CONFIDENTIAL
Exhibit 10.1
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
SUPPLY AGREEMENT
THIS SUPPLY AGREEMENT (this "Agreement") dated as of March 27, 2006
("Effective Date"), by and between Laboratorios PISA S.A. de C.V., a corporation
organized under the laws of Mexico having offices at Xxxxx 0 Xx. 0000 Xxxx
Xxxxxxxxxx, X.X. 00000 Xxxxxxxxxxx, Xxx., Xxxxxx ("PISA") and NxStage Medical,
Inc., a Delaware corporation, having offices at 000 Xxxxx Xxxxx Xxxxxx, 0xx
Xxxxx, Xxxxxxxx, Xxxxxxxxxxxxx 00000, XXX ("NxStage").
BACKGROUND
NxStage desires to purchase from PISA, and PISA desires to supply NxStage
with, the Products (as defined below), under and subject to the terms and
conditions set forth in this Agreement.
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants and agreements provided herein, the parties hereto, intending to be
legally bound hereby, agree as follows:
1. Definitions. When used in this Agreement, capitalized terms, including their
plural form, shall have the following meanings:
1.1 "Agreement" means this Agreement and all appendixes, exhibits and
schedules hereto, and all modifications, amendments and supplements hereof.
1.2 "FDA" means the United States Food and Drug Administration, or any
successor thereto.
1.3 "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.
1.4 "NxStage Trademarks" means, collectively, the trademarks, the service
marks and related intellectual property rights, which NxStage owns or has the
right to use, as appropriate, in connection with the Product, all as more fully
set forth on Appendix C attached hereto.
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1.5 "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.
1.6 "Specifications" means the Product specifications together with GMP and
manufacturing protocols, shipping and packaging requirements included as part of
the Technical Agreement.
1.7 "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.
1.8 "Territory" means all territories worldwide.
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 [**] prior to the first
requested delivery date for such Products. The 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 [**] 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 [**] period, the
first [**] 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 delivery dates and shipping
instructions. Orders placed for each type of Product shall be in a minimum
quantity of one batch of 2,560 bags of Product per each requested delivery date
as more specifically described in Appendix A. Delivered quantity for each batch
of Product may differ by +/- [**] % of the ordered quantity.
PISA shall accept all purchase orders that are in line with the Volume
Commitment and shall manufacture and supply the Products corresponding to the
quantities and delivery dates set forth in such purchase orders. PISA shall use
commercially reasonable efforts to accept and satisfy all orders that exceed
NxStage's Volume Commitment as well as rolling forecasts and shall notify
NxStage within [**] of receipt of any purchase order if PISA is not able to
satisfy such order. Unless NxStage receives written notice from PISA within such
[**] period, PISA shall be deemed to have accepted such purchase order placed by
NxStage.
2.3 Minimum Annual Volume Commitments
During the Initial Term of this Agreement, NxStage hereby agrees to purchase
from PISA and PISA hereby agrees to sell to NxStage a quantity of Products
constituting not less than the annual minimum order volumes (the "Volume
Commitment") specified in Appendix A. The parties acknowledge that the Volume
Commitment reflects [**] percent of the NxStage forecast, as of the effective
date of the Technical Agreement, of total unit sales for the
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Products in the United States market over the Initial Term. The Volume
Commitment is as specified in Appendix A and is made by NxStage in exchange for
the volume pricing as also specified in Appendix A.
Within a given calendar year of the Agreement term (the first calendar year of
the Agreement term shall be deemed to include the period from December 1, 2005
to December 31, 2006), if it becomes evident that NxStage will not achieve the
Volume Commitment, NxStage shall inform PISA 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
discussions, and such shortfall is due to circumstances beyond the control of
NxStage, which both parties expressly agree such circumstances include the
market adoption of the NxStage System One and the Products, NxStage shall pay to
PISA an amount equal to [**]% of the unit shortfall for the contractual year
multiplied by the Product price in force for that calendar year. If such a
shortfall is due to NxStage's decision to purchase the Products from an
alternate supplier or due to other circumstances within the control of NxStage,
which both parties expressly agree such circumstances do not include market
adoption of the NxStage System One and the Products, NxStage shall pay to PISA
an amount equal to [**]% of the unit shortfall for the contractual year
multiplied by the product price in force for that calendar year.
