EXHIBIT 10.8
EXCLUSIVE DISTRIBUTION AGREEMENT
This Agreement by and between
The TRYLON CORPORATION, a Company organized and existing under the laws of
----------------------
California with registered office in 000 Xxxx 000xx Xxxxxx, Xxxxx 000, Xxxxxxxx,
Xxxxxxxxxx hereinafter referred to as "TRYLON",
and
BRACCO S.p.A, a Company organized and existing under the laws of Italy with
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registered office in Milan, Via Xxxxxx Xxxxx No. 50, hereinafter referred to as
"BRACCO"
WHEREAS
- TRYLON is the owner or licensee of any and all rights - including know-how,
patent and trademark - concerning the Product (as hereinafter defined), which
is manufactured in TRYLON's plant.
- BRACCO is willing to execute an agreement with TRYLON for the exclusive
distribution of the Product in the Territory and TRYLON is willing to grant
such right to BRACCO at the terms and conditions herein set forth.
NOW IN CONSIDERATION OF THE PREMISES, WHICH FORM AN INTEGRAL PART OF THE PRESENT
AGREEMENT, THE PARTIES HEREBY AGREE AS FOLLOWS.
ARTICLE I - Definitions
Wherever used in this Agreement the following terms shall have the following
meaning:
1.01 "Product": shall mean the diagnostic device for vaginal illumination
whose specifications are set forth as per Schedule A attached hereto,
which forms an integral part of this Agreement, as well as any other
improvement of it in the application field covered by this Agreement.
1.02 "Territory": shall mean the Republic of Italy, the Republic of San
Marino and Vatican City.
1.03 "Trademark": shall mean the trademark "SPECULITE" filed to cover the
Territory on January 10, 1996 application number RM96C000095.
1.04 "Patent Rights": shall mean the patent granted/issued and/or the
intellectual property rights on the Product indicated in Schedule B
hereto.
1.05 "Effective Date": shall mean the date, to be indicated in writing, in
which BRACCO and TRYLON shall reach the agreement foreseen in para 9.03.
ARTICLE 11 - Grant
2.01 On the terms and conditions as set forth in this Agreement TRYLON hereby
grants BRACCO, that accepts, the exclusive right of promoting, marketing
and selling the Product in the Territory, using the Trademark.
2.02 By appointing BRACCO as its exclusive distributor in the Territory, it
is intended and agreed that TRYLON shall not itself sell the Product in
the Territory and shall not grant to any third party distribution rights
or other rights in the Territory for the Product.
ARTICLE III - Right of First Refusal
With reference to any improvement of the Product outside the application
field governed by the rules of the present Agreement the Parties hereby
agree that TRYLON shall grant to BRACCO a right of first refusal to market
in the Territory, under terms to be proposed by TRYLON, any new product
which embodies improvements of the Product in application fields other than
that covered by the present Agreement.
XXXXXX'x right of first refusal to any such product shall be exercisable
only during the three (3) month period, beginning with TRYLON's offer of
terms for marketing rights for that Product. BRACCO shall notify TRYLON in
writing of its exercise of the right of first refusal.
In case BRACCO does not exercise its right of first refusal within said
three (3) month period, TRYLON shall be entitled to license a third party to
market the particular product in the Territory on generally equivalent
terms. XXXXXX'x right to market any product for which it has exercised its
right of first refusal under this Paragraph shall terminate on expiry of
five (5) years from the Effective Date of this Agreement or four (4) years
of commercial sale of that product, whichever period is the last to expire.
The Parties shall also agree upon reasonable minimum quantities to be
purchased by BRACCO, during each year of such term. Such agreement shall
take in any case into consideration the minimum purchase quantities, already
agreed by the Parties for the Product.
ARTICLE IV - Trademark and Infringement
4.01 The Product shall be marketed by BRACCO in the Territory under the
Trademark. The ownership of any rights in the Trademark shall remain
solely with TRYLON and BRACCO shall only be entitled to use the
Trademark for the
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purposes provided for in the present Agreement.
