Document:

EX-10.35  CONFIRMATION OF LABORATORY SERVICES

 

Exhibit 10.35

Appendix I-1

CONFIRMATION OF

CENTRAL LABORATORY SERVICES

Rx Development Resources

Protocol DE002

August 26, 2005

CONFIDENTIAL

Protocol DE002

QLAB Project Code TBD

(Version 00 exhibits dated 09 Aug 2005)

 

TABLE OF CONTENTS

	 	 	 	 	 
	PROTOCOL IMPLEMENTATION AND SUPPORT
	 	 	1	 
	A.1 Projected Time Period and Scope of Services
	 	 	1	 
	A.2 Protocol Specific Laboratory Specifications document
	 	 	1	 
	A.3 Protocol Support and Project Delays
	 	 	1	 
	A.4 Visit Specific Kits
	 	 	2	 
	A.5 Investigator Training
	 	 	2	 
	A.6 Expedited Specimen Transport
	 	 	2	 
	A.7 Dry Ice Services
	 	 	3	 
	A.8 Patient Identification
	 	 	3	 
	DATA GENERATION AND TRANSMITTAL
	 	 	3	 
	B.1 Laboratory Data Reporting
	 	 	3	 
	B.2 Notification of Alerts
	 	 	3	 
	B.3 Blinding
	 	 	3	 
	B.4 Electronic Data Transmission
	 	 	4	 
	B.5 Status Report
	 	 	4	 
	B.6 Data Retention
	 	 	4	 
	B.7 Confidentiality
	 	 	4	 
	B.8 QNETTM Software Product
	 	 	4	 
	B.9 Electronic Records
	 	 	4	 
	ANALYTICAL SERVICES
	 	 	5	 
	C.1 Laboratory Events Schedule
	 	 	5	 
	C.2 Test Groups
	 	 	5	 
	C.3 Analytical Standards and Certification
	 	 	5	 
	C.4 Analytical Methodology Comparability
	 	 	5	 
	C.5 Specimen Stability
	 	 	5	 
	C.6 Reference Ranges and Reporting Units
	 	 	6	 
	C.7 Exclusion Criteria
	 	 	6	 
	C.8 High and Low Flags
	 	 	6	 
	C.9 Telephone Alert and Panic Alert Values
	 	 	6	 
	C.10 Delta Flags
	 	 	6	 
	C.11 Specimen Retention
	 	 	6	 
	C.12 Specimen Management
	 	 	7	 
	C.13 Specimen Storage
	 	 	7	 
	C.14 Central Laboratory Auditing
	 	 	7	 
	C.15 Contractors
	 	 	7	 
	FEES AND BILLING
	 	 	7	 
	D.1 Scheduled Visit Fees
	 	 	7	 
	D.2 Kit Construction Fees
	 	 	7	 
	D.3 Transportation Fees
	 	 	8	 
	D.4 Project Setup and Project Management Fees
	 	 	8	 
	D.5 Unscheduled Visit Fees
	 	 	8	 
	D.6 Expenses
	 	 	8	 
	D.7 Terms of Project Initiation Invoicing
	 	 	9	 
	D.8 Invoices and Billing
	 	 	9	 
	D.9 Test and Fee Cancellation
	 	 	9	 
	D.10 Clinical Trial Reconciliation
	 	 	9	 
	D.1l Cancellation of the Clinical Trial
	 	 	9	 
	D.12 Approval of Fee and Period in Force
	 	 	10	 
	D.13 Currency Exchange
	 	 	10	 
	D.14 Transmission of Information
	 	 	11	 
	D.15 Insurance
	 	 	11	 

CONFIDENTIAL

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This Confirmation of Central Laboratory Services constitutes a CCLS under the Master
Laboratory Services Agreement (the “MLSA”) between Rx Development Resources (“The Sponsor”) and
Quintiles Laboratories Limited (“QLAB”) and specifies the terms and conditions upon which QLAB
will provide analytical and data management services for the clinical trial described herein. QLAB,
or its agents, make no other commitments or warranties, either expressed or implied, concerning the
scope of services to be provided during the course of this agreement. The Sponsor and its agents
recognize and affirm that the liability for any breach by QLAB shall be limited to the amount of
fees paid to QLAB by Rx Development Resources or its agents before and during the course of Rx
Development Resources Protocol DE002.

PROTOCOL IMPLEMENTATION AND SUPPORT

A.1 Projected Time Period and Scope of Services

	 	 	 
	Confirmation of Central Laboratory Services Date:
	 	August 26, 2005
	 
	 	 
	Protocol Number:
	 	DE002
	 
	 	 
	Project Initiation:
	 	October 2005
	 
	 	 
	Investigator Sites:
	 	10—United States
	 
	 	 
	Enrolled Patients:
	 	106
	 
	 	 
	Average Patients per Site:
	 	10-11

A.2 Protocol Specific Laboratory Specifications document

QLAB, in conjunction with The Sponsor, will complete a protocol specific Laboratory Specifications
document. The Laboratory Specifications document will define the protocol and procedural parameters
necessary for database construction, kit specification & design, customized requisitions & reports,
and the laboratory instruction manual.

A.3 Protocol Support and Project Delays

The Sponsor shall forward to QLAB in a timely manner all documents, materials and information in
The Sponsor’s possession or control necessary for QLAB to conduct the Services. QLAB shall not be
liable to The Sponsor nor be deemed to have breached this Agreement for errors, delays or other
consequences arising from The Sponsor’s failure to timely provide, documents, materials or
information or to otherwise cooperate with QLAB in order for QLAB to timely and properly perform
its obligations, and any such failure by The Sponsor shall automatically extend any timelines
affected by a time period reasonably commensurate to take

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into account such failure, unless The Sponsor agrees in writing to pay any additional costs
that would be required to meet the original timeline. If The Sponsor delays a project from its
agreed starting date or suspends performance of the project, then either: a) The Sponsor will pay
the standard daily rate of QLAB’s personnel assigned to the project, based on the percentage of
their time allocated to the project, for the period of the delay, in order to keep the current team
members; or, b) QLAB may re-allocate the personnel at its discretion. In addition, The Sponsor will
pay all non-cancelable costs and expenses incurred by QLAB due to the delay and will adjust all
timelines to reflect additional time required due to the delay.

A.4 Visit Specific Kits

QLAB will provide to each investigator site all materials necessary for collection and transport of
specimens to be tested at QLAB in accordance with industry standards. These materials will include
visit-specific laboratory requisitions and kits designed to meet the needs of this clinical trial.
All laboratory requisitions, collection materials and mailers will be pre-labeled with a unique
bar-coded accession number. The accession number will be used throughout the study to ensure
accurate tracking, collation, and reporting of patient laboratory data.

A.5 Investigator Training

QLAB will provide a protocol-specific laboratory instruction manual to each investigator and
training to the study coordinators in all laboratory procedures and services pertaining to this
clinical trial at the Investigator meeting. Items to be covered will include, but will not be
necessarily limited to, proper specimen collection and processing, on-site archival of frozen
specimens, and shipping of samples under conditions to maximize analyte stability. The Sponsor or
its designated representative will provide QLAB with investigator delivery addresses for supplies
and laboratory reports as well as 24-hour, 7-day telephone numbers for communication of telephone
and panic alert test results. QLAB will attend up to two (2) investigator meetings per region free
of charge. The Sponsor will be charged a professional fee for attendance at investigator meetings
in excess of this amount. QLAB will be eligible for reimbursement of all production and
distribution costs of investigator meeting materials as well as any reasonable travel-related
expenses incurred therein. All Materials will be printed in English. Documents printed in languages
other than English will result in additional fees.

A.6 Expedited Specimen Transport

If requested in the Laboratory Specifications document, QLAB will be responsible for arranging for
express shipping with a courier who provides a system by which clinical trial specimens can be
tracked during shipment. The risk of loss during shipment, however, shall be borne by The Sponsor,
and Quintiles disclaims any liability for loss or damage occurring during shipment, except to the
extent that such loss or damage is caused by the negligence or intentional misconduct of QLAB.

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In the continental United States, ambient specimens can be shipped Monday through Saturday
on the day of collection. Ambient specimen shipments from sites in Canada will be limited to Monday
through Friday on the day of collection, with the exception of remote locations. Ambient specimen
shipments from sites in Alaska and Hawaii will be limited to Monday through Thursday on the day of
collection. Frozen shipments from sites in the continental United States
and Canada will be limited to Monday through Thursday, and Monday through Wednesday for
sites in Alaska and
Hawaii.

A.7 Dry Ice Services

QLAB does not provide dry ice services. However, QLAB can assist in the coordination of dry ice
services in certain regions on an optional basis only.

A.8 Patient Identification

From customized visit specific laboratory requisitions, QLAB will collect and report patient
demographic data as required by The Sponsor’s protocols and procedures and based on QLAB’s
capabilities.

DATA GENERATION AND TRANSMITTAL

B.1 Laboratory Data Reporting

The laboratory report is custom designed to meet The Sponsor’s specific CRF format. Faxed and/or
hard copy laboratory reports are sent to the investigator centers, The Sponsor and CRO as defined
in the Laboratory Specifications document.

B.2 Notification of Alerts

QLAB will contact investigators by telephone with Telephone High, Telephone Low, Panic High, Panic
Low and Exclusion Alerts on the day testing is completed. QLAB will contact The Sponsor or its
designated representative with Panic Highs and Lows and for all flags if the investigator cannot be
reached.

