Document:

exv10w1

Exhibit 10.1

SUPPLY AGREEMENT

This Supply Agreement (the “Agreement”) is effective as of the 4th day of April, 2011
(the “Effective Date”) by and between

	(1)	 	Fresenius Kabi AB, Rapsgatan 7, 75324 Uppsala, Sweden (“FRESENIUS”)

and

	(2)	 	Cardiovascular Systems, Inc, 651 Campus Drive, Saint Paul, MN 55112, USA (“CSI”).

Recitals

	(A)	 	WHEREAS, CSI holds the market authorization of a product that requires the Product (as
defined herein) as a lubricant which is used as a medical device.
	 
	(B)	 	WHEREAS, FRESENIUS has a NDA (new drug application) approval of the Product in bags in the
United States of America.
	 
	(C)	 	WHEREAS, FRESENIUS is willing to provide all information to CSI that is required to receive
an approval from the FDA for the Product for the intended use as a lubricant.
	 
	(D)	 	WHEREAS, CSI is willing to purchase the Product from FRESENIUS.
	 
	(E)	 	WHEREAS, FRESENIUS is willing to manufacture the Product and supply it to CSI.
	 
	(F)	 	WHEREAS, the parties have agreed to enter into this Agreement to set forth the terms and
conditions on which FRESENIUS will manufacture and supply the Product to CST.

Agreement

NOW, THEREFORE, the parties hereto agree as follows:

	1.	 	Definitions
	 
	 	 	Unless otherwise specifically provided in this Agreement, the following terms shall have the
following meanings:
	 
	1.1	 	“The Act” means the United States Federal Food, Drug and Cosmetic Act, as amended from time
to time, and the rules and regulations promulgated thereunder.
	 
	1.2	 	“Affiliates” means, with respect to a Party, any person that controls, is controlled by or is
under common control with such first person. For purposes of this definition only, “control”
means (a) to possess, directly or indirectly, the power to direct the management or policies
of a person, whether through ownership of voting securities or by contract relating to voting
rights or corporate governance, or (b) to own, directly or indirectly, more than fifty percent
(50%) of the outstanding voting securities or other ownership interest of such person.

 

 

	1.3	 	“Change of Control,” with respect to any Party, means an event in which:

	 	1.3.1	 	any other person or group of persons acquires beneficial ownership of
securities of the Party representing more than fifty percent (50%) of the voting power
of the then outstanding securities of such Party with respect to the election of
directors of such Party; or
	 
	 	1.3.2	 	the Party enters into a merger, consolidation or similar transaction with
another person in which such Party is not the surviving entity in such transaction.

	1.4	 	“Confidential Information” means all Information, disclosed by or on behalf of the relevant
Party to the other Party pursuant to this Agreement in written, oral or any other form.
	 
	1.5	 	“Disclosing Party” means the Party disclosing Confidential Information.
	 
	1.6	 	“Effective Date” means the date as set forth in the preamble to this Agreement.
	 
	1.7	 	“FDA” means the United States Food and Drug Administration or any successor entity thereto.
	 
	1.8	 	“First Price Review Date” means the date on which the then current Price for the Product will
first be reviewed and negotiated, as specified in item C.4 of the Product Schedule.
	 
	1.9	 	“Fixed Price Term” means the term for which the Price specified in the Product Schedule at
the time of signing will remain fixed, as specified in item C.3 of the Product Schedule.
	 
	1.10	 	“Forecast” means a listing of the quantities of the Product that CSI expects to order from
FRESENIUS within a rolling time-frame.
	 
	1.11	 	“Invoice Currency” means the currency in which the Product will be invoiced and paid, as
specified in Part C.2 of the Product Schedule.
	 
	1.12	 	“Loss” means any and all liabilities, claims, demands, causes of action, damages and
expenses, including interest, penalties, and reasonable lawyers’ fees and disbursements.
	 
	1.13	 	“Parties” means FRESENIUS and CSI. “Party” means either FRESENIUS or CSI.
	 
	1.14	 	“Price” with respect to the Product, means the amount payable for such Product, as determined
in accordance with the terms hereof and the Product Schedule.
	 
	1.15	 	“Product” means the medical device product to be supplied pursuant to, and as detailed in
Part A (Specification) of the Product Schedule.
	 
	1.16	 	“Product Schedule” means a schedule executed and delivered by the Parties in accordance with
Section 2.1.

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	1.17	 	“Purchase Order” means a binding order for such quantities of the Product as CSI commits to
order from FRESENIUS during the Term, with a statement of the date on which delivery of such
shipment shall be required.
	 
	1.18	 	“Quality Agreement” means the Quality Agreement(s) entered into by the Parties simultaneously
with the execution and delivery of the Product Schedule and attached hereto as Exhibit 2.
	 
	1.19	 	“Receiving Party” means the Party to whom Confidential Information is disclosed.
	 
	1.20	 	“Regulatory Approval” shall mean any approval (including supplements, amendments, pre- and
post-marketing approval, and pricing and reimbursement approval), license, registration or
authorization of any national, supra-national, regional, state or local regulatory agency,
department, bureau, commission, council or other governmental entity, necessary for the
manufacture, distribution, use or sale of the Product as a Device in a regulatory
jurisdiction. For purposes of this definition, Regulatory Approval shall mean a 510(k) Device
approval issued by the FDA (as defined below) or any other relevant Regulatory Authority (as
defined below).
	 
	1.21	 	“Regulatory Authority” shall mean any federal, state or local or international regulatory
agency, department, bureau or other governmental entity including the FDA which is responsible
for issuing approvals, licenses, registrations or authorizations necessary for the
manufacture, use, storage, import, transport or sale of the Product as a Device in a
regulatory jurisdiction.
	 
	1.22	 	“Specification(s)” with respect to the Product, means the specifications for the Product as
specified in Part A of the Product Schedule, as the same may be updated from time to time in
accordance with the current Quality Agreement.
	 
	1.23	 	“Term” means the period beginning on the Effective Date and continuing until the date upon
which this Agreement is terminated or not renewed in accordance with Article 14.
	 
	1.24	 	“Third Party” shall mean a party other than FRESENIUS or the CSI and their respective
Affiliates.
	 
	2.	 	Product
	 
	2.1	 	The parties shall enter into a Product Schedule for the supply of the Product they wish to be
governed by the terms and conditions of this Agreement, Exhibit 1.
	 
	2.2	 	Purchase and Sale of Product. Pursuant to the terms and conditions of this Agreement and for
the duration of this Agreement, FRESENIUS shall manufacture, sell and deliver the Product to
CSI, and CSI shall purchase and take delivery of the Product exclusively from FRESENIUS.
FRESENIUS shall manufacture Product in accordance with the Specifications. The parties may
alter from time to time the Specifications by written agreement without amending this
Agreement.
	 
	2.3	 	Government Approvals. FRESENIUS shall consult with and advise CSI in responding to questions
from Regulatory Authorities regarding CSI’s submission(s) for the Product.

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	 	 	CSI shall be the sole owner of any regulatory submission filed pursuant to this Agreement.
CSI shall provide to FRESENIUS for its files a final copy of the CMC section of any such
regulatory submission(s).
	 
	2.4	 	Product Labeling. FRESENIUS shall label Product in accordance with label copy that CSI
provides. Such copy may be modified from time to time by delivery of written notice by CSI to
FRESENIUS. CSI shall reimburse FRESENIUS for FRESENIUS’s actual costs of making any label
copy changes and for the cost of any labeling that FRESENIUS is unable to use due to such
label copy changes.
	 
	2.5	 	CSI shall be allowed to market the Product for its specific purposes. The usage and
marketing of the Product for parenteral nutrition is explicitly excluded.
	 
	3.	 	Forecasting; Minimum purchase quantity
	 
	3.1	 	Initial Forecast. Attached hereto under Part B.3 of the Product Schedule is a binding
forecast of the amount of Product that CSI agrees to order during the first twelve (12) month
period of this Agreement (“Initial Binding Forecast”).
	 
	3.2	 	Ongoing Forecasts. On or before the 31st of December and the 30th of
June of each calendar year occurring after the time period covered by the Initial Binding
Forecast, CSI shall submit to FRESENIUS a rolling forecast covering the time period of one
year, broken down on a monthly basis. The first six (6) months of any given Forecast shall be
binding to CSI. The Forecasts concerning this time period cannot be changed as the
forecasting roles on over the months, unless FRESENIUS agrees to such changes in writing. The
succeeding six (6) months of any Forecast are estimations and shall be used by FRESENIUS for
planning purposes only. The forecasts amounts for the second six month period may be changed
by CSI without FRESENIUS’ written consent.
	 
	3.3	 	Failure to Purchase. If CSI fails to submit purchase orders in the amount of a binding
forecast, FRESENIUS shall have the right to demand compensation from CST in the amount
provided for in Part C.6 of the Product Schedule.
	 
	3.4	 	Obligation to Supply. FRESENIUS shall be required to supply the quantity of Product set
forth in the binding portion of any forecast. FRESENIUS shall inform CSI of any
unavailability of capacity it might face in fulfilling CSI’s needs during the non-binding
portion of the rolling forecast.
	 
	4.	 	Orders
	 
	 	 	CST shall submit to FRESENIUS Purchase Orders for its planned requirements of Product not
later than three (3) months prior to the shipment date. Each Purchase Order shall detail
the CSI purchase order number, FRESENIUS product code and product name, CST product code,
and CSI product name as well as the required quantities per delivery date. All Purchase
Orders shall be in writing, and shall be confirmed by FRESENIUS in writing at the latest ten
(10) working days after receipt of each firm purchase order, naming the calendar week of
delivery.

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	5.	 	Quality
	 
	5.1	 	Quality Control. FRESENIUS shall manufacture the Product in accordance with the
Specifications as set forth in Part A of the Product Schedule. FRESENIUS shall comply with
the provisions and requirements of the Quality Agreement with regard to the manufacturing,
testing and supplying of the Product to CSI.
	 
	5.2	 	Permits. FRESENIUS shall maintain at all relevant times governmental permits, licenses and
approvals enabling FRESENIUS lawfully and properly perform its obligations under this
Agreement.
	 
	5.3	 	Raw Materials. The materials which are needed to manufacture the Products shall be tested by
FRESENIUS to ensure that they meet applicable specifications and quality standards as set
forth in the Specifications and the Quality Agreement.
	 
	5.4	 	Responsibilities. Further quality relevant issues and the allocation of the responsibilities
are listed in the Quality Agreement.
	 
	5.5	 	Rejection of Nonconforming Product. CSI shall have a period of thirty (30) days from the
date of its receipt of a shipment of Product to inspect and reject such shipment for
nonconformance with the Specifications. If CSI rejects such shipment, it shall promptly so
notify FRESENIUS and provide to FRESENIUS samples of such shipment for testing. If FRESENIUS
tests such shipment and determines that it did conform to the Specifications, the parties
shall submit samples of such shipment to a mutually acceptable independent laboratory for
testing. If such independent laboratory determines that the shipment conformed to the
Specifications, CSI shall bear all expenses of shipping and testing such shipment samples. If
FRESENIUS or such independent laboratory confirms that such shipment did not meet the
Specifications, FRESENIUS shall replace, at no cost to CSI, that portion of the Product
shipment which does not conform to the Specifications, and shall bear all expenses of shipping
and testing the shipment samples. Any nonconforming portion of any shipment shall be disposed
of as directed by FRESENIUS, at FRESENIUS’ expense.
	 
