Exhibit 10.45
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisk denote omissions.
SUPPLY AGREEMENT
     THIS SUPPLY AGREEMENT (this “Agreement”) is dated as of April 10, 2009
(“Effective Date”), and is by and between Laboratorios PiSA S.A. de C.V., a
corporation organized under the laws of Mexico having offices at Calle 7
No. 1308 Zona Industrial, C.P. 44940 Guadalajara, Jal., Mexico (“PiSA”) and
NxStage Medical, Inc., a Delaware corporation, having office at 439 South Union
Street, 5th Floor, Lawrence, Massachusetts 01843, USA (“NxStage”).
BACKGROUND
     WHEREAS, NxStage and PiSA entered into that certain Supply Agreement dated
as of March 27, 2006 (“Original Agreement”) pursuant to which NxStage agreed to
purchase from PiSA, and PiSA agreed to supply NxStage with, the Products (as
defined below); and
     WHEREAS, NxStage and PiSA desire to enter into a new Agreement to
incorporate additional concentrate Products and to reflect further agreements of
the parties.
     The Original Agreement shall terminate upon the Effective Date of 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 “Contract Year” means each calendar year period during the Term of this
Agreement, commencing on January 1, 2009. The parties agree that the first
Contract Year hereunder shall be the period beginning on the effective date and
ending December 31, 2009.
     1.3 “FDA” means the United States Food and Drug Administration, or any
successor thereto.
     1.4 “GMP” or “Good Manufacturing Practice” means those current Good
Manufacturing Practices as reflected in the pharmaceutical and medical device
industry standards for the FDA in the United States, inclusive of the Quality
Systems Regulation (QSR), 21 CFR part 820, and similar guidelines of any other
recognized national regulatory body applicable to the Territory, as amended from
time to time during the Term of this Agreement.
     1.5 “NxStage Trademarks” means, collectively, the trademarks, the service
marks and related intellectual property rights, which NxStage owns or has the
right to use, as appropriate, in connection with the Product, all as more fully
set forth on Appendix C attached hereto.

 

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     1.6 “Product” means, individually and collectively, the Products listed on
Appendix A hereto, as further described in the Technical Agreement. The Parties
may agree to add new products to “Appendix A” by mutual written agreement.
     1.7 “Purchase Order” means a purchase order submitted by NxStage in
accordance with Section 2.2.
     1.8 “Shipping Date” means the date on which the Products are confirmed to
NxStage to have shipped from PiSA’s manufacturing facilities as defined in 3.7
pursuant to a Purchase Order.
     1.9 “Specifications” means the Product specifications together with GMP and
manufacturing protocols, shipping and packaging requirements included as part of
the Technical Agreement.
     1.10 “Technical Agreement” means the Technical Agreement between NxStage
and PiSA, dated October 11, 2005, a copy of which is attached as Appendix B
hereto, which includes the Specifications and is hereby made a part of this
Agreement, and any modifications, amendments and supplements thereto.
     1.12 “Term” The term of this Agreement shall include the Initial Term and
any extension and/or renewals thereof. For purposes hereof, the Initial Term
shall mean the period commencing on the Effective Date and continuing through
December 31, 2011. Renewal Term shall mean any extension to this Agreement
mutually agreed to by the parties hereto, or pursuant to Section 4.1(d). The
first Renewal Term, if any, shall commence on January 01, 2012.
     1.13 “Territory” means all territories worldwide.
     1.14 “Unit Shortfall”. shall mean, during any Contract Year, the Minimum
Purchase Commitment for each of Lactate-Based Premixed Dialysate,
Bicarbonate-Based Premixed Dialysate, and Concentrate Products (each, as defined
on Appendix A) for such Contract Year as specified in Section 2.3 hereof, less
the quantity of each of such Products actually purchased by NxStage during such
Contract Year.
2. Manufacture and Supply of Product.
     2.1 General. During the Term of this Agreement (including any extension or
renewal thereof), PiSA shall manufacture and supply to NxStage and NxStage shall
purchase from PiSA on a non-exclusive basis the Products for sale in the
Territory under NxStage ’s trademark, own name, and account. All Products shall
be manufactured and supplied to NxStage in accordance with the Specifications.
     2.2 Purchase Orders; Forecasts. From time to time, NxStage shall submit
binding Purchase Orders for Products not less than [**] days prior to the first
requested Shipping Date for such Products. The Purchase Orders shall be made by
NxStage in writing and sent via fax, email, personal delivery or courier to
PiSA. PiSA shall confirm receipt in a term of [**] working days following
receipt of the same. NxStage shall also provide to PiSA on a

 