B.3 Blinding

Blinding of selected laboratory results is available as an optional service from QLAB. If
The
Sponsor determines that there is a requirement for blinding of results in this clinical trial, such
requirements will be defined in the Laboratory Specifications document.

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B.4 Electronic Data Transmission

QLAB will transfer clinical trial data in one of QLAB’s standard formats or a mutually agreed-upon format, media
and schedule directly from our facility to The Sponsor’s data management
facility or designated representative
location.

B.5 Status Report

QLAB will provide The Sponsor or its designated representative with status reports throughout the
conduct of this trial summarizing the number of patients tested to date by visit for each
investigator site. The frequency and mode of distribution of the status report are defined in the
Laboratory Specifications document.

B.6 Data Retention

QLAB will maintain all electronic laboratory data compiled from this clinical trial for the term of
the clinical trial plus an additional fifteen years. At the end of that fifteen-year period, QLAB
will forward electronic records to The Sponsor or retain for an additional fee, according to The
Sponsor’s written instructions.

B.7 Confidentiality

QLAB will maintain the confidentiality of information related to the conduct and results of this
clinical trial as set forth in the MLSA.

B.8 QNETTM Software Product

If Sponsor requests the use of QNETTM in the Laboratory Specifications document, QLAB will provide
Sponsor or its designated party with the services of the QNETTM software product according to the
terms and conditions of the QNET SOFTWARE LICENSE AGREEMENT agreed to under separate signature of
both QLAB and Sponsor. QLAB will be eligible for reimbursement of all travel-related expenses
incurred with the installation of QNET at the Sponsor designated location(s) as well as
travel-related expenses incurred as part of any required QNET support.

B.9 Electronic Records

Regarding the FDA’s electronic records and signatures regulation, 21 CFR Part 11 (“Part 11”), QLAB
has a compliance plan in place as to its applicable database applications and electronic records
systems and it is working diligently to implement its plan. QLAB, however, is not responsible for
the compliance or non-compliance of applications or systems used by third

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parties (including, but not limited to, investigative sites or third party laboratories), or
for any Part 11 audits or assessments thereof, unless such applications or systems are owned by
QLAB.

ANALYTICAL SERVICES

C.1 Laboratory Events Schedule

The schedule for analytical and related laboratory services for The Sponsor’s Protocol DE002
is outlined as Exhibit A.

C.2 Test Groups

Analytical services referenced in the Laboratory Events Schedule for Protocol DE002 are outlined as Exhibit
B.

C.3 Analytical Standards and Certification

QLAB will maintain all state and federal licenses required to perform diagnostic testing on
interstate specimens. QLAB documents all in-house quality control and quality assurance programs
and will make available applicable results from inter-laboratory proficiency programs conducted by
the College of American Pathologists or similar accrediting organizations during central laboratory
audits (see section C.14 Central Laboratory Audits).

C.4 Analytical Methodology Comparability

In order to provide consistency of results throughout the clinical trial program, QLAB will
maintain the same test methodology and procedures utilized for the first laboratory-testing visit.
The Sponsor may elect to adopt new and improved technology or revised procedures whenever QLAB
makes them available. The Sponsor recognizes that circumstances beyond the control of QLAB can
arise which would preclude the use of the same testing methodology throughout the clinical trial.
Should this situation arise, QLAB will confer with The Sponsor prior to the selection of an
alternative methodology.

C.5 Specimen Stability

Analytical services will not be performed on specimens for which the elapsed time from collection
to analysis exceeds established limits of analyte stability. QLAB also reserves the right to cancel
testing on specimens whose physical or chemical condition may jeopardize result integrity.

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C.6
Reference Ranges and Reporting Units

Reference ranges and units will be those established by QLAB’s Global Technical Harmonization
Committee as those, which are appropriate and available for the test methodologies being used in
this clinical trial. QLAB reserves the right to periodically amend reference ranges as changes in
instrumentation, reagent formulation, international standards, governmental recommendations, and
testing methodologies are adopted throughout the clinical laboratory industry. However, no changes
will be implemented without the explicit knowledge and consent of The Sponsor.

C.7 Exclusion Criteria

One exclusion value for each analyte and at specified visits may be selected by The Sponsor. All
test results for a given analyte will be compared to this value. Results will be flagged as EX on
the QLAB laboratory report.

C.8 High and Low Flags

Test results will be compared to sex stratified ranges and will be flagged as High or Low if the
result violates the established range.

C.9 Telephone Alert and Panic Alert Values

Telephone and Panic Alert values will be those levels selected by the Sponsor where such levels
are appropriate and available from QLAB. QLAB reserves the right to not implement a Panic Alert
level that is inconsistent with generally accepted clinical laboratory standards. QLAB’s
Laboratory Director will discuss the setting of Panic Alert levels with the Sponsor as
appropriate.

C.10 Delta Flags

Delta flags will be reported for those patients whose laboratory values differ by a specified
percentage relative to the laboratory visit established by The Sponsor as the baseline and will be
set forth in the Laboratory Specifications document. Delta changes will be reported as +D or -D if
the checked value has increased or decreased relative to the reference visit.

C.11 Specimen Retention

All specimens will be retained for a period of up to 7 days after reporting and will be made
available for repeat testing if the elapsed time since specimen
collection falls within the
established limits of stability. Repeat testing will be performed at no additional charge if it is
required due to the negligent acts or omissions of QLAB.

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C.12 Specimen Management

QLAB will be responsible for monitoring and maintaining the temperature and other environmental
conditions for frozen specimens which are being stored for an interim period prior to batch testing
or shipping to another analysis facility. Storage times and conditions will be specified by The
Sponsor in advance of the clinical trial commencement.

C.13 Specimen Storage

Long term specimen storage is a standard service offering of QLAB. Long term storage is
defined as being a period greater than seven (7) days. If The Sponsor requests this service from
QLAB, additional fees will be included in the Line Item Budget.

C.14 Central Laboratory Auditing

The Sponsor shall have the ability, upon reasonable notice to QLAB, to visit QLAB and examine all
systems, documents and other materials related to the study. If The Sponsor audits QLAB, the
parties shall cooperate and work in good faith to resolve any unsatisfactory audit findings. In
addition, QLAB shall reasonably cooperate with and shall allow the Food and Drug Administration
(FDA) and other governmental agencies to visit QLAB and to examine all systems, documents and
other materials related to the study.

C.15 Contractors

QLAB will not retain any contractors to provide any of the services covered herein without the
consent of The Sponsor; provided, however, QLAB may in its sole discretion assign at any
time any or all of its rights and obligations under this Agreement to any of its corporate
affiliates or may utilize any such affiliates to carry out its obligations under this Agreement.

FEES AND BILLING

D.1 Scheduled Visit Fees

Scheduled visit fees which include analytical testing and specimen management services by visit
and reporting along with specimen storage, kit construction, database development and
transmissions, set up and project management, and transportation costs are included in the Line
Item Budget, attached hereto as Exhibit C (the “Budget”).

D.2 Kit Construction Fees

Kit construction fees which include the cost of visit specific collection kits and
materials, as well as shippers, are included in the Budget. Sponsor will be invoiced for these
costs at the time the collection kits are shipped to the investigator sites.

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D.3 Transportation Fees

All transportation fees in the Budget are estimates. Transportation will be handled as a direct
pass through cost to The Sponsor on the monthly invoice. QLAB applies a kit transportation
management fee to each kit for the administrative cost of managing the transportation of supplies
to the sites and the movement of samples to QLAB and/or a sponsor designated location.

D.4 Project Setup and Project Management Fees

Project Setup fees include the cost of database development, laboratory specifications development
and laboratory instruction manual development. Project Management includes, but is not limited to,
investigator support, data clarifications, turnaround monitoring, reporting (safety, pending test,
overdue frozen, and protocol status), courier performance monitoring, and sponsor communications.
The fees for Project Setup and Project Management services are included in the Budget. These fees
are estimates based upon the study length provided by The Sponsor. However, QLAB will invoice The
Sponsor for the actual period of time that service is provided. The Sponsor will be invoiced on a
monthly basis until there is written notification from The Sponsor to close all the study
activities (i.e. The study data clean up has been completed).

D.5 Unscheduled Visit Fees, Optional Test Fees, and Non-Protocol Add Test Fees

The fee for unscheduled visits is set forth in the Budget and shall be paid in accordance with the
terms set forth therein. Any additional visits not listed in the Budget are considered unscheduled
visits, fees for which are to be paid pursuant to the terms of the Budget. Unscheduled visit fees
will be invoiced during the course of the study when they occur. Fees for optional tests are set
forth in the Budget and relate to laboratory procedures required by the Protocol but performed
only on selected patients under certain conditions, and will be invoiced as appropriate during the
course of the study. (Example: Optional Test — Serum Pregnancy). Fees for non-protocol add tests
are not included in the Budget. Non-protocol add tests relate to laboratory procedures requested
by an investigator due to patient safety concerns. Costs associated with this service include
analytical, faxed laboratory reporting, handling and, if appropriate,
transportation fees. The
Sponsor will be invoiced for non-protocol add tests on the final reconciliation invoice.

D.6 Expenses

QLAB shall be reimbursed by The Sponsor for all-reasonable and necessary travel and lodging
expenses incurred in the performance of services provided herein which have been requested or
approved by The Sponsor. Additionally, investigator site special requests for supplies that are
not included in the bulk supply kit or other special requests shall be approved by and reimbursed
by The Sponsor. Payment for such services shall be made to QLAB within thirty (30) days of receipt
by The Sponsor of invoices or other evidence of such expenditures. Sponsor/CRO

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provided investigator information (name, address, phone and fax number) will be used when
shipping study collection materials to investigators, as well as the construction of investigator
data base information.

