Document:

Exhibit 10.15

 

AMENDMENT NO. 1 TO MASTER MANUFACTURING SERVICES AGREEMENT

 

This Amendment No. 1 to the Master Manufacturing Services Agreement (this “Amendment”) effective January 1, 2017 (the “Amendment Effective Date”), between Osmotica Pharmaceutical US LLC, a Delaware limited liability company, having its principal place of business at 895 Sawyer Road, Marietta, Georgia 30062 (“Client”) and Patheon Pharmaceuticals Inc. a Delaware corporation having its principal place of business at 2110 East Galbraith Road, Cincinnati, OH 45237-1625 (“Patheon”), and together with Client, the “Parties”, and each, a “Party”).

 

Background:  The Parties entered into a Master Manufacturing Services Agreement effective August 21, 2014 (the “Master Agreement”). The Parties desire to amend the Master Agreement i) to revise the Confidentiality provisions, ii) to allow Client to use alternate suppliers in certain circumstances, and iii) to allow Client to maintain one alternate, qualified source for tablet, manufacturing, packaging and bottling to be utilized by Client under certain circumstances. Under Section 13.11 of the Master Agreement, any amendment to the Master Agreement must be in writing signed by an authorized representative of each Party.

 

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

 

1.                                      Definitions. Capitalized terms used and not defined in this Amendment have the respective meanings assigned to them in the Master Agreement.

 

2.                                      Amendments to the Master Agreement. As of the Amendment Effective Date, the Master Agreement is hereby amended as follows:

 

(a)                                 Section 11.1, Confidentiality, is deleted in its entirety and replaced with the following:

 

“11.1                  Confidentiality. The Confidentiality Agreement is hereby incorporated into this Agreement by reference and will apply to all information disclosed by the parties under this Agreement or any Product Agreement. The confidentiality terms of this Agreement will apply during the term of this Agreement and any Product Agreement and will survive the termination or expiration of this Agreement for three years. But with respect to any Confidential Information that constitutes a “trade secret”, the confidentiality obligations and restrictions will remain in effect for so long as the Confidential Information retains its hade secret status under applicable law.

 

(b)                                 Section 5.1(e) is hereby amended by adding the following language as a new Section 5.1(e)(iv):

 

“(iv)                        Alternate Qualified Source

 

A)                                   Performance Issues. In addition to the provisions of Sections 5.1(e)(ii) and 5.1 (e)(iii) and any other rights and remedies in this Agreement, if Patheon a) is unable to supply the 

 

 

Product to Client in the amount and in the manner ordered by Client in any Purchase Order for three or more consecutive months; or b) has Late Deliveries on three or more Purchase Orders in a single quarter, Client will have the right to use one or more alternate suppliers of the Product, including Client and its affiliates, to provide Product, packaging and/or labeling to Client. Client will have the right to continue using these alternate suppliers for supply of Product until Patheon provides Client written notice that Patheon has corrected the foregoing performance issues. After receipt of this notice, the parties will reasonably agree to a schedule to increase the supply of Product supplied by Patheon and decrease the supply of Product provided by the alternate suppliers. Client will not place any new orders with the alternate suppliers for delivery of Product more than 90 days after receipt of the notice unless Patheon approves. Client will begin placing new Finn Orders with Patheon for delivery in the fourth month following receipt of the notice and going forward as provided in this Agreement.

 

B)                                   Force Majeure Events. In addition to the provisions of Sections 5.1(e)(ii) and 5.1(e)(iii) and any other rights and remedies in this Agreement, and notwithstanding anything to the contrary in Section 13.7, Force Majeure, if Patheon is unable to supply the Product to Client in the amount and in the manner ordered by Client in any Purchase Order due to a Force Majeure Event, Client will have the right to use one or more alternate suppliers of the Product, including Client and its affiliates, to provide Product, packaging and/or labeling to Client instead of buying the Product from Patheon. Client will have the right to continue using the alternate suppliers for supply of Product until Patheon provides Client written notice that Patheon has corrected the issues related to the Force Majeure Event. After receipt of this notice, the parties will reasonably agree to a schedule to increase the supply of Product supplied by Patheon and decrease the supply of Product provided by the alternate suppliers. Client will not place any new orders with the alternate suppliers for delivery of Product more than 90 days after receipt of the notice unless Patheon approves. Client will begin placing new Finn Orders with Patheon for delivery in the fourth month following receipt of the notice and going forward as provided in this Agreement.

