Document:

EXHIBIT 10.1

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

FIRST AMENDMENT TO CAPITAL EXPENDITURE AND EQUIPMENT AGREEMENT 

 

THIS FIRST AMENDMENT TO CAPITAL EXPENDITURE AND EQUIPMENT AGREEMENT (this “Amendment”) is effective as of                  , 2013 (the “Amendment Effective Date”) between

		
POZEN INC.,

		
a corporation existing under the laws of the State of Delaware

		
("Pozen")

 -and-

		
PATHEON PHARMACEUTICALS INC.,

		
a corporation existing under the laws of the State of Delaware,

		
(“Patheon”)

BACKGROUND

Pozen and Patheon entered into a Capital Expenditure and Equipment Agreement dated December 19, 2011 (the “Agreement”).  The purpose of this Amendment is to revise the Agreement to include capital required for a new 81/40 mg tablet Product and to update the capital for the 325/40 mg tablet strength Product.

AGREEMENT

NOW, THEREFORE, in consideration of the rights conferred and the obligations assumed herein, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the parties hereby agree as follows:

	1.	Amendment

		(a)	In the Background Section, the first sentence is deleted and replaced by this following new sentence; “Pozen and Patheon are parties to a Master Pharmaceutical Development Agreement dated August 18, 2010 and a Manufacturing Services Agreement (the “MSA”) dated December 19, 2011 under which Patheon will perform certain manufacturing services (the “Services”) related to Pozen’s PA 325 and PA 81 Tablets (the “Products”).”

		(b)	In Section 2, Payment and Expenditures, first paragraph, line six, the reference to “$***” is deleted and replaced with “$*** plus to-be-determined Non-Dedicated Equipment and Facility Modification costs as shown on Schedule A Part III.”

		(c)	In Section 2, Payment and Expenditures, paragraph 2 is deleted in its entirety, and replaced with the following new paragraph.

Page 1 of 4

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Patheon has reviewed the capacity of its existing ***, which will be used for Pozen and also for other Patheon clients, to determine if additional *** will be required to perform the Services for Pozen. Based on the current long range forecasts for the Product and for third party products, Patheon anticipates being able to support most, if not all of the Pozen’s projected forecast for the Product using the existing ***. If for some unforeseen reason, additional *** capacity is required, the Parties will negotiate responsibility for the additional capital in good faith.

		(d)	In Section 6, Term; Termination; Effect of Termination on Future Spending, subsection (a), Term, Termination, paragraph (iii) and subsection (b), the third paragraph, are deleted in their entirety since the Parties have entered into an MSA, and this language is no longer relevant.

		(e)	Schedule A to the Agreement is deleted its entirety and is replaced with revised Schedule A as attached hereto.

		(f)	The “Background” section of this document set forth above is expressly incorporated into this Amendment.

	2.	General

All other terms and conditions of the Agreement shall continue unchanged and remain in full force and effect.

IN WITNESS WHEREOF the duly authorized representatives of the parties have executed this Agreement.

	
POZEN INC.

	
 

		
PATHEON PHARMACEUTICALS INC.

	
	
 

	
 

		
 

	
 

	
	
By:

	
/s/ John R. Plachetka

		
By:

	
/s/ Francis P. McCune

	
	
 

	
 

		
 

	
 

	
	
Name:

	
John R. Plachetka

		
Name:

	
Francis P. McCune

	
	
 

	
 

		
 

	
 

	
	
Title:

	
Chairman, CEO & President

		
Title:

	
Secretary

	

Page 2 of 4

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Schedule A

(as revised by First Amendment to Capital and Expenditure Agreement)

	
Part I. Required Expenditures

	
 

	
 

	
 

	
 

	
Pozen Funded Capital

	
PA 325/40

	
Timing

	
PA 81/40

	
Timing

	
Dedicated Equipment

	
Cost

	
 

	
Cost

	
 

	
Miscellaneous Screens and cloth Items

	
***

	
***

	
***

	
***

	
Compression tooling (single tip) 1set

	
***

	
***

	
 

	
 

