AZIENDA OSPEDALIERO UNIVERSITARIA MEYER
AZIENDA OSPEDALIERO UNIVERSITARIA XXXXX
Delibera del Direttore Generale n. 160 del 16-03-2022
Proposta n. 304 del 2022
Oggetto: LETTERA CONTRATTO CON VERTEX PHARMACEUTICALS, INC., PER LA FORNITURA DI MEDICINALE SPERIMENTALE PER USO TERAPEUTICO – APPROVAZIONE SCHEMA DI ACCORDO
Dirigente: XXXX XXXXX
Struttura Dirigente: RESPONSABILE AFFARI GENERALI E SVILUPPO
Delibera del Direttore Generale n. 160 firmata digitalmente il 16-03-2022
AZIENDA OSPEDALIERO UNIVERSITARIA XXXXX
(Art. 33 L.R.T. 24 febbraio 2005 n. 40)
Xxxxx Xxxxxxxxxx, 00 - 00000 XXXXXXX
C.F. P.Iva 02175680483
DELIBERAZIONE DEL DIRETTORE GENERALE
Oggetto | Contratto |
Contenuto | LETTERA CONTRATTO CON VERTEX PHARMACEUTICALS, INC., PER LA FORNITURA DI MEDICINALE SPERIMENTALE PER USO TERAPEUTICO – APPROVAZIONE SCHEMA DI ACCORDO |
Area Tecnico Xxx.xx | AREA TECNICO AMMINISTRATIVA |
Coord. Area Tecnico Xxx.xx | XXXX XXXXX |
Struttura | AFFARI GENERALI E SVILUPPO |
Direttore della Struttura | XXXX XXXXX |
Responsabile del procedimento | XXXXXXX XXXXXXXX |
Immediatamente Esecutiva | SI |
Conti Economici | |||
Spesa prevista | Conto Economico | Codice Conto | Anno Bilancio |
Estremi relativi ai principali documenti contenuti nel fascicolo | ||
Allegato | N° di pag. | Oggetto |
1 | 10 | Schema di Lettera contratto |
“documento firmato digitalmente”
IL DIRETTORE GENERALE
Dr. Xxxxxxx Xxxxxxxx (D.P.G.R.T. n. 99 del 30 luglio 2020)
Visto il D. Lgs.vo 30/12/1992 n. 502 e sue successive modifiche ed integrazioni e la L. R. Toscana n. 40 del 24/02/2005 e s.m.i. di disciplina del Servizio Sanitario Regionale;
Dato atto:
- che con deliberazione del Direttore Generale n. 54 del 01.02.2021 è stato approvato il nuovo Atto Aziendale dell’A.O.U. Xxxxx, ai sensi dell’art. 6 del Protocollo d’intesa del 22.04.2002 fra Regione Toscana e Università degli Studi di Firenze, Siena e Pisa, con decorrenza dal 1.2.2021;
- che con deliberazione del Direttore Generale n. 55 del 1.02.2021 sono stati assunti i primi provvedimenti attuativi in relazione alla conferma/riassetto delle strutture complesse e semplici dotate di autonomia ed al conferimento dei relativi incarichi di direzione;
- che con deliberazione del Direttore Generale n. 56 del 1.02.2021 sono state assunte determinazioni attuative del nuovo Atto aziendale in relazione alla conferma/riassetto delle strutture Dipartimentali e/o a valenza dipartimentale, delle Aree Funzionali Omogenee, dell’Area Servizi dell’Ospedale, dell’Area dei Diritti del Bambino, dell’Area Tecnico Amministrativa ed al conferimento di relativi incarichi di direzione;
- che con successiva deliberazione del Direttore Generale n.92 del 15.02.2021 si è provveduto ad assumere ulteriori disposizioni attuative relative all’organizzazione dell’AOU Xxxxx in ordine alle Strutture semplici Intrasoc, Unità Professionali, Uffici e Incarichi professionali;
Dato atto altresì che con deliberazione del Direttore Generale n. 70 del 04.02.2022 è stato disposto che in assenza della Dott.ssa Xxxxx Xxxx:
- le funzioni vicarie di Coordinatore dell’Area Tecnico Amministrativa siano estese al Xxxx. Xxxxxxxxx Xxxxxxxx, Responsabile della SOC Amministrazione del Personale;
- le funzioni vicarie di Responsabile della SOC Affari Legali e Rapporti con l’Università, di Responsabile ad interim della SOC Supporto Amministrativo al Funzionamento dell’Ospedale e di Responsabile ad interim della SOC Affari Generali e Sviluppo siano altresì attribuite al Dr. Xxxxxxxxx Xxxxxxxx, Responsabile della SOC Amministrazione del Personale;
Su proposta del Xxxx. Xxxxxxxxx Xxxxxxxx, in sostituzione del Responsabile ad interim della SOC Affari Generali e Sviluppo Dr.ssa Xxxxx Xxxx, il quale, con riferimento alla presente procedura, attesta la regolarità amministrativa e la legittimità dell’atto;
Premesso che questa Azienda, tra le proprie finalità istituzionali, promuove la cura in campo pediatrico offrendo livelli di eccellenza nel trattamento di malattie gravi o rare e che taluni medicinali in sperimentazione possono essere richiesti per uso terapeutico dai medici alle case farmaceutiche di produzione, ai sensi del DM 7 settembre 2017 avente ad oggetto “Disciplina dell’uso terapeutico di medicinale sottoposto a sperimentazione clinica”;