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monthly basis a rolling forecast of its expected Product purchase requirements
from PiSA for the succeeding [**] month period, the first [**] months of which
shall be binding with firm Purchase Orders. Each Purchase Order shall specify
the Product name, Product number and quantities of each of the Products to be
purchased, the desired Shipping Dates and shipping instructions.
PiSA shall accept all Purchase Orders that are in line with the Minimum Purchase
Commitment (as defined below) assuming the annual Minimum Purchase Commitment is
spread equally on a monthly basis) and shall manufacture and supply the Products
corresponding to the quantities and Shipping Dates set forth in such Purchase
Orders. PiSA shall use commercially reasonable efforts to accept and satisfy all
orders that exceed NxStage’s Minimum Purchase Commitment as well as rolling
forecasts and shall notify NxStage within [**] working days of receipt of any
Purchase Order if PiSA is not able to satisfy such Purchase Order. Unless
NxStage receives written notice from PiSA within such [**] working day period,
PiSA shall be deemed to have accepted such Purchase Order placed by NxStage.
     2.3 Minimum Purchase Commitment. During each Contract Year hereunder,
NxStage hereby agrees to purchase from PiSA and PiSA hereby agrees to sell to
NxStage a quantity of Products constituting no less than the annual minimum
number of units of Products as provided in Appendix A of this Agreement
(“Minimum Purchase Commitment”). If it becomes evident, during any given
Contract Year, that NxStage will not achieve the Minimum Purchase Commitment,
NxStage shall promptly notify PiSA in writing and both parties shall meet in
person or by phone to discuss in good faith acceptable solutions to the
shortfall. Any acceptable solution shall be agreed to in writing.
If the parties fail to reach a mutually acceptable solution following such good
faith discussions, NxStage shall pay to PiSA an amount equal to [**] percent
([**]%) of the Unit Shortfall for the applicable Contract Year’s Minimum
Purchase Commitment multiplied by the Product Purchase Price (as defined below)
in force for that Contract Year.
     2.4 Allocation of Supply. In the event PiSA is not able to supply all of
NxStage’s needs for the Product, for causes of Force Majeure as established in
section 14, PiSA shall allocate its available supply and production capacity
equitably among NxStage and other PiSA customers in proportion to NxStage’s and
such customers’ reasonably forecasted needs as provided to PiSA prior to the
occurrence of the supply shortfall.
     2.5 Failure to Supply. If, for reasons which are not due to Force Majeure
as established in Section 14, PiSA is unable to fulfill by the Shipping Date at
least [**] percent ([**]%) of the amount of Products ordered under any accepted
Purchase Order (“Failure to Supply”) over [**] successive calendar months,
without limiting any other rights NxStage may have, NxStage shall have the right
to reduce the Minimum Purchase Commitments for that Contract Year (whereby, the
Minimum Purchase Commitment applicable for that Contract Year shall be reduced
by 1/12th for each month following such a Failure to Supply) until such time as
PiSA has demonstrated an ability to supply at least [**] percent ([**]%) of
NxStage Purchase Order quantities for [**] successive calendar months, during
which period the pricing set forth in Appendix A shall remain in force. If,
after any reinstatement of Minimum Purchase Commitments, there is another
Failure to Supply for [**] calendar months (which need not be successive), the
Minimum Purchase Commitments shall be suspended for the remaining Term of this
Agreement, during which period the pricing set

 

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forth in Appendix A shall remain in force. In any case, if PISA ’s inability to
supply is due to Force Majeure event Section 14 shall apply.
     2.6 Cancellations. In the event NxStage cancels all or any part of any
accepted Purchase Order, NxStage shall pay PiSA (a) [**] for the cancelled
Purchase Order or for the number of Products partially cancelled for which the
requested Shipping Date is within [**] days or less of the date of NxStage’s
written notice of cancellation, and (b) the average direct product cost (assumed
for purposes of this Agreement to be [**]% of the Purchase Prices outlined in
Appendix A) for the number of Products cancelled for which the requested
Shipping Date is within [**] to [**] days of the date of NxStage’s notice of
cancellation. NxStage shall have no penalty associated with the cancellation of
any accepted Purchase Order for Products with a requested Shipping Date more
than [**] days after the date of NxStage’s notice of cancellation. Nothing in
this Section 2.6 shall affect NxStage’s Minimum Purchase Commitment specified in
Section 2.3 hereof. For purposes of this Section the calculation of the days
herein established shall begin from the moment PiSA has received the written
notice from NxStage.
3. Product Specifications; Manufacturing Processes; Etc.
     3.1 NxStage Initiated Modifications. If at any time during the Term of this
Agreement, NxStage desires to modify the Specifications, NxStage shall have the
right to modify or change the Specifications, subject to PiSA’s written
approval, which approval shall not be unreasonably withheld or delayed. Upon
receipt by PiSA of notice requesting a Specification change, PiSA shall have the
right (a) to adjust the Purchase Price of the Product to reflect any actual and
necessarily incurred changes in the cost of raw materials, direct labor,
equipment and overhead that will result from such modification or change
(provided that PiSA has reasonable documentation of the basis for any price
increases and such price change is agreed to by NxStage, and (b) to the extent
necessary, extend the Shipping Dates for the Products affected by the change in
Specifications, as agreed by the parties and (c) to require NxStage to purchase
(i) at its current Purchase Price all Products affected by a change in
Specifications in PiSA’s finished goods inventory which were manufactured
pursuant to accepted Purchase Orders, and (ii) at the book value reflected on
PiSA’s books, any and all molds and materials produced or acquired by PiSA in
order to manufacture Products affected by the change in Specifications hereunder
which cannot be used in the manufacture of any other Product hereunder, unless
PiSA, at its sole and good faith discretion, determines that such molds and
materials can be used to fulfill orders by other PiSA customers. For NxStage
initiated changes which can be implemented with flexible timing, and hence do
not have the potential to impact the continuous supply of the Product to
NxStage, PiSA shall be allowed up to [**] days to implement such changes. For
changes that require more urgent timing or could potentially interrupt supply of
the Product to NxStage, PiSA will work with NxStage and exert best commercial
efforts to effect such change to avoid any interruption in supply, thus
accomplishing such changes in a period of less than [**] days. If PiSA fails to
accept any requested change to Specifications, NxStage shall have the right to
terminate its Minimum Purchase Commitments upon [**] days prior notice to PiSA.
     3.2 PiSA Initiated Modifications. PiSA shall have the right to modify or
change the manufacturing procedures or practices used to make the Product, which
modification or change does not cause or necessitate a change to or in any
Specifications; provided that PiSA may not increase the Purchase Price of the
Product as a result of such modification or change without NxStage’s prior
written approval. PiSA shall inform NxStage of any such

 

