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Title: |
Agreement |
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Entities: |
AstraZeneca plc; K-V Pharmaceutical Co.; Merck & Co., Inc.; Pharmacia Corp.; FemmePharma, Inc.; KV Pharmaceutical Co. |
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Date: |
2003 |
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Size: |
Preview shows 6KB of 120KB total |
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Price: |
$63 |
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ID: |
#142576 |
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AGREEMENT BETWEEN
FEMMEPHARMA, INC. AND
K-V PHARMACEUTICAL COMPANY
--------------------------
This Agreement is entered into as of the 18th day of April 2002 by
and between FEMMEPHARMA, INC. ("FemmePharma"), 37 West Avenue, Suite 101,
Wayne, Pennsylvania 19087, and K-V PHARMACEUTICAL COMPANY ("KV"), 2503 South
Hanley Road, St. Louis, Missouri 63144.
A. FemmePharma is the owner of certain technology and patent rights
applicable to intravaginal products containing Danazol and vaginal
anti-infective products.
B. In the course of obtaining the regulatory approvals contemplated
in this Agreement, and during the term of this Agreement, FemmePharma may
develop certain inventions and other proprietary rights relating to the
manufacture, use and sale of intravaginal products containing Danazol and
vaginal anti-infective products and FemmePharma is willing to grant KV an
exclusive license for the manufacture, use and sale of intravaginal products
containing Danazol and vaginal anti-infective products, and KV desires to
acquire the same from FemmePharma.
Therefore, in consideration of the mutual covenants and agreements
contained herein, and other valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, FemmePharma and KV, intending
to be legally bound, agree as follows:
1. DEFINITIONS.
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As used herein, capitalized terms shall have the respective
meanings set forth below.
"Act" means the United States Federal Food, Drug, and Cosmetic Act,
---
as amended, and rules and regulations thereunder.
"Affiliate" of a Person means a Person that directly, or indirectly
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through one or more intermediaries, controls, is controlled by or is under
common control with such Person. For purposes of this definition, "control"
(and, with correlative meanings, the terms "controlled by" and "under common
control with") shall mean the possession of the power to direct or cause the
direction of the management and policies of such Person, whether through the
ownership of voting stock, by contract or otherwise. In the case of a
corporation or other entity "control" shall be presumed to exist by, among
other things, the direct or indirect ownership of more than fifty percent
(50%) in voting power of its outstanding voting stock, or other voting
rights.
"Anti-infective Product" means any product used for the treatment
----------------------
of candidiasis, bacterial vaginosis or trichomoniasis, whether such
conditions are described by such terms or any other terminology.
{PAGE}
{PAGE}
"Claim" means any and all liabilities, damages, losses,
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settlements, claims, actions, suits, penalties, fines, costs or expenses
(including, without limitation, reasonable attorneys' fees and expenses).
"Commercially Reasonable" shall mean reasonable efforts and
-----------------------
diligence in developing and commercializing a Product in accordance with a
party's business, legal, medical and scientific judgment, such reasonable
efforts and diligence to be no less than the efforts and resources the party
would use for a product owned by it or to which it has rights, which is of
similar market potential at a similar stage in its product life, taking into
account the competitiveness of the marketplace, the proprietary position of
the compound, the regulatory structure involved, the profitability of the
applicable products, and other relevant factors including, without
limitation, technical, legal, scientific or medical factors.
"Confidential Information" is defined in Section 12.1.
------------------------
"Danazol" has the meaning ascribed thereto in The Merck Index, 12th
-------
Edition (1996, 1997).
"Danazol Product" is defined under the definition of KV Product.
---------------
"DMF" means the Drug Master File, as defined at 21 C.F.R. Section
---
314.420, for any Product or any manufacturing facility of KV at which a
Product is manufactured.
"Existing Patent" means any issued patent which falls within (a) or
---------------
(b) of the definition of Patent Rights.
"Fair Market Value" means the cash consideration which the selling
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party would realize from an unaffiliated, unrelated buyer in an arm's length
sale of an identical item sold in the same quantity and at the same time and
place of transaction.
"FDA" means the United States Food and Drug Administration.
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"FemmePharma Improvements" means any Technology discovered,
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developed or otherwise owned, acquired or controlled by FemmePharma or its
Affilitates before or during the Term (except as covered by the Existing
Patents).
"FemmePharma Indemnitee" means FemmePharma and its Affiliates and
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their directors, officers, employees, agents, professional consultants,
successors and assigns.
"FemmePharma Product(s)" means all products other than KV Products.
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"FemmePharma Technology" means all Technology owned or controlled
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by FemmePharma or its Affiliates before or during the Term.
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