Document:

EX-10.39  CARDINAL HEALTH PTS,LLC QUOTATION

 

Exhibit 10.39

PORTIONS OF THIS EXHIBIT MARKED “[* * *]” HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND THE
OMITTED PORTIONS HAVE BEEN FILED SEPARATELY IN PAPER FORM WITH THE SECURITIES AND EXCHANGE
COMMISSION.

QUOTATION

[* * *] Difluprednate Ophthalmic Emulsion

NDA Stability and Clinical Supply Batches

Version 00

Sirion Therapeutics

(referred to as “Customer”)

3110 Cherry Palm Drive, Suite 340

Tampa, FL 33619

Client Contact: Bill Stringer

Phone: 813-496-7325 Ext. 240

Cardinal Health Contact: Patrick Poisson

Phone: 815-206-1217

QTE-6122-31 1600.00

Date: May 23, 2006

CONFIDENTIAL

Pharmaceutical Technologies and Services

and Sterile Life Sciences Group

Woodstock, Illinois

CardinalHealth

 

 

			
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Executive Summary

This Quotation describes the basic scope of work to be performed by Cardinal Health with
respect to manufacture of Customer’s [* * *] Difluprednate multi-dose ophthalmic product
(“Product”) using blow/fill/seal technology, and Cardinal Health’s pricing for such manufacture.
For purposes of clarification, the pricing included herein is based on the following limited
information:

GENERAL REQUIREMENTS

	 	 	 
	Product Name

	 	[* * *] Difluprednate
	 
	 	 
	Indication

	 	Ophthalmic
	 
	 	 
	Therapeutic Category

	 	Glucocorticoid; anti-inflammatory
	 
	 	 
	Proposed Batch Size

	 	[* * *]
	 
	 	 
	Number of Batches

	 	[* * *]
	 
	 	 
	Number of Units per Batch

	 	Fill [* * *] vials ([* * *] of expected batch yield)
	 
	 	 
	Resin Type

	 	LDPE w/ pink cap* (Pantone 197 or 212)
	 
	 	 
	Container Description

	 	5mL multi dose vial with tip/cap
	 
	 	 
	Manufacturing Directions

	 	Cardinal Health Standard
	 
	 	 
	Method of Sterilization

	 	Filter Sterilization
	 
	 	 
	Packaging

	 	Bulk pack vials into shipper
	 
	 	 

 

			
	*	 	AAO Recommended Color Code for Anti-Inflammatories/Steroids

Section 1. Version History

	 	 	 	 	 
	VERSION	 	DATE ISSUED	 	REASON
	00

	 	May 23, 2006
	 	New Issue

Section 2. Scope of Work

	2.1	 	Cardinal Health’s Responsibilities.

	 	2.1.1	 	Facility and Equipment. Cardinal Health will provide an FDA registered drug
establishment, which is maintained in accordance with applicable US laws, rules and
regulations, including without limitation, applicable current Good Manufacturing
Practices.

	 	•	 	Cardinal Health will manufacture the Product
using a BFS machine.
	 
	 	•	 	Cardinal Health will use [* * *]-cavity tooling with
insertion.

	 	2.1.2	 	Records. Cardinal Health will provide all administration, supervision and
record keeping, as required by applicable law and in accordance with Cardinal Health’s
standard operating procedures and practices.
	 
	 	2.1.3	 	Master Batch Record. Cardinal Health will provide labor and materials for
preparation and approval of the Master Batch Record and any subsequent revisions
thereto.

2200 Lake Shore Drive • Woodstock, Illinois 60098

Direct: (815) 338-9500 • Facsimile: (815) 338-3989 • www.cardinal.com/pts

CONFIDENTIAL

 

 

			
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	 	2.1.4	 	Materials. Cardinal Health will provide the following raw materials:

	 	•	 	The following cGMP released components:

	 	•	 	Low Density Polyethylene resin, as required
	 
	 	•	 	Pre-sterilized tip/cap assemblies, as required
	 
	 	•	 	Shipping carton
	 
	 	•	 	Water for Injection for batch formulation and
clean-up, tested per current USP methodology

	 	•	 	The following cGMP released in house excipients:

	 	•	 	Glycerin,
	 
	 	•	 	Sodium Acetate
	 
	 	•	 	Boric Acid
	 
	 	•	 	Castor Oil
	 
	 	•	 	Polysorbate 80
	 
	 	•	 	Sodium Edetate
	 
	 	•	 	Sorbic Acid
	 
	 	•	 	Sodium Hydroxide

	 	•	 	0.22 micron product sterilizing filters, as required.
	 
	 	•	 	5 micron pre-filters, as required.
	 
	 	•	 	0.2 micron air sterilizing filters, as required.

	 	2.1.5	 	API Receiving Tests. Cardinal Health will conduct the following API receiving
tests in accordance with the test requirements, methods and specifications provided
and/or approved by Customer and agreed to by Cardinal Health:

	 	•	 	Identification testing only

	 	2.1.6	 	In Process Tests. Cardinal Health will conduct the following in process tests
in accordance with the test requirements, methods and specifications provided and/or
approved by Customer and agreed to by Cardinal Health:

	 	•	 	Incoming resin certification and testing
	 
	 	•	 	Current USP water testing
	 
	 	•	 	Pre-filtration Bioburden
	 
	 	•	 	pH
	 
	 	•	 	Appearance
	 
	 	•	 	Assay (HPLC)
	 
	 	•	 	Environmental Monitoring, per Cardinal Health SOPs
	 
	 	•	 	Personnel Monitoring
	 
	 	•	 	Fill weight monitoring by production personnel
	 
	 	•	 	Filter Integrity
	 
	 	•	 	First acceptable vial testing, as follows:

	 	•	 	Package Condition
	 
	 	•	 	pH
	 
	 	•	 	Appearance
	 
	 	•	 	Assay (HPLC)

2200 Lake Shore Drive • Woodstock, Illinois 60098

Direct: (815) 338-9500 • Facsimile: (815) 338-3989 • www.cardinal.com/pts

CONFIDENTIAL

 

 

			
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	 	2.1.7	 	Manufacture, Inspection and Packaging. Cardinal Health will provide
manufacture, inspection and packaging, in accordance with a master batch record
approved by the parties, as follows:

	 	•	 	Set-up and takedown BFS machines
	 
	 	•	 	Formulate the bulk solution using tested and released ingredient(s).
	 