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modification at least [**] days prior to the implementation thereof. All changes
in materials, processes, components or otherwise that are proposed by PiSA and
which cause or necessitate a change to or in any Specifications are subject to
NxStage’s prior written approval.
     3.3 Technical Assistance. At NxStage’s request, PiSA 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 the cost
to be agreed by the parties in writing on a case by case basis. No agent,
employee or other representative has the right to modify or expand PiSA’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.
     3.4 Labeling. All Product provided by PiSA will contain NxStage’s labeling
for sale to end user customers and/or distributors of NxStage. The labeling will
contain a statement that the Product is “Made in Mexico” and such other labeling
as may be required by law. NxStage 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 Products labels/labeling and
instructions for use included with the Product.
     3.5 Trademarks. NxStage hereby grants to PiSA a non-exclusive,
non-transferable, royalty-free license, without the right to sublicense, to use
the NxStage Trademarks without alteration or modification solely with respect to
PiSA’s labeling of the Products during the Term of this Agreement and not for
any other purpose. PiSA acknowledges NxStage’s ownership of or other right to
use the NxStage Trademarks. PiSA further acknowledges that neither this
Agreement nor the use by PiSA of the NxStage Trademarks shall create any right,
title or interest in or to the NxStage Trademarks by PiSA. This Agreement is not
intended to convey and does not convey to PiSA the right to use any trademarks
or service marks of NxStage other than the NxStage Trademarks for the use set
forth herein. Upon reasonable prior notice, PiSA shall permit NxStage to perform
audits and inspections at PiSA’s facilities to confirm PiSA’s compliance with
the terms of this Section 3.5.
     3.6 Third-Party Patents.
     (a) As of the date hereof, PiSA has no actual knowledge of any issued
Mexican third-party patents concerning the components or sub-assemblies used in
the Products or the procedures used in manufacturing the Products that would be
infringed by selling, marketing or manufacturing the Products in Mexico. If at
any time during the Term of this Agreement, a third-party suit for U.S. patent
infringement or misappropriation of trade secret relating to any of the
components or sub-assemblies used in the Product is (i) threatened against
NxStage (and NxStage reasonably determines that such threat is credible) or
(ii) filed against NxStage, then (A) NxStage may cease purchasing the Product
which is the subject of the third-party suit (and only such Product) without any
liability hereunder immediately upon providing written notice to PiSA (it being
understood that all Minimum Purchase Commitments with respect to such affected
Product shall immediately thereafter cease), and (B) PiSA shall, at PiSA’s
option, either (1) replace such allegedly infringing Products with
non-infringing Products as long as such non-infringing Products have the same
functionality as the allegedly infringing Products and conform to the
Specifications, or (2) if replacement

 

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is not practicable, buy back from NxStage unused inventories of such Products at
the Purchase Price paid by NxStage for such Products.
     (b) As of the date hereof, NxStage 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 suit
for U.S. patent infringement or misappropriation of trade secret concerning the
dialysate formulations used in a Product is (i) threatened against PiSA (and
PiSA reasonably determines that such threat is credible) or (ii) filed against
PiSA, then PiSA may cease supplying the Product which is the subject of the
third-party suit (and only such Product) without any liability hereunder
immediately upon providing written notice to NxStage and NxStage shall pay to
PiSA an amount equivalent to PiSA’s direct product cost (assumed for purposes of
this Agreement to be [**]% of the Purchase Prices outlined in Appendix A) for
all existing Product in stock, provided the total existing quantity does not
exceed the quantity on order through accepted Purchase Orders.
     3.7 Manufacturing Facilities. Without limiting PiSA’s obligations under the
Technical Agreement, PiSA shall be responsible for obtaining and maintaining
manufacturing facilities in Guadalajara, Mexico or at other PiSA manufacturing
facilities subject to NxStage’s prior written consent, which shall not be
unreasonably withheld, and other equipment, supplies and staff necessary to
perform its obligations hereunder in accordance with this Agreement and the
Technical Agreement. PiSA will manufacture the Product at such facilities and
shall not change the location of such manufacture without NxStage’s prior
written consent, not to be unreasonably withheld (it being understood that,
without limiting the foregoing, NxStage shall have no obligation to consent to a
request to change the location of manufacture which would increase NxStage’s
Product shipping costs). PiSA undertakes that the facility where PiSA will
manufacture the Product, and all the procedures used in manufacturing and
processing, shall enable PiSA to maintain manufacturing of Product according to
the Specifications. PiSA acknowledges that the manufacturing facilities for the
Product must be registered with the FDA under the requirements of the current
GMP and shall comply with the requirements of FDA 21 CFR Part 820 Quality System
Regulation.
4. Pricing and Payment; Record-Keeping; Audit Rights.
     4.1 Pricing. Except as provided in Section 3.1, the purchase price
(“Purchase Price”) of the Products shall be as set forth in Appendix A hereto.

  (a)   The parties agree that pricing for the Products during each Contract
Year of the Agreement shall be subject to review and modification at least [**]
days prior to the end of each Contract Year and only in cases of substantial
increases (an increase of more than [**]% in [**] during the Term, or over the
period commencing at the start of the Term through the end of the
then-applicable Contract Year and/or in the accumulative years since the last
price increase) in any direct material cost that adversely impacts PiSA’s direct
cost of manufacture, provided that PiSA can provide detailed justification of
the basis for such pricing increase (including the reason for such pricing
increase and an accounting of its impact on total direct manufacturing cost,
independent of exchange rate fluctuation). Consistent with provisions of section
4.1 (c) below, it is recognized

 

