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 X. XXXXX MEDIZINTECHNOLOGIE GMBH, a corporation organized under the
laws of Germany having offices at Xxxxxxxxxxxxxxx Xxx 00-00, 00000 Xxxxxxxxx,
Xxxxxxx, ("X. Xxxxx") and NxStage Medical, Inc., a Delaware corporation, having
offices at 000 Xxxxx Xxxxx Xxxxxx, 0xx Xxxxx, Xxxxxxxx, Xxxxxxxxxxxxx, XXX
("Company").
BACKGROUND
Company desires to purchase from X. Xxxxx, and X. Xxxxx 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.
Technical Agreement between NxStage and BMT
Page 2
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, X. Xxxxx shall manufacture and supply to Company and Company shall
purchase from X. Xxxxx 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 X. Xxxxx 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.
Technical Agreement between NxStage and BMT
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 X. Xxxxx to
xxxxx 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 X. Xxxxx
[**]% 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 X. Xxxxx to ensure that purchase orders correspond to anticipated
requirements set forth in the rolling forecasts delivered to X. Xxxxx. X. Xxxxx
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 X. X. Xxxxx 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 X.
Xxxxx 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 X. Xxxxx (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.
Technical Agreement between NxStage and BMT
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 X. Xxxxx'x approval, which approval shall not be
unreasonably withheld. Upon receipt by X. Xxxxx of notice requesting a
Specification change, X. Xxxxx 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 X. Xxxxx 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 X. Xxxxx'x inventory (if such Products were made pursuant to
accepted purchase orders) and (b) reimburse X. Xxxxx 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 X. Xxxxx 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 X. Xxxxx 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. X. Xxxxx shall inform Company about such modification. Company
shall not assert any right to the design of the Products in contravention of X.
Xxxxx'x rights.
3.3 At Company's request, X. Xxxxx 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 X. Xxxxx'x 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 X. Xxxxx 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 X. Xxxxx, except for
the express representations and warranties provided in this Agreement.
Technical Agreement between NxStage and BMT
Page 5
3.4 All Product provided by X. Xxxxx 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 X. Xxxxx a non-exclusive, non-transferable,
royalty-free license to use the Company Trademarks without alteration or
modification solely with respect to X. Xxxxx'x labeling of the Products during
the term of this Agreement and not for any other purpose. X. Xxxxx acknowledges
Company's ownership of or right to use the Company Trademarks. X. Xxxxx further
acknowledges that neither this Agreement nor the use by X. Xxxxx of the Company
Trademarks shall create any right, title or interest in or to the Company
Trademarks by X. Xxxxx. This Agreement is not intended to convey and does not
convey to X. Xxxxx 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 X. Xxxxx to sublicense the Company Trademarks to any
of X. Xxxxx'x suppliers of the Product or Product components for similar
labeling purposes and under similar conditions.
3.6 As of the date hereof, X. Xxxxx 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 X. Xxxxx or
Company (and either X. Xxxxx or Company, respectively, reasonably determines
that such threat is credible) or (ii) filed against either X. Xxxxx or Company,
then X. Xxxxx 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.
Technical Agreement between NxStage and BMT
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 X. Xxxxx has reasonable
documentation of the basis for such change). If X. Xxxxx 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 X. Xxxxx 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 X.
Xxxxx with all appropriate tax exemption certificates acceptable to the taxing
authorities imposing such taxes, if Company desires not to make such payments.
4.3 X. Xxxxx shall invoice Company concurrently with any shipment of
Products and Company shall make full payment to X. Xxxxx, 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 X. Xxxxx 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 X. Xxxxx 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 X. Xxxxx 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 X.
Xxxxx, and if Company is in payment default, Company shall be obligated to
notify its customers holding Products to which X. Xxxxx legally retains title
hereunder of the assignment and to furnish X. Xxxxx with all information
required for collection of the claim and to provide X. Xxxxx with all necessary
documents. As long as X. Xxxxx 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 X. Xxxxx mentioning the default and
X. Xxxxx shall not contact such customers prior to the expiration of such 20 day
period. As far as not otherwise stipulated by X. Xxxxx, 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 X. Xxxxx, and which shall be held by Company
separately from other means of payment for X. Xxxxx'x 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
Technical Agreement between NxStage and BMT
Page 7
X. Xxxxx continues to retain title (by means of attachment or through a claim to
proceeds, or otherwise), Company shall inform X. Xxxxx without any delay and
notify the third party making such a claim of X. Xxxxx'x rights under this
Section.
5. Delivery.
5.1 All shipments of Products shall be made F.O.B. mutually agreed
European seaport. X. Xxxxx 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 X. Xxxxx 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 X. Xxxxx 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 X. Xxxxx without undue delay of a failure
and within the warranty period (6.1) and therefore rejects any Product shown and
documented to be defective, X. Xxxxx agrees to replace such Product at X.
Xxxxx'x sole cost and expense (including freight charges) or, at X. Xxxxx'x
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 X. Xxxxx represents and warrants to Company that, at the time of
delivery, the Product delivered by X. Xxxxx 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 X. Xxxxx of any of the
warranties contained herein shall be at X. Xxxxx'x option, either the repair or
replacement by X. Xxxxx 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). X. Xxxxx'x 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 X. Xxxxx, 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.
Technical Agreement between NxStage and BMT
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. X. XXXXX 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 X. Xxxxx, 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. X. Xxxxx shall provide technical support for
investigating any complaints. If X. Xxxxx receives any information regarding
adverse reactions or defects of the Products, X. Xxxxx 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 X. Xxxxx
after consultation with X. Xxxxx. Although Company shall in good faith consider
X. Xxxxx'x 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 X. Xxxxx 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, X. Xxxxx shall credit Company's account for the Products recovered
and returned to it as a result of any recall (or destroyed at X. Xxxxx'x
request). In all other cases, Company shall bear all costs of any recall and
shall reimburse X. Xxxxx for any of its reasonable out-of-pocket costs in
connection therewith. X. Xxxxx and Company shall reasonably cooperate with each
other in the event of any recall of any Product
Technical Agreement between NxStage and BMT
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, X. Xxxxx shall permit authorized
representatives of relevant regulatory authorities, including FDA, to audit and
inspect X. Xxxxx'x 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. X. Xxxxx 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 X. Xxxxx, make all reasonable endeavors to
support X. Xxxxx in preparing such responses. X. Xxxxx shall advise Company of
the findings of any such audits or inspections and X. Xxxxx shall correct all
deficiencies identified in the course of such audit or inspection relating to
the manufacture of the Product.