Notwithstanding the provisions of foregoing, in the event that during the term
of the agreement for causes attributable to PISA, PISA is unable to fulfill [**]
percent ([**]%) of accepted Purchase Order quantities for [**] months then,
NxStage shall have the right to suspend PISA's Volume Commitment rights
hereunder, and the Pricing in Appendix A shall remain in force throughout the
suspended period and the remainder of the term of the Agreement. If such
inability to supply is due to a force majeure event Section 14 shall apply.
2.4 Cancellations. In the event NxStage cancels any accepted purchase
orders for Products within thirty (30) days of the scheduled Delivery Date,
NxStage shall pay PISA (a) [**] for the cancelled Products for which delivery is
scheduled within such [**] period, and (b) the average direct product cost
(assumed for purposes of this Agreement to be [**]% of the pricing outlined in
Appendix A) for the remainder of the Products which is due during the subsequent
[**] period.
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 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 Delivery Dates for the Products affected by the change in
Specifications, as agreed by the parties (c) to require NxStage to purchase all
existing Product in finished goods inventory at PISA, and manufactured pursuant
to accepted purchase orders, as well as molds and materials produced or acquired
by PISA, consistent with accepted purchase orders for such Products, at PISA's
costs plus a reasonable xxxx-up,
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not to exceed [**]%. 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 [**] 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 period of less than [**].
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 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 [**] 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 "Manufactured 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 Product 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 or marketing 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
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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, 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 cost of all existing Product in stock,
provided the total existing quantity does not exceed the quantity on order
through binding 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. 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.
4. Pricing and Payment; Record-Keeping; Audit Rights.
4.1 Pricing. Except as provided in Section 2.3, the pricing of the Products
shall be as set forth in Appendix A hereto, which shall govern pricing for the
Products for the Term of the Agreement, so long as NxStage meets the Volume
Commitments indicated in Appendix A.
Except as provided in Section 3.1, the parties agree that pricing for the
Products during the term of the Agreement shall be subject to review and
modification no more than [**] and only in cases of substantial increases (an
increase of more than [**]% in [**]) in any single production factor that
adversely impacts PISA's direct cost of manufacture (labor and raw
materials), provided that PISA can provide reasonable evidence of the basis for
such pricing increase at NxStage demand.
In the event PISA increases the Product price pursuant to this Section 4.1 by
more than [**]% over the fixed pricing established in Appendix A, NxStage shall
have the right to obtain third
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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 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 price increase intact. PISA shall
make such determination within [**] of notice from NxStage of the third party
quotation. If PISA decides to match the third party pricing, it shall inform
NxStage in writing and the new reduced price shall become effective with the
next subsequent Purchase Orders placed by NxStage. If PISA decides to maintain
the price increase intact, NxStage shall be free to purchase from the third
party and may rescind its Volume Commitment (Section 2.3) to PISA in writing
with [**] advance notice.
At least [**] prior to the end of the initial term of the Agreement, the parties
shall meet in person or by phone to negotiate possible pricing for any renewal
term. If PISA and NxStage do not reach an agreement following good faith
negotiations, on such Product pricing during such [**] period, this Agreement
shall terminate upon [**] after the end of the initial term of the Agreement.
During such an extended period the price of the Product shall remain as the last
price agreed to by PISA.
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 its 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 by email to a designated
NxStage contact concurrent with the final quality release of the Product from
its production operation, and NxStage shall make full payment to PISA in U.S.
Dollars by bank transfer directly to the bank account designated by PISA, upon
shipment of the Product from PISA and following NxStage's receipt of the
invoice.
At such time that PiSA deems that NxStage has performed acceptably in meeting
its payment obligations within the payment terms described above, PISA agrees to
reasonably consider NxStage's request for [**] payment terms. Such determination
will be made at PISA's sole discretion.
Dispute of Invoices. If NxStage disputes all or any part of an invoice, NxStage
shall provide PISA a notice of the dispute within [**] of its receipt of such
invoice, and shall pay any undisputed portion of the invoice. NxStage and PISA
agree to use all commercially reasonable efforts to resolve any disputes
concerning the payment of invoices under this Section.within [**] after NxStage
has provided such notice of dispute. If the parties are unable to resolve or to
compromise such dispute within such [**] 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 PISA's
manufacturing facilities, Guadalajara, Mexico. Title to and risk of loss for the
Product shall
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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.
