EXHIBIT 10.2
ORIGINAL EQUIPMENT MANUFACTURER
AGREEMENT
This Original
Equipment Manufacturer Agreement (the "Agreement") is entered into
as of the 25TH day of June, 2002, by and between BOVIE MEDICAL
CORPORATION, a Delaware corporation with its principal place of
business at 7100 30th Avenue North, St. Petersburg, FL 33710-2902
("Bovie"), and ARTHREX, INC., a Delaware corporation having its
principal place of business at 2885 South Horseshoe Drive, Naples,
FL 34104 ("Arthrex").
WHEREAS, Bovie manufactures, packages and sells
certain devices and components for resale and desires to
manufacture and supply certain Products (as defined
below);
WHEREAS, Bovie desires to invest time and
resources in the development and the improvement of the Products,
and in consideration therefor, Arthrex desires to purchase its
Products inventory from Bovie; and
WHEREAS, Arthrex desires that Bovie manufacture
and supply the Products to Arthrex;
NOW, THEREFORE, in consideration of the terms
and provisions of this Agreement, and for other good and valuable
consideration, the receipt and sufficiency of which is hereby
acknowledged, Bovie and Arthrex agree as follows:
1.1 An "Affiliate" of a Person
means any company, corporation, partnership, limited liability
company, association, organization, entity, individual or other
that directly or indirectly controls, is controlled by or is under
common control with such Person.
1.2 "Delivery Date" means a date for which delivery
of Product is properly requested in a Purchase Order (as such term
is hereinafter defined).
1.3 "FDA" means the United States Food and Drug
Administration or any successor agency or authority, the approval
of which is required to market, distribute, supply and sell health
care products in the United States.
1.4 "Product or Products" mean any one or more of
the devices and components set forth in Appendix A, and such other
devices and components as may be added, in writing, to Appendix A
by Arthrex from time to time.
1.5 "Purchase Order" means a written order issued by
Arthrex to Bovie with respect to purchases of Products,
substantially in the form attached hereto as Appendix B, which
shall be subject to, and governed exclusively by, the terms of this
Agreement.
1.6 "Ramp-Up Period" shall mean the first six months
of the Term (as defined below) of this Agreement.
2.0
PURCHASE AND SALE OF PRODUCTS.
2.1 Bovie's
Supply Obligations
(a) Bovie
shall use its best efforts to supply Arthrex with Product
inventory. Subject to the provisions of Section 5 below, all
Products sold under this Agreement shall conform in all material
respects to the product specifications ("Product Specifications")
and manufacturing processes ("Manufacturing Processes") as set
forth in Appendix A as such Products, Product Specifications and
Manufacturing Processes may be modified from time to time by
Bovie's engineering and design teams; provided,
however, that no changes, modifications or improvements may
be made to, or implemented within, any Products delivered to
Arthrex pursuant to this Agreement without Arthrex's prior written
consent, such consent not to be unreasonably withheld.
(b) Subject
to Section 2.1(c), Bovie shall agree to any reasonable and lawful
modification to the Product Specifications requested by Arthrex in
writing, which are designed to improve the Products;
provided, however, that Bovie shall have a reasonable
period of time to implement such Product Specifications.
(c) Notwithstanding
anything to the contrary in Sections 2.1(a) and (b), in the event
that any change or modification to the Products or the Product
Specifications results in a material change to the costs incurred
by Bovie in the development, production, manufacture, sterilization
and/or packaging of the Products, Bovie shall so notify Arthrex
prior to the implementation of the change or modification and, upon
the written consent of Arthrex thereto, the purchase prices, as set
forth in Section 3.1, shall be modified accordingly.
(d) Bovie
agrees, and shall cause its officers, directors, employees,
advisers, agents and consultants (collectively, "Representatives")
to agree, that if any Product Specification requested by Arthrex in
accordance with Section 2.1(b), includes changes to the Products or
to the Product Specifications ("Inventions"), that all Inventions
shall be the sole property of Arthrex to the maximum extent
permitted by applicable law and to the extent permitted by law
shall be "works made for hire" as that term is defined in the
United States Copyright Act (17 USCA, Section 101). Arthrex shall
be the sole owner of all patents, copyrights, trade secret rights
and other intellectual property or other rights in connection with
the Inventions. Bovie shall, and shall cause its Representatives
to, assign to Arthrex all right, title and interest Bovie and/or
its Representatives may have or acquire in any and all Inventions.