D.7 Terms of Project Initiation Invoicing

At the point The Sponsor asks QLAB to begin work on an individual project, Sponsor shall pay QLAB
an amount equal to ten percent (10%) of the applicable Budget as a project initiation
payment, which project initiation payment shall be credited back to Sponsor on the final invoice.
QLAB will draw from these funds in order to pay for services and related costs and expenses
consistent with the terms of this Agreement.

D.8 Invoices and Billing

Laboratory services will be invoiced based on the receipt of specimens. An invoice for all visit
specific specimens received during the month plus any expenses incurred will be issued to The
Sponsor the following month. Payment is due within thirty (30) days of the invoice date.

D.9 Test and Fee Cancellation

If some or all testing for a particular visit cannot be completed due to circumstances beyond the
control of QLAB, all valid test results will be reported and the total visit fee will remain in
effect. Examples of circumstances which can result in billable test cancellations would be: (1)
failure to include a specimen required to complete testing for the visit, (2) specimen handling
prior to courier pickup which does not meet written guidelines established by the laboratory and
(3) provision of a QNS specimen for which all requested testing cannot be completed.

D.10 Clinical Trial Reconciliation

When The Sponsor informs QLAB in writing of the completion or cancellation of the clinical trial,
reconciliation will be conducted. This accounting will reconcile any outstanding clinical
trial-specific project initiation expenses, scheduled or unscheduled visit fees and specimen
collection materials. A credit or debit invoice will be issued. Any additional charges not
currently received at the time of reconciliation (ie. courier services, third party laboratory
services, etc.) will be issued to The Sponsor in a separate invoice.

D.11 Cancellation of the Clinical Trial

Upon receiving written notification of early cancellation of the clinical trial, QLAB will provide
The Sponsor with an accounting of all clinical trial-specific project initiation expenses,
scheduled and unscheduled visit fees and unsalvageable specimen collection materials at the
investigator sites. QLAB will charge 6% of the Budget as a cancellation fee. If the value of

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efforts extended and supplies shipped exceeds 6% of the total Budget, an invoice will be
presented for those fees.

D.12 Approval of Fee and Period in Force

Upon receiving confirmation from The Sponsor that the project has been awarded to QLAB, QLAB will
implement project initiation activities as outlined previously in Sections A.2 and D.7. If there is
a substantive change in the expected number of investigators, number or schedule of visits, testing
requirements, anticipated commencement date, length of project or overall protocol specific
database design, QLAB will revise the Budget to reflect the increase or decrease in the scope of
work. Otherwise, the fees will remain in effect for 12 months from the date study kits were first
forwarded to investigator sites. QLAB’s fee schedule will be subject to review on an annual basis
and will be increased for the next 12 month period based upon the greater of four percent (4%) or
the average percentage change in the wages/earnings survey as published in the Economist
(or as reported at www.economist.com) over the preceding twelve (12) month period. In the
unforeseen event of governmentally mandated changes or transportation industry regulation changes
which require significant changes in the conduct of the clinical laboratory industry, QLAB will
contact The Sponsor if there will be any cost impact on the study in progress. Additionally, any
fuel surcharges, tariffs or import duties imposed on QLAB for courier services will be passed
through to The Sponsor on the monthly invoice.

D.13 Currency Exchange

The currency to be used for invoice and payment shall be the currency stated in the Budget
attached to this CCLS (the “Contracted Currency”). If a currency referenced within the Budget is
replaced by the Euro or otherwise ceases to become legal tender, the applicable replacement
currency will be substituted for such currency for the purposes of this clause using the
conversion rate established at www.oanda.com. The Sponsor acknowledges that, due to
fluctuations in currency exchange rates, QLAB’s actual fees & pass-through costs may be greater or
lesser than the budgeted or estimated amounts contained in this CCLS.

If QLAB incurs pass-through costs in a currency other than the Contracted Currency, then The
Sponsor shall reimburse QLAB for QLAB’s actual costs in the Contracted Currency based on the Oanda
foreign currency exchange rate for the applicable currencies on the last business Friday of the
month.

If this CCLS involves the performance of Services by QLAB or its affiliates in any country that
uses a currency other than the Contracted Currency, then the Budget for those services will be
based on the local rates in the currency used by QLAB for pricing in that country, but converted
to and reflected in the Contracted Currency. If the fees for Services under this CCLS exceed
$200,000, and the conversion rate between the local currencies and the Contracted Currency has
fluctuated more than 2% plus or minus, since the budget was prepared, QLAB may calculate a foreign
currency exchange adjustment. The adjustment will be calculated every six (6) months

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after the contract execution date, by comparing the foreign currency exchange rate stated in
the Budget attached to this CCLS to the Oanda average rate over the preceding six (6) months. Any
resulting decrease in costs will be immediately credited to The Sponsor and any resulting increase
in costs will be invoiced to The Sponsor, and shall be due for settlement without delay.

D.14 Transmission of Information.

All information transmitted by QLAB pursuant to this agreement will be sent by the standard
transmission method selected by QLAB (telephone, facsimile, mail, personal delivery or email). The
Sponsor hereby consents and authorizes QLAB to send facsimiles relating to the Services, or
relating to potential future services, to any office of The Sponsor or The Sponsor’s affiliates.

D.15 Insurance

During the term of this Agreement to cover its obligations hereunder, each party shall maintain
insurance coverage as follows: 1) (a) Professional Liability for QLAB in an amount of at least
US$10,000,000.00; (b) Product Liability for The Sponsor in an amount of at least US$10,000,000.00;
and 2) General Liability in amounts of at least US$3,000,000.00. All insurance amounts may be
obtained by full, individual primary policy amount; a primary amount of less than minimum
requirement enhanced by a blanket excess umbrella policy; or a combination of either. Each party
shall provide the other party with a certificate of insurance upon request. The insured shall
provide the other party with at least thirty (30) days prior written notice of any material
change, cancellation or expiration of the above-required insurance.

ACKNOWLEDGED, ACCEPTED AND AGREED TO BY:

	 	 	 	 
	/s/ Thomas Wollman
 

	 	 	9/7/05
	Thomas Wollman
	 	 	Date 
	Vice President
	 	 	 
	Global Central Laboratories
	 	 	 

Authorized Representative of Rx Development Resources:

	 	 	 	 
	Barry Butler 

(Type or print name)
	 	 	 
	 
	 	 	 
	Partner / CEO
	 	 	 
	(Type or print title)
	 	 	 
	 
	 	 	 
	/s/ Barry Butler
	 	 	 
	Signature

	 	 	9/1/05
	 

	 	 	Date 

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EXHIBIT A

	 	 	 
	 

	 	LABORATORY EVENTS SCHEDULE

	VERSION: 00

	 	START DATE (1st Lab Draw) OCTOBER 2005
	RX DEVELOPMENT RESOURCES

PROTOCOL: DE002

INDICATION: DRY EYE

                                        Number of Countries 1

	 	ENROLLMENT            6 MONTHS

PATIENT DURATION           2 MONTHS

STUDY DURATION            8 MONTHS

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	No. of	 	 	 	 	 	 	 	 	 	Early	 	 	 	 	 	Total
	COUNTRIES	 	Centers	 	Screen	 	Day 42	 	Term	 	Unsch	 	Visits
	U.S.
	 	 	10	 	 	 	150	 	 	 	106	 	 	As	 	As	 	 	256	 
	 	 	 	 	 	 	 	 	 	 	 
	TOTAL
	 	 	10	 	 	 	150	 	 	 	106	 	 	Needed	 	Needed	 	 	256	 
	 	 
	Chemistry w/ 14 Constituents
	 	 	 	 	 	 	l	 	 	 	l	 	 	 	l	 	 	 	m	 	 	 	 	 
	Haematology w/ Differential
	 	 	 	 	 	 	l	 	 	 	l	 	 	 	l	 	 	 	m	 	 	 	 	 
	Urinalysis w/ Microscopic
	 	 	 	 	 	 	l	 	 	 	l	 	 	 	l	 	 	 	m	 	 	 	 	 
	Serum b-hCG
	 	 	 	 	 	 	v	 	 	 	v	 	 	 	v	 	 	 	m	 	 	 	 	 

 

	 	 	 
	Key
	 	l Scheduled Testing
	 	 	m Unscheduled/Repeat Testing
	 	 	v Required for females of childbearing potential. Budget assumes 50% of patients.

QuintilesLaboratories\ATL\KT\9Aug2005\l\commdocs\RXDEVELOPMENT\DE002\psb\kt.V00.
09Aug2005

 

 

EXHIBIT B

LABORATORY TESTING REQUIREMENTS

VERSION: 00

RX DEVELOPMENT RESOURCES 
PROTOCOL: DE002 
INDICATION: DRY EYE

	 	 	 	 	 	 	 
	1 Chemistry

	 	1 Haematology
	 	1 Urinalysis
	 	Endocrinology
	Sodium

	 	WBC
	 	Color
	 	Serum b-hCG
	Potassium

	 	Haemoglobin
	 	Clarity/Appearance
	 	Method: Bayer Chemiluminescence
	BUN/Urea

	 	Haematocrit
	 	Specific Gravity	 	 
	Creatinine

	 	RBC
	 	pH	 	 
	Glucose

	 	MCV
	 	Protein	 	 
	Calcium

	 	MCH
	 	Blood	 	 
	Phosphorus

	 	MCHC
	 	Glucose	 	 
	Total Protein

	 	RDW	 	Ketones	 	 
	Albumin

	 	Platelet Count
	 	Bilirubin	 	 
	AST (SGOT)

	 	Differential
	 	Urobilinogen	 	 
	ALT (SGPT)

	 	Method: Beckman/Coulter/
	 	Nitrite	 	 
	Alkaline Phosphatase

	 	Microscopy
	 	Leukocyte Esterase	 	 
	Total Cholesterol

	 	 	 	Microscopic	 	 
	Triglycerides

	 	 	 	Method: Bayer Multistix/	 	 
	Method: Roche BMD

	 	 	 	Manual Microscopy	 	 

PLEASE NOTE; Quintiles Laboratories will provide the centers with all
the materials necessary for specimen collection, temporary storage and
overnight shipping of samples. Services assume that all samples will ship
protected ambient on the day of collection using standard courier services,
unless otherwise noted. Laboratory reports will be provided via fax daily
with weekly hard copies to sponsor.

