EXTRACARPARCAL DISPOSABLES DISTRIBUTION AGREEMENTDistribution Agreement |
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Exhibit 10.4
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
Securities and Exchange Commission. Asterisks denote omissions.
EXTRACORPOREAL DISPOSABLES DISTRIBUTION AGREEMENT
This
Agreement, dated as of July 25, 2007 (the “Effective
Date”), is between Medisystems Corporation, a Washington
corporation with offices at 701 Pike Street, 16th Floor, Seattle,
Washington 98101-3016 (“MDS”) and Henry Schein, Inc. a
Delaware corporation with offices at 135 Duryea Road, Melville, NY
11747 (together with its subsidiaries, “Schein”).
In
consideration of the mutual promises made herein and other good and
valuable consideration, the receipt of which is hereby
acknowledged, the parties hereto agree as follows:
1.0 BACKGROUND
1.1 The following are examples of
certain disposable medical devices useful in dialysis and pheresis
therapies (collectively, the “Products”):
| a. | Blood, dialysate and/or fluid sets for dialysis such as blood tubing sets, peritoneal sets, reversing connector sets, priming sets and the like (“BTL”), | ||
| b. | extracorporeal access needle sets such as AVF needle sets, pheresis needle sets, ButtonHole needle sets, Vasca access needle sets and the like (“AVF”), | ||
| c. | antistick, plastic access needle/connectors and the like (“Needleless”), and | ||
| d. | air filters, such as transducer protectors, diagnostic pressure measurement devices and the like (“TP”). |
MDS designs and supplies certain
Products under Specifications (as hereinafter defined) including
MDS labeling which MDS controls and currently has produced by
subsidiaries or contract manufacturers (“MDS
Products”). Schein wishes to purchase certain MDS Products
for resale to its dialysis customers in certain countries of the
world as listed in Exhibit A (the
“Territory”).
2.0 TERM OF AGREEMENT
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2.1 The term (including any
extensions, the “Term”) of this Agreement shall be for
a two year period beginning on the Effective Date of this
Agreement. The Agreement shall terminate at the end of the Term,
unless the parties agree on provisions for an extension of the Term
not less than six (6) months prior to the date on which this
Agreement would otherwise terminate.
3.0 MDS PRODUCTS
3.1 The MDS Products that Schein
wishes to purchase pursuant to this Agreement are listed in
Exhibit B as “MDS BTL”, “MDS AVF”,
“MDS Needleless”, “MDS TP”, etc., as such
Exhibit B may be amended from time to time by mutual agreement
of the parties. The codes of the MDS Products that are the subject
of this Agreement are hereafter referred to as “Codes”.
The Codes shall meet specifications as set forth in Exhibit C,
or as such specifications, including labeling may be modified from
time to time pursuant to Sections 9.1, 9.2 and 9.3 (the
“Specifications”), provided that such modifications are
agreed upon in amendments to Exhibit C signed pursuant to
Section 18.3 hereof.
MDS reserves the right, at its sole
discretion, to incorporate clinical use enhancements or
developments in existing Codes of the MDS Products or to supply
existing Codes from alternate manufacturing sites even if MDS
designates them with a different Code prefix, provided that no
price increase is requested by MDS.
4.0 PURCHASES AND ORDERS
4.1 Subject to the terms and
conditions of this Agreement, MDS shall sell the MDS Products
listed in Exhibit B to Schein and Schein shall purchase the
MDS Products listed in Exhibit B for use or resale by Schein
only in the Territory.
4.2 “Contract Year” shall
mean the twelve-month period commencing on the Effective Date and
each subsequent twelve-month period during the Term.
4.3 During the Term of this
Agreement, Schein hereby agrees to sell in the Territory BTL and
AVF sourced only and exclusively from among MDS BTL and MDS AVF
listed in Exhibit B (the “Exclusive Products”).
Except as provided in this Agreement, Schein shall not purchase or
sell in the Territory any Products identical, similar or
competitive to Exclusive Products from any other supplier
(“Competing Products”).
