Document:

exv10w45

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.

 

 

     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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

	 	 	 	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

 

 

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

 

 

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

 

 

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.

 

 

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.

 

 

     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.

 

 

     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

 

 

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
OneTM. 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 OneTM 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 OneTM).
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 OneTM product in such

 

 

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.

 

 

     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]

 

 

     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

 

 

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

 

 

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.

 

 

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.

 

 

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.

 

 

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.

 

 

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:

 

 

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
	 
	[**]

	 	[**]
	 	[**]
	[**]

	 	[**]
	 	[**]
	[**]

	 	[**]
	 	[**]
	[**]

	 	[**]
	 	[**]

 

 

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

	 	[**]
	 	[**]	 	 

[**]

 

 

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

	 	[**]
	 	[**]	 	 

 

 

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

[**]

 

 

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”

 

 

APPENDIX C

NXSTAGE TRADEMARKS

(1) NxStage ®

(2) Pureflow SolutionTM

(3) Pureflow B SolutionTMexv10w46

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisk denote omissions.

Exhibit 10.46

EXTRACORPOREAL DISPOSABLES DISTRIBUTION AGREEMENT

               This Agreement, dated as of June 15, 2009 (the “Effective Date”), is between Medisystems
Corporation, a Washington corporation with offices at 439 South Union Street, 5th Floor,
Lawrence, Massachusetts 10843 (together with its affiliates, “MDS”) and Gambro Renal Products,
Inc., a Colorado corporation with offices at 14143 Denver West Parkway, Lakewood, Colorado 80401
(together with its affiliates, “Gambro”). MDS and Gambro shall each be referred to herein as a
“Party” and collectively as the “Parties”.

               In consideration of the mutual promises made herein and other good and valuable consideration,
the receipt of which is hereby acknowledged, the Parties hereto agree as follows:

     1.0 BACKGROUND

          1.1 The following are examples of certain disposable medical devices useful in dialysis
therapies (collectively, the “Products”):

                    Non-cartridge blood tubing sets designed for use with Fresenius dialysis monitors (“BTL”).

          MDS designs and supplies certain Products under Specifications (as hereinafter defined)
including MDS labeling which MDS controls and currently has produced by subsidiaries or contract
manufacturers as set forth in Exhibit B (“MDS Products”). Gambro wishes to purchase certain MDS
Products for resale to DaVita (as defined below) and certain of its other dialysis customers in
certain countries of the world as listed in Exhibit A (the “Territory”).

     2.0 TERM OF AGREEMENT

          2.1 The term (including any extensions, the “Term”) of this Agreement shall be for a five (5)
year period beginning on the Effective Date of this Agreement. The Agreement shall terminate at the
end of the Term, unless the Parties agree on provisions for an extension of the Term not less than
six (6) months prior to the date on which this Agreement would otherwise terminate.

     3.0 MDS PRODUCTS

          3.1 The MDS Products that Gambro wishes to purchase pursuant to this Agreement are listed in
Exhibit B as “MDS BTL”, as such Exhibit B may be amended from time to time by mutual agreement of
the Parties. The codes of the MDS Products that are the subject of this Agreement are hereafter
referred to as “Codes”. The Codes shall meet specifications as set forth in Exhibit C, or as such
specifications, including labeling, may be modified from time to time pursuant to Sections 9.1, 9.2
and 9.3 (the “Specifications”), provided that such modifications are agreed upon in amendments to
Exhibit C signed pursuant to Section 18.2 hereof.

          3.2 MDS reserves the right, at its sole discretion, to incorporate clinical use enhancements
or developments in existing Codes of the MDS Products or to supply existing Codes from alternate
manufacturing sites or manufacturers even if MDS designates them with a different Code suffix,
provided that (i) no price increase is requested by MDS, (ii) the change does not alter the
Specifications (other than the Code suffix), and (iii) the change does not, in MDS’ reasonable
opinion, materially change the manufacturing process for the Codes or materially change the Codes.
If any of the preceding clauses are not satisfied, Gambro shall not be required to accept such
change, unless, in the reasonable opinion of Gambro, the change does not adversely affect the
Code’s conformance to the Code’s material performance characteristics.

     4.0 PURCHASES AND ORDERS

          4.1 Subject to the terms and conditions of this Agreement, MDS shall sell the Codes listed in
Exhibit B to Gambro and Gambro shall purchase the Codes listed in Exhibit B for use or resale by
Gambro only in the Territory.

          4.2 “Contract Year” shall mean for the first Contract Year, that period of time commencing on
the Effective Date of this Agreement and ending on December 31, 2009. Thereafter, each Contract
Year shall be from January 1 through December 31 of each calendar year during the Term of this
Agreement, except that the last Contract Year

1

 

shall end on the termination or expiration date, if different than December 31.

          4.3 During the Exclusive Period (as defined below), Gambro hereby agrees to sell, directly or
indirectly (including without limitation to include sales through agents, representatives or
distributors) to DaVita Inc., DaVita affiliated entities, DaVita dialysis clinics, DaVita
management contract clinics, and clinics or entities jointly owned by DaVita or DaVita affiliates
(collectively, “DaVita”) BTL sourced only and exclusively from among MDS BTL listed in Exhibit B
(the “Exclusive Products”). During the Exclusive Period, MDS hereby agrees not to sell, directly
or indirectly (including without limitation to include sales through agents, representatives or
distributors) MDS BTL to DaVita; provided, however, that this obligation shall expire prior to the
expiration of the Term or earlier termination of this Agreement in the event DaVita (i) ceases to
have any material contractual ongoing purchase obligations with respect to BTL to Gambro which can
be satisfied through the purchase of MDS BTL from Gambro, or (ii) ceases to purchase at least [**]
percent ([**]%) of its BTL requirements (such requirements including, without limitation, all of
DaVita’s purchase, use, and/or inventory requirements for BTL (hereinafter, “BTL Requirements”))
from Gambro in the form of MDS BTL (as measured by Calendar Quarter, or at the reasonable request
of MDS, on a rolling [**] month basis),it being understood that Gambro shall not be deemed to be in
breach of this requirement, and MDS shall not have the right to immediately terminate this
Agreement, if such failure to satisfy such requirement is due to (i) DaVita’s purchases of MDS BTL
from MDS, Henry Schein or other third party MDS customers, (ii) MDS’ failure to deliver conforming
MDS BTL pursuant to accepted Gambro Delivery Orders, or (iii) a material increase in the percentage
of DaVita joint venture or managed clinics, to the extent such clinics are not obligated to
purchase at least [**]% of their BTL requirements from Gambro under any agreement with DaVita;
provided that during the Term Gambro shall not enter into any agreement or amendment with DaVita
which imposes a lower purchase requirement for DaVita with respect to BTL to be purchased from
Gambro in aggregate or with respect to any type of DaVita dialysis clinic or facility, or which
would impair in any way DaVita’s obligation to buy MDS BTL from Gambro hereunder. Notwithstanding
the foregoing, Gambro shall be deemed to be in breach of this requirement, and MDS shall have the
right to immediately terminate this Agreement, if in any [**] consecutive Calendar Quarters (or at
the reasonable request of MDS, [**] consecutive rolling [**] month periods) during the Exclusive
Period DaVita purchases less than [**] percent ([**]%) of its BTL Requirements from Gambro in the
form of MDS BTL, except if such failure occurs due to DaVita’s purchases of MDS BTL from MDS, Henry
Schein or other third party MDS customers, or due to MDS failure to deliver conforming MDS BTL
pursuant to accepted Gambro Delivery Orders. Gambro agrees that during the Exclusive Period, MDS
shall not be deemed to be in breach of its exclusivity obligations under this Section 4.3 with
respect to MDS BTL sold to DaVita, and that Gambro shall not have the right to immediately
terminate this Agreement, if (X) sales to DaVita of MDS BTL made by third party customers of MDS do
not in any given month exceed [**] percent ([**]%) of DaVita’s BTL Requirements (such sales to be
counted as sales by Gambro for purposes of determining compliance with the [**]% requirement set
forth herein), (Y) MDS agrees to use commercially reasonable efforts to stop such third party sales
promptly upon receiving notice thereof from Gambro, and (Z) MDS agrees to use commercially
reasonable efforts to ensure that, from and after the start of the Exclusive Period, MDS’
agreements with third party customers (including distributors) prohibit sales of MDS BTL to DaVita.
If such sales exceed [**] percent ([**]%) of DaVita’s BTL Requirements for [**] consecutive months
following the delivery of written notice thereof to MDS, Gambro shall have the right to terminate
this Agreement upon thirty (30) days notice. For purposes hereof, the “Exclusive Period” shall
mean the period of time commencing on [**] and continuing through the expiration of the Term,
except as provided herein (it being understood that MDS shall use commercially reasonable efforts
to have the Exclusive Period commence prior to [**]). In the event [**], Gambro agrees that the
Exclusive Period shall not commence until MDS is [**], it being understood that MDS shall endeavor
in good faith to ensure that the Excusive Period can commence on [**], and further that in any
event that the Exclusive Period shall start on or before [**]. Gambro further agrees
that the Exclusive Period shall not commence until Gambro has confirmed to MDS that (i) Gambro has
sufficient warehouse space and inventory of MDS BTL (consistent with the initial Delivery Orders
set forth Section 4.5 below) to support its obligations hereunder and (ii) DaVita shall purchase
MDS BTL from Gambro pursuant hereto (provided that in any event Gambro warrants that DaVita shall
commence purchasing at least [**] percent ([**]%) of its BTL Requirements from Gambro in the form
of MDS BTL on or before [**], it being understood that Gambro shall not be deemed to
be in breach of this requirement and that MDS shall not have the right to immediately terminate
this Agreement if the reason for DaVita’s failure to purchase [**]% of its BTL requirements from
Gambro in the form of MDS BTL is due to (i) DaVita’s purchases of MDS BTL from MDS, Henry Schein or
other third party MDS customers, or (ii) MDS failure to deliver conforming MDS BTL pursuant to
accepted Gambro Delivery Orders). MDS agrees that Gambro may commence non-exclusive sales of MDS
BTL to DaVita as soon as practical after receipt of the MDS BTL deliveries