7.4 X. Xxxxx shall be responsible for the archiving and retention of all
relevant documentation fully in compliance with GMP.
7.5 On request, Company and X. Xxxxx shall provide to each other all
available regulatory registration documentation and supporting data (including,
without limitation, 510(k) and CE xxxx 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. X. Xxxxx 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 X.
Xxxxx 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.
Technical Agreement between NxStage and BMT
Page 10
10 Indemnification.
10.1 X. Xxxxx 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 X. Xxxxx'x breach of any warranty, representation
or agreement of X. Xxxxx in this Agreement, to the extent such Claim could have
been, but need not have been, brought against X. Xxxxx.
10.2 Company hereby indemnifies and agrees to defend and hold X. Xxxxx,
its officers, directors, agents and employees and their successors and assigns
(individually and collectively, "X. Xxxxx 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 written consent of
the indemnifying party, which consent shall not be unreasonably withheld. At the
request of the indemnifying party, the indemnified party shall settle a claim;
provided, however, that (i) such settlement involves only the payment of
monetary damages and no injunctive relief binding on the indemnified party, and
such monetary damages are paid by the indemnifying party, (ii) the indemnified
party does not admit any liability, and (iii) the indemnified party is released
from all further liability with respect to such claim.
Technical Agreement between NxStage and BMT
Page 11
10.6 The obligations of this Section 10 shall survive any termination or
expiration of this Agreement and shall not terminate until after the expiration
of all applicable statutes of limitation that could apply to any actions,
claims, proceedings or demands that could be asserted by a third party.
11. Term; Termination; Default & Remedies.
11.1 This Agreement shall commence on the date set forth above and shall
continue until December 31, 2009, unless sooner terminated in accordance with
the provisions hereof. Thereafter, the Agreement shall continue for an
indefinite period. Either party may terminate the Agreement with 12-months prior
written notice of its intent to terminate the Agreement, though at the earliest
with effect to December 31, 2009.
11.2 Either party may terminate this Agreement, effective upon delivery
of a termination notice, if the other party (i) files in any court pursuant to
any statute of the United States or of any individual state, a petition in
bankruptcy or insolvency or for reorganization or for an arrangement or at the
appointment of a receiver or trustee of the party of its assets, (ii) is served
with an involuntary petition against it, filed in any insolvency proceeding, and
such petition shall not be dismissed within sixty (60) days after filing
thereof, (iii) is a party to any dissolution or liquidation, (iv) makes an
assignment for the benefit of creditors, or (v) discontinues its operations for
any reason whatsoever.
11.3 Either party may terminate the Agreement effective twelve (12)
months after giving notice in the event of a change in the legal or beneficial
ownership in the other party if a competitor of Company or the X. Xxxxx Group
holds the majority of the stock/shares of, or otherwise controls, the other
party.
11.4 In addition to all other rights granted to the parties hereunder,
either party may terminate this Agreement effective thirty (30) days after
giving notice of intent to terminate, if the other party fails or neglects to
perform any material covenant or provision of this Agreement, and such default
is not materially cured within [**] after receiving written notice with respect
to such default. In addition to, and notwithstanding the foregoing, if Company
fails to make any payment when due as provided in this Agreement or if Company
becomes insolvent or bankrupt, X. Xxxxx, at its option and without prejudice to
its other rights and remedies herein or at law or equity, may withhold further
shipment of Product until all legally overdue balances are made current, and may
require payment for future orders prior to delivery thereof for a commercially
reasonable period of time.
11.5 Termination of this Agreement shall not relieve either party from
its duty to discharge all obligations accruing prior to such termination,
including parties' obligations pursuant to any purchase order outstanding on the
date of such termination and for payment for 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 X. Xxxxx for other
customers, 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.
Technical Agreement between NxStage and BMT
Page 12
11.6 Upon termination of this Agreement for any reason whatsoever, (i)
Company shall return to X. Xxxxx all X. Xxxxx confidential information and
documents relating to or containing X. Xxxxx confidential information, together
with all copies made thereof and extracts made therefrom, and (ii) X. Xxxxx
shall return to Company all Company confidential information and documents
relating to or containing Company confidential information, together with all
copies made thereof and extracts made therefrom; provided that the parties shall
be entitled to retain one copy of the Confidential Information in their legal
department files for the purpose of insuring compliance with their obligations
under Sections 7, 8 and 15.1 and complying with any applicable governmental
rules and regulations.
12. Limitation of Liability. The total liability of X. Xxxxx arising from this
Agreement or the Products is limited to US$ two million five hundred thousand
(US Dollar 2,500,000). This limitation does not apply in the event X. Xxxxx acts
with gross negligence or willful misconduct. In no event, regardless of any
claim or action, whether brought in contract, tort (including without
limitation, negligence), warranty or otherwise, shall X. Xxxxx or Company be
liable for any indirect, special, punitive, incidental or consequential damages
from any cause whatsoever, regardless if any remedy herein fails, including
without limitation, damages for loss of profits, loss of enterprise valuation or
opportunity and cost of substitute products or services.
13. Intellectual Property. Except as expressly provided herein, neither party
shall be deemed to have granted to the other party any right to any patents or
other intellectual property owned, licensed or controlled by a party. All
intellectual property rights which may arise in any documents, drawings, items,
designs, processes, software or any other thing developed jointly by X. Xxxxx or
any of its employees or agents and the Company or any of its employees or agents
in performance of this Agreement shall be held jointly by the parties, unless
otherwise agreed in writing between the parties. All intellectual property which
may arise in any documents, drawings, items, designs, processes, software or any
other thing developed solely by X. Xxxxx or any of its employees or agents or
Company or any of its employees or agents shall be the sole and exclusive
property of X. Xxxxx or Company, respectively.
