Home

Intelligence

Services

Subscriptions

News

About Us

Sign In

 

Document Preview

Finished Product Supply Agreement

 

Click "Add to Cart" button to purchase document. 
Documents are emailed immediately after purchase. 
You can also browse documents by
title, category, or company... or click here for help finding documents.

 

Title:

Finished Product Supply Agreement

Entities:

Aventis Pharmaceuticals Inc.; KOS Pharmaceuticals, Inc.; Aeropharm Technology Inc.

Date:

2004

Size:

Preview shows 9KB of 95KB total

Price:

$38

ID:

#281585

 

 

► Business ► Supply ► Misc. Supply Agreements
► Biotechnology & Drugs
► Biotech & Drugs ► Pharmaceutical Preparations

 

 

Start of Preview


         THIS FINISHED PRODUCT SUPPLY AGREEMENT, dated as of March 5, 2004 and

effective as of the Effective Date, is made and entered into by and between
Aventis Pharmaceuticals Inc., a company organized and existing under the laws of
the State of Delaware, and its Affiliates ("AVENTIS"), and Aeropharm Technology,
Inc., a company organized and existing under the laws of the State of Delaware
("PURCHASER"). Capitalized terms used in this Agreement shall have the meanings
ascribed to them in Article 1 hereof or as otherwise set forth herein.

RECITALS

WHEREAS, Aventis is engaged in the manufacture of a finished product
form of the compound Triamcinolone Acetonide in a chlorofluorocarbon ("CFC")
based propellant driven inhaler as sold in the United States under the
registered trademark Azmacort(R);

WHEREAS, this Agreement is being entered into in connection with
certain transactions in which Aventis and its Affiliates are divesting and
licensing certain assets related to the Product to Kos Life Sciences, Inc., an
Affiliate of Purchaser, pursuant to a Product Acquisition Agreement dated as of
the date hereof (the "PRODUCT ACQUISITION AGREEMENT");

WHEREAS, Purchaser desires to have Aventis manufacture and supply it
with finished Product for sale and distribution in the Territory during the Term
in accordance with this Agreement; and

WHEREAS, Aventis agrees to manufacture and supply to Purchaser finished
Product for sale and distribution in the Territory upon the terms and subject to
the conditions provided herein.

NOW, THEREFORE, in consideration of the mutual covenants and agreements
set forth in this Agreement, and for other good and valuable consideration, the
receipt of which are hereby acknowledged, the parties hereto hereby agree as
follows:


1
{PAGE}

ARTICLE 1

DEFINITIONS

The following terms shall have the meanings set forth below. Unless the
context indicates otherwise, the singular shall include the plural and the
plural shall include the singular.

1.1 "4.5 DATE" has the meaning set forth in Section 7.10.

1.2 "ACT" means the United States Federal Food, Drug and Cosmetic Act,
as amended.

1.3 "ACTUAL LOST SALES" means the product of (i) the number of days
between the first day of a Canister Shortage and the last day of the Payment
Term and (ii) the Average Daily Sales Quantity.

1.4 "ADDITIONAL AGREEMENTS" has the meaning set forth in Section 7.1.

1.5 "ADJUSTED GROSS MARGIN PER UNIT" means ****.

1.6 "AFFILIATE" means a person or entity that, directly or indirectly,
through one or more intermediates, controls, is controlled by, or is under
common control with the person or entity specified. For the purposes of this
definition, control shall mean the direct or indirect ownership of (i) in the
case of corporate entities, securities authorized to cast more than fifty
percent (50%) of the votes in any election for directors, or (ii) in the case of
non-corporate entities, more than fifty percent (50%) ownership interest with
the power to direct the management and policies of such non-corporate entity.

1.7 "AGREEMENT " means this Finished Product Supply Agreement and all
schedules and exhibits attached hereto.

1.8 "ALTERNATE SUPPLIER" has the meaning set forth in Section 2.10.

1.9 "AVENTIS FACILITY" has the meaning set forth in Section 2.4(b).

1.10 "AVERAGE DAILY SALES QUANTITY" means the quotient obtained by
dividing (i) the total quantity of Product sold in the twelve (12) month period
ending on the last day of the month immediately preceding the month in which a
Canister Shortage occurs by (ii) three hundred sixty-five (365).