	 	•	 	Blow, Fill and Seal the formulated bulk drug solution
into BFS containers within the tolerance limits set by the master batch
record.
	 
	 	•	 	Deflash BFS containers
	 
	 	•	 	Perform 100% visual inspection of the finished product.
	 
	 	•	 	Bulk pack vials into polybags.

	 	2.1.8	 	Finished Product Tests. Cardinal Health will conduct the following finished
Product tests in accordance with the test requirements, methods and specifications
provided and/or approved by Customer and agreed to by Cardinal Health:

	 	•	 	Package Condition
	 
	 	•	 	Sterility

	 	2.1.9	 	Cleaning. Following batch manufacture, Cardinal Health will clean the
Facilities and Equipment in accordance with Cardinal Health’s standard operating
procedures.
	 
	 	2.1.10	 	Waste Disposal. Cardinal Health will engage a contractor to dispose of all Product
related waste in accordance with applicable laws, rules and regulations.
	 
	 	2.1.11	 	Post-Manufacture Review. Following manufacture of the Product as provided above,
Cardinal Health will review and approve the lot specific batch records prior to
Customer’s final release of product for clinical use.
	 
	 	2.1.12	 	Batch Records. Cardinal Health will provide Customer with a copy of each lot
specific Batch Record.
	 
	 	2.1.13	 	Samples. Cardinal Health will maintain up to 2x the number of samples for release
testing as retention samples, as requested by Customer.
	 
	 	2.1.14	 	Storage. Cardinal Health will store the API and Product in accordance with storage
specifications provided by Customer. Cardinal Health will store finished Product for up
to [* * *] following release by Cardinal Health. If Cardinal Health consents to store
the Product for a longer period of time, Cardinal Health will charge storage fees in
accordance with this Quotation and Customer will be required to provide Cardinal Health
with a letter confirming the following: (i) Customer has made a fixed commitment to
purchase such Product, (ii) risk of ownership for such Product passes to Customer,
(iii) such Product shall be on a bill and hold basis for legitimate business purposes,
(iv) if no delivery date is determined at the time of billing, Cardinal Health shall
have the right to ship the Product to Customer within four months after billing, and
(v) Customer will be responsible for any decrease in market value of such Product that
relates to factors and circumstances outside of Cardinal Health’s control.

2200 Lake Shore Drive • Woodstock, Illinois 60098

Direct: (815) 338-9500 • Facsimile: (815) 338-3989 • www.cardinal.com/pts

CONFIDENTIAL

 

 

			
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	 	2.1.15	 	Delivery. Cardinal Health will bulk pack the Product using standard Cardinal Health
shippers. These shippers are not validated for Customer Product. If requested by
Customer or if otherwise necessary, Cardinal Health will palletize the Product on 40” x
48” wooden pallets for delivery to Customer or its designated recipient. All shipments
shall be F.O.B. Cardinal Health’s shipping docks. If Customer has not specifically
designated a preferred carrier, Cardinal Health will select the carrier for shipment.

	2.2	 	Customer’s Responsibilities

	 	2.2.1	 	Project Instructions. Customer will:

	 	•	 	Provide manufacturing instructions to enable Cardinal
Health to prepare the master batch record.
	 
	 	•	 	Review and approve the master batch record and any subsequent revisions.
	 
	 	•	 	Provide test requirements, specifications, and methods as provided below.

	 	2.2.2	 	Test Requirements, Methods & Specifications. Customer will provide (I) test
requirements, (ii) validated or reproducible analytical methods and related
documentation, and (iii) applicable Specifications for the following:

	 	•	 	API Receiving Tests
	 
	 	•	 	In-process Assay (H PLC)

	 	2.2.3	 	Materials. Customer will supply the following materials and items to Cardinal Health:

	 	•	 	Pre-released Active Pharmaceutical Ingredient (“API”).
	 
	 	•	 	Reference standards, if required.
	 
	 	•	 	HPLC columns required for testing the API supplied by
Customer and for the In- Process Assay.
	 
	 	•	 	Certificate of analysis for the API supplied by
Customer which includes, without limitation, information relating to
release potency, BSEITSE free certification and, in the case of biologic
products only, mycoplasma level and proof of viral inactivation.

	 	2.2.4	 	Equipment. Customer will supply unique processing and analytical equipment to
Cardinal Health including, but not limited to, the following items:

	 	•	 	Microfluidizer
	 
	 	•	 	Particle Size Test Unit
	 
	 	•	 	Misc. valves and piping

	 	2.2.5	 	Safety Information. Customer will provide all known safety information
relating to the Product, API and other raw materials supplied by Customer under this
Quotation, including without limitation Material Safety Data Sheets (‘MSDS”) applicable
to each such item.
	 
	 	2.2.6	 	Artwork. If Cardinal Health is labeling the Product, Customer will provide
approved artwork that meets all applicable regulatory requirements.
	 
	 	2.2.7	 	Samples. Customer will maintain all reserve samples and stability samples.
	 
	 	2.2.8	 	Cleaning. Customer will provide cleaning method and testing support, as
necessary, for cleaning verification of product contacting equipment.

2200 Lake Shore Drive • Woodstock, Illinois 60098

Direct: (815) 338-9500 • Facsimile: (815) 338-3989 • www.cardinal.com/pts

CONFIDENTIAL

 

 

			
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Section 3. Pricing

	3.1	 	Project Pricing. Cardinal Health’s price to perform the Project defined in this Quotation
will be as follows:

COST: [* * *] PER BATCH

TOTAL COST: [* * *]

	3.2	 	Revisions to Pricing. In addition to any reasons for price changes expressly set forth in
Exhibit 1, Cardinal Health may revise the prices provided in this Quotation if reasonably
unforeseeable circumstances affect the work required to complete the Project. Cardinal Health
will notify Customer immediately if the costs to complete the Project exceed the prices stated
in this Quotation. Cardinal Health will not commence work involving charges in excess of those
stated in this Quotation without Customer approval unless such advance notice was not possible
due to the circumstances.