14. Force Majeure.
14.1 If X. Xxxxx becomes unable to perform any of its obligations
hereunder, in whole or in part, by reason of an event of Force Majeure (as
defined below), such failure of performance shall be excused during the
continuance of and to the extent of such Force Majeure event; provided that if
as a consequence of any such Force Majeure the total demands for the Products
cannot be supplied by X. Xxxxx, X. Xxxxx will allocate its available supply to
its customers on such basis as X. Xxxxx may deem fair and practicable, without
liability for any failure to perform this Agreement. X. Xxxxx will promptly
notify Company of any occurrence of an event of Force Majeure and of the
termination thereof. Company may terminate this Agreement in the event the Force
Majeure event continues for more than [**].
Technical Agreement between NxStage and BMT
Page 13
14.2 Force Majeure shall mean any cause beyond Company's, X. Xxxxx'x or
its supplier's or subcontractor's reasonable control, such as acts of God,
delays caused by shortage of raw materials, manufacturing problems, delivery or
labor problems, shortages in energy supply or interruption in transportation,
acts of government, regulatory agencies or judicial bodies, civil or military
authorities, fires, strikes, floods, wars, riots and other causes of a similar
nature.
15. Miscellaneous Terms and Conditions.
15.1 Confidentiality. Each party agrees to hold in confidence and refrain
from using, distributing, disseminating or disclosing to others any information
of the other party, including without limitation business and Product
information and the terms of this Agreement, that is disclosed between the
parties during the term of this Agreement or pursuant hereto, or from making or
causing to be made, or selling or distributing, any product embodying
confidential information, other than pursuant to this Agreement. The
restrictions set forth in the preceding sentence shall not apply to confidential
information that a receiving party proves: (a) was, at the time of disclosure
hereunder, in the public domain or becomes at a later date reasonably available
to the public through no fault of the recipient; (b) was in the possession of
recipient prior to disclosure hereunder, as evidenced by recipient's written or
tangible evidence; (c) was disclosed to recipient by a third party that has an
independent right to disclose the information; (d) was independently developed
by recipient as evidenced by competent proof, or (e) was required to be
disclosed by judicial order, statute or governmental regulation, provided that
the disclosing party is given, where feasible, reasonable prior written notice
of any such required disclosure and the opportunity to seek to limit such
disclosure or otherwise to preserve its confidential nature. This Section shall
survive termination of this Agreement and any extension thereof, for a period of
[**].
15.2 Independent Contractors. The parties hereto shall be deemed to have
the status of independent contractors, and shall have the relationship of buyer
and seller. Nothing in this Agreement shall be deemed to place the parties in
the relationship of partners, principal-agent or joint venturers, etc. Neither
party shall be deemed to be an agent or representative of the other party, and
neither party shall have any right or authority to create or assume any
obligation or to bind the other party in any manner whatsoever.
15.3 Assignment. Neither party shall assign this Agreement or their
rights hereunder without the prior written consent of the other party; provided
that this Section shall not apply to an assignment by either party to an
affiliated company. This Agreement shall inure to the benefit of, and be binding
upon, the permitted assigns of the parties hereto, and their respective
successors, including any purchaser of their respective businesses through
merger, sale of stock, assets, business line, or otherwise.
15.4 Notices. Any notice or request required or permitted to be given
under or in connection with this Agreement shall be in writing and shall be
deemed given only if delivered personally, sent by fax, by registered or
certified mail, return receipt requested, or by overnight delivery service to
the applicable address set forth above or such other address as a party may have
specified in a notice duly given to the other party as provided herein.
Technical Agreement between NxStage and BMT
Page 14
15.5 Entire Agreement; Amendment; Waiver; Etc. This Agreement, including
the Appendixes attached hereto (and any future addenda referencing this
Agreement) contains the entire agreement and understanding between the parties
with respect to the subject matter hereof and supersedes all prior proposals and
agreements between the parties, whether oral or written, and there are no other
promises or representations relating to the subject matter hereof that is not
incorporated herein. No addition to, amendment of, or waiver or modification of,
any provision of this Agreement shall be binding unless in writing and signed by
a duly authorized representative of each party. Without limiting the generality
of the foregoing, no modification or amendment shall be effected by, or result
from, the receipt, acceptance, signing or acknowledgment of any party's purchase
orders, order acknowledgments, invoices, shipping documents or other business
forms containing terms or conditions in addition to, or different from, the
terms and conditions set forth in this Agreement. Such documentation is
permitted only as a convenience to the parties, and all such purchase orders and
other documentation shall be governed and superceded by the terms and conditions
of this Agreement. Any failure by either party to enforce any of their
respective rights herein shall not be deemed a waiver of such rights, and it
may, from time to time, and at its option, enforce any of its rights hereunder,
notwithstanding any course of dealing or performance. Notwithstanding the
termination of this Agreement, the provisions of Sections 3.1, 3.6, 4.3, 6, 7,
8, 9, 10, 11.5, 11.6, 12, 13 and 15 of this Agreement shall survive the
termination of this Agreement in accordance with their terms.
15.6 Technical Agreement. The detailed instructions in the Technical
Agreement attached as Appendix B shall control the way in which the parties
shall perform. To the extent that any provision of the Technical Agreement is in
conflict with the terms of this Agreement, the terms of the Technical Agreement
shall control.
15.7 Binding Obligation. Each party represents and warrants that (i) it
has the right to enter into this Agreement and to perform all of its obligations
hereunder, and (ii) this Agreement, when executed and delivered, will be a
legal, valid, and binding obligation of such party, enforceable against such
party in accordance with its terms.