 

			
	1	 	Quintiles Laboratories assumes standard test
panels. Customization of testing may result in
budget changes.

Quintiles
Laboratories\ATL\KT\9Aug2005\l\commdocs\RXDEVELOPMENT\DE002\psb\kt.V00.09Aug2005

 

 

RX
DEVELOPMENT RESOURCES

PROTOCOL: DE002

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	optional	 	 	NORTH AMERICA	 
	 	 	services	 	 	Units	 	 	Fee $	 	 	TOTAL $	 
	ADMINISTRATIVE FEES
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	lp
	 	 	 	 	 	 	 	 	 	 	 	 	 	$	6,563.50	 
	Project
Management (Monthly fee)
	 	 	 	 	 	 	8	 	 	$	360.91	 	 	$	2,887.28	 
	Date Transmission File Development — QLAB Standard Format
	 	 	 	 	 	 	 	 	 	 	 	 	 	no charge	 
	Data
Transmissions & Routine Maintenance — QLAB Standard Format
(monthly fee)
	 	 	 	 	 	 	8	 	 	$	388.89	 	 	$	3,111.12	 
	Translation Administrative Fee (per study)
	 	optional	 	 	0	 	 	$	100.00	 	 	$	—	 
	Database Modifications / Special Programming (per hour)
	 	as needed	 	 	0	 	 	$	138.89	 	 	$	—	 
	Dry Ice Coordination Fee (per shipment)
	 	as needed	 	 	 	 	 	 	 	 	 	 	 	 
	Sample Storage (per tube per month)
	 	as needed	 	 	0	 	 	$	0.56	 	 	$	—	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	ADMINISTRATIVE SUBTOTAL
	 	 	 	 	 	 	 	 	 	 	 	 	 	$	12,561.89	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	ANALYTICAL SERVICES
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Chemistry w/ 14 Constituents
	 	 	 	 	 	 	256	 	 	$	13.33	 	 	$	3,412.48	 
	Haematology w/ Differential
	 	 	 	 	 	 	256	 	 	$	13.33	 	 	$	3,412.48	 
	Urinalysis w/ Microscopic
	 	 	 	 	 	 	256	 	 	$	10.89	 	 	$	2,787.84	 
	Serum b-hCG
	 	 	 	 	 	 	128	 	 	$	24.44	 	 	$	3,128.32	 
	Non-Protocol Add Tests
	 	as needed	 	 	0	 	 	TBD	 	$	—	 
	Unscheduled/Retest Analytical Visit
	 	as needed	 	 	0	 	 	TBD	 	$	—	 
	Early Termination Analytical Visit
	 	as needed	 	 	0	 	 	TBD	 	$	—	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	ANALYTICAL SUBTOTAL
	 	 	 	 	 	 	 	 	 	 	 	 	 	$	12,741.12	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	REPORTING
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Daily Fax / Weekly Mail to Sponsor (Day of Receipt testing)
	 	 	 	 	 	 	256	 	 	$	4.00	 	 	$	1,024.00	 
	Dally Fax /
Weekly Mail (Batch &/ or ref lab testing)
	 	as needed	 	 	0	 	 	$	4.00	 	 	$	—	 
	QNETTM Laboratory Reporting Software	 	 	 	 	 	Value added service	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	REPORTING SUBTOTAL
	 	 	 	 	 	 	 	 	 	 	 	 	 	$	1,024.00	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	KITS / SUPPLIES
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Transportation Management — U.S.
	 	 	 	 	 	 	256	 	 	$	0.75	 	 	$	192.00	 
	Collection Kits — Small (1-4 tubes, baggie)
	 	as needed	 	 	0	 	 	$	5.00	 	 	$	—	 
	Collection Kits — Standard (1-10 tubes)
	 	 	 	 	 	 	256	 	 	$	8.00	 	 	$	2,048.00	 
	Bulk Supplies Box (One Per Site)
	 	 	 	 	 	 	10	 	 	$	17.11	 	 	$	171.10	 
	Diagnostic Ambient Shippers — Budget assumes 1.2 kits/shipper
	 	 	 	 	 	 	214	 	 	$	2.00	 	 	$	428.00	 
	Diagnostic Ambient/Frozen Combo Shippers
	 	as needed	 	 	0	 	 	$	9.50	 	 	$	—	 
	Diagnostic Single Frozen Shippers
	 	as needed	 	 	0	 	 	$	6.00	 	 	$	—	 
	Diagnostic Frozen Shipper (Bulk/Batch)
	 	as needed	 	 	0	 	 	$	15.00	 	 	$	—	 
	Urine Cups, Sterile ( 25 cups per site)
	 	 	 	 	 	 	250	 	 	$	0.12	 	 	$	30.00	 
	Urine Pregnancy Test Kits- Office Use
	 	as needed	 	 	0	 	 	$	51.66	 	 	$	—	 
	Miscellaneous Supplies/ Kit overage
	 	as needed	 	 	 	 	 	 	 	 	 	$	—	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SUPPLY SUBTOTAL
	 	 	 	 	 	 	 	 	 	 	 	 	 	$	2,869.10	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	TOTALS W/0 PASS-THROUGH ESTIMATES	 	 	 	 	 	 	 	 	 	$	29,196.11	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	TRANSLATION OF LAB MANUAL/FLOW CHART
	 	 	 	 	 	 	 	 	 	 	 	 	 	$	—	 
	INVESTIGATOR MEETINGS (beyond 2 meetings)
	 	 	 	 	 	 	 	 	 	 	 	 	 	$	—	 
	TRANSPORTATION: QLAB TO CENTERS
	 	 	 	 	 	 	 	 	 	 	 	 	 	$	160.00	 
	TRANSPORTATION: CENTERS TO QLAB
	 	 	 	 	 	 	 	 	 	 	 	 	 	$	1,728.00	 
	TRANSPORTATION FROM QLAB TO ANOTHER LOCATION
	 	 	 	 	 	 	 	 	 	 	 	 	 	$	—	 
	DRY ICE
	 	as needed	 	 	 	 	 	 	 	 	 	 	 	 
	Transportation Overage
	 	as needed	 	 	 	 	 	 	 	 	 	$	—	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	PASS-THROUGH SUBTOTAL
	 	 	 	 	 	 	 	 	 	 	 	 	 	$	1,888.00	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Transportation Charges are an estimate based on study
paremeters (assuming major metropolitan cities) and current
shipping costs. Actual charges will be passed through to the
sponsor. The pass-through charges may indude fuel
surcharge, duties, taxes and/or clearance/deliver charges as
applicable.	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	TOTALS W/ PASS-THROUGH
ESTIMATES	 	 	 	 	 	 	 	 	 	$	31,084.11	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

Quintiles
Laboratories\ATL\KT\9Aug2005\I\commdocs\RXDE\/ELOPMENT\DE002\psb\kt.V00.09Aug2005EX-10.36 EXCLUSIVE LICENSE AGREEMENT

 

Exhibit 10.36

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.

EXCLUSIVE LICENSE AGREEMENT

     This EXCLUSIVE LICENSE AGREEMENT (hereinafter called this “Agreement” is made and
effective as of the 15th day of June, 2006 by and between:

Laboratorios Sophia, S.A. de C.V. a legal entity duly organized and existing under
the laws of Mexico, having its principal office of business at Av. Hidalgo 737,
Colonia Centro, Guadalajara, Jalisco, C.P.44 100, Mexico (“SOPHIA”);

And

SIRION Therapeutics, Inc., a legal entity duly organized and existing under the
laws of the State of Florida, U.S.A., having its principal office of business at
3110 Cherry Palm Drive, Suite 340, Tampa, Florida 33619, U.S.A. (hereinafter called
“SIRION”);

WITNESSETH:

     WHEREAS, SOPHIA is the owner of patent rights in certain areas of the world, including the
United States, to topical ophthalmic formulations containing “Cyclosporin A” (hereinafter defined
in detail); and

     WHEREAS, SOPHIA has exclusive licensing rights, throughout the world, including the United
States, for said ophthalmic formulations containing Cyclosporin A; and

     WHEREAS, SOPHIA desires to grant SIRION an exclusive license (the “License”) to
develop, use, obtain governmental approval for, manufacture, sell, distribute, and promote an
ophthalmic solution containing Cyclosporin A in the Territory (hereinafter defined), according to
the, terms and conditions set forth herein, and SIRION wishes to receive such license and the
obligations therein; and

     WHEREAS, SOPHIA and SIRION understand and acknowledge that the exercise of this Agreement by
either Party may result in the creation of new inventions or discoveries.

