Document:

EX-10.41  CARDINAL HEALTH PTS,LLC QUOTATION

 

Exhibit 10.41

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

Bulk Feasibility Studies and Particle Size Methods Transfer

Version 01

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-6120-31 1600.01

Date: September 1, 2006

CONFIDENTIAL

Pharmaceutical Technologies and

Services Biotechnology and Sterile Life

Sciences Group

Woodstock, Illinois

     CardinalHealth

 

 

			
	QTE-6120-311600
	 	Page 2
	 	 	 

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

	 	 	 
	Study Type

	 	Bulk Feasibility
	 
	 	 
	Product Name

	 	[* * *] Difluprednate
	 
	 	 
	Indication

	 	Ophthalmic
	 
	 	 
	Therapeutic Category

	 	Glucocorticoid; anti-inflammatory
	 
	 	 
	Proposed Batch Size

	 	[* * *]
	 
	 	 
	Number of Batches

	 	[* * *]: [* * *] placebo coarse emulsion batches

[* * *] placebo fine emulsion batches with filtration study
	 
	 	 
	Manufacturing Directions

	 	Cardinal Health Standard — Bulk compounding only

Section 1. Version History

	 	 	 	 	 
	VERSION	 	DATE ISSUED	 	REASON
	00

	 	May 23, 2006
	 	New Issue
	 
	 	 	 	 
	01

	 	September 1, 2006
	 	Revised for bulk placebo formulation
manufacturing and added particle size
methods transfer

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 provide bulk tanks of appropriate size.

	 	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

 

 

			
	QTE-6120-311600.O1
	 	Page 3
	 	 	 

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

	 	•	 	Water for Injection for batch formulation and clean-up, tested per current USP
methodology
	 
	 	•	 	The following cGMP released in house excipients:

	 	•	 	Glycerin,
	 
	 	•	 	Boric Acid
	 
	 	•	 	Polysorbate 80
	 
	 	•	 	Sodium Edetate
	 
	 	•	 	Sorbic Acid
	 
	 	•	 	Sodium Hydroxide
	 
	 	•	 	0.22 micron product sterilizing filters, as required.
	 
	 	•	 	5 micron pre-filters, as required.

	 	2.1.5	 	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:

	 	•	 	Current USP water testing
	 
	 	•	 	pH
	 
	 	•	 	Particle Size

	 	2.1.6	 	Manufacture. Cardinal Health will provide manufacture in accordance with a
master batch record approved by the parties, as follows:

	 	•	 	Set-up and takedown of tanks, hompgenizer and microfluidizer.
	 
	 	•	 	Formulate the bulk solution using tested and released ingredient(s).
	 
	 	•	 	Execute study per batch record

	 	2.1.7	 	Cleaning. Following batch manufacture, Cardinal Health will clean the
Facilities and Equipment in accordance with Cardinal Health’s standard operating
procedures.
	 
	 	2.1.8	 	Waste Disposal. Cardinal Health will engage a contractor to dispose of all
Product related waste in accordance with applicable laws, rules and regulations.
	 
	 	2.1.9	 	Post-Manufacture Review. Following manufacture of the Product as provided
above, Cardinal Health will review and approve the lot specific batch records.
	 
	 	2.1.10	 	Batch Records. Cardinal Health will provide Customer with a copy of each lot
specific Batch Record.

	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.

2200 Lake Shore Drive • Woodstock, Illinois 60098

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

CONFIDENTIAL

 

 

			
	QTE-61 20-311600.01
	 	Page 4
	 	 	 

	 	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:

	 	•	 	Particle Size Test Method (Horiba)

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

	 	•	 	Pre-released Excipients as follows.

	 	•	 	Sodium Acetate

	 
	 	•	 	Castor Oil

	 	•	 	Reference standards, if required.

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

	 	•	 	[* * *] and I training day
	 
	 	•	 	[* * *] and operating instructions
	 
	 	•	 	[* * *] and operating
instructions
	 
	 	•	 	Misc. valves and piping

	 	2.2.5	 	Safety Information. Customer will provide all known safety information
relating to the raw materials supplied by Customer under this Quotation, including
without limitation Material Safety Data Sheets (“MSDS”) applicable to each such item.
	 
	 	2.2.6	 	Cleaning. Customer will provide cleaning method and testing support, as
necessary, for cleaning verification of product contacting equipment.

