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EXHIBIT 10.15
LICENSE AND DISTRIBUTION AGREEMENT
This License and Distribution Agreement (the "Agreement") is
entered
into as of this 12th day of December, 2005 (the "Effective
Date") between
SAMARITAN PHARMACEUTICALS EUROPE, S.A., with offices 41 Skoufa
Street, Athens
--- 10673 Greece, (hereinafter referred to as "SAMARITAN") and
THREE RIVERS
PHARMACEUTICALS, LLC, with offices at 312 Commerce Park Drive,
Cranberry
Township, Pennsylvania, USA 16066 (herein referred to as
"3RP").
RECITALS
WHEREAS, 3RP desires SAMARITAN to arrange for, or continue in
force,
the regulatory approval and distribution of the Product in the
Territory; and
WHEREAS, SAMARITAN is engaged in distributing pharmaceutical
products
in the Territory and possesses qualified marketing and
distribution systems to
enable it to effectively promote, market and distribute the
Product throughout
the Territory.
NOW, THEREFORE, in consideration of the representations,
warranties,
covenants and obligations hereinafter set forth, the parties
intending to be
legally bound, mutually agree as follows:
ARTICLE 1 - DEFINITIONS AND INTERPRETATION
1.1 Definitions: Whenever used in this Agreement (including the
recitals),
the words and terms set forth on Schedule "A", annexed hereto,
shall
have the respective meanings ascribed thereto.
1.2 Headings: The headings of all Articles and Sections hereof
are inserted
for convenience of reference only, are not intended to be full
or
accurate descriptions of the contents hereof and shall not
be
considered part of this Agreement or affect the construction
or
interpretation of this Agreement.
1.3 No Strict Construction: The language used in this Agreement
shall be
deemed to be the language chosen by the parties hereto to
express their
mutual intent and no rule of strict construction against any
party
shall apply to any term or condition of this Agreement.
1.4 Governing Law: This Agreement and any question concerning
its validity,
construction or performance, regardless of the forum wherein any
such
issue may be litigated, shall be governed by the laws of the
Commonwealth of Pennsylvania and the laws of the United
States
applicable therein, without reference to the Commonwealth of
Pennsylvania's conflicts of law provisions, irrespective of the
place
of execution or the order in which the signatures of the parties
are
affixed, or the place or places of performance.
1.5 Reference to Laws, etc.: Any references herein to any law,
statute,
regulation, order, rule or guideline of any government,
governmental
body or other Regulatory Authority shall be construed as a
reference
thereto as amended or re-enacted from time to time.
<PAGE>
ARTICLE 2 - EXCLUSIVE APPOINTMENT
2.1 Exclusive Distributor: Subject to the provisions of this
Agreement, 3RP
hereby appoints SAMARITAN as the sole and exclusive distributor
of the
Product in the Territory and SAMARITAN hereby accepts such
appointment
and agrees to act as such distributor upon terms and conditions
herein
provided.
2.2 Nature of Relationship: The relationship created hereby
between
SAMARITAN and 3RP is solely that of buyer and seller, and
licensor and
licensee, and each is an independent contractor engaged in
the
operation of its own respective business. Neither party shall
be
considered to be an agent of the other for any purpose
whatsoever and,
except as expressly provided herein, neither party has the power
or
authority to act for, represent, or bind the other in any
manner. This
Agreement does not constitute or create (and the parties do not
intend
to create hereby) a joint venture or partnership of any kind
between
the parties, and the rights and obligations of the parties shall
be
only those expressly set forth herein.
2.3 Territorial and Product Restrictions Applicable to
SAMARITAN: During
the term of this Agreement SAMARITAN shall not, directly or
indirectly,
sell the Product outside of the Territory. In addition,
SAMARITAN shall
not, directly or indirectly, market, sell or distribute a
Competing
Product in the Territory at any time during the term of this
Agreement.