     NOW THEREFORE, in consideration of the foregoing, the mutual covenants contained herein and
for other good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, SOPHIA and SIRION (SOPHIA and SIRION collectively called “Parties” and/or
individually called “Party”, and all other entities not hereto named will be referred to as
“Third Parties” hereby agree as follows:

 

 

Article 1

Definitions

     1.01 The following terms used in this Agreement shall have the meanings set forth in this
Article 1, unless the context clearly requires otherwise, and the singular shall include the plural
and vice versa. All other terms shall be afforded their generally accepted legal definitions.

     “Compound” shall mean a certain chemical substance having the chemical structure of
Cyclo[[(E)-(2S,3R,4R)-3-
hydroxy-4-methy-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl]. This
Compound is also referred to as “Cyclosporin A.”

     “Product” shall mean a the topical ophthalmic solution containing the Compound as an
active ingredient at [* * *], for the treatment of ophthalmic diseases and a ophthalmic carrier
solution referenced in US Patent # 6,071,958 known as “Sophisen”. The Product is already
commercialized in Mexico under the trademark of “Modusik-A”.

     “Effective Date” shall mean the date first above written on which this Agreement was
signed by the Parties and shall become effective.

     “First Commercialization” shall mean the date of the first commercial offer for sale
by SIRION of the Product in commercial quantities to a Third Party in the Territory according to
the terms of this Agreement.

     “Governmental Approval” shall mean any kind of approvals by the United States Food and
Drug Administration (“U.S. FDA”) or equivalent future governmental authority in the Territory,
necessary to commercialize the Product in the Territory, including, without limitation, any
approvals necessary for the development, manufacture, distribution, and sale of the Product in the
Territory.

     “Territory” shall mean the United States of America as well as Puerto Rico, Guam, the
U.S. Virgin Islands, and any other U.S. territories and possessions.

     “Cumulative Net Sales” shall mean the total Net Sales made according to this Agreement
that start to accumulate from the First Commercialization and may be calculated at any given time
during the term of this Agreement.

2

 

     “Net Sales” shall mean the gross invoiced amount charged by SIRION to sell the Product
to Third Parties in the Territory, less (a) all normal and customary deductions of any type or
nature (such as, e.g., returns, credits, refunds, discounts, allowances, rebates, chargebacks and
adjustments); and (b) freight, shipping, insurance costs, customs, duties, taxes and other
governmental charges and surcharges imposed upon the sale or distribution of the Product. However,
the deductions under this definition may not exceed [* * *] of the gross’ invoiced amount. For the
purpose of clarification, the gross invoiced amount and deductions thereof apply to aggregate,
rather than individual, sales of the Product, and do not apply to sales of anything other than the
Product, even if sold simultaneously with the Product.

     “Patent Rights” shall mean granted under U.S. Patents No.6,071,958 issued June 6, 2000
for “Sophisen” as well as any and all reissues, re-examinations, and patent term extensions
thereof.

     “Quarterly Period” shall mean each calendar quarter commencing January 1st,
April 1st. July 1st and October 1st and running through,
respectively, the following March 31st, June 30th, September 30th,
and December 31st.

     “Technical Information & Know-How” shall mean any and all scientific and clinical data
and knowledge which relate to the Product or the Compound, which are necessary or useful for the
practice of the Patent Rights and the grant of this Agreement, including without limitation, the
development of the Product, obtaining Government Approval, and the manufacture and sale of the
Product in the Territory.

     “Development Activity” shall mean any and all tests, studies and other activities for
SIRION to research and develop the Product, including but not limited to activities to obtain and
maintain the Governmental Approval in the Territory.

     “Financial Year” shall mean the annual twelve-month period that begins on January
1st in a given year and runs through December 31st of that year.

     “FDA” shall mean the United States Food and Drug Administration.

Article 2

Grant License

     2.01 SOPHIA hereby grants by way of a license to SIRION, and SIRION hereby accepts, a sole and
exclusive, running royalty-bearing license under the Patent Rights and using the Technical
Information & Know-How to make or have the Product made, develop, manufacture, use, market, offer
to sell, and sell the Product, in the Territory. This license shall not include the right for
SIRION to sell the Product from the Territory to any party outside of the Territory. The license
granted to SIRION herein shall not include the right to grant further licenses or sub-licenses to
any third party without the prior written consent of SOPHIA, such con not to be unreasonably
withheld. Nothing in this Agreement shall’ affect, and SOPHIA

3

 

shall retain the right to grant, other sub-licenses to the Product outside of the Territory.

     2.02 SOPHIA hereby represents that it has the full right and authority to enter into this
Agreement, to grant the licenses provided herein and to perform its obligations hereunder. SOPHIA
further represents and warrants that neither it, nor any of its affiliates or subsidiaries, shall
assert the rights granted to SIRION under this Article 2 in the Territory for the term of this
Agreement. SOPHIA’ additionally represents and warrants that as of the Effective Date it has not
licensed the right’ to import the Product into the Territory from outside the Territory to a Third
Party, nor will it do so itself or by way of a license to a Third Party for the term of this
Agreement.

     2.03 SIRION represents and warrants that SIRION will comply, with all applicable governmental
laws and regulations relating to the development, marketing, sale, distribution, and promotion to
sell of the Product in the Territory.

     2.04 Notwithstanding Section 2.01 above, SIRION shall have a right to contract for manufacture
of the Product in whole or in part with any Third Party in the Territory and subject to obtaining
prior written approval of SOPHIA, such approval not to be unreasonably withheld, until such time as
SOPHIA can make or have the Product made in an FDA-approved manufacturing facility suitable for
production of the Product.

     2.05 Further to Section 2.04 above, if SOPHIA at any point in the future does manufacture the
Product for SIRION pursuant to this Section 2.04, it shall do so on a “most-favored customer”
status as to price and all other material terms, i.e. SOPHIA shall manufacture the Product for
SIRION at least at the lowest price and, most favorable terms it offers to any other of its
customers. If the price offered to SIRION is higher than the current price paid to the FDA approved
manufacturer in use at the time of the FDA approval of the SOPHIA manufacturing facility, SIRION
will have the right to continue to purchase the product from said manufacturer.

Article 3

Term of Agreement

     3.01 This Agreement and the license granted therein shall become effective as of the Effective
Date and shall continue in effect until the later of (i) ten (10) years from the First
Commercialization, or (ii) the expiration or invalidation of all of the Patent Rights. At the
expiration of the term of this Agreement as stated in this article, but not its termination
according to Article 17, SIRION shall have a fully paid-up, perpetual right to the Technical
Information & Know-How.

Article 4

Technical Information and Know-How

     4.01 Within a reasonable period after the Effective hate, SOPHIA shall provide SIRION with

4

 

documentation of all Technical Information and Know-How, known to and reasonably available to
SOPHIA at the Effective Date, already translated into the English language. SIRION will be required
to conduct any translations of the Technical Information and Know-How of this section into a
language other than English at its own expense and risk. Specific items to be transferred include,
but are not limited to, manufacturing processes, non-clinical study data, and clinical study data.

     4.02 SOPHIA represents and warrants that the Technical Information and Know-How provided to
SIRION according to this article shall be reasonably sufficient for SIRION to effectively exercise
the rights granted to it by this Agreement.

     4.03 SIRION shall not use any Technical Information and Know-How provided under this Agreement
for any purpose other than the development, manufacture and commercialization of the Product during
the term of this Agreement or anytime thereafter.

     4.04 SIRION agrees and acknowledges that clinical data and information of the Technical
Information and Know-How may not comply with applicable regulatory requirements, codes and
regulations including Good Laboratory Practice and Good Clinical Practice, and that any failure to
apply and utilize for the Development Activities for obtaining Governmental Approval shall not be
deemed a breach by SOPHIA of this Agreement. Accordingly, if SIRION were to be requested or
required to conduct an additional clinical study, re-clinical study, or re-non-clinical study for
the clinical data, non-clinical data, and information involved in Technical Information and
Know-How, SIRION shall conduct them at its sole cost and risk.

Article 5

Product Development and Governmental Approval

     5.01 SIRION represents and promises that it will make a commercially diligent and reasonable
effort to, at its own expense and risk, develop, market, and promote the sale of the Product in the
Territory, including, but not limited to, performing all activities and preparation, filing, and
support of the application documents necessary to obtain Governmental Approvals in the Territory.
Specifically, SIRION shall be responsible for any and all clinical trials required to obtain
Governmental Approval, including those done on humans, at its sole cost and risk.

     5.02 SOPHIA shall provide SIRION with access to any and all documents in its possession that
might be required by SIRION to obtain Governmental Approval and not otherwise provided by this
Agreement, upon SIRION’s request, and in the English language if possible. hi the event that SIRION
requires the presence of personnel of SOPHIA in the Territory or at any location outside
Guadalajara, Mexico, S1RION shall provide SOPHIA, with reasonable anticipation, a proposed agenda
for the travel. In this case all travel, accommodation and food expenses of SOPHIA’s personnel
shall be borne by SIRION.

     5.03 Occasionally, but at least [* * *], SIRION shall provide SOPHIA with the written report
concerning the progress of all Development Activities and of obtaining Governmental Approval.
Further, SIRION shall

5

 

promptly notify SOPHIA upon obtaining any Governmental Approval in the Territory.

     5.04 Within [* * *] days after the Effective Date, SIRION shall provide SOPHIA with a
development plan and schedule of the Product in the Territory (the “Development Plan and
Schedule”) for SOPHIA’s review and comment. SOPHIA shall provide SIRION with SOPHIA’s comments
and advice, and SIRION shall take SOPHIA’s comments and advice into consideration for the
Development Plan and Schedule. In the event that SIRION renews or updates the Development Plan and
Schedule, above procedure shall again be applied.