	6.	 	Price
	 
	6.1	 	Taxes. The Price of the Product is exclusive of value added tax, which, if payable, shall be
borne and paid by CSI against the provision by FRESENIUS of an appropriate VAT invoice. The
Price is payable in the applicable Invoice Currency set forth in Part C.2 of the relevant
Product Schedule.
	 
	6.2	 	Price. The purchase price for the Product shall be the price set forth in Part C.1 of the
Product Schedule. Such price will remain fixed for the Fixed Price Term as provided in Part
C.3 of the Product Schedule. On the First Price Review Date (See Part C.4 of the Product
Schedule) and on each anniversary of such First Price Review Date, the Price will be
renegotiated in good faith. The Product price will be adjusted upwards only if FRESENIUS face
documented increased costs of >3% to manufacture Product due to general inflation
and increasing costs of raw materials, energy, wages or other third party factor reasonably
tied to the manufacture of Product. If the Parties are unable to agree on

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	 	 	a Price for the Products for the following period as of the start of such period, the old
Price shall remain in effect until the Parties agree otherwise in writing.
	 
	7.	 	Invoicing and Payment
	 
	7.1	 	Invoices. FRESENIUS shall issue an invoice to CSI for the applicable Price for all Products
delivered to CSI. The invoice shall contain a reference identifying this Agreement and the
Product Schedule, and shall state FRESENIUS’ registered VAT number.
	 
	7.2	 	Payment, CSI shall pay all invoices in full within thirty (30) days from the date of the
relevant invoice and certificates of the Product, whichever is later, to FRESENIUS as detailed
in Part C.5 of the Product Schedule.
	 
	8.	 	FRESENIUS’ Warranties and Covenants
	 
	8.1	 	Not Adulterated or Misbranded. FRESENIUS represents and warrants to CSI that Product
FRESENIUS delivers to CSI pursuant to this Agreement shall, at the time of delivery, not be
adulterated or misbranded within the meaning of the Act as the Act is constituted and
effective at the time of delivery and will not be an article which may not under the
provisions of Sections 404 and 505 of the Act be introduced into interstate commerce.
	 
	8.2	 	Free From Defects. FRESENIUS further represents and warrants to CSI that Product FRESENIUS
delivers to CSI pursuant to this Agreement shall, at the time of delivery, be free from
defects in material and workmanship and shall be manufactured: (a) in accordance and
conformity with the Specifications; and (b) in compliance with all applicable statutes, laws,
rules or regulations, including those relating to the environment, food or drugs and
occupational health and safety, including, without limitation, those enforced or promulgated
by the FDA (including, without limitation, compliance with cGMPs).
	 
	8.3	 	No Violation of Other Agreements. FRESENIUS further represents and warrants to CSI that
FRESENIUS’s performance of its obligations under this Agreement will not result in a material
violation or breach of any agreement, contract, commitment or obligation to which FRESENIUS is
a party or by which it is bound and will not conflict with or constitute a default under its
Certificate of Incorporation or corporate bylaws.
	 
	8.4	 	Limitation of Liability. In case of breach of pre-contractual, contractual and/or
non-contractual obligations of FRESENIUS, its statutory representative or executives,
including but not limited to defects, delay in delivery or tort, FRESENIUS’ maximum liability
shall, to the extent legally permissible, be limited to a maximum of two and a half Million
United States Dollars (US$2,500,000). FRESENIUS shall not be liable for loss of profit. Such
limitations shall not apply to amounts arising from FRESENIUS’ indemnification obligations to
CSI as outlined in Section 9.1.

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	9.	 	Indemnification
	 
	9.1	 	Indemnification by FRESENIUS. FRESENIUS shall indemnify and hold harmless CSI, its
Affiliates and their respective officers, directors and employees from and against all claims,
causes of action, suits, costs and expenses (including reasonable attorney’s fees), losses or
liabilities of any kind related to this Agreement and asserted by Third Parties to the extent
such arise out of or are attributable to: (a) FRESENIUS’s breach of any representation or
warranty set forth in Article 8; (b) any violation of any proprietary right of any Third Party
relating to FRESENIUS’s manufacturing processes used in the manufacture of Product pursuant to
this Agreement; or (c) any negligent or wrongful act or omission on the part of FRESENIUS, its
employees, agents or representatives.
	 
	9.2	 	Indemnification by CSI. CSI shall indemnify and hold harmless FRESENIUS, its Affiliates and
their respective officers, directors and employees harmless from and against all claims,
causes of action, suits, costs and expenses (including reasonable attorney’s fees), losses or
liabilities of any kind related to this Agreement and asserted by Third Parties to the extent
such arise out of or are attributable to: (a) any violation of any proprietary right of any
Third Party relating to the labeling required by CSI to be used for the Product; and (b) any
negligent or wrongful act or omission on the part of CSI, its employees, agents or
representatives.
	 
	9.3	 	Conditions of Indemnification. If either Party seeks indemnification from the other
hereunder, it shall promptly give written notice to the other Party of any such claim or suit
threatened, made or filed against it which forms the basis for such claim of indemnification
and shall cooperate fully with the other party in the investigation and defense of all such
claims or suits. The indemnifying Party shall have the option to assume the other Party’s
defense in any such claim or suit with counsel of its own choosing. The indemnified Party may
elect to be represented by its own counsel, but at its own expense. No settlement or
compromise that includes any non-monetary provisions shall be binding on an indemnified Party
without its prior written consent, such consent not to be unreasonably withheld or delayed.
	 
	10.	 	Product Recall
	 
	 	 	In the event (a) any Regulatory Authority or other national government authority issues a
request, directive or order that Product be recalled, (b) a court of competent jurisdiction
orders such a recall, or (c) CSI, in its sole discretion, determines that Product should be
recalled, the parties shall take all appropriate corrective actions, and shall cooperate in
any governmental investigations surrounding the recall. Each Party shall inform the other
Party immediately after receiving knowledge of reasons for a product recall. Such notice
shall be provided in accordance with the terms of Article 15. In the event that such recall
results from the breach of FRESENIUS’ express warranties under Article 8, FRESENIUS shall be
responsible for the expenses of the recall. In the event that the recall does not result
from the breach of FRESENIUS’ express warranties under this Agreement, CSI shall be
responsible for the expenses of the recall. For purposes of this Agreement, the expenses of
the recall shall include, but not be limited to, the expenses of notification and
destruction or return of the recalled Product, cost of the recalled Product,

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	 	 	and any costs associated with the distribution of the replacement Product, but shall not
include lost profits of either party.
	 
	11.	 	Intellectual Property
	 
	 	 	The Product itself as well as any improvement to the Product or to elements of the Product
or to the manufacturing process of the Product, patentable or non-patentable, achieved by
FRESENIUS during the Term of this Agreement will be the exclusive property of FRESENIUS.
CSI or any of its Affiliates will have the benefit of a royalty free non-exclusive license
for such exclusive property of FRESENIUS, but only as long as this Agreement is not
terminated by any of the Parties. CSI is not allowed to transfer or utilize the knowledge
gained through the cooperation with FRESENIUS for their other business activities not
related to the Products.
	 
	12.	 	Confidentiality
	 
	12.1	 	Ownership. Except as otherwise provided in this Agreement, any Confidential Information
which is disclosed by or on behalf of a Disclosing Party to the Receiving Party will remain
the property of the Disclosing Party.
	 
	12.2	 	Undertakings. The Receiving Party undertakes

	 	12.2.1	 	to use the Confidential Information solely and exclusively for the purposes of this
Agreement (or such other purpose as is agreed in writing between the Parties at the
time of disclosure), and not to use the Confidential Information for any other purpose
whatsoever, including the development, manufacture, marketing, sale or licensing of any
process or product or any other commercial purpose anywhere in the world, unless the
Parties enter into an agreement specifying otherwise; and
	 
	 	12.2.2	 	to maintain the confidentiality of the Confidential Information and not to disclose
it directly or indirectly to any other company, organization, individual or third
Person, except as expressively permitted; and
	 
	 	12.2.3	 	at the request of the Disclosing Party, to return, delete or destroy all copies of
the Confidential Information, in whatever form it is held.

	12.3	 	Allowed Disclosures. Notwithstanding Section 12.2, the Receiving Party may disclose
Confidential Information to any of its Affiliates, and its and its Affiliate’s directors,
employees and professional advisers who need to know the Confidential Information in order to
fulfill the purpose of this Agreement, provided that the Receiving Party procures that prior
to such disclosure, each such Person to whom Confidential Information is to be disclosed is
made aware of the obligations contained in this Agreement, and adheres to these terms as if it
were a party to this Agreement.
	 
	12.4	 	Required Disclosures. Nothing in Section 12.2 will preclude disclosure of any Confidential
Information required by any governmental, quasi-governmental or regulatory agency or authority
or court entitled by law to disclosure of the same, or which is required by law or the
requirements of a national securities exchange or another similar regulatory body to be
disclosed; provided that the Receiving Party promptly notifies the

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	 	 	Disclosing Party when such requirement to disclose has arisen to enable the Disclosing Party
to seek an appropriate protective order, to make known to the relevant agency, authority,
court or securities exchange the proprietary nature of the Confidential Information, and to
make any applicable claim of confidentiality. The Receiving Party agrees to co-operate in
any action which the Disclosing Party may decide to take. If the Receiving Party is
required to make a disclosure in accordance with this clause, it will only make a disclosure
to the extent to which it is obliged.
	 
	12.5	 	Exclusions. The provisions of Section 12.2 will not apply to any Confidential Information
which the Receiving Party can demonstrate, to the reasonable satisfaction of the Disclosing
Party:

	 	12.5.1	 	was already in the possession of the Receiving Party or any of its Affiliates and at
the Receiving Party’s or any of its Affiliates’ free use and disposal or in the public
domain (through in each case no fault of the Receiving Party or any of its Affiliates
or no breach of this Agreement by the Receiving Party) prior to its disclosure by the
Disclosing Party under this Agreement; or
	 
	 	12.5.2	 	is purchased or otherwise legally acquired by the Receiving Party or any of its
Affiliates at any time from a third Person having and the right to disclose it; or
	 
	 	12.5.3	 	comes into the public domain, otherwise than through the fault of the Receiving Party
or any of its Affiliates; or
	 
	 	12.5.4	 	is independently generated by the Receiving Party or any of its Affiliates without
any recourse or reference to the Confidential Information.

	12.6	 	Survival. The obligations of each Party in this Section will survive for a period of five
(5) years after the date of expiration or termination of this Agreement.
	 
	13.	 	Exclusivity
	 
	 	 	FRESENIUS undertakes to manufacture and supply the Product non-exclusively to CSI, unless
both parties have agreed upon differently in writing in the Product Schedule.
	 
	14.	 	Term and Termination
	 
	14.1	 	Term and Nonrenewable. This Agreement shall become effective at the Effective Date and shall
extend for a period of five (5) years after the Effective Date (“Initial Term”), unless
earlier termination as described in Sections 14.2 and 14.3. This Agreement shall be
automatically extended for subsequent periods of twelve (12) months (“Extension Term(s)”)
unless either Party elects not to renew this Agreement by giving the other Party a written
notice by registered mail twelve (12) months prior to the end of the Initial Term or prior to
the end of any Extension Term.
	 