5.2 Inspections. NxStage shall have the right 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 [**] 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 at PISA's sole
cost and expense and subsequently invoice NxStage for the sales value of the
replaced 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 [**]
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 the +/- [**]% difference
set forth in Section 2.2, NxStage may accept any Product in excess of the
quantity ordered as against future orders of the Product.
5.3 Without limiting the foregoing NxStage at its own expense shall
exercise its own quality control by engaging an independent expert that is
registered with the FDA, who shall assess and certify the compliance to
Specifications of the first three batches of Products delivered under this
Agreement, and thereafter an annual certification of one additional batch.
NxStage shall deliver to PISA a copy of the certification issued by said
FDA-registered independent expert when such a report becomes available.
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 formulation,
labelling, as well as distribution, sale, marketing, handling and use of the
Products.
All warranties for Product shall continue for the Product's labeled shelf life,
which shall be validated per NxStage's stability studies for the Products.
NxStage agrees to conduct such concurrent long term stability tests on the
RFP-2xx Premixed Dialysate Products produced by Pisa, following the guidelines
of ICH Stability Testing of New Drug Substances and Products, at NxStage's
expense. NxStage shall share the results of these tests with PISA upon
completion.
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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, 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.
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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 NxStage shall pay the premiums of PISA's
Product Liability Insurance policy in the coverage amount of $3.0 million USD
with regards to Products to be supplied under this Agreement. PISA shall submit
for NxStage's prior approval the quoted premiums and 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 also pay the premiums for the
extension of PISA's Umbrella Liability Insurance policy to the United States
in the coverage amount of $7.0 million USD. PISA shall submit for NxStage's
prior approval the quoted premiums and shall provide to NxStage a Certificate of
Insurance for the Umbrella Liability policy. PISA shall name NxStage as
Additional Insured on the General Liability policy which is listed as underlying
on the Umbrella Liability Insurance policy.
10. Indemnification.
10.1 PISA Indemnification Obligation. PISA hereby indemnifies and agrees to
defend and hold NxStage, its 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 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
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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 [**] 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 commence on the Effective Date and shall
continue through December 31, 2008 (the Initial Term), unless sooner terminated
in accordance with the provisions of Section 4.1 or this Section 11. Thereafter,
the Agreement shall be automatically renewed on a year to year basis, subject to
either party having the right to terminate this Agreement 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 or this Section 11.
If NxStage terminates the agreement for reasons other than those specified
within Section 4.1 or this Section 11, and such termination is due to
circumstances beyond the control of NxStage, which both parties expressly agree
such circumstances include the market adoption of the NxStage System One and the
Products, NxStage shall pay to PISA an amount equal to [**]% of the unit
shortfall according to the Volume Commitment multiplied by the Product price in
force at the date of termination. If such termination is due to NxStage's
decision to purchase the Products from an alternate supplier or due to other
circumstances within the control of NxStage, which both parties expressly agree
such circumstances do not include
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market adoption of the NxStage System One and the Products, NxStage shall pay to
PISA an amount equal to [**]% of the unit shortfall according to the Volume
Commitment, multiplied by the product price in force at the date of termination
for that calendar year.
If PISA terminates the agreement for reasons other than those specified within
Section 4.1 or this Section 11, PISA shall pay to NxStage an amount equal to the
difference between the price NxStage can obtain from a third party supplier and
the Product price hereunder, multiplied by the Volume Commitment remaining to be
fulfilled had the contract not been terminated by PISA.
11.2 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.
11.3 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 thirty (30) days after receiving
written notice with respect to such default.
11.4 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 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 therefrom, 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 therefrom; provided that the parties shall be entitled
to retain one copy of the Confidential Information in their legal department
files for the purpose of insuring compliance with their obligations under
Sections 7, 8 and 15.1 and complying with any applicable governmental rules and
regulations. PISA shall also make available upon request by NxStage, batch
records or other quality records for the Product for a period of [**] after
termination.
11
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
12
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 [**].
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 - Dialysate Concentrate. In the event that NxStage
determines that it wishes to enter into purchase arrangements for dialysate
concentrate, either in bulk form or in single use containers, PISA shall have
the first right of proposal to supply such products. For such purposes PISA
shall submit a proposal for the product within 30 days of NxStage's request for
a proposal. NxStage's decision as to awarding the business to PISA shall
consider the comprehensive economics of the PISA proposal, including but not
limited to transportation costs, lead-times, product quality, and other factors.