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      that both Parties are jointly focused on continuous improvement and best
in class performance.     (b)   In the event PiSA increases the Product Purchase
Price more than a [**] % in any calendar year during the Term, or over the
period commencing at the start of the Term through the end of the
then-applicable Contract Year and/or in the accumulative years ), NxStage shall
have the right to obtain third party price quotations related to the manufacture
and supply of Products. If any such quotation from a third party is less than
[**]% of the increased Purchase Price from PiSA, and can be substantiated in
writing by NxStage, PiSA shall have the right to match such pricing or choose to
leave its Purchase Price increase unchanged. PiSA shall make such determination
within [**] days of notice from NxStage of the third party quotation. If PiSA
decides to match the third party pricing, it shall inform NxStage in writing
within such [**] day notice period and the new Purchase Price shall become
effective with the next subsequent Purchase Orders placed by NxStage. If PiSA
decides to maintain its Purchase Price increase, NxStage shall be free to
purchase Products from the third party and may rescind its Minimum Purchase
Commitment (Section 2.3) to PiSA in writing with [**] days advance notice. From
the understanding that when not all the Products were subject to a Price
increase, the Minimum Purchase Commitment shall remain in force for the
remaining Products.     (c)   From time to time, the parties shall work together
on agreed upon joint projects to identify and implement cost saving measures
related but not limited to logistics, cost, lead-time, quality and other areas. 
Any savings that are realized through these joint efforts shall be shared fairly
between the parties based upon each party’s contribution to the project
irrespective of whether the implementation occurs at PiSA or NxStage’s
facilities. Progress on these projects will be reviewed during regularly
scheduled business reviews which will provide objective evidence of supplier
management and customer satisfaction per the ISO standard.     (d)  
Additionally, at least [**] days prior to the end of the Initial Term of the
Agreement, the parties shall meet in person or by phone to negotiate possible
Purchase Prices for any Renewal Term. If PiSA and NxStage do not reach an
agreement on Purchase Prices following good faith negotiations, this Agreement
may be automatically extended at NxStage’s option, for an additional twelve
(12) months (the “Extended Period”), during which the last Purchase Prices
agreed to by the parties and then existing will remain in effect.

     4.2 Taxes. PiSA 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 their storage, inventory, sale, transportation, delivery,
use or consumption shall be the responsibility of NxStage. NxStage shall provide
PiSA with all appropriate tax exemption certificates acceptable to the taxing
authorities imposing such taxes, if NxStage desires not to make such payments.
     4.3 Payment Terms. PiSA shall invoice NxStage concurrently with any
shipment of Products and NxStage shall make full payment to PiSA, no later than
[**] days from the Receipt Date for all shipments where the freight is exworks
Guadalajara. PiSA shall invoice NxStage concurrently with delivery of Products
and NxStage shall make full payment to

 

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PiSA, no later than [**] days from the Delivery Date for all shipments where the
freight is DAF Nuevo Laredo. Payment shall be in U.S. Dollars by bank transfer
directly to the bank account designated by PiSA. Any amounts not paid within a
[**] day period shall accrue interest at the rate of [**] percent ([**]%) per
month.
     4.4 Dispute of Invoices. If NxStage disputes all or any part of an invoice,
NxStage shall provide PiSA a notice of the dispute within [**] calendar days of
its receipt of such invoice, and shall pay any undisputed portion of the invoice
within [**] days of the Shipping Date. NxStage and PiSA agree to use all
commercially reasonable efforts to resolve any disputes concerning the payment
of invoices under this Section within [**] calendar days after NxStage has
provided such notice of dispute. If the parties are unable to resolve or to
compromise such dispute within such [**] calendar day period, each of NxStage
and PiSA agrees to submit the dispute to be settled per Section 15.9 of this
Agreement, “Governing Law and Dispute Resolution”.
5. Delivery.
     5.1 Shipments. All shipments of Products shall be made ex-works and/or
DAF,(Inconterms 2000) as requested by NxStage, according to the following:
Ex-works.- Shall be made at PiSA’s manufacturing facilities, Guadalajara,
Mexico. Title to and risk of loss for the Product shall pass from PiSA to
NxStage upon delivery of the Products to the carrier at such site. PiSA will
arrange for shipments of Products in accordance with the applicable Purchase
Order for such Products. NxStage shall be responsible for the cost of all
freight, shipping and handling, and insurance in connection with all deliveries
from such site.
DAF.- Shall be made at Nuevo Laredo Tamaulipas, Mexico, title to and risk of
loss for the Product shall pass from PiSA to NxStage upon delivery of the
Products to the carrier at such site. PiSA will arrange for shipments of
Products in accordance with the applicable Purchase Order for such Products.
NxStage shall be responsible for the cost of all freight, shipping and handling,
and insurance in connection with all deliveries from such site. Invoicing for
DAF shipments shall delineate freight charges as a separate and distinct line
item from product cost.
     5.2 Inspections. NxStage shall have the right, but not the obligation, to
inspect all Products for conformance with the Purchase Order and compliance with
the Specifications. PiSA agrees to issue a credit note on NxStage’s account for
the amount paid for the Products that is disputed or rejected after any such
inspection. NxStage shall perform such inspections within [**] days after
receipt of a shipment of Products at NxStage’s headquarters or another location
designated by NxStage, and shall promptly notify PiSA in writing of the
non-conformance of any Products or if any Product or shipment of Products is
disputed or rejected and failure to do so shall be considered as NxStage Product
acceptance. In the event NxStage rejects any Product or shipment of Products
because of any non-compliance with the Specifications, PiSA agrees to replace
such Product or shipment (the “Replaced Products”) at PiSA’s sole cost and
expense (including freight charges) and subsequently invoice NxStage for the
Purchase Price of the Replaced Product or, at PiSA’s option, reimburse NxStage
the Purchase Price paid for such rejected Products, plus the cost of freight
paid by NxStage. In either case, PiSA shall be responsible for all costs
associated with the disposition of

 