 

C)                                   Patheon will cooperate with and assist Client in good faith as reasonably requested by Client to qualify any alternate suppliers at Client’s reasonable expense.

 

3.                                      Date of Effectiveness: Limited Effect. This Amendment will become effective on the Amendment Effective Date and will apply to all information disclosed under the Master Agreement. Except as modified by this Amendment, all of the terms of the Master Agreement remain unchanged. The “Background” section of this document is incorporated into this Amendment.

 

4.                                      Miscellaneous.

 

(a)                                 This Amendment is governed by, and construed in accordance with, the laws of the State of New York without regard to the conflict of law provisions of that State.

 

(b)                                 This Amendment may be executed in counterparts, each of which is deemed an original, but all of which constitutes one and the same agreement. Delivery of an executed counterpart of this Amendment electronically will be effective as delivery of an original executed counterpart of this Amendment.

 

2

 

(c)                                  Each Party will pay its own costs and expenses in connection with this Amendment (including the fees and expenses of its advisors, accountants and legal counsel).

 

3

 

IN WITNESS WHEREOF, the Parties have executed this Amendment as of the Amendment Effective Date.

 

	
 
    	
Osmotica   Pharmaceutical US LLC
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Richard G. Buecheler
    
	
 
    	
 
    
	
 
    	
Name:   Richard G. Buecheler
    
	
 
    	
 
    
	
 
    	
Title:   Senior Vice President of Technical Operations
    
	
 
    	
 
    
	
 
    	
Date:
    	
4/27/2017
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
Patheon   Pharmaceuticals
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Nicholas M. Buschur
    
	
 
    	
 
    
	
 
    	
Name:   Nicholas M. Buschur
    
	
 
    	
 
    
	
 
    	
Title:   Executive Director and General Manager
    
	
 
    	
 
    
	
 
    	
Date:
    	
4/27/2017
    
				

 

4Exhibit 10.16

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

PRODUCT AGREEMENT

 

(Includes Schedules A to E)

 

PRODUCT AGREEMENT

 

This Product Agreement (this “Product Agreement”) is issued under the Master Manufacturing Services Agreement dated August 21, 2014 between Patheon Pharmaceuticals Inc., and Osmotica Pharmaceutical Corp., (the “Master Agreement”), and is entered into October 1, 2014 (the “Effective Date”), between Patheon Pharmaceuticals Inc., a corporation existing under the laws of the State of Delaware, having a principal place of business at 2110 East Galbraith Road, Cincinnati, OH 45237-1626 (“Patheon”) and Osmotica Pharmaceutical Corp., a corporation existing under the laws of the State of Delaware, having a principal place of business at 895 Sawyer Road, Marietta, GA 30062 (“Client”).

 

The terms and conditions of the Master Agreement are incorporated herein except to the extent this Product Agreement expressly references the specific provision in the Master Agreement to be modified by this Product Agreement. All capitalized terms that are used but not defined in this Product Agreement will have the respective meanings given to them in the Master Agreement

 

The Schedules to this Product Agreement are incorporated into and will be construed in accordance with the terms of this Product Agreement.

 

1.                                      Product List and Specifications (See Schedule A attached hereto)

 

2.                                      Manufacturing Exclusivity, Minimum Order Quantity, Annual Volume, and Price - Annual Volumes greater than [***] tablets (See Schedule B attached hereto)

 

3.                                      Manufacturing exclusivity, Minimum Order Quantity, Annual Volume, and Price - Annual Volumes less than or equal to [***] tablets (See Schedule E attached hereto)

 

4.                                      Annual Stability Testing and Validation Activities (if applicable) (See Schedule C attached hereto)

 

Active Materials, Active Materials Credit Value, and Maximum Credit Value (See Schedule D attached hereto)