15.3 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 affiliated 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.
15.4 Notices. Any notice or request required or permitted to be given under
or in connection with this Agreement shall be in writing and shall be deemed
given only if delivered personally, sent by fax, by registered or certified
mail, return receipt requested, or by overnight delivery service to the
applicable address set forth above or such other address as a party may have
specified in a notice duly given to the other party as provided herein.
15.5 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
13
documents or other business forms containing terms or conditions in addition to,
or different from, the terms and conditions set forth in this Agreement. Such
documentation is permitted only as a convenience to the parties, and all such
purchase orders and other documentation shall be governed and superceded by the
terms and conditions of this Agreement. Any failure by either party to enforce
any of their respective rights herein shall not be deemed a waiver of such
rights, and it may, from time to time, and at its option, enforce any of its
rights hereunder, notwithstanding any course of dealing or performance.
Notwithstanding the termination of this Agreement, the provisions of Sections
3.6, 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.
15.6 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.
15.7 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.
15.8 Severability. The provisions of this Agreement shall be severable from
each other and from the rest of this Agreement, and in the event that any
portion of this Agreement shall be held invalid, void, unenforceable, or
ineffective by a court of competent jurisdiction, the remaining portions thereof
shall remain in full force and effect. If any of the terms or provisions of this
Agreement are in conflict with any applicable statute or rule of law, then such
terms or provisions shall be deemed inoperative to the extent that they may
conflict therewith, and shall be deemed to be modified to conform with such
statute or rule of law and as far as possible economically corresponds with the
invalid provision.
15.9 Governing Law and Dispute Resolution.
(a) This Agreement (and any dispute, controversy, proceeding, or claim
of whatever nature arising out of or in any way relating to this Agreement or
its formation) shall be governed by and interpreted in accordance with 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
can not 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.
14
15.10 Heading. The Headings in this Agreement are included for ease of
reference only and shall have no legal effect.
15.11 Signatures. This Agreement may be executed in one or more
counterparts, each of which shall be deemed to be one and the same Agreement.
[Remainder of This Page Intentionally Left Blank]
15
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/ Xxxxxxx Xxxxxxx Xxxxxxxxxx Xxxxxxx By: /s/ Xxxxxxx X. Xxxxxxx
-------------------------------------- -------------------------------
Name: Xxxxxxx Xxxxxxx Xxxxxxxxxx Xxxxxxx Name: Xxxxxxx X. Xxxxxxx
Title: New Business Director Title: President and CEO
16
APPENDIX A
VOLUME COMMITMENTS AND PRICING
Pricing for 5 liter pre-mix Dialysate (RFP-204, RFP-207)
See Technical Agreement for Product Specifications
NxStage Volume
Unit Price per 5 liter bag Commitment for Period
Period of Term Ex-works Guadalajara, Mexico (in 5 L bags of dialysate)
-------------- ---------------------------- --------------------------
March - December, 2006 $[**] USD (Note 1) [**] K (Note 3)
January - December, 2007 $[**] USD [**] K
January - December, 2008 $[**] USD (Note 2) [**] K
1. For the period March - December, 2006, if the Volume Commitment is exceeded
by NxStage, the price for all units in excess of commitment shall be $[**]
per bag.
2. For the period January - December, 2008, if the Volume Commitment is
exceeded by NxStage, the price for all units in excess of the commitment
shall be $[**] per bag.
3. Reflects March - December volumes only.
00
XXXXXXXX X
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 000 X. Xx-xxx
Xxxxxx, Xxxxxxxx, XX 00000, Xxxxxx Xxxxxx of America (NxStage) and
(2)LABORATORIOS PISA, S.A. de C.V., whose production facility is located at
Calle 7 No. 1308 Zona Industrial X.X. 00000 Xxxxxxxxxxx, Xxx., Xxxxxx ("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.
18
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
3.1 PISA shall:
(a) manufacture, test, package, and label the Products on behalf of
NxStage at its premises in accordance with:
(i) the product specifications provided by NxStage and detailed in
Appendix 2 hereto;
(ii) the test specifications provided by PISA and approved by NxStage
and detailed in Appendix 3 hereto;
(b) provide and maintain clean and safe storage of the Products until
their dispatch from PISA.
(c) maintain all applicable regulatory authorizations, including when
obtained a current facility Registration with the US FDA with respect
to the premises and facilities to be used in the manufacture and
quality control of the Product.