Atteso che il Dr. Xxxxxxxx Xxxxxxxx, Responsabile della XXXX Fibrosi Cistica, ha fatto richiesta al produttore Vertex Pharmaceuticals, Inc. di uso terapeutico di un medicinale sperimentale per pazienti affetti da patologia rara;
Specificato che il DM 7 settembre 2017 sopra richiamato prevede, inter alia, la possibilità di somministrare medicinali sottoposti a sperimentazione per “il trattamento di pazienti affetti da patologie gravi, malattie
rare, tumori rari o in condizioni di malattie che li pongano in pericolo di vita, per i quali non siano disponibili valide alternative terapeutiche o che non possano essere inclusi in una sperimentazione clinica”;
Considerato che Vertex Pharmaceuticals, Inc. ha manifestato la propria disponibilità a fornire il suddetto farmaco per uso terapeutico e ha proposto un’apposita Lettera contratto per disciplinare i termini e le condizioni della fornitura a titolo gratuito del medicinale sperimentale;
Atteso che prima del parere favorevole del Comitato Etico Pediatrico della Regione Toscana Vertex Pharmaceuticals, Inc. richiede la sottoscrizione della suddetta Lettera contratto al fine di rendere disponibile parte della documentazione da sottomettere all’approvazione etica;
Stabilito che è tra gli impegni di questa Azienda provvedere alle migliori cure e terapie a favore dei pazienti, inclusi l’uso terapeutico di farmaci sperimentali laddove si presentino le condizioni terapeutiche definite dalla normativa applicabile e laddove si possa garantire l’accesso a farmaci sperimentali a pazienti che non possono essere inclusi in una sperimentazione clinica;
Verificato che dall’Accordo di cui sopra non derivano oneri economici a carico dell’AOU Xxxxx;
Ritenuto pertanto di stipulare la Lettera contratto per uso terapeutico di medicinale sperimentale con Vertex Pharmaceuticals, Inc. per la disciplina delle condizioni normative ed operative per la fornitura del farmaco da parte della predetta società farmaceutica che, allegato N. 1 al presente provvedimento, ne forma parte integrante e sostanziale
Rilevata l’opportunità di formalizzare quanto prima la Lettera contratto con il produttore del medicinale sperimentale al fine di avviare in tempi brevi la procedura per l’accesso all’uso terapeutico del medicinale medesimo;
Precisato che la somministrazione del farmaco sperimentale dovrà comunque ottenere il parere favorevole del Comitato Etico Pediatrico della Regione Toscana;
Considerato che il Responsabile del Procedimento, individuato ai sensi della Legge n. 241/1990 nella persona del Dr. Xxxxxxx Xxxxxxxx sottoscrivendo l’atto attesta che lo stesso, a seguito dell’istruttoria effettuata, nella forma e nella sostanza è legittimo;
Acquisito il parere del Xxxx. Xxxxxxxxx Xxxxxxxx, che svolge le funzioni vicarie del Coordinatore dell’Area Tecnico Amministrativa, espresso mediante sottoscrizione del presente atto;
Vista la sottoscrizione del Direttore Sanitario e del Direttore Amministrativo, per quanto di competenza, ai sensi dell’art. 3 del Decreto Legislativo n. 229/99;
DELIBERA
Per quanto esposto in narrativa che espressamente si richiama,
1. Di approvare lo schema di Lettera contratto per uso terapeutico di medicinale sperimentale, da stipulare con Vertex Pharmaceuticals, Inc. che, allegato N. 1 al presente atto, ne forma parte integrante e sostanziale.
2. Di dare atto che dall’Accordo non derivano oneri economici a carico dell’AOU Xxxxx.
3. Di dare atto altresì che la somministrazione del farmaco sperimentale potrà avvenire soltanto dopo il parere favorevole del Comitato Etico Pediatrico della Regione Toscana;
4. Di dichiarare il presente atto immediatamente eseguibile ai sensi dell’art. 42, comma 4 della L.R. T.
n. 40/2005 in considerazione della necessità di avviare in tempi brevi la procedura per l’accesso all’uso terapeutico del medicinale medesimo.
