NORBROOK LABORATORIES LIMITED
operating through NORBROOK s.r.o
as the Supplier
- and -
PHARMAPLAZ LIMITED
as the Buyer
- and -
SAMARITAN IRELAND PHARMACEUTICALS LIMITED
as the Finished Product License Holder
- and -
SAMARITAN PHARMACEUTICALS INC
as the Parent Company of the Finished Product
License Holder
SUPPLY AGREEMENT
PROCAINE HYDROCHLORIDE
CONTENTS
1. DEFINITIONS
2. SCOPE OF THE AGREEMENT
3. WARRANTY OF USE
4. FORECAST, ORDERING AND
5. SUPPLYPRICING AND PAYMENT ARRANGEMENTS
6. QUALITY
7. QUALITY COMPLIANCE
8. WARRANTY/LIABILITY
9. CONFIDENTIALITY
10. FORCE MAJURE
11. TERMS AND TERMINATION
12. NOTICES
13. MISCELLANEOUS
|
|
|
|
Schedule 1.1 (f)
Schedule 4.3
Schedule 5.1
|
|
SPECIFICATIONS
GENERAL TERMS AND CONDITIONS OF SALE
PRICE
|
1
SUPPLY AGREEMENT
THIS AGREEMENT
is made the day of
June 2005,
BETWEEN:
|
|
(1)
|
|
NORBROOK
LABORATORIES LIMITED of
Station Works, Newry, Co. Down BT35 6JP operating through its Czech
subsidiary, NORBROOK s.r.o, a limited liability company organized
and existing under the laws of the Czech Republic having its
registered office at Pardubice 20, Rybitvi RY 133, post code 533
54, Czech Republic (“NORBROOK”);
|
|
|
(2)
|
|
PHARMAPLAZ
LIMITED, a limited
liability company organized and existing under the laws of the
Republic of Ireland, established and having its principal office at
Daneswell Business Park, Athlone, County Roscommon, Republic of
Ireland (“PHARMAPLAZ”); and
|
|
|
(3)
|
|
SAMARITAN
IRELAND PHARMACEUTICALS LIMITED, a limited liability company organized and
existing under the laws of the Republic of Ireland, established and
having its principal office at Daneswell Business Park, Athlone,
County Roscommon, Republic of Ireland;
|
|
|
(4)
|
|
SAMARITAN
PHARMACEUTICALS INC a
company existing under the laws of the Nevada and whose address is
101 Convention Center Drive, Suite 310, Las Vegas, Nevada
89109, USA (hereinafter SAMARITAN IRELAND PHARMACEUTICALS LIMITED
and SAMARITAN PHARMACEUTICALS INC shall be referred to collectively
as “SAMARITAN”) hereinafter sometimes individually
referred to as “Party” and collectively as
“Parties”.
|
WHEREAS:
|
|
(A)
|
|
NORBROOK is
engaged in the manufacture, marketing and sale of pharmaceutical
compounds, such as Procaine Hydrochloride (hereinafter defined in
clause 1.1 (e) and referred to as the
“Material”).
|
|
|
(B)
|
|
PHARMAPLAZ is
engaged in the research, development, manufacture and sale of
various human medicines and desires to purchase certain quantities
of the Material for formulating in its own facilities and for
subsequent sales of a finished form product (hereinafter defined in
clause 1.1 (d) and referred to as “Finished
Product”) in the human medicines market for and on behalf of
SAMARITAN, and hence desires a reliable source of
supply;
|
|
|
(C)
|
|
SAMARITAN
intends to obtain marketing approval in the United States from the
US Food and Drugs Administration (“FDA”) for the
Finished Product and to be the exclusive license holder in the USA
for this Finished Product; and
|
|
|
(D)
|
|
NORBROOK is
willing to provide this supply through the sale of certain
quantities of the Material to PHARMAPLAZ in accordance with the
terms and conditions hereinafter set forth.
