Document:

exv10w1

Exhibit 10.1

PATHEON PROPOSAL :CBP-FCL1-1300-0707-RO

	 	 	 	 	 
	1. Parties:

	 	MOVA Pharmaceutical Corporation
(“MOVA”)

P.O. Box 8639

Caguas, Puerto Rico 00726

	 	Cornerstone Biopharma, Inc.
(“Client”)

2000 Regency Parkway

Suite 255

Cary, NC 27511

	 	 	 
	2. Product:

	 	• Spectracef Tablets ([***]mg Strength) (“Product”)
	 
	 	 
	3. Indication:

	 	• Antibiotic
	 
	 	 
	4. Contract:

	 	This Proposal (including the Project Scope, Budget Summary,
Standard Terms and Conditions for Pharmaceutical Development
Services (Terms and Conditions”) when accepted by Client shall
become a contract binding on the parties (“Contract”).
	 
	 	 
	5. Description of Services:

	 	See Project Scope (Part A).
	 
	 	 
	6. Payment and Currency:

	 	See Budget Summary (Part B).
	 
	 	 
	7. Legal Terms:

	 	See Terms and Conditions (Part C).
	 
	 	 
	8. Effective Date:

	 	                    , 2000
	 
	 	 
	9. Term:

	 	From the Effective Date until completion by MOVA
of the pharmaceutical development services (“Services”).
	 
	 	 
	10. Date of
	 	 
	     Confidentiality
	 	 
	     Agreement

	 	December 4, 2006
	 
	 	 
	11. Date of PatheonPartnerTM
	 	 
	     External User Account /
	 	 
	     Access Form

	 	                    , 2000 [if applicable]
	 
	 	 
	12. Date:

	 	                    , 2000

	 	 	 	 	 	 	 	 	 	 	 
	MOVA Pharmaceutical Corporation	 	 	 	Cornerstone Biopharma, Inc.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By: 

Name:

	 	/s/ Miguel Hernandez
 

Miguel Hernandez
	 	     
	 	By:

Name:
	 	/s/ Brian Dickson
 

Brian Dickson
	 	 
	Title:

	 	PDS Director
	 	 	 	Title:
	 	C.M.O.	 	 

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

CONFIDENTIAL

 

 

Patheon Proposal # CBP-FCL1-1300-0707-R0

08-August-2007

Table of Contents

Part A: PROJECT SPECIFICS AND DETAILS

	 	 	 	 	 	 	 
	 	 	1.	 	PROJECT SCOPE
	 	4
	 	 	 	 	 
	 	 
	 	 	2.	 	ENVIRONMENTAL, HEALTH AND SAFETY
	 	4
	 	 	 	 	 
	 	 
	 	 	3.	 	ANALYTICAL SERVICES
	 	4
	 	 	 	 	3.1. Cleaning Residuals Assay (Method Verification)
	 	4
	 	 	 	 	3.2. Product Potency and Related Substances Assay (Method
Development)
	 	4
	 	 	 	 	3.3. Product Dissolution Assay — Profile by HPLC (Method
Development)
	 	4
	 	 	 	 	 
	 	 
	 	 	4.	 	FORMULATION DEVELOPMENT
	 	5
	 	 	 	 	4.1. Feasibility Trials I
	 	5
	 	 	 	 	4.2. Feasibility Trials II
	 	5
	 	 	 	 	 
	 	 
	 	 	5.	 	STABILITY — FORMULATION DEVELOPMENT BATCH
	 	6
	 	 	 	 	 
	 	 
	 	 	6.	 	PROJECT SUPPORT
	 	6
	 	 	 	 	 
	 	 
	 	 	7.	 	HIGH LEVEL TIMELINE
	 	6
	 	 	 	 	 
	 	 
	 	 	8.	 	GENERAL INFORMATION
	 	6
	 	 	 	 	Standard Assumption:
	 	6
	 	 	 	 	 
	 	 
	 	 	PART B: BUDGET SUMMARY	 	 
	 	 	 	 	 
	 	 
	 	 	PART C: LEGAL TERMS AND CONDITIONS	 	 

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

Cornerstone Biopharma, Inc.

Spectracef Tablets ([***]mg Strength) — Formulation Development

CONFIDENTIAL

Page 2 of 19

 

Patheon Proposal # CBP-FCL1-1300-0707-R0

08-August-2007

PART A:

Spectracef Tablets ([***]mg Strength)

Formulation Development

For

Cornerstone Biopharma, Inc

Proposal No.: CBP-FCL1-1300-0707-R0

Dated: 08-August-2007

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

Cornerstone Biopharma, Inc.

Spectracef Tablets ([***]mg Strength) — Formulation Development

CONFIDENTIAL

Page 3 of 19

 

Patheon Proposal # CBP-FCL1-1300-0707-R0

08-August-2007

The proposal outlines the Services that MOVA is proposing to perform for the Client relating to the
Product. The initial sections describe the Services to be performed by MOVA that address Client’s
specific project requirements. The section below entitled General Information provides additional
background information on pharmaceutical development services by MOVA. The check boxes under the
General Information section will indicate whether or not a particular item is applicable to this
specific project.

1. Project Scope

For general information on the pharmaceutical development services provided by MOVA please refer to
the section below entitled “General Information”.

MOVA will perform the following activities to support the Formulation Development of Spectracef
Tablets ([***]mg Strength):

	•	 	Environmental, Health and Safety

	•	 	Analytical Development and Services

	•	 	Formulation Development

	•	 	Stability

Since Spectracef tablet manufacturing activities are currently taking place at MOVA, there will be
no duplication of costs for an Environmental, Health and Safety Assessment.

2. Environmental, Health and Safety

Active Pharmaceutical Ingredient(s):

	•	 	Cefditoren pivoxil

	•	 	MOVA’s categorization = Category 3

3. Analytical Services

MOVA will perform method development and method validation for the Client.

The following documents will be generated for each method to support the analytical work:

	•	 	Protocols (except for development work)

	•	 	Reports (data summary will be generated for development work)

Analytical Methods

	3.1.	 	Cleaning Residuals Assay (Method Verification)
	 
	3.2.	 	Product Potency and Related Substances Assay (Method Development)
	 
	3.3.	 	Product Dissolution Assay — Profile by HPLC (Method Development)

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

Cornerstone Biopharma, Inc.

Spectracef Tablets ([***]mg Strength) — Formulation Development

CONFIDENTIAL

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Patheon Proposal # CBP-FCL1-1300-0707-R0

08-August-2007

4. Formulation Development

MOVA will provide a strategy definition (protocol) and data analysis report for Formulation
Development.