3.2 In the manufacture of the Products, PISA shall utilize all know how
available to it, taking into account the current state of the scientific
and technological art, and shall comply with Specifications and all
applicable legal requirements, rules, regulations and guidelines of FDA
Quality System Regulation (QSR) 21 CFR Part 820 which are attached to this
Agreement as Appendix 5.
3.3 PISA shall maintain the Device Master Record (DMR) for the Product. The DMR
consists of specifications, formulation, production process specifications,
equipment specifications, production methods, production procedures,
production environment specifications, quality assurance procedures and
specifications including acceptance criteria, packaging and labeling
specifications including methods and processes used, and maintenance
procedures as required by NxStage.
3.4 The party which provides documentation hereunder shall be responsible for
the proper quality of such documentation and for compliance of the
documentation with all applicable laws, rules, regulations and guidelines
referred to in clause 3.2.
3.5 NxStage shall ensure that the manufacturing and test specifications conform
to all requirements contained in the pursuant marketing authorization
documentation.
19
3.6 NxStage shall ensure that this Agreement and the Appendices hereto conform
to regulatory requirements in all countries where the Products are sold and
that any change in such requirements are notified to PISA and reflected in
appropriate amendments that must be previously agreed and signed by both
parties to be effective.
3.7 NxStage shall provide PISA with the appropriate assistance for the
procurement of PISA's facility Registration with the US FDA and any other
formalities to be carried out in the United States of America in order to
enable PISA to be approved as the manufacturer of the Products.
3.8 PISA shall on a regular basis perform internal audits and inspections in
accordance with the demands of FDA Quality System Regulation (QSR) 21 CFR
Part 820 concerning medical devices and shall promptly remedy any
deficiencies found during such audits and inspections.
3.9 Subject to the Confidentiality sections of the Supply Agreement to be
entered between NxStage and PISA, NxStage may perform audits and
inspections of PISA's facilities, processes, and procedures as far as these
are involved in the manufacturing and testing of the Products, by giving
prior notice to PISA with at least 10 working days in advance.
3.10 PISA shall not sub-contract any aspects of the manufacture or quality
control of the Product to a third party without first obtaining the written
approval of NxSTAGE.
3.11 PISA shall not deviate from the manufacturing procedure identified in the
Product Specifications without the prior written agreement of NxSTAGE.
4. Qualified Person
4.1 Each party shall appoint a Qualified Person who shall be responsible for
per-forming, or supervising and ensuring the performance of, as
appropriate, such party's duties and tasks under this Agreement.
4.2 Each party shall notify the other of the particulars of its Qualified
Person (name, postal and e-mail address, telephone and fax numbers) and
said contact information shall be included in Appendix 4.
5. Raw Materials and Packaging Materials
PISA shall use raw materials, components, and packaging materials, and
sup-pliers thereof, specified in the materials specifications for the Products.
PISA shall perform quality control of all raw materials and components to ensure
that they conform to the specifications and shall be responsible for the proper
condition and quality of all materials.
6. Batch Designation and Documentation
6.1 Standard batch size shall be 13,000 liters or 2,600 5 liters bags (Pre-Mix
Dialysate).
6.2 PISA shall designate a unique batch number for each batch of Product
manufactured. Such number shall be used on all documentation relating to
the particular batch.
20
6.3 PISA shall prepare for each batch of Product a Batch Record which shall
con-tain at least the following details:
(a) name and description of product
(b) batch number
(c) date of manufacture (determined as of the date of first mixing
constitu-ent materials)
(d) expiry date (determined on the basis of the shelf life as from date of
manufacture) (to be indicated with six digits, e.g. 2005-04 = April,
2005)
(e) size of batch and composition of product in the different stages of
manufacture
(f) results of in-process checks and controls
(g) certification by persons responsible for each stage of manufacture
that the manufacture is duly made in accordance with the manufacturing
and test specifications,
(h) special observations made during manufacture
(i) lot or batch control numbers of raw materials and packaging materials
used in the manufacture of the product batch
(j) details of the type and number of batch samples.
6.4 The Batch Record may refer to other documentation regarding individual
data.
6.5 In the event there occurs any significant deviation from specified or
validated data or processes in the manufacture of the Products, such
deviating data or process shall be fully explained and documented by PISA
in an attachment, entitled "Remarks", to the Batch Record and be promptly
forwarded to NxStage. Any deviation shall be justified and approved by
PISA's Qualified Person and consented by NxStage prior to batch release,
which consent shall not be unreasonably withheld.