4.02 Trademark rights are secured and shall be maintained in the Territory by
TRYLON in its own name and its costs, for the whole duration of the
present Agreement. BRACCO shall do its best efforts to notify TRYLON as
soon as possible of any infringements of the Trademark in the Territory
which may come to its knowledge, and shall have the right to afford
TRYLON full co-operation for the defense of the Trademark in the
Territory.
BRACCO shall reasonably assist TRYLON in taking the necessary measures
in order to protect Trademark rights.
4.03 TRYLON shall take prompt action, at its expense, to stop all
infringements of its Trademark in the Territory, including court action
if necessary.
TRYLON agrees to defend, indemnify and hold BRACCO harmless from any
claims, suits or liability arising out from the marketing, advertising
and/or sale or use, by BRACCO or its customers, of the Product under the
Trademark, in case the Trademark infringes any trademark, trade name or
other interest of any third party.
ARTICLE V - Patent Rights and Infringement
5.01 TRYLON shall be the sole responsible for the application, grant,
maintenance and defense of the Patent Rights in the Territory and shall
bear all relative costs.
5.02 TRYLON shall take prompt action, at its expense, to stop all
infringements in the Territory of its Patent Rights, including court
actions if necessary, being understood that, in order to achieve this
aim, TRYLON shall choose, in its reasonable determination, which kind of
legal actions are to be taken for the defensive strategy. In the event
that BRACCO becomes aware that any of the Patent Rights is disputed or
infringed by a third party, BRACCO shall promptly inform TRYLON thereof
and reasonably assist TRYLON in taking measures necessary to protect the
Patent Rights.
5.03 TRYLON shall indemnify BRACCO against any and all third party claims of
patent infringement which may be asserted against it because of its
marketing, advertising and/or sale of the Product in the Territory, to
the extent BRACCO has not negligently or willfully contributed to the
basis for such claim. TRYLON shall bear all costs and expenses incur-red
in connection with the defence of any such claims or as a result of any
settlement made or judgements rendered on the basis of such claims.
ARTICLE VI - Sales Permissions
6.01 BRACCO shall take all the necessary steps in order to secure and
maintain those
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governmental approvals or official sales perrnissions, if any, from the
competent Health Authorities which may be required for the sale of the
Product in the Territory. It is understood that any application shall be
filed in the name of TRYLON.
6.02 Any official costs (such as fees, stamps, annuities, etc.) imposed in
the filing of the applications for or the obtention of the official
sales permissions for the Product in the Territory or related to their
maintenance in force, shall be reimbursed by TRYLON to BRACCO against
supporting documents.
ARTICLE VII - Confidentiality
All information of a confidential nature disclosed by one Party to the other
hereunder shall be marked as "CONFIDENTIAL" and, if orally given, confirmed in
writing as "CONFIDENTIAL" within thirty (30) days of the disclosure and shall be
used only for the purposes of this Agreement and shall not be revealed by the
recipient to any person, company or firm other than its employees, who have a
need to know such information, and such disclosures shall be made on a
confidential basis. No disclosure shall be governed by this Article to the
extent that the information disclosed shall be:
- public knowledge prior to or after disclosure other than through acts or
omissions attributable to the recipient or its employees, or
- already known to the recipient at the time of disclosure hereunder, or
- disclosed to the recipient by a third party having the right to use and
disclose the same.
The present obligation shall survive the termination of this Agreement for
whatever reason and shall remain in force for a period ending five (5) years
after such termination.
Either Party undertakes not to reveal the content and/or the existence of this
Agreement to third parties, without the previous written consent of the other
Party.
ARTICLE VIII - Supplies
8.01 [Omitted]
8.02 [Omitted]
8.03 [Omitted]
8.04 [Omitted]
ARTICLE IX - Packaging
9.01 TRYLON undertakes to supply BRACCO with the Product packed with the
indication of any warning, instruction and specification (e.g. batch
number, expiry date, etc.) in full accordance with all the applicable
laws, written in the Italian language.