4.1. Feasibility Trials I

	•	 	Spectracef Tablets, [***]mg Strength
	 
	•	 	5 Batches

	 	•	 	Process evaluation up to granulation stage

	•	 	Approximately 2-3 kilograms
	 
	•	 	Bulk packaged
	 
	•	 	Process i.e. Mixing and granulation
	 
	•	 	cGMP
	 
	•	 	No QA review

Feasibility batches will be tested for:

	•	 	Potency and Related substances (final two batches only)
	 
	•	 	Physical testing including appearance, particle size, bulk/tapped densities, flow properties
etc. (all batches)

4.2. Feasibility Trials II

	•	 	Spectracef Tablets, [***]mg Strength
	 
	•	 	4 Batches
	 
	•	 	Approximately 6-9 kilograms
	 
	•	 	One batch will packaged into HDPE bottles (i.e. 30’s) for stability
	 
	•	 	Process:

	 	•	 	Batch 1: Mixing and granulation
	 
	 	•	 	Batch 2: Mixing, granulation and compression
	 
	 	•	 	Batch 3: Mixing, granulation, compression and coating
	 
	 	•	 	Batch 4 (packaged batch): Mixing, granulation, compression and coating

	•	 	cGMP
	 
	•	 	No QA review

Batch 1 (Blending Study) will be tested for:

	•	 	Blend uniformity
	 
	•	 	Physical testing including appearance, particle size, bulk/tapped densities, flow properties etc.

Batches 2, 3 & 4 (Compression, Coating and Stability Study Batches) will be tested for:

	•	 	Blend uniformity
	 
	•	 	Content uniformity
	 
	•	 	Dissolution (profile by HPLC)
	 
	•	 	Potency and Related substances
	 
	•	 	Physical testing including appearance, hardness, thickness, friability and disintegration

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

Cornerstone Biopharma, Inc.

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CONFIDENTIAL

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Patheon Proposal # CBP-FCL1-1300-0707-R0

08-August-2007

5. Stability — Formulation Development Batch

	•	 	1 batches for stability testing (Stability Batch)

The following storage conditions and test-points are suggested for testing:

=> 1, 2, 3, and 6 months for 40°C ± 2°C / 75% ± 5% RH

=> 1, 2, 3, and 6 months for 25°C ± 2°C / 60% ± 5% RH

Testing per sample:

	•	 	Potency and Related substances
	 
	•	 	Dissolution (profile by HPLC)
	 
	•	 	Physical testing including appearance and moisture

6. Project Support

MOVA will provide project management support to monitor the progress of the project against
established timelines and will provide the Client with frequent updates. The project manager will
coordinate regular biweekly teleconference meetings and quarterly face-to-face meetings. The fee
for project management is incorporated in the breakdown cost for each activity in the Budget
Summary.

7. High Level Timeline

The attached High Level Timeline is presented at this stage as a projected estimate of the duration
and achievable milestones, based upon MOVA’s experience and history. The High Level Timeline should
not be taken as part of an agreed legal deliverable of this proposal.

Once the project has been awarded to MOVA and the relevant legal documentation is in place, a
revised Timeline detailing set milestones and duration of deliverables will be agreed upon between
MOVA and the Client. The revised Timeline would likely have a similar duration and would be based
upon resources and the availability of manufacturing time at the initiation of the project.

8. General Information

This section provides additional background information on the pharmaceutical development services
performed by MOVA. The check boxes below indicate whether or not a particular item is applicable to
the project described above.

Standard Assumption:

	 	1.	 	The approach used would be outlined in a more detailed protocol prepared by
MOVA and on request approved by the Client. Further studies may be required in the
later development stages of the project. Where required these would be discussed and
agreed separately with the Client.
	 
	 	2.	 	It is assumed that the API and/or formulation do not absorb/adsorb to any
metal, glass or other components used during the processing and analytical testing of
the batch. The fees for any investigational work associated with the API and/or
formulation interacting with components are not included within this proposal.
	 
	 	3.	 	The identification of unknown impurities detected during the study is not
included as part of this proposal.

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

Cornerstone Biopharma, Inc.

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CONFIDENTIAL

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Patheon Proposal # CBP-FCL1-1300-0707-R0

08-August-2007

A) Project Initiation

o       Applicable            þ       Not Applicable

The Project Initiation Fee covers a series of activities at the start of a project. These
activities include (but are not limited to) scientific review of Client documentation, literature
research and review, procurement of project specific equipment and tooling, analytical method
research and attendance by cross functional team members for initial Client “kick-off” meetings.

B) Environmental, Health & Safety

o       Applicable            þ       Not Applicable

If it is determined by MOVA’s Environmental Health and Safety personnel that any of the active
ingredients are a Category III or Category IV compound (an occupational exposure level) then an air
sampling method will be required at Client’s expense prior to commercialization. MOVA reserves the
right, in its sole and absolute discretion, to conduct an air sampling method on Category I and II
compounds, at such price and upon such terms as may be mutually agreed to between the parties prior
to commercialization.

Prior to commercialization, MOVA will evaluate the Product and the proposed launch volume and, at
the Client’s request, select the appropriate MOVA facility for commercialization. The MOVA facility
used for performance of the Services will not necessarily be the facility available for
commercialization.

MOVA will not receive any active pharmaceutical ingredients (API) from the Client until a MSDS has
been received, MOVA has completed the categorization of the API and that the Client has completed
and returned the EH&S Survey to MOVA.

C) Analytical Services

Cleaning Residuals Assay

þ       Applicable            o       Not Applicable

The Cleaning Residuals Assay method development and validation is for the detection of the API. If
an excipient, other than the API, in the product formulation has a therapeutic effect (e.g. Vitamin
E), the Client must advise Patheon. Patheon will evaluate the need for a cleaning residuals assay
for the excipient. If needed and possible, Patheon will develop and validate a combined cleaning
method for the API and the concerned excipient without additional cost. Otherwise, a separate
cleaning method may be required for the excipient at an additional cost to the Client through a
Change of Scope.

Analytical Protocols and Reports

þ       Applicable            o       Not Applicable

Analytical protocols will be drafted by MOVA for validation activities only and submitted to the
Client for approval prior to execution with the exception of the Cleaning Residuals Assay, which
will be approved internally by MOVA. No protocols will be issued for method development activities.
Upon completion of the development activities, a summary of the data will be provided to the
Client. The analytical methods have been based upon HPLC unless otherwise stated.

An analytical report will be provided to the Client once the method validation is complete. If
method validation is not specified in the title of an analytical method under this Project Scope,
then the validation

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

Cornerstone Biopharma, Inc.

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CONFIDENTIAL

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Patheon Proposal # CBP-FCL1-1300-0707-R0

08-August-2007

of such analytical method is not included in this Project Scope and the
additional method validation costs will be quoted separately by MOVA.

API Receipt and Release

þ       Applicable            o       Not Applicable

MOVA will receive and release the active pharmaceutical ingredients (API) for Clinical Trial
Material (CTM) manufacture based on the following: (i) Identification testing; and (ii) the
accompanying Certificate of Analysis (COA) from the API Vendor (Client qualified) and COA from the
Client.

