Document:

EX-10.14 Agreement with Pharmaceutics Int'l Inc

 

Development of Vigabatrin (Racemic Mixture) Film-Coated Tablets Leading

to the Manufacture of Clinical Trial Materials to Support a Phase II Study

 

	 	 	 
	CPP Contact:

	 	Patrick J. McEnany, Chief Executive Officer
	 

	 	Catalyst Pharmaceutical Partners
	 

	 	220 Miracle Mile, Suite 234
	 

	 	Coral Gables, FL 33134
	 
	 	 
	Phone:

	 	(305) 529-2522
	Fax:

	 	(305) 529-0933
	Email:

	 	mcenanv@bellsouth.net
	 
	 	 
	PII Contacts:

	 	Tammy Bryan, Associate Director, Business Development
	 

	 	David Fidler, Director Project Management
	 

	 	Pharmaceutics International, Inc.
	 

	 	10819 Gilroy Road
	 

	 	Hunt Valley, MD 21031
	 
	 	 
	Corporate Phone:

	 	(410) 584-0001 ext. 239 (TB)
	 

	 	(410) 584-0001 ext. 156 (DF)
	Corporate Fax:

	 	(410) 584-0007
	Email:

	 	tbryan@pharm-int.com / dfidler@pharm-int.com

Project number: 12CAT01

The proposal is split into three sections:

(A) Project Definition and Scope

(B) Costs

(C) Legal and Signatures

(A) Project Definition and Scope

Catalyst Pharmaceutical Partners (CPP) requires PII (Pharmaceutics International, Inc.) to develop
the formulation, perform scale-up and manufacture Clinical Trial Materials (CTM) to support a Phase
II Study for Vigabatrin tablets. PII will manufacture 100,000 tablets of Vigabatrin tablets (250
mg, 300 mg, 500 mg or 750 mg strength), the ultimate strength and color to be determined by CPP.
CPP filed the IND for vigabatrin in the treatment of cocaine addiction on December 1, 2004 and has
been accepted by the FDA.

CPP plans to conduct an approximate 100 patient multi-center double-blind, placebo controlled
Phase II study using the CTM developed by PII under this agreement. This study may in fact be
the “pivotal” study for the NDA.

The product needs to be completely bioequivalent to Sabril (per FDA’s minutes-ATTACHED) and
contain exact excipients per the Sabril Canadian monograph.

					
	 	 	 	 	 
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“Product” in Section C refers to Vigabatrin.

The documentation for PII’s activities will be complete, accurate and suitable for submission to or
review by regulatory authorities in the event CPP submits an application for marketing for a dosage
form developed by PII.

CPP has the right to audit PII at reasonable times and in a reasonable manner. PII will be required
to notify CPP of any inspection by FDA or other regulatory authorities, any observations or other
communications, and PII’s response. CPP will be notified of any inspection relating to the CPP
project immediately, and will have the right to participate in the inspection and review any
responses. Neither PII, nor any of it’s subcontractors use the services of any individual that has
been debarred.

Vigabatrin drug substance should be stored at controlled room temperature (15C -30C) protected from
moisture.

CPP will supply:

	•	 	API — Vigabatrin with Certificate of Analysis (C of A) and Material Safety Data
Sheet (MSDS)
	 
	•	 	Reference standard and impurities
	 
	•	 	Technical data package, if any
	 
	•	 	Quantitative formulation
	 
	•	 	Product samples of the Sabril 500 mg tablet (10) and 500 mg sachet, C of A,
MSDS
	 
	•	 	Analytical methods for API and drug product with validation package, if available
	 
	•	 	Safety Information (for NCEs): Investigator’s Brochure or Summaries of Pre-
clinical safety/activity data, where available, including:

	 	•	 	Safety Pharmacology Studies
	 
	 	•	 	Mutagenicity Studies (eg. AMES test)
	 
	 	•	 	Non-GLP and/or GLP acute and sub-chronic/chronic toxicity trials in any
species
	 
	 	•	 	Pharmacology Summary
	 
	 	•	 	Teratogenicity Studies

PII will order and invoice to CPP at cost plus 10%:

	•	 	Excipients
	 
	•	 	Packaging components — HPDE bottles
	 
	•	 	Analytical columns

					
	 	 	 	 	 
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	•	 	Tooling

PII Services:

	1.	 	Materials: PII will order sufficient materials for all
activities in this proposal. PII will use stock excipients
where possible and will bill for materials and testing at the
completion of this contract.

	 	1.1	 	Vigabatrin — PII will receive with C of A and perform ID testing.

	 	1.1.1	 	Description.
	 
	 	1.1.2	 	Identification by IR (USP <197K>).
	 
	 	 	 	API usage table:

	 	 	 
	Cleaning method development and validation

	 	5gm
	Preformulation activities for dissolution, API
characterization and tablet compaction properties

	 	600 gm
	Formulation Development — 2 prototypes x 10,000 batch sizes

	 	5.0 Kg
	Feasibility Batch Size of 100,000
tablets

	 	50.0 Kg
	CTM batch size of 100,000 tablets

	 	50.0 Kg
	Analytical method development and validation for dissolution,
assay and related substance

	 	5-10gm
	Subtotal

	 	105.61 Kg
	Overage-30%

	 	33.4 Kg
	Total

	 	109.01 Kg *

			
	*	 	Based on 500 mg strength

	 	1.2	 	Excipients — PII will receive and perform all appropriate testing, including ID testing.

	 	•	 	Magnesium Stearate (Lubricant)
	 
	 	•	 	Ac-Di-Sol or Sodium Starch Glycolate (Disintegrant)
	 
	 	•	 	Colloidal Silicon Dioxide
	 
	 	•	 	Microcrystalline Cellulose (Avicel PHI01)

	 
	 	•	 	Colorcon Opadry Film Coating Materials (to be confirmed)
	 
	 	•	 	Cab-O-Sil (Glidant)
	 
	 	 	 	NOTE: Excipients may be adjusted based on initial studies

					
	 	 	 	 	 
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	 	1.3	 	Packaging components — PII will receive on C of C and perform ID release
testing.

	 	•	 	HDPE bottles
	 
	 	•	 	Child Resistant Closures

	2.	 	Pre-formulation

	 	2.1	 	PII will review CPP supplied information including purity profiles,
process related degradants, and related substances of API.
	 