15.8 Severability. The provisions of this Agreement shall be severable
from each other and from the rest of this Agreement, and in the event that any
portion of this Agreement shall be held invalid, void, unenforceable, or
ineffective by a court of competent jurisdiction, the remaining portions thereof
shall remain in full force and effect. If any of the terms or provisions of this
Agreement are in conflict with any applicable statute or rule of law, then such
terms or provisions shall be deemed inoperative to the extent that they may
conflict therewith, and shall be deemed to be modified to conform with such
statute or rule of law and as far as possible economically corresponds with the
invalid provision.
15.9 Governing Law and Dispute Resolution.
(a) This Agreement (and any dispute, controversy, proceeding, or
claim of whatever nature arising out of or in any way relating to this Agreement
or its formation) shall be governed by and interpreted in accordance with Swiss
substantive laws, excluding conflicts of law provisions. The parties hereto
expressly reject the application of the United Nations Convention on Contracts
for the International Sale of Goods.
Technical Agreement between NxStage and BMT
Page 15
(b) In the event of any dispute, claim or controversy (a "Claim")
arising out of or relating to this Agreement or the purchase of Products
hereunder, the parties agree to make a good faith attempt to negotiate an
amicable resolution to any and all such Claims. Sole venue shall be Zurich,
Switzerland. Language of the proceeding shall be English.
15.10 Heading. The Headings in this Agreement are included for ease of
reference only and shall have no legal effect.
15.11 Signatures. This Agreement may be executed in one or more
counterparts, each of which shall be deemed to be one and the same Agreement.
IN WITNESS WHEREOF, the parties hereto have executed and delivered this
Agreement as of the date set forth above.
X. XXXXX Medizintechnologie GmbH NXSTAGE MEDICAL, INC.
By: /s/ X. Xxxxxx By: /s/ Xxxxxxx X. Xxxxxxx
------------------------------------------ -------------------------
Name: Xx. X. Xxxxxx Name: Xxxxxxx X. Xxxxxxx
Title: VP Marketing & Development Dialysis Title: President & CEO
X. XXXXX Medizintechnologie GmbH NXSTAGE MEDICAL, INC.
By: /s/ X. Xxxxxx By: _________________________
------------------------------------------
Name: Xx. X. Xxxxxx Name:
Title: President Title:
Technical Agreement between NxStage and BMT
Page 16
APPENDIX A
PRODUCT LIST AND PRICES
Maximum
Annual min. Order*
Purchase Quantity Per Price per Bag* FOB
Product Description Batch Size Requirement** Month Glandorf, Germany
------------------- ---------- -------------- ------------ ------------------
[**] (See Technical [**] bags [**] bags (all [**] bags EURO [**]
Agreement for Product
specific Product purchases are
numbers) counted toward
this number
[**] (See Technical [**] bags collectively) [**] [**] bags
Agreement for [**] EURO
specific Product
numbers) [**] bags
[**] EURO
[**] bags
[**] EURO
* To be reset for the following Contract Year at least [**] prior to the
expiration of the then-current Contract Year, by mutual agreement of the
parties, subject to the limitation herein.
** Company's total Product orders shall be considered in the aggregate when
determining whether minimum Purchase Requirements have been met. [**] bags
assumes not more than [**] different Product numbers. Should more than [**]
Product numbers be required, minimum purchase requirements shall be
renegotiated.
*** NxStage shall pay for Products based on the volume of Products purchased
during the entire Contract Year. Volume discounts apply to all Product purchases
during the Contract Year, not just volumes purchased after the above volume
thresholds are met. At the end of the year, X. Xxxxx shall recalculate pricing
for the Contract Year, and either credit or invoice NxStage for any difference
to reflect discrepancies between the price charged and the pricing to which
NxStage was entitled over the Contract Year due to actual volumes purchased.
Technical Agreement between NxStage and BMT
Page 17
[**][**] solutions
mEq/l
--------------
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**]
[**] [**] [**]
[**] solutions
mEq/l
--------------
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**]
[**] [**] [**]
Product List Lactate Buffered Solutions
NxStage Product code Product Name X. Xxxxx Product code
-------------------- ------------ ---------------------
RFP 200 1081
RFP 206 1086
RFP 208
Product List Bicarbonate Buffered Solutions
NxStage Product code Product Name X. Xxxxx Product code
-------------------- ------------ ---------------------
RFP 000
XXXXXXXX X
TECHNICAL AGREEMENT
Technical Agreement between NxStage and BMT
Page 19
TECHNICAL AGREEMENT
THIS TECHNICAL AGREEMENT (this "Agreement") is made on January 24, 2003
BETWEEN:
1. NXSTAGE MEDICAL Inc., whose principal place of business is at 000 X. Xxxxx
Xxxxxx, Xxxxxxxx, XX 00000, Xxxxxx Xxxxxx of America (NxStage) and
2. X. XXXXX MEDIZINTECHNOLOGIE GmbH site Glandorf, located at Xxxxxxxxxxxx
Xxxxxxx 00, 00000 Xxxxxxxx, Xxxxxxx ("BMT"), as a subsidiary of X. XXXXX
MEDIZINTECHNOLOGIE GmbH, whose principal place of business is at
Xxxxxxxxxxxxxxx Xxx 00-00, 00000 Xxxxxxxxx, Xxxxxxx
WHEREAS:
1. Both BMT and NxStage hold current manufacturing licenses, which
enable them to manufacture the medical devices listed in Appendix 1.
2. This Agreement sets forth manufacturing, quality control and product
release procedures to be followed for the purpose of ensuring
compliance with medical device laws, rules, regulations and
guidelines.
OPERATIVE PROVISIONS:
1. Definitions and Applicability
1.1 This Agreement applies to supply arrangements pursuant to which BMT
manufactures medical devices in the capacity of contract manufacturer for
NxStage in the capacity of final manufacturer in accordance with the Supply
Agreement to be entered into between BMT and NxStage.
1.2 This Agreement shall form an appendix of the Supply Agreement to be
concluded between NxStage and BMT and shall remain in force as long as the
Supply Agreement.