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9.02 BRACCO undertakes not to make any changes or integrations on the
packagings of the Product as supplied by TRYLON without having
previously obtained the written approval of TRYLON, provided however
that at all events, XXXXXX'x name and xxxxxxxx shall clearly appear on
all the packagings,, leaflets and labels, together with the mention that
the Product is manufactured by TRYLON and sold by BRACCO.
9.03 The parties shall cooperate in a very interactive manner in order to
realize the correct packaging and labelling of the Product. For this
purpose it is, however, agreed that in case the parties do not reach an
agreement with reference to all the practical aspects ( e.g.
translations, expenses, etc.) necessary for the realization of said
correct packaging and labelling, within one hundred and eighty (180)
days to be calculated as of the Effective Date, the present Agreement
shall be considered forthwith terminated by the Parties at the
expiration af said term, unless otherwise agreed in writing by BRACCO
and TRYLON.
ARTICLE X - Promotion
10.01 BRACCO shall use its best endevours to promote the sale of the Product
in the Territory by using adeguate promotional efforts. The times and
the programs of launching, introduction and promotion of the Product in
the Territory shall be negotiated and agreed between the Parties.
10.02 TRYLON shall keep BRACCO informed of all promotional activities
concerning the Product outside the Territory. TRYLON shall also keep
BRACCO informed, by advance written notice and in reasonable time, of
all changes concerning the Product (e.g. changes in characteristics,
performance, packaging, labelling, etc.).
TRYLON shall provide to BRACCO, free of charge, the quantities of
promotional materials in connection with the Product, that TRYLON and
BRACCO shall agree and that TRYLON in any case customarily provides to
other distributors of the Product outside the Territory.
Upon the termination of this Agreement, and upon request of TRYLON,
BRACCO shall return all such unused literature, drawings, and other
sales materials to TRYLON.
10.03 The costs of medical visitors, distribution of samples, mailing of
literature, circulars and advertising shall be borne by BRACCO.
10.04 [Omitted]
ARTICLE XI - New Experiences
11.01 The Parties undertake to put at each other disposal, free of charge,
all
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results of new experiences made with the Product during the life of
this Agreement.
11.02 TRYLON particularly undertakes to put at XXXXXX'x disposal, free of
charge, the clinical studies and reports carried out by it or by third
parties on the Product, even if not yet published,
11.03 The provisions set forth in para. 11.01 and 11.02 shall apply provided
that the disclosing Party dord not 'eopardize or impair its, or a third
party's, ability to publish such experience or findings, and provided
that the disclosing Party has the night to disclose such information
without the requirement from the receiving Party of incurring in
additional costs or expenses.
ARTICLE XII - Warranties and Liabilities
12.01 TRYLON represents and warrants that the Product delivered to BRACCO
shall confonn to the specifications submitted and listed in Schedule A
and shall have a minimum shelflife of twenty-four (24) months from the
date of delivery by TRYLON to BRACCO. The Product will be free from
defects of whatever nature and shall be packed and shipped so as to
avoid freight stress.
TRYLON warrants the merchantability of the Product and its fitness
thereof for the particular purpose for which it is sold and takes upon
itself any responsibilities and liabilities applicable to the
manufacturer of the Product, according to any applicable UE and/or local
laws and regulations.
Furthermore, TRYLON hereby declares that TRYLON itself and its
manufacturer of the Product are in compliance with all the rules of the
United States Food and Drug Administration ("FDA") and Good
Manufacturing Procedures ("GMP") with respect to the Product, and that
West Springfield facility at which the Product is manufactured has been
approved by the FDA as a medical diagnostic manufacturing facility.
TRYLON intends to comply with all the applicable U.E. and local laws and
regulation with respect to the Product and undertakes to proceed
diligently to effect such compliance, within one hundred and eighty
(180) days as of the Effective Date. For this purpose, BRACCO agrees to
cooperate with TRYLON and provide it with information and assistance.