	14.2	 	Termination by Either Party. In addition to any other provision of this Agreement expressly
providing for termination of this Agreement, this Agreement may be terminated immediately by
either Party upon delivery of written notice to the other Party:

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	 	•	 	in the event of a material breach of this Agreement by the other Party, where such
breach is capable of cure and such breach remains uncured for thirty (30) days after
notice of such breach;
	 
	 	•	 	in the event of a breach of this Agreement by the other Party where such breach is
not capable of cure;
	 
	 	•	 	if the other Party shall file in any court or agency, pursuant to any statute or
regulation of any state or country, a petition in bankruptcy or insolvency or for
reorganization or for an the appointment of a receiver or trustee of such other Party
or of its assets, or if the other Party proposes a written agreement of composition or
extension of its debts, or if the other Party shall be served with an involuntary
petition against it, filed in any insolvency proceeding, or if the other Party shall
propose or be a party to any dissolution or liquidation, or if the other Party shall
make an assignment for the benefit of its creditors;
	 
	 	•	 	if any encumbrance takes possession of any material part of the assets of the other
Party;
	 
	 	•	 	if any distress, execution or other such process is levied or enforced upon or
against any of the material assets of the other Party;
	 
	 	•	 	if the other Party ceases or threatens to cease to carry on the whole or
substantially the whole of its business or that part of its business to which this
Agreement relates.

	14.3	 	Termination by CSI. CSI shall have the right to terminate this Agreement immediately upon
delivery of written notice to FRESENIUS should the FDA fail to approve the Product for resale.
	 
	14.4	 	Obligations on Termination or Expiration. Without prejudice to any other rights or remedies
which either Party may have, upon the termination of this Agreement, howsoever the same
occurs, each Party shall:

	 	•	 	immediately pay to the other Party all undisputed sums which at the date of
termination are due and payable to the other Party under this Agreement; and
	 
	 	•	 	immediately cease all use of any property of the other Party, including any
Intellectual Property Rights of the other Party; and
	 
	 	•	 	within twenty eight (28) days of such termination, at its own expense, return to the
other Party any property of the other Party in its possession, custody or control,
including all Confidential Information of that Party and copies of it.

	14.5	 	Open Purchase Orders. In the event this Agreement is terminated by FRESENIUS pursuant to
Section 14.2, FRESENIUS may terminate or fill, at its option, any open firm purchase orders
for Product. In the event this Agreement is not renewed or is terminated by CSI pursuant to
Section 14.2, CSI may terminate or require FRESENIUS to fill, at CSI’s option, any open firm
purchase orders for Product.

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	14.6	 	Survival. The Parties rights and obligations under Articles 1, 8, 9, 10, 11, 12 and this
Section 14.5 will survive expiration or termination of this Agreement, howsoever the same
occurs.
	 
	15.	 	Notices
	 
	 	 	Any notice, request, demand, waiver, consent, approval or other communication permitted or
required under this Agreement shall be in writing and shall be deemed given only if
delivered by hand, sent by facsimile transmission (with transmission confirmed), or by
internationally recognized express delivery service that maintains records of delivery,
addressed to the Parties at their respective addresses specified in the Quality Agreement or
to such other addresses of which notice shall have been given. Such Notice shall be deemed
to have been given as of the date received if delivered by hand, the date of transmission if
sent by facsimile (with transmission confirmed) or on the second business day after deposit
with an internationally recognized express delivery service. Any notice delivered by
facsimile shall be confirmed by a hard copy delivered as soon as practicable thereafter.
This Section is not intended to govern the day-to-day business communications necessary
between the Parties in performing their obligations under the terms of this Agreement.
	 
	16.	 	General Provisions
	 
	16.1	 	Entire Agreement. This Agreement contains the entire understanding between the parties
hereto with respect to the subject matter and supersedes any and all prior agreements,
understanding and arrangements, whether written or oral, between the parties relating to the
subject matter of this Agreement.
	 
	16.2	 	Amendments and Modifications. No amendments, changes, modifications or alterations of the
terms and conditions of this Agreement shall be binding upon either party hereto unless in
writing and signed by both parties.
	 
	16.3	 	Assignment. This Agreement is personal to FRESENIUS and CSI and neither Party shall be
entitled to assign any of its rights or obligations hereunder to any Third Party without the
express, prior written consent of the other Party; provided, however: (a) Affiliates of a
Party shall not be considered a Third Party; and (b) either party may assign this Agreement,
without consent of the other party, in connection with the transfer, sale or divestiture of
substantially all of its business to which this Agreement pertains or in the event of its
merger or consolidation with another party. Any permitted assignee shall assume all
obligations of its assignor under this Agreement. No assignment shall relieve any Party of
responsibility for the performance of any accrued obligation which such Party then has
hereunder.
	 
	16.4	 	Severability. Both parties hereby expressly state that it is the intention of neither party
to violate any existing rule, law or regulations. If any of the provisions of this Agreement
are held to be void or unenforceable, then such void or unenforceable provisions shall be
replaced by valid and enforceable provisions which will achieve as far as possible the
economic business intentions of the parties.

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	16.5	 	Waivers. No purported waiver of any provision of this Agreement shall be binding unless set
forth in a writing signed by the party to be charged thereby. Any waiver shall be limited to
the circumstance or event specifically referenced in the written waiver document and shall not
be deemed a waiver of any other term of this Agreement or of the same circumstance or event
upon any recurrence thereof.
	 
	16.6	 	Inconsistencies. If there is any inconsistency between a Product Schedule, a Quality
Agreement or between any other Exhibit on the one side and this Agreement on the other, the
terms of this Agreement shall govern, unless it is written expressively in the Exhibit that
the terms (or a single term) of the Exhibit shall govern.
	 
	17.	 	Governing Law
	 
	 	 	This Agreement shall be governed, construed and interpreted in accordance with the laws of
Sweden without reference to its conflict of law provisions and excluding specifically the UN
Convention on the International Sale of Goods.
	 
	18.	 	Arbitration
	 
	18.1	 	Dispute/Initiation. Any dispute, claim or controversy arising out of or relating to this
Agreement, including any action in tort, contract or otherwise, at equity or at law, and any
claims of fraud in the inducement (a “Dispute”), shall be resolved in a manner set forth in
this Article 18. Either party may initiate negotiation proceedings by writing a letter to the
other party setting forth the particulars of the Dispute, the terms of the contract that are
involved and the suggested resolution of the Dispute. If the Dispute is not resolved within
thirty (30) days after delivery of the initial written letter setting forth the particulars of
the Dispute, either party may submit such Dispute to binding arbitration conducted pursuant to
the provisions of this Agreement and the arbitration provisions of the International Chamber
of Commerce (“ICC”) in effect on the Effective Date of this Agreement (“ICC”), unless such ICC
rules are inconsistent with the provisions of this Agreement. Even though the arbitrator(s)
shall apply the ICC rules, the arbitration shall not be conducted through the ICC.
	 
	18.2	 	Selecting Arbitrator(s). The case shall be submitted to a single arbitrator who shall be a
retired judge or an attorney who has practiced business litigation or in the substantive area
of law related to this Agreement for at least ten (10) years. Each party shall submit a list
of three (3) arbitrators to the other party within ten (10) days after the initiating party
has delivered a written notice to the other party demanding arbitration of the Dispute. From
the combined list, the parties shall mutually agree on the arbitrator. Should the parties be
unable to agree on the choice of an arbitrator within thirty (30) days after delivery of the
written notice demanding arbitration, a panel of three (3) arbitrators shall conduct the
arbitration. Each party shall choose one arbitrator within ten (10) after the expiration of
the above thirty (30) day period and the two selected shall choose a third arbitrator within
five (5) days after their appointment.
	 
	18.3	 	Location/Costs. The site of the arbitration shall be in Stockholm, Sweden or such other
location as the parties may mutually agree. The exact location within such metropolitan area
shall be designated by the arbitrator(s). The non-prevailing party shall pay all expenses of
the arbitration proceeding, including the expenses and fees of the parties’

- 12 -

 

	 	 	witnesses and legal counsel and of the arbitrator(s), unless otherwise provided in the
award.
	 
	18.4	 	Discovery/Interim Relief. The arbitrator(s) shall allow the parties to conduct limited
discovery. The arbitration shall be conducted in English. Either party may apply to any
court having jurisdiction hereof seeking injunctive relief so as to maintain the status quo
until such time as the arbitration award is rendered or the Dispute is otherwise resolved.
	 
	18.5	 	Final Award. The arbitration award shall be final and binding upon the parties and may be
entered and enforced at any court having jurisdiction.

THIS SUPPLY AGREEMENT is executed by the authorized representatives of the Parties to be effective
as of the Effective Date set forth on the first page hereof.

	 	 	 

	SIGNED for and on behalf of

	 	SIGNED for and on behalf of
	 
	 	 
	Fresenius Kabi AB

	 	Cardiovascular Systems, Inc.
	 
	 	 
	/s/ Christoph Funke

	 	/s/ James E. Flaherty
	 

	 	 
	Signature

	 	Signature
	 
	Name: Christoph Funke

	 	Name: James E. Flaherty
	Title: Managing Director

	 	Title: Chief Administrative Officer
	 
	 	 
	SIGNED for and on behalf of
	 	 
	 
	 	 
	Fresenius Kabi AB
	 	 
	 
	 	 
	/s/ Anton Gerdenibch
	 	 
	 

	 	 
	Signature
	 	 
	 
	Name: Anton Gerdenibch
	 	 
	Title: Director, CM, Sterile Solutions
	 	 

Exhibit 1: Product Schedule(s)

Exhibit 2: Quality Agreement

- 13 -

 

EXHIBIT 1

Product Schedule

to the SUPPLY AGREEMENT dated 4th day of April 2011 (“the Supply Agreement”), entered
into between:

	(1)	 	Fresenius Kabi AB, Rapsgatan 7, 75324 Uppsala, Sweden
	 
	 	 	(“FRESENIUS”)

and

	(2)	 	Cardiovascular Systems, Inc, 651 Campus Drive, Saint Paul, MN 55112, USA
	 
	 	 	(“CSI”).

This Product Schedule is made effective as of same day as of the Effective Date of the Supply
Agreement (the “Product Schedule Effective Date”), and is subject to all of the terms and
conditions contained in the Supply Agreement. Together, this Product Schedule and the Supply
Agreement form a binding agreement between the parties in relation to the details set out in this
Product Schedule.

The term of this Product Schedule is the same term as the Term of the Supply Agreement. It will
terminate at the time of any termination or non-renewal of the Supply Agreement.

This Product Schedule consists of the following parts:

Part A:      Product Specification

Part B:      Delivery terms and orders

Part C:      Pricing and Payment

1-1

 

PART A: PRODUCT SPECIFICATION

	1.	 	Product:

Injectable lipid emulsion compound in a final dosage form, packaged and labeled with CSI’s
proprietary trademark in a 100mL Excel bag, meeting the Specifications.

	2.	 	Product Specification

The Product Specifications are set forth in the Quality Agreement attached to the Supply Agreement
as Exhibit 2 and its relevant Annex.

1-2

 

PART B: DELIVERY TERMS AND ORDERS

	1.	 	Delivery Term (Incoterms 2010)

CIP upon custom transfer at a named destination in the USA*.

