EXHIBIT 10.16
DISTRIBUTION AGREEMENT
This distribution agreement (the "Agreement") is made and entered into by and
between:
X. XXXXXXX & C. dei F.lli Alitti Societa di Esercizio S.p.A., a company existing
and organized under the laws of Italy, with registered office at Xxxxxx Xxxxxxx
00 (Xxxxxxxx Xxxxxxxxxx), Xxxxxxxxx, Xxxxxxxx, Xxxxx, represented by Xx.
Xxxxxxxx Xxxxx-Recli, in his capacity as Managing Director, (hereinafter
referred to as "MOLTENI");
on the one part
and
SAMARITAN PHARMACEUTICALS EUROPE S.A., a company existing and organized under
the laws of Greece, with registered office at 00 Xxxxxx Xxxxxx, Xxxxxx (Xxxxxx),
represented by Xx. Xxxxxxxx Xxxxx, in his capacity as Managing Director,
(hereinafter referred to as "SAMARITAN"),
on the other part
(MOLTENI and SAMARITAN are herein jointly referred to also as the "Parties" and
each individually as a "Party", as the case may be.)
WHEREAS
A) MOLTENI is engaged in the manufacturing, marketing and distribution of
pharmaceutical products worldwide and is, among others, holder of the
relevant marketing authorizations of the Products (as defined
hereinafter) in Italy and owner of the Trademarks (as defined
hereinafter).
B) SAMARITAN is a company engaged in the distribution of pharmaceutical
products in the Greek and Cypriot territory, is duly organized and
qualified to performs all acts required herein and possesses the
necessary organization, manpower and experience ensure the
distribution of the Products (as defined hereinafter) in the Territory
(as defined hereinafter) under the terms and conditions contained in
this Agreement.
C) SAMARITAN wishes to be appointed as exclusive distributor of the
Products in the Territory and MOLTENI intends to grant the exclusive
distribution of the Products in the Territory to SAMARITAN, pursuant
to the terms and Products in the Territory to SAMARITAN, pursuant to
the terms and conditions set forth herein.
D) On 1 January 2007 the Parties entered into an agreement which governs
the mutual obligations to keep confidential certain information
disclosed under this Agreement (the "Confidentiality Agreement").
NOW, THERETOFORE, on the basis of the foregoing Recitals, which together with
the Annexes attached hereto form an integral and essential part of this
Agreement, and on the basis of the mutual obligations and conditions set forth
herein, MOLTENI and SAMARITAN agree as follows.
1. CERTAIN DEFINITIONS
(i) "Products" shall mean the pharmaceutical preparation or
preparations for human use in the finished packaged form as
described in Annex 1 attached hereto.
(ii) "Samaritan Group" shall mean any companies directly or indirectly
controlled by SAMARITAN under paragraph 1, n.1 of article 2359 of
the Italian Civil Code.
(iii) "Trademarks" shall mean the trademarks registered in the
Territory as listed in Annex 2 attached hereto. (iv) "Marketing
Year" shall mean a calendar year provided that the first
Marketing Year shall run from 1
January 2007
(v) "Price" shall mean the price to be paid for the supply of the
Products from MOLTENI to SAMARITAN as set forth in Annex 3
attached hereto.
(vi) "Territory" shall mean the Republics of Greece and Cyprus
2. SUBJECT MATTER
2.1 MOTENI hereby grants to SAMARITAN, who hereby accepts, the exclusive right
to import, promote, advertise, market and distribute (hereinafter, the
"Selling Activities") the Products in the Territory, subject to the terms
and conditions set forth in this Agreement.
2.2 In the light of the exclusive nature of the relationship set forth herein,
for the duration of this Agreement, MOLTENI grants to SAMARITAN an
exclusive right to use in the Territory the trademarks owned and registered
by MOLTENI, as listed in Annex 2 attached hereto (hereinafter, the
"Trademarks").