In any and all events, if SAMARITAN receives an order for or an
inquiry
concerning the Product from any potential customer for delivery
outside
of the Territory, SAMARITAN shall promptly refer such order or
inquiry,
or cause such order or inquiry to be referred, to 3RP. 3RP may
suspend
supply of the Product to SAMARITAN during any period of time
that
SAMARITAN is in violation of the covenant made under this
Section 2.3.
2.4 Territorial Restrictions Applicable to 3RP: 3RP agrees that
during the
term of this Agreement it shall not, directly or indirectly,
sell the
Product or a Competing Product in the Territory. If, during the
term of
this Agreement 3RP receives an order for or inquiry concerning
the
Product from a potential customer for delivery in the Territory,
3RP
shall promptly refer such order or inquiry to SAMARITAN.
ARTICLE 3 - LICENSE AND TRANSFER OF PRODUCT INFORMATION
3.1 License of Product Information: 3RP hereby grants to
SAMARITAN, for the
term hereof and all renewals and extensions thereof, and
SAMARITAN
hereby accepts, an exclusive license to use the Product
Information (as
defined in Section 3.2 below) to obtain and maintain the
required
Regulatory Approval in the Territory to enable SAMARITAN to
market,
sell and distribute the Product in the Territory for its
approved use.
SAMARITAN hereby acknowledges and agrees that the license
hereby
granted is a limited license (without right to sublicense) to
use such
Product Information solely for the purpose of acquiring and
maintaining
such Regulatory Approval and distributing the Product in the
Territory
pursuant to and in accordance with the provisions of this
Agreement and
for no other purpose (it being understood and agreed that the
Product
Information shall form part of the Confidential Information of
3RP and
shall be subject to the provisions of Article 13 hereof).
<PAGE>
3.2 Product Information:
(a) For purposes of this Agreement the "Product Information"
shall be
comprised of all or such portions of the Product dossier and
Product information including, without limitation,
formulation,
analytical, cleaning, dissolution and manufacturing and
testing
methodologies and processes, which SAMARITAN reasonably
needs,
and is required by the Regulatory Authority, to obtain and
maintain the Regulatory Approval. 3RP shall, throughout the
term
of this Agreement, promptly provide to SAMARITAN all
relevant
information which 3RP shall from time to time have available
to
it regarding any changes or additions to the Product
Information
(including, without limitation, sources of raw materials,
formulae, methods of manufacture, specifications, primary
packaging components and stability) which is applicable to
obtaining or maintaining any Regulatory Approval;
(b) 3RP agrees that during the term of this Agreement it will
not
directly or indirectly use (except in fulfilling its
obligations to SAMARITAN under this Agreement), or license
any
other Person to use, the Product Information in the
Territory
in connection with the Product or a Competing Product.
ARTICLE 4 - REGISTRATION
4.1 Product Registration and Maintenance: SAMARITAN shall at its
own cost
and expense apply for, obtain, maintain and renew all
necessary
registrations, permits and other approvals necessary to
obtain
Regulatory Approval of the Product in the Territory. All
necessary
registrations, permits or other approvals received in connection
with
any Regulatory Approval shall be held under SAMARITAN'S name.
SAMARITAN
acknowledges and agrees that 3RP is the beneficial of the
Regulatory
Approval and upon any termination of the Agreement SAMARITAN
shall
assign cause the transfer of any such registrations, permits or
other
approvals to 3RP or 3RP's designee as provided under Section
11.2
hereof;
4.2 Regulatory Compliance:
(a) 3RP shall during the term of this Agreement manufacture
the
Product under the requirements of the relevant Code of Good
Manufacturing Practice of the Territory as in effect at the
time of delivery of the Product. Throughout the term of this
Agreement SAMARITAN shall notify 3RP of any changes to the
Code of Good Manufacturing Practices of the Territory;
(b) Except with SAMARITAN's prior written approval, such
approval
not to be unreasonably withheld, 3RP shall not make any
alteration or change to the Specifications for the Product
if
such change would adversely affect Regulatory Approval in
the
Territory.