	
Compression tooling (single tip) 2 sets

	
 

	
 

	
***

	
***

	
Packaging Change parts

	
 

	
 

	
***

	
***

	
Printer Change parts

	
***

	
***

	
***

	
***

	
Subtotal Dedicated Equipment

	
***

	
 

	
***

	
 

	
 

	
 

	
 

	
 

	
 

	
Non-Dedicated Equipment

	
 

	
 

	
 

	
 

	
Initial Engineering - 48" coating pan upgrade (exhaust temp control/RAFT)

	
***

	
***

	
Water activity equipment

	
***

	
***

	
***

	
***

	
Coating support equipment

	
 

	
 

	
***

	
***

	
Subtotal Non-Dedicated Equipment

	
***

	
 

	
***

	
 

	
Grand Total Phase I Pozen Funded Capital

	
***

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
Part II. Supply Continuity Related Expenditures

	
 

	
 

	
 

	
 

	
Pozen Funded Capital

	
PA 325/40

	
Timing

	
PA 81/40

	
Timing

	
Non-Dedicated Equipment

	
 

	
 

	
 

	
 

	
48" coating pan upgrade (exhaust temp control/RAFT)

	
 

	
 

	
***

	
***

	
Process Engineering and Qualification

	
 

	
 

	
***

	
***

	
***

	
 

	
 

	
***

	
***

	
Subtotal Non-Dedicated Equipment

	
 

	
 

	
***

	
 

	
Grand Total Phase II Pozen Funded Capital

	
***

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
Part III. Capacity (Product Volume) Related Expenditures

	
 

	
 

	
 

	
 

	
Pozen Funded Capital

	
PA 325/40

	
Timing

	
PA 81/40

	
Timing

	
Dedicated Equipment

	
 

	
 

	
 

	
 

	
Compression tooling (multi tip) 2 sets

	
 

	
 

	
***

	
***

	
Subtotal Dedicated Equipment

	
***

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
Non-Dedicated Equipment

	
 

	
 

	
 

	
 

 

Page 3 of 4

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

	
Various capital equipment as volume increases, e.g. blender vacuum charging, drum dumper, bins, etc.

	
***

	
***

	
 

	
 

	
Process Engineering and Qualification

	
***

	
***

	
 

	
 

	
***

	
***

	
***

	
 

	
 

	
Subtotal Non-Dedicated Equipment

	
***

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
Facility Modifications

	
 

	
 

	
 

	
 

	
Facility Study and Preliminary Design*

	
***

	
***

	
 

	
 

	
Facility Modifications* (estimated at $***)

	
***

	
***

	
 

	
 

	
Facility Engineering and Qualification*(estimated at $***)

	
***

	
***

	
 

	
 

	
***

	
***

	
***

	
 

	
 

	
Subtotal Facility Modifications

	
***

	
 

	
 

	
 

	
Subtotal Phase III Pozen Funded Capital

	
***

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
Patheon Funded Capital

	
 

	
 

	
 

	
 

	
HPLC

	
***

	
***

	
 

	
 

	
Dissolution Bath

	
***

	
***

	
 

	
 

	
Subtotal Patheon Funded Capital

	
***

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
Total Pozen Funded Capital

	
***

	
 

	
 

	
 

	
Grand Total Capital

	
***

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 

	
 *Facility Modification are costs  for potential changes required to support the increasing forecasts.    These potential modifications will be in the areas of material handling, material flow, solution prep, printer facilities, WIP storage, and other miscellaneous items.  Specific needs and timing will depend on the actual Product demand and the changing demands for other products at the site.

 

 

 

Page 4 of 4EXHIBIT 10.2

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

First Amendment to Manufacturing Services Agreement

between Patheon Pharmaceuticals Inc., and Pozen Inc.

Background: Patheon Pharmaceuticals Inc., (“Patheon”) and Pozen Inc., (“Pozen”) entered into a Manufacturing Services Agreement effective December 19, 2011 (the “Agreement”).  Patheon and Pozen wish to amend the Agreement to incorporate Pozen’s PA81/40 coated tablet Product into the Agreement, to revise the definition of “Commencement  Date” and to clarify that the manufacture of validation batches of Product are included within the definition of “Manufacturing Services” under the Agreement.