1.11 "BUSINESS DAY" means a day other than Saturday, Sunday or any day
on which a commercial bank in New York, New York is authorized to close. Any
reference in this Agreement to "day" whether or not capitalized shall refer to a
calendar day, not a Business Day.



2
{PAGE}

1.12 "CANISTER" means an Azmacort Unprinted Canister, Part #CA-2742B
included in the Components sold to Purchaser pursuant to Section 2.5 of the
Product Acquisition Agreement and as set forth in SCHEDULE 4.5.

1.13 "CANISTER SHORTAGE" means the cessation of supply of Product by
Aventis hereunder due to an exhaustion of the supply of Canisters and the
resulting complete depletion of all inventories of Product held by Purchaser, as
demonstrated by reasonable documentary evidence thereof provided by Purchaser to
Aventis; PROVIDED, HOWEVER, that a Canister Shortage shall be deemed not to have
occurred in the event Purchaser takes any action outside the ordinary course of
business to deplete its inventory of the Product.

1.14 "CFC" has the meaning set forth in the first recital.

1.15 "CFC EVENT" has the meaning set forth in Section 7.19.

1.16 "CGMP" means current Good Manufacturing Practices as promulgated
under the Act at 21 CFR (chapters 210 and 211), as the same may be amended or
re-enacted from time to time.

1.17 "COMPONENTS" shall mean the canisters, valves, actuators and other
components used in connection with the manufacture of the Product and as listed
on SCHEDULE 1.17 attached hereto.

1.18 "CONVERSION DATE" has the meaning set forth in Section 7.10

1.19 "DISCRETIONARY MANUFACTURING CHANGES" has the meaning set forth in
Section 2.7(b).

1.20 "EFFECTIVE DATE" means the Closing Date as defined in the Product
Acquisition Agreement.

1.21 "FDA" means the United States Food and Drug Administration or any
successor agency thereof.

1.22 "FORCE MAJEURE" has the meaning set forth in Section 10.3.

1.23 "INDEMNITEE" has the meaning set forth in Section 9.3(a).

1.24 "INDEMNITOR" has the meaning set forth in Section 9.3(a).

1.25 "INITIAL PRODUCT COSTS" has the meaning set forth in Section 3.1.

1.26 "LAWS" means all laws, statutes, rules, regulations, ordinances
and other pronouncements having the effect of law of the United States, any



3
{PAGE}

foreign country, supranational entity or any domestic or foreign state,
province, county, city or other political subdivision of any Regulatory
Authority.

1.27 "LOSS THRESHOLD" means losses of Canisters equal to or greater
than ****, calculated over the period commencing on the Effective Date and
ending on the day immediately prior to a Canister Shortage, such calculation to
be made solely by taking into account the following factors: (i) normal process
loss, (ii) loss due to human error of Aventis personnel or its subcontractor,
(iii) loss due to Product rejected for failure to meet Specifications, (iv)
deemed losses pursuant to Section 6.1 in the event, and solely to the extent,
that a recall results from any cause or event as a result of the defective
manufacture, testing, storage or handling of the Product by Aventis or its
Affiliates or its subcontactor and (v) any loss or use of Canisters for
validation or other purposes pursuant to any Discretionary Manufacturing Change
requested by Aventis, even if such Discretionary Manufacturing Change is
consented to by Purchaser.

1.28 "METHOD TRANSFER" has the meaning set forth in Section 5.10.

1.29 "NDA" means a New Drug Application pursuant to Section 505 of the
Act (21 U.S.C. Section 355) submitted to the FDA or any successor application or
procedure or any foreign counterpart of a U.S. New Drug Application for approval
to market, including, where applicable, applications for pricing and
reimbursement approval.

1.30 "NEW COMPONENTS" means the new canisters and valves to be used in
connection with the manufacture of the Product and to be supplied by Purchaser
upon the exhaustion or expiration of, and as a replacement for, the Old
Components purchased by Purchaser on the Effective Date.

 

End of Preview

 

Home        Intelligence        Services        Subscriptions        News        About Us

Contact Us       Terms of Use       Resend Documents       Shopping Cart

Copyright © 2008 The Consus Group LLC