     5.05 Notwithstanding anything else to the contrary stated herein, in the event that the
schedule of the Development Plan and Schedule is delayed due to SIRION’s complete omission and
gross negligence, SOPHIA shall have a right to notify SIRION :thereof and if SIRION fails to remedy
the situation in all material respects within [* * *] days after receiving SOPHIA’s notice then
SOPHIA shall have the option, upon notice to SIRION, to terminate this Agreement.

     5.06 Upon the request of SOPHIA, SIRION shall provide SOPHIA with any data, information and
result (the “Results”) generated from the Development Activities. SIRION agrees and
acknowledges that SOPHIA and its affiliates, subsidiaries, or sub-licensees shall have the right to
use the Results for the sole purposes of development, manufacture, obtaining the governmental
approval and sale of the Product outside of the Territory without any compensation to SIRION.
SIRION shall provide SOPHIA with the reliability assurance certificates that the Results would be
generated by SIRION in compliance with applicable GLP (Good Laboratory Practice), GCP (Good
Clinical Practice).

     5.07 Upon the request of SOPHIA, SIRION shall provide SOPHIA with any and all copies of the
New Drug Application Dossier (“NDA”) submitted to the FDA for obtaining the Governmental
Approval and copy of certificate of Governmental Approval. SIRION agrees and acknowledges that
SOPHIA and its affiliates, subsidiaries, or sub-licensees shall have the right to use, free of
charge, such copies of the NDA and copy of certificate of Governmental Approval for the sole
purposes of development, manufacture, obtaining the Governmental Approval and sale of the Product
outside of the Territory without any compensation to SIRION.

     5.08 If SIRION, in its reasonable but sole business judgment, no longer wishes to develop,
obtain Governmental Approval for, or commercialize the Product according to this Agreement, it
shall notify SOPHIA of this fact and the Parties shall discuss a resolution thereof. In such a
case, with the express written permission of SOPHIA, such permission not to be unreasonably
withheld, the terms of this Agreement may be altered or the entire Agreement terminated according
to the terms of Section 17.04. In the event of a termination of the Agreement under this section,
SIRION shall have [* * *] to pay SOPHIA any outstanding debts remaining under this Agreement.

     5.09 In the event that
 SIRION have not obtain the Governmental Approval as of the
[***], then SOPHIA shall have
 the option, upon notice to SIRION, to
terminate this Agreement.

6

 

Article 6

Marketing

     6.01 Within [* * *] of obtaining Governmental Approval, SIRION shall launch, promote, and sell
the Product in the Territory.

     6.02 SIRION shall, in advance of any sales or distribution, furnish SOPHIA with a copy of the
package inserts included with the Product, and thereafter, any revised version thereof. In all
cases the inserts shall include the notice that the Product is sold under License of SOPHIA.

     6.03 SIRION shall prepare, at its own costs and expenses, appropriate marketing, advertising
and promotional material for the Product.

     6.04 At least [* * *] months before the occurrence of First Commercialization, SIRION shall
submit to SOPHIA a sales forecast of the Product covering the [* * *] Financial Years after the
Financial Year of the First Commercialization, addressing each subsequent Financial Year
separately, including a forecast of a sales peak of the Product and its timing, for SOPHIA’s
review.

Article 7

Governance

     7.01 In an effort to facilitate this Agreement, the Parties together shall form a development
and commercialization committee (hereinafter referred to as the ‘Joint Committee’ or “JC”)
comprised of members from each Party, the purpose of which is to oversee and achieve the individual
Party requirements, including those of Articles 4, 5, and 6, as well as the ultimate success of the
Agreement. With respect to the clinical and regulatory development of the Product, the JC shall be
advisory in nature, but shall not interfere with the judgment of SIRION as to the best course of
action to achieve a regulatory approval and maximize commercial potential.

     7.02 Within ninety (90) days of the Effective Date, the Parties shall form the JC comprised of
at least one (1) and up to three (3) members from each Party, provided that the number from each
Party be equal at all times. The JC committee members shall work in mutual cooperation to achieve
the purpose of the JC. A Party’s members on the JC may be employees or consultants of, or other
individuals that are contractually bound to, such Party, and have agreed to be bound by the terms
of confidentiality and other pertinent provisions of this Agreement. The agenda of the JC shall
include the issues that each Party desires to discuss at the JC, taking into consideration the
requirements of this Agreement. and the stated purpose of the JC. Each JC member shall have
expertise in a relevant discipline, such as pre-clinical development, clinical and/or regulatory
affairs, business development, or sales or marketing. Each Party shall retain the right to change
its representatives to the JC from time to time, upon prior written notice to the other Party, or
to appoint one or more temporary substitutes to serve in the place of an absent member(s), said
substitutes to be bound by the same duties and obligations

7

 

of the members. In the event that the JC cannot come to a decision regarding an issue, then the
matter will be referred to one executive representative from each Party who are not already members
of the JC, who will discuss the matter in an effort to resolve the disagreement. It is noted that
the JC does not have the right to amend or waive compliance with the terms and conditions of the
Agreement or approve actions of the Parties inconsistent with the Agreement.

     7.03 The JC shall meet at least once every six (6) months, or more frequently as either Party
may request, at such times and at such locations as shall be mutually agreed by the Parties. In
regards the locations the Parties agree to meet once in Mexico and once in the USA, alternatively.
Meetings of the JC may be held in person, by teleconference or by videoconference. The JC members
shall set any other rules and protocols of the JC in good faith.

Article 8

Trademark

     8.01 SIRION shall have the right to select the trademark to be used in connection with its
marketing of the Product subject to obtaining prior written approval I of SOPHIA, such approval not
to be unreasonably withheld. In this case, SIRION shall, at its sole cost and risk, and at its
option (after discussion with SOPHIA), file to obtain the registration of the trademark in the
Territory, and thereafter maintain the trademark. Any trademark submitted by SIRION to SOPHIA shall
be deemed approved by SOPHIA [* * *] business days after its submission, unless SIRION receives
from SOPHIA written objection within this [* * *] day period.

     8.02 In the event that SOPHIA or its sub-licensees desire to use a trademark made by SIRION
under this article in certain countries or areas outside of the Territory, they may do so only with
the consent of SIRION, which shall not be unreasonably withheld. The Parties shall discuss and work
in good faith to agree upon terms for such use in advance of such use.

     8.03 In the event that SIRION desire to use Modusik-ATM (trademark of SOPHIA), in
connection with its marketing of the Product, it may do so, free of charge, during the term of this
Agreement. In this case, SIRION shall file to obtain the registration of the trademark in the
Territory in the name of SOPHIA. SOPHIA shall bear all cost resulting thereof, and shall remain as
the owner of the trademark.

Article 9

Availability of the Compound

     9.01 SIRION shall procure the Compound necessary for manufacture the Product for Development
Activities and for manufacture of the commercial Product, and shall file the Drug Master File to
the FDA and maintain it, at its sole cost and responsibility. SOPHIA shall cooperate with SIRION in
providing the information necessary for manufacturing of the Compound, provided, however, that the
information provided by SOPHIA will be limited to that within the possession of SOPHIA as of the
Effective Date. For the purpose of confirmation, this article does not impose upon SOPHIA any
obligations to provide or obtain any data or

8

 

information which is not in possession of SOPHIA, nor to conduct any test or study specifically for
the benefit of SIRION.

Article 10

Payments and Royalties

     10.01 In consideration of and in exchange for SOPHIA’s grant of the exclusive license in the
Territory in accordance with Article 2 above, SIRION shall, during the term of this Agreement, make
payments to SOPHIA based on the happening of events and/or sales totals, as well as royalties on
sales.

     (a) Event Payments

	 	 	 
	Milestone Event:
	 	Amount of Payment due:
	[* * *]

	 	[* * *]

     (b) Royalties. For [* * *], SIRION shall pay SOPHIA a royalty of [* * *] of its Net
Sales during each Quarterly Period that there are Net Sales under this Agreement. This royalty rate
shall apply even if there are Net Sales for only part of the Quarterly Period or the Agreement is
in effect for only part of a Quarterly Period in which Net Sales occur.

     10.02 Event and Sales Payments. Unless otherwise provided herein, no event or sales
payments to SOPHIA under this article shall be refundable in whole or in part, except in the case
of overpayment. Each of the foregoing payments shall be payable one time only, even if the event
occurs on more than one occasion. Each payment shall be: due and payable in full by SIRION within
[* * *] of completion of the applicable milestone, even if this Agreement terminates after such
event occurs.

     10.03 Royalty Payments.

     (a) SIRION shall make and keep true and accurate records of its of the Product in the
Territory. These records shall be sufficient to prove the accuracy of SIRION’s calculations of the
above royalties payable to SOPHIA. SIRION shall keep relevant records for [* * *] from the date
that SIRION has made a specific royalty payment. Upon SOPHIA’s demand, SIRION shall provide SOPHIA
with a copy of such sales records.

     (b) SOPHIA shall have the right to inspect, at its own expense, the records prepared and kept
in accordance with the above Section 10.03(a). This inspection shall be carried out by a certified
public accountant designated by SOPHIA on a confidential basis, for the sole purpose of verifying
the accuracy of any SIRION royalty payments for all or any portion of a period not exceeding [* *
*] after the date of that royalty payment. This inspection shall be

9

 

carried out during usual business hours at SIRION’s appropriate facility. The fees and expenses of
the accountants performing such inspection shall be borne by SOPHIA, as the case may be, unless any
amount actually due exceed [* * *] or more of amounts reported, in which case SIRION shall bear the
costs and expenses of such inspection.

