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AZIENDA OSPEDALIERO UNIVERSITARIA MEYER
Delibera del Direttore Generale n. 492 del 30-10-2020
Proposta n. 997 del 2020
Oggetto: ACCORDO DI LICENZA NON ESCLUSIVA CON LABSYSTEMS DIAGNOSTICS OY. – APPROVAZIONE
SCHEMA DI ACCORDO
Dirigente: LUCANIA MARIA CONCETTA
Struttura Dirigente: AFFARI GENERALI E SVILUPPO
Delibera del Direttore Generale n. 492 firmata digitalmente il 30-10-2020AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER
(Art. 33 L.R.T. 24 febbraio 2005 n. 40)
Viale Pieraccini, 24 - 50139 FIRENZE
C.F. P.Iva 02175680483
DELIBERAZIONE DEL DIRETTORE GENERALE
Oggetto Accordo di licenza
Contenuto ACCORDO DI LICENZA NON ESCLUSIVA CON LABSYSTEMS
DIAGNOSTICS OY. – APPROVAZIONE SCHEMA DI ACCORDO
Area Tecnico Amm.va AREA TECNICO AMMINISTRATIVA
Coord. Area Tecnico Amm.va BINI CARLA
Struttura AFFARI GENERALI E SVILUPPO
Direttore della Struttura LUCANIA MARIA CONCETTA
Responsabile del ALESSIO FABBIANO
procedimento
Immediatamente Esecutiva NO
Spesa prevista Conto Economico Codice Conto Anno Bilancio
Estremi relativi ai principali documenti contenuti nel fascicolo
Allegato N° di pag. Oggetto
1 30 Non-Exclusive License Agreement (Accordo di licenza non esclusiva)IL DIRETTORE GENERALE
Dr. Alberto Zanobini
(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. 133 del 29.12.2015 è stato approvato il nuovo Atto
Aziendale dell’AOU Meyer, 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 1.1.2016;
- che con deliberazione del Direttore Generale n. 134 del 30.12.2015 si è provveduto a definire
l’organigramma complessivo dell’AOU Meyer e sono stati assunti i primi provvedimenti attuativi
relativi al conferimento degli incarichi di direzione delle strutture Dipartimentali e/o a valenza
dipartimentale, delle Aree Funzionali Omogenee, dell’Area Servizi dell’Ospedale, dell’Area delle
Professioni Sanitarie e dell’Area Tecnico Amministrativa;
- che con deliberazione del Direttore Generale n. 140 del 30.12.2015 sono state assunte
determinazioni attuative del nuovo Atto aziendale in merito alla conferma/riassetto delle strutture
organizzative complesse e semplici;
- che con deliberazione del Direttore Generale n. 492 del 2.12.2016 si è provveduto ad approvare la
sistematizzazione della organizzazione aziendale, dopo un primo percorso attuativo dello Statuto
Aziendale;
- che con deliberazione del Direttore Generale n. 543 del 29.12.2016 sono state assunte
determinazioni volte al conferimento degli incarichi delle Strutture Complesse dell’Area Tecnico
Amministrativa, così come rimodulate a seguito delle azioni di attualizzazione dell’organizzazione
aziendale;
- che con successiva deliberazione del Direttore Generale n. 173 del 05.04.2018 si è altresì provveduto
ad ulteriori azioni di sistematizzazione dell’organizzazione aziendale ed all’integrazione dell’art. 63
dell’Atto Aziendale “Promozione della salute nella comunità”;
- che con successiva deliberazione del Direttore Generale n. 739 del 31.12.2019 si è provveduto ad
approvare ulteriori azioni di sistemazione dell'organizzazione aziendale in ambito amministrativo;
Su proposta del Responsabile della S.O.C. Affari Generali e Sviluppo, Dr.ssa Maria Concetta Lucania la
quale, con riferimento alla presente procedura, ne attesta la regolarità amministrativa e la legittimità
dell’atto;
Visto il D.Lgs. n. 30 del 10.02.2005 “Codice della proprietà industriale” che all’art. 65 prevede la speciale
disciplina delle invenzioni dei ricercatori universitari o dipendenti da pubbliche amministrazioni aventi la
ricerca tra gli scopi istituzionali;
Richiamata la Delibera n. 341 del 25.11.2011 del Direttore Generale con cui è stato approvato il
Regolamento dell’Azienda Ospedaliero-Universitaria Meyer sulla proprietà intellettuale;
Premesso che questa Azienda è titolare di un brevetto nell’ambito del proprio know-how sviluppato in
attività di ricerca in campo pediatrico e che ha l’interesse ad attivarsi per una valorizzazione economica del
brevetto medesimo, attraverso la cessione a titolo oneroso dei relativi diritti di sfruttamento;
Atteso che Labsystems Diagnostics Oy., una società con sede in Finlandia, ha manifestato l’intenzione di
ottenere una licenza non esclusiva per l’Europa per lo sfruttamento del suddetto brevetto e che è altresì
interesse di questa Azienda concedere tale licenza in modo da valorizzarne i diritti di brevetto ad essa
correlati, stipulando un apposito Accordo di licenza non esclusiva per regolamentarne la concessione;Dato atto che la suddetta società necessita, per motivi inerenti alla protezione dei dati personali e alla
tutela dei propri interessi economici e commerciali, ivi compresi la proprietà intellettuale ed i segreti
commerciali, di omettere, ai fini della pubblicazione del presente atto, alcune parti sostanziali del su citato
Accordo;
Visto l’art. 5-bis del D. Lgs. n. 33 del 14/03/2013, come modificato dal D. Lgs. n. 97 del 25/05/2016, che
disciplina l’esclusione e i limiti all’accesso civico;
Ritenuto pertanto, al fine di evitare pregiudizio alla tutela dei dati personali e degli interessi privati
economici e commerciali della società interessata allo sfruttamento dei diritti di brevetto, di pubblicare
l’Accordo di licenza in duplice versione (inglese e italiano) con le opportune cancellazioni individuate
come omissis;
Vista la bozza di Accordo di licenza che, corredata dei necessari omissis, è unita quale allegato N. 1 al
presente provvedimento a formarne parte integrante e sostanziale;
Rilevato che è interesse di questa Azienda allargare lo sfruttamento dei diritti di brevetto relativi alla
proprietà intellettuale sviluppata nel proprio ambito di attività e di ricerca;
Ritenuto pertanto di stipulare l’Accordo di licenza non esclusiva con Labsystems Diagnostics Oy., nella
sua versione integrale in lingua inglese, agli atti di questa Azienda, per la disciplina delle condizioni
normative, economiche ed operative per la concessione della licenza di cui trattasi;
Considerato che il Responsabile del Procedimento, individuato ai sensi della Legge n. 241/1990 nella
persona del Dott. Alessio Fabbiano sottoscrivendo l’atto attesta che lo stesso, a seguito dell’istruttoria
effettuata, nella forma e nella sostanza è legittimo;
Acquisito il parere del Coordinatore dell’Area Tecnico Amministrativa, Dr.ssa Carla Bini, espresso
mediante sottoscrizione del presente atto;
Con la sottoscrizione del Direttore Amministrativo e del Direttore Sanitario, ciascuno 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 Accordo di licenza non esclusiva da stipulare con Labsystems
Diagnostics Oy. che, allegato N. 1 al presente atto, ne forma parte integrante e sostanziale, nella
duplice versione inglese e italiana.