2

 

set forth in Section 4.5. Gambro understands and agrees that Henry Schein may continue to sell to
DaVita during the Exclusive Period any inventories it may have of MDS BTL supplied by MDS prior to
the start of the Exclusive Period pursuant to Henry Schein’s contract with DaVita; provided that
MDS agrees that it will not accept purchase orders for MDS BTL from Henry Schein for sale to
DaVita after [**]. Gambro and MDS shall endeavor in good faith to agree on the most suitable
transition to the Exclusive Period, including but not limited to providing Gambro the option,
subject to Henry Schein’s consent, to purchase any inventory in Henry Schein’s possession as of
[**]. Gambro represents that DaVita is obligated, during the Term of this Agreement, to purchase
at least [**] percent ([**]%) of its BTL requirements from Gambro, and that Gambro may satisfy this
requirement through the sale to DaVita of the MDS BTL to be sold hereunder. Gambro further
represents that it shall use all commercially reasonable efforts to ensure that DaVita satisfies
this obligation.

          4.4 This Agreement does not confer any additional distribution rights to Gambro. The Parties
agree to evaluate, in good faith, any opportunity to expand or modify the Territory as such
opportunities materialize, provided (i) that any exclusivity agreed by the Parties shall be deemed
irreversible for the remaining term of the Agreement, except as otherwise provided herein
(including, without limitation, as provided in Section 4.3 hereof), and (ii) that both MDS and
Gambro will have the right to suggest such expansion or modification. The Parties further agree to
undertake such evaluation in a manner which is not unreasonably conditioned or delayed.

          4.5 On or before the [**] day of each month (or if the [**] falls on a non-business day, the
day immediately thereafter which is a business day) during the Term of this Agreement (the “Order
Date”), Gambro will provide MDS with one or more non-cancellable delivery order(s) (a “Delivery
Order” or “Delivery Orders”) for the MDS Products. All Delivery Orders provided on or before the
[**] day of a month (or the next succeeding business day) shall be deemed to have the same Order
Date; any Delivery Order provided to MDS after the [**] day of the month (or the next succeeding
business day) shall be deemed to have an Order Date on the [**] day of the subsequent month (or the
next succeeding business day of that subsequent month). The requested delivery date (“Due Date”)
provided by Gambro on each Delivery Order having the same Order Date shall be not earlier than [**]
days after such Order Date. Unless MDS has otherwise notified Gambro within [**] business days of
receipt from Gambro, MDS shall be deemed to have accepted the Delivery Order, including Due Date.
Each Gambro Delivery Order for delivery to each DDP Location (as hereinafter defined) shall conform
to the per Code or per MDS Product quantity minimums and multiples stated in Exhibit B.
Notwithstanding the foregoing, within [**] business days of the Effective Date, Gambro shall place
Delivery Orders for [**] MDS BTL for delivery in [**], and [**] MDS BTL for delivery in [**] (such
Delivery Orders collectively hereinafter referred to as the “Initial Orders”), provided that, in
selling these volumes, Gambro will not be bound by the exclusivity obligations set forth in Section
4.3 above until the commencement of the Exclusive Period. MDS agrees that Gambro shall have no
obligation to place Delivery Orders, other than Initial Orders, pursuant to this Section 4.5 until
the commencement of the Exclusive Period. MDS agrees that the MDS BTL shipped to Gambro under the
Initial Orders shall have at least [**] months remaining shelf life at the time of delivery to
Gambro. MDS shall promptly notify Gambro in the event it anticipates any delay to the start of the
Exclusive Period beyond [**] due to anticipated ongoing sales of MDS BTL from Henry Schein to
DaVita, and shall discuss in good faith with Gambro alternatives for reducing Gambro’s carrying
costs associated with the Initial Orders, including, without limitation, delayed payment terms on
the Initial Orders or delayed delivery schedules on such orders.

          4.6 Any Delivery Orders with a common Due Date and DDP Location that cumulatively comprise
less than the number of pallets required to comprise full container loads or truck loads as
indicated in Exhibit B, shall be subject to freight cost premiums as quoted to Gambro by MDS at the
time the Delivery Order is accepted.

          4.7 During the period commencing [**] months after the commencement of the Exclusivity Period
through the expiration of the Term, and except as set forth in Section 4.8 below, MDS shall not be
required to accept any Gambro Delivery Orders with a common Order Date to the extent that the
aggregate quantity of Codes in any Code Group (as defined in Exhibit B) so ordered exceeds [**]
percent ([**]%) of the average monthly quantity ordered of that Code Group during the immediately
preceding [**] months, provided that MDS will make commercially reasonable efforts to accept such
excess. If accepted, such excess quantities shall, at MDS’ option, be deemed to have an Order Date
on the [**] day of the next subsequent calendar month and shall remain subject to the provisions of
this Section. In such event, however, such excess amount shall count towards the [**]% limit
applicable to such following Order Date; provided that MDS will make commercially reasonable
efforts to supply such excess. If MDS reallocates any Gambro Delivery Orders pursuant to this
Section 4.7, it shall consult with Gambro to

3

 

determine which orders shall be reallocated to a future Order Date. During the period commencing
on the start date of the Exclusivity Period through [**] months after the commencement of the
Exclusivity Period, Gambro Delivery Orders with a common Order Date must be for a minimum of [**]
units (it being understood that MDS shall consider in good faith Gambro Delivery Orders below this
unit level during this [**] month period where such lower unit levels are due to DaVita’s inventory
levels of MDS BTL purchased from Henry Schein or DaVita’s ongoing purchases of MDS BTL directly
from MDS, out of Henry Schein inventories or out of the inventories of other third party MDS
customers) and no more than [**] units. During the period commencing on the Effective Date through
the start of the Exclusive Period, MDS shall not be required to accept any Gambro Delivery Orders
other than the Initial Orders; provided that MDS will make commercially reasonable efforts to
accept orders in excess of the Initial Orders.

          4.8 Notwithstanding the foregoing, during the final [**] months of this Agreement as
determined in accordance with Section 2.1 hereof, MDS have no obligation to accept Gambro Delivery
Orders to the extent that the aggregate quantity of Codes in any Code Group so ordered for delivery
in such final [**] month period exceeds the aggregate quantities ordered by Gambro during the
immediately preceding [**] months.

          4.9 By the [**] business day of each month during the Term of this Agreement, Gambro shall
provide MDS with a non-binding forecast of the quantity of each Code Gambro estimates it shall
place orders for during the following [**] months. These forecast figures will be e-mailed to the
General Manager, Medisystems.

          4.10 By the [**] business day of each [**], Gambro shall provide its ending inventory by Code
and warehouse and aggregate end user sales information by Code and warehouse for DaVita as well as
for all other customers in aggregate, in each case from the previous [**] to MDS.

     5.0 SHIPMENT OF MDS PRODUCTS

          5.1
MDS will ship the MDS Products, [**] to Gambro’s warehouses in
[**] (the “DDP Locations”) at
the prices listed in Exhibit D. Title for MDS Products shall pass to Gambro upon delivery at the
DDP Locations. MDS and Gambro may agree to add new DDP Locations in the Territory at any time
provided the incremental cost for delivery to such DDP Locations shall be added to the delivery
price by amendment to Exhibit D, signed pursuant to Section 18.2 hereof.

          5.2 MDS shall prepare and send by facsimile transmission or via e-mail to Gambro a packing
list for each shipment of MDS Products. This shipping information will include Gambro’s specific
purchase order number, item shipping quantities, and item back order information. When MDS has the
necessary systems and procedures in place, the packing slip will also accompany the shipment to
avoid loss of missing faxes and to reduce the chance of mismatching the paper to the shipment.