 

5.                                      Yearly Forecasted Volume: Not applicable

 

6.                                      Territory: United States of America

 

7.                                      Manufacturing Site: Patheon Pharmaceuticals Inc., 2110 East Galbraith Road, Cincinnati, OH 45237-1625

 

8.                                      Governing Law: Refer to Section 13.7 of the Master Agreement

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

9.                                      Inflation Index: Refer to Section 4.2(a) of the Master Agreement

 

10.                               Currency: Refer to Section 1.4 of the Master Agreement

 

11.                               Initial Set Exchange Rate: Not applicable

 

12.                               Initial Product Term: Refer to Section 8.1 of the Master Agreement

 

13.                               Notices: Refer to Section 13.9 of the Master Agreement

 

14.                               Other Modifications to the Master Agreement: The last sentence of Section 2.1(f) of the Master Agreement, “For Active Materials or Client-Supplied Components, which may be subject to import or export, Client agrees that its vendors and suppliers will comply with applicable requirements of the U.S. Customs and Border Protection Service and the Customs Trade Partnership Against Terrorism (“C-TPAT”),” does not apply to Venlafaxine API.

 

IN WITNESS WHEREOF, the duly authorized representatives of the parties have executed this Product Agreement as of the Effective Date set forth above.

 

	
 
    	
 
    	
 
    	
PATHEON   PHARMACEUTICALS INC.
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
APPROVED   BY LEGAL
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
By:
    	
/s/ Francis P. McLure
    
	
 
    	
FPM                      8-31-14
    	
 
    	
Name:
    	
Francis P. McLure
    
	
 
    	
Initials           Date
    	
 
    	
Title:
    	
Secretary
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
OSMOTICA PHARMACEUTICAL CORP.
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
/s/ Kenneth Gagnon
    
	
 
    	
Name:
    	
Kenneth Gagnon
    
	
 
    	
Title:
    	
Chief Financial Officer
    

 

2

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

SCHEDULE A

 

PRODUCT LIST AND SPECIFICATIONS

 

Product List

 

Venlafaxine ER 37.5mg 30Tab US

 

Venlafaxine ER 37.5mg 90Tab US

 

Venlafaxine ER 75mg 30TabUS

 

Venlafaxine ER 75mg 90Tah US

 

Venlafaxine ER 150mg 30Tab US

 

Venlafaxine ER 150mg 90Tab US

 

Venlafaxine ER 225mg 3QTab US

 

Venlafaxine ER 225mg 90Tab US

 

Venlafaxine HCL ER 37.5mg 30Tab US

 

Venlafaxine HCL ER 37.5mg 90Tab US

 

Venlafaxine HCL ER 75mg 30Tab US

 

Venlafaxine HCL ER 75mg 90Tab US

 

Venlafaxine HCL ER 150mg 30Tab US

 

Venlafaxine HCL ER 150mg 90Tab US

 

Venlafaxine HCL ER 225mg 30Tab US

 

Venlafaxine HCL ER 225mg 90Tab US

 

Specifications

 

Prior to the start of commercial manufacturing of Product under this Agreement Client will give Patheon the originally executed copies of the Specifications as approved by the applicable Regulatory Authority. 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 toe revised Specifications.

 

3

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Following the transition Year 2018, Patheon will be the sole manufacturer of Products offered for sale by Client in the Territory.

 

Pricing

 

Annual Volume Forecasts

 

Patheon pricing for three campaigns a year for all the sku’s listed in the table below.

 

	
Product
    	
 
    	
FY2015 Forecast
    	
 
    
	
Venlafaxine ER 37.5mg 30Tab US
    	
 
    	
[***]
    	
 
    
	
Venlafaxine ER 37.5mg 90Tab US
    	
 
    	
[***]
    	
 
    
	
Venlafaxine ER 35mg 30TabUS
    	
 
    	
[***]
    	
 
    
	
Venlafaxine ER 75mg 90Tab US
    	
 
    	
[***]
    	
 
    
	
Venlafaxine ER 150mg 30Tab US
    	
 
    	
[***]
    	
 
    