5. Di trasmettere il presente atto al Collegio Sindacale ai sensi dell’art. 42, comma 2, della L.R.T. n. 40/2005 contemporaneamente all’inoltro all’albo di pubblicità degli atti di questa A.O.U. Xxxxx.
IL DIRETTORE GENERALE | |
(Dr. Xxxxxxx Xxxxxxxx) | |
IL DIRETTORE SANITARIO | IL DIRETTORE AMMINISTRATIVO |
(Dr.ssa Xxxxxxxxx Xxxxxxx) | (Dr. Xxxx Xxxxx) |
VERTEX PHARMACEUTICALS INCORPORATED 00 XXXXXXXX XXXXXX • XXXXXX, XX 00000
TEL. 000-000-0000 • xxxx://xxx.xxxx.xxx
…/…/2022
Dr. Xxxxxxxx Xxxxxxxx
Centro Regionale Toscano di Riferimento per la Fibrosi Cistica Xxxxx Children’s Hospital
Xxxxx Xxxxxxxxxx 00 – 00000 Xxxxxxx, Xxxxx
Re: VX20-445-906 Terms and Conditions for provision of ELX/TEZ/IVA Managed Access for Patients 6 Through 11 Years of Age With Cystic Fibrosis
Dear Dr. Xxxxxxxx Xxxxxxxx:
Background
The purpose of this Letter Agreement (“Letter Agreement”) is to govern the terms under which Vertex Pharmaceuticals Incorporated or one of its affiliated companies (“Vertex”) agrees to provide elexacaftor/tezacaftor/ivacaftor regimen (“ELX/TEZ/IVA”) pursuant to an unsolicited request from you, a registered healthcare professional (“Requesting Physician”), in accordance with applicable laws governing the supply of unlicensed or commercially non available medicinal products, to certain patients with cystic fibrosis (“CF”) who, (a) are in critical need; (b) are not eligible for participation in other Vertex-sponsored clinical studies; (c) may benefit from treatment with ELX/TEZ/IVA but who do not have access to ELX/TEZ/IVA; (d) meet all other inclusion and exclusion criteria.
Vertex has established a Managed Access Program (“MAP”) to handle unsolicited requests for the supply of ELX/TEZ/IVA on named patient or compassionate use basis and will supply (or arrange for the supply of) ELX/TEZ/IVA free of charge (or for a nominal fee) under the MAP in response to your request if the conditions set out are satisfied and on the basis that the Requesting Physician and the Institution he or she represents (“Institution”) agree to the conditions of supply set out in this Letter Agreement.
Centro Regionale Toscano di Riferimento per la Fibrosi Cistica, a facility of Xxxxx Children’s Hospital, Xxxxx Xxxxxxxxxx 00 – 00000, Xxxxxxx, Xxxxx (“Institution”) has advised Vertex that it would like to participate in the MAP and that Dr. Xxxxxxxx Xxxxxxxx is the Requesting Physician for the MAP. (For purpose of this Letter Agreement, the use of the term “you or “your” and the like shall mean Institution and shall include Requesting Physician as appropriate). (Institution and Vertex each a “Party” and collectively, the “Parties”).
By this Letter Agreement, effective as of the date of the last party’s signature below (“Effective Date”), you are representing to Vertex that one or more patients of yours have been identified as individuals of six (6) to
VX20-445-906_Row LoA Template v.1.1 27-Jul-2021 FINAL 203488_8/284164_1/284208_1 i
376332v1
eleven (11) years of age (the “Patients”), have CF and otherwise satisfy all MAP Criteria. You have requested, along with the Patients or families of the Patients (if a Patient is a “minor” as applicable law) that Vertex provide ELX/TEZ/IVA to each Patient through the MAP. Vertex has agreed to provide you with ELX/TEZ/IVA exclusively for each Patient’s use in the MAP and in accordance with this Letter Agreement, and any such other conditions and eligibility criteria as Vertex may determine from time to time (“MAP Criteria”). You understand and agree, however, that Vertex has the right at any time to limit the number of Patients who may participate at Institution in the MAP.
By signing this Letter Agreement, you represent that you understand and agree that you are solely responsible for the conduct of the MAP in connection with each Patient including the storage and dispensing of the ELX/TEZ/IVA, and all regulatory and other obligations in connection with the MAP as it concerns each Patient.
1. Scope of Individual Patient Use
Vertex will provide ELX/TEZ/IVA to you, at no cost, in accordance with this Letter Agreement, for the exclusive use and treatment of each Patient. Institution will not make the ELX/TEZ/IVA available to any other third-party.