3. MARKETING AUTHORIZATION
3.1 SAMARITAN and MOLTENI shall use their best effort to obtain the issuance
of all approvals or authorizations that, pursuant to local regulatory
authorities, may be necessary for the marketing of the Products in the
Territory (each, a "Marketing Authorization"). In this respect, MOLTENI
shall provide SAMARITAN with all necessary documentation (including but
not limited to the pharmaceutical dossier of the Products).
32 SAMARITAN acknowledges that any and all rights deriving from the
Marketing Authorization shall remain the exclusive property of MOLTENI.
SAMARITAN acknowledges that any Marketing Authorization resulting from
the registration process will be obtained in the name of MOLTENI and it
will be sole proprietary of MOLTENI.
3.3 Upon request by MOLTENI, SAMARITAN shall promptly file with the
competent authorities complete applications to obtain the required
Marketing Authorization. All governmental costs and fees of such
applications, if authorized in writing and in advance by MOLTENI, shall
be borne by MOLTENI.
3.4 Promptly after obtaining the Marketing Authorization, SAMARITAN shall
provide MOLTENI with the original documentation containing the Marketing
Authorization.
4. UNDERTAKINGS OF SAMARITAN
4.1 In addition to the other duties set out in this Agreement. SAMARITAN
shall:
a) purchase the Products exclusively from MOLTENI, or from those
persons or entities who MOLTENI may specifically authorize in
writing, Under no circumstances whatsoever shall SAMARITAN have
the right to purchase the Products from persons or entities to
whom MOLTENI has given no specific written authorization;
b) market and distribute the Products exclusively in the
Territory. Under no circumstances whatsoever SAMARITAN shall
have the right to market or distribute, directly or indirectly,
the Products outside the Territory. SAMARITAN shall promptly
inform MOLTENI, in writing, of any request coming from any
purchaser located outside the Territory;
c) market and distribute the Products exclusively under the
Trademarks.
d) use its best reasonable commercial efforts to maximize sales in
the Territory and to secure the proper use and efficient
distribution of the Product in full adherence with all the
local applicable regulations.
e) maintain at all times any required governmental, public health,
import permits, licenses, approvals to the extent required to
enable it lawfully to properly import Product and to perform
Selling Activities in the Territory.
f) import and sell the Products in compliance with all applicable
laws and regulations in the Territory.
4.2 Furthermore, SAMARITAN shall not:
a) manufacture, market or distribute, directly or indirectly, any
pharmaceutical products and/or brands that may, directly or
indirectly, be confused or be in competition with the Products;
or
b) carry out, with respect to the Products, a sale policy
different from the one set out under this Agreement.
c) be in any way, directly or indirectly, involved in or connected
with the marketing and/or distribution in the Territory of
other pharmaceutical products that either contain the same
active pharmaceutical ingredients or have the same dosage form
of the Products.
d) assign this Agreement, in whole or in part, without the prior
written consent of
MOLTENI, provided, however that SAMARITAN may assign this
Agreement, in whole or in part, to any companies of the
Samaritan Group.
5. UNDERTAKINGS OF MOLTENI
5.1 In addition to the other duties set out in this Agreement, MOLTENI
shall:
a) keep SAMARITAN informed of any changes in the composition of the
Products as well as of any other matters pertaining to the use
and efficacy of the Products.
b) be responsible for maintaining throughout the term of this
Agreement all necessary marketing authorisations at the Products
(including amendments and variations where necessary).
c) fill in all orders for the Products in a proper and accurate way,
pursuant to the terms and conditions set forth in this Agreement.
5.2 Furthermore, during the term of this Agreement, SAMARITAN shall not:
a) authorize any other person to market the Products in the
Territory; or
b) sell or supply the Products to any person or entity which
informed MOLTENI of its intention to sell or market the Products
in the Territory.
6. PURCHASE OF THE PRODUCTS
6.1 During the term of this Agreement, SAMARITAN shall provide MOLTENI, on a
quarterly basis, with a written 18 (eighteen) month rolling forecast,
setting forth SAMARITAN'S estimated quantities of the Products to be
purchased by SAMARITAN during the following 18 (eighteen) months. The
first of such forecasts shall be submitted to MOLTENI at least 5 (five)
months before the estimated date of launch of the Products.
