FIRST AMENDMENT TO DISTRIBUTION AGREEMENTDistribution Agreement |
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Exhibit 10.1
FIRST AMENDMENT TO DISTRIBUTION AGREEMENT
THIS FIRST AMENDMENT TO DISTRIBUTION AGREEMENT (the
“First Amendment”) is made this 14th day of
December 2007 by and between ETHICON ENDO-SURGERY, INC.
, an Ohio corporation, and NEOPROBE CORPORATION , a Delaware
corporation.
WHEREAS , the parties hereto
are parties to a Distribution Agreement dated September 28,
1999 (the “Agreement”); and
WHEREAS , the parties desire
to amend the Agreement as set forth herein.
NOW, THEREFORE , in
consideration of the mutual promises and covenants contained
herein, the receipt and sufficiency of which are hereby
acknowledged, the parties hereto agree as follows:
1. Capitalized terms not otherwise defined herein shall have
the meaning ascribed to such terms in the Agreement.
2. The term of this First Amendment shall commence on
January 1, 2009 and shall terminate on December 31, 2013,
unless the Agreement and this First Amendment are sooner terminated
as provided in the Agreement. Within ten (10) business days of
execution of this First Amendment, Ethicon shall pay Neoprobe Five
Hundred Thousand US Dollars (US$500,000) as consideration for
extending the term of the Agreement and as reimbursement for
research and development work performed by Neoprobe.
3. Article 2 of the Agreement is hereby amended to
include the following definitions:
2.21 “Field” shall mean
all intraoperative or imaging medical applications related to the
use of hand-held instruments or devices in radiation detection
procedures for the diagnostic treatment of oncology.
2.22 “System” shall mean
a combination of a control unit and a probe consisting of either a
neo2000 model 2200 Control Unit used in connection with a reusable
model 1017 14mm probe or one (1) model 1100 or model 1101 Bluetooth
probe and shall include all standard accessories issued by Ethicon
to customers in the United States (i.e., Model nos. 1013, 2009,
2010).
2.23 “Transfer Price
Adjustment” shall mean the difference, whether positive or
negative, between the Provisional Transfer Price and the Actual
Transfer Price.
4. Article 3 of the Agreement is hereby amended to
include the following Paragraphs 3.4 and 3.5:
3.4 Development and Supply
Rights . Subject to the terms and conditions of this Agreement,
Ethicon hereby appoints Neoprobe, and Neoprobe herby accepts
appointment, as Ethicon’s exclusive supplier for all
instruments and devices used for radiation detection within the
Field on a worldwide basis during the Term. Ethicon further agrees
that it will not directly, or indirectly through third parties,
develop instruments or devices used for radiation detection within
the Field, but that it will conduct such development activities
solely through Neoprobe unless otherwise agreed to in writing
between the Parties.
3.5 Supply to Century Medical,
Inc. (“CMI”) . The Parties acknowledge that
Neoprobe has, since September 28, 1999, terminated all the
outstanding distribution arrangements listed in Schedule 3.2
except with respect to the current distribution agreement in place
between Neoprobe and CMI covering distribution, sales and marketing
of substantially all of the Products in Japan. Ethicon has
previously indicated to Neoprobe that Ethicon did not wish to add
Japan to the Territory prior to the expiration of the original Term
of this Agreement on December 31, 2008. The Parties therefore
acknowledge that Neoprobe therefore has no further termination
obligations under Section 3.2 of the Agreement.
Neoprobe’s agreement with CMI is currently set to expire
under its own terms on December 31, 2009. In the event Ethicon
should desire to distribute the Products in Japan, it must notify
Neoprobe in writing of this intention prior to January 15,
2009.
5. Paragraph 5.1 of the Agreement is hereby amended and
restated in its entirety as follows:
5.1 Supply of the Product .
During the term of this Agreement, Neoprobe shall manufacture and
sell the Products and Improved Products exclusively to Ethicon in
accordance with the Specifications, and shall not sell, supply or
distribute any Products or Improved Products to any third party
except CMI. Neoprobe shall supply Ethicon (and its Affiliates) with
all of those quantities of Products as ordered by Ethicon (and its
Affiliates) pursuant to this Agreement.
6. Paragraph 5.3 of the Agreement is hereby
deleted.