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Further, during each [**] month
period during the Term of this Agreement, Schein shall purchase
from MDS, by way of valid Delivery Orders (as hereinafter defined)
only, not less than [**] pairs of MDS BTL and [**] each-equivalents
of MDS AVF (the “Purchase Commitment”).
Notwithstanding the above, if during
any Contract Year during the Term of this Agreement MDS or its
affiliates sells more than $[**] worth of either the MDS BTL or the
MDS AVF listed in Exhibit B directly to any provider of
chronic in-center dialysis services, then for such Contract Year
and for any remaining Contract Year during the Term of this
Agreement, Schein shall be relieved of its obligation not to
purchase or sell either BTL and/or AVF, as the case may be, that
are Competing Products.
The failure of Schein to order the
minimum quantities of the Purchase Commitments shall be a material
breach of this Agreement, and shall entitle MDS to terminate this
Agreement pursuant to Section 14.1 hereof and to seek any and
all other remedies provided for in this Agreement.
4.4 Schein hereby warrants that as of
the Effective Date, Schein neither purchases from any source nor
sells, any Competing Products in the Territory.
4.5 After the Effective Date, except
as set forth in Sections 8.1 and 8.9, MDS shall not sell
Exclusive Products to any Med/Surg Distributor (as hereinafter
defined), other than Schein, in the Territory. For the purposes of
this Agreement a “Med/Surg Distributor” is defined as a
distributor who distributes general medical/surgical items such as
syringes, gauze, drugs, etc. rather than one who distributes
primarily dialyzers, dialysis services and/or dialysis machines.
Med/Surg Distributors include [**] and other similar general
medical surgical item distributors.
4.6 Notwithstanding 4.5 above, as of
the Effective Date, MDS sells or may sell MDS Products, including
Exclusive Products, to dialysis specialty distributors currently
including Fresenius Medical Care, Inc., Baxter Healthcare
Corporation, NxStage, Inc., Gambro Renal Products, Inc., B. Braun
Medical and Sorb Technology, each of which is a manufacturer or
exclusive importer of a hemodialyzer, hemodialysis machine,
implanted dialysis access port or provider of specific dialysis
services. All MDS Products sold to [**] are
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intended
for exclusive use by [**] as a provider of specific dialysis
services in its owned or managed facilities and for the home-care
patients thereof. MDS, to the extent allowable by law, will not
sell MDS Products to [**] with the intent that [**] will
distribute, redistribute, resell, or otherwise transfer to any
other third party any MDS Products during the term of this
Agreement.
4.7 Except as set forth in
Section 8.9, MDS shall not sell Exclusive Products to any
distributor at more favorable prices, including [**], discounts and
the like, than those offered to Schein for similar Delivery Order
or Purchase Commitment quantities.
4.8 Prior to the [**] day of each
month during the Term of this Agreement (the “Order
Date”), Schein will provide MDS with one or more
noncancellable delivery order(s) (a “Delivery Order” or
“Delivery Orders”) for the MDS Products. Any Delivery
Order provided to MDS after the [**] day of the month shall be
deemed to have an Order Date on the [**] day of the subsequent
month. The requested delivery date (“Due Date”)
provided by Schein on each Delivery Order shall be not earlier than
[**] days after the Order Date for all Products. Each Schein
Delivery Order for delivery to each FOB Location (as hereinafter
defined) shall conform to the per Code or per MDS Product quantity
minimums and multiples stated in Exhibit B.
Any Delivery Orders with a common Due
Date, FOB Location and Manufacturing Location that cumulatively
comprise less than the number of pallets required to comprise full
container loads or truck loads as indicated in Exhibit B,
shall be subject to freight cost premiums as quoted to Schein by
MDS at the time the Delivery Order is accepted.
4.9 MDS shall not be required to
accept any Schein Delivery Orders with a common Order Date to the
extent that the quantity of Codes in any Code Group so ordered
exceeds [**] percent ([**]%) of the average monthly quantity
ordered during the immediately preceding [**] months. If accepted,
such excess quantities shall be deemed to have an Order Date on the
[**] day of the next subsequent calendar month and shall remain
subject to the provisions of this Section. If MDS reallocates any
Schein Delivery Orders pursuant to this Section 4.9, it shall
consult with Schein to determine which orders shall be reallocated
to a future Order Date.