|
IT IS AGREED:
1. DEFINITIONS
|
|
1.1
|
|
Whenever used in
this Agreement, the following capitalized terms (including the
preambles) shall have the following meanings:
|
2
|
|
(a)
|
|
“Affiliate”, shall mean: with respect
to a Party to this Agreement, an entity which is directly or
indirectly controlled by, in control of, or under common control
with such Party. For the purposes of this definition,
“control” shall be deemed to exist in the event of
ownership of fifty percent (50%) or more of the voting stock of an
entity;
|
|
|
(b)
|
|
“Agreement”, shall mean: this present
Supply Agreement together with the Schedules, Exhibits and Annexes
attached hereto, and including any and all modifications and
alterations thereto made in writing in accordance with the terms
thereof, after the date of signature hereof;
|
|
|
(c)
|
|
“Effective
Date” shall mean date of first registration of the Finished
Product;
|
|
|
(d)
|
|
“Finished
Product”, shall mean: a finished dosage form product
manufactured by PHARMAPLAZ containing, inter alia, in its
formulation the Material, suitable for the treatment of humans and
licensed exclusively for such purpose to SAMARITAN by the US Food
and Drug Administration (“FDA”);
|
|
|
(e)
|
|
“Material” shall mean: Procaine
Hydrochloride, manufactured by NORBROOK at a worldwide approved
production site, including approval by the FDA and with a US Drug
Master File (“DMF”) in accordance with the
Specifications;
|
|
|
(f)
|
|
“Specifications”: shall mean, the
technical characteristics of the Material complying with the most
current version of the US Pharmacopoeia. The current version as at
the date of this Agreement are as set out in Schedule 1.1
(f);
|
|
|
(g)
|
|
“Euro”, shall mean the EU currency
Euro;
|
|
|
1.2
|
|
This Agreement
is a contract of sale/purchase and shall not be interpreted as a
contract of license, agency or the like.
|
|
|
|
1.3
|
|
References to
Recitals, Clauses, sub-clauses and Schedules are to recitals,
clauses, sub-clauses and schedules of this Agreement.
|
|
|
|
1.4
|
|
References
herein to a “third party” are references to any person,
corporation, firm, partnership or other entity other than
PHARMAPLAZ, SAMARITAN, or NORBROOK, or any Affiliate of PHARMAPLAZ,
SAMARITAN or NORBROOK.
|
|
|
1.5
|
|
Unless otherwise
stated, references herein to days, weeks, quarters and years are
references to calendar days, calendar weeks, calendar quarters and
calendar years.
|
|
|
|
1.6
|
|
The headings in
this Agreement are for convenience only and shall not affect the
construction or interpretation of this Agreement.
|
|
2. SCOPE OF THE
AGREEMENT
|
|
2.1
|
|
During the term
of this Agreement, PHARMAPLAZ wishes to purchase from NORBROOK the
Material solely for the purpose of converting and/or formulating
the Material into Finished Product.
|
|
|
|
2.2
|
|
Subject to the
terms and conditions of this Agreement, NORBROOK shall sell and
deliver the Material to PHARMAPLAZ and PHARMAPLAZ shall purchase
the Material exclusively from NORBROOK in the following minimum
quantities:
|
|
|
|
|
2.2.1
2.2.2
2.2.3
2.2.4
2.2.5
|
|
in year 1 a
minimum quantity of 20,000 kg.
in year 2 a minimum quantity of 40,000 kg.
in year 3 a minimum quantity of 80,000 kg.
in year 4 a minimum quantity of 80,000 kg.
in year 5 a minimum quantity of 80,000 kg.
|
|
|
2.3
|
|
Without
detriment to the above, in any year PHARMAPLAZ may order quantities
of the Material exceeding the volumes mentioned in sub-clause 2.2.
