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.

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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).

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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.

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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.

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(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.

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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

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(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.

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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