Bovie shall, and shall cause its Representatives to, assist Arthrex
in every proper way to obtain, and from time to time, enforce, all
patents, copyrights or other rights on said improvements in any and
all countries, and to that end Bovie shall, and shall cause its
Representatives to, execute all documents necessary. Arthrex shall
have the sole and exclusive right to:
(i) apply for, obtain and vest in the name
of Arthrex alone (unless Arthrex otherwise directs) letters patent,
copyrights or other analogous protection in any country throughout
the world and when so obtained or vested to renew and restore the
same in its sole discretion; and
(ii) defend any opposition proceedings in
respect of such applications and any opposition proceedings or
petitions or applications for revocation of such letters patent,
copyright or other analogous protection.
(e) Bovie's and its Representatives' obligations
to assist Arthrex in obtaining and enforcing patents and copyrights
for the Inventions in any and all countries, as set forth above,
shall continue beyond the Term, at Arthrex's cost.
2.2 Arthrex's
Purchase Obligations
(a)
Subject to Section 2.11,
Arthrex shall engage Bovie as the ** **
manufacturer of ** ** percent
(** **) of its Product requirements in the
marketplace, including, without limitation, Products required for
engineering, testing and clinical trials, if any. Except as
expressly set forth herein, Arthrex agrees to purchase
** ** its Product requirements
** ** from Bovie, and from no
other manufacturer, person or entity, including, without
limitation, any entity belonging, in whole or in part, to
Arthrex.
(b)
Subject to Section 2.2(a) above,
Arthrex shall provide Bovie with firm Purchase Orders for Products
in accordance with the lead-times set forth in Section 2.4(a);
provided, that Arthrex shall have the right, up to the date
of manufacture, and with the consent of Bovie, which shall not be
unreasonably withheld, to issue binding, written change orders to
increase or decrease the quantity of such Purchase Orders. Arthrex
agrees to accept partial shipments of Products should it, for any
commercially reasonable reason, become necessary to ship in advance
of order completion. Bovie shall make all commercially reasonable
efforts to comply with any revisions to Purchase Order requirements
consistent with the provisions of Section 2.3. Within seven days
after receipt of a Purchase Order from Arthrex, Bovie shall
acknowledge such receipt and confirm whether the order can be
supplied.
2.3 Estimates
of Requirements
(a) (i) Upon execution and delivery of this
Agreement, and upon each successive
** ** anniversary of the
execution and delivery of this Agreement, Arthrex shall deliver to
Bovie a rolling ** ** written
commitment of Arthrex's requirements of Products for the
immediately succeeding
** ** period (each, a
** ** Commitment"). Arthrex shall
deliver ** ** Commitments to
Bovie no later than ** ** days
prior to the applicable
** ** anniversary date. Bovie
shall, no later than ** ** days
after receipt of each
** ** Commitment, notify Arthrex
of any prospective problems, of which Bovie is aware, that might
prevent Bovie from meeting Arthrex's order quantities or estimated
Delivery Dates.
(ii) Upon execution and delivery of this
Agreement, and upon each successive
** ** anniversary of the
execution and delivery of this Agreement, Arthrex shall deliver to
Bovie a written, non-binding good faith estimate of Arthrex's
requirements of Products from Bovie for delivery during the
immediately succeeding
** ** (each,
** ** Forecast"). Arthrex shall
deliver Annual Forecasts to Bovie no later than
** ** days prior to the applicable
** ** anniversary date. Bovie
shall, no later than ** ** days
after receipt of each
** ** Forecast, notify Arthrex of
any prospective problems, of which Bovie is aware, that might
prevent Bovie from meeting Arthrex's forecasted requirements or
estimated Delivery Dates.
(b) Bovie and Arthrex agree to cooperate with
each other and work jointly to establish and maintain a smooth and
efficient timetable for the manufacture and supply of Products to
Arthrex hereunder. Bovie shall use commercially reasonable efforts
to supply Arthrex with all of its Product requirements, including,
but not limited to, the use of commercially reasonable efforts to
accommodate "Rush" orders from Arthrex; provided,
however, Bovie shall not be in breach of this Agreement for
any failure to supply quantities of Products which exceed the
** ** Commitments provided by
Arthrex under Section 2.3(a) by more than
** **.
2.4 Orders,
Packaging and Delivery
(a) Unless
otherwise agreed to in writing by the parties, all Products
purchased pursuant to this Agreement shall be effected by Arthrex's
issuance of a firm written Purchase Order, consistent with Section
2.3 above. Each Purchase Order shall specify the type and quantity
of the Product to be delivered, as well as requested Delivery
Dates. All requested Delivery Dates shall provide for at least
** ** days lead time for the
manufacture and delivery of the Products ordered (taking into
consideration the production schedule established in the
** ** . After the end of the Ramp-Up Period,
subject to Section 2.3(b), a failure by Bovie to deliver Products
within** ** days of a Delivery
Date shall be a material breach of this Agreement and be subject to
Section 7.1.