NOW THEREFORE in consideration of the premises hereof and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged by the Parties, the Parties agree to amend the Agreement as follows:

	A.	Amendment to Agreement:

		1.	Schedules A-D are deleted in their entirety and replaced with the attached Revised Schedules A-D.

		2.	In Section 1.1, the definition of “Commencement Date” is deleted in its entirety and is replaced with the following new definition:

 

“Commencement Date” means a date certain, 60 days after Client submits the First Firm Order to Patheon under Section 5.1(b) for any Product under this Agreement excluding validation batches; 

 

		3.	In Section 1.1, the definition of “Manufacturing Services” is deleted in its entirety and is replaced with the following new definition:

"Manufacturing Services" means the manufacturing, quality control, quality assurance, retention of samples, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components and to release and deliver such Products to Client and will include the manufacture of validation batches of Product;

  

		4.	Section 2.1(f) is deleted in its entirety, and replaced with the following new Section 2.1(f):

Active Materials.  Patheon will provide a monthly order to the Client by the 20th day of the month, specifying the quantities and delivery dates of the Active Materials required to meet the Client’s orders for finished products.  The Client will place the orders with the Active Material manufacturer specifying that the Active Material should be shipped to Patheon and the invoices sent to the Client for payment.  Patheon will charge Client a handling fee of ***% of the cost of the Active Materials which will be included in the Price for the Products.  All shipments of Active Material will be accompanied by certificate(s) of analysis from the Active Material manufacturer confirming the identity and purity of the Active Materials and its compliance with the Active Material specifications.  Patheon will test all Active Materials in accordance with Patheon’s then current standard operating procedures.

 

		5.	Section 2.2(a) is revised to include the following two new sentences at the beginning of the section:

“The inventory calculations performed in this Section 2.2 will be a combined yield for the two product strengths.  Individual Target Yields may be required based on actual manufacturing experience, and therefore require a modification to the calculation.”

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

		6.	The word “validation” is deleted from the last sentence of Section 2.2(a) Active Material Yield, Reporting, Quantity Dispensed, and from Schedules H and I, footnote 1.

		7.	In Section 13.6(b), the second sentence is deleted in its entirety and is replaced with the following sentence:

 

“But Client will give Patheon prior written notice of any assignment and any assignee will covenant in writing with Patheon to be bound by the terms of this Agreement.”

	B.	No Other Modifications.  The “Background” section of this document is incorporated into the Amendment.  Except as modified by this Amendment, the terms and conditions of the Agreement remain unchanged.

IN WITNESS WHEREOF, the Parties have caused this First Amendment to be duly executed by their authorized representatives, effective as of ___________, 2013.

 

	
POZEN INC.

	
 

		
PATHEON PHARMACEUTICALS INC.

	
	
 

	
 

		
 

	
 

	
	
By:

	
/s/ John R. Plachetka

		
By:

	
/s/ Francis P. McCune

	
	
 

	
 

		
 

	
 

	
	
Name:

	
John R. Plachetka

		
Name:

	
Francis P. McCune

	
	
 

	
 

		
 

	
 

	
	
Title:

	
Chairman, CEO & President

		
Title:

	
Secretary

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

SCHEDULE A

PRODUCT LIST AND SPECIFICATIONS

Product List

PA 325/40 Tablets, packaged in 7, 30, 90, and 500 count bottles and bulk drums.

PA 81/40 Tablets, packaged in 7, 30, 90, and 500 count bottles, and bulk drums.

Specifications

Prior to the start of commercial manufacturing of Product under this Agreement Client will give Patheon the originally executed copies of the FDA approved Specifications. If the Specifications received are subsequently amended, then Client will give Patheon the revised and originally executed copies of the revised Specifications.  Upon acceptance of the revised Specifications, Patheon will give Client a signed and dated receipt indicating Patheon’s acceptance of the revised Specifications. If the manufacture of validation batches occurs prior to the receipt of final FDA approved Specifications, the proposed Specifications in the FDA filing will be used to manufacture the validation batches.