Section 4. Terms and Conditions

	4.1	 	Standard Terms and Conditions. The Standard Terms and Conditions attached to this
Quotation as Exhibit 1 are an integral part of this Quotation and are incorporated herein by
reference. In the event of a conflict between the terms of this Quotation and the attached
Standard Terms and Conditions, the Standard Terms and Conditions shall govern. In the event of
a conflict between the terms and conditions of this Quotation and any purchase order or other
documentation submitted by Customer, this Quotation shall govern.
	 
	4.2	 	Invoicing and Payment Terms. Cardinal Health will invoice as follows:
An invoice will be issued to the customer upon shipment of the product
to the location designated by the Customer.
	 
	4.3	 	Initial Batches. Each batch of Product manufactured under this Quotation will be considered
to be a “Development Batch” until Cardinal Health has manufactured [* * *] consecutive batches
of Product which meet the applicable Specifications. The term “Development Batch” shall
include without limitation any batch manufactured (I) following a change in Specifications,
(ii) following a scale-up in the manufacturing process to produce greater quantities of
Product, until Cardinal Health has manufactured [* * *] consecutive batches of Product meeting
the new Specifications or, (iii) for a feasibility, stability or clinical study. Customer
shall be responsible for the cost of each Development Batch that fails to meet the
Specifications unless Cardinal Health was grossly negligent in the manufacture of the
out-of-Specification batch. Cardinal Health and Customer shall cooperate in good faith to
resolve any problems causing the out-of-Specification batch.
	 
	4.4	 	Commercial Salability. Each batch of Product manufactured under this Quotation will be
considered a “Development Batch” and is not for commercial sale or distribution.
	 
	4.5	 	Unlabeled Product. If Cardinal Health is to provide Customer with product which is not
labeled, Customer represents and warrants that it will comply with all applicable regulations,
including without limitation 21 CFR § 201.150.

2200 Lake Shore Drive • Woodstock, Illinois 60098

Direct: (815) 338-9500 • Facsimile: (815) 338-3989 • www.cardinal.com/pts

CONFIDENTIAL

 

 

			
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	4.6	 	Termination. Either party may terminate this Quotation: (i) effective upon [* * *] days
prior written notice to the other party, if the other party commits a material breach of this
Quotation and fails to cure such breach by the end of such [* * *] period; provided, however,
that failure to pay amounts due under this Quotation within [* * *] after such payments are
due shall constitute cause for immediate termination of this Quotation, or at Cardinal
Health’s discretion, Cardinal Health shall be relieved of any further obligation to perform
under this Quotation until all outstanding payments are brought current, or (ii) effective
upon written notice to the other party, if the other party becomes insolvent or admits in
writing its inability to pay its debts as they become due, files a petition for bankruptcy,
makes an assignment for the benefit of its creditors or has a receiver, trustee or other court
officer appointed for its properties or assets.

2200 Lake Shore Drive • Woodstock, Illinois 60098

Direct: (815) 338-9500 • Facsimile: (815) 338-3989 • www.cardinal.com/pts

CONFIDENTIAL

 

 

			
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Quotation Acceptance Sheet

Invoice referencing the
customer’s Purchase Order Number:                                                             

(please attach Purchase Order) should be sent directly to:

	 	 	 
	Contact

	 	Address:
	 
	Name: William Stringer

	 	3110 Cherry Palm Drive
	 
	 	 
	Telephone
	 	 
	Number: 813-496-7325x240

	 	Suite 340
	 
	 	 
	Fax
	 	 
	Number: 813-496-7328

	 	Tampa, Florida 33619
	 
	 	 
	Federal ID

	 	E-mail
	Number: 20-3943372

	 	Address: wstringer@siriontherapeutics.com

Modifications to this Quotation must be made with written approval by both parties.

THIS QUOTATION IS SUBJECT TO RECONFIRMATION AND ACCEPTANCE BY CARDINAL HEALTH AT THE TIME OF ORDER
PLACEMENT.

	 	 	 
	Customer	 	Cardinal Health PTS, LLC
	/s/ William Stringer

	 	/s/ Patrick Poisson
	 

	 	 
	Signature

	 	Signature
	 
	 	 
	William Stringer

	 	Patrick Poisson
	 

	 	 
	Printed Name

	 	Printed Name
	 
	 	 
	VP Manufacturing & Compliance

	 	Sr. Director, Business Development
	 

	 	 
	Title

	 	Title
	 
	 	 
	9-9-06

	 	9-8-06
	 

	 	 
	Date

	 	Date

	 	 	 
	Mail or fax the Acceptance Sheet to:

	 	Patrick Polsson
	 

	 	Sr. Director, Business Development
	 

	 	Cardinal Health
	 

	 	220 Lake Shore Blvd.
	 

	 	Woodstock, Illinois 60098
	 

	 	Fax: (815) 338-3989

2200 Lake Shore Drive • Woodstock, Illinois 60098

Direct: (815) 338-9500 • Facsimile: (815) 338-3989 • www.cardinal.com/pts

CONFIDENTIAL

 

 

					
	QTE-6122-311600.00	 	EXHIBIT 1: STANDARD TERMS AND CONDITIONS	 	Page 9

 

A. Expiration.   This Quotation is valid for 30 days from the date hereof,
and becomes binding if signed and delivered by both parties during that period.

B. Audits.  Client may conduct one quality assurance facility audit per year at
no cost. Additional audits will be invoiced separately at the current rate for
such services.

C. Regulatory Inspections.   Cardinal Health will promptly notify Client of any
regulatory inspections directly relating to the Project. Client accepts
reasonable and documented costs charged by a regulatory authority for such
inspections.

D. Price Changes.   Cardinal Health may revise the prices provided in this
Quotation (i) if Client’s requirements or any Client-provided information is
inaccurate or incomplete; (ii) if Client revises Cardinal Health’s
responsibilities or the Project specifications, instructions, procedures,
assumptions, processes, test protocols, test methods or analytical requirements;
or (iii) for such other reasons set forth in this Quotation.

E. Payments.   Cardinal Health will invoice Client as set forth in this
Quotation. Cardinal Health charges a late payment fee of 11/2% per month for
payments not received by the dale specified in this Quotation (or if no date is
specified, within 30 days of invoice date). Failure to bill for interest due
shall not be a waiver of Cardinal Health’s right to charge interest.