1.3 The term "Products" and other terms and expressions defined in the
Supply Agreement shall have the same meanings when used herein as therein.
2. Appendices
The following documents are appended to, and shall form an integral
part of, this Agreement:
List of Products and Product Codes Appendix 1
Technical Agreement between NxStage and BMT
Page 20
NxStage Product Specifications Appendix 2
BMT Test Specifications Appendix 3
Qualified Persons and Emergency Contact Numbers Appendix 4
3. General
3.1 BMT shall:
(a) manufacture, test, package and label the Products on behalf of
NxStage at its premises in accordance with:
the product specifications provided by NxStage and detailed in Appendix 2
hereto;
the test specifications provided by BMT and approved by NxStage and detailed in
Appendix 3 hereto;
(b) provide and maintain clean and safe storage of the Products
until their dispatch from BMT.
Technical Agreement between NxStage and BMT
Page 21
3.2 In the manufacture of the Products, BMT shall utilize all know how
available to it, taking into account the current state of the scientific and
technological art, and shall comply with all applicable legal requirements,
rules, regulations and guidelines of the Federal Republic of Germany and the
European Community, including Directive 00/00 XXX concerning medical devices and
21 CFR Part 820 FDA Current Good Manufacturing Practices.
3.3 The party which provides documentation hereunder shall be
responsible for the proper quality of such documentation and for compliance of
the documentation with all applicable laws, rules, regulations and guidelines
referred to in clause 3.2.
3.4 NxStage shall ensure that the manufacturing and test specifications
conform to all requirements contained in the pursuant marketing authorization
documentation.
3.5 NxStage shall ensure that this Agreement and the Appendices hereto
conform to regulatory requirements in all countries where the Products are sold
and that any change in such requirements are notified to BMT and reflected in
appropriate amendments.
3.6 BMT shall on a regular basis perform internal audits and inspections
in accordance with the demands of EN/ISO 9001, EN/ISO 46001, and 21 CFR Part 820
FDA Current Good Manufacturing Practices concerning medical devices and shall
promptly remedy any deficiencies found during such audits and inspections.
3.7 Subject to the Confidentiality sections of the Supply Agreement to
be entered between NxStage and BMT, NxStage may perform audits and inspections
of BMT's facilities, processes and procedures as far as these are involved in
the manufacturing and testing of the Products.
4. Qualified Person
4.1 Each party shall appoint a Qualified Person who shall be responsible
for performing, or supervising and ensuring the performance of, as appropriate,
such party's duties and tasks under this Agreement.
4.2 Promptly after the signature of this Agreement, each party shall
notify the other of the particulars of its Qualified Person (name, postal and
e-mail address, telephone and telecopier nos.).
5. Starting and Packaging Materials
BMT shall use starting and packaging materials and suppliers thereof
specified in the materials specifications for the Products. BMT
shall perform quality control of all starting materials to ensure
that they conform to the starting materials specifications and shall
be responsible for the proper condition and quality of materials.
Technical Agreement between NxStage and BMT
Page 22
6. Batch Size and Designation
6.1 Minimum batch size shall be 3000 liters and maximum batch size shall
be 17000 liters with standard batch sizes 5000 liters, 10000 liters and 15000
liters.
6.2 BMT shall designate a number for each batch of Product. Such number
shall be used on all documentation relating to the particular batch.
7. Batch Documentation
7.1 BMT shall prepare for each batch of Product a manufacturing protocol
which shall contain at least the following details:
(a) [**]
(b) [**]
(c) [**]
(d) [**]
(e) [**]
(f) [**]
(g) [**]
(h) [**]
(i) [**]
(j) [**]
Technical Agreement between NxStage and BMT
Page 23
7.2 The manufacturing protocol may refer to other documentation
regarding individual data.
7.3 In the event there occurs any significant deviation from specified
or validated data or processes in the manufacture of the Products, such
deviating data or process shall be fully explained and documented by BMT in an
attachment, entitled "Remarks", to the manufacturing protocol and be promptly
forwarded to NxStage. Any deviation shall be justified and approved by BMT's
Qualified Person and consented by NxStage prior to batch release, which consent
shall not be unreasonably withheld.
7.4 At request, BMT shall promptly furnish NxStage with copies of full
batch documentation. BMT shall retain original documentation for regulatory
inspection compliance and shall make the documentation available for inspection
by the competent regulatory authorities and NxStage.
8. Quality Control and Test Protocol
8.1 BMT shall perform in-process testing and finished product quality
control in accordance with the manufacturing and test specifications. BMT will
inform NxStage when in its opinion the test specifications and test methods used
are no longer in accordance with the state of the scientific and technological
art and no longer suitable for assessment of the quality of the Product.
8.2 BMT shall record the results of tests and quality control measures
in a test protocol.
9. Release of Product
9.1 If (i) the tests and other quality control measures have shown that
the batch of Product meets the required quality and are in compliance with the
product specifications, (ii) the manufacturing and test protocols have been duly
signed, and (iii) the batch file has been approved by BMT's Qualified Person,
BMT shall release the batch for delivery and shall furnish NxStage with a
certificate of analysis, as signed by BMT's Qualified Person.
For handling of deviations from specified processes in the
manufacture or testing of the Products refer to clause 7.3 of this
Agreement.
Technical Agreement between NxStage and BMT
Page 24
9.2 NxStage shall be responsible for release of the Product for
commercial sale (final release).
10. Bag Print, Instructions for Use, Carton label
10.1 NxStage shall be responsible that bag prints, instructions for use
and carton labels are in accordance with the marketing authorization and all
other applicable regulations.
10.2 NxStage shall provide BMT with the artwork necessary to prepare the
printing plates for the Product. Contact prints shall be approved by NxStage
before BMT uses the plates for manufacture of the Product.
11. Sample Retention
BMT shall retain two samples (single units) of each batch of Product
until one year after the expiry of the Product.