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

SCHEDULE B

MINIMUM ORDER QUANTITY, ANNUAL VOLUME, AND PRICE

Pricing for 81/40 mg Tablets

 

Annual Volume Forecasts

 

Pricing is based on the following volume tiers.

 

	
Product

	
Volume Tier (Tablets)

	  	
***

	
PA 81/40mg Coated Tablets

	
***

	  	
***

 

Manufacturing and Packaging Pricing Tables

 

Pricing includes the cost of *** and ***.

 

7ct. Bottles w/Carton (Single Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

30ct. Bottles (Single Tip Tooling)

 

	
Product

	
Batch

Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

Schedule B - Page 1

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

90ct. Bottles (Single Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

500ct. Bottles (Single Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

Bulk Tablets (Single Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(‘000)

	
Price per 1,000

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

Schedule B - Page 2

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

7ct. Bottles w/Carton (Single Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

30ct. Bottles (Single Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

90ct. Bottles (Single Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

500ct. Bottles (Single Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

Schedule B - Page 3

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Bulk Tablets (Single Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(‘000)

	
Price per 1,000

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

 

***7ct. Bottles w/Carton (Multi Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

30ct. Bottles (Multi Tip Tooling)

 

	
Product

	
Batch

Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

Schedule B - Page 4

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

90ct. Bottles (Multi Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

500ct. Bottles (Multi Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

Schedule B - Page 5

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Bulk Tablets (Multi Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(‘000)

	
Price per 1,000

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

7ct. Bottles w/Carton (Multi Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

30ct. Bottles (Multi Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

 

Schedule B - Page 6

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

90ct. Bottles (Multi Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

Schedule B - Page 7

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

500ct. Bottles (Multi Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

Bulk Tablets (Multi Tip Tooling)

 

	
Product

	
Batch Size

(Kg)

	
Volume Tier (Tablets)

	
Minimum Ordering Quantity

(‘000)

	
Price per 1,000

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
***

 

Note: Refer to Campaign Assumptions, for additional detail on the manufacturing and packaging batch campaigns assumed in this pricing.

Schedule B - Page 8

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

*** that the *** based on previous experience.

 

	
Parameter

	
PA 81/40mg Tablets

	
PA 81/40mg Tablets

	
Tablet weight (mg)

	
***

	
***

	
Batch size at Patheon (tablets)

	
***

	
***

	
Batch size at Patheon (Kg)

	
***

	
***

The following manufacturing equipment train is proposed for PA 81/40mg Coated Tablets.

	
Process Step

	
503 Kg Batch Size  - Equipment

	
1,250 Kg Batch Size -  Equipment

	
Screen

	
***

	
***

	
Blend

	
***

	
***

	
Compress

	
***

	
***

	
Coating

	
***

	
***

	
Printing

	
***

	
***

 

***The number of *** required will be ***.

A manufacturing yield of ***.

Schedule B - Page 9

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Campaign Assumptions

 

The pricing outlined in the Pricing Table, reflects the campaigns listed below.

 

7ct. Bottles

 

	
Product Description

	
Batch Size

(Kg)

	
Volume Tier

(Tablets)

	
Manufacturing Campaign (Batches)

	
Packaging Campaign (Batches)

	
Bottles per Packaging Campaign

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

 

30ct. Bottles

 

	
Product Description

	
Batch Size

(Kg)

	
Volume Tier

(Tablets)

	
Manufacturing Campaign (Batches)

	
Packaging Campaign (Batches)

	
Bottles per Packaging Campaign

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

 

90ct. Bottles

 

	
Product Description

	
Batch Size

(Kg)

	
Volume Tier

(Tablets)

	
Manufacturing Campaign (Batches)

	
Packaging Campaign (Batches)

	
Bottles per Packaging Campaign

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

 

500ct. Bottles

 

	
Product Description

	
Batch Size

(Kg)

	
Volume Tier

(Tablets)

	
Manufacturing Campaign (Batches)

	
Packaging Campaign (Batches)