6.2 SAMARITAN shall provide MOLTENI with written purchase orders for the
Products at least 90 (ninety) days before the requested delivery date.
No order for the Products shall be binding on MOLTENI unless MOLTENI
accepts it in writing. All purchase orders provided by SAMARITAN to
MOLTENI shall set forth for each and all Products, among other things,
(i) quantity, (ii) price, and (iii) requested delivery date. MOLTENI
will use reasonable commercial endeavour to accept and fulfill orders
for the Product placed by SAMARITAN.
6.3 Every 3 (three) months during the term of this Agreement, SAMARITAN
shall send to MOLTENI a detailed statement of the Products sold in the
period, by the end of the following month. This statement will show the
different presentation of the Products sold, using the latest data
available and/or any other market information available to SAMARITAN
(including IMS data).
7. MINIMUM PURCHASE TARGETS
7.1 SAMARITAN undertakes to sell Products in compliance with the Minimum
Purchase Targets as set forth in Annex 4 attached hereto. In the event
that at the end of each Marketing Year, SAMARITAN failed to reach the
Minimum Purchase Targets during the immediately preceding Marketing
Year, MOLTENI shall have the right to terminate this Agreement with
immediate effect. In each case, SAMARITAN shall not be held liable to
pay damages to MOLTENI in respect of such termination as it is set out
in this article and such termination shall be MOLTENI's sole remedy in
respect of such breach. For the purposes of this article, SAMARITAN is
deemed to have reached the Minimum Purchase Targets where it has placed
orders with MOLTENI, in accordance with obligations of article 6 which,
had they been accepted by MOLTEN1 would have brought SAMARITAN above the
relevant Minimum Purchase Targets.
8. USE OF THE TRADEMARK
8.1 MOLTENI authorizes SAMARITAN to use the Trademarks as indicated under
Annex 3 attached hereto in the Territory for the sole purpose of
performing its obligations as distributor of the Products under this
Agreement and for the sole period of this Agreement.
8.2 SAMARITAN expressly acknowledges that the use of the Trademark is limited
to the sole purpose of performing its obligations as distributor of the
Products in the Territory under this Agreement and that such use shall
not grant SAMARITAN any greater title or right, including the rights as
licensee and the right to register the Trademarks under its name or for
its own benefit. SAMARMAN acknowledges that the Trademark shall remain
the exclusive property of MOLTENI.
8.3 Upon termination or expiration of this Agreement or on final sale of
Product, whichever is the latest, SAMARITAN will cease all use of the
Trademark. SAMARITAN shall not make any use or take any action with
respect to the Trademark to prejudice or infringe MOLTENI rights thereto
including the use of any confusingly similar trademark and shall
forthwith, upon objection by MOLTENI, desist from any use thereof or
action therewith which is in violation of this Agreement.
8.4 SAMARITAN shall use its best efforts to preserve the commercial
reputation, value and prestige of the Trademark. Therefore, SAMARITAN
shall refrain from performing any activity that may be detrimental to the
reputation, value and prestige of the Trademark.
8.5 SAMARITAN shall promptly and fully notify MOLTENI, in writing, (,)of any
actual or threatened infringement of the Trademark which shall come to
its attention, and shall assist MOLTENI, at MOLTENI's request and
expenses, in taking all necessary steps to defend the rights of MOLTENI
in relation to such infringement. MOLTENI reserves the right to take
whatever action it deems necessary to protect its Trademarks, reputation
or Products against imitations, counterfeiting and unfair competition.
Any such action to be at MOLTENI`s expense. SAMARITAN shall give all
reasonable assistance to MOLTENI in taking action against imitations,
counterfeiting and unfair competition by others and will give MOLTENI
written notice of all such conduct which comes to its attention.
9. REPRESENTATIONS AND WARRANTIES OF THE PARTIES
9.1 MOLTENI warrants that the Products will conform in all respects to the
specifications of the Products as set out in Annex 1 attached hereto
(including, for the avoidance of doubt, its packaging) and the
provisions of all licenses applicable to the supply of the Products
within the Territory.