* Destination depends on mode of transport (air freight or ship) and carrier. Destination will be
named prior to each shipment and in the shipping documents.

	2.	 	Packaging, Labeling and Export Documentation Requirements

The regulations of the Quality Agreement attached to the Supply Agreement as Exhibit 2 apply.

	3.	 	Binding Forecast of Product

CSI agrees to order the following amount of Product during the first twelve (12) months of the
Agreement.

[*******]*

 

			
	*	 	Confidential treatment has been requested with respect to certain portions of this
exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.

1-3

 

PART C: PRICING AND PAYMENT

1. Price

	 	 	 

	units ordered / year
	 	Price [USD] per container
	 
	[*******]*
	 	[*******]*

The price calculations are based on following assumptions:

	 	•	 	Price CIP (Incoterms 2010)
	 
	 	•	 	Shipping costs (freight, insurance, custom clearance for export) will be accounted
separately and have to be born by CSI
	 
	 	•	 	The parties will agree in advance on the estimated freight cost and insurance
coverage/cost.
	 
	 	•	 	Exchange rate: 1 USD = 6.5 Swedish Krona (SEK)*
	 
	 	•	 	100% optical control
	 
	 	•	 	batch size >10 000 units
	 
	 	•	 	raw materials and packaging materials prices given by FRESENIUS standard suppliers.
	 
	 	•	 	Product related registration fees (e.g. according to 21 CFR 820) are not included and
have to be born by CSI

* If the exchange rate varies more than 10% the Parties have the right to adjust the Price
accordingly.

	2.	 	Invoice Currency

United States Dollars (USD)

	3.	 	Fixed Price Term

Annually beginning from the 1st of January of each year.

	4.	 	First Price Review Date

1st of September 2011

	5.	 	Payment details

30 days after date of invoice or delivery of certificates of the Product, whichever is later

	6.	 	Compensation in case of CSI’s failure to order the amount of Product specified in binding
forecasts according to Section 3.3 of the Supply Agreement

 

			
	*	 	Confidential treatment has been requested with respect to certain portions of this
exhibit. Omitted portions have been filed separately with the Securities and Exchange
Commission.

1-4

 

If CSI does not submit purchase orders for the full amount of Products set forth in a binding
forecast, CSI has to pay compensation concerning the Product of this Product Schedule as follows:

	a.	 	FRESENIUS’ full price for all work in progress on non-ordered Product, and
	 
	b.	 	FRESENIUS’ direct costs for the labeling materials in stock at the time the product orders
should have been placed and were purchased for the dedicated use in the labeling of the Product.

The compensation under this paragraph 6 is given provided that:

	 	(i)	 	the work in process and the labeling materials were related to Product volumes
which were within CSI`s binding forecast; and
	 
	 	(ii)	 	the work in process and labeling materials cannot reasonably be used for other
purposes by FRESENIUS; and
	 
	 	(iii)	 	CSI is entitled to collect such labeling materials for its own use or sale,
without additional charge.

THIS PRODUCT SCHEDULE IS EXECUTED by the authorized representatives of the Parties as of the date
first written above.

	 	 	 	 	 

	SIGNED for and on behalf of

	 	SIGNED for and on behalf of	 	 
	 
	 	 	 	 
	Fresenius Kabi AB

	 	Cardiovascular Systems, Inc.	 	 
	 
	 	 	 	 
	/s/ Christoph Funke
 

Signature

	 	/s/ James E. Flaherty
 

Signature
	 	 
	 
	 	 	 	 
	Name: Christoph Funke

	 	Name: James E. Flaherty	 	 
	 
	 	 	 	 
	Title: Managing Director

	 	Title: Chief Administrative Officer	 	 
	 
	 	 	 	 
	SIGNED for and on behalf of
	 	 	 	 
	 
	 	 	 	 
	Fresenius Kabi AB
	 	 	 	 
	 
	 	 	 	 
	/s/ Anton Gerdenibch
	 	 	 	 
	Signature
	 	 	 	 
	 
	 	 	 	 
	Name: Anton Gerdenibch
	 	 	 	 
	 
	 	 	 	 
	Title: Director, CM, Sterile Solutions
	 	 	 	 

1-5

 

EXHIBIT 2

Quality Agreement

— Contract Manufacturer Pharmaceuticals —

between

FRESENIUS KABI Uppsala, Rapsgatan 7, S-751 74 Uppsala, Sweden

represented by its management

- hereinafter referred to as “Fresenius Kabi” -

and

CARDIOVASCULAR SYSTEMS INC., 651 Campus Drive, Saint Paul, MN 55112, USA

represented by its management

- hereinafter referred to as “CSI” -

Preamble

This Quality Agreement is intended to regulate pharmaceutical and medical device, quality assurance
and safety issues.

	§ 1	 	 Subject Matter of the Quality Agreement
	 
	(1)	 	FRESENIUS KABI is a manufacturer of pharmaceutical products/medical devices for which CSI has
a marketing authorization.
	 
	(2)	 	FRESENIUS KABI shall manufacture for CSI the products as specified in Appendix 3 to this
Quality Agreement (the “Contractual Products”) pursuant to the terms of a Supply Agreement
entered into between FRESENIUS KABI and CSI, dated April 4, 2011 (the “Supply Agreement”).
	 
	(3)	 	FRESENIUS KABI is subject to monitoring by the competent national authority. FRESENIUS KABI
has a manufacturing authorization according to the respective legislation.
	 
	§ 2	 	 Obligations and Responsibilities
	 
	(1)	 	FRESENIUS KABI shall manufacture and release the Contractual Products based on the current
registration and specification as specified in the Appendix 3.
	 
	(2)	 	FRESENIUS KABI shall comply with any recognized pharmaceutical and medical device rules and
applicable legal provisions with regard to the manufacture of the

2-1

 

	 	 	Contractual Products. This includes especially the requirements of the EU and US Good
Manufacturing Practices and the applicable Pharmacopoeias in their actual version.
	 
	(3)	 	Any additional request by FRESENIUS KABI or CSI that special instructions or guidelines which
are not covered by the generally accepted instructions and guidelines are to be observed for
the manufacture of certain Contractual Products must be set down and executed by the parties
in writing.
	 
	(4)	 	Both parties will strictly observe the detailed pharmaceutical and medical device
responsibilities which are specified in Appendix 1 (“Responsibilities”).
	 
	(5)	 	FRESENIUS KABI and CSI appoint Contact Persons as named in Appendix 2 (“Contact Persons”).
	 
	(6)	 	CSI may perform audits by itself or delegate the audit to external experts at the
manufacturing site of FRESENIUS KARI after having agreed on a date with FRESENIUS KABI. The
audits will cover processes and facilities related to the Contractual Products including the
Quality System only.
	 
	(7)	 	Under no circumstances must any other products which may present a potential hazard to the
contractual products, such as beta-lactam and cephalosporin antibiotics, certain potent
hormones, cytotoxic compounds, highly potent drugs, biological preparations or
non-pharmaceutical chemicals, be manufactured, processed, or packaged with the same production
equipment used for CSI product(s).
	 
	§ 3	 	 Final Provision
	 
	(1)	 	The contract comes into force after signature of the contractual parties. Term of this
contract shall be the same as the Supply Agreement. This contract shall renewal upon renewal
of the Supply Agreement and shall terminate upon termination of the Supply Agreement. It is
understood that FRESENIUS KABI’s obligation pursuant to the paragraphs in the Appendix 1
“Retaining of batch related Documentation”, “Retaining of analytical data” and “Retaining of
samples” shall survive the formal end of the contract period.
	 
	(2)	 	The General Provisions of Article 16, the Governing Law of Article 17 and the Arbitration
Provisions of Article 18 of the Supply Agreement shall apply to this contract.

2-2

 

Appendices

Appendix 1   Responsibilities

Appendix 2   Contact Persons

Appendix 3   Contractual Products and Specification

	 	 	 

	/s/ Christoph Funke
	 	/s/ Alexander Stoll
	 
	 	 
	Fresenius Kabi Uppsala
	 	Fresenius Kabi Uppsala
	Mr. Christoph Funke
	 	Dr. Alexander Stoll
	Managing Director
	 	Head of Quality Management

	 	 	 

	/s/ James E. Flaherty
	 	/s/ Jim Murray
	 
	 	 
	CSI
	 	CSI
	Jim Flaherty
	 	Jim Murray
	Chief Administrative Officer
	 	Director, Quality Assurance and
	 
	 	Supply Chain

2-3

 

Responsibilities: Contract Manufacturing Pharmaceuticals

Abbreviations used in the different chapters:

	 	 	 
	Term	 	Definition
	Annual Product 

Review

	 	Annual review of quality standards and batch documentation to determine the need
for Specification and Manufacturing changes, as determined by EU Annex 18, 2.5
and/or CFR 211.180(e)
	 
	 	 
	BOM

	 	Bill of Materials
	 
	 	 
	CFR

	 	U.S. Code of Federal Regulations
	 
	 	 
	cGMP

	 	Current Good Manufacturing Practices
	 
	 	 
	CMC

	 	Chemistry, Manufacturing and Controls
	 
	 	 
	CMO

	 	Contract Manufacturing Organization
	 
	 	 
	Device History 

Record (DHR)

	 	A compilation of records containing the product history of a finished device
	 
	 	 
	Device Master 

Record (DMR)

	 	A compilation of records containing the procedures and specification for a
finished device
	 
	 	 
	Manufacturing

	 	The processes of producing and filling of Drug Product into final container
closure system
	 
	 	 
	NDA

	 	New Drug Application
	 
	 	 
	OOS

	 	Out of Specification
	 
	 	 
	Packaging

	 	All operations, including filling and labeling, which a bulk product has to
undergo in order to become a finished product.
	 
	 	 
	Primary Packaging 

Material

	 	Material employed in the packaging of the PRODUCT that comes in direct contact
with the product.
	 
	 	 
	Printed Components

	 	Any component that is controlled for artwork and text including, but not limited
to, the Package insert, bag film, carton labels, and cartons.
	 
	 	 
	PRODUCT

	 	Formulation of Intralipid 10% (ViperSlide®) as detailed in Appendix 3.
	 
	 	 
	QA

	 	Quality Assurance
	 
	 	 
	QC

	 	Quality Control
	 
	 	 
	Regulatory 

Authorities

	 	The U. S. Food and Drug Administration and its successors (the “FDA”) and
similar governmental agencies outside the United States and throughout the world
that are responsible for granting manufacturing, marketing, price and/or
reimbursement price authorizations and includes applicable national,
supra national (e.g. the European Commission or the Council of the European
Union), state or local regulatory authorities, departments, bureaus,
commissions, councils or other governmental entities that have jurisdiction over
the PRODUCT, whether the development, manufacture, handling, storage,
transportation, destruction, or otherwise.
	 
	 	 
	Reference Samples

	 	Representative reserve of each batch of API or drug product stored to meet CFR
211.170 and/or EU Annex 18, 11.7 requirements.
	 
	 	 
	SOP

	 	Standard Operating Procedure
	 
	 	 
	Secondary Packaging 

Material

	 	Material employed in the packaging of the PRODUCT that does not come in direct
contact with the product.