	 	2.2	 	PII will perform the following studies on the API:

	 	•	 	Bulk / Tap Density
	 
	 	•	 	Flow
	 
	 	•	 	Screen Analysis
	 
	 	•	 	Appearance
	 
	 	•	 	Hygroscopicity at 25°C/60%RH (6 hours, 24 hours, 48 hours)

	 	2.3	 	Tablet compaction properties (neat API with lubricant)

	3.	 	Formulation Development — Two (2) prototype batch sizes up to 10,000 film-
coated tablets (5.0 kg API)

	 	3.1	 	PII will review the technical data package supplied by CPP and prepare a
development protocol to be authorized by CPP prior to initiation of
formulation activities. CPP will provide quantitative formulation prior to
the start of the development activities.
	 
	 	3.2	 	PII will develop (2) prototypes (batch sizes of up to 10,000 tablets).
	 
	 	3.3	 	The first prototype batch will be a batch of core tablets at the smallest
reasonable scale (approximately 3,000 tablets) needed to determine the
compression characteristics and compression parameter ranges. (The core
tablet formula will be composed of Vigabatrin, Avicel PH101 (or
equivalent), Ac-Di-Sol (or equivalent), Cab-O-Sil (or equivalent), and
magnesium Stearate.
	 
	 	3.4	 	The second prototype batch will be a batch to optimize process and
coating parameters.
	 
	 	3.5	 	The prototypes will be packaged in HPDE bottles of 100 count.
	 
	 	3.6	 	The prototypes will be tested for the following in-process tests:

					
	 	 	 	 	 
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	 	3.6.1	 	Tablet properties (hardness, thickness, weight and friability)
	 
	 	3.6.2	 	Bulk and Tap Density / Flow
	 
	 	3.6.3	 	Sieve Analysis

	 	3.7	 	The prototypes will be tested for the following finished product tests:

	 	3.7.1	 	Physical Appearance
	 
	 	3.7.2	 	Assay and related substances
	 
	 	3.7.3	 	Dissolution Profile
	 
	 	3.7.4	 	Moisture -KF
	 
	 	3.7.5	 	Hardness Profile

	 	3.8	 	Prototypes will be placed on accelerated stability at 40°C/75% RH and
will be tested at 1, 2 and 3 months for dissolution profile and assay and
related substances.

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Condition	 	Initial	 	1 Month	 	2 Months	 	3 Months
	40°C/75%RH

	 	X
	 	 	X	 	 	 	X	 	 	 	X	 
	25°C/60%RH

	 	 	 	 	0	 	 	 	0	 	 	 	0	 

 

0-Optional

*Note: The formulation development for CPP’s Vigabatrin equivalent to Sabril shall be owned
exclusively by CPP.

	4.	 	Manufacture of Feasibility / Scale-up Batches — One (1) active batch size up to 100,000 Vigabatrin
250 mg or 500 mg film-coated tablets (50.0 kg API) and one (1) placebo batch size up to 10,000
tablets

	 	4.1	 	Materials: See Section 1.1 & 1.2
	 
	 	4.2	 	PII will develop a matching placebo based upon the data obtained in
Section 3. Per CPP the placebo will be of the same physical dimension as
the active tablet. The run weight does not need to match the run weight of
the active tablet and is at PII’s discretion. The physical appearance and
size are the critical design parameters for the placebo tablets.
	 
	 	4.3	 	PII will prepare Batch Records that will be used for the manufacture of the
Feasibility Batch.
	 
	 	4.4	 	PII will use the following equipment train as needed:

	 	4.4.1	 	V-Blender
	 
	 	4.4.2	 	Comil
	 
	 	4.4.3	 	Roll Compactor / Mill (if required)
	 
	 	4.4.4	 	Tablet Press

					
	 	 	 	 	 
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	 	4.4.5	 	Coating Pan

	 	4.5	 	PII will manufacture (1) Feasibility Batch of Vigabatrin 500 mg tablets
and one (1) Matching Placebo.
	 
	 	4.6	 	Operators will use appropriate personal protective equipment.
	 
	 	4.7	 	A portion of the Feasibility Batch will be packaged in HDPE bottles of
100 count to satisfy stability requirements and placed on accelerated
stability at 40°C/75% RH and tested at 1, 2, and 3 and at 25°C/60% at 6
months. PII will comply with good documentation practices and that all
underlying data will be accurate, complete and suitable for submission to
or review by regulatory authorities.

	 	4.8	 	PII will perform the following in process testing for the blend and tablets:

	 	4.8.1	 	Tablet properties (weight, thickness, hardness and friability)
	 
	 	4.8.2	 	Bulk and Tap Density / Flow
	 
	 	4.8.3	 	Sieve Analysis

	 	4.9	 	PII will perform the following tests on the packaged Feasibility Batches:

	 	4.9.1	 	Physical Appearance
	 
	 	4.9.2	 	Dissolution Profile (media and time points to be provided by CPP)
	 
	 	4.9.3	 	Assay and Related Substances
	 
	 	4.9.4	 	Content Uniformity (calculated based on average tablet weight)
	 
	 	4.9.5	 	Moisture (USP<921>)

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Condition	 	Initial*	 	1 Month	 	2 Months	 	3 Months	 	6 Months
	40°C/75%RH

	 	X
	 	 	X	 	 	 	X	 	 	 	X	 	 	 	0	 
	25°C/60%RH

	 	 	 	 	0	 	 	 	0	 	 	 	0	 	 	 	X	 

 

* Release data will be used if initiated within one (1) month from manufacture

0-Optional

	 	4.10	 	After completion of one (1) month accelerated stability, PII will prepare a
formulation development report.

	5	 	Manufacture of Clinical Trial Materials (CTM) Batch — One (1) active batch and one (1)
placebo batch of Vigabatrin 500 mg film-coated tablets — batch sizes up to 100,000 tablets
each

	 	5.1	 	All materials used for the manufacture of the CTM Batches will be fully
released by PII unless otherwise specified by CPP. See Materials: Sections 1.1 & 1.2

					
	 	 	 	 	 
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	 	5.2	 	PII will prepare Master Batch Records that will be approved by CPP at
least one (1) week prior to manufacture of the CTM Batches.
	 
