore di Bio- logia Cellulare e Molecolare presso l’Università di Oxford, ha trasmesso lettera di intenti alla Dr.ssa Xxxxxxxxx Xxxxxxxx, Dirigente Biologo presso la UOSD Oncogenomica ed Epigenetica degli IFO-IRCCS IRE, agli atti della scrivente, per comunicare l’accettazione di un progetto dal titolo “Talazoparib and Chlo- rambucil combination as a therapeutic strategy for BRCA1/2-deficient tu- mours” da parte della Breast Cancer Now Catalist Programme e chiedere l’atti- vazione di una collaborazione scientifica tra le parti al fine di valutare l’effica- cia antitumorale della combinazione Clorambucile-Talazoparib in modelli di tumore BRCA deficienti e proficienti,
che con la medesima nota, propone di supportare le attività da svolgere presso IFO-IRCCS IRE con un contributo di ricerca pari a GBP 34.000,00 (sterline in- glesi);
Tenuto conto della nota n. 8672 del 6 luglio 2020 con la quale la Dr.ssa Xxxxxxxx ha richiesto di procedere all’attivazione della collaborazione scientifica con l’Università di Oxford, al fine di regolamentare le attività previste per l’attuazione del Proget- to summenzionato e accettare il contributo di ricerca di GBP 34.000,00 per l’esecuzione delle attività, dettagliate nel preventivo prodotto e agli atti della scrivente;
Considerato che è stato predisposto un Accordo di Collaborazione tra Università di Oxford e IFO-IRCCS IRE, parte integrante e sostanziale del presente atto, per discipli- nare le attività previste per l’esecuzione del progetto;
Visto il parere favorevole del Direttore Scientifico IRE;
Ritenuto opportuno stipulare un accordo di collaborazione tra Università di Oxford e IFO-IRCCS IRE, al fine di regolamentare le attività previste per l’attuazione del Progetto di Ricerca dal titolo “Talazoparib and Chlorambucil combination as a therapeutic strategy for BRCA1/2-deficient tumours” e accettare il contri- buto di ricerca di GBP 34.000,00 (sterline inglesi) per l’esecuzione delle attivi- tà, dettagliate nel preventivo prodotto e agli atti della scrivente, da svolgere sot- to la responsabilità della Dr.ssa Xxxxxxxxx Xxxxxxxx presso IFO-IRCCS IRE;
Vista la deliberazione IFO n. 801 del 26 ottobre 2015 con la quale è stato disposto di accantonare, dai finanziamenti acquisiti per la ricerca finalizzata provenienti da Enti erogatori pubblici e privati, una quota pari al 10% da suddividere come di seguito specificato:
- 5,75% Direzione Scientifica IRE
- 4,25% Ente;
Attestato che il presente provvedimento, a seguito dell’istruttoria effettuata, nella forma e nella sostanza è totalmente legittimo e utile per il servizio pubblico, ai sensi dell’art. 1 della Legge 14 gennaio 1994, n. 20 e successive modifiche, nonché alla stregua dei criteri di economicità e di efficacia di cui all’art. 1, primo com- ma, della Legge 7 agosto 1990, n. 241, come modificata dalla Legge 11 febbra- io 2005, n. 15;
in particolare, che il presente provvedimento è stato predisposto nel pieno ri- spetto delle indicazioni e dei vincoli stabiliti dai decreti del Commissario ad acta per la realizzazione del Piano di Rientro dal disavanzo del settore sanitario della Regione Lazio;
Propone
Per i motivi di cui in narrativa che si intendono integralmente confermati di:
- stipulare un Accordo di collaborazione tra Università di Oxford e IFO-Istituto Nazionale Tu- xxxx Xxxxxx Xxxxx al fine di regolamentare le attività previste per l’attuazione del Progetto di Ricerca dal titolo “Talazoparib and Chlorambucil combination as a therapeutic strategy for BR- CA1/2-deficient tumours” da svolgere sotto la responsabilità della Dr.ssa Xxxxxxxxx Xxxxxxxx per IFO-IRCCS IRE;
- accettare il contributo di GBP 34.000,00 (sterline inglesi) per l’esecuzione delle attività pre- viste presso IFO-IRCCS IRE, dettagliate nel preventivo prodotto dalla Dr.ssa Xxxxxxxx e agli atti della scrivente;
- dare esecuzione alla deliberazione IFO n. 801 del 26 ottobre 2015 e detrarre dal contributo previsto una quota pari al 10% da suddividere come di seguito specificato:
5,75% Direzione Scientifica IRE
4,25% Ente;
- dare mandato al Servizio Risorse Economiche di iscrivere al piano dei conti n. 401030401 la somma di GBP 34.000,00 (sterline inglesi trentaquattromila,00), da convertire in Euro con il tas- so di cambio vigente al momento dell’incasso.
