Exhibit
10.1
Portions of this Exhibit were
omitted and filed separately with the Secretary of the Commission
pursuant to an application for confidential treatment filed with
the Commission pursuant to Rule 406 under the Securities Act of
1933. Such omissions are designated as ***.
AMENDMENT NO. 1 TO DISTRIBUTION
AGREEMENT
This Amendment No. 1 to
Distribution Agreement (this “Amendment”), dated as of
February 10, 2006, is between OraSure Technologies, Inc., a
Delaware corporation (“OSUR”), and Medtech Holdings,
Inc. (“Medtech Holdings”) and Medtech Products, Inc.
(“Medtech Products”), each of which are Delaware
corporations and wholly-owned subsidiaries of Prestige Brands
Holdings, Inc. (Medtech Products, as the assignee of Medtech
Holdings hereunder, is referred to as
“Distributor”).
BACKGROUND
OSUR and Distributor previously
entered into that certain Distribution Agreement, dated as of
April 24, 2003 (the “Original Agreement”),
pursuant to which OSUR agreed to manufacture and supply the
Original Product (as defined below) for distribution by the
Distributor into the OTC Market in the Territory. Capitalized terms
not otherwise defined in this Amendment shall have the meanings set
forth in the Original Agreement. The parties desire to amend the
Original Agreement in order to provide for (i) the assignment
of the Original Agreement as amended hereby by Medtech Holdings to
Medtech Products and (ii) the distribution of a new
promotional product into the OTC Market in the Territory, pursuant
to the terms set forth in the Original Agreement as amended by this
Amendment.
AGREEMENT
NOW, THEREFORE, in consideration of
the foregoing, and the other mutual promises and covenants
contained in this Amendment, OSUR and Distributor, intending to be
legally bound, hereby agree as follows:
1. Definitions .
1.1 “Freezone
®
Product” means
salicylic acid corn and callus remover that is manufactured,
marketed and sold by Distributor or its Affiliates under the
Freezone ® trade name, together with all
modifications and improvements that may be made by Distributor to
such product from time to time.
1.2 “Freezone
®
Specifications”
means the Freezone ® Product specifications set forth in
Exhibit 1.2 to this Amendment.
1.3 “Original Product”
means the cryosurgical wart removal product supplied by OraSure to
Distributor under the Prior Agreement and originally defined as the
“Product” therein.
1.4 “Promo Footcare
Product” means the Original Product and the Freezone
®
Product either singly or
combined with non-medicated (containing no salicylic acid or other
pharmacologically active substance) woven “comfort
pads” contained in a single package for promotional
purposes.
1.5 “Promo Unit” means a
single unit of the Promo Footcare Product, consisting of
(i) one (1) Unit of the Original Product, (ii) one
(1) bottle of the corn and callus remover used in the
Freezone ® Product, and (iii) one
(1) resealable plastic bag containing twelve
(12) non-medicated ( containing no salicylic acid or other
pharmacologically active substance) woven “comfort
pads”.
2. Assignment . Medtech
Holdings hereby transfers and assigns to Medtech Products all of
its rights, and delegates all of the duties and obligations, under
the Original Agreement as amended by this Amendment, and Medtech
Products hereby accepts such rights and assumes such duties and
obligations. As a result of such transfer and assignment, Medtech
Products shall be deemed to be Distributor under the Original
Agreement and this Amendment. OSUR hereby consents to the foregoing
assignment and assumption.
3. Promo Footcare Product .
Subject to the terms and conditions of this Amendment and the
Original Agreement, OSUR shall assemble and supply the Promo
Footcare Product to Distributor, and Distributor shall purchase the
Promo Footcare Product for distribution solely in the OTC Market in
the Territory. Except as provided herein and subject to the terms
of this Amendment, the Promo Footcare Product shall be deemed to be
an additional Product for purposes of the Original Agreement as
amended hereby.
4. Supply of Distributor
Components . The following shall constitute the Distributor
Components for the Promo Footcare Product, which Distributor shall
supply, at its sole cost, to the Assembly Contractor for use in
packaging and assembling each Promo Unit purchased by
Distributor:
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(i)
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one
(1) box for each Promo Unit with labeling mutually approved by
OSUR and Distributor;
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(ii)
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package insert
or instructions for the Original Product in form approved by
OSUR;
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(iii)
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package insert
or instructions for use for the Freezone ® Product in form mutually approved by
OSUR and Distributor, to the effect that the Freezone
®
Product and Original
Product should not be used together;
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(iv)
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shipping case
(standard corrugated);
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(v)
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shipping case
label in form mutually approved by OSUR and Distributor;
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(vi)
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security
detection devices (Checkpoint or SensorMatic);
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(vii)
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transparent
tamper-resistant labels for box lids (if required);
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(viii)
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a bottle of the
Freezone ® salicylic acid corn and callus
remover containing labeling which complies with Section 5
below; and
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(ix)
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twelve
(12) untreated “comfort pads” contained in a
resealable plastic bag.
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Distributor shall ensure that all of
the foregoing Distributor Components are manufactured, stored and
supplied in accordance with the Specifications (as defined in the
Original Agreement), the Freezone ® Specifications and in compliance
with all applicable treaties, laws, rules and regulations within
the Territory. Distributor shall supply the foregoing Distributor
Components with sufficient lead times and in sufficient quantities
as directed by OSUR to permit the packaging and assembly of Promo
Footcare Products purchased by Distributor and delivery to
Distributor in accordance with Distributor’s Purchase
Orders.
5. Price . Pricing for the
Promo Footcare Products when produced in facilities of OSUR or the
Assembly Contractor shall be as specified in Schedule 5 to this
Amendment (as amended from time to time). OSUR shall have no
obligation to supply the Promo Footcare Products produced in
facilities of OSUR or the Assembly Contractor unless the pricing
therefor is agreed to by the parties.
6. Labeling; Compliance with Law;
Specifications . Distributor shall ensure that the
Freezone ® Product is manufactured, packaged
and labeled in compliance with all applicable treaties, laws, rules
and regulations, including all applicable FDA or other regulatory
approvals, clearances or registrations required for the
manufacture, sale or distribution of the Freezone
®
Product. Distributor
shall also ensure that all packaging and labeling provided for the
Promo Footcare Product contains language (including applicable
warnings and cautionary language) required under all applicable
treaties, laws, rules and regulations for the inclusion of the
Freezone ® Product as a component of the Promo
Footcare Product, including under all applicable FDA or other
regulatory approvals, clearances or registrations. Distributor
represents, warrants and agrees that the Freezone
®
Product shall be
manufactured in accordance with and shall comply with the
specifications set forth in the Freezone ® Specifications. Distributor shall be
solely responsible for obtaining and maintaining, at its sole cost,
all regulatory approvals, clearances or registrations, including
all applicable FDA approvals, required for the manufacture,
sa