	 	5.3	 	The CTM batches will be manufactured under cGMP conditions as
directed in the Master Batch Records.
	 
	 	5.4	 	PII will remove periodic samples per the agreed sampling protocols.
	 
	 	5.5	 	PII will employ the following equipment train as needed:

	 	5.5.1	 	V-Blender
	 
	 	5.5.2	 	Roll Compactor / Mill — (if required)
	 
	 	5.5.3	 	Tablet Press
	 
	 	5.5.4	 	Coating Pan (2 pan loads may be required dependent on final tablet
weight)

	 	5.6	 	Operators will wear respirators and Tyvex suits if necessary.
	 
	 	5.7	 	Based on the experience gained from manufacture of the Feasibility
Batches (See Section 4), PII will manufacture (1) Active CTM Batch (500
mg strength of Vigabatrin film-coated tablets, batch size up to 100,000
tablets).
	 
	 	5.8	 	PII will manufacture (1) matching Placebo Batch (batch size of 100,000
tablets).
	 
	 	5.9	 	PII will perform the following in-process testing on the Active Batch (to
be confirmed by CPP):

	 	5.9.1	 	Weight variation, Hardness, Thickness and Friability
	 
	 	5.9.2	 	Bulk and Tap Density
	 
	 	5.9.3	 	Sieve Analysis

	 	5.10	 	PII will perform the following finished product testing on the Active Batch
or as per mutually agreed upon by CPP and PII (should meet MasterSpecifications):

	 	5.10.1	 	Physical Appearance
	 
	 	5.10.2	 	Dissolution Profile (media and time points to be provided by CPP)
	 
	 	5.10.3	 	Assay and Related Substances
	 
	 	5.10.4	 	Content Uniformity (calculated based on assay and weight)
	 
	 	5.10.5	 	Moisture (USP<921>)

	 	5.11	 	PII will perform the following finished product testing on the Placebo
Batches or as per mutually agreed upon by CPP and PII (should meet
Master Specifications):

					
	 	 	 	 	 
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	 	5.11.1	 	Physical Appearance
	 
	 	5.11.2	 	Absence of active
	 
	 	5.11.3	 	Disintegration

	 	5.12	 	PII will store, monitor and test the stability of CTM Batches per the CPP
approved protocols. See Section (7).
	 
	 	5.13	 	Once the Batches are released, PII will ship to CPP or CPP designated
facility (address to be provided by CPP).

	6.	 	Packaging and Labeling of CTM Batches — to be confirmed with CPP

	 	6.1	 	Materials: See Section 1.3.
	 
	 	6.2	 	Packaging and labeling protocols will be prepared by PII and approved by
CPP one (1) week prior to the manufacture of the batches.
	 
	 	6.3	 	One (1) active batch and one (1) placebo batch will be packaged in HPDE
bottles of 100 count per CPP approved packaging protocols.
	 
	 	6.4	 	If PII is not labeling, the packaged bottles will have the PII lot number ink
jetted on them and shipped to the contract packager for clinical labeling
and packaging.
	 
	 	6.5	 	Any remaining tablets will be stored in bulk.
	 
	 	6.6	 	PII will perform 200% count check on materials going into clinical trials.

	7.	 	Stability of Clinical Trial Material (CTM) Batches

	 	7.1	 	PII will monitor and test, using CPP approved stability protocol, the
stability of the Active and Placebo Batches of Vigabatrin tablets
manufactured by PII; the stability program is to be initiated as soon as the
Vigabatrin tablets are manufactured and packaged.
	 
	 	7.2	 	Stability of the Packaged Product

	 	7.2.1	 	Two (2) batches (1 active and 1 placebo) of 500 mg Vigabatrin
tablets packaged in (configuration — bottles of 100 count) will be
set down on stability.
	 
	 	7.2.2	 	Stability protocols will be developed per ICH guidelines. The
stability protocols will include a 24 month long term stability at
25°C ±2°C /60% RH ±5% RH (25°C/60% RH) and a 6 month
accelerated stability at 40°C ±2°C /75% RH ±5% RH (40°C/75%
RH). CPP may elect to include a 12 month intermediate stability

					
	 	 	 	 	 
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	 	 	 	at 30°C ±2°C /65% RH ±5% RH (30°C/65% RH) in the protocol. Sufficient
samples will be placed on stability to meet the stability protocol
requirements.
	 
	 	7.2.3	 	The packaged product on stability will be tested at
Initial, 3 and 6 months at 40°C/75% RH and 3, 6, 9, 12, 18, and 24 months at
25°C/60% RH. Samples stored at 30°C/65% RH will be tested if significant
change occurs at the accelerated conditions or by CPP’s request.

Active Batch:

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Initial	 	1	 	2	 	3	 	6	 	9	 	12	 	18	 	24
	Condition	 	*	 	Month	 	Months	 	Months	 	Months	 	Months	 	Months	 	Months	 	Months
	25°C/60%RH

	 	 	 	 	 	 	 	 	 	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	X
	 	X
	40°C/75%RH

	 	X
	 	 	0	 	 	 	0	 	 	 	X	 	 	 	X	 	 	 	 	 	 	 	 	 	 	 	 	 
	30°C/65%RH*

	 	 	 	 	 	 	 	 	 	 	 	 	0	 	 	 	0	 	 	 	0	 	 	 	0	 	 	 	 	 

Placebo Batch:

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Initial	 	1	 	2	 	3	 	6	 	9	 	12	 	18	 	24
	Condition	 	*	 	Month	 	Months	 	Months	 	Months	 	Months	 	Months	 	Months	 	Months
	25°C/60%RH

	 	 	 	 	 	 	 	 	 	 	 	X
	 	X
	 	X
	 	X
	 	X
	 	X
	40°C/75%RH

	 	X
	 	 	0	 	 	 	0	 	 	X
	 	X	 	 	 	 	 	 	 	 

 

0 = Optional, will be initiated subsequent to failure at 40°C/75% RH or at CPP’s request

*Release data will be used at Time 0 (initial) if stability is initiated within one (1) month from
manufacture

	 	7.4	 	Stability Tests:

	 	7.4.1	 	The following tests will be performed on the Active Batches if not
specified in the approved protocol otherwise:
	 
	 	7.4.1.1	 	Physical Appearance
	 
	 	7.4.1.2	 	Assay and Related Substances
	 
	 	7.4.1.3	 	Dissolution Single Time Point (to be determined by CPP)
	 
	 	7.4.1.4	 	Moisture (USP<921>)

	 
	 	7.4.2	 	The following tests will be performed on the Placebo Batches if
not specified in the approved protocol otherwise:

	 	7.4.2.1	 	Physical Appearance

	 	7.5	 	General Stability Support:

					
	 	 	 	 	 
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	 	7.5.1	 	PII will prepare stability protocols and CPP will review and
approve the stability protocols one (1) week prior to initiation of
stability study.
	 