Non-GMP Excipient Receipt and Release

þ       Applicable            o       Not Applicable

MOVA will receive and release materials / excipients (other than API) for non-GMP Formulation
Development Batches based on receipt of a Certificate of Analysis (CoA), Certificate of Conformance
(CoC), or an equivalent document from the vendor of such materials/excipients, the client, or a
third party testing lab. At a minimum the document must contain the results from ID testing and
assay.

Reference Standards for APIs and Related Substances

þ       Applicable            o       Not Applicable

The Client shall provide MOVA with accurate, appropriate, sufficient and the most current
applicable reference standards (such as USP, NF, BP, EP, and JP) for the APIs and related
substances to complete the scope of work outlined herein.

Method Development

þ       Applicable            o       Not Applicable

The method development will cover the sample preparation procedures, HPLC conditions, calibration
procedures, specificity, detection limit (if applicable), quantitation limit (if applicable),
accuracy and repeatability. Should the effort to develop the method exceed 80 bench work hours,
additional costs may be incurred and would be covered by a change of scope.

Forced Degradation Study

o       Applicable            þ       Not Applicable

In order to assess whether the API or product potency assay is suitable for use as
stability-indicating assay, a series of experiments will be performed to study degradation. The API
or product will be treated with acidic, basic, oxidative, light and thermal conditions, the
stressed samples will be analyzed by the potency method using DAD and ensure that the active peak
is pure from peak purity assessment. If the peak purity fails, the method needs to be redeveloped
for stability-indicating, and a change of scope will be issued.

Product Dissolution Assay by HPLC (Method Development)

þ       Applicable            o       Not Applicable

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

Cornerstone Biopharma, Inc.

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Patheon Proposal # CBP-FCL1-1300-0707-R0

08-August-2007

MOVA will develop the assay required for testing dissolution of the product. The development will
challenge the following parameters. Should the effort to develop the method exceed 60 bench work
hours, additional costs may be incurred and would be covered by a change of scope.

	 	 	 	 	 	 	 
	•

	 	Sink condition
	 	•
	 	Specificity
	 
	•

	 	Selection of medium, apparatus speed
	 	•
	 	Accuracy
	 
	•

	 	Optimization of medium cone. & pH
	 	•
	 	Repeatability
	 
	•

	 	System suitability	 	 	 	 

Interlab Qualification

o       Applicable            þ       Not Applicable

Inter-Laboratory Qualification involves the comparison of two different series of laboratory
analyses for the same lot of material/product. This verifies that both laboratories (i.e., the
originating and receiving laboratories) are following the same procedure accurately and producing
results that are precise and equivalent. The Client needs to provide to MOVA the method validation
report. The following parameters will be performed at both MOVA and the originating laboratory:

	 	 	 	 	 	 	 
	•

	 	System Suitability
	 	•
	 	Quantitation Limit (if applicable)
	 
	•

	 	Stability of Standard and Sample Solution
	 	•
	 	Detection Limit (if applicable)
	 
	•

	 	Repeatability	 	 	 	 

Method Transfer

o       Applicable            þ       Not Applicable

Method Transfer is an on site validation process in the receiving laboratory, which verifies that
method performs in the receiving laboratory in an equivalent manner to the originating laboratory.
The Client needs to provide to MOVA the method validation report. The following parameters will be
performed at MOVA as the receiving laboratory:

	 	 	 	 	 	 	 
	•

	 	System Suitability
	 	•
	 	Repeatability
	 
	•

	 	Linearity
	 	•
	 	Quantitation Limit (if applicable)
	 
	•

	 	Stability of Standard and Sample
Solutions
	 	•
	 	Detection Limit (if applicable)

Method Evaluation

o       Applicable            þ       Not Applicable

MOVA will evaluate the test method(s) required to support the Project. Method evaluation will cover
the sample preparation procedures, HPLC conditions, calibration procedures, specificity, accuracy,
repeatability and detection/quantitation limits (if appropriate). If the method(s) is/are deemed
unsuitable, new method(s) will be developed and billed as a change of scope.

Method Validation Phase Levels

MOVA will validate the test method required to support the Project. The validation will challenge
the following parameters based on the Project Clinical Phase Level:

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

Cornerstone Biopharma, Inc.

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Patheon Proposal # CBP-FCL1-1300-0707-R0

08-August-2007

Phase I

o       Applicable            þ       Not Applicable

	 	 	 	 	 	 	 
	•

	 	System Suitability
	 	•
	 	Repeatability
	 
	•

	 	Linearity
	 	•
	 	Solution Stability
	 
	•

	 	Specificity
	 	•
	 	Quantitation Limit (if applicable)
	 
	•

	 	Range
	 	•
	 	Detection Limit (if applicable)
	 
	•

	 	Accuracy	 	 	 	 

Phase II

o       Applicable            þ       Not Applicable

	 	 	 	 	 	 	 
	•

	 	System Suitability
	 	•
	 	Intermediate Precision
	 
	•

	 	Linearity
	 	•
	 	Repeatability
	 
	•

	 	Specificity
	 	•
	 	Solution Stability
	 
	•

	 	Range
	 	•
	 	Quantitation Limit (if applicable)
	 
	•

	 	Accuracy
	 	•
	 	Detection Limit (if applicable)

Phase Ill

o       Applicable            þ       Not Applicable

	 	 	 	 	 	 	 
	•

	 	System Suitability
	 	•
	 	Repeatability
	 
	•

	 	Linearity
	 	•
	 	Solution Stability
	 
	•

	 	Specificity
	 	•
	 	Robustness
	 
	•

	 	Range
	 	•
	 	Quantitation Limit (if applicable)
	 
	•

	 	Accuracy
	 	•
	 	Detection Limit (if applicable)
	 
	•

	 	Intermediate Precision	 	 	 	 

D) Microbiology

o       Applicable            þ       Not Applicable

The cost allocated to this Service in the Budget Summary of Part B is the per sample price and will
vary depending on the number of samples required for method validation. If a worst case scenario
approach were taken, the cost would be based upon testing MLT and PET (if applicable) at two
dilutions and/or the usage of the largest volume of diluent(s) based on specification. Testing will
be done in compliance with the applicable Pharmacopeia (i.e. USP/NF, EP, JP etc.). Client will be
billed based on the actual number of samples required in order to successfully validate the
Product.

E) Stability

þ       Applicable            o       Not Applicable

The analytical data used for the release of each lot manufactured at MOVA will be considered as
initial (T=0) data if the stability study commences not more than 1 month after release testing.

Cost efficiencies for analytical testing have been built into the stability program based upon the
number of samples pulled in a given month. The cost for this stability program assumes that all
lots will be placed on stability at the same time. If these lots are not placed on stability at the
same time, the cost will be adjusted accordingly through a change of scope agreement.