<PAGE>
4.3 Mutual Disclosure of Adverse Effects: SAMARITAN and 3RP each
agrees
that it will inform the other of them of all information that
comes
into its possession or control and is not otherwise public
knowledge
concerning side effects, injury, toxicity or sensitivity
reactions and
incidents and severity thereof associated with commercial and
clinical
uses, studies, investigations or tests (animal and human)
directly
relating to the Product throughout the world, whether or not
determined
to be attributable to the Product.
ARTICLE 5 - MANUFACTURE AND SUPPLY OF PRODUCT
5.1 Exclusive Supplier: 3RP shall manufacture and supply to
SAMARITAN, in
accordance with the terms and conditions set forth herein and in
a
timely fashion, the quantities of the Product ordered by
SAMARITAN from
time to time. Subject to the provisions hereof, SAMARITAN shall
order
from 3RP all of its requirements of the Product for the
Territory in
accordance with the terms and conditions set forth herein.
5.2 Product Warranty: 3RP warrants that all Product supplied by
it to
SAMARITAN pursuant to this Agreement shall be manufactured,
packaged,
tested, stored, handled and shipped in accordance with the
Specifications and applicable Regulatory Approval in the
Territory. 3RP
MAKES NO OTHER WARRANTY OF ANY KIND AND EXCLUDES AND DISCLAIMS
ANY AND
ALL IMPLIED WARRANTIES TO THE FULLEST EXTENT PERMITTED BY
APPLICABLE
LAW, INCLUDING WITHOUT LIMITATION THOSE CONCERNING THE
MERCHANTABILITY
OF ANY PRODUCT OR ITS SUITABILITY OR FITNESS FOR ANY PARTICULAR
PURPOSE
OR USE.
ARTICLE 6 - PRODUCTION FORECASTS, ORDERS AND DELIVERIES
6.1 Forecasts:
(a) Within thirty (30) days after the Effective Date, SAMARITAN
shall
submit to 3RP a written non-binding estimate of its
quarterly
requirements for the Product for each of the next succeeding
six
(6) Quarters. The forecast shall be updated quarterly on or
before the fifth (5th) day of the beginning of each Quarter on
a
rolling basis. 3RP shall respond within fifteen (15)
business
days if any additional quantities are included within the
forecast for any Quarters previously forecasted. If 3RP is
unable
to accept such additional quantities, such additional
quantities
shall be removed form the forecast. SAMARITAN shall have five
(5)
days to respond to 3RP changes. If 3RP does not receive a
response within five (5) days, it shall be assumed that such
quantities are approved and acceptable to SAMARITAN.
(b) The forecast for the most current two (2) Quarters shall
be
binding on the parties regarding the amount of Product to be
supplied and purchased. The forecast for the remaining four
(4)
Quarters of each rolling forecast is for planning purposes
only
and shall not constitute a commitment to purchase or supply
Product. In the event that SAMARITAN does not ultimately
purchase
the forecasted quantities for the binding two (2) Quarters,
it
shall nevertheless be obligated to make payment to 3RP for
any
deficient quantities on the basis of the Transfer Price.
6.2 Purchase Orders: All orders for Product shall be placed
using
SAMARITAN's standard form of purchase order and shall be
invoiced using
3RP's standard form of invoice. Purchase orders shall not
contain terms
which are inconsistent with the terms and conditions of this
Agreement
and shall specify, amongst other things, the desired delivery
date,
which delivery date shall be not less than thirty (30) days from
the
submission date of the purchase order to 3RP. 3RP shall use its
best
efforts to deliver the ordered Product to SAMARITAN within seven
(7)
days of the desired delivery date specified in the purchase
order.
6.3 Delivery of Product: The Product will be prepared for
shipment in
accordance with the reasonable directions of SAMARITAN (or
failing such
reasonable directions in a commercially reasonable manner), the
storage
and transportation conditions forming part of the Product's
Specifications, cGMP and applicable laws. Title and risk of loss
and/or
damage shall pass to SAMARITAN upon delivery of the Product
to
SAMARITAN's warehouse site in the Territory.