2-4

 

	 	 	 
	Term	 	Definition
	Specification

	 	A set of criteria to which a material must conform to be considered acceptable
for its intended use
	 
	 	 
	USP

	 	United States Pharmacopeia

2-5

 

	 	 	 	 	 	 	 
	 	 	 	 	 	 	FRESENIUS
	 	 	RESPONSIBILITIES	 	CSI	 	KABI
	 
	1

	 	General	 	 	 	 
	 
	 	 	 	 	 	 
	1.1

	 	Both parties are
responsible for
ensuring that the
terms of the Quality
Agreement are
complied with and
performed in
accordance with
cGMP.
	 	X
	 	X
	 
	 	 	 	 	 	 
	1.2

	 	This Quality
Agreement may be
revised on an
“as-needed” basis or
whenever the
Manufacturing
Agreement is
amended. All
changes in the
Quality Agreement
must be documented,
reviewed and
approved by both
parties.
	 	X
	 	X
	 
	 	 	 	 	 	 
	1.3

	 	The parties will
attempt to resolve
disputes or
conflicts in a
timely and equitable
manner and in
compliance with all
applicable quality
and regulatory
requirements.
Resolutions will be
documented and
signed by both
parties.
	 	X
	 	X
	 
	 	 	 	 	 	 
	1.4

	 	CSI is responsible
for marketing
authorization and
import licenses for
PRODUCT.
	 	X	 	 
	 
	 	 	 	 	 	 
	2

	 	Compliance Requirements	 	 	 	 
	 
	 	 	 	 	 	 
	2.1

	 	Regulatory	 	 	 	 
	 
	 	 	 	 	 	 
	2.1.1

	 	FRESENIUS KABI will
Manufacture, test,
Package, and hold
the PRODUCT in
accordance with
cGMP, all applicable
requirements of the
FDA and/or other
Regulatory
Authorities.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.1.2

	 	FRESENIUS KABI will
Manufacture and
Package the PRODUCT
in strict adherence
to the approved drug
application.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.1.3

	 	CSI shall maintain
regulatory filings
for the PRODUCT and
allow visibility of
applicable
information to
FRESENIUS KABI.
FRESINIUS KABI shall
maintain the
regulatory filings
for Intralipid 10%
and allow visibility
of applicable
information to CSI
as required.
	 	X
	 	X
	 
	 	 	 	 	 	 
	2.1.4

	 	FRESENIUS KABI will
provide to CSI a
letter of access to
the Intralipid 10%
NDA.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.1.5

	 	FRESENIUS KABI will
permit, at CSI’s
expense, one
escorted audit by
CSI and/or its
designee(s) (two (2)
auditors, two (2)
days free of charge)
within any twelve
month interval, or
at any time in the
event of a
compliance issue, of
all relevant
premises,
procedures, and
documentation.
	 	 	 	X
	 
	 	 	 	 	 	 

2-6

 

	 	 	 	 	 	 	 
	 	 	 	 	 	 	FRESENIUS
	 	 	RESPONSIBILITIES	 	CSI	 	KABI
	2.1.6

	 	FRESENIUS KABI will
not subcontract any
Manufacturing,
Packaging, or
testing to a third
party without prior
written agreement by
CSI.
Sub-contractors will
meet FRESENIUS
KABI’s requirements
for approved
vendors. If CSI
requests the use of
a non-FRESENIUS KABI
approved
subcontractor, CSI
will be responsible
for the
qualification of
that subcontractor.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.1.7

	 	FRESENIUS KABI will
permit inspection by
Regulatory
Authorities. CSI
representatives will
be allowed on-site
during inspections
specific to the
manufacture of
PRODUCT at FRESENIUS
KABI under the
reasonable
discretion of
FRESENIUS KABI. CSI
personnel
interactions with
the inspector(s)
shall be under
direction of the
FRESENIUS KABI agent
in charge.
FRESENIUS KABI
personnel will
address all
Manufacturing
questions.
	 	X
	 	X
	 
	 	 	 	 	 	 
	2.1.8

	 	Each party shall
notify the other
party of any
applicable
inspections by
Regulatory
Authorities, Form
483s, Warning
Letters or other
communications
relating to the
PRODUCT from
Regulatory
Authorities within
two (2) business
days after receipt
of such
communications.
Each party will have
opportunity to
review and comment
on subsequent
responses(s) if they
would have an impact
on the PRODUCT.
	 	X
	 	X
	 
	 	 	 	 	 	 
	2.1.9

	 	Upon request,
FRESENIUS KABI will
provide copies to
CSI of any FDA Form
483, Establishment
Inspection Report,
or other similar
Regulatory Authority
notice normally
available through
Freedom of
Information,
redacted as
necessary where the
PRODUCT is
specifically
mentioned or
directly impacted.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.1.10

	 	In the event of an
inspection of CSI by
any Regulatory
Authority, FRESENIUS
KABI shall make
every effort to make
available to the
Regulatory Authority
any production,
validation,
stability, or
testing records
requested within two
(2) business days of
the request,
according to the
inspection policy of
FRESENIUS KABI.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.1.11

	 	FRESENIUS KABI will
notify CSI within
one (1) business day
of receipt of any
information which
could result in any
event which could
lead to regulatory
action.
	 	 	 	X
	 
	 	 	 	 	 	 

2-7

 

	 	 	 	 	 	 	 
	 	 	 	 	 	 	FRESENIUS
	 	 	RESPONSIBILITIES	 	CSI	 	KABI
	2.1.12

	 	FRESENIUS KABI shall
notify CSI prior to
submitting
PRODUCT-specific
responses,
request(s) for
PRODUCT sample(s),
and batch records to
the Regulatory
Authorities for
PRODUCT supplied to
CSI. FRESENIUS KABI
will respond within
a reasonable
timeframe to
questions that may
arise from
Regulatory
Authorities.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.1.13

	 	FRESENIUS KABI shall
complete and provide
a copy of the Annual
Product Review to
CSI, per
21CFR211.180(e).
FRESENIUS KABI will
assess trending and
confirm the process
is under a state of
control. Any
changes will be
managed through
Change Control (see
Section 2.5)
	 	 	 	X
	 
	 	 	 	 	 	 
	2.1.14

	 	Each party
represents that it
is not debarred
under the U.S.
Generic Drug
Enforcement Act of
1992 or employs or
uses the services of
any individual who
is debarred or who
has engaged in
activities that
could lead to being
debarred.
	 	X
	 	X
	 
	 	 	 	 	 	 
	2.1.15

	 	FRESENIUS KABI will
conduct and maintain
operations in
compliance with
current applicable
environmental and
occupational health
and safety laws and
regulations.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.1.16

	 	FRESENIUS KABI will
document,
investigate, and
resolve deviations
from approved
Manufacturing
instructions,
testing
instructions, and/or
Specifications. All
deviations shall be
recorded and
justified. Copies
in local Swedish
language may be
provided to CSI of
all deviations
related to PRODUCT
upon CSI request.
FRESENIUS KABI will
notify and supply an
English summary to
CSI, before batch
release, of all
major and critical
deviation. CSI will
approve major
deviations
assessments prior to
batch release.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.1.17

	 	FRESENIUS KABI shall
maintain all
documentation for
excipients and
PRODUCT
Manufacturing and
Packaging processes
as per current
applicable
regulations.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.1.18

	 	FRESENIUS KABI will
conduct stability
testing according to
the ICH guidelines
and the protocol.
All PRODUCT related
documentation
including Product
Stability Monitoring
as filed in the
regulatory
submission will be
made available to
CSI for inspection
upon request.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.2
 	 	Complaints — Product Quality and Adverse Drug Experience

2-8

 

	 	 	 	 	 	 	 
	 	 	 	 	 	 	FRESENIUS
	 	 	RESPONSIBILITIES	 	CSI	 	KABI
	2.2.1

	 	CSI will maintain
the collection,
logging, and
resolution of
complaints and
adverse drug
experiences. CSI
will notify
FRESENIUS KBI of any
complaint or ADR
where the quality of
PRODUCT is
questioned.
	 	X	 	 
	 
	 	 	 	 	 	 
	2.2.2

	 	CSI shall
investigate and
track any adverse
events it receives.
	 	X	 	 
	 
	 	 	 	 	 	 
	2.2.3

	 	FRESENIUS KABI
agrees to transmit
to CSI any reports
of unexpected side
effects or similar
problems associated
with the PRODUCT or
Intralipid 10%.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.2.4

	 	CSI shall
investigate and
track any complaints
it receives.
FRESENIUS KABI will
forward all PRODUCT
complaint reports to
CSI within two (2)
business days after
receipt by FRESENIUS
KABI. CSI will
investigate,
resolve, file, and
track all complaint
reports per CSI
SOPs. FRESENIUS
KABI will use
commercially
reasonable efforts
to report the
findings of the
investigation to CSI
within 60 calendar
days of
notification. CSI
will be responsible
for customer
response
communications.
Both parties shall
agree upon follow up
corrective action.
	 	X
	 	X
	 
	 	 	 	 	 	 
	2.3

	 	Product Recalls	 	 	 	 
	 
	 	 	 	 	 	 
	2.3.1

	 	In the event that
either party
determines that the
PRODUCT violates
applicable laws,
regulations, agreed
upon Specifications,
or is deemed
unacceptable for
some other reason,
FRESENIUS KABI and
CSI must notify each
other within one (1)
business day of such
determination and
meet within two (2)
business days of
such determination.
	 	X
	 	X
	 
	 	 	 	 	 	 
	2.3.2

	 	CSI will make the
decision to initiate
a recall of the
PRODUCT.
	 	X	 	 
	 
	 	 	 	 	 	 
	2.3.3

	 	CSI will notify the
appropriate
Regulatory
Authorities in the
event of a recall.
	 	X	 	 
	 
	 	 	 	 	 	 
	2.3.4

	 	FRESENIUS KABI will
investigate PRODUCT
issues, using the
appropriate
procedures, to the
extent that the
issue relates to or
affects the PRODUCT
as it is
Manufactured at
FRESENIUS KABI.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.3.5

	 	CSI will manage
recalls with
assistance from
FRESENIUS KABI as
requested.
	 	X
	 	X
	 
	 	 	 	 	 	 
	2.3.6

	 	CSI will be
responsible for
reconciliation of
returned PRODUCT
with assistance from
FRESENIUS KABI as
required.
	 	X
	 	X
	 
	 	 	 	 	 	 
	2.4	 	Responsibility to Authorities
	 
	 	 	 	 	 	 
	2.4.1

	 	CSI will liaise with
Regulatory
Authorities on
PRODUCT inquiries
and adverse events.
	 	X	 	 

2-9

 

	 	 	 	 	 	 	 
	 	 	 	 	 	 	FRESENIUS
	 	 	RESPONSIBILITIES	 	CSI	 	KABI
	2.4.2

	 	FRESENIUS KABI will
maintain
safety/hazard and
handling data on
excipients and the
PRODUCT.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.5

	 	Change Control	 	 	 	 
	 
	 	 	 	 	 	 
	2.5.1

	 	Change Control for
the PRODUCT will be
administered through
FRESENIUS KABI’s
Change Control
system.
Changes subject to
Change Control
(“Changes”) include,
but are not limited
to, the
Manufacturing and
Packaging processes,
the cleaning
processes, process
equipment,
facilities,
utilities,
Specifications, and
analytical test
methods.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.5.2