Notwithstanding the foregoing, MDS
shall be obligated to deliver MDS Products in excess of such [**]%
if the Delivery
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Orders
for such excesses are for Codes to be sold by Schein to customers
already purchasing such Codes from another MDS Contract
Distributor, but only to the extent that the excesses in Delivery
Orders are for such sales.
4.10 To the extent Schein commences
sale to any new customer with more than [**] hemodialysis patients
and, as a result, Schein’s Delivery Orders to MDS increase
significantly, MDS’s timely delivery of such increased
quantities of MDS Products shall not be subject to the provisions
of Section 8.5. In such a circumstance, however, MDS will use
reasonable commercial efforts to fulfill all of Schein’s
requirements as soon as commercially possible.
4.11 Notwithstanding the foregoing,
during the final [**] months of this Agreement as determined in
accordance with Section 2.1 hereof, MDS shall not be obligated
to accept Delivery Orders to the extent that they cumulatively
exceed [**]% of the cumulative quantity of MDS Products ordered
pursuant to Delivery Orders placed in the immediately preceding
[**] month period.
4.12 In the event that either Schein
or MDS determines that [**], Schein and MDS shall [**]. In the
event that Schein and MDS agree on a [**], MDS and Schein shall
[**] agree to a [**] which will include such [**]; provided,
however, that Schein [**] to the extent of [**]. As of the
Effective Date, all [**] under any previous agreement between MDS
and Schein are [**], and new [**] may be [**]. All [**]. The [**]
will be [**] as reasonably possible
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based on
[**].
MDS shall be [**] including but not
limited to; [**].
4.13 By the [**] day of each month
during the Term of this Agreement, Schein shall provide MDS with a
non-binding forecast of the quantity of each Code Schein estimates
it shall place orders for during the following [**] months. These
forecast figures will be e-mailed to the Marketing Services Manager
[**].
By the [**] day of each month, Schein
shall also provide Schein end-user sales information to MDS from
the previous month, including MDS Product sales across all Schein
divisions. Such sales information shall include; the Code,
quantity, end-user name, end-user city and end-user state. By the
[**] day of each month, Schein shall also provide its ending
inventory information from the previous month to MDS, including
inventory amounts across all Schein divisions, by Code and
warehouse.
5.0 SHIPMENT OF MDS PRODUCTS
5.1 MDS will ship the MDS Products,
freight and insurance paid, to the F.O.B. location specified on
Schein’s Delivery Order (“F.O.B. Location”) at
the prices listed in Exhibit D, provided however, Schein shall
only specify F.O.B. Locations listed in Exhibit D. MDS and
Schein may agree to add new F.O.B. Locations at any time provided
the prices for delivery to such F.O.B. Locations shall be added by
amendment to Exhibit D, signed pursuant to Section 18.3
hereof.
5.2 MDS shall prepare and send by
facsimile transmission or via e-mail to Schein a packing list for
each shipment of MDS Products. This shipping information will
include Schein’s specific purchase order number, item
shipping quantities, and item back order information. When MDS has
the necessary systems and procedures in place, the packing slip
will also accompany
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the
shipment to avoid loss of missing faxes and to reduce the chance of
mismatching the paper to the shipment.
5.3 MDS shall notify Schein as soon
as MDS becomes aware that any shipment may not be delivered within
a period commencing [**] days prior to the Due Date and ending [**]
days after the Due Date applicable to a Delivery Order, such period
being hereinafter referred to as the “Delivery Window”.
Except as set forth in Section 8.1, if MDS is delinquent with
Delivery Orders properly placed by Schein and accepted by MDS in
accordance with the terms of this Agreement, and as a result, to
the degree that Schein has insufficient MDS Products to ship to its
customer in its customary manner and at customary prices, MDS will
be responsible for incremental freight costs including all priority
and cross shipping charges associated with MDS delayed order
fulfillment provided that the proper documentation of such
incremental charges is produced, with prior written authorization
by MDS, of which such authorization shall not be unreasonably
withheld.