2. Your Obligations, Responsibilities, & Acknowledgements
2.1 For purposes of this MAP, you agree that you have certain obligations under, and that you shall conduct the MAP in accordance with, applicable laws, rules, regulations and guidance each as amended and in effect from time to time (collectively, “Applicable Law”) and any applicable institutional requirements and ethical standards regarding the treatment of Patients including safety reporting, informed consent, patient rights ethics committees review, documentation and retention of records and all applicable principles of good clinical practices in Italy (“The Territory”). You are responsible for determining and complying with all those obligations, including submitting any notifications to and/or obtaining any prior approvals from the applicable regulatory authorities and/or ethics committees (“Regulatory Approvals”). You will promptly provide Vertex with a copy of all such Regulatory Approvals. If you are aware that any Regulatory Approvals must be obtained by Vertex to permit the supply of ELX/TEZ/IVA to you pursuant to this Letter Agreement, you shall promptly notify Vertex of the applicable regulatory requirements and shall provide Vertex with any assistance that Vertex may reasonably request to obtain the necessary Regulatory Approvals.
2.2 You specifically represent and agree that the provision of ELX/TEZ/IVA is subject to the following terms and conditions, and that Vertex may rely on these representations and agreements:
(a) Prior to the provision of ELX/TEZ/IVA, you will (i) advise each Patient of the risks and benefits of the use of ELX/TEZ/IVA (which will be provided in writing by Vertex), including the use of ELX/TEZ/IVA in this MAP and outside a Vertex-sponsored clinical trial, and (ii) ensure each Patient or the legal representative of each Patient (if the Patient is a “minor” as applicable law) signs, as applicable, an informed consent form ( “Authorization”) that (i) authorizes you to treat Patient with VX445/TEZ/IVA; (ii) authorizes (A) Institution to maintain and retain accurate case history and drug disposition records and (B) Institution to disclose and transfer data and information related to Medical Records (as defined below) to Vertex on an de-identified basis, and (C) Vertex to use Patient Documentation in the research, development and commercialization of products or as required or otherwise permitted by Applicable Law. Further, you agree that the Authorization shall (1) comply with this Letter Agreement; (2) comply with Applicable Law.
(b) You shall safeguard the ELX/TEZ/IVA with the same degree of care used for your own property and in accordance with Applicable Law. You shall, following completion or termination of the MAP, return or otherwise dispose of any unused ELX/TEZ/IVA in accordance with written instructions from Vertex and Applicable Law. You shall maintain complete and accurate drug accountability records, and shall
promptly provide such records to Vertex upon request. You represent that ELX/TEZ/IVA shall be used solely for the benefit of each Patient in the context of this MAP in accordance with all of the requirements specified in this Letter Agreement and the Physician Guidance Document (“Physician Guidance Document”);
(c) You shall not, under any circumstances, submit any invoice or charges to any Patient, government payer, insurer, or any other person for payment with respect to ELX/TEZ/IVA or any other procedures or products provided at no cost by Vertex; and
(d) You have the necessary personnel, equipment, experience, qualifications, and capabilities to perform the MAP and treat each Patient in a timely, professional, and competent manner.
2.3 Based on your best medical judgment and on your personal professional knowledge of each Patient’s medical condition and medical history, you represent that:
(a) As of the date at which each Patient commences participation in the MAP, each such Patient (i) has CF; (ii) is in critical medical need; (iii) has no satisfactory treatment options open to him other than receipt of ELX/TEZ/IVA, through this MAP; and (iv) is not eligible for and is excluded from participation in any Vertex sponsored clinical trials in connection with ELX/TEZ/IVA;
(b) As of the date at which each Patient commences participation in the MAP, each such Patient meets all of the MAP Criteria. You agree that throughout this MAP and at appropriate intervals as determined in your medical judgment, or requested by Vertex you will monitor each Patient and reconfirm each Patient’s compliance with the MAP Criteria as such may be amended by Vertex from time to time.
(c) You will use your independent medical judgment throughout the MAP as to all aspects of each Patient’s medical care and treatment.
2.4 You further specifically represent and agree that you will comply with all applicable reporting obligations for any adverse events that arise in connection with the MAP and that adverse events shall be reported by you to Vertex. Requesting Physician agrees to follow Institution’s policies and procedures regarding the reporting of such adverse events. Vertex agrees to comply with all Applicable Laws regarding its obligations for reporting adverse events to health authorities.
2.5 You will report Product Complaints via phone or email to:
Territory | Email address | Phone number |
North American (US and Mexico) | (000)000-0000 | |
Canada | (000) 000-0000 | |
United Kingdom | x000000000000 | |
Switzerland | 0000-00-0000 | |
Brazil | 0000-000-0000 | |
Australia | 0000-000-000 | |
Rest of the world | x00000000000 |
For the purposes of this agreement a “Product Complaint” or PC means any verbal or written communication of inquiry or dissatisfaction with the identity, strength, quality or purity of a released drug product. In addition, suspected Counterfeit/Falsified Product is considered a Product Complaint.