	 	All major Changes
proposed by
FRESENIUS KABI for
Intralipid 10% in
bags will be
forwarded to the CSI
QA contact for
information as soon
as practicable.
FRESENIUS KABI
decision will be
final on changes
that effect
Intralipid 10%
registrations.
CSI’s decision will
be final on changes
that affect the
PRODUCT
registrations.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.5.3

	 	All Changes proposed
by CSI will be
forwarded to the QA
contact at FRESENIUS
KABI’s Manufacturing
site using CSI
internal procedures
for Change Control.
	 	X	 	 
	 
	 	 	 	 	 	 
	2.5.4

	 	CSI shall obtain all
necessary and
appropriate
regulatory and
quality approvals
prior to authorizing
any Change in a
timely manner as
required.
	 	X	 	 
	 
	 	 	 	 	 	 
	2.5.5

	 	Upon approval by CSI
(and within the
ability of FRESENIUS
KABI to do so),
FRESENIUS KABI will
initiate the Changes
as defined by
internal FRESENIUS
KABI SOP’s. All
Change Control
documentation will
be available to CSI
upon request in
local Swedish
language or English
summary. CSI will
receive final copies
of all updated
documents in local
Swedish language
upon request.
FRESENIUS KABI shall
obtain and maintain
all necessary
regulatory and
quality approvals as
required by
FRESENIUS KABI in
connection with such
Changes.
	 	 	 	X
	 
	 	 	 	 	 	 
	2.5.6

	 	Formatting changes,
and other
non-technical
changes, to master
records, analytical
test methods or
Specifications will
not require prior
approval by CSI.
Changes to methods
and/or
Specifications for
consistency with USP
or other compendia
will not require
prior approval by
CSI.
	 	 	 	X
	 
	 	 	 	 	 	 
	3	 	PRODUCT MANUFACTURING
	 
	 	 	 	 	 	 
	3.1	 	Excipient and Raw Material Handling

2-10

 

	 	 	 	 	 	 	 
	 	 	 	 	 	 	FRESENIUS
	 	 	RESPONSIBILITIES	 	CSI	 	KABI
	3.1.1

	 	FRESENIUS KABI will complete qualification,
procurement, inspection, storage, sampling,
testing, and release of excipients, and raw
materials used in the Manufacture of the PRODUCT.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.1.2

	 	FRESENIUS KABI has established validated test
methods for all excipient testing. In the event
new validations are required, FRESENIUS KABI will
draft the test method validation protocol and
execute the protocol following CSI ‘s approval for
PRODUCT specific testing. CSI will review all
associated data and approve the final reports that
are generated from the validation.
	 	X
	 	X
	 
	 	 	 	 	 	 
	3.1.3

	 	FRESENIUS KABI will follow written procedures
describing the identification, quarantine,
handling, sampling, testing and approval or
rejection of excipients and raw materials.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.1.4

	 	FRESENIUS KABI will only use approved raw material
and excipient manufacturers, distributors, and
suppliers. CSI will be responsible for approval
of all such suppliers specified by CSI. If CSI
adds, deletes, or changes a
manufacturer/distributor/supplier, CSI will notify
FRESENIUS KABI and FRESENIUS KABI will issue a
Change Control request prior to implementing the
change. CSI will provide an audit of all vendors
that are not also approved by FRESENIUS KABI. Any
changes made to the manufacturer, distributor,
and/or supplier of the raw materials will not
require a prompt revision of the Quality
Agreement. They will be incorporated on the next
revision of the Quality Agreement.
	 	X
	 	X
	 
	 	 	 	 	 	 
	3.1.5

	 	FRESENIUS KABI will use reasonable efforts to
obtain material that conforms to agreed-upon
Specifications. If the primary supply source
becomes unavailable, CSI will assist FRESENIUS
KABI with identifying a new source. Auditing of
vendors is the responsibility of the party who
sources the material.
	 	X
	 	X
	 
	 	 	 	 	 	 
	3.1.6

	 	FRESENIUS KABI will qualify vendors per FRESENIUS
KABI SOPs. FRESENIUS KABI shall have sufficient
documentation in place to justify any reduced
sampling and testing.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.1.7

	 	FRESENIUS KABI will retain Reference Samples of
excipients, including samples for periodic
re-tests, for one (1) year beyond expiry of last
lot of PRODUCT.
	 	 	 	X

2-11

 

	 	 	 	 	 	 	 
	 	 	 	 	 	 	FRESENIUS
	 	 	RESPONSIBILITIES	 	CSI	 	KABI
	3.1.8

	 	FRESENIUS KABI shall certify that raw materials
and processes are Transmissible Spongiform
Encephalopathy and Bovine Spongiform
Encephalopathy free.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.2

	 	Validation	 	 	 	 
	 
	 	 	 	 	 	 
	3.2.1

	 	FRESENIUS KABI will perform and maintain all
validation including but not limited to: process,
analytical method, cleaning, computer, Packaging,
and sanitization. Changes to validated systems
are subject to Change Control (see Section 2.5).
	 	 	 	X
	 
	 	 	 	 	 	 
	3.3

	 	Maintenance and Calibration	 	 	 	 
	 
	 	 	 	 	 	 
	3.3.1

	 	FRESENIUS KABI will complete all equipment and
instrument maintenance and calibration.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.4

	 	Manufacturing Documentation	 	 	 	 
	 
	 	 	 	 	 	 
	3.4.1

	 	FRESENIUS KABI will maintain the batch
identification system for the PRODUCT Manufactured
by FRESENIUS KABI (i.e. batch number assignment)
and ensure that unique batch numbers are used for
each batch of the PRODUCT.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.4.2

	 	FRESENIUS KABI will compile the BOM for PRODUCT
Manufacturing with CSI’s final approval.
	 	X
	 	X
	 
	 	 	 	 	 	 
	3.4.3

	 	FRESENIUS KABI will maintain all batch records and
associated PRODUCT documentation for a minimum of
one year beyond expiry date of the PRODUCT.
FRESENIUS KABI shall keep validation batch
production and testing records permanently.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.4.4

	 	FRESENIUS KABI will ensure executed batch records
contain the following information to meet Device
History Record (DHR) requirements.
• Dates of manufacture;

• Quantity manufactured;

• Quantity released for distribution;

• Acceptance records which
demonstrate the device
is manufactured in accordance with the DMR;

• The primary identification
label and labeling
used for each production unit; and

• Any identification(s) and control
number(s) used. 

	 	 	 	X
	 
	 	 	 	 	 	 
	3.4.5

	 	FRESENIUS KABI will draft and approve master
Manufacturing batch records.
	 	 	 	X

2-12

 

	 	 	 	 	 	 	 
	 	 	 	 	 	 	FRESENIUS
	 	 	RESPONSIBILITIES	 	CSI	 	KABI
	3.4.6

	 	FRESENIUS KABI shall Manufacture the PRODUCT in
accordance with principles of cGMP as described by
the Regulatory Authority appropriate for the type
of PRODUCT.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.4.7

	 	FRESENIUS KABI shall assure that the PRODUCT is
Manufactured, Packaged, held, labeled, and tested
according to FRESENIUS KABI’s procedures and batch
records and fulfills the PRODUCT Specification.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.5

	 	Packaging of the PRODUCT	 	 	 	 
	 
	 	 	 	 	 	 
	3.5.1

	 	FRESENIUS KABI will complete qualification,
procurement, incoming inspection, storage,
sampling, testing, and release of Primary and
Secondary Packaging Materials and Printed
Components according to approved Specifications.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.5.2

	 	FRESENIUS KABI will follow written procedures
describing the identification, quarantine,
handling, sampling, testing and approval or
rejection of the PRODUCT, Printed Components, and
Primary and Secondary Packaging Materials.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.5.3

	 	FRESENIUS KABI will qualify Packaging vendors per
FRESENIUS KABI SOPs. FRESENIUS KABI shall have
sufficient documentation in place to justify any
reduced sampling and testing. FRESENIUS KABI
will only use approved Packaging manufacturers,
distributors, and suppliers.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.5.4

	 	FRESENIUS KABI will ensure that the PRODUCT is
Packaged, inspected, and held according to
FRESENIUS KABI’ s procedures and Packaging
instructions, and fulfills the PRODUCT
Specification.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.5.5

	 	FRESENIUS KABI will control Specifications for
Primary and Secondary Packaging Materials and
provide reference copies to CSI.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.5.6

	 	CSI will control content including artwork and
labeling text Specifications of Printed
Components.
	 	X	 	 
	 
	 	 	 	 	 	 
	3.5.7

	 	FRESENIUS KABI will retain samples of Primary
Packaging Materials for one year past expiry of
last lot of the PRODUCT contained in the Primary
Packaging Materials.
	 	 	 	X

2-13

 

	 	 	 	 	 	 	 
	 	 	 	 	 	 	FRESENIUS
	 	 	RESPONSIBILITIES	 	CSI	 	KABI
	3.5.8

	 	FRESENIUS KABI will complete reconciliation of
Primary Packaging Material and Printed Components
after all critical process steps. FRESENIUS KABI
will perform component accountability per its
approved SOPs. Any reconciliation outside of
pre-established limits must be investigated and a
copy of the investigation included in the
reconciliation.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.5.9

	 	FRESENIUS KABI will create and maintain the BOM
for PRODUCT Packaging and provide copies of the
BOM to CSI.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.5.10

	 	FRESENIUS KABI will create and maintain master
Packaging instructions in accordance with the
PRODUCT Specifications and/or CSI instructions and
provide official copies to CSI when the documents
are revised.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.5.11

	 	FRESENIUS KABI will maintain all executed master
Packaging instructions and associated PRODUCT
documentation for a minimum of one year beyond
expiry date of the PRODUCT. FRESENIUS KABI, if
applicable, shall keep validation batch production
records permanently.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.5.12

	 	FRESENIUS KABI will provide CSI with customer
samples of Printed Components, as requested.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.6

	 	QC Testing of the PRODUCT	 	 	 	 
	 
	 	 	 	 	 	 
	3.6.1

	 	FRESENIUS KABI will generate and maintain the
PRODUCT sampling plan and sample the PRODUCT
according to the approved sampling plan.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.6.2

	 	FRESENIUS KABI has established validated test
methods for PRODUCT. In case of need for new
validations to perform FRESENIUS KABI will draft
the test method validation protocol and execute
the protocol following CSI ‘s approval. CSI will
review all associated data and approve the final
reports that are generated from the validation.
	 	X
	 	X
	 
	 	 	 	 	 	 
	3.6.3

	 	FRESENIUS KABI will participate in test method
transfers if applicable (ref 3.6.2) and test
method validations as applicable. All method
transfers and validations shall be performed
according to a CSI approved protocol, which shall
include acceptance criteria.
	 	X
	 	X
	 
	 	 	 	 	 	 
	3.6.4

	 	FRESENIUS KABI will complete in-process and final
analysis of the PRODUCT per approved test methods.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.6.5

	 	FRESENIUS KABI will complete QC equipment
instrument maintenance and calibration.
	 	 	 	X

2-14

 

	 	 	 	 	 	 	 
	 	 	 	 	 	 	FRESENIUS
	 	 	RESPONSIBILITIES	 	CSI	 	KABI
	3.6.6

	 	CSI will provide FRESENIUS KABI with the PRODUCT
final release and stability Specification.
	 	X	 	 
	 
	 	 	 	 	 	 
	 