Section 3. Pricing

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

	 	 	 	 	 
	 	 	COST: [* * *] for Coarse Emulsion Studies
	 

	 	 	 	         [* * *] for Fine Emulsion and Filtration Studies

	 

	 	 	 	         [*
* *] for [***] Set-Up and Methods Transfer
	 
	 	 	 	 
	 	 	TOTAL COST: [* * *]

3.2 Revisions to Pricing. In addition to any reasons for price changes expressly set forth in
Exhibit I, 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.

2200 Lake Shore Drive • Woodstock, Illinois 60098

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

CONFIDENTIAL

 

 

			
	QTE-61 20-311600.01
	 	Page 5
	 	 	 

Section 4. Terms and Conditions

	4.1	 	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.
	 
	4.2	 	Invoicing and Payment Terms. Cardinal Health will invoice as follows:
	 
	 	 	An invoice will be issued to the customer upon execution of each set of studies and completion
of methods transfer.
	 
	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.
	 
	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

 

 

			
	QTE-61 20-311600.01
	 	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: 813-496-7325x240

	 	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 Drive
	 

	 	Woodstock, Illinois 60098
	 

	 	Facsimile: (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

CONFIDENTIALEX-10.42  BINDING LETTER

 

Exhibit 10.42

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.

PLANTEX USA, INC.

2 University Place, Suite 305

Hackensack, New Jersey 07601

July 20, 2006

Sirion

3110 Cherry Palm Drive, Suite 340

Tampa, FL 33619

Attn: Barry Butler

	 	 	 	 	 
	 

	 	Re:
	 	Proposed Development and Supply Agreement between Sirion Therapeutics, Inc.
(“Sirion”) and Plantex USA, Inc. (“Plantex”) for Diflurprednate

Ladies and Gentlemen:

     Plantex and Sirion, each a “party”, intend to pursue a business arrangement on substantially
the binding terms set forth in the term sheet attached hereto as Exhibit A (the “Term
Sheet”). Capitalized terms used and not otherwise defined herein shall have the meanings ascribed
to them in the Term Sheet.

	 	1.	 	Each party will keep the contents, terms and existence of this letter and the Term
Sheet, as well as information received from the other party (the “disclosing party”)
relating to the API, including, without limitation, technical information, know-how,
scientific information, formulae, manufacturing data and procedures, marketing information
and strategies, sales and financial data (collectively, the disclosing party’s
“Confidential Information”), in complete confidence and will not, without the prior written
consent of the other party, use or exploit, in whole or in part, any Confidential
Information other than as contemplated herein or disclose any Confidential Information to
any person not otherwise contemplated herein; provided, however that (a)
each party may disclose Confidential Information to its affiliates and third-party
manufacturers and their respective officers and employees and to their respective legal,
accounting, tax, regulatory and other professional advisors whose knowledge of such
Confidential Information, in the reasonable opinion of the disclosing party, is necessary
for assessing and/or implementing the transactions contemplated hereby; (b) each party will
use reasonable efforts to ensure that each person to whom any Confidential Information is
disclosed pursuant to clause (a) above adheres to the terms of this undertaking as if he,
she or it were a party hereto; and (c) either party may disclose Confidential Information to
the extent required by law but shall use commercially reasonable efforts to provide adequate
prior notice to the other party to seek a protective order or other relief to prevent such
disclosure. These obligations of confidentiality will terminate [* * *] from the expiration
or termination of the Term Sheet or the Definitive Agreement, as applicable.

 

 

Plantex USA, Inc.

July 20, 2006

Page 2

	 	2.	 	Sirion and Plantex acknowledge and agree that the parties will be bound by the terms of
this letter and the attached Term Sheet during the Term Sheet Term (as defined in the Term
Sheet). Upon its due execution and delivery the Definitive Agreement shall supercede this
letter and the Term Sheet.
	 
	 	3.	 	The terms and conditions of this letter and the Term Sheet shall prevail to the extent
that any terms and conditions of Sirion’s purchase orders or Plantex’s invoices are
inconsistent with this letter and the Term Sheet. No additional term or condition set forth
in any purchase order will be binding upon Plantex unless agreed to in writing by Plantex.
	 
	 	4.	 	This letter and the Term Sheet shall be construed and interpreted in accordance with
the laws of the State of New York applicable to agreements made and to be performed
entirely within such State. This letter and the Term Sheet may not be assigned or delegated
by any party without the prior written consent of the other party, and any purported
assignment or delegation without such consent shall be null and void.

     If this letter and the Term Sheet accurately reflect our agreement, please so indicate by
signing a duplicate of this letter in the space provided below and returning a copy to us,
whereupon this letter and the Term Sheet shall, subject to paragraph no. 2 above, be a valid and
binding agreement between us.

