<PAGE>
Exhibit 10.17
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
SUPPLY AGREEMENT
THIS
SUPPLY AGREEMENT (the "Agreement") dated as of October 26, 2004,
by
and between B. BRAUN MEDIZINTECHNOLOGIE
GMBH, a corporation organized under the
laws of Germany having offices at
Schwarzenberger Weg 73-79, 34212 Melsungen,
Germany, ("B. Braun") and NxStage Medical,
Inc., a Delaware corporation, having
offices at 439 South Union Street, 5th
Floor, Lawrence, Massachusetts, USA
("Company").
BACKGROUND
Company
desires to purchase from B. Braun, and B. Braun desires to
supply
Company with, the products described
herein, under and subject to the terms and
conditions set forth in this Agreement.
AGREEMENT
NOW,
THEREFORE, in consideration of the foregoing premises and the
mutual
covenants and agreements provided herein,
the parties hereto, intending to be
legally bound hereby, agree as follows:
1. Definitions. When used in this
Agreement, capitalized terms, including their
plural form, shall have the following
meanings:
1.1
"Agreement"
means this Agreement and all appendixes, exhibits and
schedules hereto, and all modifications,
amendments and supplements hereof.
1.2
"Company
Trademarks" means, collectively, the trademarks, the
service marks and related intellectual
property rights, which Company owns or
has the right to use, as appropriate, all
as more fully set forth on Appendix C
attached hereto.
1.3
"Contract Year"
means each twelve (12) month period during the term
of this Agreement, commencing on January 1,
2005 and each annual anniversary of
this date, and ending one day prior to the
commencement of the succeeding
Contract Year.
1.4
"Delivery Date"
means the date on which the Products are delivered
to a European seaport mutually acceptable
to both parties.
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Technical Agreement between NxStage and
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1.5
"GMP" or "Good
Manufacturing Practice" means the part of quality
assurance which ensures that medicinal
products are consistently produced and
controlled to the quality standards
appropriate to their intended use, as
reflected in the pharmaceutical and medical
device industry standards for the
European Union and the FDA in the USA and
the similar guidelines of any other
recognized national regulatory body
applicable to the Territory, as amended from
time to time in force at the relevant time
during the term of this Agreement.
1.6
"Product" means,
individually and collectively, the Products listed
on Appendix A hereto, as further described
in the Technical Agreement.
1.7
"Specifications"
means the Product Specifications included as part
of the Technical Agreement.
1.8
"Technical
Agreement" means the Technical Agreement signed by the
parties attached as Appendix B hereto,
which includes the Product
Specifications, and hereby made a part of
this Agreement, and any modifications,
amendments and supplements thereof and
thereto.
1.9
"Territory"
means Canada and the United States of America, including
Puerto Rico and the U.S. Virgin Islands,
but no other U.S. territories or
possessions.
2. Manufacture and Supply of Product.
2.1
During the term
of this Agreement and any extension or renewal
thereof, B. Braun shall manufacture and
supply to Company and Company shall
purchase from B. Braun on a non-exclusive
basis the Products for sale in the
Territory. Company shall not market, sell
or distribute, directly or indirectly,
any Products manufactured by B. Braun for
Company outside the Territory or to
any party for use outside the Territory.
Company further agrees that all
bicarbonate-based Products shall only be
sold to customers within the Territory
that are using the NxStage System One, or
its successor product. All Products
shall be manufactured and supplied to
Company in accordance with GMP.
2.2
Company shall
submit binding purchase orders for Products not less
than [**] prior to the requested Delivery
Date for Products, together with a
rolling non-binding forecast of orders of
Products for the succeeding nine
months. Each purchase order shall specify
the name, Product number and
quantities of each of the Products to be
purchased, the desired Delivery Dates
and shipping instructions. Orders placed
for each type of Product shall be in a
minimum quantity of one batch per each
requested Delivery Date as more
specifically described in Appendix A.
Delivered quantity for each item code will
be [**]% of order quantity.