12. Complaints and Recalls
12.1 NxStage shall be responsible for initial handling of customer
complaints relating to the Products and shall give prompt written notice to BMT
of the same. BMT shall then take prompt action to make such internal
investigations as are called for in the circumstances and report its findings to
NxStage.
12.2 NxStage shall be responsible for initiating any recall action
involving the Products and shall keep BMT appropriately informed of the same.
12.3 Emergency contact numbers are set out in Appendix 4.
13. Changes and Amendments
13.1 BMT may not relocate the manufacture or testing of the Products from
its premises without NxStage's prior written consent.
13.2 BMT may not without NxStage's prior written consent make any change
in processes, equipment or facilities which may adversely affect the quality of
the Products. Without limiting the foregoing, BMT may not make any change to the
Product specification without NxStage's prior written consent.
13.3 Any amendment to this Agreement or to any Appendix hereto shall be
made in writing and be agreed to and duly signed on behalf of both parties.
Neither party may refuse to accept any amendment required to comply with laws,
rules and regulations or requests by regulatory authorities.
IN WITNESS WHEREOF, this Agreement has been duly executed in duplicate as of the
date first above written.
NXSTAGE MEDICAL Inc.
By: /s/ Xxxxxxx X. Xxxxxxx
----------------------------
Name: Xxxxxxx X. Xxxxxxx
Title: President & CEO
X. XXXXX MEDIZINTECHNOLOGIE GmbH
By: /s/ Xxx Xxx /s/ X.Xxxxxxx /s/ X.Xxxxxxxx
---------------------------- ---------------- --------------
Name: Xxx Xxx Xx. X. Xxxxxxx X. Xxxxxxxx
Title: QA QC Manager Production Manager
Appendix 1
to Technical Agreement between
NXSTAGE MEDICAL Inc. and
X. XXXXX MEDIZINTECHNOLOGIE GmbH
List of Products and Product Codes
Lactate Buffered Solutions
Product name NxStage product code BMT product code
------------------ -------------------- ----------------
Premixed Dialysate RFP-200 1081
Premixed Dialysate RFP-206 1086
Premixed Dialysate RFP-208 1087
Bicarbonate Buffered Solutions
Product name NxStage product code BMT product code
----------------------------- -------------------- ----------------
Pureflow Solution Bicarbonate RFP 400 4234
Appendix 2
to Technical Agreement between
NXSTAGE MEDICAL Inc. and
X. XXXXX MEDIZINTECHNOLOGIE GmbH
NxStage Product Specifications
LACTATE BUFFERED SOLUTIONS
DOCUMENT TYPE TITLE DOCUMENT NO. REVISION
---------------------- ----------------------------------- ------------ ---------
Assembly Specification Premixed Dialysate, 4500ml, Germany RFP-200 Rev A
Assembly Specification Premixed Dialysate, 4500ml, Made in RFP-206 Rev A
Germany, Lactate 40
Assembly Specification Premixed Dialysate, 4500ml, Made in RFP-208 Rev A
Germany, Lactate 45
BICARBONATE BUFFERED SOLUTIONS
DOCUMENT TYPE TITLE DOCUMENT NO. REVISION
---------------------- ----------------------------------- ------------ ---------
Assembly Specification Pureflow Solution - Bicarbonate, RFP-400 Rev 1
5000ml, Germany
NXSTAGE Assembly Specification RFP-200
PREMIXED DIALYSATE, 4500ML, GERMANY Rev A
Page 1 of 3
XXXX OF MATERIALS
(Label Contents controlled by NxStage)
PART NUMBER DESCRIPTION
------------------- ------------
NxStage Controlled:
NC0155 [**]
NC0156 [**]
NC0130 [**]
X. Xxxxx Controlled:
PMS-754320 [**]
653191 [**]
602005 [**]
613256 [**]
613217
640280 [**]
CHEMICAL COMPOSITION
Eq/l mmol/l Tolerance
---- ------ ---------
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
CHEMICAL COMPOSITION
g/l
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
Osmolarity [**]
pH [**]
CONFIDENTIAL
THIS DOCUMENT AND THE ATTACHED PAGES ARE THE PROPERTY OF NXSTAGE MEDICAL, INC.
AND MAY NOT BE REPRODUCED WITHOUT THE WRITTEN PERMISSION OF THE MANAGEMENT OF
NXSTAGE MEDICAL, INC.
NXSTAGE Assembly Specification RFP-200
PREMIXED DIALYSATE, 4500ML, GERMANY Rev A
Page 2 of 3
X. Xxxxx Product Part Number: 1081
X. Xxxxx Finished Product Specification Document Number:
FPS-05-310, rev B
CONTAINER MATERIALS - FLUID CONTACTING:
COMPONENT SUPPLIER MATERIAL
--------- -------- --------
Film [**] PVC 9006
PVC 3256
Tubing [**] PVC 9006
PVC 3274
Connectors [**] Lexan 164R
Makrolon 2858
GENERAL SPECIFICATIONS:
# ATTRIBUTE REQUIREMENT
----- ---------------- -----------
1 Container [**]
2 Connectors [**]
3 Ingredients [**]
4 Shelf-life [**]
5 Appearance [**]
6 Particulate [**]
7 Aluminum [**]
8 Sterility [**]
9 Endotoxins [**]
10 Biocompatibility [**]
11 Labeling [**]
SUPPLIER
X. Xxxxx Xxxxxxxxxxxxxxxxxx XxxX
Xxxxxxxxxxxx Xxxxxxx 00
D-49219 Glandorf
Germany
RECORD OF REVISIONS
REVISION DCO NO. DESCRIPTION OF CHANGES
-------- ------- ----------------------
1 DCO01571 Initial Release
CONFIDENTIAL
THIS DOCUMENT AND THE ATTACHED PAGES ARE THE PROPERTY OF NXSTAGE MEDICAL, INC.
AND MAY NOT BE REPRODUCED WITHOUT THE WRITTEN PERMISSION OF THE MANAGEMENT OF
NXSTAGE MEDICAL, INC.