6.4 Documentation to Accompany Deliveries: All deliveries of
Product by or
on behalf of 3RP shall be accompanied by all documentation
required
under applicable law to import the Product into, and for
SAMARITAN to
offer the Product for sale in, the Territory including,
without
limitation, certificate of analysis and batch manufacturing
records
confirming that the Product supplied hereunder has been
manufactured in
conformity with applicable requirements of the Regulatory
Authority.
6.5 Assistance With Export & Import Laws: SAMARITAN and 3RP
shall provide to
each other such commercially reasonable assistance as the other
may
request relative to the exportation or importation of Product
not
expressly provided in this Agreement.
ARTICLE 7 - TRANSFER PRICE AND INSPECTION
7.1 Purchase Price:
(a) The purchase price payable by SAMARITAN for Product
supplied
to it shall be as set forth on Schedule "B" annexed hereto
(the
"Transfer Price").
(b) Except as hereinafter provided, any increase to the
Transfer
Price shall be mutually agreed upon by the parties. If 3RP's
manufacturing, API or distribution costs for the Product
materially increase from the date the Transfer Price was
last
established, and 3RP desires to increase the Transfer Price,
SAMARITAN agrees to discuss and negotiate in good faith with
3RP
an increase to the Transfer Price to cover 3RP's increased
costs... The new Transfer Price shall apply to all orders for
the
Product received by 3RP after the sixty (60) day notice
period.
<PAGE>
(c) In addition to the Transfer Price, SAMARITAN shall be
responsible for all taxes (including but not limited to
value-added and withholding taxes), customs and excise
duties
with respect to the importation of the Product into the
Territory, transfer of the Product within the Territory and
promotion, marketing, distribution and sale of the Product
within the Territory, whether currently in force or coming
into force after the Effective Date of this Agreement
(collectively the "Sales Taxes").
(d) 3RP shall submit an invoice to SAMARITAN with each shipment
of
the Product. Payment for the Product shall be due within
sixty
(60) days after delivery date of the Product to SAMARITAN.
All
payments hereunder shall be made in United States Dollars
and
shall be wire transferred to an account designated by 3RP,
from time to time, or paid in accordance with any method
agreed in writing by the parties. Distributor shall notify
3RP
by facsimile when any payment is made.
(e) 3RP and SAMARITAN shall meet in good faith to discuss
and
negotiate the Transfer Price, should the selling price to
hospitals in Greece as published in the official Greek
government gazette not allow SAMARITAN an operational
working
margin, according to the Greek Industry Standard in similar
cases.
7.2 Inspection: 3RP shall have the right, upon reasonable
advance notice
and at 3RP's expense to inspect and make copies of the records
of
SAMARITAN pertaining to the Product, including but not limited
to,
records relating to Regulatory Approval, pharanacovigilence,
product
liability and the sale and distribution of the Product in
the
Territory.
ARTICLE 8 - DISTRIBUTION
8.1 SAMARITAN's Obligation re Marketing: SAMARITAN shall use
reasonable
commercial efforts to develop a market for the Product in the
Territory
and to actively and continuously promote the sale of the Product
in the
Territory. SAMARITAN shall be solely responsible for the
advertising
and promotion of the Product and shall comply with all
applicable laws,
rules and regulations in that regard including, without
limitation,
applicable Regulatory Authority regulations and guidelines.
8.2 Pricing: SAMARITAN shall have sole discretion in setting the
price for
the sale of the Product in the Territory, subject to
guidelines
established by the Regulatory Authority.
8.3 Storage and Handling by SAMARITAN: SAMARITAN shall ensure
that the
Product supplied to it by 3RP pursuant to this Agreement is
received,
handled, stored and delivered in accordance with the
Specifications for
the Product applicable thereto and applicable cGMP and other
requirements of the Regulatory Authority so that such Product
does not
become adulterated or otherwise cease to meet its Specifications
as a
result of any acts or omissions of SAMARITAN, and its
respective
agents, employees, transporters or those for whom SAMARITAN
is
responsible.
<PAGE>
8.4 Release of Product by SAMARITAN: SAMARITAN shall conduct or
cause to be
conducted such quality control tests as it deems necessary
and/or as
are required by law (including any rules, regulations and
requirements
of the Regulatory Authority) prior to sale or other release of
a
Product in the Territory.