12.02 Should BRACCO discover any batch of the Product failing to satisfy the
specifications in Schedule A, TRYLON shall, within forty-five (45) days
after receipt of a written notice from BRACCO, replace the Product at
its own expense, including duties. BRACCO shall provide TRYLON with a
sample of the defective Product reflecting the defects noted.
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As an alternative to replacement, BRACCO may elect to obtain the refund
or credit of the purchase price and of the import duty, as well as the
insurance and shipping costs.
Any other quantity of the defective Product, other than the sample above
mentioned, shall be, at TRYLON's election, either returned to TRYLON, or
destroyed in accordance with the applicable laws in the Territory
12.03 TRYLON shall defend, indemnify and hold BRACCO harmless as to any
product liability claims arising out of the use of the Product, except
to the extent such claims arise out of or relate to mishandling,
modification or misuse of the Product or otl-ier negligence by BRACCO.
12.04 TRYLON represents and warrants that it has the full right and power to
grant the distribution rights set forth in Article Two (2) and that
there are not outstanding agreements, assignments, or encumbrances of
whatever nature inconsistent with the provisions of this Agreement.
Without limiting the generality of the foregoing, TRYLON represents and
warrants that: i) any and all authorizations or consents required to be
obtained by the beneficial owner of the Patent Rights, in order to allow
TRYLON to perform its obligations hereunder, have been obtained by
TRYLON; ii) TRYLON shall fully comply with the terms and conditions set
forth in the license agreement with the beneficial owner of the Patent
Rights so as to avoid the lapsing or the impairment and/or other
negative consequence of whatever nature to any of XXXXXX'x right granted
under this Agreement.
ARTICLE XIII - Term and Termination
13.01 Unless sooner terminated as provided hereinafter, this Agreement, shall
be binding upon the Parties promptly upon its signature and shall have
an initial term of five (5) years as of the Effective Date. Thereafter,
it shall be renewable for an additional five (5) year term and so on for
other possible renewals, provided that each Party shall have the right
to terminate this Agreement at the end of the initial term or of any
renewal term, giving a twelve (12) month prior written notice to the
other Party.
13.02 Either Party shall have the right to terminate at any time this
Agreement by giving a thirty (30) day advance written notice to the
other Party, should any of the following conditions arise:
a) the other Party changes substantially the ownership of its voting shares
or otherwise its control, except: (i) such change takes place within the
existing group of companies to which such other Party presently belongs
to, or:(ii) the third party attaining a majority interest or control of
said other Party is not one to which TRYLON or BRACCO have reasonable
grounds
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for objection.
Notwithstanding the foregoing, BRACCO shall be entitled to terminate the
present Agreement under this sub-clause if any competitor of BRACCO,
having its principal place of business in the Territory or anywhere
else, purchases a fifteen percent (15%) or greater interest in TRYLON's
voting stocks and/or assets or other interest.
b) the other Party becomes insolvent or goes into bankruptcy, liquidation,
receivership or into any comparable proceedings for settlement of debts.
13.03 BRACCO shall have the option to terminate this Agreement upon a
fortyfive (45) day prior written notice by registered letter if:
a) the warranties in Article XII are not met for two different Product
shipments and XXXXXX'x quality control department has refused to accept
such shipments in any consecutive twelve (12) month period. In the event
this conditions occurs and TRYLON fails to remedy, as provided for in
para 12.02, the present Agreement shall terminate at the end of the
forty- fifth day herein foreseen. It is however understood that TRYLON
shall bear no liability in case the Product has not been properly stored
by BRACCO or in case of damages occurred during the relevant shipment.
c) the Product falls to comply with at least one (1) of U.E. and/or
local laws or regulations in the Territory.
d) TRYLON has materially breached any of its other obligations hereunder.
Notwithstanding the above, BRACCO shall not have the right to terminate
the present Agreement as per para 13.03 b) or c) and d), unless it
provides TRYLON a period of forty-five (45) days to cure and remedy said
conditions. If the condition forming the basis for termination cannot,
with diligent effort, be cured within such forty-five day period, TRYLON
shall have a reasonable additional time to effect such cure, provided
that TRYLON commences to cure the condition within such forty-five (45)
day period, and proceeds diligently and continuously thereafter to cure
the condition.