	
Bottles per Packaging Campaign

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

Schedule B - Page 10

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Bulk

 

	
Product Description

	
Batch Size

(Kg)

	
Volume Tier

(Tablets)

	
Manufacturing Campaign (Batches)

	
1,000’s per Bulk Packaging Campaign

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

 

7ct. Bottles

 

	
Product Description

	
Batch Size

(Kg)

	
Volume Tier

(Tablets)

	
Manufacturing Campaign (Batches)

	
Packaging Campaign (Batches)

	
Bottles per Packaging Campaign

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

 

30ct. Bottles

 

	
Product Description

	
Batch Size

(Kg)

	
Volume Tier

(Tablets)

	
Manufacturing Campaign (Batches)

	
Packaging Campaign (Batches)

	
Bottles per Packaging Campaign

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

 

90ct. Bottles

 

	
Product Description

	
Batch Size

(Kg)

	
Volume Tier

(Tablets)

	
Manufacturing Campaign (Batches)

	
Packaging Campaign (Batches)

	
Bottles per Packaging Campaign

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

Schedule B - Page 11

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

500ct. Bottles

 

	
Product Description

	
Batch Size

(Kg)

	
Volume Tier

(Tablets)

	
Manufacturing Campaign (Batches)

	
Packaging Campaign (Batches)

	
Bottles per Packaging Campaign

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
***

 

Bulk

 

	
Product Description

	
Batch Size

(Kg)

	
Volume Tier

(Tablets)

	
Manufacturing Campaign (Batches)

	
1,000’s per Bulk Packaging Campaign

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

	
PA 81/40mg Coated Tablets

	
***

	
***

	
***

	
***

Packaging Assumptions

 

PA 81/40mg Coated Tablets will be packaged into the configurations listed in the tables below.

 

	
PA 81/40mg Coated Tablets

	
7ct. Bottles w/ Carton

	
30ct. Bottles w/o Carton

	
90ct. Bottles w/o Carton

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	  	  

 

Schedule B - Page 12

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

	
PA 81/40mg Coated Tablets

	
500ct. Bottles

	
Bulk Tablets

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

 

The packaging component specifications have been ***.  *** to the *** *** in *** of the ***.

 

Individual coating pans will be release tested on an individual basis.

 

A packaging yield of ***% for bottle and ***% for the bulk sku’s ***.

Schedule B - Page 13

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Pricing for 325/40 mg Tablets

 

Manufacturing and Packaging Pricing Tables

 

Pricing includes the cost of *** and ***.

 

7 Count Bottles in a Carton

 

	
Product

	
Annual Quantity

(Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA325/40 Tablets – Vol. 1

	
***

	
***

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 2

	
***

	
***

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 3

	
***

	
***

	
***

	
***

	
***

30 Count Bottles

 

	
Product

	
Annual Quantity

(Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA325/40 Tablets – Vol. 1

	
***

	
***

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 2

	
***

	
***

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 3

	
***

	
***

	
***

	
***

	
***

90 Count Bottles

 

	
Product

	
Annual Quantity

(Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA325/40 Tablets – Vol. 1

	
***

	
***

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 2

	
***

	
***

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 3

	
***

	
***

	
***

	
***

	
***

Schedule B - Page 14

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

500 Count Bottles

 

	
Product

	
Annual Quantity

(Tablets)

	
Minimum Ordering Quantity

(Bottles)

	
Price per Bottle

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA325/40 Tablets – Vol. 1

	
***

	
***

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 2

	
***

	
***

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 3

	
***

	
***

	
***

	
***

	
***

Bulk

 

	
Product

	
Annual Quantity

(‘000’s)

	
Minimum Ordering Quantity

(‘000)

	
Price per 1,000

	
Material Price

	
Conversion Price

	
Full Service Price

	
PA325/40 Tablets – Vol. 1

	
***

	
***

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 2

	
***

	
***

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 3

	
***

	
***

	
***

	
***

	
***

Note: Refer to Campaign Assumptions, for additional detail on the manufacturing and packaging batch campaigns assumed in this pricing.