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Technical Agreement between NxStage and
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Page 3
2.3
During each
Contract Year hereunder, Company agrees to purchase the
minimum number of units of Products as
provided in Appendix A of this Agreement
("Minimum Purchase Requirement"). If the
Agreement terminates prior to the full
duration of any Contract year, then the
Minimum Purchase Requirement will be
pro-rated in proportion to the number of
months in such Contract Year prior to
termination. Company acknowledges that the
Minimum Purchase Requirement is a
material term of this Agreement and is a
material inducement for B. Braun to
grant the pricing and other terms of this
Agreement as provided herein, and if
Company fails to achieve the Minimum
Purchase Requirement in any Contract Year,
or partial Contract Year, as the case may
be, then Company will pay to B. Braun
[**]% of the Average Product Price (as
defined below) multiplied by the amount
of the shortfall. For purposes hereof,
"Average Product Price" shall mean the
quotient of Company's gross purchases in a
Contract Year divided by the total
number of units of Products purchased by
Company during the Contract Year.
2.4
Company shall
use all reasonable endeavors when placing purchase
orders with B. Braun to ensure that
purchase orders correspond to anticipated
requirements set forth in the rolling
forecasts delivered to B. Braun. B. Braun
shall use all reasonable endeavors to
accept purchase orders that are in line
with rolling forecasts and that are not in
excess of Maximum Order Quantities
defined in Appendix A. B. Braun shall use
all reasonable endeavors to satisfy
purchase orders that are not in line with
the rolling forecasts or Maximum Order
Quantities on a date that shall be agreed
between both companies. Company and B.
Braun shall agree to monthly Maximum Order
Quantities for the succeeding
Contract Year at least 30 days prior to the
end of the then-current Contract
Year.
2.5
In the event
Company cancels any accepted purchase orders for
Products, Company shall be responsible to
pay B. Braun (a) the full price for
the cancelled Products for which delivery
is scheduled within the next [**], and
(b) the average gross margin (assumed for
purposes of this Agreement to be [**]%
of the pricing outlined in Appendix A) for
the remainder of the Products covered
by the order.
3. Product Specifications; Manufacturing
Processes; Etc.
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Technical Agreement between NxStage and
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Page 4
3.1
Company
represents, warrants and agrees that the Specifications for
the Products satisfy Company's requirements
for its intended use of the
Products. If at any time during the term of
this Agreement, Company desires to
modify the Specifications, Company shall
have the right to modify or change the
Specifications, subject to B. Braun's
approval, which approval shall not be
unreasonably withheld. Upon receipt by B.
Braun of notice requesting a
Specification change, B. Braun shall have
the right (i) to adjust the price of
the Product to reflect any actual and
necessarily incurred changes in the cost
of raw materials, direct labor and overhead
that will result from such
modification or change (provided that B.
Braun has reasonable documentation of
the basis for such change and provides the
Company notice of such price change
before accepting Company's order for the
new Products), and (ii) to the extent
necessary, extend the Delivery Dates for
the Products. Following a change to
Product Specifications, Company shall (a)
purchase all Products made for Company
that are in B. Braun's inventory (if such
Products were made pursuant to
accepted purchase orders) and (b) reimburse
B. Braun for the cost of all raw
materials and components purchased on
behalf of Company, if such materials and
components are unique to Company or cannot
be used in the manufacture of
products by B. Braun for other customers or
in the manufacture of future
Products for Company and if the quantities
ordered of such materials and
components are consistent with Company's
forecasted demand for Products over the
succeeding three-month period, and (c)
reimburse all reasonable termination fees
with its suppliers and reasonable
administrative termination costs with respect
thereto, if applicable, again to the extent
the fees and costs relate to orders
with suppliers that are consistent with
Company's forecasted demand for Products
over the succeeding three-month period.
3.2
B. Braun shall
have the right to modify or change the manufacturing
procedures or practices used to make or
assemble the Product; provided that,
following such modification or change, the
Product continues to meet the
Specifications. B. Braun shall inform
Company about such modification. Company
shall not assert any right to the design of
the Products in contravention of B.
Braun's rights.
3.3
At Company's
request, B. Braun may from time to time furnish
technical and design assistance, advice and
information with respect to the
Products, which assistance, advice and
information is provided at no additional
cost to Company and at Company's own risk.
No agent, employee or other
representative has the right to modify or
expand B. Braun's warranty applicable
to the Products or to make any
representations other than those warranties and
representations expressly provided in
Section 6 of this Agreement, and if made,
should not be relied upon by Company.