NXSTAGE Assembly Specification RFP-200
PREMIXED DIALYSATE, 4500ML, GERMANY Rev A
Page 3 of 3
A ECO00792 Initial alpha release in preparation of manufacturing; Add
additional bag materials that meet biocompatibility
requirements of SOP076 (see TR0505); update shelf life [**]
as X. Xxxxx data supports [**] claim (see TR0496); Added X.
Xxxxx packaging materials to BOM; update X. Xxxxx name from
Schiwa to Medizintechnologie GmbH
CONFIDENTIAL
THIS DOCUMENT AND THE ATTACHED PAGES ARE THE PROPERTY OF NXSTAGE MEDICAL, INC.
AND MAY NOT BE REPRODUCED WITHOUT THE WRITTEN PERMISSION OF THE MANAGEMENT OF
NXSTAGE MEDICAL, INC.
NXSTAGE Assembly Specification RFP-400
PUREFLOW SOLUTION - BICARBONATE, 5000ML, GERMANY Rev 1
Page 1 of 4
XXXX OF MATERIALS
(Label Contents controlled by NxStage)
PART NUMBER DESCRIPTION
------------------- -----------------------------------------------------------
NxStage Controlled:
NC0737 PureFlow Solution - Xxxxxxxxxxx xxx xxxxx, XXX-000, 0000xx,
Xxxxxxx
NC0738 PureFlow Solution - Bicarbonate carton label, RFP-400,
5000ml, Germany
NC0736 PureFlow Solution - Bacarbonate IFU RFP-4XX
X. Xxxxx Controlled:
See X. Xxxxx Product Specification FPS-01-3352
CHEMICAL COMPOSITION - AFTER MIXING
mEq/l mmol/l Tolerance
----- ------ ---------
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**]
[**] [**] [**] [**]
CHEMICAL COMPOSITION - G/L
BICARBONATE SOLUTION 4445ML
g/l
[**] [**]
[**] [**]
[**] [**]
CONFIDENTIAL
THIS DOCUMENT AND THE ATTACHED PAGES ARE THE PROPERTY OF NXSTAGE MEDICAL, INC.
AND MAY NOT BE REPRODUCED WITHOUT THE WRITTEN PERMISSION OF THE MANAGEMENT OF
NXSTAGE MEDICAL, INC.
NXSTAGE Assembly Specification RFP-400
PUREFLOW SOLUTION - BICARBONATE, 5000ML, GERMANY Rev 1
Page 2 of 4
CHEMICAL COMPOSITION - G/L
ELECTROLYTE SOLUTION 555 ML
g/l
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
Osmolarity [**]
pH [**]
X. Xxxxx Finished Product Specification (as manufactured): FPS-01-3352, rev B
X. Xxxxx Specification of the Ready-to-Use Solution (after mixing): FPS-01-3352,
rev B
RAW MATERIAL SPECIFICATIONS:
RAW MATERIAL PH. EUR. MONOGRAPH
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
* [**]
CONFIDENTIAL
THIS DOCUMENT AND THE ATTACHED PAGES ARE THE PROPERTY OF NXSTAGE MEDICAL, INC.
AND MAY NOT BE REPRODUCED WITHOUT THE WRITTEN PERMISSION OF THE MANAGEMENT OF
NXSTAGE MEDICAL, INC.
NXSTAGE Assembly Specification RFP-400
PUREFLOW SOLUTION - BICARBONATE, 5000ML, GERMANY Rev 1
Page 3 of 4
CONTAINER MATERIALS:
COMPONENT SUPPLIER MATERIAL
--------- -------- --------
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
GENERAL SPECIFICATIONS:
# ATTRIBUTE REQUIREMENT
--------- --------- -----------
1 [**] [**]
2 [**] [**]
3 [**] [**]
4 [**] [**]
5 [**] [**]
6 [**] [**]
7 [**] [**]
8 [**] [**]
9 [**] [**]
10 [**] [**]
10 [**] [**]
11 [**] [**]
SHIPPING INSTRUCTIONS:
Product to be palletized when shipped. Parcel shipments require an additional
over carton with cushioning material to support the primary package.
SUPPLIER:
X. Xxxxx Xxxxxxxxxxxxxxxxxx XxxX
Xxxxxxxxxxxx Xxxxxxx 00
D-49219 Glandorf
Germany
RECORD OF REVISIONS
REVISION DCO NO. DESCRIPTION OF CHANGES
-------- ------- ----------------------
1 02214 Initial release
CONFIDENTIAL
THIS DOCUMENT AND THE ATTACHED PAGES ARE THE PROPERTY OF NXSTAGE MEDICAL, INC.
AND MAY NOT BE REPRODUCED WITHOUT THE WRITTEN PERMISSION OF THE MANAGEMENT OF
NXSTAGE MEDICAL, INC.
NXSTAGE Assembly Specification RFP-400
PUREFLOW SOLUTION - BICARBONATE, 5000ML, GERMANY Rev 1
Page 4 of 4
CONFIDENTIAL
THIS DOCUMENT AND THE ATTACHED PAGES ARE THE PROPERTY OF NXSTAGE MEDICAL, INC.
AND MAY NOT BE REPRODUCED WITHOUT THE WRITTEN PERMISSION OF THE MANAGEMENT OF
NXSTAGE MEDICAL, INC.
X.XXXXX FINISHED PRODUCT Document No: FPS-05-310
MEDIZINTECHNIK
SPECIFICATION Page: 1 of 2
PREM. DIALYSATE RFP-200, NXSTAGE REF 1081
1 COMPOSITION
1000 ml solution contain: concentration mmol/l
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
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2 DOSAGE FORM
Solution for dialysis
3 IDENTITY
The identity is given by each specific assay
4 TESTS
4.1 [**] Requirement: [**]
[**]
4.2 [**] Requirement: [**]
[**]
[**]
4.3 [**]
[**] Limit: [**]
[**] [**]
[**]
4.4 [**] Limit:
[**]
[**]
4.5 [**] Limit:
[**]
CONFIDENTIAL
THIS DOCUMENT AND THE ATTACHED PAGES ARE THE PROPERTY OF NXSTAGE MEDICAL, INC.