3. Additional Conditions to the Provision of ELX/TEZ/IVA
You agree that Vertex has the right, upon mutually agreeable times during regular business hours to conduct periodic audits and reviews to determine the status of the MAP and whether the MAP is being conducted and ELX/TEZ/IVA used in compliance with this Letter Agreement and Applicable Laws. All inspections, audits, and reviews will be conducted in accordance with all applicable patient privacy laws and confidentiality considerations.
The Parties represent that the provision of ELX/TEZ/IVA by Vertex under this Letter Agreement is not conditioned in a manner that takes into account the volume or value of any past, present or anticipated future referrals or business, and is not conditioned on any future business relationship between the Parties or other decisions that Institution or Physician have made, or may make, relating to Vertex or its products.
4. Additional Obligations of Vertex
4.1 Subject to the terms and conditions of this Letter Agreement, during the Term (as defined below), Vertex will provide a sufficient quantity of ELX/TEZ/IVA for treating Patient at Vertex’s expense. Vertex will have no obligation to provide ELX/TEZ/IVA after expiration of the Term. In addition to the provision of ELX/TEZ/IVA, Vertex shall provide you with a copy of its standard use and dispensing instructions for ELX/TEZ/IVA.
4.2 Vertex reserves the right to engage a clinical research organization (“CRO”), to act as an independent contractor, to carry out on behalf of Vertex, certain aspects of Vertex’s responsibilities hereunder and other MAP management activities.
4.3 Vertex may withhold shipment of ELX/TEZ/IVA at any time in the event Requesting Physician or Institution materially breaches this Agreement.
4.4 During the Term and for a period of five (5) years thereafter, Vertex or its representatives shall have the right, upon seven (7) days prior written notice (or sooner if the audit is for cause, but in any event after the provision of written notice), to conduct audits of Medical Records as well as Institution’s and Requesting Physician’s other records which are reasonably required by Vertex to verify compliance with the terms and conditions of this Letter Agreement. Requesting Physician and other relevant Institution staff shall be reasonably available during such audits to discuss the Medical Records and cooperate with Vertex in resolving questions regarding the subject of the audit.
5. Confidentiality
5.1 Confidential Information
(a) During the Term and for seven (7) years thereafter, Institution, Requesting Physician and its/their other employees and agents (each a “Recipient”, collectively “Recipients”) shall not disclose to any third party or use for any purpose, other than as set forth in this Article 5: (i) any information disclosed to Recipients by or on behalf of Vertex relating to ELX/TEZ/IVA or the MAP; and (ii) the Vertex Inventions (as defined below); (collectively “Confidential Information”). Such Confidential Information shall remain the confidential and proprietary property of Vertex.
(b) Notwithstanding the foregoing, the obligations of confidentiality and nondisclosure shall not apply to information Recipient can demonstrate by written record: (i) was already known by Recipient at the time of disclosure, other than as a result of Recipient’s breach of any legal obligation; (ii) is publicly known through no fault of Recipient and was not obtained from a third party that was obligated to Vertex to retain such Confidential Information in confidence; (iii) is rightfully received by Recipient from a third-party having a legal right to make such disclosure and not having any contractual obligation not to make such
disclosure; or (iv) is independently developed by Recipient without use or disclosure of or reliance upon Confidential Information.
5.2 Disclosure Required by Law. Institution may disclose Confidential Information to the extent that it is required to be disclosed to a government authority or by order of a court of competent jurisdiction, provided that Institution makes all reasonable efforts to provide Vertex with prompt written notice prior to the disclosure in order to allow Vertex to contest such request, requirement or order and further provided that Institution shall disclose only that portion of such Confidential Information that Institution is legally required to disclose. Institution shall, and shall cause each Recipient to, cooperate fully with Vertex in protecting against any such disclosure or obtaining a protective order or other remedy narrowing the scope of the compelled disclosure.
5.3 Use and Non-Disclosure. Institution shall, and shall cause each Recipient to: (a) use Confidential Information solely in connection with the MAP; (b) disclose Confidential Information only to persons who have a need to know such Confidential Information in connection with the MAP and who are under written obligations to protect the confidentiality of such Confidential Information on terms at least as protective of Vertex’s rights as those set forth in this Letter Agreement; and (c) protect Confidential Information using not less than the same care with which Institution treats its own confidential information, but at all times shall use at least reasonable care. Upon termination of this Agreement, Institution will return or destroy all Confidential Information as directed by Xxxxxx.