5.4 Schein will notify MDS in writing
of any receiving discrepancy (over, short or patently damaged),
within [**] business days of receipt of such delivery. Schein
hereby agrees to hold the relevant part (over, short or patently
damaged) intact pending resolution by MDS. At the time of receipt
of MDS Products by Schein, any damage, shortage or overage noted at
that time must be noted by Schein on the Bill of Lading. Credit
will be issued only upon MDS’ verification of such damage,
shortage or overage, which verification shall not be unreasonably
with-held. MDS hereby agrees to arrange verification and to provide
a disposition of such receiving discrepancy within [**] business
days from receipt of such notice. In the event of a receiving
discrepancy, for the purpose of Section 7.1, MDS’s
invoice shall be deemed to be dated on the date MDS provides the
disposition.
5.5 Schein accepts MDS’s
standard packaging and palletizing methods. MDS will examine
proposals to modify the palletizing methods as requested by Schein,
and provided these modifications are approved by MDS, Schein agrees
to pay any additional costs and to accept responsibility for any
damage related to the new packaging methods. MDS will use
reasonable best efforts to revisit its pallet size and work to
conform to the Schein rack height configurations.
6.0 PRICES
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6.1 During [**] of this Agreement,
MDS will sell the Codes meeting the Specifications set forth in
Exhibit C to Schein, and Schein agrees to buy the MDS Products
from MDS at the base prices and at F.O.B. Locations listed in
Exhibit D (“Base Prices”). MDS makes no commitment
to provide any Code at these Base Prices beyond [**] of this
Agreement. Any price increase for [**] shall be limited to
MDS’ increased costs of goods sold. MDS shall notify Schein
of the prices for the second Contract Year [**] months after the
Effective Date.
6.2 [**] months prior to the end of
the initial two year Term of this Agreement, and [**] months prior
to the end of the last year of any extension of the Term of this
Agreement, MDS may submit to Schein a written proposal for a
revised Exhibit D which, if submitted, shall set forth
MDS’ proposed prices for MDS Products applicable during the
next term of this Agreement, subject to the other terms and
conditions of this Agreement, if the parties agree to extend this
Agreement.
6.3 The quantity prices listed in
Exhibit D are set forth on the basis of the total quantity of
Delivery Orders placed during each Contract Year for Codes. Prices
include all United States import duties, clearing charges, and
freight up to the F.O.B. Location designated.
6.4 It is expressly agreed that Base
Prices for the MDS Products include delivery in full trailer load
or container load quantities to each F.O.B. Location, by ocean
freight or least cost overland method. Premiums for (i) air
freight, (ii) LTL shipments, (iii) expedited delivery,
(iv) shipments of partial orders, or (v) other unusual or
extra transportation expenses, if authorized in advance by Schein
in writing, (“Premiums”) will be invoiced to
Schein.
6.5 Schein will qualify for an
additional [**]% discount (“Additional Discount”) from
MDS, provided their Net Purchases (as hereinafter defined) from MDS
are greater than $[**] over the most recent [**]-month period. If
Schein does qualify for such Additional Discount, the Additional
Discount will be calculated at the conclusion of each calendar
quarter, and shall be credited to Schein within 30 days of the
end of the calendar quarter. Net Purchases are equal to the dollar
amount invoiced by MDS to Schein, less all credits and discounts,
including but not limited to all product returns, [**] and
quick-pay discounts. MDS and Schein agree that should a change
occur within section 4.6 of this Agreement with respect to a
dialysis specialty customer, and as a result of such change the
amount of
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MDS
Products that Schein is purchasing would materially increase, the
companies agree to adjust the Net Purchases requirement of $[**] to
a new figure mutually agreeable to both companies.
7.0 PAYMENT
7.1 The terms of payment for the MDS
Products purchased by Schein under this Agreement shall be [**]
days [**] from MDS’s invoice date, as determined by the date
of collected funds receipt of wire transfer or ACH transfer to
MDS’ designated financial institution. Any amounts not paid
within [**] days from the invoice date shall be subject to a
service charge until paid, in an amount equal to [**]% per month.