2. Di stipulare l’Accordo di licenza con la su richiamata società nella sua versione integrale in lingua
inglese.
3. Di dare atto che lo schema di Accordo, in duplice versione (inglese e italiano) di cui all’allegato N.
1 è pubblicato con omissis, ai sensi della normativa vigente e per le motivazioni espresse in
premessa, e che l’Accordo nella sua versione integrale è conservato agli atti.4. Di trasmettere il presente atto al Collegio Sindacale ai sensi dell’art. 42, comma 2, L. R.T. n.
40/2005 contemporaneamente all’inoltro all’albo di pubblicità degli atti di questa AOU Meyer.
IL DIRETTORE GENERALE
(Dr. Alberto Zanobini)
IL DIRETTORE SANITARIO IL DIRETTORE AMMINISTRATIVO
(Dr.ssa Francesca Bellini) (Dr. Tito Berti)NON-EXCLUSIVE LICENSE AGREEMENT
THIS LICENSE AGREEMENT hereinafter (“Agreement”) is entered into as of
the date of the signature of the last party to sign herein(hereinafter the “Effective Date”)
by and between:
AziendaOspedaliero-Universitaria Meyer having its registered office at Viale
Pieraccini 24, Florence, Italy, represented by Managing Director dr. Alberto Zanobini
(hereinafter “AOUM” or “LICENSOR”), domiciled for the purposes of this agreement at
the same Hospital offices
And
Labsystems Diagnostics Oy., having an office and its principal place of business at
Tiilitie 3, 01720 Vantaa, Finland(hereinafter “COMPANY” or “LICENSEE”),
represented by Sameer D.Saral, Chief Operating Officer
RECITALS
WHEREAS, LICENSOR is the owner of certain PATENT RIGHTS (omissis);
WHEREAS, LICENSOR, acting on its own behalf, has the authority to enter into
this Agreement for the licensing and commercialization of said PATENT RIGHTS;
WHEREAS, LICENSOR is willing to grant a non-exclusive license for Europe,
(EU License) in the defined FIELD OF USE to LICENSEE subject to the terms,
conditions, limitations and restrictions set forth below;
WHEREAS, COMPANY desires to acquire the non-exclusive license and
commercialization rights from LICENSOR in and to said intellectual property rights and
technology on the terms and conditions set forth below; and
WHEREAS, COMPANY has represented to LICENSOR that it shall commit
itself to thorough and diligent efforts to develop, produce, manufacture, market and sell
products under said PATENT RIGHTS.
NOW, THEREFORE, in consideration of the mutual covenants and promises
contained herein, the sufficiency of which is hereby acknowledged, LICENSOR and
COMPANY, intending to be legally bound, hereto agree as follows:
Page 1 of 15ARTICLE 1
DEFINITIONS
1.1 “LICENSEE” shall mean Labsystems Diagnostics Oy. and shall include a related
company of LICENSEE, the voting stock of which is directly or indirectly at least Fifty
Percent (50%) owned or controlled by Labsystems Diagnostics Oy.
1.2 “PATENT RIGHTS” shall mean (omissis).
1.3 A “LICENSED PRODUCT” shall mean any product or part thereof which:
a. is covered in whole or in part by an issued, unexpired claim or a pending
claim contained in the PATENT RIGHTS in the country in which any such product or
part thereof is made, used or sold; or
b. is manufactured by using a process or is employed to practice a process
which is covered in whole or in part by an issued, unexpired claim or a pending claim
contained in the PATENT RIGHTS in the country in which any LICENSED PROCESS
is used or in which such product or part thereof is used or sold.
If a claim has been abandoned or judged invalid or unenforceable by a court of
competent jurisdiction, or an administrative agency, from which no appeal can be or is
taken in any country, then any product or process falling only under that claim shall not
be considered to be a LICENSED PRODUCT or LICENSED PROCESS in that country
for the purposes of this Agreement.
1.4 A “LICENSED PROCESS” shall mean any process which is covered in whole or
in part by an issued, unexpired claim or a pending claim contained in the PATENT
RIGHTS.
1.5 “FIELD” or “FIELD OF USE” shall mean (omissis).
1.6 “SALE” or “SOLD” shall mean the transfer or disposition of a LICENSED
PRODUCT to an entity other than COMPANY or an AFFILIATE for value, whether in
the form of cash payments, royalties, fees, stock, or any other form of compensation.
1.7 “NET SALES” shall mean the gross amounts billed and/or invoiced by
COMPANY, its AFFILIATES customers for SALES of the LICENSED PRODUCT less
the following reasonable and customary deductions: (a) trade discounts and rebates, (b)
credits or allowances actually credited to third parties for returned, recalled, damaged or
destroyed LICENSED PRODUCTS, (c) sales and excise taxes and other taxes paid by
COMPANY, its AFFILIATES, which taxes are based or levied on the SALES price of a
LICENSED PRODUCT, and (d) transportation, packaging, shipping and handling fees.
1.8 “AFFILIATE” shall mean any entity which controls, is controlled by or is under
common control with COMPANY. An entity shall be regarded as in control of another
Page 2 of 15entity for purposes of this definition if it owns or controls more than fifty percent (50%)
of the shares of the subject entity entitled to vote in the election of directors (or, in the
case of an entity that is not a corporation, more than fifty percent (50%) control in the
election or appointment of the corresponding managing authority).
1.9 “PARTY” shall mean either COMPANY or LICENSOR, and "the PARTIES"
shall mean COMPANY and LICENSOR.
1.10 “THIRD PARTY” shall mean a person or entity who or which is neither a
PARTY nor an AFFILIATE of a PARTY.
1.11 “VALID PATENT CLAIM” shall mean a claim of an issued and unexpired patent
or a pending claim in a pending patent application within the PATENT RIGHTS which
has not been (i) revoked or held unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, which is unappealable, or is unappealed
within the time allowed for appeal, or (ii) disclaimed.
ARTICLE 2
REPRESENTATIONS AND WARRANTIES
2.1 Each PARTY represents and warrants to the other that:
(a) It validly exists under the laws of its jurisdiction of incorporation, with full
power and authority to conduct its business as currently owned or licensed and
conducted;
(b) It has the corporate power and authority to execute and deliver this
Agreement, and to carry out all the terms and provisions hereof to be carried out by it;
(c) The execution and delivery of this Agreement has been duly authorized by
all necessary corporate action; and
(d) This Agreement has been duly executed and delivered and is a legal, valid
and binding obligation enforceable in accordance with its terms.
2.2 LICENSOR represents and warrants to COMPANY that:
(a) LICENSOR has not previously granted and will not grant any
rightsunder the PATENT RIGHTS that are inconsistent with the rights and licenses
granted to COMPANY herein. Notwithstanding the afore-stated, LICENSOR may, at its
discretion, grant non-exclusive licenses to the PATENT RIGHTS to THIRD PARTIES;
(b) to the best of its knowledge as of the Effective Date, without prior
research, there are no claims of any third parties that would call into question the rights of
LICENSOR to grant to COMPANY the rights and licenses contemplated hereunder; and
(c) LICENSOR has received and currently holds valid and effective
assignments of Inventor’s rights to the PATENT RIGHTS.