La UOSD Servizio Amministrativo per la Ricerca, curerà tutti gli adempimenti per l’esecuzione del- la presente deliberazione.
Il Dirigente della Servizio Amministrativo della Ricerca Xxxxxxxx Xxxxxxx
Il Direttore Generale
Visto il decreto legislativo 30 dicembre 1992, n. 502 e successive modificazioni ed integrazioni; Visto il decreto legislativo 16 ottobre 2003, n. 288;
Vista la legge regionale 23 gennaio 2006, n. 2;
In Virtù dei poteri conferitigli dal Presidente della Regione Lazio con Decreto del 23 novembre 2016, n. T00248;
Preso atto che il Dirigente proponente il presente provvedimento, sottoscrivendolo, attesta che lo stesso a seguito dell’istruttoria effettuata, nella forma e nella sostanza è totalmente legitti- mo e utile per il servizio pubblico, ai sensi della legge 14 gennaio 1994, n. 20 art. 1 e suc- cessive modifiche, nonché alla stregua dei criteri di economicità e di efficacia di cui alla legge 7 agosto 1990, n. 241 art. 1, primo comma come modificata dalla legge 11 febbraio
2005, n. 15;
Preso atto altresì che il Dirigente proponente il presente provvedimento, sottoscrivendolo attesta, in particolare, che lo stesso è stato predisposto nel pieno rispetto delle indicazioni e dei vinco- li stabiliti dai decreti del Commissario ad acta per la realizzazione del Piano di Rientro dal disavanzo del settore sanitario della Regione Lazio;
Visto il parere favorevole del Direttore Amministrativo e del Direttore Sanitario Aziendale; ritenuto di dover procedere;
Delibera
di approvare la proposta così formulata concernente “STIPULA ACCORDO DI COLLABORAZIONE SCIENTIFICA CON UNIVERSITA' DI OXFORD E ACCETTAZIONE CONTRIBUTO DI RICERCA DI GBP 34.000,00 PER L'ESECUZIONE DI ATTIVITA' RELATIVE AL PROGETTO DAL TITOLO "TALAZOPARIB AND CHLORAMBU- CIL COMBINATION AS A THERAPEUTIC STRATEGY FOR BRCA1/2-DEFICIENT TUMOURS" DA SVOLGERSI SOTTO LA SUPERVISIONE DELLA DR.SSA XXXXXXXXX BIROCCIO” e di renderla disposta.
Il Direttore Generale Xxxx. Xxxxxxxxx Xxxx di Meana
Documento firmato digitalmente ai sensi del D.Lgs 82/2005 s.m.i. e norme collegate
COLLABORATION AGREEMENT
between
THE XXXXXXXXXX, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
and
ISTITUTI FISIOTERAPICI OSPITALIERI – REGINA XXXXX NATIONAL CANCER INSTITUTE
COLLABORATION AGREEMENT
between
The Xxxxxxxxxx, Masters and Scholars of the University of Oxford, a charitable body registered in United Kingdom, incorporated under the Act for Incorporation of Both Universities 1571 and having its main administrative offices at Xxxxxxxxxx Xxxxxxx, Xxxxxxxxxx Xxxxxx, Xxxxxx, XX0 0XX, Xxxxxx Xxxxxxx (the “Lead”)
and
Istituti Fisioterapici Ospitalieri – Regina Elena National Cancer Institute (“IFO/IRE”), whose address is at Xxx Xxxx Xxxxxxxx 00, XXX 00000, Xxxx, Xxxxx, duly represented by Director General, Xxxx. Xxxxxxxxx Xxxx xx Xxxxx, (“IFO/IRE” or “Collaborator”)
hereinafter referred to as the “Parties” and each of them being a “Party”)
BACKGROUND
A. The Lead has been awarded a grant from Breast Cancer Now (the “Funder”) in respect of a project titled “TALAZOPARIB AND CHLORAMBUCIL COMBINATION AS A THERAPEUTIC STRATEGY FOR BRCA1/2-DEFICIENT TUMOURS” approved by the Breast Cancer Now Catalyst Programme (the “Project”), the terms of which are attached as Part 1 of the Schedule to this Agreement (the “Head Terms”). The Principal Investigator is Xxxxxxxx Xxxxxxxxx at the Lead; the Co-Investigator is Dr. Xxxxxxxx Xxxxxxxxx at IFO/IRE.