Company is solely responsible for making
its own independent determination whether
the Products and the Specifications
will suit its needs and intended uses (even
if B. Braun is aware of Company's
needs and intended uses), and Company
acknowledges that it does not rely upon,
and will not rely upon any representation
or warranty of B. Braun, except for
the express representations and warranties
provided in this Agreement.
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Technical Agreement between NxStage and
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Page 5
3.4
All Product
provided by B. Braun will contain Company's labeling for
sale to end user customers and/or
distributors of Company. The labeling will
contain a statement that the Product is
"Manufactured for NxStage" and such
other labeling as may be required by law.
Company shall be responsible for all
regulatory requirements relating to the
labeling and sale of Products, and shall
review and approve, and be solely
responsible for all Product labels/labeling
and instructions for use included with the
Product. Any additional costs due to
copy and artwork changes shall be borne by
Company.
3.5
Company hereby
grants to B. Braun a non-exclusive, non-transferable,
royalty-free license to use the Company
Trademarks without alteration or
modification solely with respect to B.
Braun's labeling of the Products during
the term of this Agreement and not for any
other purpose. B. Braun acknowledges
Company's ownership of or right to use the
Company Trademarks. B. Braun further
acknowledges that neither this Agreement
nor the use by B. Braun of the Company
Trademarks shall create any right, title or
interest in or to the Company
Trademarks by B. Braun. This Agreement is
not intended to convey and does not
convey to B. Braun the right to use any
trademarks or service marks of Company
other than the Company Trademarks for the
use set forth herein. This license
shall include the right of B. Braun to
sublicense the Company Trademarks to any
of B. Braun's suppliers of the Product or
Product components for similar
labeling purposes and under similar
conditions.
3.6
As of the date
hereof, B. Braun has no actual knowledge of any
issued U.S. third-party patents concerning
the containers or flexible bags used
in the Products or the procedures used in
manufacturing the Products that would
be infringed by selling or marketing the
Products in the Territory. As of the
date hereof, Company has no actual
knowledge of any issued U.S. third-party
patents concerning the dialysate
formulations used in the Products that would be
infringed by selling or marketing the
Products in the Territory. If at any time
during the term of this Agreement, a
third-party U.S. or European (including
especially German or Swiss) patent
infringement or misappropriation of trade
secret suit relating to any Product is (i)
threatened against B. Braun or
Company (and either B. Braun or Company,
respectively, reasonably determines
that such threat is credible) or (ii) filed
against either B. Braun or Company,
then B. Braun or Company, respectively, may
cease supplying or purchasing,
respectively, such Product (and only such
Product) without any liability
hereunder immediately upon providing
written notice to the other party.
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Technical Agreement between NxStage and
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Page 6
4. Price and Payment.
4.1
The price of the
Products shall be as set forth in Appendix A
hereto. The price for Products shall remain
firm for the first Contract Year of
this Agreement. At least [**] prior to the
end of each Contract Year, the
parties shall meet in person or by phone to
negotiate new Product pricing to
account for changes in Product volumes,
process improvements, and other changes
to direct manufacturing costs (provided
that B. Braun has reasonable
documentation of the basis for such
change). If B. Braun and Company do not
reach an agreement, following good faith
negotiations, on the new Product
pricing until the end of a Contract Year,
the agreement may be terminated by
either party by three (3) months written
notice. Until said agreement on
purchase pricing or said termination, the
purchase price then existing will
remain in effect.
4.2
B. Braun shall
bear all taxes based upon or measured by its net
income. Any other tax, however denominated
and howsoever measured, imposed upon
the Products or upon its storage,
inventory, sale, transportation, delivery, use
or consumption shall be the responsibility
of Company. Company shall provide B.
Braun with all appropriate tax exemption
certificates acceptable to the taxing
authorities imposing such taxes, if Company
desires not to make such payments.
4.3
B. Braun shall
invoice Company concurrently with any shipment of
Products and Company shall make full
payment to B. Braun, at the address
specified on the invoice, no later than
[**] days from the Delivery Date. Any
amounts not paid within such [**] period
shall accrue interest at the rate of
[**] percent ([**]%) per month. If it
becomes necessary for B. Braun to employ
any agents or attorneys to collect any
amounts due to it under this Agreement,
the reasonable fees and costs of collection
will be added to any amounts owed by
Company hereunder.