2.3 EXCEPT AS PROVIDED IN THIS ARTICLE 2, NEITHER PARTY
MAKES ANY WARRANTIES OR CONDITIONS (EXPRESS, IMPLIED,
Page 3 of 15STATUTORY, OR OTHERWISE) WITH RESPECT TO THE SUBJECT MATTER
HEREOF.
2.4 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH,
LICENSORAND ITS RESPECTIVE INVENTORS AND AFFERENTS MAKE NO
REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER
EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF
PATENT RIGHTS, EITHER ISSUED OR PENDING, AND THE ABSENCE OF
LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE. IN NO
EVENT SHALL LICENSOROR ITS INVENTORS AND AFFERENTS BE LIABLE
FOR INCIDENTIAL OR CONSEQUENTIAL DAMAGES OF ANY KIND,
INCLUDING ECONOMIC DAMAGE OR INJURY TO PROPERTY OR LOST
PROFITS, REGARDLESS OF WHETHER LICENSOR SHALL BE ADVISED,
SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE
POSSIBILITY.
ARTICLE 3
GRANT OF LICENSE RIGHTS
3.1 LICENSOR hereby grants to COMPANY, subject to all the terms and conditions
of this Agreement, anon-exclusive royalty-bearing license to the EU PATENT RIGHTS
in the FIELD(hereinafter “EU License”), including the right to develop, use, market,
distribute, make, have made, sell, have sold, offer to sell, import and export LICENSED
PRODUCTS.
3.2 COMPANY shall have the right to extend this License to any AFFILIATE
provided that such AFFILIATE consents to be bound by this Agreement to the same
extent as COMPANY and provided that COMPANY provides a copy of such prior
written consent to LICENSOR within thirty (30) days of such prior written consent,
provided that Company retains control of its AFFILIATES as set forth in Section 1.8. In
the event Company loses control of said AFFILIATES, LICENSOR shall have a right to
re-negotiate this Agreement with the assignee.
3.3 LICENSOR reserves the right to use, make and/or practice the PATENT
RIGHTS solely for its own educational and academic research purposes and to grant non-
exclusive rights to other parties, academic institutions or to the Inventors to use, make
and/or practice PATENT RIGHTS solely for educational and academic research
purposes.
3.4 AOUM, and any non-profit health care institutions affiliated with AOUM,
shall have the right to use, free of charge, any product or process, developed by
LICENSEE which contains or is based on any of the PATENT RIGHTS and/or
LICENSED PRODUCTS, for research, patient care, educational, academic, or
administrative purposes.
Page 4 of 15ARTICLE 4
ROYALTIES
In consideration of the license rights granted by LICENSOR to COMPANY
under this Agreement, COMPANY will make to LICENSOR the following payments:
4.1 (omissis)
4.2 LICENSEE shall pay LICENSOR running royalties on NET SALES of
LICENSED PRODUCT as follows:
(a) In countries where the EU PATENT RIGHTS exist, and the patents
are granted and in force: a royalty of (omissis) received by COMPANY and
AFFILIATES for each LICENSED PRODUCT for the remaining life of each patent;
(b) In the event a LICENSED PRODUCT is sold for other than cash, the
royalty to be paid will be based on the NET SALES price of a comparable LICENSED
PRODUCT.
(c) COMPANY agrees that the royalty rates paid by its
AFFILIATES shall in no event be less than the royalty rate paid herein to LICENSOR
by COMPANY for NET SALES of LICENSED PRODUCTS.
ARTICLE 5
PAYMENT, RECORDS AND REPORTS
5.1 Beginning in 2021, COMPANY shall deliver to LICENSOR a true and
accurate report, giving such particulars of the business conducted by COMPANY and its
AFFILIATES, on a country-by-country basis, during each six (6) calendar months
preceding June 30 and December 31, as are pertinent to an account for payments
hereunder. Such reports shall be due to LICENSOR on July 31 and January 31 of each
year and shall include at least:
(a) a detailed description and accounting of all COMPANY’s
preclinical development, clinical development, marketing and business development
efforts to commercially develop LICENSED PRODUCTS containing all particulars that
may be necessary for the purpose of showing the amounts payable to LICENSOR
hereunder. The relating books of account shall be kept at COMPANY’s principal place of
business;
(b) the quantities of LICENSED PRODUCT produced;
(c) the total SALES and NET SALES of such LICENSED
PRODUCT;
(d) a detailed listing of all permitted deductions from the total amount
of NET SALES of such LICENSED PRODUCTS;
(e) the calculation of royalties thereon;
(f) the total royalties so computed and due to LICENSOR.
Page 5 of 15Simultaneously with the delivery of each report, COMPANY shall pay to LICENSOR
the amount, if any, due for the period of such report. If no payments are due, it shall be
so reported. Payment due under this Section 5.1 of the Agreement is due within Forty-
five (45) days after the conclusion of the period in which the SALE of a LICENSED
PRODUCT is completed, and is subject to receipt of payment by COMPANY.
5.2 Amounts payable under this Agreement shall be paid in Euros by bank
wire transfer.
All payments due under this Agreement shall be sent by bank transfer to the
following address and bank codes:
Address:
Azienda Ospedaliero-Universitaria Meyer
S.O.S. Risorse Economiche e Finanziarie
Attn.: Simona Paoli (simona.paoli@meyer.it)
Bank Routing Codes:
Bank: Intesa Sanpaolo
IBAN: IT94X0306902887100000046031
SWIFT/BIC: BCITITMM
Such payments shall be subject to applicable law and regulations. NET SALES
of LICENSED PRODUCTS not denominated in Euro and the royalties payable thereon
shall first be determined in the currency in which such LICENSED PRODUCTS were
sold and shall then be converted into the equivalent number of Euros at the exchange rate
published by The Wall Street Journal Eastern Edition as of each respective June 30 and
December 31
5.3 In the event that any payment due hereunder to LICENSOR is not
received when due, that payment shall accrue interest beginning on the tenth calendar day
following the due date thereof, calculated at the annual rate of the sum of the prime
interest rate quoted by The Wall Street Journal Eastern Edition on the date said payment
is due plus two percent (2%) interest, the interest being compounded on the last day of
each calendar quarter, provided, however, that in no event shall said annual interest rate
exceed the maximum legal interest rate for corporations. Each such royalty payment
when made shall be accompanied by all interest so accrued. Said interest and the
payment and acceptance thereof shall not negate or waive the right of LICENSOR to seek
any other remedy, legal or equitable, to which it may be entitled because of the
delinquency of any payment. Nothing in this Article 5.3 shall be construed as a waiver
by LICENSOR of timely payment to LICENSOR from COMPANY.