Manufacturing Assumptions

 

The manufacturing process at Patheon will follow the process information provided by Pozen and Patheon’s experience with the product.

The core tablet weight and manufacturing batch sizes proposed by Patheon is summarized in the following table.

 

 

	
Parameter

	
Value

	
Tablet weight (mg)

	
***

	
Batch size at Patheon (tablets)

	
***

	
Core Batch size at Patheon (Kg)

	
***

	
Coating Batch size at Patheon (Kg)

	
***

 

Schedule B - Page 15

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

The following manufacturing equipment train is proposed for PA 325/40 tablets.

 

	
Process Step

	
PA325/40 Tablets

	
Weighing

	
***

	
Blending

	
***

	
Compressing

	
***

	
Coating

	
***

	
Printing

	
***

 

The *** will be *** for ***.

 

Individual coating pans will be release tested on an individual basis.

 

A manufacturing yield of ***.

 

Campaign Assumptions

 

7 Count Bottles in a Carton

 

	
Product Description

	
Manufacturing Campaign (Batches)

	
Packaging Campaign (Batches)

	
Bottles per Packaging Campaign

	
PA325/40 Tablets – Vol. 1

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 2

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 3

	
***

	
***

	
***

 

30 Count Bottles

 

	
Product Description

	
Manufacturing Campaign (Batches)

	
Packaging Campaign (Batches)

	
Bottles per Packaging Campaign

	
PA325/40 Tablets – Vol. 1

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 2

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 3

	
***

	
***

	
***

Schedule B - Page 16

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

 90 Count Bottles

 

	
Product Description

	
Manufacturing Campaign (Batches)

	
Packaging Campaign (Batches)

	
Bottles per Packaging Campaign

	
PA325/40 Tablets – Vol. 1

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 2

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 3

	
***

	
***

	
***

 

 500 Count Bottles

 

	
Product Description

	
Manufacturing Campaign (Batches)

	
Packaging Campaign (Batches)

	
Bottles per Packaging Campaign

	
PA325/40 Tablets – Vol. 1

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 2

	
***

	
***

	
***

	
PA325/40 Tablets – Vol. 3

	
***

	
***

	
***

 Bulk

 

	
Product Description

	
Manufacturing Campaign (Batches)

	
Cartons per Packaging Campaign

	
PA325/40 Tablets – Vol. 1

	
***

	
***

	
PA325/40 Tablets – Vol. 2

	
***

	
***

	
PA325/40 Tablets – Vol. 3

	
***

	
***

Schedule B - Page 17

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Packaging Assumptions

 

PA 325/40 tablets will be packaged into the configurations listed in the tables below.

 

	
PA 325/40 Tablets

	
7’s Bottles in a Carton

	
30’s Bottles

	
90’s Bottles

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

 

	
PA 325/40 Tablets

	
500’s Bottles

	
Bulk

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

	
***

 

The packaging component specifications have been ***. *** to the *** *** in *** of the ***.

Schedule B - Page 18

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

A packaging yield of ***% is assumed for bulk and ***% for bottles.

Key Technical Assumptions

 

Below are listed the main assumptions that were utilized by Patheon for quoting this product. Should any of the assumptions change, then the prices will be revised accordingly.

 

Manufacturing Assumptions

 

		·	The manufacturing process at Patheon will follow the process information provided by Pozen and Patheon’s experience with the product.

 

		·	The core tablet weight and manufacturing batch sizes for each strength proposed by Patheon are summarized in the following table.

 

		·	Pricing for both a 503 and 1250Kg batch size is being presented for comparison purposes.

 

Testing Assumptions

 

		·	*** for *** and *** are *** on ***.

 

		·	It is *** that the *** would only be required to *** of the ***.  *** can fully *** and this *** can be ***.

 

		·	It is *** that *** are *** and ***.

 

		·	Each *** has *** to the ***.

 

		·	*** has been included on the finished product.

 

		·	*** may be subject to change after the *** on *** and ***.

 

Cleaning Assumptions

 

		·	It is *** that *** are *** and *** after each campaign.