5.4 Injunctive Relief. Institution agrees that (a) any breach or threatened breach of Articles 5 or 7 would result in significant and irreparable damage to Vertex, and (b) Vertex shall be entitled, in addition to any other remedies available at law, to injunctive or other equitable relief by a court of appropriate jurisdiction.
6. Ownership
6.1 You shall own all right, title and interest in and to each Patient’s primary medical records you generate and/or keep per internal policies (“Medical Records”). Within seven (7) days of Vertex’s written request, Physician and Institution shall provide copies of data and information related to Medical Records and collected under the MAP in a totally de-identified format to Vertex. Physician and Institution hereby grant Vertex the perpetual, irrevocable right to use de-identified data and information related to Medical Records collected under the MAP, as well as any other reports or information provided by Physician or Institution under this Agreement, in the research, development and commercialization of products or as required or otherwise permitted by applicable law. Vertex shall not alter, manipulate, omit, or otherwise modify Medical Records- related data and information collected under the MAP or any other reports or information provided hereunder in any unlawful or improper manner.
6.2 For the purposes of this Letter Agreement, “MAP Documentation” includes, but is not limited to, all documents you generate in the treatment of each Patient under this Letter Agreement and the MAP. You shall own MAP Documentation. Vertex shall have the right to access, use, and disclose the MAP Documentation during the term of this Letter Agreement and thereafter as permitted by, and subject to, the Authorization and Applicable Law.
6.3 You shall retain and maintain the MAP Documentation and Medical Records in the manner and duration required by the Applicable Law.
6.4 For so long as you are obligated to retain the MAP Documentation and Medical Records, Vertex and/or its representatives may, upon seven (7) days prior written notice (or sooner if the audit is for cause, but in any event after the provision of written notice), conduct audits of the Medical Records and MAP Documentation. You shall be reasonably available during such audits to discuss the MAP and otherwise cooperate with Vertex.
6.5 It is recognized and agreed that certain existing inventions and technologies are the separate property of Vertex or the Institution and are not affected by this Letter Agreement, and no Party shall have any claims to or rights to the other Parties’ separate inventions and technologies.
(a) Definitions. For purposes of this Agreement:
(i) “Inventor” means Institution, the Physician, or persons who assists in performing the MAP, whether solely or jointly with others.
(ii) “Intellectual Property” means each invention, discovery, know-how, trade- secret, and other intellectual property, including improvements, whether patentable or not, including any patent, trade secret, trademark, copyright or other proprietary right with respect thereto.
(iii) “Rights” means all right, title and interest of a Party.
(iv) “Tangible Property” means all work, reports, writings, designs, methods, samples, computer software, and data, recorded in any form, and is not otherwise considered Intellectual Property.
(b) Retained Rights. Each Party retains all its Rights in Intellectual Property and Tangible Property that was owned by such Party prior to the date of this Agreement and no license, grant, or assignment, express or implied, by estoppels or otherwise, with regard thereto is intended by, or shall be inferred from, this Agreement.
(c) Ownership. Vertex hereby owns all Rights in and to Intellectual Property and Tangible Property that is/are conceived, reduced to practice, created, developed, or otherwise made by an Inventor(s) as a result of or in connection with the MAP, ELX/TEZ/IVA, or the performance of obligations under this Letter Agreement (“Vertex Property”). Institution shall promptly notify Vertex in writing of the conception, reduction to practice, creation, development or making of all Vertex Property. Institution agrees to assign and hereby assigns and transfers to Vertex all its Rights in and to Vertex Property and Vertex hereby accepts such assignment and transfer. Institution shall cause each Inventor promptly to take any actions necessary to memorialize such assignment and transfer to Vertex of all of its, his/her Rights in each Vertex Property, and, without additional consideration, assigning and transferring to Vertex all Rights to patents, patent applications and rights to file for patent protection or other intellectual property protection for such Vertex Property throughout the world.
7. Publication
You recognize that Vertex is currently sponsoring a research program studying the effectiveness of ELX/TEZ/IVA and that there is a need for a coordinated approach to the publication or presentation of the results from such research program. You may publish on information generated at Institution in the conduct of the MAP, provided, however, that neither Institution nor Requesting Physician shall publish or present information from the MAP to any third parties until (a) Vertex publishes the results of the ELX/TEZ/IVA research program; (b) Institution receives notification from Vertex that publication of the ELX/TEZ/IVA research program results is no longer planned; or (c) eighteen (18) months following the close of the last clinical study of the ELX/TEZ/IVA program, whichever occurs first.