9.2 MOLTENI further warrants that the Products, on the date of supply to
SAMARITAN, will have at least seventy percent (70%) of its shelf-life
unelapsed, unless otherwise agreed between the Parties.
9.3 MOLTENI represents to the best of its knowledge and belief and having
made all due enquiry that the Products will not infringe any third
party's intellectual property rights.
9.4 SAMARITAN represents to be fully qualified to perform all acts required
under this Agreement, and to possess the necessary organization,
manpower, and experience to ensure an accurate distribution of the
Products in the Territory.
10. INDEMNIFICATION
10.1 MOLTENI shall indemnify SAMARITAN and hold it harmless from any personal
injury claims, demands, liability, suits or expenses of any kind arising
out of damages to or defects in the Products or in the process of
manufacturing the Products or transport of the Products.
10.2 Where SAMARITAN receives notice of any claim from a third party claiming
infringement of that third party's intellectual property rights,
SAMARITAN shall promptly inform MOLTENI thereof and MOLTENI, at its sole
discretion, shall conduct any defense of such claim or suit at its own
expense. MOLTENI shall hold SAMARITAN harmless from and against any
loss, claim, damage, expense or liability resulting from such claim or
infringement with the exception of lost future profits. In any such
action that MOLTENI will decide to undertake in the Territory, SAMARITAN
shall assist MOLTENI in any reasonable ways without, however, assuming
any monetary obligation.
10.3 SAMARITAN shall hold MOLTENI harmless with respect to any claims by
other persons who allege injury or loss as a result of SAMARITAN'S (a)
"Selling Activities" (b) use of Products, or (C) as a result of any
other action of SAMARITAN, in each case in violation of its covenants
under this Agreement.
10.4 SAMARITAN shall hold MOLTENI harmless from and against any claim,
damage, injury or loss whatsoever caused and resulting from SAMARITAN's
performance of this Agreement and any commercial activity carried out by
SAMARITAN not in compliance with local laws and regulations. In this
respect, SAMARITAN shall insure itself against such risks, and provide
adequate evidence of such insurance to MOLTENI upon request.
11. PROMOTION ACTIVITY
11.1 During the period of September/October preceding each Marketing Year,
SAMARITAN shall submit to MOLTENI the Products promotion and marketing
program prepared and proposed by SAMARITAN for the following Marketing
Year. Any promotional material (including advertising, technical
information, promotional materials) which SAMARITAN intends to use for
the Selling Activities of the Products shall be submitted to MOLTENI for
prior written approval, it being understood that such materials shall be
deemed approved unless MOLTENI notifies SAMARITAN in writing 10 (ten)
working days after receipt of the materials that the materials are not
acceptable.
11.2 All costs related to the promotional material prepared and used by
SAMARITAN for the Selling Activities of the Products will be borne by
SAMARITAN.
12. PRICES AND PAYMENT
12.1 As consideration for the supply of the Products SAMARITAN shall pay to
MOLTENI the Price in compliance with the terms and conditions set
forth in Annex 4 attached hereto.
12.2 Should any material changes of production cost and/or inflation rate
occur after the first Marketing Year such as to increase the MOLTENI's
cost by more than ten percent (10%), the Parties agree to negotiate in
good faith a possible modification of Price, it being understood that
MOLTENI shall make such information available to SAMARITAN in order to
verify that such circumstances exist.
13. STOCK OF THE PRODUCTS
SAMARITAN shall maintain adequate stock of the Products consistent with
the forecasted demand of Products in the Territory and the purchase
orders delivered to MOLTENI as provided herein. SAMARITAN use only
wholesalers who maintain or shall have maintained in a suitable and
authorized warehouse in the Territory, properly rotated stocks of
Products under proper storage and security conditions that comply with
international good manufacturing practices and in sufficient quantity to
satisfy the reasonably anticipated market requirements of at least three
months period subject to MOLTENI having accepted and fulfilled orders.