7. Paragraph 5.7 of the Agreement is hereby amended and
restated in its entirety as follows:
5.7 Transfer Price and Forecasts
for New Products . The Parties will use commercially reasonable
efforts to negotiate Transfer Prices, including Provisional
Transfer Prices and forecasted demand, for New or Improved Products
in accordance with Article 6.
8. Paragraph 5.20 of the Agreement is hereby amended
and restated in its entirety as follows:
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* Portions have been omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for
confidential treatment.
5.20 Extended Warranty Program
. The Parties agree to use commercially reasonable efforts to sell
and honor extended warranty arrangements in accordance with the
terms of Schedule 5.20.
9. Paragraph 5.24(a) of the Agreement is hereby amended
and restated in its entirety as follows:
5.24 (a) Ethicon shall, within
thirty (30) days from the end of each calendar quarter during
the term of this Agreement, deliver to Neoprobe reports of actual
sales prices and unit quantities from sales in the United States
and preliminary reports of sales prices and unit quantities from
sales from major markets outside the United States, as mutually
agreed by the Parties. Ethicon shall, within sixty (60) days
from the end of each calendar year during the term of this
Agreement, deliver to Neoprobe reports of actual sales prices and
unit quantities from sales on a worldwide basis. The reports of
sales shall be in adequate detail to enable Neoprobe and Ethicon to
estimate ASP (as defined by Schedule 5.2) for Products sold
during the preceding calendar year. Neoprobe and Ethicon shall
reasonably cooperate in calculating an estimate of the Transfer
Price Adjustment, if any, due Neoprobe or Ethicon. Within ninety
(90) days from the end of a Commercial Year (i.e., within
90 days of December 31 of each calendar year during the
term of this Agreement), the parties shall use commercially
reasonable efforts to reach written agreement on the amount of any
Transfer Price Adjustment. In the event that Ethicon owes
additional funds to Neoprobe, Ethicon shall pay such amount within
thirty (30) days of reaching such agreement in writing. In the
event that Neoprobe owes funds back to Ethicon, Neoprobe shall,
within 30 days of reaching such agreement in writing, at
Ethicon’s option, pay Ethicon such amount or prepare credit
memo(s) to offset against the next delivery of Product(s) due to be
delivered to Ethicon until such amount due shall be fully
satisfied.
10. Paragraph 5.27 of the Agreement is hereby amended
and restated in its entirety as follows:
5.27 Exclusivity Maintenance
Requirements . Ethicon has no obligation to purchase from
Neoprobe any minimum dollar or unit volume of the Products;
however, commencing in 2010 and, for each Commercial Year
thereafter, Ethicon shall be required to sell not less than [*]
percent ([*]%) of the number of Systems sold by Ethicon on a
worldwide basis during the prior Commercial Year (the
“Exclusivity Maintenance Requirement” or
“EMR”). In the event Ethicon does not meet the EMR for
any Commercial Year, within thirty (30) days following the
expiration of such Commercial Year, Ethicon must either
(a) pay to Neoprobe the additional amount (based on the ASP
for the then most recently completed calendar quarter) that
Neoprobe would have earned if Ethicon had met the EMR or
(b) terminate Neoprobe’s exclusivity obligation to
Ethicon under this Agreement. In no case can the EMR for the Second
Commercial Year or any subsequent Commercial Years be less than [*]
Systems.
11. Article 6 of the Agreement is hereby amended and
restated in its entirety as follows:
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ARTICLE 6 — PRODUCT IMPROVEMENTS
AND RESEARCH AND DEVELOPMENT
AND RESEARCH AND DEVELOPMENT
6.1 Purpose of Research and
Development . The Parties agree that a key objective of their
relationship is the further commercialization of Products and
support the development of New Products and Improved Products that
are compatible and complementary with existing Products, and that
function in a manner designed to protect, to the maximum extent
reasonably possible, the intellectual property rights of the
parties and the distinctiveness of the Products in the marketplace.
The Parties therefore agree that they will design or redesign their
respective products for use in the Field consistent with the
foregoing objectives. Without limiting the foregoing, in order to
accomplish this objective, the Parties have agreed to establish a
Development Committee (the “Development Committee”) as
defined in Section 6.2 below.