          5.3 MDS shall notify Gambro as soon as MDS becomes aware that any shipment may not be
delivered on or within the period prior to the Due Date and ending [**] days after the Due Date
applicable to a Delivery Order, such period being hereinafter referred to as the “Delivery Window”.
Except as set forth in Section 8.1, if MDS is delinquent with Delivery Orders properly placed by
Gambro and accepted by MDS in accordance with the terms of this Agreement, and as a result, to the
degree that Gambro has insufficient MDS Products to ship to its customer in its customary manner
and at customary prices, MDS will be responsible for incremental freight costs including all
priority and cross shipping charges associated with MDS delayed order fulfillment provided that the
proper documentation of such incremental charges is produced, with prior written authorization by
MDS, of which such authorization shall not be unreasonably conditioned, withheld or delayed.

          5.4 Gambro shall notify MDS in writing of any claim relating to: (i) any MDS Product that is
damaged or does not conform to the MDS Product Specifications at the time title to such MDS Product
is transferred to Gambro, or any MDS Product packaging that is damaged at the time title to such
MDS Product is transferred to Gambro, within [**] days of Gambro’s receipt of such shipment; or
(ii) any shortage in quantity of any shipment of MDS Product, within [**] days of Gambro’s receipt
of such shipment. In the event of rejection of such non-conforming or damaged MDS Product, any
such damaged MDS Product packaging, or shortage, MDS, unless it reasonably

4

 

disputes Gambro’s claim,
shall, subject to Section 5.5 below, replace the MDS Product or make up the shortage
within [**] days of receiving such notice, provided that MDS has sufficient conforming MDS
Products in its inventory to do so, at no additional cost to Gambro, and shall make arrangements
with Gambro for the return or destruction of any rejected MDS Product, such return shipping charges
or costs of destruction to be paid by MDS. If sufficient conforming MDS Products are not
available, MDS shall use commercially reasonable efforts to replace the nonconforming MDS Products
with conforming MDS Products at no additional cost to Gambro as soon as possible, but in no event
shall the replacement time exceed [**] days. In addition to the foregoing, in order to minimize
the possibility of any inventory shortages resulting from the unavailability of sufficient
conforming MDS Product, MDS agrees that it will deliver conforming MDS Product as it becomes
available and will not wait until full replacement quantities are available. The provisions of
this Section 5.4 apply only to claims relating to MDS Products that have not yet been shipped to
customers. Returns of MDS Products that have been shipped to customers are governed by the
provisions set forth in Section 11.3.

          5.5 In the event of a conflict regarding any nonconforming MDS Product which Gambro and MDS
are unable to timely resolve, samples of the MDS Products shall be submitted by [**] to an
independent laboratory reasonably acceptable to both Parties for testing against the Product
Specifications and the test results obtained by such laboratory shall be final and binding upon the
Parties. The fees and expenses of such laboratory testing shall be borne entirely by the Party
against whom such laboratory’s findings are made. In the event the test results indicate that the
MDS Product in question does not conform to the Product Specifications, MDS shall replace such MDS
Product with conforming MDS Product at no additional cost to Gambro within [**] days after receipt
of such results, provided that MDS has sufficient conforming MDS Product in its inventory to do so.
If sufficient conforming MDS Product is not available, MDS shall use commercially reasonable
efforts to replace the nonconforming MDS Product with conforming MDS Product at no additional cost
to Gambro as soon as possible, but in no event shall the replacement time exceed [**] days. In
addition to the foregoing, in order to minimize the possibility of any inventory shortages
resulting from the unavailability of sufficient conforming MDS Product, MDS agrees that it will
deliver conforming MDS Product as it becomes available and will not wait until full replacement
quantities are available.

          5.6 Gambro accepts MDS’s standard packaging and palletizing methods as specified in Exhibit B.
MDS will examine proposals to modify the palletizing methods as requested by Gambro, and provided
these modifications are approved by MDS, Gambro agrees to pay any additional costs and to accept
responsibility for any damage related to the new packaging methods. MDS will use reasonable best
efforts to revisit its pallet size and work to conform to the Gambro rack height configurations.

     6.0 PRICES

          6.1 MDS will sell the Codes meeting the Specifications set forth in Exhibit C to Gambro, and
Gambro agrees to buy the Codes from MDS at the base prices and at DDP Locations listed in Exhibit D
(“Base Prices”). MDS makes no commitment to provide any Code at these Base Prices beyond [**], provided, that, any such increases shall be subject to verification by an
independent third party auditor selected and engaged by Gambro, and reasonably acceptable to MDS,
of the underlying cost increases. The Parties agree that any information provided to such
independent third party auditor shall be treated as strictly confidential by such auditor, and
shall not be disclosed to Gambro; such independent third party auditor only being authorized to
verify or not verify the requested price increase and the extent to which the underlying costs are
reasonably within MDS’ control. No information provided to any such independent third party auditor
may be copied, reproduced or removed from MDS’s premises.

          6.2 The quantity prices listed in Exhibit D are set forth on the basis of the total quantity
of Delivery Orders placed during each Contract Year for Codes. Prices include [**] DDP Gambro’s warehouse locations specified in Exhibit
D.

5

 

          6.3 It is expressly agreed that Base Prices for the Codes include [**], (“Premiums”) will be
invoiced to Gambro.

          6.4 Gambro agrees to sell the MDS Products in accordance with the terms, covenants and
conditions contained in this Agreement. Notwithstanding the foregoing or anything contained in
this Agreement to the contrary, Gambro shall, in its sole and absolute discretion, determine the
resale prices for the MDS Products.

     7.0 PAYMENT

          7.1 The terms of payment for the MDS Products purchased by Gambro under this Agreement shall
be [**] days from MDS’s invoice date; provided that Gambro shall receive a [**] percent ([**]%)
discount from the invoiced amount in the event payment is received by MDS on or before [**] days
after the invoice date. Any amounts not paid within [**] days from the invoice date shall be
subject to a service charge until paid, in an amount equal to [**]% per month. Such service charge
shall be computed on the last working day of the calendar month, on a pro rata basis if applicable,
for invoices [**] days old or more. In addition, if full payment including service charge is not
received by MDS within [**] days from MDS’s invoice date MDS may restrict weekly sales to Gambro to
a dollar amount equal to the payments received from Gambro in the previous week. If full payment is
not received by MDS within [**] days of MDS’s invoice date Gambro shall be considered to be in
material breach of this Agreement and subject to Section 14.1. MDS may invoice Gambro upon email
notification to Gambro that Codes are available for carrier pickup at the DDP Locations listed in
Exhibit D.

          7.2 All Gambro payments are to be made by either wire transfer or ACH transfer and remitted to
the financial institution designated by MDS to receive such payments.

     8.0 ADDITIONAL OBLIGATIONS REGARDING DELAYED AND REPLACEMENT PRODUCTS

          8.1 MDS assumes no liability and shall not be liable to Gambro for any failure to fill or
delay in filling Delivery Orders received from Gambro and accepted by MDS to the extent such
failure or delay results from strikes, lockouts, or any other labor troubles, floods, fires,
accidents, import or shipping delays, delays in the delivery of raw materials, parts or completed
merchandise by the supplier thereof, or any cause beyond the reasonable control of or occurring
without the fault of MDS. In the event of any delay caused by any of the above, MDS shall use
commercially reasonable efforts to fulfill Gambro’s Delivery Orders in a timely fashion, provided,
however, that in the event of a shortage of available MDS Products, whether resulting from market
conditions, manufacturing constraints, FDA action against any company or otherwise, MDS will use
commercially reasonable best efforts to allocate in reasonable proportion to Gambro’s market share,
as compared to the total market size. MDS shall notify Gambro promptly if it anticipates any
potential delay in the filling of any of Gambro’s Delivery Orders caused by any of the above.

          8.2 Notwithstanding Section 4.3, Gambro may, at its option, be relieved of its commitment to
purchase the BTL listed in the Exclusive Products only from MDS and shall have the right to
purchase replacement Products from other suppliers or manufactured by Gambro, in whole or in part,
at Gambro’s option and at its own expense, should MDS, for the reasons specified in Section 8.1, be
unable to supply Delivery Orders and such inability continues for [**] days after the first
delivery date is missed; provided that Gambro, prior to exercising its option hereunder, must
provide MDS written notice of its intention to exercise its option hereunder, and provide MDS the
opportunity to cure such inability to supply within [**] days of receipt of Gambro’s notice
thereof. Gambro agrees to work in good faith with MDS to resolve any issues associated with any
inability to supply hereunder.

          8.3 Notwithstanding Section 4.3, Gambro may, at its option, be relieved of its obligations
with respect to any specific Delivery Order, in whole or in part, at Gambro’s option, should a
delay caused by an event described in Section 8.1 occur, if such delay is uncured within [**] days
after the Delivery Window of such Delivery Order. To the extent MDS is unable to deliver within
[**] days after the Delivery Window applicable to any Delivery Order MDS Products delayed by an
event described in Section 8.1, Gambro may purchase replacement Products from

6

 

other suppliers or
manufactured by Gambro, in each case at its own expense, notwithstanding the obligations of
Section 4.3.