F. Taxes.   All sales, use, gross receipts, compensating, value-added or other
taxes, duties, licenses or fees (excluding Cardinal Health’s net income and
franchise taxes) assessed by any tax jurisdiction arising from the Project are
the responsibility of Client, whether paid by Cardinal Health or Client.

G. Hazardous Materials.   Client warrants to Cardinal Health that no specific
safe handling instructions are applicable to any Client-supplied materials,
except as disclosed to Cardinal Health in writing by the Client in sufficient
time for review and training by Cardinal Health prior to delivery. Where
appropriate or required by law, Client will provide a Material Safety Data Sheet
for all Client-supplied materials and finished product.

H. Shipment.   Unless otherwise specified in this Quotation, all products and
other materials shipped by Cardinal Health are delivered EXW (Incoterms 2000)
Cardinal Health’s facilities and the title shall pass to Client upon such
delivery.

I. Limitations of Liability.  CARDINAL HEALTH’S TOTAL LIABILITY UNDER THIS
QUOTATION SHALL IN NO EVENT EXCEED THE TOTAL FEES PAID UNDER THIS QUOTATION (BUT
EXCLUDING FEES FOR PROCURING COMPARATOR DRUG). CARDINAL HEALTH’S LIABILITY UNDER
THIS QUOTATION FOR ANY AND ALL CLAIMS FOR LOST, DAMAGED OR DESTROYED API OR
CLIENT-SUPPLIED MATERIALS, WHETHER OR NOT INCORPORATED INTO FINISHED PRODUCT,
SHALL NOT EXCEED $5,000. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR
INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF
PERFORMANCE UNDER THIS QUOTATION, INCLUDING WITHOUT LIMITATION LOSS OF REVENUES,
PROFITS OR DATA, WHETHER IN CONTRACT OR IN TORT, EVEN IF SUCH PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

J. Confidentiality.   All information disclosed by a party in connection with
this Quotation shall be confidential information, unless such information is (I)
already known to the receiving party, as evidenced by written records; (ii)
independently developed or discovered by the receiving party without the use of
the disclosing party’s confidential information, as evidenced by written
records; (iii) in the public domain, other than through the fault of the
receiving party; (iv) disclosed to the receiving party by a third party not in
breach of a duty of confidentiality owed to the disclosing party; or (v)
required to be disclosed by law, or court or administrative order; provided,
that the receiving party first gives prompt notice thereof to the disclosing
party. Neither party shall, without the other party’s prior written consent, use
the confidential information of the other party or disclose such information to
anyone other than employees of the receiving party or its affiliated entities
who require such information to perform such party’s obligations under this
Quotation. This undertaking shall survive for 7 years following the date of this
Quotation.

K. Intellectual Property.   For purposes hereof, “Client IP” means all
intellectual property and embodiments thereof owned by or licensed to Client as
of the date hereof or developed by Client other than in connection with the
Project; “Cardinal Health IP” means all intellectual property and embodiments
thereof owned by or licensed to Cardinal Health as of the date hereof or
developed by Cardinal Health other than in connection with the Project;
“Invention” means any intellectual property developed by either party in
connection with the Project; “API Inventions” means any Invention that relates
exclusively to the Client IP or Client’s patented API; and “Process Inventions”
means any Invention, other than an API Invention, that relates exclusively to
the Cardinal Health IP or relates to developing, formulating, manufacturing,
filling, processing, packaging, analyzing or testing pharmaceutical products
generally. All Client IP and API Inventions shall be owned solely by Client and
no right therein is granted to Cardinal Health under this Quotation except for
use in performing the Project. All Cardinal Health IP and Process Inventions
shall be owned solely by Cardinal Health and no right therein is granted to
Client under this Quotation. All Inventions to generic API (other than API
Inventions and Process Inventions), if any, shall be owned jointly by Cardinal
Health and Client. The parties shall cooperate to achieve the allocation of
rights to Inventions anticipated herein and each party shall be solely
responsible for costs associated with the protection of its intellectual
property.

L. Warranties.   Cardinal Health will perform the Project in accordance with the
written specifications and Project instructions expressly set forth or
referenced in this Quotation and United States current Good Manufacturing
Practices or current Good Laboratory Practices, as applicable. THE WARRANTIES
SET FORTH IN THIS ARTICLE ARE THE SOLE AND EXCLUSIVE WARRANTIES MADE BY CARDINAL
HEALTH TO CLIENT, AND CARDINAL HEALTH MAKES NO OTHER REPRESENTATIONS, WARRANTIES
OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING ANY IMPLIED WARRANTIES OF
MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

M. Client.   Obligations Unless otherwise agreed to by the parties in writing,
Client is solely responsible to (i) provide complete and accurate scientific
data regarding the Project; (ii) if applicable, review and approve all
in-process and finished product test results to ensure conformity of such
results with the product specifications, regardless of which party is
responsible for finished product release; (iii) prepare all submissions to
regulatory authorities; and (iv) perform such other obligations of Client set
forth in this Quotation.

N. Indemnification.   Client will indemnify Cardinal Health, Its affiliates and
their respective directors, officers, employees and agents against any
third-party claim arising directly or indirectly from (i) the manufacture,
promotion, marketing, distribution or sale of, or use of or exposure to, the
product, API and Client-supplied materials that are the subject of the Project;
(ii) the negligence or willful misconduct of Client; (iii) the breach of this
Quotation by Client; or (iv) the use of any intellectual property provided by
Client to Cardinal Health. Cardinal Health will indemnify Client against any
third-party claim arising directly or indirectly from the negligence or willful
misconduct of Cardinal Health or the breach of this Quotation by Cardinal
Health.

O. Set-Off.   Without limiting Cardinal Health’s rights under law or in equity,
Cardinal Health and its affiliates, parent or related entities, collectively or
individually, may exercise a right of set-off against all amounts due to
Cardinal Health from Client. For purposes of this Article, Cardinal Health, its
affiliates, parent or related entities, shall be deemed to be a single creditor.

P. Force Majeure.   Neither party will be liable for any failure to perform or
for delay in performance resulting from any cause beyond its reasonable control,
including without limitation acts of God, fires, floods or weather, strikes or
lockouts, factory shutdowns, embargoes, wars, hostilities or riots, or shortages
in transportation. If the cause continues unabated for 90 days, then both
parties shall meet to discuss and negotiate in good faith what modifications to
this Quotation should result from such cause.