14. NON COMPETITION
During the term of this Agreement and for an additional one year period,
except for termination of this agreement by MOLTENI's fault, neither
SAMARITAN nor any companies of the Samaritan Group shall be in any way
involved or connected with the manufacture, sale, distribution or
promotion in the Territory, either directly or indirectly, of Products
which consist of the same active ingredient of the Product in any
presentation and/or formulations whatsoever.
15. CLINICAL TRIALS
15.1 SAMARITAN shall not perform clinical trials on the Products without the
prior written consent of MOLTENI.
15.2 According to the European regulations in force, both parties shall
report to each other promptly any information on adverse reactions
attributable to the use of the Products following the S.O.P. hereby
attached in Annex 5 attached hereto.
16. TERM
16.1 This Agreement shall come into force on January 1, 2007 and shall
remain in effect for a period of 4 (four) years. Thereafter, the
Agreement will be automatically extended for consequent periods of 2
(two) years each unless terminated by one of the Parties with a 6 (six)
months prior written notice.
17 TERMINATION
17.1 Either Party shall be entitled to terminate this Agreement at any time,
in case the other Party materially breaches any of the terms and
conditions of this Agreement, by giving notice of the breach to the
Party in default. If the defaulting Party does not cure the breach
within 30 (thirty) days after receipt of the notice, the Party who gave
notice may terminate this Agreement upon the expiration of the 30
(thirty) day period without prejudice to such Party's claims for damages
or indemnification for the losses incurred by reason of such breach of
the Agreement.
17.2 In the event either Party becomes the subject of proceedings involving
bankruptcy, insolvency, moratorium of payment, reorganization or
liquidation, or if either Party makes any assignment for the benefit of
its creditors, then this Agreement may be immediately terminated by the
other Party by written notice, without prejudice to its claims for
damage, reimbursement or indemnification for losses incurred in by
reason of such termination.
17.3 Each Party shall report promptly to the other Party any major or
significant change in its legal or beneficial ownership. If the notified
Party reasonably believes that such change is prejudicial to its
interests or to the proper and efficient marketing of the Products and
the beneficial ownership of more than fifty percent (50%) of any class
of the shares of the first party has been transferred, the notified
Party may terminate this Agreement by giving ninety (90) days prior
written notice within thirty (30) days after it (,)is informed of the
change of ownership. In such instance the terminating party shall not
owe the other for any damages or indemnification whatsoever resulting
from the termination. Transfers of shares from existing shareholders to
relatives or trusts for the benefit of such relatives shall not
constitute a change in ownership and will not require notification.
17.4 Under article 1456 of the Italian Civil Code, MOLTENI shall be entitled
to terminate the Agreement at any time, by giving written notice to
SAMARITAN, in the event that at the end of each Marketing Year,
SAMARITAN failed to reach the Minimum Purchase Targets during the
immediately preceding Marketing Year.
17.5 Upon expiry or termination of this Agreement, SAMARITAN shall immediately:
o cease to refer to itself as distributor of MOLTENI;
o cease to make any use of the Products, the samples and any promotional
material concerning the Products;
o cease to use in any manner whatsoever the Trademark as well as all
documents containing the Trademark, including but not limited to
booklets, other branded material, packaging material or labels; and
o return to MOLTENI all the all confidential information as provided
under the Confidentiality Agreement.
17.6 In addition to the preceding paragraph, upon expiry or termination of this
Agreement, SAMARITAN shall immediately stop selling the Products and
promptly deliver to MOLTENI a list of its inventory of Products. SAMARITAN
must be able to fill orders received. Assuming that the inventory of
Products is in sellable conditions, MOLTENI may, at its sole discretion,
require SAMARITAN to:
o destroy such inventory of the Products, it being understood that
MOLTENI shall reimburse SAMARITAN for these items at the price paid
by SAMARITAN to MOLTENI plus eventual costs related to this operation,
or
o deliver such inventory Product to MOLTENI or to a third party
indicated in writing by MOLTENI, it being understood that MOLTENI
shall reimburse SAMARITAN for these items at the price paid by
SAMARITAN to MOLTENI plus eventual costs related to this operation,
or
o grant to SAMARITAN a reasonable period of time for selling the
remaining inventory of Products, and SAMARITAN shall promptly react
accordingly.