13.04 TRYLON shall have the option to terminate this Agreement upon a
fortyfive (45) day prior written notice by registered letter if BRACCO
does not perform the due payments at the terms and conditions set forth
in Schedule C. Notwithstanding the above, TRYLON shall not have the
right to terminate the present Agreement as per this Section 13.04
unless it provides BRACCO a period of forty-five (45) days to cure and
remedy said condition. If the condition forming the basis for
termination cannot, with diligent effort, be cured within such forty-
five day period, BRACCO shall have reasonable additional time to effect
such cure, provided that BRACCO commences to cure the condition within
such forty-five (45) day period, and proceeds diligently and
continuously thereafter to cure the condition.
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ARTICLE XIV - Assignment
Neither Party shall assign or otherwise transfer any of its right or
obligations under this Agreement to any third party without the prior written
approval and consent of the other Party.
However, each Party shall be entitled to assign this Agreement (both rights
and obligations) or delegate its obligation to be performed to an affiliate,
without the prior approval of the other Party. For purpose of this Agreement,
the term "affiliate" shall mean any corporation or business entity controlled
by, controlling or under common control with such Party. In case of any
assignment provided for herein, the assignor shall remain jointly and severally
liable with the assignee for the proper performance by the assignee.
ARTICLE XV - Indemnity
In case of termination of the present Agreement due to initiative of
TRYLON, other than termination pursuant to Article 13 for XXXXXX'x
unfullfillment, BRACCO shall be entitled to ask and receive from TRYLON an
indemnity in money concerning any expense borne by BRACCO under this Agreement,
and hereby mutually agreed by the Parties in a measure equal to fifty per cent
(50%) of the net sales of the Product, made by BRACCO in the previous calendar
year.
ARTICLE XVI - Rights and Duties after Termination
16.01 In the event of termination or expiration, BRACCO shall have the
option, at its own discretion,
a) to re-sell to TRYLON, even through a third party designated by this
latter, all quantities of the Product in XXXXXX'x possession at prices
not to exceed XXXXXX'x landed cost.
b) to go on selling, using the Trademark, the quantities of Product in
its possession, up to the exhaustion of the Product.
16.02 Such termination or expiration shall not affect the obligation of BRACCO
to pay TRYLON any amount accrued to TRYLON under the provisions of this
Agreement while it was in effect, to the extent that said amount cannot
be compensated with any XXXXXX'x credit of whatever nature towards
TRYLON. Furthermore, such termination or expiration shall not affect
VII[ hereinbefore.
ARTICLE XVII - Force Majeure
If, in the performance of this Agreement, any obligation hereunder is prevented,
restricted or interfered with by reason of any cause beyond the control of the
affected Party, including but not limited to: war or hostility; crime, tort or
other unlawful act, act of
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any government or agency, subdivision or branch thereof, strikes or other labour
disputes; accident, fire, explosion, flood, storm or other act of God; fuel,
power, inventory or machinery; technical failure; or, in general, any other
contingency whatsoever (whether similar or dissimilar to those set forth
herein), the Party so affected, upon prompt cabled notice to the other Party,
shall be excused from such performance to the extent of such prevention,
restriction or interference provided that the Party so affected shall use its
best efforts to avoid or remove such cause or causes of non-performance and
shall continue performance hereunder whenever such cause is removed. If the
Party so affected cannot resume performance within six (6) months, the other
Party shall have the right to terminate this Agreement.
ARTICLE XVIII - Notices
Any notice to be notified to the Parties hereto shall be mailed by telex or
telefax and confirmed by registered airmail letter if intended for BRACCO to:
XXXXXX S.p.A.
