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Development and Supply Agreement

 

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Title:

Development and Supply Agreement

Entities:

Barrier Therapeutics, Inc.

Date:

2004

Size:

Preview shows 6KB of 55KB total

Price:

$47

ID:

#286380

 

 

► Business ► Supply ► Development & Supply Agreements
► Biotech & Drugs ► Pharmaceutical Preparations

 

 

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DEVELOPMENT AND SUPPLY AGREEMENT

THIS AGREEMENT (hereinafter "AGREEMENT") is made by and between Abbott GmbH &
Co. KG, having a place of business at Knollstrasse 50, 67061 Ludwigshafen,
Germany (hereinafter "ABBOTT"), and Barrier Therapeutics, Inc. having a place of
business at 100 Princeton Overlook, Princeton, NJ 08540, USA (hereinafter
"BARRIER"). This Agreement is effective as of the date of the last signature
below (hereinafter "EFFECTIVE DATE").

WHEREAS Abbott has developed inter alia Meltrex(TM) Technology (as hereinafter
defined) that can be used in the formulation of pharmaceutical products and has
rights to certain patents and patent applications claiming the same; and

WHEREAS Barrier has rights to develop, market and sell a certain pharmaceutical
Drug Substance (as hereinafter defined); and

WHEREAS Abbott has previously carried out studies successfully demonstrating the
feasibility of formulating said Drug Substance using Meltrex(TM) Technology, and

WHEREAS Abbott and Barrier wish to enter into a Development Programme (as
hereinafter defined) with respect to the development of Bulk Product and
Finished Product (as hereinafter defined); and

WHEREAS upon successful completion of such development and obtaining marketing
approval for Finished Product, Barrier intends to entrust the manufacturing of
both Bulk Product and Finished Product to Abbott; and

WHEREAS Abbott has adequate manufacturing facilities and capacity to undertake
the manufacture and to ensure the supply of both Bulk Product and Finished
Product to Barrier for Barrier's total worldwide requirements of Finished
Product.

NOW THEREFORE the parties agree as follows:

1
{PAGE}
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.

ARTICLE I
DEFINITIONS

1.1 AFFILIATE means any person or business entity which directly or indirectly
controls, is controlled by, or is under common control with a party to
this Agreement. A business entity shall be deemed to "control" another
business entity, if it owns directly or indirectly, more than fifty
percent (50%) of the outstanding voting securities, capital stock, or
other comparable equity or ownership interest of such business entity, or
exercises equivalent influence over such entity. If the laws of the
jurisdiction in which such entity operates prohibit ownership by a party
of fifty percent (50%) or more, "control" shall be deemed to exist at the
maximum level of ownership allowed by such jurisdiction.

1.2 BULK PRODUCT means Drug Substance formulated by Abbott using its
Meltrex(TM) Technology according to the terms of this Agreement.

1.3 DELIMITATION OF RESPONSIBILITIES AGREEMENT means the document setting out
the respective pharmaceutical responsibilities of the parties with regard
to the preparation of Finished Product to be attached hereto as Schedule
C.

1.4 DEVELOPMENT PROGRAMME means the outline programme set out in Schedule A
hereto and all the detailed Workplans for the development of Bulk Product
and Finished Product attached hereto from time to time as Schedule B and
made a part hereof.

1.5 DRUG SUBSTANCE means the antifungal compound itraconazole, alone or as a
premix ("Triaset").

2
{PAGE}
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.

1.6 FINISHED PRODUCT means the final tablets made by milling and compressing
Bulk Product according to the terms of this Agreement and suitable for
marketing and sale.

1.7 MELTREX(TM) TECHNOLOGY means any and all know-how, proprietary data,
patents and patent applications owned or controlled by Abbott or any of
its Affiliates relating to the formulation and shaping of pharmaceutical
products by melt-extrusion.

1.8 REGULATORY AGENCIES means the regulatory authorities having jurisdiction
over the clinical testing, manufacture, marketing and sale of Finished
Product.

1.9 SPECIFICATIONS means the manufacturing and test procedures for Drug
Substance, components, intermediates, Bulk Product and Finished Product,
and in-process controls, including without limitation legal label text and
unit descriptions if applicable.

1.10 WORKPLAN means each detailed programme of technical work, including the
timetable and cost, which is required for the development of Bulk Product
and Finished Product and which will be set out from time to time as
Schedule B (i.e. Schedule B-1, Schedule B-2, etc) hereto.

ARTICLE II
DEVELOPMENT PROGRAMME

2.1 Abbott hereby agrees to undertake the Development Programme as outlined in
Schedule A hereto, including, without limitation, manufacturing Bulk
Product and Finished Product in accordance with the Specifications which
shall be agreed to by the parties. On payment by Barrier of the
irrevocable sum of US$ [**] prior to commencement of Stage 2 of the

 

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