	
Venlafaxine ER 150mg 90Tab US
    	
 
    	
[***]
    	
 
    
	
Venlafaxine ER 225mg 30Tab US
    	
 
    	
[***]
    	
 
    
	
Venlafaxine ER 225mg 90Tab US
    	
 
    	
[***]
    	
 
    
	
Venlafaxine HCL ER 37.5mg 30Tab US
    	
 
    	
[***]
    	
 
    
	
Venlafaxine HCL ER 37.5mg 90Tab US
    	
 
    	
[***]
    	
 
    
	
Venlafaxine HCL ER 75mg 30Tab US
    	
 
    	
[***]
    	
 
    
	
Venlafaxine HCL ER 75mg 90Tab US
    	
 
    	
[***]
    	
 
    
	
Venlafaxine HCL ER 150mg 30Tab US
    	
 
    	
[***]
    	
 
    
	
Venlafaxine IICI FR 150mg 90Tab US ‘
    	
 
    	
[***]
    	
 
    
	
Venlafaxine HCL ER 225mg 30Tab US
    	
 
    	
[***]
    	
 
    
	
Venlafaxine HCL ER 225rng 90Tab US
    	
 
    	
[***]
    	
 
    
	
Total
    	
 
    	
[***]
    	
 
    

 

4

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Pricing Table

 

Manufacturing and Packaging Prices

 

Pricing includes the cost of labor, overhead, raw materials, packaging components and QC testing.

 

Venlafaxine HCI ER Tablets Generic and Branded Bottle Packaging - 30ct Bottles

 

	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Price per Bottle
    
	
Strength
    	
 
    	
Annual Quantity
   (Bottles)
    	
 
    	
Minimum
   Ordering Quantity
   (Bottles)
    	
 
    	
Material
   Price
    	
 
    	
Conversion
   Price
    	
 
    	
Full
   Service
   Price
    
	
37.5mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
75mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
150mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
225mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

Venlafaxine HCI ER Tablets Generic and Branded Bottle Packaging - 30ct Bottles

 

	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Price per Bottle
    
	
Strength
    	
 
    	
Annual Quantity
   (Bottles)
    	
 
    	
Minimum
   Ordering Quantity
   (Bottles)
    	
 
    	
Material
   Price
    	
 
    	
Conversion
   Price
    	
 
    	
Full
   Service
   Price
    
	
37.5mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
75mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
150mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
225mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

Pricing Note: It is understood that the filing for the 37.Smg and 225mg is targeted for the 1S* quarter of 2016 using a QBE 30 filing. The Parties will work In good faith to achieve this milestone. The Parties understand that the 225mg strength will represent a large portion of the commercial volumes. Once approved, Osmotica will transition 100% of the market volumes as estimated in Schedule B of the 37.5mg, 75mg, 150mg and 225mg strengths as set forth herein. The pricing above is based on Annual Volumes in excess of [***] tablets but Patheon will honor these prices at a lower Annual Volume during foe 2016 transition Year to allow foe new strengths to enter the market. If the Annual volumes do not exceed [***] tablets in the 2017 Year and going forward, foe prices for volumes less than [***] tablets as listed in Schedule E will apply and will be subject to an annual price reconciliation per Section 4.2(e) of the Master Agreement.

 

Pricing Note: To provide the same pricing during the first 1-2 years on the 75mg and 160mg strengths prior to foe addition of foe 37.5mg and 225mg strengths. The 75mg and 150mg labels and Pls will be purchased as one annual buy. If these materials are not used or are replaced by new designs Osmotica will be responsible to pay for the unused obsolete materials.

 

Note: Refer to “Campaign Assumptions” below for additional detail on the manufacturing and packaging batch campaigns assumed for this Pricing.

 

5

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Key Technical Assumptions

 

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

 

Manufacturing Assumptions

 

·                              The manufacturing process at Patheon will closely follow the process information provided by Osmotica and Patheon’s best estimates.