[Remainder of Page Intentionally Blank]

 

 

Plantex USA, Inc.

July 20, 2006

Page 3

     We look forward to working with you on this proposed transaction.

	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Very truly yours,	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	PLANTEX USA, INC.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	By:
	 	/s/ George Svokos
 

Name: George Svokos
	 	 
	 

	 	 	 	 	 	 	 	Title: President	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Agreed and accepted this of 20th day
of July 2006:	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	SIRION

	 	THERAPEUTICS, INC.	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Barry Butler
 

	 	 	 	 	 	 	 	 
	Name: Barry Butler	 	 	 	 	 	 	 	 
	Title: President and CEO	 	 	 	 	 	 	 	 

 

 

CONFIDENTIAL DRAFT — FOR DISCUSSION PURPOSES ONLY

EXHIBIT A

TERM SHEET

Plantex USA, Inc. (“Plantex”)

and

Sirion (“Sirion”)

	 	 	 
	Effective Date;

Term Sheet Term

	 	July 11, 2006.

Plantex and Sirion shall be bound by the provisions of this
Term Sheet during the term (the “Term Sheet Term”) beginning
on the Term Sheet Date (as defined below) and ending on the
earlier to occur of: (i) due execution and delivery of the
Definitive Agreement (as defined below); or (ii) [* * *]
from the commercial launch of the Product (as defined
below).
	 
	 	 
	Project Objective:

	 	(a) Plantex or its affiliates have developed the active
pharmaceutical ingredient Diflurprednate (the “API”);

	 
	 	 
	 

	 	(b) Sirion, its affiliate and/or licensor intends to obtain
approval of a new drug application for Diflurprednate (the
“NDA”) from the U.S. Food and Drug Administration (the
“FDA”) for sale of an ophthalmic dosage finished product
form of Difiurprednate (the “Product”) in the US (the
“Territory”); and

	 
	 	 
	 

	 	(c) Subject to the foregoing and to the terms and conditions
set forth below, Plantex shall maintain a Drug Master File
“DMF”) with respect to the API and shall supply the API to
Sirion, and Sirion shall purchase the API from Plantex.

	 
	 	 
	Drug Master File; API
Manufacture:

	 	Plantex or its affiliates shall file the DMF and, throughout
the Term Sheet Term or, if applicable, the Definitive
Agreement Term (as defined below), shall maintain the DMF.
Plantex or its affiliates shall use commercially reasonable
efforts to respond promptly to any deficiencies in the DMF
and to comply promptly with the comments of applicable
governmental regulatory authorities in respect thereof.
Plantex or its affiliates shall exercise its best efforts to
have the DMF filed no later than [* * *].

	 
	 	 
	 

	 	Sirion shall pay Plantex a DMF
filing fee of [* * *]. This fee will be payable [*
* *].
	 
	 	 
	 

	 	Plantex or its affiliates shall manufacture any API in
compliance with the applicable provisions of the Federal
Food, Drug, and Cosmetic Act and all relevant regulations,
guidelines, and guidances, including the current Good
Manufacturing

 

 

	 	 	 
	 

	 	Practices regulations (as in effect from time
to time) of the FDA contained in 21 C.F.R. pts. 210 and 211
(“cGMP”).
	 
	 	 
	Product Manufacture:

	 	Sirion, its affiliate and/or licensor shall exercise its best
efforts to file the NDA no later than [* * *]. During the
Term Sheet Term and, if applicable, the
Definitive Agreement Term,
•    to the extent that Sirion manufactures any Product, Sirion
or its affiliate shall, at Sirion’s sole cost and expense,
(i) maintain the NDA; (ii) use commercially reasonable
efforts to respond promptly to any deficiencies in the NDA
and to comply promptly with the comments of applicable
governmental regulatory authorities in respect thereof; and
(iii) manufacture any Product in compliance with the
applicable provisions of the Federal Food, Drug, and
Cosmetic Act and all relevant regulations, guidelines, and
guidances, including the cGMP.

	 
	 	 
	 

	 	•    to the extent its licensor or third-party manufacturer
manufactures any Products, Sirion or its affiliate shall, at
its sole cost and expense, obtain the agreement of such
licensor or manufacturer to (i) maintain the NDA; (ii) use
commercially reasonable efforts to respond promptly to any
deficiencies in the NDA and to comply promptly with the
comments of applicable governmental regulatory authorities
in respect thereof; and (iii) manufacture any Products in
compliance with the applicable provisions of the Federal
Food, Drug, and Cosmetic Act and all relevant regulations,
guidelines, and guidances, including the cGMP.