In such event, NORBROOK shall use its reasonable commercial
endeavors to supply such additional quantities of the Material to
PHARMAPLAZ, provided however, that nothing herein shall create an
obligation on the part of NORBROOK to supply to PHARMAPLAZ any such
additional quantities of the Material.
|
|
|
|
2.4
|
|
Subject to the
terms of clause 13.4 hereunder, SAMARITAN shall ensure that during
the term of this Agreement the US license holder(s) of the Finished
Product as regulated by the FDA shall be a party to the terms of
this Agreement.
|
|
|
|
2.5
|
|
Nothing in this
Agreement shall be construed so as in any way to limit or restrict
NORBROOK’s right to sell the Material to third
parties.
|
|
3. WARRANTIES
|
|
3.1
|
|
PHARMAPLAZ and
SAMARITAN warrant that during the term of this Agreement they shall
purchase the Material exclusively from NORBROOK.
|
|
|
|
3.2
|
|
PHARMAPLAZ and
SAMARITAN warrant that they shall not on-sell the Material to any
third party save where the Material is contained and/or formulated
within the Finished Product.
|
|
|
|
3.3
|
|
PHARMAPLAZ and
SAMARITAN warrant that they shall use the Material exclusively for
formulating in a Finished Product.
|
|
4. FORECAST, ORDERING,
SUPPLY AND DELIVERY
|
|
4.1
|
|
To enable
NORBROOK to organize an adequate supply of the Material to
PHARMAPLAZ, PHARMAPLAZ shall submit on or before 1 September of
each year or any other date as agreed between the Parties a written
forecast of the quantities of Material PHARMAPLAZ estimates it
shall require during the next following year, divided in quarters.
The quantities per quarter shall not deviate more than thirty
percent (30%) from the average quantity per quarter over the
forecasted year.
|
|
|
|
4.2
|
|
NORBROOK’s
obligation to supply any Material to PHARMAPLAZ shall be contingent
upon NORBROOK’s acceptance of a firm purchase order. At least
forty-five (45) days before each quarter, PHARMAPLAZ shall
submit to NORBROOK a firm purchase order setting forth the
quantities of the Material to be supplied during such quarter, the
required delivery dates and the source of supply. When submitting
such purchase order, PHARMAPLAZ shall take into account the
NORBROOK preferred order sizes.
|
|
|
|
4.3
|
|
Upon acceptance
by NORBROOK of a firm purchase order, such order shall become a
binding commitment of NORBROOK to supply and dispatch within at
least 30 days and of PHARMAPLAZ to purchase the Material in
accordance with the General Conditions of Sale as set out in
Schedule 4.3.
|
|
|
|
4.4
|
|
All shipments of
the Material under this Agreement shall be delivered to PHARMAPLAZ
CIF at such site as agreed between the Parties in writing. The term
“CIF” used herein shall have the meaning assigned to
them in the latest version of the INCOTERMS published by the
International Chamber of Commerce at Paris, France at the time of
delivery.
|
|
|
|
4.5
|
|
Each shipment of
the Material made hereunder shall be accompanied by a commercial
invoice in duplicate, a Certificate of Analysis and any other
document required by the relevant authorities for the import of the
Material.
|
|
3
5. PRICING AND PAYMENT
ARRANGEMENTS
|
|
5.1
|
|
During the term
of this Agreement, the price to be paid for the Material shall be
agreed upon by both Parties in good faith at least sixty
(60) days before the commencement of every twelve
(12) month period as from the Effective Date. The price for
the Material to be paid by PHARMAPLAZ to NORBROOK for the first
twelve (12) month period is set out in
Schedule 5.1 .
|
|
|
5.2
|
|
Both NORBROOK
and PHARMAPLAZ will do their utmost to reach an agreement on price
for the Material. However, in case both Parties fail to reach an
agreement at least sixty (60) days prior to the commencement
of each twelve (12) month period, then the price for the
Material will be increased: (i) by an amount equal to the
vouched percentage increase in the cost of ingredients and
materials portion (which shall include all raw material and
packaging used in the manufacture of the Material) of the
price; and (ii) an inflationary price based on (RPI) Retail
Price Index as published by the Czech Government for the remaining
portion of the relevant price. In both cases calculated from the
date of the last price change for the Material to the commencement
date o
|
|