exv10w2






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.