4.4
Title to the
Products shall remain with B. Braun until the purchase
price for such Products has been paid in
full. As long as Company has not paid
in full it is not permitted to deposit or
assign the Products. Company may sell
Products in the ordinary course of its
business before payment has been made in
full. Company herewith assigns to B. Braun
all future rights and claims
including all ancillary rights, including
but not limited to customer bank
guarantees, towards Company's customers
resulting from the sales of Products for
which the purchase price has not yet been
paid in full. Upon request of B.
Braun, and if Company is in payment
default, Company shall be obligated to
notify its customers holding Products to
which B. Braun legally retains title
hereunder of the assignment and to furnish
B. Braun with all information
required for collection of the claim and to
provide B. Braun with all necessary
documents. As long as B. Braun has no doubt
about the Company's ability to pay,
Company shall have no obligation to notify
its customers of the assignment of
title until [**] after receiving a notice
of B. Braun mentioning the default and
B. Braun shall not contact such customers
prior to the expiration of such 20 day
period. As far as not otherwise stipulated
by B. Braun, Company is entitled and
obliged to collect the proceeds of Products
resold, which proceeds shall, in the
event the purchase price therefore has not
yet been fully paid by Company,
become ipso jure property of B. Braun, and
which shall be held by Company
separately from other means of payment for
B. Braun's benefit until payment in
full of the purchase price has been made.
In case of any doubts, retention of
title remains effective until Company
proves that it has paid the purchase price
for such Products in full. In the event a
third party asserts a claim to
Products in which
<PAGE>
Technical Agreement between NxStage and
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Page 7
B. Braun continues to retain title (by
means of attachment or through a claim to
proceeds, or otherwise), Company shall
inform B. Braun without any delay and
notify the third party making such a claim
of B. Braun's rights under this
Section.
5. Delivery.
5.1
All shipments of
Products shall be made F.O.B. mutually agreed
European seaport. B. Braun will attempt to
arrange shipments as nearly in
accordance with the Delivery Dates set
forth in a purchase order as its shipping
facilities and manufacturing schedules
permit. Risk of loss shall pass to
Company upon delivery of the Products to
the carrier at European seaport.
Company shall be responsible for the cost
of all freight, shipping and handling,
and insurance in connection with all
deliveries from the European seaport.
5.2
Company shall
have the obligation to inspect the Products for
compliance concerning identity without
undue delay. Notwithstanding the
provisions of Section 4.3 hereof, Company
shall not be required to accept or pay
for any Product that fails to conform to
the Specifications, provided that the
claimed failure is not ascribable to wrong
transport, handling or storage for
which B. Braun is not responsible. Company
shall perform such inspections
without undue delay, but in any event
within [**] days after receipt at
Company's headquarters or another location
designated by Company, and shall
immediately notify B. Braun in writing if
any Product fails to conform to the
Specifications. In the event Company has
inspected the Products within the
aforementioned period and has notified B.
Braun without undue delay of a failure
and within the warranty period (6.1) and
therefore rejects any Product shown and
documented to be defective, B. Braun agrees
to replace such Product at B.
Braun's sole cost and expense (including
freight charges) or, at B. Braun's
option, reimburse Company the purchase
price paid for such Product, plus the
cost of freight paid by Company. The
acceptance of the Products hereunder shall
not be deemed a waiver by the Company of
the Warranties set forth in Section 6
hereof.
6. Warranties.
6.1
B. Braun
represents and warrants to Company that, at the time of
delivery, the Product delivered by B. Braun
to Company under this Agreement is
free from defects in material and
workmanship, and in accordance with the
applicable Specifications for such Product,
as attached hereto as Appendix B.
All warranties for Product shall continue
for (agreed) Product shelf life.
Company's sole remedy in the event of a
breach by B. Braun of any of the
warranties contained herein shall be at B.
Braun's option, either the repair or
replacement by B. Braun of the defective
Product (along with the cost of
freight) or the reimbursement to Company of
the purchase price Company paid for
such defective Product (plus the cost of
freight paid by the Company for such
Product). B. Braun's warranty, as provided
herein shall be void if any repairs,
changes through the manufacturing process,
alterations or other work has been
performed on such Product, or if the
alleged defect is a result of abuse,
misuse, improper maintenance, accident or
the actions or inactions of any party
other than B. Braun, or if the alleged
defect or harm is caused by the use of
the Product in a manner that diverges from
its U.S. FDA approval or Canadian
Ministry of Health approval, as applicable.
