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NORBROOK LABORATORIES LIMITEDoperating through NORBROOK s.r.o as the Supplier- and -PHARMAPLAZ LIMITED as the Buyer and - SAMARITAN IRELAND PHARMACEUTICALS LIMITEDas the Finished Product License Holder- and -SAMARITAN PHARMACEUTICALS INC as the Parent Company of the Finished Product License Holder SUPPLY AGREEMENT PROCAINE HYDROCHLORIDE

Technology License Assignment Agreement

NORBROOK LABORATORIES LIMITEDoperating through NORBROOK s.r.o as the Supplier- and -PHARMAPLAZ LIMITED as the Buyer and - SAMARITAN IRELAND PHARMACEUTICALS LIMITEDas the Finished Product License Holder- and -SAMARITAN PHARMACEUTICALS INC as the Parent Company of the Finished Product License Holder SUPPLY AGREEMENT PROCAINE HYDROCHLORIDE | Document Parties: NORBROOK LABORATORIES LIMITED | PHARMAPLAZ LIMITED  | SAMARITAN IRELAND PHARMACEUTICALS LIMITED | SAMARITAN PHARMACEUTICALS INC You are currently viewing:
This Technology License Assignment Agreement involves

NORBROOK LABORATORIES LIMITED | PHARMAPLAZ LIMITED | SAMARITAN IRELAND PHARMACEUTICALS LIMITED | SAMARITAN PHARMACEUTICALS INC

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Title: NORBROOK LABORATORIES LIMITEDoperating through NORBROOK s.r.o as the Supplier- and -PHARMAPLAZ LIMITED as the Buyer and - SAMARITAN IRELAND PHARMACEUTICALS LIMITEDas the Finished Product License Holder- and -SAMARITAN PHARMACEUTICALS INC as the Parent Company of the Finished Product License Holder SUPPLY AGREEMENT PROCAINE HYDROCHLORIDE
Date: 9/27/2005

NORBROOK LABORATORIES LIMITEDoperating through NORBROOK s.r.o as the Supplier- and -PHARMAPLAZ LIMITED as the Buyer and - SAMARITAN IRELAND PHARMACEUTICALS LIMITEDas the Finished Product License Holder- and -SAMARITAN PHARMACEUTICALS INC as the Parent Company of the Finished Product License Holder SUPPLY AGREEMENT PROCAINE HYDROCHLORIDE, Parties: norbrook laboratories limited , pharmaplaz limited  , samaritan ireland pharmaceuticals limited , samaritan pharmaceuticals inc
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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


 
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