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 ###-###-####

Cardinal Health Contact: Patrick Poisson
Phone: 815 ###-###-####

QTE-6121-31 1600.00
Date: May 23, 2006

CONFIDENTIAL

Pharmaceutical Technologies and Services
Biotechnology and Sterile Life Sciences Group
Woodstock, Illinois

CardinalHealth

QTE-6121-311600.00		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)  ###-###-#### • Facsimile: (815)  ###-###-#### • www.cardinal.com/pts
CONFIDENTIAL

QTE-6121-311600.00		Page 3

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)  ###-###-#### • Facsimile: (815)  ###-###-#### • www.cardinal.com/pts
CONFIDENTIAL

QTE-6121-311600.00		Page 4

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)  ###-###-#### • Facsimile: (815)  ###-###-#### • www.cardinal.com/pts
CONFIDENTIAL

QTE-6121-311600.00		Page 5

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)  ###-###-#### • Facsimile: (815)  ###-###-#### • www.cardinal.com/pts
CONFIDENTIAL

QTE-6121-311600.00		Page 6

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 ###-###-####		Suite 340
Fax
Number: 813 ###-###-####		Tampa, Florida 33619
Federal ID		E-mail
Number: 20 ###-###-####		Address: ***@***

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)  ###-###-####

2200 Lake Shore Drive • Woodstock, Illinois 60098
Direct: (815)  ###-###-#### • Facsimile: (815)  ###-###-#### • 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)  ###-###-#### • Facsimile: (815)  ###-###-#### • www.cardinal.com/pts
CONFIDENTIAL