	 	7.5.2	 	PII will complete stability testing within thirty (30) calendar days
from the scheduled pull date. CPP will be notified in writing of
any testing that will not be completed in this time frame.
	 
	 	7.5.3	 	PII will provide to CPP test results upon completion at each
stability time point and not later than forty-five (45) calendar days
from the scheduled pull date.
	 
	 	7.5.4	 	CPP will be notified of any Out-of-Specification (OOS) Result
within three (3) days of completion of Phase I Investigation when
the OOS Result was confirmed.
	 
	 	7.5.5	 	PII will provide to CPP an updated stability summary table after
each stability time point.

	8.	 	Analytical Support

	 	8.1	 	PII will develop and validate the following drug product methods:

	 	•	 	Cleaning
	 
	 	•	 	Dissolution
	 
	 	•	 	HPLC assay and related substances

	 	 	 	NOTE: Method Validation will include the following activities:

	 	•	 	System Precision
	 
	 	•	 	Accuracy/Recovery
	 
	 	•	 	Method Precision (Repeatability/Intermediate)
	 
	 	•	 	Linearity
	 
	 	•	 	Limit of Quantitation (LOQ) — impurities only
	 
	 	•	 	Limit of Detection (LOD) — impurities only
	 
	 	•	 	Range
	 
	 	•	 	Specificity (including degradation studies)
	 
	 	•	 	Robustness
	 
	 	•	 	Relative Response Factors (RRF) (impurities only)
	 
	 	•	 	Relative Retention Time (RRT) (impurities only)
	 
	 	•	 	Filter Interference
	 
	 	•	 	Solution Stability

	 	8.2	 	PII will develop and validate the following drug substance methods:

					
	 	 	 	 	 
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	 	•	 	Particle Size — PII will subcontract

	 	8.3	 	PII will transfer the following drug substance methods

	 	•	 	Moisture
	 
	 	•	 	HPLC assay and related substances
	 
	 	•	 	Residual Solvents
	 
	 	•	 	IR Identification

	 	 	 	NOTE: Method Transfer includes the following activities:

	 	•	 	Validation report/package from API supplier
	 
	 	•	 	Support from the API supplier that validated these methods
	 
	 	•	 	System Precision
	 
	 	•	 	Method Precision (reproducibility)
	 
	 	•	 	Linearity
	 
	 	•	 	Limit of Quantitation (LOQ) — impurities only
	 
	 	•	 	Limit of Detection (LOD) — impurities only

	9.	 	Project Management

	 	9.1	 	PII will provide project management including project team meetings,
summary status reports, conference calls, project coordination and on site visits.

	10.	 	General Support

	 	10.1	 	PII will be responsible for report writing and issuance of the final report,
as well as approval of the final report. CPP will have the right to review
draft reports and all underlying data.
	 
	 	10.2	 	Method Validation or Transfer Protocols for the drug product will be
prepared by PII and approved by CPP, if required.
	 
	 	10.3	 	Waste from the manufacturing process will be incinerated. Any unused
excipients will be destroyed after expiry date, as it arises.
	 
	 	10.4	 	Dedicated excipients and packaging components will be destroyed six (6)
months after completion of the manufacturing campaign. If CPP elects for
PII to store the materials longer than six (6) months then there will be a
storage charge of $200 per month per pallet.
	 
	 	10.5	 	PII will prepare necessary documentation for NDA submission. However,
the NDA submission will be the responsibility of CPP.

					
	 	 	 	 	 
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	11	 	NDA Documentation

	 	11.1	 	Master Specifications
	 
	 	11.2	 	Master and Executed Batch Records
	 
	 	11.3	 	Packaging and Labeling Protocols
	 
	 	11.4	 	Invalidation Reports for Analytical Methods
	 
	 	11.5	 	Master Labels
	 
	 	11.6	 	Stability Test Reports

Timing and Project Initiation:

The project will commence upon receipt of the signed contract, the drug substance, and the
initiation payment, thereafter payments are due thirty (30) days from the date of invoice. Unpaid
balances shall bear interest at a rate of 18% per annum unless determined not to be properly
payable.

Timing — Timing will be finalized once the contract is signed but will be in line with CPP needs.

Microsoft Project timeline will be provided once contract is signed.

Month 1: Cleaning method will be completed four (4) to six (6) weeks from receipt of API

					
	 	 	 	 	 
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	(B)	 	Cost:

The Cost Table below lists the cost of each step of the program. If PII and CPP mutually agree in
writing that additional man-hours are required for completion of a step, PII shall invoice such
additional man-hours to CPP, provided however, such invoice describes in detail the additional
work conducted by PII.

	 	 	 	 	 	 	 
	Activity	 	Cost
	 
	Section 1: Materials	 	 	 	 
	1.1

	 	API- ID release at $1,500/lot.
	 	$TBC

	1.2

	 	Excipients — full release testing will be charged up to $3,000 / lot; PII
will use stock excipients where applicable and may opt to charge on a per Kg basis.
	 	 $TBC

	1.3

	 	Packaging Components — release testing will be charged up to $2,500 /lot;
PII will use stock components where applicable and may opt to charge on a per
bottle basis.
	 	$TBC

	 
	Section 2: Pre-formulation	 	 	 	 
	2.2

	 	API testing
	 	$	13,000	 
	 
	Section 3: Formulation Development	 	 	 	 
	3.2

	 	Prototype Development — $20,000 per prototype
	 	$	40,000	 
	3.3

	 	Accelerated stability testing: (3 pull points x two (2) batches x $2,500)
	 	$	15,000	 
	 
	Section 4: Manufacture of Feasibility Batches	 	 	 	 
	4.4

	 	Development of Matching Placebo
	 	$	15,000	 
	4.5

	 	Manufacture of two (2) Feasibility Batches — one of Vigabatrin Tablets
and one of Matching Placebo ($50,000 for active and $25,000 for placebo)
	 	$	75,000	 
	4.6

	 	Packaging in bottles of 100 to satisfy stability requirements
	 	$	10,000	 
	4.7

	 	Accelerated stability testing of (1) batch: (4 pull points x 1 batch x 1
packaging configuration x $3,500)
	 	$	14,000	 
	 
