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:
1.1 “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 Original 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:
(i) one (1) box
for each Promo Unit with labeling mutually approved by OSUR and
Distributor;
(ii)
package insert or instructions for the Original Product in form
approved by
(iii)
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;
(iv)
shipping case (standard corrugated);
(v) shipping case
label in form mutually approved by OSUR and Distributor;
(vi) security
detection devices (Checkpoint or SensorMatic);
(vii) transparent
tamper-resistant labels for box lids (if required);
(viii) a bottle of
the Freezone ® salicylic acid corn and callus
remover containing labeling which complies with Section 5 below;
and
(ix)
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, sale or distributio