     (c) Royalty payments made under this article shall be due in full from SIRION within [* * *]
of the end of the applicable Quarterly Period. All royalty payments shall include an accounting of
the actual amount of the Product sold, the Net Sales calculation.

     (d) Unless otherwise expressly provided herein, no royalty pay to SOPHIA under this Agreement
shall be refundable in whole or in part, except for the case of overpayment.

Article 11

Method of Payments

     11.01 Any payment from SIRION to SOPHIA under this Agreement including those under Article 10,
shall be remitted to the bank account designated by SOPHIA in United States Dollar currency by
means of a wire transfer, for which SIRION will pay any commission fees and associated costs.

Santander Overseas Bank, Puerto Rico

Account: [* * *]

ABA: 0215 02341

Swift: BKTRUS33

Beneficiary: Laboratorios Sophia SA de CV

     SIRION is responsible for, at its own cost, going through all the formalities required by
making remittance of the payments under this Agreement according to relevant prevailing local laws.

     11.02 SOPHIA and SIRION shall take any and all necessary steps or the payment to be made under
this Agreement in accordance with the Convention for Avoiding Double Taxation between US and
Mexico.

Article 12

Exchange of Information and Reports

     12.01 From time to time during the term of this Agreement, the Parties shall exchange, free of
charge, clinical and commercial data and information regarding the Compound or Product, including
applicable Technical Information and Know- that comes to either Party’s attention or is generated
by either Party during the term of this Agreement. SIRION shall not use the information it receives
under this article for any other purpose than the performance of this Agreement.

     12.02 Within a reasonable time following the Effective Date, the Parties shall

10

 

negotiate in good faith and execute a mutually acceptable pharmacovigilance agreement, and they
shall perform their respective obligations in accordance with such agreement. SIRION shall be
responsible, at its expense, for all pharmacovigilance in the territory and for compliance with all
applicable laws, regulations and requirements in connection therewith, and SOPHIA shall be
responsible, at its expense, for all, pharmacovigilance in Mexico, such that it has governmental
approval for the Product there, and for compliance with all applicable laws, regulations and
requirements in connection therewith. The Parties acknowledge that the pharmacovigilance agreement
shall also cover the exchange of safety data relating to the Product.

     12.03 SOPHIA shall have the right to disclose any mat disclosed by SIRION under this article,
to any Third Party, free of charge to that Third Party, including SOPHIA’s existing and future
licensees outside the Territory.

     12.04 SIRION shall not use any materials provided under this article for any purpose other
than the ophthalmological use of the Compound or of the Product as a result of the exercise of this
Agreement.

11

 

Article 13

Maintenance of the Patent Rights

     13.01 SOPHIA shall be responsible for the maintenance of the Patent Rights, including by
payment of any fees required therein, and accordingly represents and warrants that it will do so
for the term of this Agreement. SOPHIA shall provide yearly updates to SIRION regarding the status
of the Patent Rights included in this Agreement.

Article 14

Patent Litigation

     14.01 In the event that SIRION is aware of or suspects that a Third Party is violating the
Patent Rights, it shall immediately notify SOPHIA of this fact. Thereafter, the litigation or
settlement of such a matter will be SIRION’s responsibility and at its cost, provided that SOPHIA
shall have the option, but not the obligation, to participate in any litigation or settlement
thereof. If SOPHIA decides to participate in such litigation or settlement, the Parties shall
cooperate for a mutually beneficial resolution of the matter, including the distribution of any
monetary award. In the event that SOPHIA declines to participate in such litigation or settlement,
SIRION shall have the right to pursue a remedy for its own benefit at its sole cost and
responsibility, however, SIRION shall obtain the prior written consent of SOPHIA before any
settlement thereof, such consent not to be unreasonably withheld. SOPHIA shall provide reasonable
assistance, without any monetary obligation, to SIRION in the enforcement of any patent rights
infringement claims, regardless of whether or not SOPHIA participates in such litigation or
settlement.

     14.02 In the event that SIRION is sued by a Third Party for patent infringement for its
exercise of the rights granted by this Agreement, it shall immediately notify SOPHIA of this fact.
Thereafter, the defense or settlement of such a matter will be SIRION’s responsibility and at its
cost, provided that SOPHIA shall have the option, but not the obligation, to participate in any
litigation or settlement thereof. If SOPHIA participates in such a matter, the Parties shall
cooperate for a mutually beneficial resolution of the matter. In the e that SOPHIA declines to
participate in such a matter, SIRION shall obtain the prior written consent of SOPHIA before any
settlement thereof, such consent not to be unreasonably withheld. SOPHIA shall provide reasonable
assistance, without any monetary obligation for the payment of damages, losses, settlements or
litigation expenses and any other form of running royalty or compensation to such Third Party, to
SIRION in the defense of patent infringement claims, regardless of whether or not SOPHIA
participates in such litigation or settlement.

Article 15

New Inventions or Discoveries

     15.01 Any new inventions or discoveries, whether patentable or not, made by the Parties
jointly or solely by SIRION as a result of the exercise of this Agreement, shall be the SOPHIA’s
property. SIRION shall have the first refusal right to execute and new license agreement for such
new inventions or discoveries in the field of ophthalmics inside of the

12

 

Territory. In this case, the Payments and Royalties conditions of the new license agreement
shall be the same as the established in the Article 10 of this Agreement [* * *]. The Parties shall
cooperate in any patent application procedures for inventions or discoveries made under this
section.

Article 16

Representations and Warranties

     16.01 SOPHIA SHALL MAKE NO WARRANTIES WHATSOEVER, EXPRESS OR IMPLIED, WITH RESPECT TO THE
PRODUCT MANUFACTURED AND/OR SOLD HEREUNDER INCLUDING WITHOUT LIMITATION ANY WARRANTY OF THE
MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE OF THE PRODUCT SOLD BY SIRION.

     16.02 SOPHIA SHALL MAKE NO WARRANTIES WHATSOEVER, EXPRESS OR IMPLIED, THE PATENT RIGHTS,
TECHNICAL INFORMATION AND KNOW-HOW AND PRODUCT MANUFACTURED AND/OR SOLD HEREUNDER WILL NOT INFRINGE
ANY THIRD PARTY’S INDUSTRIAL PROPERTY IN THE TERRITORY.

Article 17

Termination

     17.01 Notwithstanding the term of this Agreement, defined in Article 3, either Party may
terminate this Agreement (and all obligations therein) at any time by giving written notice to the
other Party in the event that:

     (i) the other Party materially defaults on this Agreement, or is in breach of the performance
of any material obligation imposed on it by this Agreement, and such breach or default is not
remedied in all respects within [* * *] days of receipt of a written demand from the notifying
Party to cure the breach or default; OR

     (ii) the other Party shall have become insolvent or bankrupt, or shall have made a general
assignment for the benefit of its creditors, or any case or proceeding s have been commenced by or
against the Other Party in bankruptcy or seeking reorganization, liquidation, dissolution, or any
such relief under any bankruptcy, insolvency, reorganization or other similar act or law, and any
such event shall have continued for [* * *] days undismissed or undischarged.

     17.02 If this Agreement is terminated at the request of SOPHIA in accordance with this article
SIRION shall promptly cease its development activities, and/or commercial activities, as the case
may be, concerning the Product, and, at its option, destroy the Product then stocked by SIRION, or
sell the remaining inventory of the Product and settle its obligation, if any, to pay any royalties
or other payments due under this Agreement within [* * *] days after the termination thereof.
Additionally, upon SOPHIA’s request, SIRION shall return to SOPHIA all the Technical

13

 

Information and Know-How provided by SOPHIA under this Agreement and shall assign to SOPHIA,
without any compensation, all the rights, titles and interests pertaining to the Product.

     17.03 Expiration or termination of this Agreement shall not affect the rights and obligations
of the Parties which are expressly intended to survive expiration or termination of the Agreement,
including, without limitation, those rights and obligations set forth in this article.

     17.04 In the event of any termination (but not expiration) of this Agreement, at SOPHIA’s
request, SIRION will arrange for the transfer of any and all of the title and interest in any of
the Governmental Approvals for the Product, including any related documents, free of charge, to
SOPHIA or any third party that SOPHIA designates. Additionally, in the event of any termination of
this Agreement, at SOPHIA’s request, SIRION will return any information and materials provided to
it by SOPHIA, including the Technical Information and Know How, and provide SOPHIA, free of charge,
with any information and material including raw data, related to the Product, that it produced as a
result of this Agreement. SOPHIA shall have a right, without compensation to SIRION, to use or to
have any third party use such information, materials, raw data for any purpose. For the purpose of
clarification, in the event that this Agreement terminates according to this article, then SIRION
shall not have the continuing right to the Technical Information & Know-How that is stated in
Article 3.

Article 18

Confidentiality

     18.01 Both Parties hereto undertake to keep confidential all of the information and reports,
materials, data, results of the investigations and other materials regarding the Compound or the
Product which is received from or provided by the other Party under this Agreement, including
Technical Information and Know-How under Article 4, and is marked or otherwise indicated that the
same is confidential in nature (hereinafter collectively called “Information” in this article),
provided, however, that such Information as itemized below shall be excluded from this
confidentiality obligation:

     (i) Information which was at the time of disclosure in the public domain;

     (ii) Information which after the time of disclosure became a part of the public domain,
through no fault or act of omission by the recipient Party;

     (iii) Information which was at the time of disclosure lawfully in the recipient’s possession
on a non-disclosure basis;

     (iv) Information received from any Third Party who has no obligation to keep the Information
confidential against any of Parties hereto;

     (v) Information which may be disclosed to Third Parties according to the terms of this
Agreement; OR

14

 

     (vi) Information which both Parties hereto agree in writing to disclose to a Third Party or to
make public; provided, further, that the recipient Party shall have t proof for proving the fact
that the Information in question falls into the category of any of the exceptions herein above.