5.4 During the term of this Agreement and for five(5) years thereafter,
COMPANY shall keep complete, true and correct records of its and its AFFILIATES'
SALES and NET SALES of LICENSED PRODUCTS in sufficient detail to enable the
royalties payable hereunder to be determined. COMPANY shall permit LICENSOR or
Page 6 of 15its representatives to periodically examine, upon ten (10) days prior written notice, but no
more than once per year, its books, ledgers, and records for the purpose of conducting an
inspection and audit and to the extent necessary to verify any report required under this
Agreement. Such books, ledgers, and records shall be available for inspection, audit, and
copying by LICENSOR or LICENSOR’S representative or agent at COMPANY’S
principal place of business, during reasonable business hours. LICENSOR or
LICENSOR’S representative or agent will be obliged to execute a reasonable
confidentiality agreement prior to commencing any such inspection. COMPANY will
cooperate with LICENSOR or LICENSOR’S representatives in the performance of their
inspection and audit, and COMPANY agrees to cause its accountants and bookkeepers to
cooperate fully in the inspection and audit. Such inspection and audit shall be at the sole
expense of LICENSOR.
5.5 All amounts due and payable by COMPANY under this Agreement shall
be made without deductions for taxes, assessments, fees or other charges of any kind
which may be imposed on LICENSOR by any government outside of the United States or
any political subdivision of such government with respect to any amounts payable to
LICENSOR pursuant to this Agreement. LICENSOR will cooperate with COMPANY in
assisting COMPANY to obtain any credit to which COMPANY may be entitled with
respect to such payments.
ARTICLE 6
DUE DILIGENCE REQUIREMENTS
6.1 COMPANY shall proceed diligently with the development of LICENSED
PRODUCTS and shall use its reasonable commercial efforts to bring LICENSED
PRODUCTS to market through a thorough, vigorous and diligent commercialization
program, which shall include but not be limited to the development, marketing,
promotion, distribution and sale of LICENSED PRODUCTS.
6.2 If COMPANY fails to achieve any of the development events set forth in
this Article 6, and LICENSOR so notifies COMPANY in writing, COMPANY and
LICENSOR will negotiate in good faith to determine how COMPANY can either remedy
such failure or achieve alternate development events. If COMPANY fails to make any
required efforts, after they are so determined, and does not remedy that failure within
sixty (60) days of written notice by LICENSOR, then LICENSOR may, by written notice
to COMPANY, terminate this License, at LICENSOR’S sole discretion.
6.3 It is acknowledged by the PARTIES that development can be delayed by
unforeseen and unusual consequences neither caused by nor under the control of
COMPANY. Should such delays cause COMPANY to fail to complete any development
event within the allotted time, the periods allotted may be extended by mutual agreement,
following sufficient documentation of such delays by COMPANY.
ARTICLE 7
Page 7 of 15PATENT PROSECUTION
7.1 The LICENSOR agrees to take responsibility, at its discretion, for the
preparation, filing, prosecution, and maintenance and enforcement of any and all the
PATENT RIGHTS included in the LICENSED PRODUCTS.
ARTICLE 8
INDEMNIFICATION, PRODUCT LIABILITY& INSURANCE
8.1 COMPANY will protect, defend, hold harmless and indemnify
LICENSOR, and their respective administrators, directors, trustees, officers, managers,
employees, agents, and the insurers, successors and assigns of any of the foregoing
(collectively, the "Indemnitees") at the expense of COMPANY for and from any and all
third party claims, causes of action, court or administrative orders, and liability (including
but not limited to product liability and strict liability) for any loss, expense (including
reasonable attorney’s fees, court costs, any costs of settlement and other legal expenses),
injury, damage, or act solely in conjunction with or arising out of(1) use by COMPANY,
its AFFILIATES, their directors, trustees, officers, employees, contractors,
subcontractors and agents, of the PATENT RIGHTS in breach of this Agreementor (2)
the design, manufacture, distribution or use of LICENSED PRODUCTS in breach of this
Agreement.
8.2 COMPANY agrees that the Indemnitees shall have no liability to
COMPANY or to any purchasers or users of LICENSED PRODUCTS for any claims,
demands, losses, costs, or damages suffered by COMPANY or purchasers or users of
LICENSED PRODUCTS, or any other party, which may result from personal injury,
death, or property damage related to the manufacture, use or sale of such LICENSED
PRODUCTS ("Claims").COMPANY agrees to defend, indemnify and hold harmless the
Indemnitees from any such Claims, provided that (i) COMPANY is promptly notified of
any Claims, (ii) COMPANY has the sole right to control and defend or settle any
litigation within the scope of this indemnity, and (iii) all Indemnitees cooperate to the
extent necessary in the defense of any Claims.
8.3 COMPANY shall provide LICENSOR with written evidence of such
insurance, including the policies and declarations pages, within thirty (30) days of
obtaining such insurance. COMPANY shall provide LICENSOR with notice at least
fifteen (15) days prior to any cancellation, non-renewal or material change in such
insurance, to the extent COMPANY receives advance notice of such matters from its
insurer. If COMPANY does not obtain replacement insurance providing comparable
coverage within sixty (60) days following the date of such cancellation, non-renewal or
materials change, LICENSOR shall have the right to require that COMPANY cease
further clinical testing or commercial sales of LICENSED PRODUCTS until such
insurance is obtained for such LICENSED PRODUCTS.
8.4 LICENSOR shall be solely responsible for all infringements and resulting
claims, demands, expenses, losses, costs, damages or other liabilities suffered by
Page 8 of 15COMPANY on account of the use by COMPANY of the PATENT RIGHTS, and
LICENSOR shall defend, indemnify and hold COMPANY harmless from and against all
claims, expenses, damages, penalties and other liabilities arising on account of or in
association with COMPANY’s use of the PATENT RIGHTS. It is understood that
COMPANY is responsible for providing evidence that possible claims involving the
LICENSED PRODUCTS are relevant to the PATENT RIGHTS.
8.5 Notwithstanding anything to the contrary, the liability of the COMPANY
shall be limited to the royalty paid by COMPANY to the LICENSOR in the twelve (12)
months preceding the Claims.
ARTICLE 9
USE OF NAMES AND CONFIDENTIALITY
9.1 Except as required by law or in the normal course of business
identification and description, neither COMPANY nor LICENSOR shall issue any press
release or other public statements in connection with this Agreement intended for use in
the public media without the express written approval of the other PARTY, which
approval shall not be unreasonably withheld.
9.2. "Confidential Information" shall mean any confidential or proprietary
information furnished by one PARTY to this Agreement (the "Disclosing Party") to the
other PARTY to this Agreement (the "Receiving Party") in connection with the
performance of any obligation under this Agreement, provided that such information is
specifically designated as confidential. Such Confidential Information includes, without
limitation, tangible materials (such as prototype products), patent applications and
materials related to the preparation, prosecution, and maintenance of any Patent Rights,
trade secrets, know-how, PATENT RIGHTSs, PATENT RIGHTS disclosures or
descriptions, technical data or specifications, testing methods, descriptions of research
and development activities, research and development data and results, processes, and
procedures.
9.3. Confidential Information that is disclosed in writing shall be marked with
a legend indicating its confidential status (such as "Confidential" or "Proprietary").