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

Cornerstone Biopharma, Inc.

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Patheon Proposal # CBP-FCL1-1300-0707-R0

08-August-2007

F) Formulation Development, Manufacturing, Protocols and Reports

þ       Applicable            o       Not Applicable

Formulation Development

The approach used in formulation development would be outlined in a detailed protocol prepared by
MOVA and approved by the Client. The formulation development studies would be conducted using
suitable laboratory scale equipment. If stated in the formulation development section, product will
be hand packaged into suitable containers for the stability study.

Report

Upon completion of the manufacturing activities, a minimum of one formulation development report
(formulation development report would include all formulation development activities up until and
including prototype batch manufacture) will be provided to the Client for review and approval.

G) Manufacturing Validation

Master Validation Plan

o       Applicable            þ       Not Applicable

This high level document outlines the planned validation activities. The price includes protocol
generation and approval. For multiple strengths, a single master validation plan is typically
generated.

Process Validation

o       Applicable            þ       Not Applicable

The process validation includes the generation and approval of the process validation protocol,
execution of the validation batches, and the generation and approval of a final process validation
report. The specific testing plan for a process validation is not known at the time of quotation,
therefore the pricing is based on the following assumptions for testing and sampling of solid dose
products on a per batch basis. Blender and drums: blend uniformity (up to a total of 24 samples),
physical blend testing (bulk/tapped density, sieve analysis); Cores: Beginning, middle and end (30
cores for content uniformity), ID, appearance, dissolution, water content; Coated Tablets (one
coating pan): release testing per pan, (ID, appearance, potency, content uniformity, related
substances, dissolution, weight variation, water content, micro).

For liquids and semi-solids, it is assumed that the testing consists of the following: ID,
appearance, blend homogeneity, potency and related substances, viscosity, foreign particulate
testing, specific gravity and micro. These tests could be performed on the primary finished pack
(e.g. uniformity within a filled tube).

Packaging Validation

o       Applicable            þ       Not Applicable

The packaging validation includes the generation and approval of the packaging validation protocol,
execution time for the validation batches, and the generation and approval of a final packaging
validation

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

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Patheon Proposal # CBP-FCL1-1300-0707-R0

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report. Packaging validation is a standard solid dose or semi-solid/liquid into a single
SKU (stock keeping unit), and that three batches are to be packaged per SKU. For additional
strengths or SKUs, it is assumed that there will be a separate protocol and report generated. It is
assumed that for analytical tests, only identification will be required during the packaging
activities. Packaging validation will analyze for fill count, fill volume, labelling, lot numbering
and expiration date printing, cartoning, tube crimping, tube seal, bottle/cap seal etc.

Bulk Hold Time Study

o       Applicable            þ       Not Applicable

The bulk hold time study includes the generation and approval of a protocol, the execution of the
protocol, and the generation and approval of a final report. It is assumed that the study will be
conducted for one strength, for each of the blend (solid or liquid/semi solid), cores and coated
tablets. Three time points is assumed for the study and that the testing will consist of the
following: Blend: potency and related substances; Cores: Appearance, dissolution, water content,
potency and related substances Coated Tablets: ID, appearance, potency and related substances,
dissolution, weight variation, water content, micro.

Cleaning Validation

o       Applicable            þ       Not Applicable

The cleaning validation includes the generation and approval of a protocol, execution and the
generation and approval of a final cleaning validation report. It is assumed that 3 separate trials
will be required for the study, and that each trial will cover up to 16 pieces of equipment
(analyzed in 4 groups of 4 pieces of equipment).

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

Cornerstone Biopharma, Inc.

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Patheon Proposal # CBP-FCL1-1300-0707-R0

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Part B: Budget Summary

Once a project has been awarded to MOVA, a similar budget will be presented to the Client that will

include Unique Identity Numbers for invoicing purposes only.

THE FOLLOWING COSTS ARE ALL QUOTED IN: USD

All amounts quoted are valid for sixty (60) days from the date of this Proposal.

	 	 	 	 	 	 	 	 	 
	2.0 ENVIRONMENTAL HEALTH AND SAFETY	 	 	 	USD
	 
	 	 	 	 	 	 	 	 
	 	 	ACTIVITY	 	 	 	PRICE
	 
	 	 	 	 	 	 	 	 
	 	 	EH&S Assessment	 	 	 	[***]
	 
	 	 	 	 	 	 	 	 
	3.0 ANALYTICAL DEVELOPMENT	 	 	 	USD
	 
	 	 	 	 	 	 	 	 
	 
	 	ACTIVITY	 	 	 	PRICE	 	PRICE
	 
	 	 	 	 	 	 	 	 
	 	 	3.1 Cleaning Resicuals Assay (method Verification)	 	 	 	 
	 
	 	 	 	Protocol	 	$[***]	 	 
	 
	 	 	 	Benchwork	 	[***]	 	 
	 
	 	 	 	Report	 	[***]	 	[***]
	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	3.2 Product Potency and Related Substances Assay (Method Development)	 	 
	 
	 	 	 	Benchwork	 	[***]	 	 
	 
	 	 	 	Data Summary	 	[***]	 	[***]
	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	3.3 IR — Product Dissolution Assay by HPLC (Method Development)	 	 
	 
	 	 	 	Benchwork	 	[***]	 	 
	 
	 	 	 	Data Summary	 	[***]	 	[***]
	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	TOTAL (Analytical Development)	 	 	 	[***]
	 
	 	 	 	 	 	 	 	 
	4.0 FORMULATION DEVELOPMENT	 	 	 	USD
	 
	 	 	 	 	 	 	 	 
	 
	 	ACTIVITY	 		 	PRICE	 	PRICE
	 
	 	 	 	 	 	 	 	 
	 	 	Protocol Preparation	 	 	 	[***]
	 	 	Report Writing and Data	 	 	 	[***]
	 
	 	 	 	 	 	 	 	 
	 	 	4.1 Feasibility Trials I	 	 	 	 
	 	 	Manufacturing	 	[***]	 	 
	 	 	Analytical Support	 	[***]	 	 
	 	 	Project Support	 	[***]	 	[***]
	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	4.2 Feasibility Trials II	 	 	 	 
	 	 	Manufacturing	 	[***]	 	 
	 	 	Analytical Support	 	[***]	 	 
	 	 	Project Support	 	[***]	 	[***]
	 
	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	TOTAL (Formulation Development)	 	 	 	[***]

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

Cornerstone Biopharma, Inc.