     18.02 Notwithstanding the provisions of this article, SIRION may disclose the Information
disclosed by SOPHIA to its directors, officers, employees, consultants or contract workers,
engaging in any activity for the development or commercialization of the Product including clinical
studies and other activities for obtaining the Governmental Approval in the Territory and contract
manufacturer of the Product under Section 2.04, so far as the disclosure is necessary for their
performance of such activity, provided, however, that SIRION shall take any adequate measure to
cause such persons to keep the information disclosed confidential under the same conditions
provided in any provision of this Agreement.

     18.03 Notwithstanding the provision of this article, SOPHIA may, disclose the Information
disclosed by SIRION, to its licensees, officers, employees, consultants or contract workers
engaging in any activity for the commercialization of the Product including clinical studies and
other activities for obtaining and maintaining the Governmental Approval outside the Territory, or
for obtaining patent rights including any patent application and prosecution of the patent
application, so far as the disclosure is necessary for their performance of such activity,
provided, however, that SOPHIA shall take any adequate measure to cause them to keep the
Information disclosed confidential under the same conditions provided in this article of this
Agreement.

     18.04 Notwithstanding this article, a Party (a “disclosing Party”) may disclose the
Information of the other Party (the “nondisclosing Party”) in response to a valid order of a court
or any governmental agency or regulatory body or as otherwise required by law or regulation or the
requirements of the exchange or listing body on which a disclosing Party’s securities are listed;
provided that, the disclosing Party notifies the non-disclosing Party of such requirement so that
the non-disclosing Party may seek a protective order or other appropriate remedy; and provided
further that, in the event that no such protective order or other remedy is obtained, then the
disclosing Party will furnish only that portion of the nondisclosing Party’s Information which it
is advised by counsel it is legally required to furnish and will exercise all reasonable efforts to
obtain assurance that confidential treatment will be accorded the Information so furnished.

     18.05 The provisions of this article shall survive for [* * *] years upon the expiration or
early termination of this Agreement.

Article 19

Publication and Publicity

     19.01 Neither Party shall use the name of the other Party in any publicity or advertising
without the prior written approval of an authorized representative of that other party.

     19.02 Each Party agrees not to issue any public statement, press release or other disclosure
to

15

 

Third Party concerning the existence of or terms of this Agreement, without first obtaining the
prior written approval of the other Party and agreement upon the nature and text of such
announcement or disclosure, provided however that neither Patty will be prevented from complying
with any duty of disclosure it may have pursuant to law or governmental regulation or pursuant to
the rules of any recognized stock exchange or related body. The Party desiring to make such public
announcement or other disclosure shall inform the other Party of the proposed announcement or
disclosure in reasonably sufficient time prior to public release, and shall provide the other Party
with a written copy thereof, in order to allow such other Party to comment upon such announcement
or disclosure.

Article 20

Governing Laws and Arbitration

     20.01 This Agreement shall be governed by and interpreted in accordance with the Laws of the
United States of America.

     20.02 All disputes, controversies or differences which may arise between the Parties hereto or
for the breach thereof shall be referred to and settled by arbitration in accordance with the
Arbitration Rules of the International Chamber of Commerce as currently in force by one or more
arbitrators appointed under such Rules. Such arbitration here shall be conducted in the English
language and shall be held in Mexico if the arbitration is requested by SIRION, and in the United
States if the arbitration is requested by SOPHIA. The determination of the arbitration shall be
final, binding and conclusive upon the Parties hereto. Notwithstanding anything herein to the
contrary, the relevant cure periods for breach under this Agreement shall toll while either Party
pursues resolution to a dispute through arbitration.

Article 21

Parties in Interest

     21.01 Nothing in this Agreement, whether express or implied, is intended to confer any rights
or remedies under or by reason of this Agreement on any persons other than the Parties to it and
their respective successors and assigns, nor is anything in this Agreement intended to relieve or
discharge the obligation or liability of any third persons to any party to this Agreement, nor
shall any provision give any third persons any right of subrogation or action over or against any
party to this Agreement.

Article 22

Independent Contractor Status, No Agency

     22.01 SOPHIA’s and SIRION’s activities hereunder shall be conducted as independent contractors
and no agency relationship shall exist between the parties.

Article 23

Force Majeure

16

 

     23.01 Neither Party hereto shall be liable for any failure to perform as required through this
Agreement by reason of Force Majeure, to the extent s failure to perform is due to circumstances
reasonably beyond the control of such Party, such ‘as requisition or interference by any
government, state or local authorities, war, strikes, lockout or other labor disputes, civil
disorders or commotions, act of aggression, acts of God, energy or Other conservation shortages,
disease, or occurrences of a similar nature.

     23.02 If and when any Party is hindered in its performance of its obligations under this
Agreement by reason of Force Majeure, the performance of those obligations shall be suspended for
the duration of, but not longer than, the continuance of such circumstances.

     23.03 Either Party hereto whose performance of obligation has been hindered by reason of Force
Majeure shall inform the other Party immediately, and shall use its reasonable best effort to
overcome the effect of the Force Majeure.

Article 24

Authentic Text

     24.01 This text of this Agreement in the English language shall be authentic text, and any text in
another language, even if such text is made by translation of this text of this Agreement or
prepared by any of the Parties hereto for any purpose, shall have no meaning for any purpose
between the Parties hereto.

Article 25

Entire Agreement

     25.01 This Agreement shall constitute the entire agreement between the Parties hereto
concerning the subject matter hereof and shall supersede any other agreements, whether oral or
written, express or implied, and may not be changed or modified or revised except as specifically
agreed upon by the Parties hereto in a written: document bearing the respective signatures of the
authorized officers.

Article 26

Separability

     26.01 Even in the event that any portion of this Agreement shall be held illegal, void,
ineffective or unenforceable, the remaining portion shall remain in full force and effect.

     26.02 If any of the terms or provisions of this Agreement are in conflict with any applicable
statute or rule of law, such terms and provisions shall be deemed inop to the extent that may
conflict therewith and shall be deemed to be modified to conform 1 such statute or rule of law.

17

 

     26.03 In the event that -the terms and conditions of this Agreement are materially altered as
a result of the provision in Section 25.01, or other sections of this Agreement, the Parties will
re-negotiate the terms and conditions of this Agreement to resolve any inequities.

Article 27

Notice

     26.01 Any notice to be given to a Party under or in connection with this Agreement shall be in
writing and shall be (i) personally delivered, (ii) delivered by an internationally recognized
overnight courier, (iii) delivered by facsimile transmission to the Party, at the address or
facsimile number set forth below for such Party or such other address or facsimile number as a
Party may from time to time designate by written notice to the other:

	 	 	 
	If to SOPHIA:

	 	If to SIRION:
	Eleuterio Lopez Sanchez

	 	Barry Butler
	Av. Hidalgo 737, Colonia Centro

	 	3110 Cherry Palm Drive, Suite 340
	Guadalajara, Jalisco, C.P. 44100

	 	Tampa, FL 33691
	Mexico

	 	USA
	Facsimile: (33) 3942-5644

	 	and
	 

	 	Reid Haney
	 

	 	Ward Rovell, Professional Association
	 

	 	101 E. Kennedy Blvd.
	 

	 	Suite 4100
	 

	 	Tampa, FL 33602
	 

	 	U.S.A.
	 

	 	Facsimile: (813) 222-8701

     26.02 Any such notice shall be deemed to have been received the addressee where the notice or
other document is sent by overnight courier, by hand or is given by facsimile, simultaneously with
the transmission or delivery. To prove the giving of a notice or other document it shall be
sufficient to show that it was dispatched.

     IN WITNESS WHEREOF, SOPHIA and SIRION have caused this Agreement to be executed in duplicate
counterparts by their duly authorized officers, each fully executed copy hereof to be deemed as
original, as of the date and year first above written.

	 	 	 	 	 	 	 	 	 
	SOPHIA:	 	 	 	SIRION:
	Laboratorios Sophia	 	 	 	SIRION Therapeutics, Inc.
	 
	 	 	 	 	 	 	 	 
	Signature:

	 	/s/ Eleuterio L. Sanchez
	 	 	 	Signature:
	 	/s/ Barry Butler
	 

	 	 
	 	 	 	 	 	 
	Name:

	 	Eleuterio Lopez Sanchez
	 	 	 	Name:
	 	Barry Butler
	Title:

	 	General Director
	 	 	 	Title:
	 	Chief Executive Officer
	Name:

	 	Hector E. Hernandez Magos	 	 	 	 	 	 
	Title:

	 	Attorney In Fact	 	 	 	 	 	 

18

 

WITNESSES

	 	 	 	 	 	 	 	 	 
	Signature:

	 	/s/ Fernando Manuel Tamez Orozco
	 	 	 	Signature:	 	 
	 

	 	 	 	 	 	 	 	 
	Name:

	 	Fernando Manuel Tamez Orozco
	 	 	 	Name:	 	 
	 

	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	Signature:

	 	 	 	 	 	Signature:	 	 
	 

	 	 
	 	 	 	 	 	 
	Name:

	 	Jose Ruben Tornero Montano
	 	 	 	Name:	 	 
	 

	 	 	 	 	 	 	 	 

19

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