Such service charge shall be computed on the last working day of
the calendar month, on a pro rata basis if applicable, for invoices
[**] days old or more. In addition, if full payment including
service charge is not received by MDS within [**] days from
MDS’s invoice date MDS may restrict weekly sales to Schein to
a dollar amount equal to the payments received from Schein in the
previous week. If full payment is not received by MDS within
[**] days of MDS’s invoice date Schein shall be
considered to be in material breach of this Agreement and subject
to Section 14.1.
MDS may invoice Schein upon email
notification to Schein that MDS Products are available for carrier
pickup at the FOB location listed in Exhibit D.
7.2 All Schein payments are to be
made by either wire transfer or ACH transfer and remitted to the
financial institution designated by MDS to receive such
payments.
8.0 DELAYED AND REPLACEMENT PRODUCTS
8.1 MDS assumes no liability and
shall not be liable to Schein for any failure to fill or delay in
filling Delivery Orders received from Schein to the extent such
failure or delay results from strikes, lockouts, or any other labor
troubles, floods, fires, accidents, delays in the delivery of raw
materials, parts or completed merchandise by the supplier thereof
or any cause beyond the control of or occurring without the fault
of MDS. In the event of any delay caused by any of the above, MDS
shall use commercially reasonable best efforts to fulfill
Schein’s orders in a timely fashion, provided, however, that
in the event of a shortage of available MDS Products, whether
resulting from market conditions, manufacturing
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constraints, FDA action against any company or otherwise, MDS may
allocate supply between Schein and other MDS customers at its
discretion, but will use commercially reasonable best efforts to
allocate in reasonable proportion to Schein’s market share,
as compared to the total market size. MDS shall notify Schein
promptly if it anticipates any potential delay in the filling of
any of Schein’s Delivery Orders caused by any of the
above.
In the event an FDA action against
any company results in a reduction of [**]% or more in the overall
market supply within the Territory of any product type (AVF, BTL,
etc.) MDS may allocate supply of MDS Products within such product
type to any customer or distributor at its discretion without
regard to the provisions of Sections 4.5, 4.6 or 4.7.
8.2 Schein assumes no liability and
shall not be liable to MDS for any failure to place Delivery Orders
to the extent that such failure is because of strikes, lockouts, or
any other labor troubles, floods, fires, accidents, or any cause
beyond the control of or occurring without the fault of
Schein.
8.3 Notwithstanding Section 4.3,
Schein may be relieved of its commitment to purchase Exclusive
Products only from MDS, in whole or in part, at Schein’s
option, should MDS be in material breach of this Agreement, if such
breach remains uncured [**] days after MDS receives notice from
Schein of such breach.
8.4 Notwithstanding Sections 4.3
and 4.8 Schein may, at its option, be relieved of its obligations
with respect to any specific Delivery Order, in whole or in part,
at Schein’s option, should a delay caused by an event
described in Section 8.1 occur, if such delay is uncured
within [**] days after the Delivery Window of such Delivery Order.
To the extent MDS is unable to deliver within [**] days after the
Delivery Window applicable to any Delivery Order MDS Products
delayed by an event described in Section 8.1, Schein may
purchase replacement Products from others.
8.5 Except as set forth in
Sections 4.8 and 8.1, if MDS is unable to deliver MDS Products
during the Delivery Window applicable to a Schein Delivery Order,
or MDS replaces MDS Products pursuant to sections 11.3, 13.2 or
16.1, MDS will deliver or replace the MDS Products as soon as
possible, on an expedited basis (via air freight, exclusive use
truck, overtime customs clearance or similar means) at MDS’
expense if requested by Schein.
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8.6 To the extent MDS is unable to
deliver MDS Products within [**] days of the Delivery Window
applicable to a Schein Delivery Order, Schein may, at its option,
purchase Products from other suppliers to meet its immediate needs.
Schein also reserves the right to cancel outstanding orders if the
[**] day Delivery Window is not met, up to the amount of orders not
delivered to Schein within the Delivery Window.