Confidential Information that is disclosed orally or visually shall be documented in a
written notice prepared by the Disclosing Party and delivered to the Receiving Party
within thirty (30) days of the date of disclosure; such notice shall summarize the
Confidential Information disclosed to the Receiving Party and reference the time and
place of disclosure.
9.4. Except as provided below in Sections 9.5, during the Term and thereafter
for a period of five (5) years, the Receiving Party shall (i) maintain all Confidential
Information in strict confidence, using at least the same degree of care that the Receiving
Party uses to protect its own confidential information, except that the Receiving Party
may disclose or permit the disclosure of any Confidential Information to its directors,
officers, employees, faculty, students, consultants, and advisors who are obligated to
Page 9 of 15maintain the confidential nature of such Confidential Information and who reasonably
need to know such Confidential Information for the performance of the Receiving Party's
obligations under this Agreement; (ii) use all Confidential Information solely for the
performance of the Receiving Party's obligations under this Agreement; and (iii) allow its
directors, officers, employees, faculty, students, consultants, and advisors to reproduce
the Confidential Information only to the extent reasonably necessary for the performance
of the Receiving Party's obligations under this Agreement. All reproductions of
Confidential Information made pursuant to this Section 9.4shall be considered as being
Confidential Information.
9.5. The obligations of the Receiving Party under Section 9.4 above shall not
apply to the extent that the Receiving Party can demonstrate that certain Confidential
Information (i) was in the public domain prior to the time of its disclosure under this
Agreement; (ii) entered the public domain after the time of its disclosure under this
Agreement through means other than an unauthorized disclosure resulting from an act or
omission by the Receiving Party; (iii) was independently developed or discovered by the
Receiving Party without use of the Confidential Information; (iv) is or was disclosed to
the Receiving Party at any time, whether prior to or after the time of its disclosure under
this Agreement, by a third party having no fiduciary relationship with the Disclosing
Party and having no obligation of confidentiality with respect to such Confidential
Information; and/or (v) is required to be disclosed to comply with applicable laws or
regulations or with a court or administrative order, provided that the Disclosing Party
receives reasonable prior written notice of such disclosure.
9.6. Receiving Party acknowledges that the Disclosing Party (or any third party
entrusting its own information to the Disclosing Party) claims ownership of its
Confidential Information in the possession of the Receiving Party. Upon the expiration
or termination of this Agreement and at the written request of the Disclosing Party, the
Receiving Party shall return to the Disclosing Party all originals, copies, and summaries
of documents, materials, and other tangible manifestations of Confidential Information in
the possession or control of the Receiving Party, except that the Receiving Party may
retain one copy of the Confidential Information solely for record purposes.
9.7 COMPANY shall not disclose any Confidential Information to any third
party except: (i) in accordance with the exceptions recited in Section 9.4 of this
Agreement; and/or (ii) with the prior written consent of LICENSOR shall not disclose
any Confidential Information to any third party except: (i) in accordance with the
exceptions recited in Section 9.4 of this Agreement or (ii) with the written consent
ofCOMPANY.
9.8 Notwithstanding the foregoing, COMPANYacknowledges that pursuant to
Italy’s Legislative Decree n. 33 of 14 March 2013 as subsequently amended, AOUMhas
the obligation to publish on its website, in a specifically dedicated section and for fifteen
(15) consecutive days, the internal measure authorising this Agreement together with a
copy of this Agreement. AOUM’s compliance with the above shall not be of prejudice,
pursuant to article 5-bis of Italy’s Legislative Decree n. 33 of 14 March 2013, to
Page 10 of 15COMPANY’s legitimate rights to protect its economic and commercial interests. The
PARTIES agree to abide by regulations set forth by the above mentioned Legislative
Decree as regards the right to civic access and relating obligations concerning
transparency and information disclosure.
ARTICLE 10
TERM AND TERMINATION
10.1 Unless earlier terminated as hereinafter provided, the “Term” of this
Agreement shall mean a period of time commencing on the Effective Date and ending, on
a country by country basis, on the date of expiration of the last to expire of PATENT
RIGHTS in countries where PATENT RIGHTS exist. Thereafter, the Agreement shall
expire automatically and COMPANY shall have a fully paid up, perpetual, royalty-free
license without further obligation to LICENSOR.
10.2 Except as otherwise provided by law, this Agreement may be terminated
with immediate effect (a) by either PARTY in the event of a material breach of this
Agreement by the other PARTY which is not remedied within ninety (90) days from
notice of such breach; or (b) by either PARTY, in any of the following events:
bankruptcy, insolvency of the other PARTY, or, should any PARTY make an assignment
for the benefit of creditors or commit an act of bankruptcy or file or have filed against it a
petition in bankruptcy or reorganization proceedings.
10.3 Termination of this Agreement for any reason shall not release either
PARTY hereto from any liability, which at the time of such termination has already
accrued to the other PARTY.
10.4 Article 2 (representations & warranties), Article 5.4 (maintenance of
records), Article 8(Indemnification, Product Liability & Insurance), Article 9(Use of
Names & Confidentiality), Article 13(Dispute Resolution) and Article 14.1 (governing
law) shall survive the expiration and any termination of this Agreement, in accordance
with the terms and conditions set forth thereof.
10.5 Except as otherwise provided in this Article 10, all rights and obligations
of the PARTIES under this Agreement shall terminate upon the expiration or termination
of this Agreement.
ARTICLE 11
GOVERNMENTAL COMPLIANCE
11.1 COMPANY shall at all times during the term of this Agreement and for so
long as it shall use the PATENT RIGHTS or sell LICENSED PRODUCTS and/or
Licensed Services comply and use commercially reasonable effort to cause its
AFFILIATES to comply with all laws that may control the import, export, manufacture,
use, sale, marketing, distribution and other commercial exploitation of the PATENT
Page 11 of 15RIGHTS, LICENSED PRODUCTS, Licensed Services or any other activity undertaken
pursuant to this Agreement.
ARTICLE 12
RIGHTS TO DATA
12.1 Should this Agreement be terminated or cancelled, COMPANY will turn
over to LICENSOR any and all data relating to the PATENT RIGHTS, including but not
limited to COMPANY’s processes for manufacturing LICENSED PRODUCT and other
data. Such transfer of said data from COMPANY to LICENSOR shall occur within
thirty (30) days of termination or cancellation of this Agreement. LICENSOR shall have
the full ownership rights to this data and shall be able to use it in any way to further
develop the PATENT RIGHTS.
ARTICLE 13
DISPUTE RESOLUTION
13.1 LICENSOR and COMPANY shall attempt to settle between them
amicably any controversy arising out of or related to this Agreement or the breach
thereof. A senior executive from each PARTY shall consult and negotiate to reach a
solution. The PARTIES agree that the period of amicable resolution shall toll any
otherwise applicable statute of limitations. However, nothing in this clause shall preclude
any PARTY from commencing mediation if said negotiations do not result in a signed
written settlement agreement within thirty (30) days after written notice that these
amicable resolution negotiations have commenced. In the event the applicable statute of
limitations shall expire prior to the expiration of the thirty (30) day period set forth in this
section, either PARTY may commence an action as set forth in Section 13.3 of this
Agreement.