6.6 Upon request, PISA shall promptly furnish NxStage with copies of full batch
documentation. PISA shall retain original documentation for regulatory
inspection compliance and shall make the documentation available for
inspection by the competent regulatory authorities and NxStage.
7. Quality Control and Test Protocol
7.1 PISA shall perform in-process testing and finished product quality control
in accordance with the manufacturing and test specifications. PISA will
inform NxStage when in its opinion the test specifications and test methods
used are no longer in accordance with the state of the scientific and
technological art and no longer suitable for assessment of the quality of
the Product.
7.2 PISA shall record the results of tests and quality control measures in the
appropriate Batch Record.
8. Release of Product
8.1 If (i) the tests and other quality control measures have shown that the
batch of Product meets the required quality and are in compliance with the
product specifications, (ii) the manufacturing Batch Records have been duly
signed, and (iii) the Batch Record has been approved by PISA's Qualified
Person, PISA shall release the batch for delivery and
21
shall furnish NxStage with a Certificate of Analysis ("C of A"), as signed
by PISA's Qualified Person. The format of the C of A will be agreed upon by
NxStage Quality Assurance.
For handling of deviations from specified processes in the manufacture or
testing of the Products refer to clause 6.5 of this Agreement
8.2.1 NxStage shall be responsible for release of the Product for commercial
sale (final release).
8.2.2 Should there be a discrepancy between test results carried out by each
party, and if both parties do not find a mutually agreeable solution, such
discrepancies shall be finally resolved by testing performed by an
independent third party mutually agreed upon by both parties. The costs of
such testing shall be borne by the party against whom the discrepancy is
resolved.
9. Bag Print, Instructions for Use, Labeling
9.1.1 NxStage shall be responsible that bag prints, instructions for use and
carton and bottle labels are in accordance with the marketing authorization
and all other applicable regulations.
9.1.2 NxStage shall provide PISA with the artwork necessary to prepare the
printing plates for the Product. Contact prints shall be approved by
NxStage before PISA uses the plates for manufacture of the Product. Any
change or modification in the artwork shall be previously agreed between
the parties.
10. Sample Retention
PISA shall retain at least two samples (single units) of each batch of Product
until one year after the expiry of the Product.
11. Complaints and Recalls
11.1 NxStage shall be responsible for initial handling of customer complaints
relat-ing to the Products and shall give prompt written notice to PISA of
the same. PISA shall then take prompt action to make such internal
investigations as are called for in the circumstances and report its
findings to NxStage.
11.2 NxStage shall be responsible for initiating any recall action involving the
Products and shall keep PISA appropriately informed of the same. PISA shall
reimburse all Product recall costs attributable to PISA reasonably incurred
by NxStage with prior consent of PISA, except where the Product recall is
not caused by a failure of the Product to meet specifications, or
misleading in-formation in bag prints, instructions for use and carton and
bottle labels, and, wrong handling and storage by NxStage.
11.3 Emergency contact numbers are set out in Appendix 4.
12. Changes and Amendments
22
12.1 PISA may not relocate the manufacture or testing of the Products from its
premises without NxStage's prior written consent.
12.2 PISA may not without NxStage's prior writing consent make any change in
processes, equipment or facilities which may adversely affect the quality
of the Products. Without limiting the foregoing, PISA may not make any
change to the Product specification without NxStage's prior written
consent.
12.3 Any amendment to this Agreement or to any Appendix hereto shall be made in
writing and be agreed to and duly signed on behalf of both parties. Neither
party may refuse to accept any amendment required to comply with laws,
rules and regulations or requests by regulatory authorities.
IN WITNESS WHEREOF, this Agreement has been duly executed in duplicate as of the
date first above written.
NXSTAGE MEDICAL Inc.
By: /s/ Xxxxxx X. Xxxxxx
---------------------------------
Name: Xxxxxx X. Xxxxxx
Title: Senior Vice President and
Chief Operating Officer
LABORATORIOS PISA, S.A. de C.V.
By:
---------------------------------
Name:
-------------------------------
Title:
------------------------------
23
PLEASE USE PAPER APPENDICES ALREADY SENT - PISA AND NXSTAGE TEAMS PREPARED THOSE
APPENDICES CAREFULLY.