          8.4 Except as set forth in Sections 4.5, 4.7, 4.8 and 8.1, if MDS is unable to deliver MDS
Products during the Delivery Window applicable to an accepted Gambro Delivery Order, or MDS
replaces MDS Products pursuant to sections 11.3, 13.2 or 16.1, MDS will deliver or replace the MDS
Products as soon as possible, on an expedited basis (via air freight, exclusive use truck, overtime
customs clearance or similar means) at MDS’ expense if requested by Gambro.

          8.5 In addition to those rights set forth in Sections 5.4 and 8.4, and except as set forth in
Sections 4.5, 4.7, 4.8 and 8.1, to the extent MDS is unable to deliver MDS Products within [**]
days of the Delivery Window applicable to an accepted Gambro Delivery Order (the number of units of
MDS Products not delivered within [**] days of the Delivery Window applicable to an accepted Gambro
Delivery Order hereinafter referred to as the “Shortfall”), MDS shall promptly notify Gambro
thereof and, in MDS’ sole discretion, deliver to Gambro within [**] days of the Delivery Window
either (i) alternate MDS BTL in quantities equivalent to the Shortfall, or (ii) alternate Products
at effective pricing no greater than as listed on Exhibit D for the MDS BTL subject to the
Shortfall, provided such alternate Products are determined to be reasonably suitable alternatives
by Gambro or its customers (such alternate Products under this Section 8.5 (ii) hereinafter
referred to as “Substitute Product”) for purposes of addressing the Shortfall. If MDS does not
have sufficient quantities of alternate MDS BTL to deliver to address the Shortfall within such
[**] day window, or Gambro or its customers reasonably determines that no other alternate Product
offered by MDS is a suitable alternative to the MDS BTL sold hereunder, then Gambro may, at its
option, purchase replacement Products from other suppliers or manufactured by Gambro to the extent
necessary to meet its and its customers’ immediate needs, up to
the amount of the Shortfall, and [**] and in no event shall [**] hereunder. In the event MDS remains unable to deliver MDS Products or Substitute Products
in full satisfaction of accepted Gambro Delivery Orders placed over [**] consecutive months, either
Gambro or MDS may terminate this Agreement upon written notice to the other effective at the end of
such [**] month period. In addition to the foregoing, Gambro also reserves the right to cancel
outstanding accepted Gambro Delivery Orders if not delivered within [**] days of the Delivery
Window and MDS is not able to provide, within that [**]day period, assurances reasonably acceptable
to Gambro that MDS will be able to fulfill those outstanding orders.

          8.6
In addition to the rights and obligations set forth in
Section 8.5, MDS shall[**], and provided that Gambro will [**]; and provided further that MDS shall
have no obligation to[**] pursuant hereto over the Term of this
Agreement. MDS may [**]

          8.7 Gambro and MDS will make a cooperative effort to evaluate and implement supply chain
improvement opportunities, as mutually agreed upon.

     9.0 MDS PRODUCT CHANGES AND NEW MDS PRODUCTS

          9.1 During the Term of this Agreement, MDS shall offer to incorporate into the MDS BTL to be
sold by Gambro under this Agreement any MDS BTL clinical use enhancements or developments or new
MDS BTL that MDS designs, which enhancements, developments or products MDS controls, such
enhancements being subject to prior sale, exclusive license or exclusive contract.

          9.2 If Gambro agrees in writing to accept any such enhancement or development or new MDS BTL,
then the

7

 

Parties shall meet in good faith to discuss any price adjustment made necessary or
possible by such enhancement or
development, provided (i) that such price adjustment for such improvement shall be no more than
proportionate to any price adjustment MDS is able to successfully negotiate with other key
customers, and (ii) that such price adjustment is not higher than the volume-based price adjustment
to any other MDS customer in the Territory. Pursuant to agreement between the Parties in writing on
any price adjustment for such enhancement or development, Exhibits B, C and D shall be amended to
incorporate such changes. Notwithstanding the above, MDS reserves the right to incorporate clinical
use enhancements or developments in MDS BTL as described herein, in accordance only with Section
9.3, provided that no price increase is requested by MDS.

          9.3 MDS shall notify Gambro in writing, using the “Vendor Notice of Change” form attached as
Exhibit E, at least [**] days prior to any substantial change in Specifications of the MDS
Products, components of the MDS Products or packaging which may necessitate in-servicing or
notification to end-users. Notwithstanding anything in this Agreement to the contrary, if MDS
provides such notice to Gambro, Gambro shall have the right to test such MDS Product, components or
packaging, including [**], to confirm that it would not result
in an adverse change in the clinical results and/or product quality/reliability of the MDS Product.
If Gambro, upon completion of such testing, notifies MDS in writing (which must occur no later
than [**] days following MDS’ Vendor Notice of Change) that, in Gambro’s reasonable judgment, an
adverse change would result, MDS shall notify Gambro in writing, within [**] days thereafter,
whether it will continue to supply the existing MDS Product to Gambro. If MDS notifies Gambro that
it will not, Gambro shall have the right to terminate this Agreement on one hundred and eighty
(180) days written notice; provided that, during such 180-day period, MDS shall, at Gambro’s
option, continue to supply the existing MDS Product to Gambro.

     10.0 REGULATORY RESPONSIBILITY; LABELING; ADVERTISING, PROMOTIONS AND TRADE NAMES

          10.1 MDS shall be responsible, at its expense, for complying with all applicable regulatory
requirements of the U.S. Food and Drug Administration (“FDA”) relating to the sale or use of the
MDS Products, including but not limited to obtaining authorization or clearance under Section
510(k) of the U.S. Federal Food, Drug, and Cosmetic Act, as amended (the “Act”). Failure of an MDS
Product to meet the applicable FDA requirements or to obtain FDA approval or clearance shall be
considered a material breach of this Agreement by MDS, except where such failure results from any
cause or event arising from the responsibility of Gambro under this Agreement or from a breach by
Gambro or one or more of its representations and warranties under this Agreement, or is otherwise
attributable to Gambro or its customers. In such event, Gambro shall have the right to (i)
terminate this Agreement under Section 14.1 (provided such breach is not cured within [**] days of
notice from Gambro thereof), (ii) terminate any specified Delivery Order(s) under Section 12.1
and/or (iii) if MDS is unable to deliver alternate MDS BTL or Substitute Products within [**] days
of receipt of notice of such failure from Gambro to replace those MDS Products which fail to meet
the applicable FDA requirements, or which fail to obtain FDA approval, purchase Products from
others or to manufacture such Products itself to replace those MDS Products which fail to meet the
applicable FDA requirements, or which fail to obtain FDA approval. In the event Gambro exercises
its rights under Section 10.1 (iii), MDS shall [**].  Notwithstanding the foregoing, if MDS’
inability to supply MDS Products complying with applicable regulatory requirements persists for
longer than [**] months and MDS is unable to provide Substitute Products, either Gambro or MDS may
terminate this Agreement effective at the end of such [**]
month period. [**] as a result of a failure or inability to
supply product complying with applicable regulatory requirements; provided that Gambro will [**] and provided further that MDS shall have
no obligation [**] in connection with
any Delivery Order not complying with applicable regulatory requirements  [**], in
aggregate, pursuant hereto over the Term of this

8

 

Agreement. [**], subject to applicable confidentiality
restrictions, and [**].

          10.2 Each use on the MDS Products of any MDS trade name owned or controlled by MDS (a “MDS
Trade Name”) shall inure to the benefit of MDS. Should any such use vest in Gambro any rights in
any MDS Trade Name, Gambro shall transfer such rights to MDS or its designee upon request of MDS.

          10.3 MDS represents and warrants to Gambro that MDS has the right to authorize and so
authorizes Gambro to use any MDS Trade Name that MDS requests be used on or with MDS Products sold
under this Agreement. MDS shall indemnify and hold Gambro harmless from any and all claims,
liability, damages, loss, cost, or expense (including reasonable attorneys’ fees and expenses)
arising out of, based on, or caused by any claim that the use by Gambro of an MDS Trade Name in a
manner approved by MDS infringes (or is alleged to infringe) upon any copyright, right to use,
trade name, trademark or other right of any person or entity.