The following cost items are included in the Price for the Products:

 

*** and ***

 

***of ***

 

***of ***

 

***

 

*** for *** ***, and *** thereafter

Schedule B - Page 19

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

*** and ***

 

*** of the ***

 

*** and ***

 

***

 

*** of *** and other *** for ***

 

*** of *** and other *** for *** or *** ***

 

*** and *** of *** and ***

 

*** of *** and *** for ***

 

*** and *** by *** to be *** by *** and***.

 

Costs Not Included in Unit Pricing:

 

*** to be *** by ***, *** and ***

 

***

 

***

 

*** and ***

 

*** and ***

 

*** of *** not *** on ***

 

*** and *** in *** with an *** and ***

 

 *** and ***, ***

 

*** of the *** or the *** of ***

 

*** for *** which will be *** are ***

Schedule B - Page 20

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

SCHEDULE C

ANNUAL STABILITY TESTING

Patheon and Client will agree in writing on any stability testing to be performed by Patheon on the Products.  This agreement will specify the commercial and Product stability protocols applicable to the stability testing and the fees payable by Client for this testing.

	
STABILITY – COMMERCIAL PA8140 TABLETS

	
USD

	
ACTIVITY

	
PRICE

 

Number of Lots ***

Total Samples ***

 

	
Pullpoint

Months

	 	
25°C / 60% RH

	 	 	
Samples per 

pullpoint

	 	 	
Cost per 

pullpoint 

(Milestone 

Price)

	 
	
T=0

	 	 	
x

	  	   	   	
***

		   	
$

	
***

	
	
T=6

	 	 	
x

	    	   	   	
***

	  	   	
$

	
***

	
	
T=12

	 	 	
x

	  	   	   	
***

	  	   	
$

	
***

	
	
T=24

	 	 	
x

	  	   	   	
***

	  	   	
$

	
***

	
	
T=36

	 	 	
x

	  	   	   	
***

	  	   	
$

	
***

	
	
 

	 	 	
x

	   	   	   	 	   	   	 	 	 
	
 

	 	 		
Total per Batch (one SKU)

	 	 	
$

	
***

	

 

	
STABILITY – COMMERCIAL PA32540 TABLETS

	
USD

	
ACTIVITY

	
PRICE

 

Number of Lots ***

Total Samples ***

 

	

Pullpoint

Months

	 	
25°C / 60% RH

	   	   	
Samples per 

pullpoint

	 	 	
Cost per 

pullpoint 

(Milestone 

Price)

	 
	
T=0

	 	 	
x

	  	   	   	
***

	  	   	
$

	
***

	
	
T=6

	 	 	
x

	  	   	   	
***

	  	   	
$

	
***

	
	
T=12

	 	 	
x

	  	   	   	
***

	  	   	
$

	
***

	
	
T=24

	 	 	
x

	  	   	   	
***

	  	   	
$

	
***

	
	
T=36

	 	 	
x

	  	   	   	
***

	  	   	
$

	
***

	
	
 

	 	 	
x

	   	   	   	 	   	   	 	 	 
	
 

	 	 		
Total per Batch (one SKU)

	   	   	
$

	
***

	

 

SCHEDULE D

ACTIVE MATERIALS

	
Active Materials

	
Supplier

	
Omeprazole, USP

	
***

	
Aspirin/Starch

	
***

ACTIVE MATERIALS CREDIT VALUE

 

The Active Materials Credit Value will be as follows:

 

	
PRODUCT

	
ACTIVE MATERIALS

	
ACTIVE MATERIALS

CREDIT  VALUE

	
PA 325/40 and PA 81/40 Tablets

	
Omeprazole

	
***

	
 

	
Aspirin/Starch

	
***

MAXIMUM CREDIT VALUE

 

Patheon's liability for Active Materials calculated in accordance with Section 2.2 of the Agreement [for any Product] in a Year will not exceed, in the aggregate, the maximum credit value set forth below:

 

	
PRODUCT

	
MAXIMUM CREDIT VALUE

	
PA 325/40 and PA 81/40 Tablets

	
***

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