Q. Use and Disposal.   Client represents and warrants to Cardinal Health that
Client will hold, use and/or dispose of products and other materials provided by
Cardinal Health in accordance with all applicable laws, rules and regulations.
Client grants Cardinal Health full authority to use any Client-supplied
materials for purposes of the Project.

R. Record Retention.   Unless the parties otherwise agree in writing, Cardinal
Health will retain batch, laboratory and other technical records for the minimum
period required by applicable law.

S. Independent Contractor.   The relationship of the parties is that of
independent contractors and not of joint venturers, co-partners,
employer/employee or principal/agent.

T. Publicity.   Neither party will make any press release or other public
disclosure regarding this Quotation or the transactions contemplated hereby
without the other party’s express prior written consent, except as required by
applicable law, by any governmental agency or by the rules of any stock exchange
on which the shares of the disclosing party are listed, in which case the party
required to make the press release or public disclosure shall use commercially
reasonable efforts to obtain the approval of the other party as to the form,
nature and extent of the press release or public disclosure prior to issuing the
press release or public disclosure.

U. Amendment & Precedence.   These Standard Terms and Conditions constitute a
part of the Quotation to which they are attached (collectively, “this
Quotation”); provided that these Standard Terms and Conditions supersede any
conflicting terms and conditions set forth in the Quotation to which they are
attached or any Client purchase order. This Quotation constitutes the entire
understanding between the parties, and supersedes any contracts, agreements or
understandings (oral or written) of the parties, with respect to the Project. No
term of this Quotation may be amended except upon written agreement of both
parties.

V. Dispute Resolution.   If a dispute arises between the parties in connection
with this Quotation, the respective presidents or Senior Executives of Cardinal
Health and Client shall first attempt to resolve the dispute. If such parties
cannot resolve the dispute, such dispute shall be resolved in the jurisdiction
of the defendant party by binding arbitration in accordance with the then
existing commercial arbitration rules of The CPR Institute for Dispute
Resolution, 366 Madison Avenue, New York, NY 10017.

W. Survival.   Subject to execution, the rights and obligations of Client and
Cardinal Health in Articles I, J, K, N, T, V and W of these Standard Terms and
Conditions shall survive termination or expiration of this Quotation.

 

2200 Lake Shore Drive • Woodstock, Illinois 60098

Direct: (815) 338-9500 • Facsimile: (815) 338-3989 • www.cardinal.com/pts

CONFIDENTIALEX-10.40  CARDINAL HEALTH PTS,LLC QUOTATION

 

Exhibit 10.40

PORTIONS OF THIS EXHIBIT MARKED “[* * *]” HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED, AND THE OMITTED PORTIONS HAVE BEEN FILED SEPARATELY IN PAPER FORM WITH THE SECURITIES AND
EXCHANGE COMMISSION.

QUOTATION

[* * *] Difluprednate Ophthalmic Emulsion

Registration Sterility Assurance Validation Services

and Methods Transfer

Version 00

Sirion Therapeutics

(referred to as “Customer”)

3110 Cherry Palm Drive, Suite 340

Tampa, FL 33619

Client Contact: Bill Stringer

Phone: 813-496-7325 Ext. 240

Cardinal Health Contact: Patrick Poisson

Phone: 815-206-1217

QTE-6121-31 1600.00

Date: May 23, 2006

CONFIDENTIAL

Pharmaceutical Technologies and Services

Biotechnology and Sterile Life Sciences Group

Woodstock, Illinois

CardinalHealth

 

 

			
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	 	Page 2
	 	 	 

Executive Summary

Cardinal Heath will provide validation services to support registration manufacturing for
Customer’s [* * *] Difluprednate multi-dose ophthalmic product (“Product”) in accordance with the
terms and conditions set forth in this Quotation.

Section 1. Version History

	 	 	 	 	 
	VERSION	 	DATE ISSUED	 	REASON
	00

	 	May 24, 2006
	 	New Issue

Section 2. Project Instructions

	2.1	 	Project. For purposes of this Quotation, the products and services to be provided by Cardinal
Health pursuant to this Quotation shall be the “Project.”
	 
	2.2	 	Project Instructions. The Project Instructions applicable to the Project (“Project
Instructions’) are the following:

	 	•	 	This Quotation, and
	 
	 	•	 	Cardinal Health’s Standard Operating Procedures in effect at the Facility,
	 
	 	•	 	Validation Master Plan
	 
	 	•	 	Validation Protocols
	 
	 	•	 	Validation Summary Reports

	2.3	 	Specifications. The Specifications applicable to the Project shall be as set forth in the
Project Instructions (“Specifications”).

Section 3. Scope of Work

	3.1	 	Cardinal Health’s Responsibilities.

	 	3.1.1	 	Facility and Equipment. Cardinal Health will provide an FDA registered drug
establishment, which is maintained in accordance with applicable US laws, rules and
regulations, including without limitation, applicable current Good Manufacturing
Practices.

	 	•	 	Cardinal Health will provide a BFS machine for validation activities.

	 	3.1.2	 	Records. Cardinal Health will provide all administration, supervision and
record keeping, as required by applicable law and in accordance with Cardinal Health’s
standard operating procedures and practices.

2200 Lake Shore Drive • Woodstock, Illinois 60098

Direct: (815) 338-9500 • Facsimile: (815) 338-3989 • www.cardinal.com/pts

CONFIDENTIAL

 

 

			
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	 	3.1.3	 	Validation Support. Cardinal Health will provide validation support as
follows:

	 	•	 	Preparation of Validation Master Plan, Validation Protocols and
Validation Summary Reports to support validation activities.
	 