ARTICLE 9 - PRODUCT REJECTIONS AND RETURNS
9.1 Product Rejection:
(a) Within sixty (60) days from the date of receipt of
delivery
of Product SAMARITAN shall inspect the Product and shall
advise
3RP in writing (a "Rejection Notice") if a shipment of Product
is
not in conformity with 3RP's obligations hereunder or is
otherwise defective. If SAMARITAN delivers a Rejection Notice
in
respect of all or any part of a shipment of Product, then 3RP
and
SAMARITAN shall have thirty (30) days from the date of 3RP's
receipt of such notice to resolve any dispute regarding
whether
all or any part of such shipment of Product fails to conform
with
the Specifications or is otherwise defective. Disputes
between
such parties as to whether all or any part of a shipment
rejected
by SAMARITAN conforms with Specifications not resolved in
the
thirty (30) day period shall be resolved by an independent
testing laboratory or a consultant (if not a laboratory
analysis
issue) mutually acceptable to SAMARITAN and 3RP, the cost of
which shall be paid by the party least successful in such
dispute
as determined by such independent testing laboratory or
consultant.
(b) In the event any Product is appropriately rejected by
SAMARITAN as aforesaid, (being Product which does not satisfy
the
Product warranty contemplated in Section 5.2 or are
otherwise
defective as a result of any act by or omission of 3RP or
those
for whom it is responsible), 3RP shall replace such Product
with
conforming goods as quickly as possible, or if requested by
SAMARITAN, provide a credit to SAMARITAN for the Transfer
Price
previously paid by SAMARITAN to 3RP on account of the Product
in
question. The credit shall be provided immediately following
the
expiry of the period during which 3RP may dispute a
Rejection
Notice as contemplated in Subsection (a) above (unless the
Rejection Notice is disputed by 3RP, in which event such
credit
shall only be given upon resolution of the dispute).
Replacement
Product shall be delivered to SAMARITAN at no cost to
SAMARITAN
if SAMARITAN has already paid for the rejected Product and
not
received a credit therefore, as aforesaid.
(c) For purposes of this Agreement once a Product is rejected
by
SAMARITAN, SAMARITAN's obligation to pay for such Product
shall be suspended until such time as it is determined:
(i) by the independent testing laboratory or consultant
that the Product should not have been rejected by
SAMARITAN; or
<PAGE>
(ii) by the parties or by an arbitration conducted
pursuant hereto or by a final order of a court of
competent jurisdiction (which is not subject to
further appeal) that no act or omission of SAMARITAN
was the cause of the problem.
9.2 Exclusive Remedy: Subject to Section 10.1 hereof and to its
rights, if
any, to recover expenses associated with a Recall as herein
contemplated, SAMARITAN hereby acknowledges and agrees that the
sole
remedy of SAMARITAN against 3RP for failure of Product
supplied
hereunder to meet the Product warranty set forth in Section 5.2
hereof
shall be to require 3RP to replace the Product that does not
meet the
Product warranty hereunder with conforming goods or to
provide
SAMARITAN with a credit for the Transfer Price and that 3RP
shall not
be liable to SAMARITAN for any indirect, special, consequential
or
incidental damages including, without limitation, loss of
profits or
prospective profits of any kind.
9.3 Return Policy: Other than Product which has been
appropriately rejected
by SAMARITAN pursuant to Section 9.1 above, SAMARITAN shall not
have
the right to return to 3RP any Product purchased by it without
3RP's
prior written consent.
9.4 Survival of Provisions: The provisions of this Article 9
shall
survive the termination or expiration of the Agreement.