18 FORCE MAJEURE
Neither Party to this Agreement shall be liable for failure to perform
if the failure is attributable to any cause which is reasonably beyond
the party's control, including:
(a) war (declared or undeclared), riot, political insurrection,
rebellion, revolution, terroristic acts;
(b) acts or orders of or expropriation by any government (whether de
facto or de jure) prohibiting the import or export of the goods
covered hereby imposing or rationing;
(c) inability to procure or shortage of supplies of necessary materials,
equipment, or Production facilities;
(d) quarantine restrictions;
(e) fuel shortage;
(f) strike lockout, or other labour troubles which interfere with the
manufacture, sale or transportation of the goods covered hereby or
with the supply of raw materials necessary for their Production;
(g) fire, flood, explosion, earthquake, tornadoes or other natural
events.
19. NOTICES
Any notice or communication to be given or any request to be made by either
Party to the other pursuant to the provisions of this Agreement shall be given
by sending such notice via registered mail to the following addresses, or to
such other addresses each Party may have designated to the to the other in
writing:
a) As to MOLTENI:
Address: Localita Granatieri Scandicci Firenze Italy
Phone number: x00 000 0000000
Fax number: x00 000 0000000
To the kind attention of: Xxxxxxxxx Xxxxx
b) As to SAMARITAN
Address: 00 Xxxxxx Xxxxxx, Xxxxxx-000 73 Phone number: + 30 210
0000000
Fax number: x00 000 0000000
To the kind attention of: Xx. Xxxxxxxx Xxxxx
00. MISCELLANEOUS
20.1 The relationship between the Parties is that of independent contractors
and each Party agrees to conduct its affairs accordingly. Nothing in
this Agreement or in the activities engaged in by MOLTENI or SAMARITAN
hereunder shall create an agency, partnership, employment or joint
venture relationship between the Parties.
20.2 English shall be the official version of the Agreement for the purpose
of interpretation,
20.3 The failure of either Party in any one or more instances to insist upon
strict performance of any of the terms and conditions of this Agreement
shall not be construed as a waiver or relinquishment, to any extent, of
the right to assert or rely upon any such terms or conditions on any
future occasion.
20.4 This Agreement constitutes the definitive agreement of the Parties on
the subject matter hereof and supersedes, cancels and annuls all prior
agreements, understandings and undertakings relating to the subject
matter hereof. This Agreement shall not be modified or amended except by
a written document signed by a duly authorized officer of the parties.
There are no verbal agreements, warranties, representations or
understandings affecting this Agreement and all previous or other
negotiations, representations, and understandings between the parties
are merges herein.
20.5 If any provision of this Agreement is found by any court or
administrative body of competent jurisdiction to be invalid or
unenforceable, the invalidity or unenforceability of such provision
shall not effect the other provisions of this Agreement, and all
provisions not effected by such invalidity or unenforceability shall
remain in full force and effect. The Parties agree to attempt to
substitute for any invalid or unenforceable provision a valid or
enforceable provision which achieves to the greatest extent possible
economic objectives of the invalid or unenforceable provision.
20.6 This Agreement shall be governed by and construed in accordance with the
laws of Italy.
20.7 The Court of Milan shall have exclusive jurisdiction over any dispute
arising out from or in connection with this Agreement.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
in 2 (two) original copies by their duly authorized representatives, on the date
written below.
X. XXXXXXX & C. dei F .lli Alitti Societa di Esercizio S.p.A. Samaritan
Pharmaceutical Europe SA Esercizio S.p.A.
By: /s/ Xxxxxxxx Xxxxx-Recli, By: /s/ Xxxxxxxx Xxxxx
Managing Director Managing Director
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Xxxxxxxx Xxxxx-Recli Xxxxxxxx Xxxxx