(b) (1)
Bovie shall be responsible for, in accordance with the terms,
provisions and conditions set forth in this Agreement: (i) the
sterilization of the Products at its facility or facilities or at
any contract facility or facilities; (ii) the packaging of the
Products for shipment in accordance with validated procedures; and
(iii) the shipment of such Products. Arthrex, at its own expense,
will provide Bovie with Arthrex's labeling for the Products bearing
Arthrex's corporate name and trade dress. Bovie will print, either
directly or through a third party, labels and other printed
material to be included as part of the finished Products. Products
manufactured by or on behalf of Bovie after Bovie's receipt of any
new or altered labeling for the Products, shall bear such new
labeling. Bovie shall also place other required notices and marks,
such as ETL and CE (both as defined below) notices and markings, as
Arthrex may hereafter prescribe from time to time as it deems
appropriate, on all copies and embodiments of the Products and
associated documentation and advertising. Bovie shall not remove
any Arthrex approved or designated notice from any Products. As set
forth in Section 3.1, ** ** will pay the
costs of all private labeling by
** **.
(2) Bovie shall not hire, contract with or
otherwise engage any one or more contract facilities to perform any
of its obligations as set forth in this Agreement with respect to
the sterilization of the Products without the prior written consent
of Arthrex, which consent shall not be unreasonably withheld or
delayed; provided, that any contract facility that is
engaged in any way with the sterilization of the Products shall (i)
perform the sterilization of the Products in accordance with
specifications that have been provided or approved in writing by
Arthrex and (ii) meet the same governmental and regulatory
requirements, and maintain the same registrations and
certifications, as applicable, that Bovie is required to meet under
Section 2.5; provided, further, that Bovie shall be
liable for, and shall indemnify and hold Arthrex harmless in
connection with liabilities arising from, any violations of this
Section 2.4(b)(2).
(c) Unless
otherwise agreed to, in writing, by the parties, all Products
manufactured for Arthrex shall be delivered to Arthrex at its
principal place of business in Naples, Florida. All shipments of
Products to Arthrex shall be billed F.O.B. Bovie's
** ** plant in
** ** All deliveries shall be
delivered in a manner as may be, intermittently, agreed to by the
parties. Title to and risk of any loss and/or damage to the
Products shall pass to Arthrex upon delivery of such Product by
Bovie, or any agent of Bovie, to the shipping agent.
(d) Bovie
shall assist Arthrex in arranging any desired shipping insurance
(in amounts that Arthrex shall determine) and shall use its best
efforts to deliver all Products by their respective requested
Delivery Dates (provided that in no event shall a Delivery Date be
less than 30 days after the date the Purchase Order is issued,
unless otherwise consented to by Bovie), using mutually agreeable
carriers. All costs and expenses relating to transportation and
delivery shall be at Arthrex's expense. Arthrex shall have the
right to require and inspect any special or varied packing that it
believes is reasonably necessary to meet the customs, regulatory or
other requirements within a territory.
(e) Bovie
shall certify, in writing, upon Arthrex's written request, that
each delivery of Product was produced and tested in compliance with
the Product Specifications.
(f) Arthrex
may return any defective Products to Bovie, pursuant to a product
recall or otherwise, for credit or replacement as Arthrex shall
determine.
2.5 Quality
Control and Regulatory Compliance
(a) During
the Term, Bovie shall establish and maintain a quality assurance
control program to be maintained by its Quality Control Team. Bovie
shall enter into Arthrex's Contract Manufacturers/Suppliers/Vendors
Agreement with respect to quality assurance, a copy of which is
attached hereto as Appendix C. Arthrex shall maintain its Quality
Control Department, which shall provide technical and other
assistance to Bovie in order for Bovie to better understand and
meet the Product Specifications and manufacturing requirements.
Bovie's Quality Control Team and Arthrex's Quality Control
Department shall work together in an effort to establish total
quality assurance.
(b) During
the Term, Bovie shall manufacture the Products in a manner that is
in compliance with all federal and state governmental and
regulatory requirements in the United States of which Bovie is
legally required to comply