Xxx Xxxxxx Xxxxx Xx. 00
00000 XXxxx,
XXXXX
and if intended for TRYLON to:
THE TRYLON CORPORATION
000 Xxxx 000xx Xxxxxxx
Xxxxx 000
00000-0000 Torrance
CALIFORNIA
ARTICLE XIX - Applicable Law and Arbitration
The present Agreement is governed by the Italian law. All divergencies which
might arise in relation to the present Agreement, including those concerning its
validity, interpretation, performance, termination and expiration, will be
settled by a decision of one arbitrator, to be named in accordance with the
"National Arbitration Regulations" of the National and International Arbitration
Chamber in Milan, which regulations the Parties expressively declare to know and
accept, with particular reference, but not limited to, the modalities of
appointment of the arbitrator. The arbitrator will decide in accordance with
the rules of the Italian Civil Procedural Code (arbitrate rituale secondo
diritto).
The place of arbitration shall be Milan and the language to be used in the
arbitral proceedings shall be English.
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The Parties undertake to give prompt execution to the award in no event later
than ten (10) days from the date of the communication of the arbitrator's
judgement. The fees and the expenses of such arbitration shall be borne by the
losing Party.
ARTICLE XX - Amendments
20.01 The foregoing constitutes the entire agreement between the Parties about
the promotion, marketing and sale of the Product in the Territory.
20.02 This Agreement shall not be considered as extended, cancelled or amended
in any respect unless done so in writing by means of formal contractual
Amendments to be executed by both Parties.
THIS AGREEMENT has been drawn up in duplicate, in witness whereof the Parties
hereto have caused it to be duly executed by their respective officers hereunder
duly authorized and each Party hereto shall receive one copy duly signed.
signed in Milan on February 14, 1996
The TRYLON CORPORATION XXXXXX S.p.A.
/s/ Xxxxxx X. Xxxxx /s/ Xxxxx Xxxxxx
------------------------ --------------------
Xx. Xxxxxx X. Xxxxx Dr.a Xxxxx Xxxxxx
President General Manager
[CERTAIN PORTIONS OF THIS DOCUMENT, AS INDICATED WITHIN, HAVE BEEN OMITTED
PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST]
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SCHEDULE A
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Specifications
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Products:
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1. Speculite - Blue/White
Descriptions:
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1. Speculite: Chemiluminescent light sticks, with fracturable glass ampules
imbedded in polypropylene containers, approximately 52 mm in length. Each
light stick is packaged with a double sided adhesive polymer, intended to
provide adhesive capability of the light stick to disposable and re-usable
specula.
Medical Indication:
-------------------
Speculite, Blue/White - viewing pathological demarcations during speculoscopy
procedures.
Packaging:
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to be agreed as per para. 9.3
The TRYLON CORPORATION XXXXXX S.p.A.
/s/ Xxxxxx X. Xxxxx /s/ Xxxxx Xxxxxx
------------------------ ---------------------
Xx. Xxxxxx X. Xxxxx Dr.a Xxxxx Xxxxxx
President General Manager
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SCHEDULE B
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Patent Rights
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--------------------------------------------------------------------------------
TITLE COUNTRY FILED ISSUED SERIAL REG. EXPIRY DATE
No.
--------------------------------------------------------------------------------
Endoscopic EPO 01/23/85 86300457.8 1/23/2006
Instruments
and
Illuminating
Attachments
for Same
--------------------------------------------------------------------------------
Same as above Italy Same as 0190014 Same as
above above
--------------------------------------------------------------------------------
The TRYLON CORPORATION XXXXXX S.p.A.
/s/ Xxxxxx X. Xxxxx /s/ Xxxxx Xxxxxx
------------------------ ---------------------
Xx. Xxxxxx X. Xxxxx Dr.a Xxxxx Xxxxxx
President General Manager
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SCHEDULE C
----------
[Omitted]
The TRYLON CORPORATION XXXXXX S.p.A.
/s/ Xxxxxx X. Xxxxx /s/ Xxxxx Xxxxxx
------------------------ ---------------------
Xx. Xxxxxx X. Xxxxx Dr.a Xxxxx Xxxxxx
President General Manager
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