	 
	 	 
	Definitive Agreement:

	 	The parties shall use commercially reasonable efforts to
enter into a definitive agreement containing the provisions
contemplated herein and other provisions customary for a
transaction of this type (the “Definitive Agreement”) within
90 days after the later of the dates upon which the parties
shall have signed the letter to which this Term Sheet is
attached (the “Term Sheet Date”).
	 
	 	 
	Certain Terms:

	 	The parties agree to the following provisions, which will
also be included in the Definitive Agreement:
	 
	 	 
	 

	 	(a) Plantex shall cooperate with Sirion and shall, in a
commercially timely manner, provide Sirion with all
documentation and information relating to the API and/or the
DMF reasonably necessary for Sirion or its designee to
maintain the NDA.

	 
	 	 
	 

	 	(b) During the Term Sheet Term and, if applicable, the
Definitive Agreement Term, Sirion, its affiliates and/or
third-party manufacturers shall purchase from Plantex all

 

 

	 	 	 
	 

	 	of
Sirion’s API requirements, and Plantex shall supply API for
the Product to Sirion in such quantities as Sirion shall
determine from time to time in accordance with the terms and
conditions of this Term Sheet or the Definitive Agreement,
as applicable, on an exclusive basis for the Territory, as
long as Sirion has filed the NDA no later than [* * *] and
as long as Sirion uses its best efforts to have the NDA
approved and to launch the Product in the Territory in a
timely manner. Sirion (i) will not sell, (ii) will cause its
affiliates not to sell and (iii) will use its reasonable
efforts to cause its third-party manufacturer(s) not to
sell, to any third party, any API supplied by Plantex that
is not incorporated into the Products. Plantex reserves the
right to sell API to third parties developing,
manufacturing, distributing and selling finished
pharmaceutical products that are not the Product.

	 
	 	 
	 

	 	(c) Sirion shall provide Plantex with a [* * *] forecast on
a [* * *] basis of its API requirements. Quantities of API
forecasted for the [* * *] of each forecast shall be deemed
a firm purchase commitment binding upon Sirion.

	 
	 	 
	 

	 	(d) The price at which Sirion, its affiliates or third party
manufacturer shall purchase the API from Plantex is [* * *].

[* * *]

	 
	 	 
	 

	 	(e) Notwithstanding any other provision in this Term Sheet
or the Definitive Agreement, as applicable, during the Term
Sheet Term or the Definitive Agreement Term, as applicable,
[* * *].

	 
	 	 
	 

	 	(f) Beginning [* * *] and during [* * *], as applicable,
Sirion shall pay Plantex a royalty of [* * *]. This royalty
shall be paid, [* * *].

	 
	 	 
	 

	 	For the purpose of this Term Sheet or the Definitive
Agreement, as applicable, “net sales” shall mean the
aggregate amounts invoiced by or for the benefit of Sirion
(and any affiliates) or permitted licensees and distributees
respecting the Products sold to independent and unrelated
third parties in the Territory, less chargebacks, discounts,
credits, allowances, refunds and rebates actually provided,
all to the extent attributable to the Product and all as
determined in accordance with U.S. generally accepted
accounting principles, consistently applied.

	 
	 	 
	 

	 	(g) No party shall be liable to the other party for any
special,

 

 

	 	 	 
	 

	 	indirect, incidental, consequential damages or lost
profits, whether in contract, warranty, negligence, tort,
strict liability or otherwise.

	 
	 	 
	Marketing and
Distribution:

	 	Marketing and Marketing, distribution and sale of the
Products shall be the
Distribution: sole responsibility of Sirion. Sirion shall
use commercially reasonable efforts to market the Products.
	 
	 	 
	Representations and
Warranties;
Confidentiality and
Other
Terms:

	 	Customary for a supply arrangement of this nature as set out
in Plantex’s standard terms and conditions of supply.
	 
	 	 
	Term and Termination:

	 	The initial term of the Definitive Agreement shall be [* *
*] from the date of commercial launch of the Product thereof
(the “Definitive Agreement Term”); thereafter, the
Definitive Agreement may be extended for successive [* * *]
periods unless terminated by either party on at least [* *
*] prior written notice. The Definitive Agreement will
include other termination rights customary for a transaction
of this nature.
	 
	 	 
	Expenses:

	 	The expenses of entering into this transaction shall be
borne by each party.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00110-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00110-of-00352.parquet"}]]