	 	•	 	Particle Size Methods Transfer ([* * *]x)
	 
	 	•	 	Microfluidizer IQ/OQ ([* * *]x)
	 
	 	•	 	BFS Machine Steam Sterilization Performance Qualification ([* * *]x)
	 
	 	•	 	Process Simulation Media Fills ([* * *]x)
	 
	 	•	 	Post-Campaign Cleaning Verification ([* * *]x)

General Media Fill Requirements

	 	 	 
	Number of Batches

	 	[* * *]
	 
	 	 
	Number of Formulations

	 	[* * *]
	 
	 	 
	Number of Units per Batch

	 	Minimum [* * *]
	 
	 	 
	Resin Type

	 	[* * *]
	 
	 	 
	Container Description

	 	5mL round vial with tip/cap insertion
	 
	 	 
	Fill Weight Specifications

	 	Target 2.5g
	 
	 	 
	Batch Details

	 	Batch procedures and active ingredients
dictated by STW aseptic process validation
procedures
	 
	 	 
	Manufacturing Directions

	 	Cardinal Health PTS, LLC Standard; cGMP
	 
	 	 
	Method of Sterilization

	 	Filter Sterilization

Cardinal Health’s validation programs are extensive in nature and cover those
aspects most associated with the validation of an aseptic process. The machine
chosen for this product has been subjected to validation challenges, therefore in
some cases, actual validation will not occur. Documents would be prepared as
required to cross-reference the validation work. The Customer and Cardinal Health’s
objective is to prepare a concise well thought out document to cover the rigorous
reviews during the pre-approval inspection.

	 	3.1.4	 	Materials. Cardinal Health will provide the following raw materials:

	 	•	 	The following cGMP released components:

	 	•	 	Huntsman 6010 LDPE, as required
	 
	 	•	 	Tryptic Soy Broth (Media)
	 
	 	•	 	Biological Indicators (Bi’s)
	 
	 	•	 	Shipping carton

	 	•	 	Water for Injection for batch formulation and clean-up, tested
per current USP methodology
	 
	 	•	 	0.22 micron product sterilizing filters, as required.
	 
	 	•	 	5 micron pre-filters, as required.
	 
	 	•	 	0.2 micron air sterilizing filters, as required.

	 	3.1.5	 	In Process Tests. Cardinal Health will conduct in process tests in accordance
with the test requirements, methods and specifications provided and/or approved by
Customer and agreed to by Cardinal Health in the applicable master batch records and
validation protocols.

2200 Lake Shore Drive • Woodstock, Illinois 60098

Direct: (815) 338-9500 • Facsimile: (815) 338-3989 • www.cardinal.com/pts

CONFIDENTIAL

 

 

			
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	 	3.1.6	 	Manufacture, Inspection and Packaging. Cardinal Health will provide
manufacture, inspection and incubation of process simulation batches, in accordance
with a Master Batch Record, as follows:

	 	•	 	Set-up and takedown BFS machines.
	 
	 	•	 	Set-up tank of formulated media.
	 
	 	•	 	Blow, Fill and Seal the media solution into BFS containers
within the tolerance limits set by the master batch record.
	 
	 	•	 	Incubate product for minimum 14 days.
	 
	 	•	 	Perform visual inspection.

	 	3.1.7	 	Cleaning. Following batch manufacture, Cardinal Health will clean the
Facilities and Equipment in accordance with Cardinal Health’s standard operating
procedures.
	 
	 	3.1.8	 	Waste Disposal. Cardinal Health will engage a contractor to dispose of all
Product related waste in accordance with applicable laws, rules and regulations.
	 
	 	3.1.9	 	Post-Manufacture Review. Following manufacture of the Product as provided
above, Cardinal Health wilt review and approve the lot specific batch records, along
with in-process and finished product results from testing performed by Cardinal Health.
	 
	 	3.1.10	 	Batch Records. Cardinal Health will provide Customer with a copy of each tot specific
Batch Record.

	3.2	 	Customer’s Responsibilities

	 	3.2.1	 	Project Instructions. Customer will:

	 	•	 	Provide manufacturing instructions to enable Cardinal Health to
prepare the master batch record.
	 
	 	•	 	Provide training support for use of particle size analyzer.

Section 4. Pricing

	4.1	 	Project Pricing. Cardinal Health’s total price to perform the Project defined in this
Quotation will be [* * *] or if current media fill and BFS Machine SIP validation can be
utilized [* * *].
	 
	4.2	 	Revisions to Pricing. In addition to any reasons for price changes expressly set forth in
Exhibit 1, Cardinal Health may revise the prices provided in this Quotation if reasonably
unforeseeable circumstances affect the work required to complete the Project. Cardinal Health
will notify Customer immediately if the costs to complete the Project exceed the prices stated
in this Quotation. Cardinal Health will not commence work involving charges in excess of those
stated in this Quotation without Customer approval unless such advance notice was not possible
due to the circumstances.
	 
	4.3	 	Changes to Protocol Design. Significant changes to the protocol design, after approval of
protocol, will be re-quoted.

2200 Lake Shore Drive • Woodstock, Illinois 60098

Direct: (815) 338-9500 • Facsimile: (815) 338-3989 • www.cardinal.com/pts

CONFIDENTIAL

 

 

			
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	4.4	 	Cancellation. If Quotation is cancelled within [* * *] after Cardinal Health’s receipt of the
signed Quotation Acceptance Sheet, P0 and down payment, customer will be invoiced for all
labor and material costs incurred. If Quotation is cancelled within [* * *] after Cardinal
Health’s receipt of the signed Quotation Acceptance Sheet, P0 and down payment, customer will
be invoiced for all labor and material costs incurred, such charges will not be less than [* *
*] of the Quotation Total.

Section 5. Terms and Conditions

	5.1	 	Standard Terms and Conditions. The Standard Terms and Conditions attached to this Quotation
as Exhibit I are an integral part of this Quotation and are incorporated herein by reference.
In the event of a conflict between the terms of this Quotation and the attached Standard Terms
and Conditions, the Standard Terms and Conditions shall govern. In the event of a conflict
between the terms and conditions of this Quotation and any purchase order or other
documentation submitted by Customer, this Quotation shall govern.
	 
	5.2	 	Invoicing and Payment Terms. Cardinal Health will invoice as follows: [* * *].
	 
	5.3	 	Termination. Either party may terminate this Quotation: (i) effective upon [* * *] prior
written notice to the other party, if the other party commits a material breach of this
Quotation and fails to cure such breach by the end of such [* * *] period; provided, however,
that failure to pay amounts due under this Quotation within [* * *] after such payments are
due shall constitute cause for immediate termination of this Quotation, or at Cardinal
Health’s discretion, Cardinal Health shall be relieved of any further obligation to perform
under this Quotation until all outstanding payments are brought current, or (ii) effective
upon written notice to the other party, if the other party becomes insolvent or admits in
writing its inability to pay its debts as they become due, files a petition for bankruptcy,
makes an assignment for the benefit of its creditors or has a receiver, trustee or other court
officer appointed for its properties or assets.