	 	FRESENIUS KABI will generate the Certificate of
Analysis (“CofA”) and the Certificate of
Conformity (CofC) per approved PRODUCT
Specification. Minimally the CofA will include
the following:	 	 	 	 
	3.6.7

	 	• PRODUCT name and strength

• Item number

• Batch Number

• Date of Manufacture

• Expiry Date

• Test, Specification, and Result

• FRESENIUS KABI Quality Signature
Minimally the CofC will include the following:

• Statement of conformance

• FRESENIUS KABI Quality Signature

	 	 	 	X
	 
	 	 	 	 	 	 
	3.6.8

	 	FRESENIUS KABI will store and retain raw data and
reports in accordance with cGMP and internal
procedures. Raw data will be accessible for
on-site review within a reasonable timeframe.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.6.9

	 	FRESENIUS KABI will qualify contract test
laboratories per FRESENIUS KABI SOPs, if required.
If the contract test laboratory is requested by
CSI and not a FRESENIUS KABI approved contract
test laboratory, CSI will be responsible for
qualification of the contract test laboratory.
	 	X
	 	X
	 
	 	 	 	 	 	 
	3.6.10

	 	FRESENIUS KABI will retain Retention Samples of
PRODUCT according to FRESENIUS KABI procedures,
for one (1) year beyond expiry date of PRODUCT.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.6.11

	 	FRESENIUS KABI will complete analysis of final
PRODUCT by Quality Control per approved methods.
	 	 	 	X
	 
	 	 	 	 	 	 
	3.6.12

	 	FRESENIUS KABI will supply reference and impurity
standards fully qualified to Compendial Standards
(as appropriate) for use in testing of the active
ingredient of the API and commercial Drug Product.
	 	 	 	X
	 
	 	 	 	 	 	 
	4

	 	STORAGE AND TRANSPORTATION OF THE PRODUCT AND WASTE DISPOSAL	 	 	 	 
	 
	 	 	 	 	 	 
	4.1

	 	CSI and FRESENIUS KABI will store the PRODUCT
according to labeled storage conditions.
	 	X
	 	X
	 
	 	 	 	 	 	 
	4.2

	 	CSI will be responsible for shipping qualification.
	 	X	 	 
	 
	 	 	 	 	 	 
	4.3

	 	FRESENIUS KABI shall package the PRODUCT per
FRESENIUS KABI’s validated procedures and transfer
the product to CSI ‘s qualified shipper.
	 	 	 	X

2-15

 

	 	 	 	 	 	 	 
	 	 	 	 	 	 	FRESENIUS
	 	 	RESPONSIBILITIES	 	CSI	 	KABI
	4.4

	 	CSI will be responsible for arrival of the PRODUCT
at the final destination free of damage and
contamination.
	 	X	 	 
	 
	 	 	 	 	 	 
	4.5

	 	FRESENIUS KABI will arrange for transportation of
the PRODUCT to CSI or a third party designated by
CSI.
	 	 	 	X
	 
	 	 	 	 	 	 
	4.6

	 	FRESENIUS KABI will dispose of waste and
rejected/non conforming PRODUCT. FRESENIUS KABI
may discard the PRODUCT only after final
disposition of the PRODUCT by CSI.
	 	 	 	X
	 
	 	 	 	 	 	 
	5

	 	RELEASE OF THE FINISHED PRODUCT	 	 	 	 
	 
	 	 	 	 	 	 
	5.1

	 	FRESENIUS KABI will complete 100% inspection of
the PRODUCT.
	 	 	 	X
	 
	 	 	 	 	 	 
	5.2

	 	FRESENIUS KABI will complete the executed batch
record and associated PRODUCT documentation
review, and disposition the batch.
	 	 	 	X
	 
	 	 	 	 	 	 
	5.3

	 	In the event FRESENIUS KABI rejection of PRODUCT,
CSI may not alter the disposition.
	 	X
	 	X
	 
	 	 	 	 	 	 
	 

	 	For each lot, FRESENIUS KABI will minimally make
available to CSI the following batch specific
documentation:	 	 	 	 
	5.4

	 	• Major Deviations and an
English summary of the
investigation reports

• QA disposition as part of CoC

• CofC

	 	 	 	X
	 
	 	 	 	 	 	 
	5.5

	 	FRESENIUS KABI will provide the required
documentation for CSI review upon completion of
batch disposition and release with a target of
thirty (30) calendar days of batch Manufacture.
	 	 	 	X
	 
	 	 	 	 	 	 
	5.6

	 	CSI will complete its batch record review and
provide final disposition notification in case of
major deviations that need CSI approval to
FRESENIUS KABI within ten (10) business days upon
receipt of required documentation from FRESENIUS
KABI. Batches without major deviations will be
directly shipped upon release by FRESENIUS KABI.
	 	X	 	 
	 
	 	 	 	 	 	 
	5.7

	 	In the event that after the release of the PRODUCT
either party becomes aware that the PRODUCT may
have a non-conformity that may affect its fitness
for use, such party shall notify the other party
within two (2) business days after it becomes
aware.
	 	X
	 	X
	 
	 	 	 	 	 	 
	5.8

	 	CSI will follow internal requirements to establish
appropriate batch record review requirements after
a minimum of three (3), complete FRESENIUS KABI
batch record reviews.
	 	X	 	 

2-16

 

	 	 	 	 	 	 	 
	 	 	 	 	 	 	FRESENIUS
	 	 	RESPONSIBILITIES	 	CSI	 	KABI
	6

	 	DOCUMENTATION	 	 	 	 
	 
	 	 	 	 	 	 
	6.1

	 	FRESENIUS KABI shall maintain all master formulas,
PRODUCT Specifications, BOM for Manufacturing the
PRODUCT, master batch records, executed batch
records, Packaging instructions, Specifications,
and validation packages per FRESENIUS KABI’s
procedures and in accordance with cGMP.
	 	 	 	X
	 
	 	 	 	 	 	 
	6.2

	 	Batch records shall be kept for a minimum of 5
years by FRESENIUS KABI. Prior to batch record
destruction for PRODUCT by FRESENIUS KABI, CSI
shall notify FRESENIUS KABI in case of transfer of
such records to CSI for storage.
	 	 	 	X
	 
	 	 	 	 	 	 
	7

	 	MEDICAL DEVICE REQUIREMENTS	 	 	 	 
	 
	 	 	 	 	 	 
	7.1

	 	CSI will be responsible for all design control
requirements as outlined in CFR 820.30.
	 	X	 	 
	 
	 	 	 	 	 	 
	7.2

	 	FRESENIUS KABI will provide CSI with any
applicable documentation to satisfy design control
requirements that are specific to FRESENIUS KABI.
	 	 	 	X
	 
	 	 	 	 	 	 
	7.3

	 	FRESENIUS KABI will create and maintain a Device
Master Record (DMR) for PRODUCT.
	 	 	 	X

2-17

 

Contact Persons: FRESENIUS KABI

	 	 	 	 	 
	Plant Uppsala	 	Contact / Function	 	 
	Address: 

Fresenius Kabi AB 

Rapsgatan 7

SE-751 74 Uppsala, Sweden

	 	Christoph Funke

Managing Director
	 	Phone                     

Fax                          

Email:                     
	 
	 	 	 	 
	 

	 	Alexander Stoll

QA/OP
	 	Phone                     

Fax                          

Email:                     
	 
	 	 	 	 
	 

	 	Cecilia Sjöstedt

Plant Manager
	 	Phone                     

Fax                          

Email:                     
	 
	 	 	 	 
	 

	 	Thomas Larsson

Supply Chain

Manager
	 	Phone                     

Fax                          

Email:                     

Contact Persons: CSI

	 	 	 	 	 

	Address: 

CSI 

651 Campus Drive 

St. Paul, MN 55112 USA

	 	Jim Murray

Quality/Supply Chain
	 	Phone                     

Fax                          

Email:                     
	 
	 	 	 	 
	 

	 	Megan Brandt

Quality/Regulatory
	 	Phone                     

Fax                          

Email:                     
	 
	 	 	 	 
	 

	 	Jim Flaherty

Legal
	 	Phone                     

Fax                          

Email:                     
	 
	 	 	 	 
	 

	 	Paul Koehn

Operations
	 	Phone                     

Fax                          

Email:                     

2-18

 

Contractual Products and Specification

The following products are matter of the Technical Agreement:

	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	Country of
	 	 	 	 	 	 	 	 	Fresenius Kabi
	 	 	 	 	 	 	Marketing	 	subsidiary where
	 	 	 	 	 	 	Authorization	 	the product is
	Material Number	 	Name of Product	 	Size of Product	 	Number	 	released
	830506350	 	 	 	 	 	 	 	 
	(ViperSlide)
	 	Intralipid 10%
	 	100m1
	 	NDA017643
	 	Sweden
	 
	 	 
	 	 
	 	 
	 	 

The specifications are to be seen in the current registration file of Intralipid 10%.

2-19Exhibit 10.66

Exhibit 10.66

American Railcar Industries, Inc.

2011 Management Incentive Plan

I.      PURPOSE & SCOPE

The purpose of the Management Incentive Plan is to provide a variable component to the total
compensation package for management and executive level employees. This “at risk” part of
total compensation encourages participating management to achieve the goals that are
important for the company.

The Plan is important to attract and retain highly qualified key employees, by providing the
opportunity to personally benefit by sharing in the results achieved for the Company. The
Plan provides a link between the performance of the Company and its management team and
encourages the behavior to drive for strong Company performance.

II.     DEFINITIONS

	 	A.	 	Base Salary equals the base annual salary effective December
31st for the year for which the award is calculated. If a Participant’s
bonus level or salary changes during the year, the Base Salary will be prorated for the
portion of the year each bonus level or salary was in effect.

	 	B.	 	Chief Executive Officer means the Chief Executive Officer of American
Railcar Industries, Inc.

	 	C.	 	Company means American Railcar Industries, Inc. and its subsidiaries
and its successors.

	 	D.	 	Compensation Committee of the Board of Directors means the members of
the American Railcar Industries, Inc. Board of Directors responsible for administering
executive and management compensation.

	 	E.	 	Fiscal Year means the Company’s fiscal year beginning January 1 and
ending December 31.

	 	F.	 	Participant(s) refer(s) to the employees eligible to participate in the
Plan pursuant to Section III.

	 	G.	 	Performance Targets are the financial goal(s) of the Company for the
Fiscal Year as defined in the annual business plan.

	 	H.	 	Personal Goals refer to the personal goals and objectives set by each
Participant and his/her supervisor at the beginning of each Fiscal Year against which
performance is measured.

	 	I.	 	Plan means the American Railcar Industries, Inc. Management Incentive
Plan, as from time to time amended.

	 	J.	 	Company Target Bonus Pool means the sum of the annual bonus targets
(base salary X bonus percentage) for all Participants in the Plan.

III.   EMPLOYEES COVERED BY THE PLAN

Participating employees (each a “Participant”) shall be subject to the approval of the
Compensation Committee of the Board of Directors. If a Participant vacates a listed
position, the employee selected as the replacement would be eligible to participate in the
Plan pro-rata for the months in the position, subject to approval by the Chief Executive
Officer (the “CEO” or, in the case of Participants who are executive officers, the
Compensation Committee of the Board of Directors).