13.2. If said controversy cannot be settled according to Section 13.1 above, the
PARTIES agree to good faith efforts to settle the controversy by mediation, in
accordance with applicable law in Italy.
13.3 If the PARTIES cannot reach agreement pursuant to Section 13.1 or
Section 13.2 above then any dispute, controversy, or claim arising out of or relating to
this Agreement, or the breach, termination or invalidity thereof, shall be finally settled
judicially according to the Italian jurisdiction by the court of Florence, Italy, with total
exclusion of any other court, whether general or facultative.
ARTICLE 14
GENERAL PROVISIONS
14.1 This Agreement shall be governed by, and construed and interpreted in
accordance with, the laws of Italy, without regard to conflicts of laws principles.
Page 12 of 1514.2 The relationship of COMPANY and LICENSOR established by this
Agreement is that of independent contractors. Nothing in this Agreement shall be
construed to create any other relationship between COMPANY and LICENSOR. Neither
PARTY shall have any right, power or authority to assume, create or incur any expense,
liability or obligation, expressed or implied, on behalf of the other.
14.3 This Agreement is binding upon and shall inure to the benefit of
LICENSOR, its successors and assigns, and shall be binding upon and shall inure to the
benefit of COMPANY and the successor to all or substantially all of its assets or business
to which this Agreement relates, but shall not otherwise be assignable or assigned by
COMPANY without prior written approval by LICENSOR being first obtained,
provided, however, that LICENSOR will not unreasonably withhold its approval if the
intended assignee from COMPANY is a COMPANY which is at least as capable of
commercializing and exploiting the PATENT RIGHTS as was COMPANY when this
Agreement was entered into.
14.4 In the event either PARTY hereto is prevented from or delayed in the
performance of any of its obligations hereunder by reason of natural disasters or
exceptionally serious events the PARTIES have no reasonable control of, the PARTY so
prevented or delayed shall be excused from the performance of any such obligation to the
extent and during the period of such prevention or delay.
14.5 Any notice or other communication required by this Agreement shall be
made in writing and shall be deemed to have been properly given if delivered in person,
or by first class certified mail, or via overnight courier, or by certified e-mail. Any such
notice shall be deemed to have been served on the date received by the addressee.
If to LICENSOR: If to COMPANY:
Azienda Ospedaliero-Universitaria Meyer (omissis)
S.O.C. Affari Generali e Sviluppo
Via G. Pieraccini, 24
50139 Florence -Italy
Attn. Dr Katalin Majer
katalin.majer@meyer.it
Certified e-mail:
meyer@postacert.toscana.it
14.6 This Agreement may not be altered, amended or modified in any way
except by a written document signed by both PARTIES. The failure of a PARTY to
enforce any provision of this Agreement shall not be construed to be a waiver of the right
of such PARTY thereafter to enforce that provision or any other provision or right.
14.7 Headings included herein are for convenience only, do not form a part of
this Agreement and shall not be used in any way to construe or interpret this Agreement.
Page 13 of 1514.8 If any provision of this Agreement shall be found by a court to be void,
invalid or unenforceable, the same shall be reformed to comply with applicable law or
stricken if not so conformable. Such holding shall have no effect on the remaining
provisions of this Agreement and they shall continue in full force and effect.
14.9 Neither LICENSOR, nor any scientists, researchers, employees, officers,
or agents assume any responsibility for the manufacture, product specifications, sale or
use of the PATENT RIGHTS or the LICENSED PRODUCTS or Licensed Services
which are manufactured by or sold by COMPANY.
14.10 The PARTIES hereto acknowledge that this Agreement sets forth the
entire agreement and understanding of the PARTIES hereto as to the subject matter
hereof, and supersedes all prior discussions, agreements and writings in respect hereto.
14.11 This Agreement may be executed in two counterparts, each of which shall
be deemed an original, but both of which shall constitute one and the same instrument.
14.12 The PARTIES pledge to refrain from engaging in unlawful and corruptive
conduct, undertaking not to behave or pursue aims which infringe applicable anti-
corruption regulations, specifically Italy’s Law n. 190 of November 6, 2012 and Law n.
69 of May 27, 2015.
14.13 This deed will be registered only in case of use, according to Italy’s
applicable law, the applicant being responsible for the necessary arrangements and
expenses. Company shall bear the costs of stamp duties for this Agreement, to be
included in the first invoice AOUM will send to Company following the execution of this
Agreement according to the Effective Date.
IN WITNESS WHEREOF, the PARTIES hereto have caused their duly authorized
representatives to execute this Agreement.
AOUM COMPANY
By: ________________________ By: ________________________
Name: Dr. Alberto Zanobini Name:Sameer D. Saral
Title: ManagingDirector Title:Chief Operating Officer
Date: ______________________ Date: ______________________
Page 14 of 15Exhibit A
(omissis)
Page 15 of 15ACCORDO DI LICENZA NON ESCLUSIVA
Il presente ACCORDO DI LICENZA (“Accordo”) è stipulato dall’ultima data di sottoscrizione
(“Data di Efficacia”) da e tra:
Azienda Ospedaliero-Universitaria Meyer con sede legale in Viale Pieraccini 24 Firenze, Italia,
rappresentata dal Direttore Generale dr. Alberto Zanobini (di seguito “AOUM” o
“LICENZIANTE”), domiciliato per la carica presso la sede dell'Azienda stessa
E
Labsystems Diagnostics Oy., con sede legale in Tiilitie 3, 01720 Vantaa, Finlandia (di seguito
“SOCIETA’” o “LICENZIATARIO”), rappresentata da Sameer D. Saral, Direttore Esecutivo
PREMESSO
CHE il LICENZIANTE è il proprietario di alcuni DIRITTI DI BREVETTO (omissis);
CHE il LICENZIANTE, che agisce in nome proprio, ha la facoltà di stipulare il presente Accordo
per la concessione in licenza e la commercializzazione dei predetti DIRITTI DI BREVETTO; e
CHE il LICENZIANTE è disposto a concedere una licenza non esclusiva per l’Europa (Licenza
UE) nel CAMPO D’USO al LICENZIATARIO secondo i termini, le condizioni, le limitazioni e le
restrizioni stabiliti di seguito
CHE la SOCIETA’ intende acquisire la licenza non esclusiva e i diritti di commercializzazione dal
LICENZIANTE per i suddetti diritti di proprietà intellettuale e per la tecnologia in base ai termini e
alle condizioni stabilite di seguito; e
CHE la SOCIETA’ ha dichiarato al LICENZIANTE l’impegno di sforzarsi con diligenza ed
accuratezza per sviluppare, produrre, fabbricare, commercializzare e vendere i prodotti coperti dai
DIRITTI DI BREVETTO.
ORA, PERTANTO, in considerazione dei reciproci impegni e delle pattuizioni qui contenuti, della
cui adeguatezza si dà qui atto, il LICENZIANTE e la SOCIETA’, avendo l’intenzione di essere
legalmente vincolati, qui concordano quanto segue:
ARTICOLO 1
DEFINIZIONI
1.1 “LICENZIATARIO” deve indicare Labsystems Diagnostics Oy. e deve includere una
società del LICENZIATARIO il cui diritto di voto è direttamente o indirettamente posseduto o
controllato per almeno il cinquanta per cento (50%) da Labsystems Diagnostics Oy.