	Section 5: Manufacture of CTM Batches / Placebo Batch	 	 	 	 
	Manufacture of (1) Active CTM Batch of Vigabatrin tablets (batch size of 100,000
tablets — $50,000 per batch).	 	$	50,000	 
	Manufacture of (1) Placebo CTM Batch of tablets
(batch size of 100,000 tablets — $25,000 per batch).	 	$	25,000	 
	 
	Section 6: Packaging and Labeling of CTM Batches	 	 	 	 
	Two (2) CTM Batches packaged in bottles of 100 count — $15,000 per batch	 	$	30,000	 
	 
	 	 	 	 	 	 
	 
	Section 7: Stability of CTM Batches	 	 	 	 
	Stability of Packaged Product	 	$	29,600	 
	8 time points x 1 active batch x $3,500	 	 	 	 
	8 time points x 1 placebo batch x $200	 	 	 	 
	 
	Section 8: Analytical Support	 	 	 	 
	•

	 	Cleaning
	 	$	20,000	 
	•

	 	Dissolution for drug product
	 	$	27,200	 
	•

	 	HPLC assay and related substances for drug product
	 	$	47,600	 
	•

	 	HPLC assay and related substances for drug substance
	 	$	10,200	 
	•

	 	IR Identification
	 	$	6,400	 
	 

					
	 	 	 	 	 
	12CAT01.04
	 	May 10, 2006
	 	Page 13 of 22

 

 

	 	 	 	 	 	 	 
	 
	•

	 	Residual solvents for drug substance
	 	$	10,200	 
	•

	 	Particle size for drug substance — PII to subcontract
	 	$TBC

	 
	 
	 	 	 	 	 	 
	Section 9: Project Management	 	$	 40,000	 
	 
	 
	 	 	 	 	 	 
	Section 10: General Support	 	$	 15,000	 
	 
	 
	 	 	 	 	 	 
	Section 11: NDA Documentation	 	$	 20,000	 
	 
	 
	 	 	 	 	 	 
	Total	 	$	513,200	 
	 

Non-Stability Payment Schedule

	 	 	 	 	 	 	 	 	 	 	 	 	 
	Invoice Issue	 	Section	 	Activity	 	Amount Due	 	Invoice Date and #
	Date	 	Reference	 	 	 	 	 	 
	 
	Mar/April 2006
	 	8-10	 	Initiation Payment — Cleaning,
Project Management & General Support
	 	$	75,000	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	April/May 2006	 	2	 	Completion of preformulation activities
	 	$	13,000	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	May 2006
	 	3	 	Completion of first prototype
	 	$	20,000	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	May/June 2006
	 	3	 	Completion of second prototype
	 	$	20,000	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	June 2006	 	3	 	Initiation of prototype stability
(non refundable up to 3 months)
	 	$	15000	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	TBC	 	4	 	Completion of matching placebo

	 	$	15,000	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	TBC	 	4	 	Initiation of Feasibility
Batches (1 active and 1 placebo)
	 	$	45,000	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	TBC	 	4	 	Completion of Feasibility Batches
Including Packaging (1 active and 1 placebo)
	 	$	40,000	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	TBC	 	4	 	Stability initiation of feasibility
batches
	 	$	14,000	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	TBC	 	5	 	Master Batch Records for Active
and Placebo Batches
	 	$	40,000	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	TBC	 	5	 	Executed Batch Records for Active and Placebo Batches
	 	$	35,000	 	 	 

					
	 	 	 	 	 
	12CAT01.04
	 	May 10, 2006
	 	Page 14 of22

 

 

	 	 	 	 	 	 	 	 	 	 	 	 	 
	TBC	 	6	 	Executed Packaging and Labeling Protocals
	 	$	30,000	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	TBC	 	8	 	API reports for IR Identification, Assay and Resdidual Solvents
	 	$	26,800	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	TBC	 	8	 	Dissolution Method for the drug product
	 	$	17,200	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	TBC	 	8	 	Validation Report for dissolution method 

for the drug product
	 	$	10,000	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	TBC	 	8	 	Validation protocal for assay method for 

the drug product
	 	$	27,600	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	TBC	 	8	 	Validation report for dissolution method 

for the drug product
	 	$	20,000	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	TBC	 	11	 	NDA documentation
	 	$	20,000	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	TBC	 	1	 	Materials & Testing
	 	$TBC
	 	 
	 
	Total	 	 	 	 	 	 
	 	$	483,600	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 
	 

Stability Study Payment Schedule

	 	 	 	 	 	 	 	 	 
	Invoice Issue	 	 	 	Amount Due	 	Invoice Date
	Date	 	 	 	 	 	and #
	 
	TBC
	 	Initiation Fee (non-refundable
up to three (3) months)

	 	$	7,400	 	 	 
	 
	TBC
	 	6th month pull points

	 	$	7,400	 	 	 
	 
	TBC
	 	9th month pull point

	 	$	3,700	 	 	 
	 
	TBC
	 	12th month pull point

	 	$	3,700	 	 	 
	 
	TBC
	 	18th month pull point

	 	$	3,700	 	 	 
	 
	TBC
	 	24th month pull point

	 	$	3,700	 	 	 
	 
	Total
	 	 

	 	$	29,600	 	 	 
	 

In addition to the above costs, CPP shall pay to PII upon receipt of PII’s invoice by CPP
for all non-capital materials (excipients, packaging components, HPLC columns, analytical
standards, microbial testing and tooling) used in the study at cost plus 10%. PII shall
obtain CPP’s prior written approval for any expenditure greater than $5,000. For high priced
items more than $5,000, PII will charge cost plus 5% to CPP. PII shall

					
	 	 	 	 	 
	12CAT01.04
	 	May 10, 2006
	 	Page l5 of 22

 

 

invoice CPP for all reasonable and normal out-of pocket travel related expenses, including airfare,
room & board, car rental and the like, of PII during any technology transfer phase or project
update meetings requested in advance by CPP. Shipments outside of Service Contract work scope will
be invoiced as per the following:

	a)	 	Shipment requests with three (3) days notice will be charged at $500 plus shipping
costs and a 10% service charge on shipping.
	 
	b)	 	Shipment requests with two (2) days notice will be charged at $1,000 plus
shipping costs and a 10% service charge on shipping.
	 
	c)	 	Shipment requests with twenty-four (24) hours notice will be charged at $1,500
plus shipping costs and a 10% service charge on shipping.