ARTICLE 10 - DAMAGES, INDEMNIFICATION AND INSURANCE
10.1 Indemnity by 3RP: Subject to the limitations set forth in
this Section
10.1 and Section 10.3 hereof, 3RP covenants and agrees to
indemnify and
save harmless and compensate SAMARITAN and its directors,
officers and
employees (collectively, "SAMARITAN Indemnified Parties") from
and
against any and all claims, demands, actions, causes of action,
suits,
proceedings, judgments, liabilities, damages, losses, costs,
expenses,
fines, penalties and other similar assessments, including but
not
limited to reasonable attorney's fees and expenses incurred
and
documented (collectively, "Liabilities") relating to or arising
out of
(i) a breach by 3RP of any of 3RP's representations,
warranties,
covenants or agreements contained in this Agreement; (ii) a
claim by
any Person that the Product as manufactured by 3RP infringes
or
allegedly infringes any proprietary right or other intellectual
or
industrial right of any Person (other than rights of any
Person
relating to patents enforceable in the Territory or the use of
any
name, logo, trade-mark (other than the Marks) or design used
by
SAMARITAN in connection with the packaging and labeling of
the
Product); (iii) the design or inherent safety of the Product
(iv) any
negligence or willful misconduct by 3RP or any 3RP Indemnified
Party
(as defined below); or (v) a regulatory enforcement action,
inspection
of Product or Recall resulting from 3RP's failure to manufacture
the
Product in accordance with the Specifications or resulting from
any
other act or omission of 3RP or those for whom it is
responsible;
provided that, except where the breach arises out of the
representation
or warranty being intentionally false or inaccurate or
constitutes a
willful material breach by 3RP of its duties or obligations
hereunder
or an act or omission constituting gross negligence, the
SAMARITAN
Indemnified Parties shall not be entitled to recover from 3RP
any of
their indirect, special, consequential or punitive damages,
including
loss of profits or loss or damage to goodwill or reputation.
SAMARITAN
shall hold the benefit of this indemnity in trust for those
SAMARITAN
Indemnified Parties who are not parties to this Agreement.
<PAGE>
10.2 Indemnity by SAMARITAN: Subject to the limitations set
forth in this
Section 10.2 and in Section 10.3 hereof, SAMARITAN covenants and
agrees
to indemnify and save harmless and compensate 3RP and its
respective
directors, officers and employees {collectively, "3RP
Indemnified
Parties") from and against any and all Liabilities relating to
or
arising out of (i) a breach by SAMARITAN of any of
SAMARITAN's
representations, warranties, covenants or agreements contained
in this
Agreement; (ii) the receiving, storage, handling, marketing,
distribution, sale or delivery of the Product by SAMARITAN
(except to
the extent that 3RP is responsible therefor pursuant to Section
10.1
above); (iii) any claim by any Person that any trade mark, trade
dress,
logo, name or design used by SAMARITAN in labeling or packaging
of the
Product (other than the Marks) or, in the case of trade dress,
the
manufacture of the Product in accordance the directions of
SAMARITAN,
infringes any trade-mark or other intellectual property right of
any
Person; (iv) any death or bodily injury to any Person or any
damage to
property arising out of, or any regulatory enforcement
action,
inspection of Product or Recall resulting from a breach by
SAMARITAN of
its obligations hereunder; or (v) any negligence or willful
misconduct
of SAMARITAN or of an SAMARITAN Indemnified Party; provided
that, except
where the breach arises out of the representation or warranty
being
intentionally false or inaccurate or constitutes a willful
material
breach by SAMARITAN of SAMARITAN's duties or obligations
hereunder or an
act or omission constituting gross negligence, the 3RP
Indemnified
Parties shall not be entitled to recover from SAMARITAN any
indirect,
special, consequential or punitive damages, including loss of
profits or
loss or damage to goodwill or reputation. 3RP shall hold the
benefit of
this indemnity in trust for those 3RP Indemnified Parties who
are not
parties to this Agreement.
10.3 Indemnification Procedure for Third Party Claims: Upon the
assertion by
any third party of a claim against a 3RP Indemnified Party or
an
SAMARITAN Indemnified Party that may give rise to right of
indemnification under this Agreement, the party who, or whose
directors,
officers or employees, is claiming a right to indemnification
(the
"Indemnified Party") shall give prompt notice to the party
alleged to
have the duty to indemnify (the "Indemnifying Party") of the
existence
of such claim (provided that the
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