You shall submit a copy of any proposed publication, presentation, or abstract (“Publication”) to Vertex for its review and comment at least forty-five (45) calendar days prior to the date of submission for publication or presentation. You shall consider all comments received from Vertex during the review period in good faith and shall delete Vertex’s Confidential Information, if any, provided, however, nothing in this
Agreement shall prohibit you from publishing information generated at the Institution during the MAP necessary for the accurate interpretation and presentation of scientific data of the Publication. In those instances where you receive comments from Vertex, the Publication shall be resubmitted to Vertex within fifteen (15) days and Vertex shall have thirty (30) calendar days to make additional comments. If Vertex determines that the Publication contains patentable subject matter that requires protection, Vertex may require the delay of submission for publication or presentation for an additional period of time not to exceed sixty (60) calendar days for the purpose of filing patent applications. You shall acknowledge Vertex’s support in all publications and presentations as appropriate. If you do not agree to such deletion or modification, you shall so notify Vertex and shall postpone such submission or presentation for an additional sixty (60) days to allow Vertex to seek legal remedies or file patent applications. Notwithstanding anything to the contrary herein, the review period under this Section 7 shall not exceed one hundred and twenty (120) calendar days from the date a Publication is first received by Vertex for review.
8. Insurance
Requesting Physician and Institution each will have and will maintain in full force during the Term and thereafter to cover any claims arising from the MAP insurance coverage for medical professional liability and for general liability in amounts appropriate to the conduct of the Physician’s medical practice and to Institution’s provision of health care services.
9. Risk
9.1 By signing this Letter Agreement, Institution represents that it understands and agrees that it is solely responsible for the conduct of the MAP in connection with each Patient including the prescribing of ELX/TEZ/IVA, the storage and dispensing of the ELX/TEZ/IVA, and all regulatory and other obligations in connection with the MAP, as it concerns each Patient.
9.2 Institution agrees that Vertex is not liable for any loss, damage, or liability arising out of the supply of ELX/TEZ/IVA to any Patient pursuant to this Letter Agreement except to the extent that such loss, damage, or liability arises as a direct result of any negligent, unlawful, or fraudulent act or omission by Vertex.
10. Termination
10.1 Patient enrollment into the MAP will not remain open past the date that is 12 months after the date that marketing authorization for ELX/TEZ/IVA for the Patient is obtained in the Territory.
10.2 At any time, Vertex has the right, in its sole discretion, to terminate and cease its provision of ELX/TEZ/IVA for a Patient for any reason. Such reasons may include, but are not limited to, the following:
(a) For any of the termination reasons mentioned in the Physician Guidance Document;
(b) The MAP is required to terminate under applicable law;
(c) Marketing authorization is denied for ELX/TEZ/IVA in the territory;
(d) Vertex withdraws the marketing authorization application for ELX/TEZ/IVA or decides that it will not commercialize the product in the territory;
(e) The pricing and reimbursement authority in the territory fails to negotiate with Xxxxxx regarding reimbursement of ELX/TEZ/IVA, fails to negotiate in good faith, ends negotiations, or reimbursement negotiations reach an impasse, such that there is no longer a reasonable probability of access;
(f) ELX/TEZ/IVA is granted marketing authorization and/or is reimbursed or is otherwise funded in the territory;
(g) A comparable or satisfactory alternative therapy becomes commercially available in the territory;
(h) Immediately upon a determination by Vertex to abandon development of ELX/TEZ/IVA; and /or
(i) Immediately upon a determination by Vertex that there is a lack of sufficient ELX/TEZ/IVA available for use in this MAP (in this event, Vertex may in its option suspend the provision of ELX/TEZ/IVA until a supply of ELX/TEZ/IVA is again available as determined by Vertex).
10.3 You or Vertex may at any time terminate this Letter Agreement upon fifteen (15) days’ prior written notice to the other Party.
10.4 You or Vertex may terminate this Letter Agreement immediately upon written notice to the other Party in the event that either you or Vertex determines that continued conduct of the MAP would be detrimental to the safety and welfare of the Patients.
11. Notices
Notices must be in writing and given to the other Party by in-hand delivery, by certified mail with return receipt, or by recognized overnight courier service to the mailing address set forth below or to such other address as may be requested by Party in writing. Notices shall be deemed to have been received (a) if delivered by hand, upon delivery; (b) if delivered by certified mail, three (3) business days after deposit in the post; or
(c) if delivered by overnight courier, the next business day. For purposes of this Letter Agreement, “business day” means each Monday through Friday except those days which are deemed to be public holidays in Italy.