          10.4 Except as provided in this Agreement, Gambro shall not use any MDS Trade Name, trademark,
logo, or any trade name, trademark or logo confusingly similar therewith in any MDS Product
advertisement or display. Notwithstanding the foregoing, MDS agrees to co-label MDS BTL sold by
Gambro hereunder with Gambro’s name and logo, if requested in writing by Gambro, so long as Gambro
orders of MDS BTL exceed [**] Units-of-Sale per month, and provided that, in the case of the first
order of co-labeled MDS Product, MDS shall have [**] days to comply with any co-labeling request by
Gambro, which shall comprise mutually approved camera-ready art. Gambro shall indemnify and hold
MDS harmless from any and all claims liability, damages, loss, cost or expense (including
reasonable attorney’s fees and expenses) arising out of, based on, or caused by any claim that the
use by MDS of a Gambro mark pursuant hereto in a manner approved by Gambro infringes (or is alleged
to infringe) upon any copyright, right to use, tradename, trademark or other right of any person or
entity.

          10.5 Packaging for each unit-of-sale comprises multiples of each Code, whether such Codes are
individually pouched or not, in cartons which are sealed, shippable and contain all such Codes’
labeling or references required by end-users (the “Unit-of-Sale”). Such Codes’ Units-of-Sale are
detailed in Exhibit B herein. Gambro acknowledges that it will store, ship, handle and sell the MDS
Products in their original, unopened Unit-of-Sale and in accordance with the labeling, and Gambro
will not remove, modify, repack, amend or relabel such Unit-of-Sale without prior, written approval
of MDS.

          10.6 Gambro hereby agrees that any written or oral statement, warning or representation made
by Gambro or its representatives in any advertising, publicity, promotion or sale regarding any of
the MDS Products shall be consistent with the labeling of the MDS Products.

          10.7 Gambro agrees to use its commercially reasonable best efforts to promptly notify MDS
whenever it becomes aware of the use of the MDS Products in a manner inconsistent with the labeling
or the indications for use.

          10.8 Gambro shall have the right to include the MDS Products as part of its marketing strategy
and value proposition for its hemodialysis products. Gambro agrees to obtain MDS’s written
authorization prior to the first publication or distribution of any advertising, displays or
promotional material regarding or referencing the MDS Products. To that end, Gambro shall provide
MDS with draft proofs of all marketing materials to be used in promoting the MDS Products. Unless
MDS has notified Gambro of its disapproval of such materials within [**] days of receipt from
Gambro, MDS shall be deemed to have consented to the use of such materials without any further
action required on the part of Gambro.

          10.9 During the Term of this Agreement, Gambro shall allow MDS to buy back MDS Product from
Gambro’s inventory, provided that, unless such buy back is intended to satisfy a regulatory
obligation (such as a recall or correction and removal), Gambro shall not be required to sell
inventory back to MDS if such sale could adversely affect Gambro’s ability to meet its customers’
requirements. Such product shall be used at MDS’ discretion for post market testing, product
quality audits, market acceptance studies, stock rotation, market withdrawal, or other purposes in
compliance with 21 CFR § 806, “Medical Devices; Reports of Corrections and Removals.” The
definition of market withdrawal, and the interpretation of stock rotation, shall be according to 21
CFR § 806.2(h). MDS shall issue a returned goods authorization to Gambro for such inventory of MDS
Products to be purchased by

9

 

MDS. MDS agrees to purchase such inventory of MDS Product from Gambro
at a cost equal to Gambro’s original
purchase price from MDS, plus any shipping or freight charges.

          10.10 Each Party shall promptly and, in any event, within [**] days of receipt of notice of
inquiry, inform the other in writing of any formal or informal inquiry relating to any MDS Product
by FDA or any regulatory agency of any state within the Territory.

     11.0 QUALITY CONTROL

          11.1 All MDS Products shall be subjected to a quality control inspection in accordance with
MDS’s quality control standards and the applicable FDA regulations. MDS shall manufacture, or
cause to manufacture, the MDS Products in accordance with (i) the applicable MDS Quality Systems
and GMP Requirements, (ii) all pertinent rules, requirements and regulations from FDA, as the same
may be amended from time to time, and (iii) the Product Specifications.

          11.2 The term “Lot” shall mean all MDS Products bearing the same lot number.

          11.3 If any customer of Gambro returns to Gambro MDS Products which are violative under the
Act or otherwise fail to perform as intended when used in accordance with the labeled indications
for use, such MDS Products may be returned to MDS, at MDS’ expense and option, provided that Gambro
requests such return within [**] days of Gambro’s receipt of the non-conforming MDS Products. Prior
to any MDS Product return, Gambro shall submit a written request to MDS to accept the MDS Product
return. Gambro’s request shall include, at a minimum, the reason for the return or the relevant
complaint reference, and the Code(s), quantities, and Lots of the MDS Products Gambro wishes to
return. MDS shall accept a return of any MDS Products that are returned by a customer to Gambro
where such customer alleges one of the reasons specified in the first sentence hereof. Within [**]
days of the receipt by MDS of a return, Gambro shall receive, at its option, a credit or refund for
such MDS Products returned to MDS, or by mutual agreement of Gambro and MDS, Gambro shall receive
replacements for such MDS Products returned to MDS; provided in each case that MDS reasonably
determines that such returned products fall within one of the reasons for return set forth in the
first sentence hereof. If MDS reasonably determines that such returned products do not fall within
one of such reasons, Gambro shall have the option to (i) either not contest the applicable
customer’s return or MDS’ determination, in which case the products wrongfully returned to MDS
shall be returned to Gambro, at Gambro’s expense, or (ii) contest the applicable customer’s return
or MDS’ determination, in which case MDS shall send samples of the returned MDS Product to an
independent third party, mutually acceptable to Gambro and MDS, to determine whether the returned
products fall within one of the reasons for return set forth in the first sentence hereof. The
determination of such third party shall be binding upon both parties. If the third party
determines that the MDS Product was not returned for one of the aforementioned reasons, the
products wrongfully returned to MDS shall be returned to Gambro at Gambro’s expense, and Gambro
shall pay such third party’s fees and expenses related thereto. If the third party determines that
the MDS Product was returned for one of the aforementioned reasons, [**].

          11.4 In the event that Gambro receives any complaint regarding the MDS Products, Gambro shall
notify MDS promptly using a complaint communication form which form shall be substantially in the
form of Exhibit F. MDS will be responsible for evaluating these complaints and promptly submitting
to Gambro a statement of its findings and corrective actions as appropriate. Nothing in this
section shall be deemed to relieve either party of its own reporting responsibilities under
applicable FDA regulations.

          11.5 MDS shall be responsible for issuing all written and oral communications with third
parties regarding any complaint about, alleged defect in, or recall of the MDS Products. Except as
required by law, Gambro will make no written or oral statements regarding any complaint about,
alleged defect in, or recall of the MDS Products without the prior written approval of MDS.

          11.6 During normal Gambro working hours, with prior written notice to Gambro, Gambro shall
allow MDS to enter Gambro’s facilities in which MDS’ Products are stored in order for MDS to
determine inventories by MDS lot

10

 

number, provided, that, unless such on-site visit is for
regulatory reasons, MDS may not conduct more than [**] in
any [**] period and no more than [**] in any Contract Year. In addition, MDS shall have regulatory
access to MDS Products in Gambro’s inventory in order for MDS to obtain MDS Product samples or
otherwise analyze MDS Products in Gambro inventory for MDS trending purposes. Gambro agrees to
assist MDS in such action. MDS agrees to reimburse Gambro for reasonable cost for Gambro’s labor
and handling resulting from Gambro’s assistance for such action. As a condition of provision to
MDS of access to Gambro’s facilities, personnel and/or documentation, all information obtained by
MDS as a result of such access shall be treated as Confidential Information of Gambro under this
Agreement and no such information may be copied, reproduced or removed from Gambro’s premises
without Gambro’s consent.

          11.7 Upon reasonable prior notice, MDS shall, from time to time during the Term of this
Agreement, but no more than [**] per Contract Year: allow an independent third party auditor
selected and engaged by Gambro and reasonably acceptable to MDS to (a) tour and inspect all
facilities utilized by MDS in manufacturing, finishing, testing, packaging, storing and shipping
MDS Products sold to Gambro under this Agreement, provided, however, that all such tours and
inspections shall be limited to a tour of the facilities and such other requirements as may be
agreed to by the Parties; (b) review MDS manufacturing quality control documentation; and (c) meet
with MDS quality and/or regulatory representatives. As a condition of provision to such an
independent third party auditor of access to MDS’s facilities, personnel and/or documentation, such
independent third party auditor shall agree to keep all information obtained as strictly
confidential and shall not disclose the same to Gambro, but shall only be able to indicate whether
MDS is compliant with MDS Quality System and GMP Requirements. No information provided to any such
independent third party auditor may be copied, reproduced or removed from MDS’s premises.

          11.8 MDS, at its expense, shall, where applicable, prepare Material Safety Data Sheets
(“MSDS”) and generate any other information and documentation related to product safety, including
but not limited to physical, chemical, and biological characteristics of each of the MDS Products
that Gambro requests as needed for addressing safety issues related to each MDS Product.