2200 Lake Shore Drive • Woodstock, Illinois 60098

Direct: (815) 338-9500 • Facsimile: (815) 338-3989 • www.cardinal.com/pts

CONFIDENTIAL

 

 

			
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Quotation Acceptance Sheet

Invoice referencing the customer’s Purchase Order
Number:                                                             

(please attach Purchase Order) should be sent directly to:

	 	 	 
	Contact

	 	Address:
	Name: William Stringer

	 	3110 Cherry Palm Drive
	 
	 	 
	Telephone
	 	 
	Number: 813-496-7325x240

	 	Suite 340
	 
	 	 
	Fax
	 	 
	Number: 813-496-7328

	 	Tampa, Florida 33619
	 
	 	 
	Federal ID

	 	E-mail
	Number: 20-3943372

	 	Address: wstringer@siriontherapeutics.com

Modifications to this Quotation must be made with written approval by both parties.

THIS QUOTATION IS SUBJECT TO RECONFIRMATION AND ACCEPTANCE BY CARDINAL HEALTH AT THE TIME OF ORDER
PLACEMENT.

	 	 	 
	Customer	 	Cardinal Health PTS, LLC
	/s/ William Stringer

	 	/s/ Patrick Poisson
	 

	 	 
	Signature

	 	Signature
	 
	 	 
	William Stringer

	 	Patrick Poisson
	 

	 	 
	Printed Name

	 	Printed Name
	 
	 	 
	VP Manufacturing & Compliance

	 	Sr. Director, Business Development
	 

	 	 
	Title

	 	Title
	 
	 	 
	9-9-06

	 	9-8-06
	 

	 	 
	Date

	 	Date

	 	 	 
	Mail or fax the Acceptance Sheet to:

	 	Patrick Poisson
	 

	 	Sr. Director, Business Development
	 

	 	Cardinal Health
	 

	 	2200 Lake Shore Blvd.
	 

	 	Woodstock, Illinois 60098
	 

	 	Fax: (815) 338-3989

2200 Lake Shore Drive • Woodstock, Illinois 60098

Direct: (815) 338-9500 • Facsimile: (815) 338-3989 • www.cardinal.com/pts

CONFIDENTIAL

 

 

					
	QTE-6122-311600.00	 	EXHIBIT 1: STANDARD TERMS AND CONDITIONS	 	Page 7

 

A. Expiration.   This Quotation is valid for 30 days from the date hereof,
and becomes binding if signed and delivered by both parties during that period.

B. Audits.  Client may conduct one quality assurance facility audit per year at
no cost. Additional audits will be invoiced separately at the current rate for
such services.

C. Regulatory Inspections.   Cardinal Health will promptly notify Client of any
regulatory inspections directly relating to the Project. Client accepts
reasonable and documented costs charged by a regulatory authority for such
inspections.

D. Price Changes.   Cardinal Health may revise the prices provided in this
Quotation (i) if Client’s requirements or any Client-provided information is
inaccurate or incomplete; (ii) if Client revises Cardinal Health’s
responsibilities or the Project specifications, instructions, procedures,
assumptions, processes, test protocols, test methods or analytical requirements;
or (iii) for such other reasons set forth in this Quotation.

E. Payments.   Cardinal Health will invoice Client as set forth in this
Quotation. Cardinal Health charges a late payment fee of 11/2% per month for
payments not received by the dale specified in this Quotation (or if no date is
specified, within 30 days of invoice date). Failure to bill for interest due
shall not be a waiver of Cardinal Health’s right to charge interest.

F. Taxes.   All sales, use, gross receipts, compensating, value-added or other
taxes, duties, licenses or fees (excluding Cardinal Health’s net income and
franchise taxes) assessed by any tax jurisdiction arising from the Project are
the responsibility of Client, whether paid by Cardinal Health or Client.

G. Hazardous Materials.   Client warrants to Cardinal Health that no specific
safe handling instructions are applicable to any Client-supplied materials,
except as disclosed to Cardinal Health in writing by the Client in sufficient
time for review and training by Cardinal Health prior to delivery. Where
appropriate or required by law, Client will provide a Material Safety Data Sheet
for all Client-supplied materials and finished product.

H. Shipment.   Unless otherwise specified in this Quotation, all products and
other materials shipped by Cardinal Health are delivered EXW (Incoterms 2000)
Cardinal Health’s facilities and the title shall pass to Client upon such
delivery.

I. Limitations of Liability.  CARDINAL HEALTH’S TOTAL LIABILITY UNDER THIS
QUOTATION SHALL IN NO EVENT EXCEED THE TOTAL FEES PAID UNDER THIS QUOTATION (BUT
EXCLUDING FEES FOR PROCURING COMPARATOR DRUG). CARDINAL HEALTH’S LIABILITY UNDER
THIS QUOTATION FOR ANY AND ALL CLAIMS FOR LOST, DAMAGED OR DESTROYED API OR
CLIENT-SUPPLIED MATERIALS, WHETHER OR NOT INCORPORATED INTO FINISHED PRODUCT,
SHALL NOT EXCEED $5,000. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR
INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF
PERFORMANCE UNDER THIS QUOTATION, INCLUDING WITHOUT LIMITATION LOSS OF REVENUES,
PROFITS OR DATA, WHETHER IN CONTRACT OR IN TORT, EVEN IF SUCH PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

J. Confidentiality.   All information disclosed by a party in connection with
this Quotation shall be confidential information, unless such information is (I)
already known to the receiving party, as evidenced by written records; (ii)
independently developed or discovered by the receiving party without the use of
the disclosing party’s confidential information, as evidenced by written
records; (iii) in the public domain, other than through the fault of the
receiving party; (iv) disclosed to the receiving party by a third party not in
breach of a duty of confidentiality owed to the disclosing party; or (v)
required to be disclosed by law, or court or administrative order; provided,
that the receiving party first gives prompt notice thereof to the disclosing
party. Neither party shall, without the other party’s prior written consent, use
the confidential information of the other party or disclose such information to
anyone other than employees of the receiving party or its affiliated entities
who require such information to perform such party’s obligations under this
Quotation. This undertaking shall survive for 7 years following the date of this
Quotation.