 

 

 

Exhibit 10.66

American Railcar Industries, Inc.

2011 Management Incentive Plan

IV.    PARTICIPANT FINANCIAL AWARD

A Participant in the Plan shall be entitled to a financial award computed as the product of:

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	Participant’s

Base Salary
	 	X
	 	Bonus Percentage
	 	X
	 	Financial

Performance

Factor
	 	X
	 	Individual

Performance Rating

on a 0-120% scale
	 	=
	 	Participant’s

Financial Award

	 	A.	 	“Participant’s Base Salary” shall be the salary as defined in Section II.A.

	 	B.	 	“Bonus Percentage” shall be determined by the Compensation Committee of the
Board of Directors, based upon the management level of each Participant.

	 	C.	 	“Financial Performance Factor” shall be determined by the Compensation
Committee of the Board of Directors in accordance with Section V below.

	 	D.	 	“Individual Performance Rating” shall be based on an individual performance
evaluation in accordance with Section VI below.

It is intended that increases and decreases in Participant Financial Awards which result
from Individual Performance Ratings shall not result in an increase in the aggregate
Plan payout that would otherwise apply based on the Company Performance as a % of Target
(as set forth below in Section V) and Individual Performance Ratings at the 100% level
(such aggregate Plan payout being referred to as the “Maximum Bonus Pool”), and in the
event that the Financial Awards otherwise calculated in accordance with this Section IV
would exceed the Maximum Bonus Pool, each of the Financial Awards calculated on that
basis shall be reduced pro rata in order that the aggregate Financial Awards shall not
exceed the Maximum Bonus Pool.

If a Participant was in more than one management level during a Fiscal Year, a separate
computation shall be made for the number of months at each level during such Fiscal
Year; the sum of the separate computations shall be the Participant’s Financial Award.

V.     FINANCIAL PERFORMANCE FACTOR

The financial performance factor is established by the Compensation Committee of the Board
of Directors based on the Company’s achievement of goals set forth in its annual business
plan.

VI.    INDIVIDUAL PERFORMANCE RATING

Personal Goals for each Participant are to be developed jointly by the Participant and
his/her supervisor for the Fiscal Year. The Personal Goals of the CEO and other executive
officers shall be subject to the review and approval of the Compensation Committee of the
Board of Directors. Attainment of such goals and other performance criteria, both
quantifiable and non-quantifiable, may be used to arrive at an overall individual
performance rating from 0% to 120%. Such criteria shall be applied consistently to
Participants with similar duties pursuant to an evaluation process

 

 

 

Exhibit 10.66

American Railcar Industries, Inc.

2011 Management Incentive Plan

to be reviewed and approved by the Company’s human resources department. Criteria that may
be weighed in arriving at an individual performance rating include, without limitation:

	 	•	 	Achievement of performance targets established in Annual Budget

	 	•	 	Development of staff

	 	•	 	Successful development of new accounts/products

	 	•	 	Improvement in product programs

	 	•	 	Attainment of self-development objectives

	 	•	 	Control or reduction of operating expenses by business unit

	 	•	 	Safety record of facility or facilities

	 	•	 	Quality program achievement

	 	•	 	Business process improvements

The supervisor will assign a personal performance rating, from 0% to 120%, reflecting the
Participant’s performance during the Fiscal Year. The Chief Executive Officer reserves the
right, in his sole discretion, to accept the personal performance percent recommendation for
each Participant or to modify any personal performance percent for any Participant to
achieve such dispersion of performance ratings as the Chief Executive Officer deems
appropriate; provided, however, that the personal performance percent recommendation of the
CEO and other executive officers shall be subject to the review and approval of the
Compensation Committee of the Board of Directors.

VII.  PERFORMANCE TARGETS

Financial performance targets are established based on the annual business plan. Targets
are recommended by the Chief Executive Officer and approved by the Compensation Committee of
the Board of Directors based on the annual business plan.

At any time prior to the final determination of awards, the Compensation Committee of the
Board of Directors, may, in its sole discretion, increase, decrease, or otherwise adjust
performance measures, targets, and payout ranges used hereunder, as a result of
extraordinary or non-recurring events, changes in applicable accounting rules or principles,
changes in the Company’s methods of accounting, changes in applicable law, changes due to
consolidation, acquisition, or reorganization affecting the Company and its subsidiaries and
affiliates; or such other material change in the Company’s business.

VIII. COMPUTATION AND DISBURSEMENT OF FUNDS

As soon as practicable after the close of the Fiscal Year, the Corporate Controller shall
calculate the financial performance and the proposed payout under the Plan based upon the
achievement of the financial performance measures. The proposed payout shall be presented
to the Compensation Committee of the Board of Directors for final approval in its sole
discretion. If approved, payment of the Financial Awards shall be made within 30 days after
completion of the annual audit but not later than September 30th of the calendar year
following the Fiscal Year for which the award is earned.

 

 

 

Exhibit 10.66

American Railcar Industries, Inc.

2011 Management Incentive Plan

All payment awards shall be reduced by amounts required to be withheld for taxes at the time
payments are made.

IX.   PAYMENT OF PRO-RATED FINANCIAL AWARDS

In order to be eligible to receive a Financial Award for a Fiscal Year, a Participant must
be employed in a bonus-eligible position for a minimum of three months during that Fiscal
Year, except as otherwise provided by the Compensation Committee of the Board of Directors.
Subject to the discretion of the Compensation Committee of the Board of Directors, a
Participant will be allowed to earn a Financial Award based on the amount of time the
eligible Participant is actively and continuously employed in an eligible position during
the Fiscal Year.

	 	•	 	New Hires and Rehires — The Financial Award will be prorated based upon the
number of months the Participant is employed during the Fiscal Year. For example,
a Participant initially hired on July 1st would be eligible for 50% of
the annual Financial Award. In the case of rehires, there is no credit for prior
service and the rehire date must occur prior to October 1st in order for
the Participant to be eligible under the Plan for the Fiscal Year.

	 	•	 	Leaves of Absence — Time taken during a leave of absence is not credited toward
eligibility for a Financial Award; therefore, awards will be prorated for the
length of time on leave of absence. Furthermore, payments of Financial Awards are
not considered earned and payable unless and until the Participant returns to work,
with the exception of Military Leave. If the leave of absence lasts nine months or
more during the Fiscal Year, the Participant will not have met the three-month
eligibility required to earn a bonus for that Fiscal Year.

	 	•	 	Promotions and Demotions — If the action results in a movement from one
bonus-eligible position to another bonus-eligible position (with either a higher or
lower bonus target) a pro-rated Financial Award will be calculated. The Financial
Award will be calculated separately by factoring the time in each bonus eligible
position by the corresponding bonus target and base pay during the Participant’s
tenure in each position. However, if a Participant is both promoted and later
demoted during the Fiscal Year, the Participant’s entire bonus eligibility and
bonus target percent will be determined by the lower grade.

	 	•	 	Status Change

	 	•	 	Change in employment status — The Financial Award is
not payable unless the Participant has occupied a bonus-eligible position
for at least three months during the Fiscal Year and meets all eligibility
criteria during the last full quarter of the Fiscal Year, i.e., from
October 1st through December 31st. The Financial
Award will be based upon the base salary and the annual bonus target while
in the bonus-eligible position.

	 	•	 	Bonus-eligible position to a non-bonus eligible
position — The Financial Award will be prorated based upon the time in a
bonus-eligible position as long as the Participant was in the position for
a minimum of three months during the Fiscal Year. A Participant must
occupy a bonus-eligible position prior to October 1st in order
to be eligible to receive a bonus payment for the Fiscal Year. The
Financial Award will be based upon the base salary and the annual bonus target while
in the bonus-eligible position.

 

 

 

Exhibit 10.66

American Railcar Industries, Inc.

2011 Management Incentive Plan

	 	•	 	Non-bonus-eligible position to a bonus-eligible
position — The Financial Award will be prorated based on the time worked,
the corresponding bonus target, and the base salary in effect while in the
bonus-eligible position as long as the Participant was in the eligible
position for a minimum of three months during the Fiscal Year. A
Participant must move into the bonus-eligible position prior to October
1st in order to be eligible to receive a bonus payment for the
Fiscal Year.

X.     FORFEITURE OF BONUS

If a Participant’s termination of employment occurs prior to the date the Financial Awards
are actually paid, the Participant will not be entitled to any bonus payment for the Fiscal
Year during which the termination occurs, except as otherwise provided by the Compensation
Committee of the Board of Directors. Financial Awards are not considered earned until they
are approved by the Compensation Committee of the Board of Directors and are actually paid
by the Company. Consequently, a Participant whose employment with the Company is
voluntarily or involuntarily terminated prior to the actual Financial Award payment date
will be deemed ineligible for payment of the Financial Award, except as otherwise provided
by the Plan and the Compensation Committee of the Board of Directors, in which case any such
Financial Award to the terminated employee shall be paid at the time Financial Awards are
paid to active employees pursuant to Section IX above.

XI.    ADMINISTRATION

This Plan shall be administered by the Manager of Human Resources of American Railcar
Industries, Inc. subject to the control and supervision of the Chief Executive Officer and
the Compensation Committee of the Board of Directors of American Railcar Industries, Inc.

In the event of a claim or dispute brought forth by a Participant, the decision of the Chief
Executive Officer as to the facts in the case and the meaning and intent of any provision of
the Plan, or its application, shall be final, binding, and conclusive, except that, with
regard to executive officers, the decision of the Compensation Committee of the Board of
Directors shall be final, binding, and conclusive.

Notwithstanding anything herein to the contrary, the Compensation Committee of the Board of
Directors shall retain sole discretion over all matters relating to this 2011 Management
Incentive Plan, including without limitation the decision to pay any financial awards, the
amount of financial awards, if any, the ability to increase or decrease any financial awards
and to make changes to any performance measures or targets and discretion over the payment
of partial financial awards in the event of employment termination.

XII.   NO EMPLOYMENT CONTRACT; FUTURE PLANS

Participation in this Plan shall not confer upon any Participant any right to continue in
the employ of the Company nor interfere in any way with the right of the Company to
terminate any Participant’s employment at any time. The Company is under no obligation to continue the
Plan in future years.

 

 

 

Exhibit 10.66

American Railcar Industries, Inc.

2011 Management Incentive Plan

XIII. AMENDMENT OR TERMINATION

The Compensation Committee of the Board of Directors may at any time, or from time to time
(a) amend, alter or modify the provisions of this Plan, (b) terminate this Plan, or (c)
terminate the participation of an employee or group of employees in this Plan; provided,
however, that in the event of the termination of this Plan or a termination of
participation, the Compensation Committee of the Board of Directors, in its sole discretion,
shall determine whether a prorated award is payable to employees who were Participants in
this Plan. If prorated awards are granted, the awards shall be paid within 30 days after
completion of the annual audit but not later than September 30 of the calendar year
following the Fiscal Year for which the award is earned.

XIV. GENERAL PROVISIONS

No right under the Plan shall be assignable, either voluntarily or involuntarily by the way
of encumbrance, pledge, attachment, level or change of any nature (except as may be required
by state or federal law).

Nothing in the Plan shall require the Company to segregate or set aside any funds or other
property for the purpose of paying any portion of an award. No Participant, beneficiary or
other person shall have any right, title or interest in any amount awarded under the Plan
prior to the payment of such award to him or her.

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