					
	 	 	 	 	 
	12CAT01.04
	 	May 10, 2006
	 	Page 16 of 22

 

 

	(C)	 	Legal and Signatures

1. CONFIDENTIALITY

The parties acknowledge that the Confidentiality Agreement between the parties dated
March 25, 2005 (the “Confidentiality Agreement”) shall continue to govern the parties’ respective
obligations to one another with regard to the confidential information each has disclosed to the
other and shall continue to disclose to the other in connection with this Agreement. The parties’
respective obligations with regard to any such confidential information shall survive the
termination of this Agreement in accordance with the terms of the Confidentiality Agreement.

2. OWNERSHIP OF MATERIALS AND INFORMATION

All data, information, reports and any and all related documentation, which are developed,
generated or derived, directly or indirectly, by PII (or by any subcontractor or agent of PII) for
Catalyst Pharmaceutical Partners during the course of this Agreement (the “Data”), and all
inventions, discoveries, formulae, procedures, any other intellectual property, and any
improvements thereto, whether patentable or not, which result or evolve directly, during the
course of this Agreement or as a result of the services performed hereunder by PII (or by any
subcontractor or agent or PII) (together with any Data relating thereto, the “Inventions”), shall
be and remain the sole and exclusive property of Catalyst Pharmaceutical Partners if related to
the Product; provided, however, any Inventions made, developed or discovered solely by PII (or by
any subcontractor or agent of PII) that constitute an invention, improvement or other intellectual
property relating to drug delivery technology, formulation, analysis or manufacturing process of
pharmaceutical products (together with any Data relating thereto, “PII Inventions”), shall be and
remain the property of PII, and PII hereby grants to Catalyst Pharmaceutical Partners a
royalty-free, exclusive license to develop, use, manufacture and sell such PII Inventions in
connection with the development, use, manufacture and sale of the Product. Except as specifically
set forth herein, neither PII nor its employees or agents shall have or acquire any right, title
or interest in Inventions. If related to the Product, PII shall promptly disclose in writing to
Catalyst Pharmaceutical Partners any Inventions. If related to the Product and to the extent not
PII Inventions, PII shall assign any and all rights in any Inventions to Catalyst Pharmaceutical
Partners and shall assist Catalyst Pharmaceutical Partners, at no cost to PII, in perfecting its
rights in such Inventions.

3. TERMINATION

Catalyst Pharmaceutical Partners, but not PII, may terminate this Agreement at any time and for
any reason at the sole discretion of Catalyst Pharmaceutical Partners upon thirty (30) days
advance written notice to PII. Upon such termination, Catalyst Pharmaceutical Partners shall pay
all costs incurred by PII for work performed prior to the effective date of termination, provided
PII provides written evidence that such costs have been incurred and such work performed. PII may
terminate this Agreement if Catalyst Pharmaceutical Partners is in default of any of its material
obligations set forth herein, and such alleged breach is not cured

					
	 	 	 	 	 
	12CAT01.04
	 	May 10, 2006
	 	Page 17 of 22

 

 

within thirty (30) days after written notice of such alleged breach is provided to Catalyst
Pharmaceutical Partners with reasonable detail of the alleged breach, which time period shall be
reduced to ten (10) days for any default of any monetary obligation.

4. NOTIFICATION OF SUB-CONTRACT LABS

Insofar as PII anticipates using contract laboratories for some of the activities described in
this Agreement, PII shall notify Catalyst Pharmaceutical Partners when use of such contract
laboratories becomes necessary. PII shall be responsible for assuring that any contract lab used
complies with Good Laboratory Practices. PII will be responsible for all laboratory work provided
by contract labs

5. WARRANTIES

PII warrants and covenants that it will perform all of its obligations under this Agreement in
accordance with all applicable laws and regulations. Without limiting the generality of the
foregoing, PII warrants and covenants that all CTM will meet the Specifications and will have been
produced in compliance with cGMPs. Except as specifically set forth in this Agreement, PII
DISCLAIMS ALL EXPRESS OR IMPLIED WARRANTIES AND COVENANTS, STATUTORY OR OTHERWISE, CONCERNING THE
DELIVERABLES. WITHOUT LIMITING THE FOREGOING, PII MAKES NO IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE REGARDING THE DELIVERABLES.

6. ACCEPTANCES OF SHIPMENTS; NON-CONFORMANCE

For each shipment hereunder, PII shall provide a Certificate of Analysis and within thirty (30)
days following delivery to Catalyst Pharmaceutical Partners, Catalyst Pharmaceutical Partners
shall have the right to give PII notice of rejection of any shipment that, in whole or part, fails
to meet Specifications or which otherwise breaches PII’s warranties set forth herein. Catalyst
Pharmaceutical Partners shall at all times supply PII with any evidence it has that relates to
whether any Product delivered to Catalyst Pharmaceutical Partners by PII is non-conforming as
contemplated hereunder. Failure by Catalyst Pharmaceutical Partners to give timely notice of
rejection shall constitute acceptance by it of the shipment to which the notice of rejection would
have otherwise applied. In the event of any disagreement between PII and Catalyst Pharmaceutical
Partners relating to Product conformance with Specifications or PII’s warranties set forth herein,
the parties will use best good faith efforts to reach an amicable resolution of such disagreement.
In the event that resolution cannot be reached, a mutually agreed upon, neutral, independent third
party laboratory shall be brought in to resolve the disagreement upon the request of either party.
The results of the independent laboratory shall be binding on the parties and non-appealable, and
the cost of such independent laboratory shall be borne by the party hereunder determined by the
independent laboratory to be the non-prevailing party in such disagreement. For any Product
properly rejected pursuant to this Section, such Product shall be returned by Catalyst
Pharmaceutical Partners to PII at PII’s expense and shall be replaced by PII at no extra charge to
Catalyst Pharmaceutical Partners. In the event PII cannot replace such defective Product, it
shall

					
	 	 	 	 	 
	12CATO1.04
	 	May 10, 2006
	 	Page 18 of 22

 

 

refund to Catalyst Pharmaceutical Partners the amount paid therefore.