K. Intellectual Property.   For purposes hereof, “Client IP” means all
intellectual property and embodiments thereof owned by or licensed to Client as
of the date hereof or developed by Client other than in connection with the
Project; “Cardinal Health IP” means all intellectual property and embodiments
thereof owned by or licensed to Cardinal Health as of the date hereof or
developed by Cardinal Health other than in connection with the Project;
“Invention” means any intellectual property developed by either party in
connection with the Project; “API Inventions” means any Invention that relates
exclusively to the Client IP or Client’s patented API; and “Process Inventions”
means any Invention, other than an API Invention, that relates exclusively to
the Cardinal Health IP or relates to developing, formulating, manufacturing,
filling, processing, packaging, analyzing or testing pharmaceutical products
generally. All Client IP and API Inventions shall be owned solely by Client and
no right therein is granted to Cardinal Health under this Quotation except for
use in performing the Project. All Cardinal Health IP and Process Inventions
shall be owned solely by Cardinal Health and no right therein is granted to
Client under this Quotation. All Inventions to generic API (other than API
Inventions and Process Inventions), if any, shall be owned jointly by Cardinal
Health and Client. The parties shall cooperate to achieve the allocation of
rights to Inventions anticipated herein and each party shall be solely
responsible for costs associated with the protection of its intellectual
property.

L. Warranties.   Cardinal Health will perform the Project in accordance with the
written specifications and Project instructions expressly set forth or
referenced in this Quotation and United States current Good Manufacturing
Practices or current Good Laboratory Practices, as applicable. THE WARRANTIES
SET FORTH IN THIS ARTICLE ARE THE SOLE AND EXCLUSIVE WARRANTIES MADE BY CARDINAL
HEALTH TO CLIENT, AND CARDINAL HEALTH MAKES NO OTHER REPRESENTATIONS, WARRANTIES
OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING ANY IMPLIED WARRANTIES OF
MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

M. Client.   Obligations Unless otherwise agreed to by the parties in writing,
Client is solely responsible to (i) provide complete and accurate scientific
data regarding the Project; (ii) if applicable, review and approve all
in-process and finished product test results to ensure conformity of such
results with the product specifications, regardless of which party is
responsible for finished product release; (iii) prepare all submissions to
regulatory authorities; and (iv) perform such other obligations of Client set
forth in this Quotation.

N. Indemnification.   Client will indemnify Cardinal Health, Its affiliates and
their respective directors, officers, employees and agents against any
third-party claim arising directly or indirectly from (i) the manufacture,
promotion, marketing, distribution or sale of, or use of or exposure to, the
product, API and Client-supplied materials that are the subject of the Project;
(ii) the negligence or willful misconduct of Client; (iii) the breach of this
Quotation by Client; or (iv) the use of any intellectual property provided by
Client to Cardinal Health. Cardinal Health will indemnify Client against any
third-party claim arising directly or indirectly from the negligence or willful
misconduct of Cardinal Health or the breach of this Quotation by Cardinal
Health.

O. Set-Off.   Without limiting Cardinal Health’s rights under law or in equity,
Cardinal Health and its affiliates, parent or related entities, collectively or
individually, may exercise a right of set-off against all amounts due to
Cardinal Health from Client. For purposes of this Article, Cardinal Health, its
affiliates, parent or related entities, shall be deemed to be a single creditor.

P. Force Majeure.   Neither party will be liable for any failure to perform or
for delay in performance resulting from any cause beyond its reasonable control,
including without limitation acts of God, fires, floods or weather, strikes or
lockouts, factory shutdowns, embargoes, wars, hostilities or riots, or shortages
in transportation. If the cause continues unabated for 90 days, then both
parties shall meet to discuss and negotiate in good faith what modifications to
this Quotation should result from such cause.

Q. Use and Disposal.   Client represents and warrants to Cardinal Health that
Client will hold, use and/or dispose of products and other materials provided by
Cardinal Health in accordance with all applicable laws, rules and regulations.
Client grants Cardinal Health full authority to use any Client-supplied
materials for purposes of the Project.

R. Record Retention.   Unless the parties otherwise agree in writing, Cardinal
Health will retain batch, laboratory and other technical records for the minimum
period required by applicable law.

S. Independent Contractor.   The relationship of the parties is that of
independent contractors and not of joint venturers, co-partners,
employer/employee or principal/agent.

T. Publicity.   Neither party will make any press release or other public
disclosure regarding this Quotation or the transactions contemplated hereby
without the other party’s express prior written consent, except as required by
applicable law, by any governmental agency or by the rules of any stock exchange
on which the shares of the disclosing party are listed, in which case the party
required to make the press release or public disclosure shall use commercially
reasonable efforts to obtain the approval of the other party as to the form,
nature and extent of the press release or public disclosure prior to issuing the
press release or public disclosure.

U. Amendment & Precedence.   These Standard Terms and Conditions constitute a
part of the Quotation to which they are attached (collectively, “this
Quotation”); provided that these Standard Terms and Conditions supersede any
conflicting terms and conditions set forth in the Quotation to which they are
attached or any Client purchase order. This Quotation constitutes the entire
understanding between the parties, and supersedes any contracts, agreements or
understandings (oral or written) of the parties, with respect to the Project. No
term of this Quotation may be amended except upon written agreement of both
parties.

V. Dispute Resolution.   If a dispute arises between the parties in connection
with this Quotation, the respective presidents or Senior Executives of Cardinal
Health and Client shall first attempt to resolve the dispute. If such parties
cannot resolve the dispute, such dispute shall be resolved in the jurisdiction
of the defendant party by binding arbitration in accordance with the then
existing commercial arbitration rules of The CPR Institute for Dispute
Resolution, 366 Madison Avenue, New York, NY 10017.

W. Survival.   Subject to execution, the rights and obligations of Client and
Cardinal Health in Articles I, J, K, N, T, V and W of these Standard Terms and
Conditions shall survive termination or expiration of this Quotation.

 

2200 Lake Shore Drive • Woodstock, Illinois 60098

Direct: (815) 338-9500 • Facsimile: (815) 338-3989 • www.cardinal.com/pts

CONFIDENTIAL

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