1.2 “DIRITTI DI BREVETTO” devono indicare (omissis);
1/151.3 Un “PRODOTTO CONCESSO IN LICENZA” deve indicare qualsiasi prodotto o sua parte
che:
a. è coperto in tutto o in parte da una rivendicazione di brevetto rilasciata non scaduta
o una rivendicazione pendente contenuta nei DIRITTI DI BREVETTO nello Stato in cui tale
prodotto o sua parte è realizzato, utilizzato o venduto; oppure
b. è fabbricato utilizzando un procedimento o è usato per compiere un procedimento
che è coperto in tutto o in parte da una rivendicazione di brevetto rilasciata o non scaduta o una
rivendicazione pendente contenuta nei DIRITTI DI BREVETTO nello Stato in cui il
PROCEDIMENTO CONCESSO IN LICENZA sia utilizzato o in cui tale prodotto o sua parte siano
utilizzati o venduti.
Se una rivendicazione di brevetto è oggetto di cessazione oppure è giudicata invalida o inapplicabile
da un tribunale di giurisdizione competente, ovvero da un’autorità amministrativa, verso cui nessun
appello può essere fatto o viene fatto in uno Stato, allora qualsiasi prodotto o procedimento che
ricada esclusivamente sotto tale rivendicazione non deve essere considerato PRODOTTO
CONCESSO IN LICENZA o PROCEDIMENTO CONCESSO IN LICENZA in quello Stato ai fini
di questo Accordo.
1.4 Un “PROCEDIMENTO CONCESSO IN LICENZA” deve indicare un procedimento che sia
coperto in tutto o in parte da una rivendicazione di brevetto rilasciata o non scaduta o una
rivendicazione pendente contenuta nei DIRITTI DI BREVETTO.
1.5 “CAMPO” o “CAMPO D’USO” deve indicare (omissis).
1.6 “VENDITA” o “VENDUTO” deve indicare il trasferimento o la cessione di un
PRODOTTO CONCESSO IN LICENZA a un soggetto diverso dalla SOCIETA’ o da un
AFFILIATO avente un valore sia in forma di pagamenti cash, royalty, commissioni, azioni ovvero
ogni altra forma di compensazione.
1.7 “VENDITE NETTE” devono indicare l’ammontare lordo addebitato e/o fatturato dalla
SOCIETA’, i suoi clienti AFFILIATI per le VENDITE del PRODOTTO CONCESSO IN
LICENZA, al netto delle seguenti deduzioni ragionevoli e di prassi: (a) sconti e riduzioni
commerciali, (b) crediti o agevolazioni effettivamente attribuiti a terzi per i PRODOTTI
CONCESSI IN LICENZA che siano stati mandati indietro, richiamati, danneggiati o distrutti, (c)
vendite e accise e altre tasse pagate dalla SOCIETA’, i propri AFFILIATI, e basate o imposte sul
prezzo delle VENDITE del PRODOTTO CONCESSO IN LICENZA e (d) spese di trasporto,
confezionamento, spedizione e gestione.
1.8 “AFFILIATO” deve indicare qualsiasi soggetto che controlla, è controllato da o è sotto il
controllo comune della SOCIETA’. Ai fini della presente definizione, un soggetto deve essere
considerato come soggetto che ha il controllo di un altro soggetto se esso possiede o controlla più
del cinquanta per cento (50%) della quota del soggetto avente il diritto di voto per l’elezione dei
direttori (o, nel caso di un soggetto che non sia una società, più del cinquanta per cento (50%) del
controllo nell’elezione o nella nomina della corrispondente autorità di gestione).
2/151.9 “PARTE” deve indicare o la SOCIETA’ o il LICENZIANTE e “le PARTI” indicano la
SOCIETA’ e il LICENZIANTE.
1.10 “TERZA PARTE” deve indicare una persona o un soggetto che non è né una PARTE né un
AFFILIATO di una PARTE
1.11 “RIVENDICAZIONE DI BREVETTO VALIDA” deve indicare una rivendicazione di un
brevetto rilasciato o non scaduto oppure una rivendicazione pendente in una domanda di brevetto
pendente nell’ambito dei DIRITTI DI BREVETTO che (i) non sia stata revocata o giudicata
inapplicabile da una decisione di un tribunale o altra autorità governativa di giurisdizione
competente che è inappellabile o è inappellata nei termini consentiti per l’appello e (ii) non sia stata
negata.
ARTICOLO 2
DICHIARAZIONI E GARANZIE
2.1 Ciascuna parte dichiara e garantisce all’altra che:
(a) essa è legalmente istituita secondo la normativa della propria giurisdizione di
costituzione, con pieni poteri e autorità per svolgere le proprie attività così come al momento
possedute o concesse in licenza e condotte;
(b) essa ha i poteri e l’autorità societaria per stipulare e rendere applicabile questo
Accordo e per eseguire tutti i termini e le previsioni qui contenuti e ad essa riferibili;
(c) la stipulazione e l’applicazione di questo Accordo sono state debitamente autorizzate
dai necessari adempimenti societari; e
(d) questo Accordo è stato debitamente stipulato e recapitato e costituisce un obbligo
legale, valido e vincolante, applicabile secondo i termini qui contenuti.
2.2 Il LICENZIANTE dichiara e garantisce alla SOCIETA’ che:
(a) il LICENZIANTE non ha precedentemente concesso e non concederà alcun diritto sulla
base dei DIRITTI DI BREVETTO che siano in contrasto con i diritti e le licenze qui attribuiti alla
SOCIETA’. Fermo restando quanto sopra, il LICENZIANTE può, a propria discrezione, concedere
licenze non esclusive relative ai DIRITTI DI BREVETTO a TERZE PARTI;
(b) per quanto di sua conoscenza, a partire dalla Data di Efficacia, senza previa ricerca, non
ci sono rivendicazioni di TERZE PARTI che metterebbero in discussione i diritti del
LICENZIANTE a concedere alla SOCIETA’ i diritti e le licenze qui contemplati; e
(c) il LICENZIANTE ha ricevuto e attualmente detiene cessioni valide ed efficaci dei diritti
dell’Inventore riguardo ai DIRITTI DI BREVETTO.
2.3 SALVO QUANTO PREVISTO NEL PRESENTE ARTICOLO 2, NESSUNA PARTE DA’
GARANZIE O PONE CONDIZIONI (ESPRESSE, IMPLICITE, DI LEGGE, O ALTRO) CON
RIGUARDO ALL’OGGETTO DI CUI AL PRESENTE ACCORDO.