7. INDEMNIFICATION

     (a) Catalyst Pharmaceutical Partners agrees to indemnify, defend and hold harmless
PII, its stockholders, directors, officers, employees and agents from and against any and all
claims, losses, liabilities, lawsuits, proceedings, costs and expenses, including without
limitation, reasonable attorney’s fees and the cost of recalls arising out of or in connection
with: (i) injuries and/or death to humans resulting from the use of any materials provided to
PII by Catalyst Pharmaceutical Partners (including all manufactured products or materials
resulting from the provision of PII’s services hereunder), including, without limitation,
claims based on negligence, warranty, strict liability or any other theory of product liability or a
violation of applicable laws or regulations, except to the extent that such injuries or
violations are the result of PII’s negligence or willful misconduct in performing the services
hereunder or breach of any covenant or agreement hereunder, (ii) negligence or willful
misconduct in advertising, labeling, or improper handling and storage by any person other
than PII, (iii) any specifications provided by Catalyst Pharmaceutical Partners that are
incorrect or do not meet FDA approved specifications, or other instructions given by Catalyst
Pharmaceutical Partners in connection with any materials provided to PII by Catalyst
Pharmaceutical Partners or PII’s services provided hereunder, (iv) any misrepresentation by
Catalyst Pharmaceutical Partners or breach by Catalyst Pharmaceutical Partners of any
covenant or agreement hereunder or (v) patent infringement relating to any materials
provided to PII by Catalyst Pharmaceutical Partners or PII’s services provided hereunder to
the extent that such infringement does not arise as a result of a breach of any representation
or warranty of PII hereunder.

     (b) PII shall indemnify and hold harmless Catalyst Pharmaceutical Partners and
Catalyst Pharmaceutical Partners’ affiliates, and its and their stockholders, directors,
officers, employees and agents from and against any and all claims, losses, liabilities, lawsuits,
proceedings, costs and expenses, including without limitation, reasonable attorney’s fees and
the cost of recalls arising out of or in connection with: (i) any negligence or willful
misconduct of PII in performing the services hereunder, (ii) any misrepresentation by PII or
breach by PII of any covenant or agreement hereunder, or (iii) any claim asserted by a third
party that PII in performing the services hereunder has infringed or misappropriated any
proprietary or confidential information or intellectual property rights of such third party,
except as relate to any materials, specifications or instructions provided to PII by Catalyst
Pharmaceutical Partners.

     (c) In no event shall either party be liable to the other for indirect damages or
consequential damages, including without limitation, lost profits or revenues.

					
	 	 	 	 	 
	12CAT01.04
	 	May 10,2006
	 	Page l9 of 22

 

 

	8.	 	FORCE MAJEURE

Failure of any party to perform its obligations under this Agreement (except the obligation to make
payments) shall not subject such party to any liability or place it in breach of any term or
condition of this Agreement to the other party if such failure is caused by any cause beyond the
reasonable control of such non-performing party, including, without limitation, acts of God, fire,
explosion, flood, drought, war, riot, sabotage, embargo, interruption of or delay in
transportation, a national health emergency or compliance with any order or regulation of any
government entity acting with color of right.

	9.	 	GOVERNING LAW

This Agreement shall be governed by and construed in accordance with the laws of the State of
Maryland (exclusive of its conflicts of laws provisions).

10. DISPUTES; ARBITRATION

   (a) Except as provided in clause (c) below or in Section 6 with respect to disputes
regarding non-conforming shipments, all disputes, controversies or claims arising out of or
relating to the operation or interpretation of this Agreement shall be resolved by arbitration
before one arbitrator in accordance with the Commercial Rules of the American Arbitration
Association. The arbitrator shall be jointly selected by the parties. Any award rendered by
the arbitrator shall be final and binding upon the parties and judgment upon any such award
may be entered in any court having jurisdiction thereof. Arbitration shall be conducted in
Baltimore, Maryland.

   (b) The arbitrator shall award attorneys’ fees and other costs of the arbitration,
including the fees and expenses of the arbitrator, to the prevailing party, as determined by the
arbitrator.

   (c) Notwithstanding anything to the contrary contained in this Section, in the event of
any breach or threatened breach of this Agreement by either party that the other party
believes will cause irreparable harm and damage to it, such party shall be entitled to an
injunction, restraining order restraining such breach or threatened breach by the other party
and all other remedies which shall be available to it at law or in equity and the parties
irrevocably submit to the jurisdiction of any state or federal court sitting in the State of
Maryland over any such suit, action or proceeding. Catalyst Pharmaceutical Partners
irrevocably waives, to the fullest extent permitted by law, any objection that it may now or
hereafter have to the laying of the venue of any such suit, action or proceeding brought in any
such court and any claim that any such suit, action or proceeding brought in any such court
has been brought in an inconvenient forum.

					
	 	 	 	 	 
	12CAT01.04
	 	May 10, 2006
	 	Page 20 of 22

 

 

11. NON-SOLICITATION AND HIRING

During the term of this Agreement and for a period of two (2) years thereafter, regardless of the
reason for such termination, neither party will, directly or indirectly, without the prior written
consent of the other party, solicit or hire, as an employee or independent contractor, any person
who is, or was at any time, employed by or under contract with the other party, unless at the time
of the solicitation or hiring, at least one (1) year shall have elapsed since the person was last
employed by or under contract with the other party.

12. MISCELLANEOUS

     (a) Waiver; Integration; Modification. The waiver of the breach of any term or
provision of this Agreement shall not operate as or be construed to be a waiver of any other
or subsequent breach of this Agreement. This Agreement sets forth the entire agreement
between the parties with respect to the subject matter of this Agreement and merges and
supersedes all prior discussions, agreements and understandings of every nature between
them. No modification or amendment to this Agreement or any other agreement with respect
to the subject matter of this Agreement shall be effective unless stated in writing and signed
by the parties.

     (b) Construction. Whenever the context may require, the singular form of names
and pronouns shall include the plural and vice-versa. The section and subsection headings
are included solely for the convenience of the parties and shall not be used in the
interpretation of this Agreement. No rule of construction shall apply to this Agreement that
construes any language, whether ambiguous, unclear or otherwise, in favor of or against any
party based on the party that drafted such language.

     (c) Counterparts. This Agreement may be executed in any number of
counterparts, and each such counterpart shall be deemed to be an original instrument, but all
such counterparts together shall constitute but one agreement.

     (d) Survival. No termination or expiration of this Agreement shall relieve the
parties hereto of any obligation hereunder which by their terms are intended to or may
survive the termination or expiration of this Agreement.