          11.9 Each Party will immediately (within [**] business days) notify the other Party in writing
of any event or complaint that gives rise or could give rise to the need to file a Medical Device
Report (an “MDR”) within the meaning of the Act, with respect to any MDS Product or the
manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. Part 803.
Each such written notice shall be Confidential Information under this Agreement. MDS shall have
sole responsibility and authority to file MDR’s relating to MDS Products sold hereunder.

          11.10 From time to time, for mutually agreed upon services and MDS Products in the Territory,
MDS may, at Gambro’s request, and as mutually agreed by the Parties, provide specialized training
to clinical and/or technical instructors designated by Gambro. Such training, to the extent deemed
relevant by MDS, shall consist of MDS’s standard courses for its MDS Products. Thereafter, Gambro
shall train its field representatives and its customers in the Territory through training sessions
or distribution of bulletins as appropriate. All incremental, out-of-pocket training course
related costs, except for the materials provided during the training courses, shall be paid by
Gambro, including, but not limited to, all travel and related out-of-pocket expenses.

          11.11 The training described in Section 11.10 shall be provided by MDS at a mutually agreeable
location in the Territory.

          11.12 In connection with the training provided by MDS as described in Section 11.10, MDS shall
furnish, at no cost to Gambro, all such training materials that are included in the course,
including, but not limited to, papers, procedures, books, and manuals, and all other training,
instruction, and presentation aids which MDS reasonably believes are necessary or appropriate (the
“Training Materials”). MDS agrees to promptly provide to Gambro, at no charge, a copy of
all additional, new and revised Training Materials which are in MDS’s possession or which MDS may
develop, for all mutually agreed upon services provided. Gambro shall also have access to MDS’s
customer support web site on which all recent up-date, download material and other key information
is published. Gambro shall be responsible for all the costs related to the training of its own
field service engineers and its customers in the field, including, but not limited to, the
reproduction of relevant training materials provided by MDS at the training sessions referred to in
Section 11.10. All equipment and training aids furnished by MDS for training purposes
shall

11

 

remain the property of MDS and will be returned to MDS upon termination of this Agreement,
ordinary wear and
tear excepted. MDS agrees that Gambro may freely reproduce any Training Materials, unless such
items are designated by MDS as Confidential Information, in which case such items may be reproduced
for Gambro’s internal use only. At MDS’s request and expense, Gambro shall return the foregoing
Training Materials to MDS.

          11.13 As soon as possible, but in any event within [**] days, after the Effective Date,
representatives from MDS’s and Gambro’s quality and regulatory organizations will meet to agree in
good faith upon quality assurance and regulatory policies and operating principles governing the
relationship hereunder.

     12.0 REPRESENTATION

          12.1 All MDS Products sold to Gambro under this Agreement are hereby represented by MDS, as of
the time the title to the MDS Products is transferred to Gambro, to be not adulterated or
misbranded within the meaning of the Act, and not articles which may not, under the provisions of
Section 510, 514, 515 or 516 of the Act, be introduced into interstate commerce. If MDS breaches
this representation with respect to any Lot, Gambro may immediately return to MDS, at MDS’s
expense, any MDS Products of such Lot received by Gambro. At Gambro’s option, MDS either will
immediately credit Gambro for such MDS Products, or repay to Gambro any moneys paid by Gambro for
such MDS Products. Without limiting Gambro’s rights under Sections 11.3 and 10.1, Gambro may
purchase Products at its own expense to replace any MDS Products which are in breach of this
representation from another supplier.

     13.0 WARRANTIES AND INDEMNIFICATIONS

          13.1 MDS warrants that MDS Products sold to Gambro under this Agreement are free from defects
in design, workmanship and materials and are merchantable and fit for their intended purposes.
EXCEPT AS SET FORTH IN THE PRECEDING SENTENCE, SECTION 12.1 AND IN THE LABELING FOR THE MDS
PRODUCT, MDS MAKES NO REPRESENTATION OR WARRANTY WHATSOEVER, WRITTEN OR ORAL, EXPRESS OR IMPLIED,
AS TO ANY OF THE MDS PRODUCTS, OR THEIR MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE, AND
MDS HEREBY EXPRESSLY DISCLAIMS ANY SUCH REPRESENTATION AND WARRANTY. ALL OF THE WARRANTIES SET
FORTH IN THIS SECTION 13.1 OR IN SECTION 12.1 ARE VOID AND OF NO EFFECT IF THE MDS PRODUCTS ARE NOT
STORED AND USED IN ACCORDANCE WITH THE DIRECTIONS ON THE LABELING OR PRODUCT INSERTS ACCOMPANYING
THE MDS PRODUCTS.

          13.2 GAMBRO ACKNOWLEDGES AND AGREES THAT, EXCEPT FOR THE PROVISIONS OF SECTIONS 10.1, 11.3,
13.3, 13.4 AND ARTICLE 14, MDS’ SOLE RESPONSIBILITY TO GAMBRO IN THE CASE OF BREACH OF THE
FOREGOING WARRANTY OR OF SECTION 12.1 SHALL BE FOR MDS, BY MUTUAL AGREEMENT OF GAMBRO AND MDS, TO
REPAIR OR REPLACE THE MDS PRODUCTS WITH RESPECT TO WHICH SUCH WARRANTY OR REPRESENTATION IS
BREACHED, OR, AT GAMBRO’S ELECTION TO RETURN ALL PAYMENTS MADE BY GAMBRO TO MDS WITH RESPECT TO
SUCH MDS PRODUCTS OR TO CREDIT GAMBRO IN THE AMOUNT OF ALL PAYMENTS MADE BY GAMBRO TO MDS WITH
RESPECT TO SUCH MDS PRODUCTS.

          13.3 MDS hereby indemnifies and agrees to hold Gambro, its affiliates, successors and assigns
harmless from and against all claims, liability, damage, cost or expense of Gambro, including its
attorneys’ fees, with respect to any product liability claim brought by a Gambro customer, an
employee or patient thereof or other third party arising out of, or in connection with, or as a
result of the failure of any of the MDS Products to meet the representation in 12.1 or the warranty
set forth in Section 13.1 at the time of delivery to Gambro. In order to discharge its obligations
under this Section 13.3, MDS shall obtain and keep in force during the Term of this Agreement,
product liability insurance with a limit of liability of not less than $[**] per occurrence,
and naming Gambro as an additional insured.

          13.4 MDS shall defend, indemnify and hold Gambro harmless with respect to any liability of
Gambro for infringement of any patent or copyright arising out of the use or sale in the Territory
of the MDS Products supplied to Gambro under this Agreement. Gambro shall communicate to MDS all
charges of alleged infringement within a reasonable time after their receipt. Gambro will cooperate
fully with MDS in defending or otherwise resolving any

12

 

charges of infringement. MDS will have full
control of the defense of any litigation brought against Gambro for
alleged infringement by MDS Products supplied under this Agreement; however, Gambro, at its
expense, may be represented by its own counsel in any such litigation. MDS agrees to bear all other
costs and expenses of litigation, including any bonds required by a court and its own attorneys’
fees in connection with such alleged infringement, and MDS will reimburse Gambro for any
disbursement made by Gambro in satisfaction of any final judgment issued in such litigation.

          13.5 Gambro shall indemnify and hold MDS harmless from any and all claims, liability, damages,
loss, cost, or expense (including reasonable attorneys’ fees) with respect to any claim brought by
a Gambro customer, an employee or patient thereof or other third party arising out of, based on, or
caused by (i) any product claims, representations, descriptions or other statements, whether oral
or written, made or alleged to be made by Gambro or its representatives in any advertising,
publicity, promotion or sale of any of the MDS Products where such product claims were inconsistent
with the labeling, and (ii) any product claim arising out of, based on, or caused by negligent
handling of the MDS Products by Gambro or its agents (including, without limitation, failure to
sell MDS Products in the original, unopened Units of Sale, as described in Exhibit B). In order to
discharge its obligations under this Section 13.5, Gambro shall obtain and keep in force during the
Term of this Agreement general liability insurance with a limit of liability of not less than
$[**], and naming NxStage as an additional insured.

          13.6 With respect to any claim for which a Party (the “Claiming Party”) seeks indemnification
from the other Party (“Indemnifying Party”) under this Agreement, the Claiming Party shall: (a)
advise the Indemnifying Party of any claim, proceeding or suit (individually, an “Action”), in
writing, within thirty (30) days after the claiming Party has received notice of such Action or
within such period of time so as not to materially prejudice the right of the Indemnifying Party
with regard to the defense of such Action, whichever period is shorter; (b) assist the Indemnifying
Party and its representatives in the investigation and defense of any Action for which
indemnification is provided; and (c) not offer to settle, settle or otherwise compromise such
Action without the Indemnifying Party’s prior written consent, which consent will not be
unreasonably withheld, unless such settlement fully releases the Claiming Party without any
liability, loss, cost or obligation to such Party.