The warranty set forth herein is
conditioned upon the proper storage and use
of the Product. The warranty
furnished hereunder does not extend to
damages to, or resulting in whole or in
part from the use of, components,
accessories, parts or supplies.
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Technical Agreement between NxStage and
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Page 8
6.2
THE LIMITED
WARRANTY SET FORTH IN SECTION 6 HEREOF IS IN LIEU OF ALL
OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING ANY WARRANTY OF MERCHANTABILITY
AND ANY WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE. B. BRAUN HEREBY DISCLAIMS
LIABILITY FOR INCIDENTAL, CONSEQUENTIAL OR
PUNITIVE DAMAGES FOR BREACH OF ANY
EXPRESS OR IMPLIED WARRANTY, INCLUDING ANY
IMPLIED WARRANTY OF MERCHANTABILITY
AND ANY IMPLIED WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE WITH RESPECT TO THE
PRODUCTS. EXCEPT AS OTHERWISE PROVIDED
UNDER SECTION 10, WITH RESPECT TO
INDEMNIFICATION FOR THIRD PARTY CLAIMS, THE
SOLE AND EXCLUSIVE REMEDIES FOR
BREACH OF ANY WARRANTY IS LIMITED TO THE
REMEDIES PROVIDED IN THIS SECTION 6 AND
SECTION 5.2.
7. Regulatory Matters.
7.1
Complaints.
Company shall be responsible for interfacing with its
customers regarding all Product complaints
and inquiries and promptly passing
all such information on to B. Braun, and
Company shall be responsible for
handling all complaints, inquiries and any
federal or state adverse device
experience reporting requirements related
to the Products, including any related
investigation and Product testing. B. Braun
shall provide technical support for
investigating any complaints. If B. Braun
receives any information regarding
adverse reactions or defects of the
Products, B. Braun shall inform Company
thereof. Each party shall reasonably
cooperate with the other in sharing any
information that may constitute an adverse
experience or complaint related to
the Products and shall designate a
representative responsible for the exchange
of such information.
7.2
Recalls. Company
shall have the right to reasonably declare any
recall of, or field corrective action to,
any Products supplied by B. Braun
after consultation with B. Braun. Although
Company shall in good faith consider
B. Braun's recommendations relating to
potential Product recalls, the decision
as to whether to declare a recall shall
belong exclusively to Company.
Notwithstanding the foregoing Company shall
be obligated to declare a recall in
the event B. Braun is convinced that
specific Products might cause serious
damage to a person. In the event of any
such recall or field corrective action
attributable to a breach of the warranties
provided in Section 6 of this
Agreement, B. Braun shall credit Company's
account for the Products recovered
and returned to it as a result of any
recall (or destroyed at B. Braun's
request). In all other cases, Company shall
bear all costs of any recall and
shall reimburse B. Braun for any of its
reasonable out-of-pocket costs in
connection therewith. B. Braun and Company
shall reasonably cooperate with each
other in the event of any recall of any
Product
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Technical Agreement between NxStage and
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Page 9
7.3
Inspections. In
accordance with applicable laws and regulations
governing regulatory inspections, and
without waiving any rights and protections
afforded under such laws and regulations,
B. Braun shall permit authorized
representatives of relevant regulatory
authorities, including FDA, to audit and
inspect B. Braun's Product manufacturing
facilities. Either party hereto shall
promptly notify the other of any
governmental regulatory inspections of which it
becomes aware in relation to the Product.
B. Braun shall have primary
responsibility for preparing any responses
that relate to its premises or any of
its obligations under this Agreement, which
may be required by the authorities,
and Company shall, upon request of B.
Braun, make all reasonable endeavors to
support B. Braun in preparing such
responses. B. Braun shall advise Company of
the findings of any such audits or
inspections and B. Braun shall correct all
deficiencies identified in the course of
such audit or inspection relating to
the manufacture of the Product.