Spectracef Tablets ([***]mg Strength) — Formulation Development

CONFIDENTIAL

Page 13 of 19

 

	 	 	 	 	 	 	 	 	 
	5.0 STABILITY — FORMULATION DEVELOPMENT BATCH	 	 	 	USD
	 
	 	 	 	 	 	 	 	 
	 
	 	ACTIVITY	 	 	 	 	 	PRICE
	 
	 	 	 	 	 	 	 	 
	 
	 	Number of Lots 1	 	 	 	 	 	 
	 
	 	Total Samples 8	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 
	 	Protocol Generation	 	 	 	Subtotal	 	 
	 
	 	 	 	 	 	[***]	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Pullpoint Month

	 	 	T = 1	 	 	 	T = 2	 	 	 	T = 3	 	 	 	T = 6	 	 	T = 9
	 	T = 12
	 	T = 18
	 	T = 24
	 	T = 36
	40°C /76% RH

	 	 	x	 	 	 	x	 	 	 	x	 	 	 	x	 	 	 	 	 	 	 	 	 	 	 
	25°C/60% RH

	 	 	x	 	 	 	x	 	 	 	x	 	 	 	x	 	 	 	 	 	 	 	 	 	 	 
	Samples per pullpoint

	 	 	2	 	 	 	2	 	 	 	2	 	 	 	2	 	 	 	 	 	 	 	 	 	 	 
	Cost per pullpoint

	 	 	[***]	 	 	 	[***]	 	 	 	[***]	 	 	 	[***]	 	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]

	 	 	 	 	 
	 	 	 
	Analytical Support (1 sample per pullpoint)

	 	[***]	 	 
	Analytical Support (2 samples per pullpoint)

	 	[***]	 	 
	Analytical Support (3-4 samples per pullpoint)

	 	[***]	 	 
	Analytical Support (5+ samples per pullpoint)

	 	[***]	 	 
	 
	 	 	 	 
	TOTAL (Stability — Formulation Development Batch)

	 	 	 	[***]

	 	 	 	 	 
	BUDGET TOTAL* (High Potency, Cat. 3)

	 	USD
	 	[***]
	Estimated Total (Low Potency, Cat. 1 & 2)

	 	USD
	 	[***]
	Deposit**

	 	USD
	 	[***]

 

*   The manufacturing cost given in this proposal is based upon the assumption that the drug substance
is classified as a Category 2 material in accordance with Patheon’s Categorization System. If it
is determined through Patheon’s Environmental Health and Safety Review that the drug substance is
not categorized as a Category 3 the manufacturing cost will be raised through a Change of Scope to
reflect handling charges for a Category 1, 2 or 4 product.

**The deposit amount will require further assessment once additional information on the Client’s
financial arrangement is provided. This proposal will only be approved once Patheon’s Finance
Department has determined that the Client has the necessary financial resources to support the
project outlined in this document. The deposit amount will be communicated to the Client by a
revised quotation or an amendment to the proposal.

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

CONFIDENTIAL

Page 14 of 19

 

Patheon Proposal # CBP-FCL1-1300-0707-R0

08-August-2007

PART C

STANDARD TERMS AND CONDITIONS

FOR PHARMACEUTICAL DEVELOPMENT SERVICES

	1.	 	Services:

	 	(a)	 	MOVA agrees to perform the pharmaceutical development services described in the
Project Scope (“Services”).
	 
	 	(b)	 	Parties must agree on changes, deletions or additions to the Services
(“Changes”).
	 
	 	(c)	 	Minor Changes shall be confirmed by electronic mail, facsimile or other written
document Significant Changes (such as a request by the Client to change the Project
Scope) shall be confirmed by a Change of Scope Agreement.

	2.	 	Payment and Deposit:

	 	A.	 	Payment

	 	(a)	 	Client shall pay MOVA for the Services as outlined in this
Contract and for any Changes which shall be invoiced separately at MOVA’s then
prevailing hourly rates.
	 
	 	(b)	 	If Client causes any delay to MOVA’s provision of Services for
reason within its control (such as a delay in responding to a MOVA inquiry or a
delay in the delivery of the active pharmaceutical ingredient (“API”)), then
MOVA shall be entitled to charge the Client for any additional costs incurred
in the provision of the Services as a result of the delay.
	 
	 	(c)	 	MOVA invoices may be issued upon completion of each milestone
set out in the Budget Summary and shall be due and payable within 30 days of
the date of such invoice. If Client anticipates not being able to meet the net
30 day terms, then Client may request that MOVA forward each invoice to the
facsimile number and/or email address stipulated by the Client from time to
time to ensure that it has the full 30 days to process payment. Interest on
past due accounts will accrue at a rate of [1.5%] per month.

	B.	 	Deposit (if Applicable as per the Budget Summary)

	 	(a)	 	Prior to the commencement of the Services, Client shall deliver to MOVA the
deposit (“Deposit”) set out in the Budget Summary.
	 
	 	(b)	 	Deposit shall be held by MOVA until the Services are fully completed or until
this Contract expires or is terminated in accordance with Section 4.
	 
	 	(c)	 	Deposit shall be credited towards the final invoice for the Services and any
remaining balance shall be returned to the Client.
	 
	 	(d)	 	MOVA may apply all or a portion of the Deposit against any accounts overdue in
excess of 60 days from the date of the invoice.
	 
	 	(e)	 	MOVA may, at its option, suspend all Services until such time as any
outstanding invoices have been paid in full and the original amount of the Deposit has
been replenished.

	3.	 	Supply of API and Materials:

	 	(a)	 	Client shall, at its expense, supply MOVA with sufficient quantities of the API
for MOVA’s use in performing the Services.
	 
	 	(b)	 	The costs of all third party suppliers’ fees and the purchase of project
specific items (such as raw materials, excipients, packaging, special equipment,
tooling, change parts, laboratory columns and reagents, reference standards including
those under the applicable United States Pharmacopoeia, the National Formulary, the
British Pharmacopoeia, the European Pharmacopoeia or the Japanese Pharmacopoeia)
necessary for MOVA to perform the Services shall be purchased by MOVA and charged to
Client at MOVA’s cost plus an additional 15% as a handling charge.
	 
	 	(c)	 	If applicable, MOVA and the Client will cooperate and provide such

CONFIDENTIAL

Page 15 of 19

 

Patheon Proposal # CBP-FCL1-1300-0707-R0

08-August-2007

	 	 	 	assistance to each other as may be reasonably necessary to permit the import of the
API and other materials into the country where the Services will be performed.

	4.	 	Termination:

	 	(a)	 	Either party may terminate this Contract if the other party is in material
breach of any provisions of this Contract and the other party fails to remedy such
breach within 30 days of the date of notice of such breach by the non-breaching party.
	 
	 	(b)	 	Client may terminate this Contract immediately for any business reason.
	 
	 	(c)	 	Any re-scheduling of any part of the Services beyond 120 days requested by
Client shall, at MOVA’s option, be deemed to be a termination of the Contract.
	 