8.7 To the extent that Schein,
pursuant to Sections 8.6, 10.1, 12.1 or 16.1, but not Section
8.1, purchases replacement products from others, which are
documented to be not of MDS origin and more expensive than the
relevant MDS Products, MDS shall credit Schein a portion of the
cost of such replacement products up to [**]% of the applicable
price of the MDS Products which were replaced or the cost of the
replacement products, whichever is less, provided that Schein
supplies MDS with copies of such orders and the invoices related
thereto. To the extent Schein purchases and is credited for such
replacement or fill-in products from others, it shall be relieved
of its obligation to take delivery of and pay for equivalent
quantities of MDS Products pursuant to Delivery Orders.
8.8 Schein and MDS will make a
cooperative effort to evaluate and implement supply chain
improvement opportunities, as mutually agreed upon.
8.9 To the degree that Schein has
Obsolete Inventory or Excess Inventory (as hereinafter defined) and
Schein advises MDS of such Product inventory, Schein and MDS will
make reasonable cooperative efforts to transfer to other MDS
Contract Distributors; return to MDS; or promote to Schein’s
customers at a reduced price. Products that are no longer sold by
MDS as a Code or specification (“Obsolete Inventory”)
or Products considered by Schein to be at inventory levels greater
than sales projections (“Excess Inventory”) may be
requested for return to MDS, up to a maximum MDS invoice value of
$[**] per calendar quarter (“Quarterly Credit”) without
carryover of such Quarterly Credit, provided that any such Products
returned to MDS are no older than [**] months after Sterilization
Date and provided further that if MDS notifies Schein (in a form
substantially similar to Exhibit I) that Schein is placing an
order for Products that MDS reasonably believes will become
Obsolete Inventory or considered Excess Inventory by Schein before
such product can be sold, and notwithstanding such advice Schein
refuses to revise such orders within [**] business days, and orders
such volume, MDS will not accept the return of such Products.
Schein must submit in writing any potential Quarterly Credit,
within the calendar quarter, or it cannot be submitted
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for that
quarter. MDS shall have the right to resell such returned Products
to any party that it wishes to, including any Med/Surg Distributor.
In addition, any approved returns pursuant to section 11.3 of this
Agreement will not be included in the Quarterly Credit.
MDS must receive any such qualified
returned Products at MDS’ specified location within [**] days
after providing written return authorization to Schein, or such
return shall be disallowed.
8.10 [**] each calendar quarter,
Schein shall conduct a physical inventory review of all MDS
Products at all Schein warehouses for the purpose of determining
any inventory greater than [**] months and [**] months old based
upon the lot number. Schein shall report to MDS each such Code,
lot, quantity and location. Schein shall prioritize all MDS
Products over [**] months old for early shipment. Schein shall
manage all MDS Products [**] months old in a high priority fashion
for immediate shipment to the next order, or in accordance with
Section 8.9 if applicable.
9.0 MDS PRODUCT CHANGES AND NEW MDS
PRODUCTS
9.1 During the Term of this
Agreement, MDS shall offer, on a non-exclusive basis, to
incorporate into the MDS Products any clinical use enhancements or
developments or new MDS BTL or MDS AVF that MDS designs, which
enhancements, developments or products MDS controls, such
enhancements being subject to prior sale, exclusive license or
exclusive contract.
9.2 If Schein agrees in writing to
accept any such enhancement or development or new MDS BTL or MDS
AVF, and the parties agree in writing on any price adjustment made
necessary or possible by such enhancement or development, Exhibits
B, C and D shall be amended to incorporate such changes.
Notwithstanding the above, MDS reserves the right to incorporate
clinical use enhancements or developments in MDS Products as
described herein, in accordance only with Section 9.3,
provided that no price increase is requested by MDS.
9.3 MDS shall notify Schein in
writing, using the “Vendor Notice of Change” form
attached as Exhibit F, at least [**] days prior to any
substantial change in design of the MDS Products, components of the
MDS Products or packaging which may necessitate in-servicing or
notification to end-users.
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