7.4
B. Braun shall
be responsible for the archiving and retention of all
relevant documentation fully in compliance
with GMP.
7.5
On request,
Company and B. Braun shall provide to each other all
available regulatory registration
documentation and supporting data (including,
without limitation, 510(k) and CE mark
filings) necessary for the registration
of Products in the Territory. The use of
these documentation and data for
registration purposes by either party shall
not be deemed as a breach of
confidentiality hereunder.
8. Compliance with Laws. B. Braun
represents, warrants and covenants to Company
that it shall, at all times, comply with
all applicable laws, rules and
regulations and standards applicable to
manufacturing of the Products in
Germany, as well as GMP, and Company
represents, warrants and covenants to B.
Braun that it shall, at all times, comply
with all applicable laws, rules and
regulations and standards applicable to the
marketing, distribution and sale of
the Products, including, without limitation
the U.S. Food, Drug and Cosmetic
Act, as amended, and the rules and
regulations promulgated thereunder.
9. Insurance. Each party represents and
warrants to the other that it is
currently insured and covenant that at all
times during the term of this
Agreement it will maintain a comprehensive
general liability insurance policy,
including without limitation, product
liability insurance, which (i) is
sufficient to adequately protect against
the risks associated with its ongoing
business, including the risks which might
possibly arise in connection with the
transactions contemplated by this
Agreement, and (ii) shall not be terminated or
canceled without giving the other party
thirty (30) days' prior written notice.
From time to time upon the request of a
party, the other party shall provide to
such party a certificate of insurance
evidencing that such insurance coverage is
in full force and effect. This Section 9
shall survive termination for a period
of six (6) years.
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Technical Agreement between NxStage and
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Page 10
10 Indemnification.
10.1
B. Braun hereby
indemnifies and agrees to defend and hold Company,
its officers, directors, agents and
employees and their successors and assigns
(individually and collectively, "Company
Parties") harmless from and against any
and all damages, liabilities, penalties,
losses or expenses including, without
limitation, reasonable legal fees
(collectively, a "Loss" or, the "Losses"),
arising out of or relating to any claims,
actions, demands or proceedings
asserted by a third party (collectively, a
"Claim") to the extent such Claim
results from or arises out of B. Braun's
breach of any warranty, representation
or agreement of B. Braun in this Agreement,
to the extent such Claim could have
been, but need not have been, brought
against B. Braun.
10.2
Company hereby
indemnifies and agrees to defend and hold B. Braun,
its officers, directors, agents and
employees and their successors and assigns
(individually and collectively, "B. Braun
Parties") harmless from and against
any and all Losses arising out of or
relating to any third party Claim to the
extent such Claim results from or arises
out of Company's breach of any
warranty, representation or agreement of
Company in this Agreement, to the
extent such third party Claim could have
been, but need not have been, brought
against Company.
10.3
Upon receiving notice
of any third party Claim under this Section
10, the indemnified party shall notify the
indemnifying party in writing within
five (5) business days following receipt of
the notice; provided, however, that
the right of an indemnified party to be
indemnified hereunder in respect of
claims made by a third party shall not be
adversely affected by a failure to
give such notice, unless, and then only to
the extent that an indemnified party
is materially prejudiced thereby.
10.4
The indemnifying party
shall undertake and control the defense
thereof by reputable counsel chosen by it,
subject to the approval of the
indemnified party, which consent shall not
be unreasonably withheld. The
indemnified party shall be entitled to join
any defense of a claim at its sole
cost and expense. If any claim is asserted
and the indemnifying party fails to
contest and defend such claim within a
reasonable period of time after the
indemnified party's notice is given, then
the indemnified party may take such
reasonable action in connection therewith
as the indemnified party deems
necessary or desirable, including
controlling the defense of such claim, subject
to the provisions of subsection 10.5 below,
and retaining counsel of its own
choosing with the reasonable costs and
expenses of such defense being borne by
the indemnifying party. The reimbursement
for all reasonable costs and expenses
incurred by an indemnified party pursuant
to this subsection 10.4 shall be paid
as and when incurred within thirty (30)
days after receipt of an invoice
therefore.
10.5
If requested by the
indemnifying party, the indemnified party agrees
to cooperate with the indemnifying party
and its counsel. The indemnified party
shall not settle or compromise such claim
without the prior