	 	(d)	 	Upon completion or expiry of the Contract or if the Client terminates the
Contract for any business reason or if MOVA terminates the Contract because of: (i)
Client’s failure to cure any default within the 30 day notice period; or (ii) Client
rescheduling any part of the Services beyond the 120 days, then Client shall pay to
MOVA:

	 	•	 	any fees and expenses due to MOVA for the Services rendered up to the date
of completion, expiry or termination;
	 
	 	•	 	all actual costs incurred by MOVA to complete activities associated with the
completion, expiry or termination and close of the Services rendered up to the
date of completion, expiry or termination including, without limitation
disposal fees that may be payable in respect of any materials and supplies
owned by the Client to be disposed of by MOVA; and
	 
	 	•	 	any additional costs incurred by MOVA in connection with the Services that
are required to fulfill applicable regulatory and contractual requirements.

	 	(e)	 	Client shall arrange for the pickup from the MOVA site of all materials and
supplies owned by Client within 5 days after the earlier of the completion, termination
or expiration of this Contract. MOVA shall charge a $30.00 per square foot per month
storage fee for all materials and supplies stored at the MOVA site after the fifth day
following the completion, termination or expiration to the Contract.

	5.	 	Intellectual Property:

	 	(a)	 	The term “Intellectual Property” includes, without limitation, rights in
patents, patent applications, formulae, trade-marks, trade-mark applications,
trade-names, trade secrets, inventions, copyright, industrial designs and know-how.
	 
	 	(b)	 	For the term of this Contract, Client hereby grants to MOVA, a non-exclusive,
paid-up, royalty-free, non-transferable license of Client’s Intellectual Property which
MOVA must use in order to perform the Services.
	 
	 	(c)	 	All Intellectual Property generated or derived by MOVA in the course of
performing the Services, to the extent it is specific to the development, manufacture,
use and sale of the Client’s Product that is the subject of the Services, shall be the
exclusive property of Client.
	 
	 	(d)	 	All Intellectual Property generated or derived by MOVA in the course of
performing the Services which are not specific to, or dependent upon, Client’s Product
and which have application to manufacturing processes or formulation development of
drug products or drug delivery systems shall be the exclusive property of MOVA. MOVA
hereby grants to Client, a non-exclusive, paid-up, royalty-free, transferable license
of such Intellectual Property which Client may use for the manufacture of Client’s
Product.

	6.	 	Indemnity:

	 	A.	 	Indemnification by Client

	 	 	Subject to Sections 6B and 6C(c), Client shall defend, indemnify and hold MOVA, its
affiliates and their respective directors, officers, employees and agents (collectively,
“MOVA Indemnitees”) harmless from and against any and all third-party actions, causes of
action, costs (including reasonable legal fees), claims, damages, liabilities and expenses
(collectively. “Losses”) relating to or arising from:

CONFIDENTIAL

Page 16 of 19

 

Patheon Proposal # CBP-FCL1-1300-0707-R0

08-August-2007

	 	•	 	the manufacture (except as may be contemplated by the Services) or distribution of
the Client’s Product or the use of the Client’s Product by patients either as part of
or outside of the scope of any clinical trials;
	 
	 	•	 	the performance of the Services in accordance with the terms of this Contract;
	 
	 	•	 	any misrepresentation, negligence or willful misconduct by Client or any of its
affiliates and their respective directors, officers, employees and agents
(collectively, “Client Indemnitees”);
	 
	 	•	 	any breach by the Client of the Client’s obligations or warranties under this
Contract; or
	 
	 	•	 	any claim of infringement or alleged infringement of any third party’s intellectual
property rights in respect of the Client’s Product.

	 	 	This indemnity shall not apply to the extent that such Losses are:

	 	•	 	determined to have resulted from the negligence or willful misconduct of MOVA; or
	 
	 	•	 	for which MOVA is obligated to indemnify the Client Indemnitees pursuant to Section
6B.

	 	B.	 	Indemnification by MOVA

	 	 	Subject to Sections 6A and 6C(c), MOVA shall defend, indemnify and hold the Client
Indemnitees harmless from and against any and all Losses resulting from, relating to or
arising from the breach by MOVA of any of its obligations or warranties under this Contract
except to the extent that such Losses are:

	 	•	 	determined to have resulted from the negligence or willful misconduct of Client; or
	 
	 	•	 	for which Client is obligated to indemnify the MOVA Indemnitees pursuant to Section
6A.

	 	C.	 	Limitation of Liability
	 
	 	(a)	 	If MOVA fails to materially perform any part of the Services in accordance with
the terms of this Contract, then Client’s sole remedy, subject to subparagraph (b),
shall be to request MOVA to:

	 	•	 	repeat that part of the Service at MOVA’s costs provided that Client
provides the API; or
	 
	 	•	 	reimburse Client for the price for that part of the Service, excluding the
cost of the API.

	 	(b)	 	Under no circumstances whatsoever shall MOVA reimburse Client for the cost of
the API.
	 
	 	(c)	 	Under no circumstances whatsoever shall either party be liable to the other in
contract, tort, negligence, breach of statutory duty or otherwise for (i) any (direct
or indirect) loss of profits, of production, of anticipated savings, of business or
goodwill or (ii) any other liability, damage, cost or expense of any kind incurred by
the other party of an indirect or consequential nature, regardless of any notice of the
possibility of such damages.

	 	D.	 	No Warranty

	 	 	MOVA MAKES NO WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN
THOSE EXPRESSLY SET FORTH IN THIS CONTRACT. MOVA MAKES NO WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE OR WARRANTY OF MERCHANTABILITY IN RESPECT OF THE CLIENTS PRODUCT.

	7.	 	Regulatory Filings:

	 	(a)	 	Client shall have the sole responsibility for filing of all documents with the
applicable regulatory authority (such as the United States Food and Drug Administration
(“FDA”), the Health Products and Food Branch of Health Canada or the European Medicine
Evaluation Agency) (the “Regulatory Authority”) and to take any other actions that may
be required for the receipt of approval from the Regulatory Authority for the
commercial manufacture of the Client’s Product.
	 
	 	(b)	 	At least 21 days prior to filing any documents with the Regulatory Authority
that incorporate data generated by MOVA, Client shall provide MOVA with a copy of the
documents incorporating such data so as to give MOVA the opportunity to verify the
accuracy and regulatory validity of such documents as it relates to the MOVA-generated
data.
	 
	 	(c)	 	If MOVA is selected as the commercial site of manufacture of the Product which
is the subject of the Services under this Contract, then at least 21 days prior to
filing with the Regulatory Authority any documentation which is or is equivalent to the
FDA’s Chemistry and Manufacturing Controls

CONFIDENTIAL

Page 17 of 19

 

Patheon Proposal # CBP-FCL1-1300-0707-R0

08-August-2007

	 	 	 	(“CMC”) portion of the New Drug Application or of the Abbreviated New Drug
Application, as the case may be, Client shall provide MOVA with a copy of the CMC
portion as well as all supporting documents which have been relied upon to prepare
the CMC portion. Such disclosure shall permit MOVA to verify that the CMC portion
accurately describes the Services that MOVA has performed and the manufacturing
processes that MOVA will perform pursuant to this Contract.