B. The Lead has entered into a Material Transfer Agreement with Pfizer under Pfizer’s Compound Transfer Program, the terms of which are attached as Part 4 of the Schedule to this Agreement (the “Pfizer MTA”).
C. This Agreement sets out the terms and conditions under which the Lead will pass on the funds allocated to the Collaborator under the Head Terms or as agreed between the Parties and approved by the Funder and under which the Parties will collaborate on the work to be conducted on the Project.
D.
TERMS AND CONDITIONS
It is hereby agreed as follows:
1. The Project shall commence on 1st June 2020 and shall continue for fifteen (15) months unless terminated earlier in accordance with this Agreement. The Parties will co-operate to perform the Project. The tasks to be undertaken by each Party for the Project are those allocated to them in the proposal made to Funder for the Project attached, or as specifically set out, at Part 2 of the Schedule to this Agreement (the “Proposal”). The Parties agree to perform such tasks with reasonable skill and care within the scope of their funding.
2. The Collaborator xxxxxx agrees to comply with the Head Terms in so far as they relate and apply to its involvement in the Project. Additionally the Collaborator agrees not to conduct itself (whether by act or omission) in such a manner that would cause the Lead to be in breach of the Lead’s obligations under the Head Terms. On termination or expiry of the Head Terms, this Agreement will automatically immediately terminate.
3. The Collaborator xxxxxx agrees to comply with the terms of the Pfizer MTA in so far as they relate and apply to its involvement in the Project. Additionally the Collaborator agrees not to
conduct itself (whether by act or omission) in such a manner that would cause the Lead to be in breach of the Lead’s obligations under the Pfizer MTA. For the avoidance of doubt, the Parties agree that no materials are to be transferred by Lead to IFO/IRE and IFO/IRE will purchase any materials required for the work to be undertaken by IFO/IRE for the Project using the funding provided.
4. The Collaborator agrees to provide to the Lead promptly on request (and where it is legally able to do so) with any information, documentary evidence and records in respect of the Project that the Lead may reasonably require from time to time in order to fulfil its reporting obligations under the Head Terms.
5. The maximum liability of a Party under this Agreement shall not exceed the amount of
£50,000 and shall not, in any case extend to indirect or consequential losses. Nothing in this Agreement limits or excludes any Party’s liability for (a) death or personal injury resulting from negligence; or (b) any fraud or for any sort of other liability which, by law, cannot be limited or excluded.
6. The funding to be provided to the Collaborator by the Lead in respect of the Project is detailed in the payment schedule contained in Part 3 of the Schedule to this Agreement. The Lead shall only pass on funds received under the Head Terms. If the Funder requires the reimbursement by the Lead of any sums paid under the Head Terms, then to the extent that such requirement arises from the acts or omissions of a Collaborator, such Collaborator agrees to reimburse the Lead together with any interest charged thereon by the Funder.
7. Intellectual Property
7.1. In this Agreement, “Intellectual Property” shall mean intellectual property of any description including but not limited to all inventions, designs, information, specifications, formulae, improvements, discoveries, know-how, data, processes, methods, techniques and the intellectual property rights therein, including but not limited to, patents, copyrights, database rights, design rights (registered and unregistered), trademarks, trade names and service marks, and applications for any of the above.