All notices shall be addressed as follows:
If to Vertex: Vertex Pharmaceuticals Attn.: Iqbal Minhas
Senior Medical Director, Medical Affairs Xxxxx 0, Xxxxxxxxxx Xxxxxxx
0 Xxxxxxx Xxxxxx Xxxxxx
X0 0XX
Xxxxxx Xxxxxxx
With a copy to: The Office of General Counsel
If to Institution: Centro Regionale Toscano di Riferimento per la Fibrosi Cistica AOU Meyer
Xxxxx Xxxxxxxxxx 00 – 00000 Xxxxxxx, Xxxxx
Attn.: Xxxxxxxx Xxxxxxxx
Address: Xxxxx Xxxxxxxxxx 00 – 00000, Xxxxxxx, Xxxxx Telephone: x00 000 0000000
Facsimile: x00 000 0000000
12. No Agency
You and Vertex are independent contractors and nothing in this Letter Agreement will create or imply any agency relationship between the Parties, nor will the Letter Agreement be deemed to constitute a joint venture or partnership between the Parties. Neither Party will have authority to bind or otherwise obligate the other Party in any manner whatsoever.
13. Survival
The terms, provisions, obligations, and conditions contained in this Letter Agreement which by their terms require performance after the expiration or termination of this Letter Agreement, including, without limitation, publication, confidentiality, and insurance, shall remain in full force notwithstanding such expiration or other termination of this Letter Agreement for any other reason whatsoever.
14. Additional Representations; Conflicts
In addition to the representations set forth above, you represent and agree (and agree Vertex may rely on these representations) that:
14.1 You have, and at all times during the MAP shall have, the appropriate licenses, approvals, and certifications necessary to safely, adequately, and lawfully perform the MAP;
14.2 You are not subject to any conflicting obligations or have any financial or other interest in the MAP nor have you entered into any contract with respect to the MAP or ELX/TEZ/IVA that might interfere with the performance of the MAP or create a conflict of interest;
14.3 You understand that the United States and other applicable securities laws prohibit any person who has material, non-public information about a company from purchasing or selling securities of such company or from communicating such information to any other person under circumstances in which it is reasonably foreseeable that such person is likely to purchase or sell such securities. You understand that participation in the MAP may allow you access to information that could potentially subject you to insider trading liability (as defined under the United States federal securities laws and regulations adopted by the United States Securities and Exchange Commission) in connection with trading in Vertex securities; and
14.4 You certify that you have not been disqualified, debarred, or banned under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. §335(a) and (b). You shall promptly notify Vertex in the event you or any individual or entity rendering services in connection with the MAP (a) is disqualified, debarred, or banned, or (b) receives notice of an action or threat of an action with respect to debarment, disqualification, or ban during the term of this Letter Agreement. You also represent that neither you nor any individual or entity rendering services in connection with the MAP has been or is the subject of a government investigation, inquiry, audit or other action (individually and collectively, “Government Action”) and no events exist to the best of your knowledge, after due inquiry, that would lead to any Government Action. You will immediately notify Vertex in the event of any Government Action (including, but not limited to, warning letters issued by the U.S. Food and Drug Administration) involving you or any individual or entity rendering services in connection with the MAP.
15. Complete Agreement/Modification
This Letter Agreement and any amendments duly executed hereunder, constitutes the entire Letter Agreement between the Parties concerning the subject matter contained and supersedes any prior or contemporaneous agreements and understandings between the Parties concerning this subject matter. No amendment or modification of this Letter Agreement shall be valid or binding upon the Parties unless executed in writing.
16. Use of Names; No Publicity.
Except to the extent required by Applicable Law, neither Party shall disclose the existence or terms of this Letter Agreement, including exhibits attached hereto, or use the name, trademark, trade name or logo of the
other Party in any form of advertising, promotion or publicity or in any press release, without the other Party’s prior written consent. Institution and Physician shall not initiate or issue, nor allow their employees or agents to initiate or issue any communication of information regarding this Letter Agreement, written or oral, to the media without Vertex’s prior written consent, provided, however, that Requesting Physician and Institution may use Vertex’s name to identify Vertex as the supplier of ELX/TEZ/IVA in the Informed Consent Form, in communications with regulatory authorities regarding the MAP, and to acknowledge Vertex’s support in academic publications prepared in accordance with this Letter Agreement without further consent from Vertex.
17. Counterparts/Delivery of Signature
This Letter Agreement may be executed and delivered by facsimile or electronically transmitted signature and in two or more counterparts, all of which together shall constitute one and the same instrument, and in pleading or proving any provision of this Letter Agreement it shall not be necessary to produce more than one such counterpart. The Parties agree that upon being signed and delivered by the Parties, this Letter Agreement shall become effective and binding and that such signed copies will constitute evidence of the existence of this Letter Agreement.
The Parties have caused this Letter Agreement to be executed by their duly authorized representatives as of the Effective Date.
VERTEX PHARMACEUTICALS INCORPORATED
By: Name: Title:
XXXXX CHILDREN’S HOSPITAL
By: Name: Xxxxxxx Xxxxxxxx
Title: Managing Director
Read and Acknowledged by Requesting Physician
By: Name: Xxxxxxxx Xxxxxxxx
Title: MD