	8.	 	Shipping (if applicable):
	 
	 	 	Shipments (if applicable) of Client’s Product shall be made EXW (as defined in INCOTERMS
2000) MOVA’s shipping point unless otherwise mutually agreed. Risk of toss or of damage to
such Product shall transfer to the Client when the Product is loaded onto the carrier’s
vehicle by MOVA for shipment at the EXW point. The Product shall be transported in
accordance with the Client’s instructions.

	9.	 	Miscellaneous:

	 	A.	 	Assignment
	 
	 	 	 	Neither this Contract, nor any of either party’s rights hereunder, may be assigned
or otherwise transferred by either party without the prior written consent of the
other party, which consent shall not be unreasonably withheld.
	 
	 	B.	 	Force Majeure
	 
	 	 	 	Except for payment obligations, neither party will be responsible for delay or
failure in performance resulting from acts beyond the reasonable control and without
the fault or negligence of such party, including, but not limited to, strikes or
other labour disturbances, lockouts, quarantines, communicable disease outbreaks,
riots, wars, acts of terrorism, fires, floods, storms, interruption of or delay in
transportation, defective equipment, lack of or inability to obtain fuel, power or
components or compliance with any order or regulation of any government entity.
	 
	 	C.	 	Survival
	 
	 	 	 	Any termination or expiration of this Contract shall not affect any outstanding
obligations or payments due hereunder prior to such termination or expiration, nor
shall it prejudice any other remedies that the parties may have under this Contract
The Confidentiality Agreement and sections 4, 5, 6 and 7 of the Contract shall
survive the expiration or termination of this Contract.
	 
	 	D.	 	Independent Contractors
	 
	 	 	 	The parties are independent contractors and this Contract shall not be construed to
create between MOVA and the Client any other relationship such as, by way of example
only, that of employer-employee, principal, agent, joint-venturer, co-partners or
any similar relationship.
	 
	 	E.	 	Confidentiality
	 
	 	 	 	The Confidentiality Agreement entered into between the parties shall apply to all
confidential Information about the parties and the Services to be conducted under
this Contract and such Confidentiality Agreement is deemed to be incorporated herein
by reference. If the Confidentiality Agreement expires or terminates prior to the
expiration or termination of this Contract, then the terms of the Confidentiality
Agreement shall nonetheless continue to govern the parties’ obligations of
confidentiality for the term of this Contract and for 5 years thereafter.
	 
	 	F.	 	Patheon PartnerTM
	 
	 	 	 	In order to participate in the PatheonPartner program, Client must submit a
completed PatheonPartnerTM External User Account/Access Form to its Patheon project
manager. If applicable, the PatheonPartnerTM External User Account/Access Form signed
by the Client shall apply to the Client’s use of the PatheonPartnerTM website in
respect of the Services.
	 
	 	G.	 	Other Terms
	 
	 	 	 	No terms, provisions or conditions of any purchase order or other business form or
written authorization used by Client or MOVA will have any effect on the rights,
duties or obligations of the parties, or otherwise modify, this Contract, regardless
of any failure of Client or MOVA to object to such terms, provisions, or conditions
unless such document specifically

CONFIDENTIAL

Page 18 of 19

 

Patheon Proposal # CBP-FCL1-1300-0707-R0

08-August-2007

	 	 	 	refers to this Contract and is signed by both parties.
	 
	 	H.	 	Insurance
	 
	 	 	 	Each party shall maintain during the term of this Contract general liability and
product liability insurance. Either party may request evidence of such insurance.
	 
	 	I.	 	Entire Agreement
	 
	 	 	 	This Contract constitutes the complete agreement between the parties with respect to
this subject matter and supersedes all other prior agreements and understandings,
whether written or oral. Any modifications, amendment or supplement to this Contract
must be in writing and signed by authorized representatives of both parties.
	 
	 	J.	 	Facsimile
	 
	 	 	 	This Contract may be signed in counterparts and by facsimile.
	 
	 	K.	 	Choice of Law
	 
	 	 	 	This Contract is governed by the laws of the Commonwealth of Puerto Rico, without
regard to any conflicts-of-law principle that directs the application to another
jurisdiction’s law.

CONFIDENTIAL

Page 19 of 19exv10w2

Exhibit 10.2

PATHEON

Change of Scope # CBP-FCL1-1300-0707-R0-COS-001-R0

Spectracef Tablets ([***]mg� Strength)

For Cornerstone Biopharma, Inc.

This Change of Scope describes Development work activities which will be performed for Cornerstone
Biopharma, Inc, (“Client”) by MOVA Pharmaceutical Corporation (“MOVA”) under the terms and
conditions of proposal CBP-FCL1-1300-0707-R0 by and between MOVA and the Client, dated October
10th, 2007, which is hereby revised to include this amendment in its entirety. This
change of scope reflects the costs associated to development work strategy for the Spectracef
[***]mg Tablet to be developed at MOVA’s Carolina, Puerto Rico facilities that were not included as
part of the original proposal.

Background

The original proposal did not contemplate GMP batches. Following the signing of the proposal the
client informed that the expectations were to perform clinical studies with at least two (2) of the
batches.

� Note: The original proposal calls for a [***]mg tablet, post approval the client decided to
increase dosage to [***]mg tablet.

Description of Additional Project Work

MOVA will perform the activities listed below in sections 1 through 3 to support the Development
and Clinical Trial Material manufacturing of Spectracef [***]mg tablets. This work will be
conducted in MOVA’s Carolina, Puerto Rico facilities.

This COS includes the changes and additions to sections 4.2 and 5 (pages 5 and 6) of the Original
Proposal # CBP-FCL1 -1300-0707-RO.

From the Original Proposal the Sections that remain the same are:

	 	•	 	Section 3 — Analytical Development [***]
	 
	 	•	 	Section 4.0 — Formulation Development [***]
	 
	 	•	 	Section 4.1 — Feasibility Trial I [***]

	 	 	Total remaining costs from the Original Proposal are [***].

The total value of work under this Change of Scope is [***]. This represents a net increase of $
74,688 from the Original Proposal.

Cornerstone Biopharma, Inc.

Spectracef [***]mg Tablets

Page 1 of 6

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

 

 

CBP-FCL1-1300-0707-R0-COS-001-R0

11.15.07

	1.0	 	Formulation Development

	 	1.1.	 	Feasibility Trials II

	      This section has been modified from the original proposal to:
	 
	o	 	 Reduce the amount of non-GMP feasibility trials II from 4 lots to 2 lots.

This section replaces in its entirety Section 4.2 “Feasibility Trials II” of Agreement #
CBP-FCL1-1300-0707-R0, pages 5 and 6.

MOVA will provide a protocol and data analysis report for Formulation Development.