          13.7 NOTWITHSTANDING ANY PROVISION IN THIS AGREEMENT THAT MAY BE INTERPRETED TO THE CONTRARY,
IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR THE OTHER PARTY’S LOSS OF PROFITS, LOSS OF USE, OR
INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES OF ANY KIND.

     14.0 TERMINATION

In addition to the rights of termination provided elsewhere in this Agreement:

          14.1 Either party may terminate this Agreement for any material breach of it by the other
party, by giving [**] days written notice to the other party, if such breach shall, as of the
expiration of this [**] day period, remain uncured.

          14.2 Either Party may terminate this Agreement upon written notice to the other in the event
of: (i) insolvency of the other Party, or the appointment of a receiver by the other Party for all
or any substantial part of its properties, provided that such receiver is not discharged within
sixty (60) days of its appointment; (ii) the adjudication of the other Party as a bankrupt; (iii)
the admission by the other Party in writing of its inability to pay its debts as they become due;
(iv) the execution by the other Party of an assignment for the benefit of its creditors; (v) the
inability of the other Party to pay its debts as they come due; or (vi) the filing by the other
Party of a petition to be adjudged as a bankrupt, or a petition or answer admitting the material
allegations of a petition filed against the other Party in any bankruptcy proceeding, or the acts
of the other Party to any other judicial proceeding intended to effect a discharge of the debts of
the other Party, in whole or in part.

     15.0 EFFECT OF TERMINATION

          15.1 No termination of this Agreement, other than by reason of breach of this Agreement by
Gambro or if Gambro has received notice of termination pursuant to Section 14.2 of this Agreement,
will relieve MDS from its obligation to deliver all MDS Products ordered pursuant to any Delivery
Order of Gambro properly placed by Gambro in accordance with the provisions of this Agreement (with
a Due Date falling within the Term of this Agreement), nor will any termination, other than by
reason of breach of this Agreement by MDS or if MDS has received notice of termination pursuant to
Section 14.2 of this Agreement, relieve Gambro from accepting and

13

 

paying for all MDS Products
ordered by Gambro under any Delivery Order properly issued by Gambro in
accordance with the provisions of this Agreement or relieve Gambro of its obligation pursuant to
Section 4.3.

          15.2 Each Party understands that the rights of termination hereunder are absolute and, except
as provided otherwise in this Agreement, are cumulative with any other legal and equitable remedies
that may be available to the terminating Party. Except as otherwise provided for in this
Agreement, neither Party shall incur any liability whatsoever for any damage, loss or expenses of
any kind suffered or incurred by the other arising from or incident to the terminating Party’s
proper exercise of its termination rights in accordance with Section 14 of this Agreement. In
particular, without in any way limiting the foregoing, neither Party shall be entitled to any
damages on account of prospective profits or anticipated sales related to such exercise of
termination rights.

          15.3 MDS shall repurchase from Gambro, upon Gambro’s or MDS’s request, on or before [**], any inventory remaining in Gambro’s inventory from the Initial Orders at the purchase
price paid for such inventory by Gambro to MDS[**], if the
Exclusive Period does not commence on or before[**], as well as, upon MDS’s request,
any inventory remaining in Gambro’s inventory following the termination date at the purchase price
paid for such inventory by Gambro to MDS (any such repurchase to occur no later than days after the
termination date). Any inventory not purchased by MDS may be sold, at Gambro’s sole discretion and
to Gambro’s sole benefit, provided that (i) Gambro must comply with all applicable terms of this
Agreement in connection with such sale and (ii) all such sales must be completed within one hundred
and eighty (180) days of termination. If Gambro elects to sell the remaining inventory of
Products, Gambro shall be considered an authorized distributor for MDS and may use any
then-existing promotional material for the sole purpose of selling such remaining Gambro inventory.

     16.0 MDS PRODUCT RECALL

          16.1 If any Product defect or any final, non-appealable governmental or court action or any
voluntary action by MDS results in: (a) the recall, destruction or withholding from the market of
any MDS Product sold under this Agreement (a “Recall”); or (b) institution of a field correction of
any MDS Product sold under this Agreement (a “Field Correction”) (Recalls and Field Corrections
shall be collectively referred to herein as “Product Actions”), MDS shall bear the Direct Costs (as
hereinafter defined) of and shall be responsible for all corrective actions associated with such
Product Action to the extent such Product Action: (i) results from any cause or event arising from
the responsibility of MDS, or from a breach by MDS of one or more of its representations and
warranties, under this Agreement; or (ii) is otherwise attributable to MDS. Gambro shall bear the
Direct Costs of and shall be responsible for all corrective actions associated with such Product
Action to the extent such Product Action: (x) results from any cause or event arising from the
responsibility of Gambro under this Agreement or from a breach by Gambro of one or more of its
representations and warranties under this Agreement; or (y) is otherwise attributable to Gambro.
If the Parties are equally at fault for such Product Action, or should it prove impossible to
assign fault to either Party, the Parties shall share such Direct Costs equally. Regardless of the
cause of the Product Action, MDS will be responsible for communication to the regulatory or
governmental entities and all customers regarding such Product Action. Gambro shall provide MDS a
list of all customer locations to enable MDS to fulfill its obligations hereunder. For purposes of
this Section 16.1, the term “Direct Costs” shall mean all reasonable out-of-pocket costs and
expenses reasonably and actually incurred by Gambro or MDS in notifying customers, destroying or
returning MDS Products in connection with the Product Action, and providing replacement MDS
Products in connection with the Product Action. Gambro’s rights hereunder shall be in addition to
those set forth in Section 10.1.

          16.2 Gambro shall maintain complete and accurate records, for such periods as may be required
by applicable law, of all the MDS Products sold by Gambro. Gambro may purchase at its own expense
from another supplier, or manufacture for itself, replacement Products for recalled MDS Products.

          16.3 In the event of a recall of any of the MDS Products sold by Gambro, the Parties will
cooperate fully with each other in effecting such a recall, including without limitation promptly
contacting any customer of Gambro and communicating to such customer of Gambro any information or
instructions that either party may desire be communicated to such customer of Gambro in conformance
with the obligations of Section 11.5.

          16.4 Gambro shall not initiate any recall of MDS Products.

14

 

     17.0 DISCLOSURE OF INFORMATION

          17.1 Disclosure of information between the Parties hereto shall be covered by that certain
non-disclosure agreement between the Parties hereto dated as of [**]

     18.0 OTHER PROVISIONS

          18.1 All sales of MDS Products to Gambro under this Agreement shall be subject to the
provisions of this Agreement and shall not be subject to the terms and conditions contained in any
Delivery Order of Gambro, or confirmation or invoice of MDS except insofar as any such Delivery
Order, confirmation or invoice establishes (i) the quantity of Codes ordered for delivery, (ii) the
Due Date of such Codes, and (iii) the quantity of Codes to be delivered at each DDP Location.

          18.2 This Agreement contains the entire agreement between the Parties relating to the MDS
Products and all prior proposals, discussions, and writings by and between the Parties and relating
to the subject matter herein are superseded by this Agreement. None of the terms of this Agreement
shall be deemed to be waived by either party or amended unless such waiver or amendment is in
writing and is signed by the party to be charged with such waiver or amendment, and such writing
recites specifically that it is a waiver of, or amendment to, the terms of this Agreement.

          18.3 All notices and other communications provided for or permitted hereunder shall be made in
writing by hand delivery, certified mail, return receipt requested facsimile transmission (with
confirmation of transmission), or air courier which guarantees overnight delivery:

          If to Gambro:

               Gambro Renal Products, Inc.

               14143 Denver West Parkway

               Lakewood, CO 80401

               Attention: Marketing Manager, Bloodlines & Concentrates

               With a copy to: Chief Legal Counsel

          If to MDS:

               President

               Medisystems Corporation

               439 South Union Street, 5th Floor

               Lawrence, MA 01843

               With a copy to: General Counsel

or to such other address as to which either party may properly notify the other. All such notices
and communications shall be deemed to have been duly given: at the time delivered by hand, if
personally delivered; three business days after being deposited in the mail, postage prepaid, if
mailed; when receipt is acknowledged, if sent by facsimile transmission; and on the day delivered,
if sent by overnight air courier guaranteeing next day delivery.

          18.4 This Agreement shall be binding upon and inure to the benefit of the Parties, their
successors and permitted assigns. This Agreement shall be assignable by either party with the
written consent of the other; provided, however, that either party may assign this Agreement to any
entity controlled by or under common control with such party and in such event the assigning party
shall provide the other party with written notice of such assignment.

          18.5 This Agreement is deemed to have been entered into in the State of Delaware and its
interpretation, construction, and the remedies for its enforcement or breach are to be applied
pursuant to and in accordance with the laws of the State of Delaware.

          18.6 In the event that a court of competent jurisdiction holds that particular provisions or
requirements of this Agreement are in violation of any law, such provisions or requirements shall
be enforced and shall remain in full force and effect to the extent they are not in violation of
any such law or are not otherwise unenforceable, and all other provisions and requirements of this
Agreement shall remain in full force and effect.