2.4 SALVO QUANTO DIVERSAMENTE STABILITO IN MODO ESPLICITO, IL
LICENZIANTE E I RISPETTIVI INVENTORI E AFFERENTI NON FANNO ALCUNA
DICHIARAZIONE E NON OFFRONO ALCUNA GARANZIA DI ALCUN TIPO, SIA EPRESSA
3/15SIA IMPLICITA, INCLUSE, MA NON LIMITATE A, GARANZIE DI COMMERCIABILITA’,
ADEGUATEZZA PER UNO SCOPO SPECIFICO, VALIDITA’ DEI DIRITTI DI BREVETTO,
SIA RILASCIATI SIA PENDENTI, E L’ASSENZA DI DIFETTI LATENTI O ALTRI DIFETTI,
INDIPENDENTEMENTE DAL FATTO CHE SIANO INDIVIDUABILI. IN NESSUN CASO IL
LICENZIANTE E I SUOI INVENTORI E AFFERENTI SONO RESPONSABILI PER DANNI
INCIDENTALI O CONSEQUENZIALI DI QUALSIASI TIPO, INCLUSI DANNI ECONOMICI
O DANNI ALLA PROPRIETA’ O MANCATI PROFITTI, INDIPENDENTEMENTE DAL
FATTO CHE IL LICENZIANTE DEBBA ESSERNE INFORMATO, DEBBA AVERE ALTRE
RAGIONI PER ESSERNE A CONOSCENZA, O DI FATTO DEBBA ESSERNE A
CONOSCENZA QUANTO ALL’EVENTUALITA’.
ARTICOLO 3
CONCESSIONE DEI DIRITTI DI LICENZA
3.1 Nel rispetto dei termini e delle condizioni di questo Accordo, il LICENZIANTE qui concede
alla SOCIETA’ una licenza non esclusiva, con royalty relativa ai DIRITTI DI BREVETTO UE nel
CAMPO (di seguito “Licenza UE”), incluso il diritto di sviluppare, utilizzare, commercializzare,
distribuire, produrre, aver prodotto, vendere, aver venduto, offrire di vendere, importare ed
esportare i PRODOTTI CONCESSI IN LICENZA.
3.2 La SOCIETA’ deve avere il diritto di estendere questa Licenza a qualsiasi AFFILIATO a
condizione che l’AFFILIATO acconsenta ad essere vincolato al presente Accordo nella stessa
misura della SOCIETA’ e che la SOCIETA’ fornisca al LICENZIANTE una copia di tale previo
consenso scritto entro trenta (30) giorni dal suddetto previo consenso scritto, fermo restando che la
Società mantenga il controllo dei propri AFFILIATI, come stabilito nell’art. 1.8. Qualora la Società
perda il controllo di detti AFFILIATI, il LICENZIANTE deve avere il diritto di rinegoziare il
presente Accordo con l’assegnatario.
3.3 Il LICENZIANTE si riserva il diritto di utilizzare, sfruttare ed esercitare i DIRITTI DI
BREVETTO per scopi esclusivamente formativi e di ricerca accademica e di concedere diritti non
esclusivi ad altre parti, istituzioni accademiche o agli Inventori per utilizzare, sfruttare e/o esercitare
i DIRITTI DI BREVETTO per finalità esclusivamente formative e di ricerca accademica.
3.4 AOUM, e le istituzioni sanitarie non-profit affiliate all’AOUM, devono avere il diritto di
utilizzare gratuitamente qualsiasi prodotto o procedimento sviluppato dal LICENZIATARIO che
contenga, o sia basato su, i DIRITTI DI BREVETTO e/o i PRODOTTI CONCESSI IN LICENZA,
per scopi di ricerca, di cura dei pazienti, formativi, accademici o amministrativi.
ARTICOLO 4
ROYALTIES
In considerazione dei diritti di licenza concessi dal LICENZIANTE alla SOCIETA’ ai sensi del
presente Accordo, la SOCIETA’ effettuerà i seguenti pagamenti a favore del LICENZIANTE:
4.1 (omissis)
4/154.2 Il LICENZIATARIO deve pagare al LICENZIANTE le royalties per unità prodotta sulle
VENDITE NETTE del PRODOTTO CONCESSO IN LICENZA nei termini che seguono:
(a) negli Stati dove i DIRITTI DI BREVETTO UE sono in essere, e i brevetti sono concessi
e in vigore: una royalty pari a (omissis) fatte dalla SOCIETA’ e dagli AFFILIATI per ciascun
PRODOTTO CONCESSO IN LICENZA per la parte restante della vita di ciascun brevetto;
(b) nel caso un PRODOTTO CONCESSO IN LICENZA sia venduto con pagamento diverso
dal contante, la royalty che deve essere pagata sarà basata sul prezzo delle VENDITE NETTE di un
PRODOTTO CONCESSO IN LICENZA comparabile.
(c) la SOCIETA’ accetta che i tassi di royalty pagati dai propri AFFILIATI non devono
essere in nessun caso inferiori alla percentuale del tasso della royalty pagata ai sensi del presente
Accordo dalla SOCIETA’ al LICENZIANTE sulle VENDITE NETTE dei PRODOTTI CONCESSI
IN LICENZA.
ARTICOLO 5
PAGAMENTI, ARCHIVIAZIONE E RESOCONTI
5.1 A partire dal 2021, la SOCIETA’ deve consegnare al LICENZIANTE un resoconto veritiero
ed accurato, fornendo i dettagli delle attività commerciali condotte dalla SOCIETA’ e dai suoi
AFFILIATI, su base nazionale, nel periodo dei sei (6) mesi precedenti il 30 giugno e il 31 dicembre,
coerentemente con un conto dei pagamenti di cui sotto. Tali resoconti devono essere dovuti al
LICENZIANTE il 31 luglio e il 31 gennaio di ciascun anno e devono includere almeno:
(a) una descrizione e una relazione contabile dettagliate di tutti gli sforzi di sviluppo
preclinico, di sviluppo clinico, di commercializzazione e di sviluppo commerciale fatti dalla
SOCIETA’ per sviluppare commercialmente i PRODOTTI CONCESSI IN LICENZA che
contengano tutti i dettagli che possano essere necessari per dimostrare le somme pagabili al
LICENZIANTE. Detti registri contabili devono essere conservati presso la sede principale della
SOCIETA’;
(b) le quantità prodotte del PRODOTTO CONCESSO IN LICENZA;
(c) le VENDITE totali e le VENDITE NETTE del PRODOTTO CONCESSO IN
LICENZA;
(d) un elenco dettagliato di tutte le deduzioni consentite dalla somma totale delle VENDITE
NETTE dei PRODOTTI CONCESSI IN LICENZA;
(f) la relativa quantificazione delle royalty;
(g) le royalty totali conseguentemente calcolate e dovute al LICENZIANTE.
Contemporaneamente alla consegna di ciascun resoconto, la SOCIETA’ deve pagare al
LICENZIANTE la somma, se dovuta, relativa al periodo di tale resoconto. Se non è dovuto alcun
pagamento, deve così essere riportato. I pagamenti dovuti ai sensi di questo articolo 5.1
dell’Accordo devono essere effettuati entro quarantacinque (45) giorni dalla fine del periodo in cui
la VENDITA di un PRODOTTO CONCESSO IN LICENZA è completata, ed è soggetta ad incasso
da parte della SOCIETA’.
5/15Puoi anche leggere