7.2. All Intellectual Property used in connection with the Project which has been generated prior to or outside the scope of the Project (“Background IP”) shall remain the property of the Party contributing the same. The Parties agree that any improvements or modifications to a Party’s Background IP arising from the Project which are not severable from that Background IP will be deemed to form part of that Party’s Background IP and be owned by that Party. Each Party acknowledges and confirms that nothing contained in this Agreement shall give it any right, title or interest in or to the Background IP of the other Party save as granted by this Agreement.
7.3 “Results” shall mean all information, data, know-how, results, inventions, software and other Intellectual Property arising through conduct of the Project. In accordance with the Head Terms, all Results shall be owned by the Lead. The Lead may commercially exploit the Results in consultation with the other Party. In such circumstances, the Lead will pay the other Party a fair and reasonable royalty rate/revenue on the value of any products or processes commercially exploited by it which incorporate any Results taking into consideration the respective financial and technical contributions of the Party to the development of the Results, the expenses incurred in securing intellectual property protection thereof and the costs of its commercial exploitation and the proportionate value of the Results in any such product or process.
7.4 Each Party grants the other Party, subject to the restrictions in clause 9, a non- exclusive, non-transferable, non-sub-licensable, royalty-free licence for the duration of the Project to use its Background IP (provided it is free to license the Background IP in question) solely to enable the other Party to carry out its respective part of the Project.
7.5 The Lead grants the other Party, subject to the restrictions in clause 9, a non- exclusive, non-transferable, non-sub-licensable, royalty-free licence to use the Results for academic and non-commercial research purposes, including research projects funded by third parties (including commercial entities) provided that those parties gain or claim no rights to such Results.
7.6 If the Lead requires the use of Background IP of the Collaborator in order to exercise its rights in the Results then, provided the Collaborator is free to license the Background IP in question, the Collaborator will not unreasonably refuse to grant or delay granting a licence to the Lead so that the Lead may use such Background IP for the purpose of exercising its rights in the Results.
8. Subject to clause 9, the Parties each agree to use reasonable endeavours to keep confidential and not to publish or disclose in any way (other than to those of its employees, students, directors, officers, advisors or representatives who have a need to know such information for the purposes of the Project) any information considered confidential by a reasonable person which is disclosed to it by the other Party in connection with the Project (including the other Party’s Results and background intellectual property) (“Confidential Information”).This clause shall not apply to information which is in the public domain other than through breach of this Agreement, which a Party can demonstrate was known to it before disclosure, which was lawfully acquired from a third party or is required to be disclosed to any regulatory authority or court of competent jurisdiction, or which is required to be disclosed pursuant to a request under the Freedom of information Xxx 0000 or the Environmental Information Regulations 2004.
9. Publications
9.1 This Agreement shall not prevent or hinder registered students of either Party from submitting for degrees of that Party theses based on results obtained during the course of work undertaken as part of the Project; or from following that Party’s procedures for examinations and for admission to postgraduate degree status.
9.2 In accordance with normal academic practice, all employees, students, agents or appointees of the Parties (including those who work on the Project) shall be permitted in pursuance of the Parties’ academic functions, to discuss work undertaken as part of the Project in internal seminars and to give instruction within their organisation on questions related to such work.
9.3 Any publication or other dissemination of the Results (or any part of them) by any of the Parties shall not occur until the Lead has published the Results of the Project in the primary publication (the “Primary Publication”). Authorship of the Primary Publication shall be in accordance with normal academic practice. Prior to the publication of articles directly arising from work on the Project, each Party shall endeavour to circulate proposed publications at least 30 days in advance of submission for publication. The provisions of this sub-clause 9.3 shall survive termination or expiry of this Agreement for the period of one year.
9.4 A draft of any publication of the conclusions of the Project shall be sent to the Funder’s representative at the same time as submission for publication or at least 30 days before the date for publication whichever is earlier, in accordance with the Head Terms.
9.5 No Party shall use the name or any trademark or logo of any other Party or the name of any of its staff or students in any press release or product advertising, or for any other commercial purpose, without the prior written consent of the Party.