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
------------ -------------------- -----------------
Premixed Dialysate, RFP-204 VERLO CON XXXXXXX
5 liters, 40 Lactate
Premixed Dialysate, RFP-207 VERLO CON XXXXXXX
5 liters, 45 Lactate
Concentrate, 1 liter bottle, VERLO CON NxSTAGE VERLO CON XXXXXXX
40 Lactate
Concentrate, 1 liter bottle, VERLO CON NxSTAGE VERLO CON XXXXXXX
45 Lactate
24
Appendix 2
to Technical Agreement between
NXSTAGE MEDICAL Inc. and
LABORATORIOS PISA, S.A. de C.V.
NxStage Product Specifications
Document type Title NxStage Document # Revision
------------- ----------------------------- ------------------ --------
Product Premixed Dialysate, 5 liters, RFP-204 &
Specification 00 Xxxxxxx XXX-000 XxXX
Product Premixed Dialysate, 5 liters, RFP-207 &
Specification 45 Lactate RFP-207 PiSA
Product Concentrate, 1 liter bottle, VERLO CON NxSTAGE
Specification 40 Lactate
Product Concentrate, 1 liter bottle, VERLO CON NxSTAGE
Specification 45 Lactate
VER QUE ESTEN DETALLADOS TODOS LOS ASPECTOS DE FABRICACION, PRUEBAS MATERIALES
DE EMPAQUE, ASI COMO ESPECIFICACIONES DEL MATERIAL IMPRESO, EN LOS DOCUMENTOS
ARRIBA SENALADOS.
DEBERAN INCLUIRSE UNA LISTA DE DEFECTOS COSMETICOS O DE APARIENCIA (ETIQUETAS
MANCHADAS, TALLADAS, ETC, PRODUCTO CON PUNTOS DE COLOR, ETC,. REFERENCIAS PARA
TABLAS DE MUESTREO, NIVELES DE ACEPTACION (AQL's) POR CUMPLIR, ETC.. PARTIR DEL
QUE YA TENEMOS EN BOLSAS Y SUEROS PLASTICO.
25
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 Premixed Dialysate, 5 liters, VERLO CON XXXXXXX
Specification 40 Lactate
Test Premixed Dialysate, 5 liters, VERLO CON XXXXXXX
Specification 45 Lactate
Test Concentrate, 1 liter bottle, VERLO CON XXXXXXX
Specification 40 Lactate
Test Concentrate, 1 liter bottle, VERLO CON XXXXXXX
Specification 45 Lactate
26
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.,
000 X. Xxxxx Xxxxxx, Xxxxxxxx, XX 00000, XXX
NXSTAGE MEDICAL Inc.,
000 X. Xxxxx Xxxxxx, Xxxxxxxx, XX 00000, XXX
Mr. Xxxxxxx Xxxx phone 000-000-0000
Vice President QA/RA fax 000-000-0000
cellular phone 000-000-0000
e-mail xxxxx@xxxxxxx.xxx
Xx. Xxxxxxx Xxxxxx phone 000-000-0000
Vice President Manufacturing fax 000-000-0000
Operations cellular phone 000-000-0000
e-mail xxxxxxx@xxxxxxx.xxx
LABORATORIOS PISA, S.A. de X.X.
Xx Xxxxxx, 0000, Xxxxxxx Moderna, X.X. 00000, Xxxxxxxxxxx, Xxx., Xxxxxx
LABORATORIOS PISA, S.A. de X.X.
Xx Xxxxxx, 0000, Xxxxxxx Moderna, X.X. 00000, Xxxxxxxxxxx, Xxx., Xxxxxx
Mr. Mario del Toro phone ______________________
Production Manager
fax ______________________
cellular phone ______________________
e-mail ______________________
Xx. Xxxxxx Xxxxxxxxx phone 00-0000-0000
QC Manager / Qualified Person fax 00-0000-0000
cellular phone 00-0000-0000
e-mail xxxxxxxxxx@xxxx.xxx.xx
Xx. Xxxxxxx Xxxxxx phone 00-0000-0000
fax 00-0000-0000
cellular phone 00-0000-0000
e-mail xxxxxxxx@xxxx.xxx.xx
27
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"
28
APPENDIX C
NXSTAGE TRADEMARKS
(1) NxStage(R)
(2) Pureflow Solution(TM)
29