AND MAY NOT BE REPRODUCED WITHOUT THE WRITTEN PERMISSION OF THE MANAGEMENT OF
NXSTAGE MEDICAL, INC.
X.XXXXX FINISHED PRODUCT Document No: FPS-05-310
MEDIZINTECHNIK
SPECIFICATION Page: 2 of 2
4.6 [**] Limit: [**]
[**]
4.7 [**] Limit:
[**]
[**]
4.8 [**] Requirement:
[**]
5. [**]
5.1 [**] Nominal: [**]
[**] Limit: [**]
5.2 [**] Nominal: [**]
[**] Limit: [**]
5.3 [**] Nominal: [**]
[**] Limit: [**]
5.4 [**] Nominal: [**]
[**] Limit: [**]
5.5 [**] Nominal: [**]
[**] Limit: [**]
5.6 [**] Nominal: [**]
[**] Limit: [**]
5.7 [**] Nominal: [**]
[**] Limit: [**]
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6 [**] [**]
Prepared: X. Xxxxx Date: 2003-01-13 Signature: X. Xxxxx
Quality Control
Released: Xx. X. Xxxxxxx Date: 2003-01-14 Signature: Xx. X. Xxxxxxx
Head of Quality Control
END OF DOCUMENT
CONFIDENTIAL
THIS DOCUMENT AND THE ATTACHED PAGES ARE THE PROPERTY OF NXSTAGE MEDICAL, INC.
AND MAY NOT BE REPRODUCED WITHOUT THE WRITTEN PERMISSION OF THE MANAGEMENT OF
NXSTAGE MEDICAL, INC.
X.XXXXX FINISHED PRODUCT Document No: FPS-05-310
MEDIZINTECHNIK
SPECIFICATION Page: 2 of 2
PREM. DIALYSATE RFP-200, NXSTAGE REF 1081
INFORMATION OF REVISION
NO. DATE KIND OF REVISION
----- ---------- ---------------------------------------------------
A 2002-11-01 First issue
B 2003-01-15 Editorial change and new bacterial endotoxins limit
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CONFIDENTIAL
THIS DOCUMENT AND THE ATTACHED PAGES ARE THE PROPERTY OF NXSTAGE MEDICAL, INC.
AND MAY NOT BE REPRODUCED WITHOUT THE WRITTEN PERMISSION OF THE MANAGEMENT OF
NXSTAGE MEDICAL, INC.
Appendix 3
to Technical Agreement between
NXSTAGE MEDICAL Inc. and
X. XXXXX MEDIZINTECHNOLOGIE GmbH
BMT Test Specifications
LACTATE BUFFERED SOLUTIONS
DOCUMENT TYPE TITLE DOCUMENT NO. REVISION
------------------------------ ----------------------------------------- ----------- --------
Finished Product Specification Prem. Dialysate RFP-200, NxStage Ref 1081 FPS-05-310 B
Finished Product Specification Prem. Dialysate RFP-206, NxStage Ref 1086 FPS-05-312 A
Finished Product Specification Prem. Dialysate RFP-208, NxStage Ref 1087 FPS-05-314 A
BICARBONATE BUFFERED SOLUTIONS
DOCUMENT TYPE TITLE DOCUMENT NO. REVISION
------------------------------ ----------------------------------------- ----------- --------
Finished Product Specification 2C-BIC-02 FPS-01-3352 B
CONFIDENTIAL
THIS DOCUMENT AND THE ATTACHED PAGES ARE THE PROPERTY OF NXSTAGE MEDICAL, INC.
AND MAY NOT BE REPRODUCED WITHOUT THE WRITTEN PERMISSION OF THE MANAGEMENT OF
NXSTAGE MEDICAL, INC.
2C-BIC-02
LARGE CHAMBER (4445 ML)
1 COMPOSITION
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[**] [**] [**] [**]
[**] [**]
[**] [**] [**] [**]
[**] [**]
2 DOSAGE FORM
[**]
3 IDENTITY
3.1 The identity is given by each specific assay
4 TESTS
4.1 [**] Requirement: [**]
[**]
4.2 [**] Requirement: [**]
[**]
[**]
4.3 [**]
[**] Limit: [**]
[**] [**]
4.4 [**] Release specification: [**]
[**] Shelf life limit: [**]
4.5 [**] Release specification: [**]
[**] Shelf life limit: [**]
[**]
4.6 [**] Limit: [**]
[**]
[**]
4.7 [**] Limit: [**]
[**]
4.8 [**] Requirement: [**]
[**]
5. [**]
5.1 [**] Nominal: [**]
[**] Limit: [**]
[**].
5.2 [**] Nominal: [**]
[**] Limit: [**]
[**]
5.3 [**] Nominal: [**]
[**] Limit: [**]
[**]
SMALL CHAMBER (555 ML)
1 COMPOSITION
1000 ml solution contain: concentration mmol/l
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[**] [**] [**] [**]
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[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**]
2 DOSAGE FORM
[**]
-3-
3 IDENTITY
3.1 The identity is given by each specific assay
4 TESTS
4.1 [**] Requirement: [**]
[**]
4.2 [**] Requirement: [**]
[**]
[**]
4.3 [**]
[**] Limit: [**]
[**] [**]
4.4 [**] Limit: [**]
[**]
4.5 [**] Release specification: [**]
[**] Shelf life limit: [**]
[**]
4.6 [**] Limit: [**]
[**]
[**]
4.7 [**] Limit: [**]
[**]
-4-
4.8 [**] Requirement: [**]
[**]
5 [**]
5.1 [**] Nominal: [**]
[**] Limit: [**]
[**]
Prepared: X. Xxxxx Date: 2003-05-28 Signature: X. Xxxxx
Quality Control
Released: Xx. X. Xxxxxxx Date: 2003-05-29 Signature: Xx. X. Xxxxxxx
Head of Quality Control
-5-