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nonconforming Product. The acceptance by NxStage of the Products hereunder shall
not be deemed a waiver by NxStage of the warranties set forth in Section 6
hereof.
In the event NxStage disputes any shipment of Products because of any
non-conformity which results from delivery of less Product than invoiced, PiSA
shall supply to NxStage, as promptly as possible but no later than [**] days
following NxStage’s notice of such non-conformity, such additional Product as is
necessary to meet the amount invoiced. In the event NxStage disputes any
shipment of Products because of any non-conformity which results from delivery
of more Product than ordered after taking into account that delivered quantity
for the Products may differ by +/- [**] % of the ordered quantity, NxStage may
accept any Product in excess of the quantity ordered as against future orders of
the Product.
6. Warranties.
     6.1 PiSA Warranties. PiSA represents and warrants to NxStage that, at the
time of delivery, the Product delivered by PiSA to NxStage under this Agreement
is free from defects in material and workmanship, and conforms to the applicable
Specifications for such Product. Pisa’s liability excludes NxStage’s selected
Product (listed in Appendix A) formulation and labelling, as well as
distribution, sale, marketing, handling and use of the Products after they are
delivered to NxStage. All warranties for Product shall continue for the
Product’s labeled shelf life.
     6.2 DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER
PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND WHATSOEVER, EITHER
EXPRESS OR IMPLIED, WRITTEN OR ORAL, INCLUDING ANY WARRANTY OF MERCHANTABILITY
AND ANY WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.
7. Regulatory Matters.
     7.1 Complaints. Subject to Section 11.1 of the Technical Agreement, NxStage
shall be responsible for interfacing with its customers regarding all Product
complaints and inquiries and promptly passing all such information on to PiSA,
and NxStage 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. PiSA shall
provide technical support for investigating any complaints. If PiSA receives any
information regarding adverse reactions or defects of the Products, PiSA shall
inform NxStage 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. The parties’ rights and obligations concerning any recall of
any Product shall be governed by the terms of Section 11.2 of the Technical
Agreement. PiSA and NxStage shall reasonably cooperate with each other in the
event of any recall of any Product.
     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, PiSA shall permit authorized
representatives of relevant regulatory

 

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authorities, including FDA, to audit and inspect PiSA’s Product manufacturing
facilities, and shall permit authorized representatives of NxStage to
participate in such audit and inspection to the extent related to the Product.
Either party hereto shall promptly notify the other of any governmental
regulatory inspections of which it becomes aware in relation to the Product.
PiSA 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 NxStage shall, upon request, assist PiSA in
preparing such responses. PiSA shall advise NxStage of the findings of any such
audits or inspections and PiSA shall correct all deficiencies identified in the
course of such audit or inspection relating to the manufacture of the Product.
PiSA shall provide NxStage with copies of all material correspondence to and
from relevant regulatory authorities concerning the Product.
     7.4 Records. PiSA shall be responsible for the archiving and retention of
all relevant documentation fully in compliance with GMP.
8. Compliance with Laws. PiSA represents, warrants and covenants to NxStage that
it shall, at all times, comply with all applicable laws, rules and regulations
and standards applicable to manufacturing of the Products as well as GMP.
NxStage shall cooperate with PiSA and, upon request, and at PiSA’s expense,
shall use reasonable efforts to assist PiSA in meeting all requirements of the
applicable regulatory agencies. NxStage represents, warrants and covenants to
PiSA 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 there under.
9. Insurance. Each party represents and warrants to the other that it will be
insured and covenants 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 (a) is sufficient to
adequately protect against the risks associated with the manufacture and supply
of Products under this Agreement, and (b) 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
requesting 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 equivalent to the labeled shelf-life of the Product last shipped to
NxStage during the Term of this Agreement.
During the Term of this Agreement PiSA shall provide and/or maintain a Product
Liability Insurance policy in the coverage amount of $10.0 million USD with
regards to Products to be supplied under this Agreement. PiSA shall provide to
NxStage a Certificate of Insurance for the Product Liability policy. The Product
Liability Insurance policy shall name NxStage as an Additional Insured.
During the Term of this Agreement NxStage shall provide and/or maintain a
Product Liability Insurance policy in the coverage amount of $10.0 million USD
with regards to Products to be supplied under this Agreement. NxStage shall
provide to PiSA a Certificate of Insurance for the Product Liability policy. The
Product Liability Insurance policy shall name PiSA as an Additional Insured.

 

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10. Indemnification.
     10.1 PiSA Indemnification Obligation. PiSA hereby indemnifies and agrees to
defend and hold NxStage, its affiliates, and each of their officers, directors,
agents and employees and their successors and assigns (individually and
collectively, “NxStage Parties”) harmless from and against any and all damages,
liabilities, penalties, losses or expenses including, without limitation,
reasonable legal fees (collectively, “Losses”), arising out of or relating to
any claims, actions, demands or proceedings asserted by a third party
(collectively, “Claims”) to the extent any such Claim (a) results from or arises
out of PiSA’s breach of any warranty, representation or agreement of PiSA in
this Agreement, or (b) results from or arises out of PiSA’s willful misconduct
or gross negligence.
     10.2 NxStage Indemnification Obligation. NxStage hereby indemnifies and
agrees to defend and hold PiSA, its affiliates and each of their officers,
directors, agents and employees and their successors and assigns (individually
and collectively, “PiSA 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 NxStage’s breach of any warranty, representation
or agreement of NxStage in this Agreement or NxStage’s willful misconduct or
gross negligence.
     10.3 Notice. 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 Procedure. 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 or
delayed. 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 [**] days after receipt of an invoice
therefore.
     10.5 Settlement. 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 (a) 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,
(b) the indemnified party does not admit any liability, and (c) the indemnified
party is released from all further liability with respect to such claim.

 