	 	•	 	Spectracef [***]mg tablets
	 
	 	•	 	2 batches
	 
	 	•	 	Approximately 6-9 kilograms
	 
	 	•	 	Process:

	 	o	 	Batch 1: Mixing and Granulation
	 
	 	o	 	Batch 2: Mixing, granulation, compression and coating

	 	•	 	Non GMP
	 
	 	•	 	No QA Review

Batch 1 (Blending Study) will be tested for

	 	•	 	Blend Uniformity
	 
	 	•	 	Physical Testing including appearance, particle size, bulk/tapped densities, flow
properties, etc.

Batch 2 (full process) will be tested for:

	 	•	 	Blend Uniformity
	 
	 	•	 	Content Uniformity
	 
	 	•	 	Dissolution (profile by HPLC)
	 
	 	•	 	Potency and Related Substances
	 
	 	•	 	Physical testing including appearance, hardness, thickness, friability and
disintegration.

Cornerstone Biopharma, Inc.

Spectracef [***] Tablets

Page 2 of 6

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

 

 

CBP-FCL1-1300-0707-R0-COS-001-R0

11.15.07

2.0 CTM Batches Manufacturing

This is a new section which has been added

MOVA will manufacture:

	 	•	 	Spectracef [***]mg tablets
	 
	 	•	 	2 batches
	 
	 	•	 	Approximately 6-9 kilograms
	 
	 	•	 	Process:

	 	o	 	Mixing, granulation, compression and coating

	 	•	 	Batches packaged into HDPE (i.e. 30’s) for Stability
	 
	 	•	 	GMP
	 
	 	•	 	QA Review

CTM batches will be tested for:

	 	•	 	Blend Uniformity
	 
	 	•	 	Content Uniformity
	 
	 	•	 	Dissolution (profile by HPLC)
	 
	 	•	 	Potency and Related Substances
	 
	 	•	 	Physical testing including appearance, hardness, thickness, friability and
disintegration.

All excipients will undergo complete analytical release testing in compliance with USP/NF
requirements.

MOVA will prepare a master batch record and protocol, which will be provided to the client for
approval prior to manufacturing.

The batches will be subsequently packaged and placed on Stability.

Cornerstone Biopharma, Inc.

Spectracef [***] Tablets

Page 3 of 6

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

 

 

CBP-FCL1-1300-0707-R0-COS-001-R0

11.15.07

3.0 Stability Program of CTM Batches

This section replaces in its entirety Section 5 “Stability-Formulation Development Batch” of
Agreement #CBP-FCL1-1300-0707-R0, page 6.

This section has been modified from the original proposal to:

	 	o	 	Clarify that the Stability will be performed on the CTM batches
	 
	 	o	 	Include one (1) batch to the Stability Program

MOVA shall design a stability program to monitor:

	 	•	 	Two (2) packaging batches under ICH conditions

The following storage conditions and test-points are suggested for testing:

=> 1, 2, 3 and 6 months for 40°C ± 2°C / 75% ± 5% RH

=> 1, 2, 3 and 6 months for 25°C ± 2°C / 60% ± 5% RH

Testing per sample:

	 	•	 	Potency and Related substances
	 
	 	•	 	Dissolution (profile by HPLC)
	 
	 	•	 	Physical testing including appearance, moisture

Cornerstone Biopharma, Inc.

Spectracef [***] Tablets

Page 4 of 6

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

 

 

CBP-FCL1-1300-0707-R0-COS-001-R0

11.15.07

	 	 	 	 	 	 	 	 	 
	4.0 Budget Summary
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	CBP-FCL1-1300-0707-R0-COS-001-R0 Project

	 	 	 	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	1.0 FORMULATION DEVELOPMENT

	 	 	 	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	Feasibility Trials II (2 lots) — Non GMP lots

	 	 	 	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	Feasibility Trials II – Manufacturing

	 	 	867	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	Feasibility Trials II -Analytical Support

	 	 	868	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	Feasibility Trials II-Project Support

	 	 	869	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	2.0 CTM Batches Manufacturing – cGMP lots

	 	 	 	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	CTM Batches – Manufacturing Report

	 	 	871	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	CTM Batches One time Fee (Inactive Ingredients Testing

	 	 	872	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	QC/QA)

	 	 	 	 	 	 
	 	 
	CTM Batches – Lot 1
	 	 	 	 	 	[***]	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	CTM Batches – Manufacturing

	 	 	874	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	CTM Batches – Packaging

	 	 	875	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	CTM Batches – Analytical Support

	 	 	876	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	CTM Batches – Project Support

	 	 	877	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	CTM Batches – Lot 2

	 	 	 	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	CTM Batches – Manufacturing

	 	 	879	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	CTM Batches – Packaging

	 	 	880	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	CTM Batches – Analytical Support

	 	 	881	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	CTM Batches – Project Support

	 	 	882	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	CTM Batches – Discount for Back to Back Manufacturing
Efficiency

	 	 	883	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	3.0 Stability – CTM Batches – 2 Lots

	 	 	 	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	Stability – CTM Protocol

	 	 	885	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	Stability – CTM Batch, T = 1 Month (40C/75% RH)

	 	 	886	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	(25C/60% RH)

	 	 		 	 	 	 	 
	Stability – CTM Batch, T = 2 Month (40C/75% RH)

	 	 	887	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	(25C/60% RH)

	 	 		 	 		 	
	Stability – CTM Batch, T = 3 Month (40C/75% RH)
	 	 	888	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	(25C/60% RH)
	 	 	 	 	 	 	 	 
	Stability – CTM Batch, T = 6 Month (40C/75% RH)
	 	 	889	 	 	[***]
	 	CBP-FCL1-1300-0707-R0-COS-001-R0
	(25C/60% RH)
	 	 	 	 	 	 	 	 
	Budget USD (Cat 3)

	 	 	 	 	 	[***]	 	 

Cornerstone Biopharma, Inc.

Spectracef [***] Tablets

Page 5 of 6

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

 

 

CBP-FCL1-1300-0707-R0-COS-001-R0

11.15.07

5.0 Approvals

This Change of Scope becomes effective and binding on both parties only when signed by each party
below.

	 	 	 	 	 	 	 	 	 	 	 
	Cornerstone Biopharma, Inc.	 	 	 	MOVA Pharmaceutical	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By: 

Name:

	 	/s/ Brian Dickson
 

Brian Dickson
	 	 
	 	By:

Name:
	 	/s/ Miguel Hernandez
 

 Miguel Hernandez
	 	 
	Title:

	 	C.M.O.
	 	 	 	Title:
	 	PDS Director	 	 
	Date:

	 	20 Nov. 2007
	 	 	 	Date:
	 	 11/20/07	 	 

Cornerstone Biopharma, Inc.

Spectracef [***] Tablets

Page 6 of 6

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00148-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00148-of-00352.parquet"}]]