15

 

          18.7 This Agreement may be executed in two (2) original counterparts, each of which shall be
deemed an
original, but both of which together shall constitute one and the same instrument. One or more
counterparts of this Agreement may be delivered by facsimile, with the intention that delivery by
such means shall have the same effect as delivery of an original counterpart hereof.

          18.8 Failure to insist upon strict compliance with any of the terms, covenants, or conditions
hereof will not be deemed a waiver of such term, covenant, or condition, nor will any waiver or
relinquishment of, or failure to insist upon strict compliance with, any right or power hereunder
at any one or more times be deemed a waiver or relinquishment of such right or power at any other
time or times.

          18.9 The relationship of the Parties under this Agreement is that of independent contractors.
Nothing contained in this Agreement is intended or is to be construed so as to constitute the
Parties as partners, joint venturers, or either Party as an agent or employee of the other.
Neither Party has any express or implied right under this Agreement to assume or create any
obligation on behalf of or in the name of the other, or to bind the other Party to any contract,
agreement or undertaking with any third party, and no conduct of the Parties shall be deemed to
infer such right.

     19.0 DEFINITIONS

          The following list of defined terms used in this Agreement is provided for convenience only.
Reference must be made to the relevant sections of this Agreement for the complete definitions.

	
	          19.1 The “Act” has the meaning set forth in Section 10.1.

	
	          19.2 “Action” has the meaning set forth in Section 13.6.

	
	          19.3 “Base Prices” means the prices indicated on Exhibit D as Base Prices
[**] (Section 6.1).

	
	          19.4 “BTL” has the meaning set forth in Section 1.1.

	
	          19.5 “Calendar Quarter” means each three (3) month period ending on March 31, June 30,
September 30 and December 31 during the Term of this Agreement

	
	          19.6 “Claiming Party” has the meaning set forth in Section 13.6.

	
	          19.7

“Codes” means the codes of each MDS Product that meet the Specifications (Section 3.1).

	
	          19.8 “Confidential Information” shall have the meaning given to it under the
Non-Disclosure Agreement entered into between the Parties dated as of October 31, 2008.

	
	          19.9 “Contract Year” has the meaning set forth in Section 4.2.

	
	          19.10 “DDP Location” has the meaning set forth in Section 5.1.

	
	          19.11 “Delivery Order” means noncancellable monthly order(s) for MDS Products that Gambro
commits to purchase from MDS (Section 4.5.).

	
	          19.12 “Delivery Window” has the meaning set forth in Section 5.3.

	
	          19.13 “Direct Costs” has the meaning set forth in Section 16.1

	
	          19.14 “Due Date” has the meaning set forth in Section 4.5.

	
	          19.15 “Effective Date” means the date set forth in the Preamble of this Agreement.

	
	          19.16 “Exclusive Period” has the meaning set forth in Section 4.2.

	
	          19.17 “Exclusive Products” has the meaning set forth in Section 4.3.

	
	          19.18 “FDA” has the meaning set forth in Section 10.1.

	
	          19.19 “Field Correction” has the meaning set forth in Section 16.1.

	
	          19.20 “Gambro” has the meaning set forth in the Preamble.

	
	          19.21 “Indemnifying Party” has the meaning set forth in Section 13.6

	
	          19.22 “Lot” has the meaning set forth in Section 11.2.

	
	          19.23 “MDR” has the meaning set forth in Section 11.10.

	
	          19.24 “MDS” has the meaning set forth in the Preamble.

	
	          19.25 “MDS Products” has the meaning set forth in Section 1.1.

	
	          19.26 “MSDS” (“Material Data Safety Sheets”) has the meaning set forth in Section 11.9.

	
	          19.27 “Order Date” has the meaning set forth in Section 4.5

	
	          19.28 “Premiums” means [**] (Section 6.3).

	
	          19.29 “Product Actions” has the meaning set forth in Section 16.1.

	
	          19.30 “Products” has the meaning set forth in Section 1.1.

16

 

	
	          19.31 “Quality Systems and GMP Requirements” means the current and any future quality system
and good
manufacturing practices regulations under 21 C.F.R. Part 820 to the extent that such
regulations are applicable to any MDS Product, as such regulations are promulgated by the
FDA. The applicable Quality Systems and GMP Requirements for any lot of MDS Product shall
be those regulations in effect when such lot, or portion thereof, is manufactured for
Gambro (Section 11.1)

	
	          19.32 “Recall” has the meaning set forth in Section 16.1.

	
	          19.33 “Specifications” means the specifications of the Codes as set forth in Exhibit C, or as
such Exhibit may be amended from time to time pursuant to Sections 9.1 or 9.2 hereof, or as
modified by Section 9.3 (Section 3.1).

	
	          19.34 “Term” means the five (5) year period beginning on the Effective Date of this Agreement
and any extensions thereof (Section 2.1).

	
	          19.35 “Territory” means the United States of America (Exhibit A and Section 1.1).

	
	          19.36 “Training Materials” has the meaning set forth in Section 11.13.

	
	          19.37 “Unit of Sale” means the packaging which comprises multiples of each Code, whether such
Codes are individually pouched or not, in cartons which are sealed, shippable and contain all
such Codes’ labeling or references required by end-users and are described in Exhibit B
(Section 10.5).

	
	          19.38 “Vendor Notice of Change” means the form set forth in Exhibit E (Section 9.3).

     IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their authorized
representatives as of the date first set forth above.

GAMBRO RENAL PRODUCTS, INC.

	 	 	 	 
	By: 
	/s/ Nick Mendez	 	 
	Name: Nick Mendez

	 	 
	Title: President Gambro Americas
		 	 

MEDISYSTEMS CORPORATION

	 	 	 	 
	By: 
	/s/ Jeffrey H. Burbank	 	 
	Name: Jeffrey H. Burbank

	 	 
	Title: President and CEO
	 	 

17

 

Exhibit A

Territory

The Territory is the United States of America for MDS Products sold to DaVita. The Territory is
the United States of America for MDS BTL sold to [**]

18

 

Exhibit B

MDS PRODUCTS

List of Codes

[**]

19

 

Exhibit C — Specifications

(sample page)

[**]
  

 
 

20

 

Exhibit D

Base Prices

	 	 	 	 	 
	
	 			 
	 [**]
	 	 	 	 
	

	 			 
	
	 	 		 

21

 

Exhibit E

VENDOR NOTICE OF CHANGE

Reference is made to the Extracorporeal Disposables Distribution Agreement dated
                     between Medisystems Corporation and Gambro, pursuant to which MDS has agreed to notify
Gambro in writing of any substantial change in design, components, or packaging of the MDS Products
which may necessitate in-servicing or notification to end-users:

MDS hereby notifies Gambro of the following change:
 

Plans for initiation of this change are as follows:
 

	 	 	 	 	 	 	 
	 	 	MEDISYSTEMS CORPORATION
	 	 	 
	 	 	 	 
	 	 	By:	 	 

	 	 	 

	 	Signature	 	 
	 	 	 
	 	 	 	 
	 	 	 

	 	Name:
	 	 

	 	 	 
	 	 	 	 
	 	 	Title:	 	 

	 	 	 
	 	 	 	 
	 	 	 

	 	Date:
	 	 

 

22

 

Exhibit F

 Medisystems Field Experience Worksheet

Date Received:                    

Received Via (Circle): Fax, Telephone, Letter            From:                    

Received By:                                                  

Incident Date:                                                                 

No. of Patients/Donors:                     No. of Incidents:                    

Product Code:                    

Lot Numbers(s):                                                              

No. of Products Involved:                    

Complainant: Name:                    

Title:                                                  

Health Care Professional (Circle): Yes/No

Occupation:                    

Facility:                    

Address:                                                                                

City:                     State & Zip:                    

Telephone: (___)                    

Complainant’s Ref. No:                    

Distributor(s):                     

Contact:                                                                 

Complaint Description:                    

 

Patient/Donor Injury? (Circle): Yes / No

 

23

 

     If yes, describe injury and any medical intervention (i.e., transfusion) required:

      

	 	 	 	 	 
	Blood Loss? (Circle): Yes/No.

	 	Amount of Blood Loss:
	 	<20cc. 20-100cc. >100cc.
	 

	 	 	 	Exact Amount if Available; if
not circle closest estimate

As appropriate list device and/or machine codes and lots which interfaced with the complaint
device: Item:                    

Code:                     Lot:                    

Item:                     Code:                     Lot:                    

Will the complainant return samples? Yes / No.

Samples may be returned via Fedex with billing to Medisystems Account # 1058-39626

Did the user clinic or distributor file a MedWatch form with the FDA? (Circle) Yes / No

	 	 	 
	 
	(Signature)

	 	(Date)

Immediately fax form with all available information to Medisystems Corporation

24

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00161-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00161-of-00352.parquet"}]]