10. Each Party shall procure that in carrying out the Project, it will comply with all applicable laws, regulations and statutes, including those relating to anti-bribery and modern slavery. Non-compliance with this clause by a Party shall not be sufficient justification for another Party to not comply with its obligations under this Agreement.
11. Any additional conditions which apply to this Agreement (over and above this Agreement) are set out in Part 4 of the Schedule to this letter.
12. This Agreement shall be regarded as though it were a complementary agreement to the Head Terms. Nothing contained in this Agreement shall be so construed or interpreted in any way as to diminish or alter the rights of the Funder as set out in the Head Terms which shall take precedence.
13. If a Party visits the premises of the other Party to carry out any of the Project, it shall comply with all works rules, safety policies and other premises regulations communicated to that Party from time to time
14. This Agreement shall be governed and construed in accordance with the laws of England and Wales and the Parties agree to the exclusive jurisdiction of the English Courts.
15. A signed copy of this Agreement delivered by e-mailed portable document format file or other means of electronic transmission shall be deemed to have the same legal effect as delivery of an original signed copy of this Agreement.
IN WITNESS WHEREOF this Agreement is executed as follows: for and on behalf of THE XXXXXXXXXX,
MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
Signed: Name:
Title:
Dated:
for and on behalf of ISTITUTI FISIOTERAPICI OSPITALIERI – REGINA XXXXX NATIONAL CANCER INSTITUTE
Signed: Name:
Title:
Dated:
SCHEDULE
Part 1 Head Terms
Grant Conditions - Nov 2018 - Final.pdf
Catalyst Grant Terms And Conditio
Proposal
FINAL-Application Form-Professor Xxx
The aim of the proposed work is to examine whether the combination of the PARP inhibitor talazoparib with the bi-functional alkylating agent chlorambucil will selectively inhibit growth of BRCA1/2-deficient tumours in vivo. We aim to show that the combination is more effective than either monotherapy, that it is well-tolerated and can induce robust tumour regression. We will also endeavour to identify potential biomarkers for the talazoparib/chlorambucil combination in tumour and non-tumour tissues. If this study meets its objectives, we will propose a phase 1 / 2 clinical trial of the combination in patients with BRCA1/2-mutated tumours.
The specific work to be undertaken by Dr. Xxxxxxxxx Xxxxxxxx at the Regina Elena National Cancer Institute involves growing tumour xenografts in mice and treating them with solvent, talazoparib, chlorambucil and the combination of the two drugs. The xenografts will be generated using human cell lines (DLD1 BRCA2+/+ and BRCA2-/-, HCT116 BRCA2+/+ and BRCA2-/- and MDA-MB-436) or patient derived xenografts. Each in vivo experiment will be performed twice. Animal work (purchase, housing, technician for tumour implant and monitoring) plus the cost of the drug will be covered by £34,000.
Payment Schedule
Payment Schedule for ISTITUTI FISIOTERAPICI OSPITALIERI – REGINA XXXXX NATIONAL CANCER INSTITUTE
The Lead shall pay to IFO/IRE, in consideration of the work carried out under this Agreement the amount detailed in the table below. All sums are inclusive of VAT, if applicable.
Payments shall be made subject to the receipt of sufficient funds from the Funder and within 30 days of receipt of quarterly invoices. Invoices must be raised in GBP for the funded amount according to the categories below.
Funded amount (GBP) | |
Animal Experiment Costs | £ 30,430 |
Total (Thirty thousand four hundred and thirty pounds sterling) | £ 30,430 |
Invoices to be addressed to:
Xxxxx Xxxxx
Department of Oncology, University of Oxford Old Road Campus Research Xxxxxxxx Xxxxxxxxx Xxxxx, Xxxxxx XX0 0XX
Tel: +44 (0) 1865 (6)17417
E-mail: xxxxx.xxxxx@xxxxxxxx.xx.xx.xx
Reference: H3R00690 (Please include this on all invoices)
Additional Conditions – Pfizer MTA
Pfizer_MTA_PFE Scan.pdf