6.2 Development Committee .
The planning, direction and activities of the research and
development program shall be under the coordination of the
Development Committee, which shall consist of four members.
Responsibilities of the Development Committee shall include, but
shall not be limited to, discussion and communications concerning
strategies for further research and development of New Products and
Improved Products, and development of product designs to assure
that Products are compatible and complementary to each other and
function in a manner designed to protect, to the maximum extent
reasonably possible, the intellectual property rights of the
Parties and the distinctiveness of the Products in the marketplace.
Neoprobe and Ethicon shall each have two (2) representatives
on the Development Committee. Each Party shall name, and may remove
and replace at any time without the consent of the other Party,
either of its representatives. The Development Committee may meet
by telephone conference or other similar means. Notwithstanding the
foregoing, the Development Committee shall not have any authority
to alter in any way the substantive rights of the parties hereto
set forth in this Agreement.
6.3 Project Review Process .
The Development Committee shall meet no less frequently than
semi-annually to review ongoing status of active projects, new
project concepts and project plans. Should Ethicon decide to fund
development of any project that may result in a New Product or
Improved Product, Neoprobe will present to Ethicon in writing a
project plan including, at a minimum, specifications for the
potential product, a budget, and a development timetable. In
addition, the parties will negotiate in good faith Provisional
Transfer Prices and purchase commitments, if any related to the
potential product. Ethicon will have sixty (60) days from
presentation of the project plan to decide whether or not to fund
the project. Should Ethicon decline to fund the development or not
respond on a timely basis, Neoprobe may elect to fund the project
at its own expense. Following completion of a functional prototype
for a New Product or Improved Product, Neoprobe will be obligated
to present the prototype to Ethicon for evaluation. Ethicon and
Neoprobe will review the prototype and related materials and use
commercially reasonable efforts to negotiate Transfer Prices,
Provisional Transfer Prices and purchase commitments. If Ethicon
declines to negotiate or if the parties
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cannot
agree on a Provisional Transfer Price and purchase commitment
within ninety (90) days following presentation of the
prototype, Neoprobe will be free to distribute the product through
third parties, provided that the terms of distribution with third
parties are not more favorable to Neoprobe than the terms of
distribution discussed with Ethicon.
6.4 Ethicon Requested Development
Projects . Should Ethicon wish to develop a product with a
third party for use within the Field that may be considered to
compete with a Product, Ethicon will request, in writing, Neoprobe
to submit a proposal on the development project. Ethicon’s
request for the development proposal shall include, at a minimum,
summary specifications for the potential product, a target
development budget, a development timetable and a target market
price. Neoprobe will have sixty (60) days from presentation of
the proposal request to determine whether or not to submit a
proposal for the project, and to notify Ethicon of its decision.
Should Neoprobe decline to submit a proposal, Ethicon may engage a
third party to develop the potential product. Should Neoprobe
decide to submit a proposal, Neoprobe will have an additional sixty
(60) days to submit a formal proposal. Neoprobe will then present
to Ethicon in writing a project plan including, at a minimum,
specifications for the potential product, a budget, and a
development timetable. Ethicon and Neoprobe agree to use
commercially reasonable efforts to negotiate for no less than
(90) days from presentation of the details of the project
plan, including, but not limited to, the development budget and
timetable, the level of funding and/or resources to be committed by
each Party, Transfer Price terms, Provisional Transfer Prices and
purchase commitments. If the parties cannot agree on terms within
ninety (90) days, Ethicon will be free to engage third parties
to develop the potential product, provided that the terms of
development and/or potential distribution with third parties are
not more favorable to Ethicon than the terms of development and/or
distribution discussed with Neoprobe.
6.5 New and Improved Products
. If the Parties agree on Transfer Price terms, Provisional
Transfer Prices and purchase commitments for any New Product or
Improved Product pursuant to Sections 6.3 or 6.4, such New
Product or Improved Product will be added to the Agreement and
shall become a Product within the meaning of
Section 2.15.
12. Paragraph 11.1 of the Agreement is hereby amended
and restated in its entirety as follows:
11.1 Warranty . Neoprobe
warrants during the warranty period set forth under Section 11.2
below that all Products delivered to Ethicon under this Agreement
shall be manufactured in a