     (e) Relationship Between Parties. PII’s relationship to Catalyst Pharmaceutical
Partners shall be that of an independent contractor. No persons engaged by PII shall be
considered under the provisions of this Agreement or otherwise as an employee of Catalyst
Pharmaceutical Partners. Nothing contained in this Agreement shall create or imply the
creation of a partnership between Catalyst Pharmaceutical Partners and PII and neither party
shall have any authority (actual or apparent) to bind the other.

					
	 	 	 	 	 
	12CAT01.04
	 	May 10, 2006
	 	Page 21 of 22

 

 

AGREED AND ACCEPTED

Pharmaceutics International, Inc.

/s/ Syed E. Abidi, Ph.D.
 

Syed E. Abidi, Ph.D.

President and CEO

5/18/06

 

Date

Catalyst Pharmaceutical Partners

/s/
Patric J. McEnany
 

Authorized Agent or Representative

Title CEO

5/17/16

 

Date

 

			
	Billing Contact:	 	E. DIAZ 

			
	   Address:	 	220 MIRACLE MILE #234 

			
	   City, State, Zip:	 	CORAL GABLES, FL 33134 

			
	   Phone:	 	305.529.2522 

			
	   Fax:	 	305.529.0933 

			
	   Email Address:	 	mcenany@bellsouth.net 

			
	   PO Number:	 	109 

					
	 	 	 	 	 
	12CAT01.04
	 	May 10,2006
	 	Page 22 of 22exv10w1

 

Exhibit 10.1

CASH BONUS AWARD AGREEMENT

     This Cash Bonus Award Agreement (the “Agreement”) is entered into as of August 31,
2006 by and between Calavo Growers, Inc., a California corporation (“Calavo”), and Lecil E.
Cole (“Cole”).

RECITALS

     A. On June 1, 2005, Calavo purchased 172,857 shares of the common stock of Limoneira Company,
a Delaware corporation (“Limoneira”), for an aggregate purchase price of $23,450,000, which
equals $135.66 per share. The current value of the Limoneira common stock as reported on the Pink
Sheets is approximately $190 per share.

     B. On June 1, 2005, Calavo and Limoneira completed several other transactions, including (i)
Limoneira’s purchase of 1,000,000 shares of Calavo common stock, (ii) Calavo’s lease from Limoneira
of office space in Santa Paula, California, and (iii) the execution of an avocado marketing
agreement between Calavo and Limoneira.

     C. Cole is the Chairman of the Board, Chief Executive Officer and President of Calavo.
Calavo’s Board of Directors and Compensation Committee have determined that Cole was primarily
responsible for the completion of the transactions described in Recitals A and B and that these
transactions, particularly Calavo’s purchase of 172,857 shares of Limoneira common stock, have
benefited Calavo.

     D. On August 24, 2006, Calavo’s Compensation Committee and Board of Directors decided to
reward Cole for his valuable contributions related to the Limoneira transactions by paying to him,
over a four-year period, cash bonuses that are equivalent to the market value of 3,690 shares of
Limoneira common stock, subject to the requirement that Cole must continue to serve as Calavo’s
Chief Executive Officer in order to obtain such bonuses.

     NOW, THEREFORE, in consideration of the foregoing and other good and valuable consideration,
the receipt and sufficiency of which hereby are acknowledged, Calavo and Cole hereby agree as
follows:

     1. Cash Bonus Awards.

          (a) As promptly as practicable after the date of this Agreement, Calavo shall pay to Cole a
cash bonus in the pre-tax amount of $140,220, which is equal to the last reported sales price of
$190 per share for Limoneira’s common stock on the Pink Sheets on August 24, 2006, multiplied by
738.

          (b) On August 24, 2007, and on each of the following three anniversaries of that date, Calavo
shall pay to Cole an additional cash bonus in a pre-tax amount that is equal to (i) 738, multiplied
by (ii) the trading volume weighted average last reported sales price of Limoneira’s common stock
for the immediately preceding thirty business days on the Pink Sheets (or on a national stock
exchange, Nasdaq or the OTC Bulletin Board, if the common stock is traded on such other market at
the time). If Limoneira’s common stock is not traded on the Pink Sheets or another national market
as of any applicable bonus payment date, Cole and

1

 

Calavo shall cooperate in good faith in determining the appropriate amount of the cash bonus
to be paid to Cole based upon the fair market value of Limoneira’s common stock. If any August 24
on which a bonus is payable to Cole is not a business day, Calavo shall make the bonus payment on
the next business day.

          (c) Cole shall not be entitled to receive any bonus from Calavo under this Agreement unless he
is serving as the Chief Executive Officer of Calavo on the applicable date described in Section
1(b). For example, if Cole’s service as Calavo’s Chief Executive Officer terminates for any reason
on June 15, 2007, he shall not be entitled to receive the bonus that is scheduled to be paid to him
on August 24, 2007 or on any subsequent date.

     2. Tax Withholding. At the time of each bonus payment under this Agreement, Calavo
shall withhold all applicable amounts for federal, state and local taxes (including for FICA and
Medicaid).

     3. Cole’s Representations. Cole understands that Calavo is not making any
representations to him regarding the future value of the Limoneira common stock, and that this
Agreement does not provide him with any right to continue serving as Calavo’s Chief Executive
Officer. Cole understands that Calavo is not making any representations to him regarding the
amount of taxes that he will be obligated to pay as a result of his receipt of cash bonuses under
this Agreement, and that he has been advised to consult with his accountant or other tax adviser
regarding such tax consequences.

     4. Complete Agreement. This Agreement constitutes the complete and exclusive
agreement between Calavo and Cole with respect to the subject matter herein and replaces and
supersedes any and all other prior written and oral agreements or statements by the parties
relating to such subject matter. This Agreement may be amended or terminated only by a writing
executed by both Calavo and Cole.

     IN WITNESS WHEREOF, Calavo and Cole have executed and delivered this Agreement as of the day
and year first written above.

	 	 	 	 	 
	  	CALAVO GROWERS, INC.

 	 
	 	By:  	 	/s/
Arthur J. Bruno
 	 
	 	 	 	 
	 	Name:	 	 Arthur J. Bruno
	 	 	 
	 	Title:	 	
Chief Operating Officer
	 	 	 
	 	 	 
	 	
/s/ Lecil E. Cole
	 	 LECIL E. COLE

2

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