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     10.6 Survival of Obligations. 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 Term. This Agreement shall remain during the Initial Term, unless
sooner terminated in accordance with the provisions of this Agreement,
including, Section 3.1 or Section 4.1 (b) and/or 4.1 (d), this Section 11, or
Section 14, or extended pursuant to Section 4.1(d).
     Subsequent to the Initial Term, this Agreement shall be automatically
extended for one (1) year periods, ( “Renewal Term”); provided that either party
shall have the right to terminate the Renewal Term with six (6) months prior
written notice of its intent to terminate this Agreement or unless sooner
terminated in accordance with the provisions of Section 4.1(d), this Section 11,
or Section 14.
     11.2 If NxStage terminates the agreement for reasons other than those
specified within Section 4.1 (b) and/or 4.1 (d), this Section 11, or Section 14,
NxStage shall pay to PISA an amount equal to [**] percent [**]% of the unit
shortfall according to the Minimum Purchase Commitment multiplied by the
Purchase Product price in force at the date of termination for that Contract
Year, and such payment shall be PISA’s sole remedy and NxStage’s sole liability
for such termination.
     If PISA terminates the agreement for reasons other than those specified
within Section 4.1 (b) and/or 4.1 (d), this Section 11, or Section 14, PISA
shall pay to NxStage an amount equal to the difference between the Purchase
Price NxStage can obtain from a third party supplier and the Purchase Price
hereunder, multiplied by the Minimum Purchase Commitment remaining to be
fulfilled had the contract not been terminated by PISA.
     11.3 Termination for Technology Change. If after the first Contract Year,
NxStage is able to demonstrate an alternative source or technology for
production exclusively of a premixed lactate product that is substantially
functionally equivalent to the Product hereunder with respect to both safety and
efficacy, then NxStage shall so notify PiSA and PiSA shall be given [**] days to
match the overall cost to NxStage of such alternative source or technology. If
PiSA elects not to so match the overall cost of such alternative source or
technology, at the end of such [**] day period, NxStage shall have the option to
terminate this Agreement solely for that specific Product upon ninety (90) days
written notice to PiSA.
     11.4 Termination for Bankruptcy. Either party may terminate this Agreement,
effective upon delivery of a termination notice, if the other party (a) files 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,
(b) 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, (c) is a party to any dissolution or liquidation,
(d) makes an assignment for the benefit of creditors, or (e) discontinues its
operations for any reason whatsoever.

 

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     11.4 Termination for Breach. In addition to all other rights granted to the
parties hereunder, either party may terminate this Agreement effective sixty
(60) 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 [**] days after receiving written
notice with respect to such default.
     11.5 Effects of Termination.
     (a) Termination of this Agreement shall not relieve either party from its
duty to discharge all obligations accruing prior to such termination, including
each party’s obligations pursuant to any accepted Purchase Order outstanding on
the date of such termination.
     (b) Upon termination of this Agreement for any reason whatsoever,
(i) NxStage shall return to PiSA all PiSA confidential information and documents
relating to or containing PiSA confidential information, together with all
copies made thereof and extracts made there from, and (ii) PiSA shall return to
NxStage all NxStage confidential information and documents relating to or
containing NxStage confidential information, together with all copies made
thereof and extracts made there from; 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. PiSA shall also make available upon request by NxStage,
batch records or other quality records for the Product for a period of [**]
years after termination.
12. Limitation of Liability. EXCEPT WITH RESPECT TO A PARTY’S INDEMNIFICATION
OBLIGATIONS UNDER THIS AGREEMENT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER
PARTY ITS AGENTS, EMPLOYEES, SUBCONTRACTORS OR CUSTOMERS FOR ANY SPECIAL,
PUNITIVE, INCIDENTAL, CONSEQUENTIAL OR OTHER INDIRECT 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, EVEN IF SUCH PARTY HAS BEEN ADVISED OF
THE POSSIBILITY THEREOF.
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 PiSA or any
of its employees or agents and NxStage or any of its employees or agents in
performance of this Agreement shall belong exclusively to NxStage. All
intellectual property which may arise in any documents, drawings, items,
designs, processes, software or any other thing developed solely by PiSA or any
of its employees or agents or NxStage or any of its employees or agents shall be
the sole and exclusive property of PiSA or NxStage, respectively.
14. Force Majeure. If PiSA 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

 

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Majeure event; provided that if as a consequence of any such Force Majeure the
total demands for the Products cannot be supplied by PiSA, PiSA will allocate
its available supply to its customers on a fair and equitable basis taking into
account the relative levels of Product purchases over the prior year, without
liability for any failure to perform this Agreement; PiSA will promptly notify
NxStage of any occurrence of an event of Force Majeure and of the termination
thereof. NxStage may terminate this Agreement in the event the Force Majeure
event continues for more than two (2) months. “Force Majeure” shall mean any
cause beyond NxStage’s, PiSA’s 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 confidential
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
other 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 without reference to or use of the disclosing party’s
confidential information 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 15
shall survive termination of this Agreement and any extension thereof, for a
period of [**] years.
     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 Additional Business – Purchase of Dialysate Concentrate and/or
Distribution of System One™. In the event that NxStage determines during the
Term of this Agreement that it wishes to enter into purchase arrangements for
dialysate concentrate either in bulk form or in single use containers, and/or to
distribute the System One™ product in Mexico, Central and South America, PiSA
shall have, respectively, the right of first proposal to supply such products
(Dialysate Concentrate )and/or the right of first proposal with respect to such
distribution (System One™). For such purposes, PiSA shall submit a proposal for
the product, and/or for such distribution rights within [**] days of NxStage’s
request for a proposal and/or notice of its decision to distribute the System
One™ product in such

 

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territories. NxStage’s decision as to awarding the business to PiSA shall
consider in good faith the comprehensive economics of the PiSA proposal
including but not limited to transportation costs, lead-times, product quality,
and other factors. NxStage shall have no obligation to accept such proposals.
     15.4 Assignment. Neither party shall assign this Agreement or their rights
hereunder without the prior written consent of the other party, which shall not
be unreasonably withheld or delayed; provided that no such consent is required
in the event of an assignment by either party to an affiliate of NxStage or in
connection with the merger or sale of all or substantially all of the assets,
stock or business to which this Agreement relates. 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. Without limiting the foregoing, PiSA agrees that NxStage may
terminate the Agreement following a Change of Control of PiSA upon sixty
(60) days notice.
     15.5 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.
     15.6 Entire Agreement; Amendment; Waiver; Etc. This Agreement, including
the Appendixes attached hereto (and any future addenda referencing this
Agreement), and the Technical Agreement contain the entire agreement and
understanding between the parties with respect to the subject matter hereof and
supersede 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. 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 superseded 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 3.6, 4.3, 6, 7, 8,
9, 10, 11.4, 12, 13 and 15 of this Agreement shall survive the termination of
this Agreement in accordance with their terms.
     15.7 Technical Agreement. The detailed instructions in the Technical
Agreement attached as Appendix B shall control the manner in which the parties
shall perform its obligations related to the manufacture of Product. 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.

