First Amendment to Manufacturing Services Agreement between Patheon Pharmaceuticals Inc., and Pozen Inc.
EXHIBIT 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.
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POZEN INC.
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PATHEON PHARMACEUTICALS INC.
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By:
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/s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇
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By:
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/s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
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Name:
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▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇
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Name:
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▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
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Title:
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Chairman, CEO & President
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Title:
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Secretary
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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.
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Product
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Volume Tier (Tablets)
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***
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PA 81/40mg Coated Tablets
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***
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***
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Manufacturing and Packaging Pricing Tables
Pricing includes the cost of *** and ***.
7ct. Bottles w/Carton (Single Tip Tooling)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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Material Price
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Conversion Price
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Full Service Price
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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30ct. Bottles (Single Tip Tooling)
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Product
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Batch
Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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Material Price
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Conversion Price
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Full Service Price
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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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)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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Material Price
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Conversion Price
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Full Service Price
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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500ct. Bottles (Single Tip Tooling)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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Material Price
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Conversion Price
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Full Service Price
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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Bulk Tablets (Single Tip Tooling)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(‘000)
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Price per 1,000
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Material Price
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Conversion Price
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Full Service Price
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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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)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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Material Price
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Conversion Price
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Full Service Price
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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30ct. Bottles (Single Tip Tooling)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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Material Price
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Conversion Price
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Full Service Price
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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90ct. Bottles (Single Tip Tooling)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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Material Price
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Conversion Price
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Full Service Price
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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500ct. Bottles (Single Tip Tooling)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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Material Price
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Conversion Price
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Full Service Price
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||||
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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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)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(‘000)
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Price per 1,000
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Material Price
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Conversion Price
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Full Service Price
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||||
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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***7ct. Bottles w/Carton (Multi Tip Tooling)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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Material Price
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Conversion Price
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Full Service Price
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||||
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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30ct. Bottles (Multi Tip Tooling)
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Product
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Batch
Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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Material Price
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Conversion Price
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Full Service Price
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||||
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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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)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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Material Price
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Conversion Price
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Full Service Price
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||||
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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500ct. Bottles (Multi Tip Tooling)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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||
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Material Price
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Conversion Price
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Full Service Price
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||||
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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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)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(‘000)
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Price per 1,000
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Material Price
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Conversion Price
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Full Service Price
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||||
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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7ct. Bottles w/Carton (Multi Tip Tooling)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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Material Price
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Conversion Price
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Full Service Price
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||||
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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30ct. Bottles (Multi Tip Tooling)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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Material Price
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Conversion Price
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Full Service Price
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||||
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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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)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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Material Price
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Conversion Price
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Full Service Price
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||||
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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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)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(Bottles)
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Price per Bottle
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||
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Material Price
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Conversion Price
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Full Service Price
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||||
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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Bulk Tablets (Multi Tip Tooling)
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Product
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Batch Size
(Kg)
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Volume Tier (Tablets)
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Minimum Ordering Quantity
(‘000)
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Price per 1,000
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||
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Material Price
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Conversion Price
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Full Service Price
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||||
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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PA 81/40mg Coated Tablets
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***
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***
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***
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***
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***
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***
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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.
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Parameter
|
PA 81/40mg Tablets
|
PA 81/40mg Tablets
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|
Tablet weight (mg)
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***
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***
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Batch size at Patheon (tablets)
|
***
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***
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Batch size at Patheon (Kg)
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***
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***
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The following manufacturing equipment train is proposed for PA 81/40mg Coated Tablets.
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Process Step
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503 Kg Batch Size - Equipment
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1,250 Kg Batch Size - Equipment
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Screen
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***
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***
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Blend
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***
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***
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Compress
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***
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***
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Coating
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***
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***
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Printing
|
***
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***
|
***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
|
***
|
|
|
|