 

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     15.8 Binding Obligation. Each party represents and warrants that (a) it has
the right to enter into this Agreement and to perform all of its obligations
hereunder, and (b) 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.
     15.9 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.
     15.10 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 the laws of
the Commonwealth of Massachusetts, U.S.A.
     (b) In the event of any dispute, claim or controversy (a “Dispute”) 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 Disputes. If such amicable resolution cannot be reached, any
unresolved dispute, controversy or claim arising out of or relating to this
Agreement, or the breach, termination or invalidity thereof, shall be finally
settled by arbitration in accordance with the Rules of Arbitration of the
International Chamber (ICC) as in force upon the execution of this Agreement, by
one arbitrator appointed in accordance with such Rules. The place of venue for
the arbitration shall be in the defendant’s domicile. The fees and expenses of
the arbitrator, as between PiSA and NxStage, shall be borne by them in such
proportions as shall be determined by the arbitrator, or if there is no such
determination, then such fees and expenses shall be borne by the non-prevailing
party.
     15.11 Heading. The Headings in this Agreement are included for ease of
reference only and shall have no legal effect.
     15.12 Signatures. This Agreement may be executed in one or more
counterparts, each of which shall be deemed to be one and the same Agreement.
[Remainder of This Page Intentionally Left Blank]

 

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     IN WITNESS WHEREOF, the parties hereto have executed and delivered this
Agreement as of the Effective Date.

              LABORATORIOS PiSA, S.A. de C.V.   NXSTAGE MEDICAL, INC.  
By:
  /s/ Ricardo Alfonso Villarreal Rosales   By:   /s/ Jeffrey H. Burbank
 
            Name: Ricardo Alfonso Villarreal Rosales   Name: Jeffrey H. Burbank
Title: New Business Director   Title: President and CEO

 

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APPENDIX A (page 1 of 4)
List of Products and Product Codes

      Product name   NxStage product code  
Premixed Dialysate, 5 liters, 40 Lactate
  RFP-204
Premixed Dialysate, 5 liters, 35 lactate, 3K
  RFP-205
Premixed Dialysate, 5 liters, 45 Lactate
  RFP-207
Bicarb Premixed Dialysate, 5 liters, 35 Bicarb, 2K
  RFP-400
Bicarb Premixed Dialysate, 5 liters, 35 Bicarb, 4K
  RFP-401
Bicarb Premixed Dialysate, 5 liters, 35 Bicarb, 0K
  RFP-402
Bicarb Premixed Dialysate, 5 liters, 25 Bicarb, 2K
  RFP-453
Bicarb Premixed Dialysate, 5 liters, 25 Bicarb, 4K
  RFP-454
20:1 Concentrate, 45 Lactate, 1K
  NX1340
20:1 Concentrate, 40 Lactate, 1K
  NX1345
20:1 Concentrate, 45 Lactate, 2K
  NX2345
32:1 Concentrate, 45 Lactate, 1K
  NX5145
32:1 Concentrate, 40 Lactate, 1K
  NX5140
32:1 Concentrate, 45 Lactate, 2K
  NX5240

 

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APPENDIX A (page 2 of 4)
MINIMUM PURCHASE COMMITMENTS* FOR LACTATE-BASED
PREMIXED DIALYSATE PRODUCTS

              Annual Minimum Purchase Contract Year   Commitment (unit of
measure = 5L bags)*  
January 1, 2009 – December 31, 2009
    [**]  
January 1, 20 10 – December 31, 2010
    [**]  
January 1, 2011 – December 31, 2011
    [**]  

Pricing for 5 liter lactate-based pre-mixed Dialysate Products
See Technical Agreement for Product Specifications

          Monthly Purchase   Unit Price† per bag of Dialysate   Unit Price† per
bag of Quantity   exworks Guadalajara packaged   Dialysate DAF NEUVO LAREDO (in
5L bags)   in Bliss Box **   packaged in Bliss Box **  
Any quantity
  $[**]   $[**] USD

 

*   The Minimum Purchase Commitment is made by NxStage in exchange for the
volume pricing as also specified in this Appendix A.   **   NxStage’s total
Product orders for all lactate-based premixed formulations shall be considered
in the aggregate when determining whether the Minimum Purchase Commitment has
been met.   †   The marked price shall govern pricing for the Products under
this Agreement, so long as NxStage meets the Minimum Purchase Commitment or pays
for any Unit Shortfall consistent with the terms of Section 2.3.

 

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APPENDIX A (page 3 of 4)
MINIMUM PURCHASE COMMITMENTS * FOR BICARBONATE-
BASED PREMIXED DIALYSATE PRODUCTS

              Annual Minimum Purchase Contract Year   Commitment (unit of
measure = 5L bags)*  
January 1, 2009 – December 31, 2009
    [**]  
January 1, 20 10 – December 31, 2010
    [**]  
January 1, 2011 – December 31, 2011
    [**]  

Pricing for 5 liter Bicarbonate-Based pre-mixed Dialysate Products
See Technical Agreement for Product Specifications

          Monthly Purchase   Unit Price† per bag of Dialysate   Unit Price† per
bag of Quantity   exworks Guadalajara packaged   Dialysate DAF NEUVO LAREDO (in
5L bags)   in Bliss Box **   packaged in Bliss Box **  
Any quantity
  $[**]   $[**] USD

 

*   The Minimum Purchase Commitment is made by NxStage in exchange for the
volume pricing as also specified in this Appendix A.   **   NxStage’s total
Product orders for all bicarbonate-based premixed formulations shall be
considered in the aggregate when determining whether the Minimum Purchase
Commitment has been met.   †   The marked price shall govern pricing for the
Products under this Agreement, so long as NxStage meets the Minimum Purchase
Commitment or pays for any Unit Shortfall consistent with the terms of
Section 2.3.

 

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APPENDIX A (page 4 of 4)
MINIMUM PURCHASE COMMITMENTS* FOR CONCENTRATE †

              Annual Minimum Purchase   Annual Minimum Purchase     Requirement
of 20:1 (in   Commitment of 32:1 (in Contract Year   liters)*   liters)*  
January 1, 2009 – December 31, 2009
  [**]   [**]
January 1, 2010 – December 31, 2010
  [**]    
January 1, 2011 – December 31, 2011
  [**]    

Pricing for Concentrate
See Technical Agreement for Product Specifications

              Unit Price† per liter of 20:1   Unit Price† per liter of 32:1
Monthly Purchase   Concentrate exworks   Concentrate exworks Quantity  
Guadalajara packaged in   Guadalajara packaged in (in liters)   reusable totes**
  reusable totes**  
Any quantity
  $ [**] USD   $[**] USD

 

*   The Minimum Purchase Commitment is made by NxStage in exchange for the
volume pricing as also specified in this Appendix A.   **   NxStage’s total
Product orders for all concentrate shall be considered in the aggregate when
determining whether Minimum Purchase Commitment has been met.   †   The marked
price shall govern pricing for the Products under this Agreement, so long as
NxStage meets the Minimum Purchase Commitment or pays for any Unit Shortfall
consistent with the terms of Section 2.3.

 

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APPENDIX B
TECHNICAL AGREEMENT
THIS TECHNICAL AGREEMENT (the “Agreement”) is made on October 20, 2005
BETWEEN:
(1) NXSTAGE MEDICAL Inc., whose principal place of business is at 439 S. Un-ion
Street, Lawrence, MA 01843, United States of America (NxStage) and
(2) LABORATORIOS PISA, S.A. de C.V., whose production facility is located at
Calle 7 No. 1308 Zona Industrial C.P. 44940 Guadalajara, Jal., Mexico (“PISA”).
WHEREAS:
A. PISA holds current Mexican manufacturing licenses, which enables them to
manufacture the medical devices listed in Appendix 1.
B. NxStage holds current regulatory authorization, which enables them to market
and sell the medical devices listed in Appendix 1.
C. This Agreement is limited to 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.
D. NxStage has performed an Audit to assess compliance of PISA ’s Quality System
and for all elements included in the audit, has found PISA’s Quality System to
conform with the requirements of 21 CFR 820 FDA current Good Manufacturing
Practices.
D. This Agreement does not constitute an obligation to supply the Products.
Supplies of Products shall be made under the final Supply Agreement to be agreed
between the parties.
OPERATIVE PROVISIONS:

1.   Definitions and Applicability

1.1   This Agreement applies to supply arrangements pursuant to which PISA
manufactures medical devices in the capacity of contract manufacturer for
NxStage in the capacity of final manufacturer and marketer in accordance with
the final Supply Agreement to be entered into between PISA and NxStage (“Supply
Agreement”).

1.2   This Agreement shall form an appendix of the Supply Agreement to be
concluded between NxStage and PISA 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.

 

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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
List of NxStage Product Specifications
  Appendix 2
List of PISA Test Specifications
  Appendix 3
Qualified Persons and Contact Numbers
  Appendix 4
FDA Quality System Regulation (QSR) 21 CFR Part 820
  Appendix 5

3. General
[**]
A total of 4 pages have been omitted pursuant to a request for confidential
treatment.
IN WITNESS WHEREOF, this Agreement has been duly executed in duplicate as of the
date first above written.
NXSTAGE MEDICAL Inc.
By: /s/ Philip R. Licari
Name: Philip R. Licari
Title: Senior Vice President and Chief Operating Officer
LABORATORIOS PISA, S.A. de C.V.
By:
Name:
Title:

 

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Appendix 1
to Technical Agreement between
NXSTAGE MEDICAL Inc. and
LABORATORIOS PISA, S.A. de C.V.
List of Products and Product Codes

          Product name   NxStage product code   PISA product code  
[**]
  [**]   [**]
[**]
  [**]   [**]
[**]
  [**]   [**]
[**]
  [**]   [**]

 

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Appendix 2
to Technical Agreement between
NXSTAGE MEDICAL Inc. and
LABORATORIOS PISA, S.A. de C.V.
NxStage Product Specifications

                      NxStage     Document type   Title   Document #   Revision
 
Product Specification
  [**]   [**]    
Product Specification
  [**]   [**]    
Product Specification
  [**]   [**]    
Product Specification
  [**]   [**]    

[**]

 

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Appendix 3
to Technical Agreement between
NXSTAGE MEDICAL Inc. and
LABORATORIOS PISA, S.A. de C.V.
PISA Test Specifications

                      Pisa     Document type   Title   Document #   Revision  
Test Specification
  [**]   [**]    
Test Specification
  [**]   [**]    
Test Specification
  [**]   [**]    
Test Specification
  [**]   [**]    

 

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Appendix 4
to Technical Agreement between
NXSTAGE MEDICAL Inc. and
LABORATORIOS PISA, S.A. de C.V.
Qualified Persons and Emergency Contact Numbers
NXSTAGE MEDICAL Inc.,
439 S. Union Street, Lawrence, MA 01843, USA
NXSTAGE MEDICAL Inc.,
439 S. Union Street, Lawrence, MA 01843, USA
[**]
LABORATORIOS PISA, S.A. de C.V.
Av España, 1840, Colonia Moderna, C.P. 44190, Guadalajara, Jal., Mexico
LABORATORIOS PISA, S.A. de C.V.
Av España, 1840, Colonia Moderna, C.P. 44190, Guadalajara, Jal., Mexico
[**]

 

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Appendix 5
to Technical Agreement between
NXSTAGE MEDICAL Inc. and
LABORATORIOS PISA, S.A. de C.V.
Copy of
“FDA Quality System Regulation (QSR) 21 CFR Part 820”

 

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APPENDIX C
NXSTAGE TRADEMARKS
(1) NxStage ®
(2) Pureflow Solution™
(3) Pureflow B Solution™