 

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

 

	
 
    	
 
    	
Venlafaxine Tablets
    
	
Parameter
    	
 
    	
37.5mg
    	
 
    	
75mg
    	
 
    	
150mg
    	
 
    	
225mg
    
	
Tablet weight (mg)
    	
 
    	
160
    	
 
    	
180
    	
 
    	
360
    	
 
    	
540
    
	
Batch size at Patheon   (tabs)
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Batch size at Patheon   (kg)
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

6

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

The following manufacturing equipment train will be used for Venlafaxine Tablets.

 

	
 
    	
 
    	
Equipment
    
	
Process Step
    	
 
    	
75mg and 150mg
    	
 
    	
37.5mg
    	
 
    	
225mg
    
	
Wet Granulation
    	
 
    	
Diosna P800 High Shear Mixer / Alexanderwerk Wet   Mill
    	
 
    	
Diosna P300
    	
 
    	
Diosna P800 High Shear Mixer / Alexanderwerk Wet   Mill
    
	
Drying
    	
 
    	
Glatt GPCG-300 Fluid Bed Dryer
    	
 
    	
Niro MP4 Fluid Bed Dryer
    	
 
    	
Glatt GPCG-300 Fluid Bed Dryer
    
	
Milling
    	
 
    	
Quadro Comil
    	
 
    	
Quadro Comil
    	
 
    	
Quadro Comil
    
	
Blending
    	
 
    	
40-60CF In-Bin Blender
    	
 
    	
15CF In-Bin Blender
    	
 
    	
40-60CF In-Bin Blender
    
	
Compressing
    	
 
    	
Fette 3090
    	
 
    	
Fette 3090
    	
 
    	
Fette 3090
    
	
Membrane Coat
    	
 
    	
48” Accela Gota
    	
 
    	
48” Accela Cota
    	
 
    	
60” Accela Cota
    
	
Laser Drilling
    	
 
    	
CMS Laser*
    	
 
    	
CMS Laser*
    	
 
    	
CMS Laser*
    
	
Color and Clear Coat
    	
 
    	
48” Accela Cota
    	
 
    	
48” Accela Cota
    	
 
    	
60” Accela Cota
    
	
Printing
    	
 
    	
Hartnett Printer
    	
 
    	
Hartnett Printer
    	
 
    	
Hartnett Printer
    

 

* Pricing is based on the assumption of a [***] tablet/hour run rate through the laser.

 

·                  A manufacturing yield of [***] on the 37.5mg and 75mg strengths and [...] on the 150mg and 225mg strengths is assumed.

 

Campaign Assumptions

 

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

 

Venlafaxine HCI ER Tablets Generic and Branded Bottle Packaging - 30ct Bottles

 

	
Strength
    	
 
    	
Batches per Manufacturing
   Campaign
    	
 
    	
Batches per Packaging
   Campaign
    	
 
    	
Bottles per Packaging
   Campaign
    
	
37.5mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
75mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
150mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
225mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

7

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Venlafaxine HCI ER Tablets Generis and Branded Bottle Packaging - 90ct Bottles

 

	
Strength
    	
 
    	
Batches per Manufacturing
   Campaign
    	
 
    	
Batches per Packaging
   Campaign
    	
 
    	
Bottles per Packaging
   Campaign
    
	
37.5mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
75mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
150mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
225mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

Packaging Assumptions

 

Venlafaxine tablets will be packaged into the configurations listed in the table below.

 

	
30ct Bottles
    	
 
    	
90ct Bottles
    
	
 
    	
 
    	
 
    
	
Bottle, 100 cc HDPE round (comp)
    	
 
    	
Bottle, 100 cc HDPE round (comp)
    
	
 
    	
 
    	
 
    
	
Closure, 38 mm SecuRx w/75M (comp)
    	
 
    	
Closure, 38 mm SecuRx w/75M (comp)
    
	
 
    	
 
    	
 
    
	
Desiccant, 2-in-1 SG/Charcoal
    	
 
    	
Desiccant, 2-in-1 SG/Charcoal
    
	
 
    	
 
    	
 
    
	
Label, PS, 2-1/4” x 4-1/2” (generic or branded)
    	
 
    	
Label, PS, 2-1/4” x 4-1/2” (generic or branded)
    
	
 
    	
 
    	
 
    
	
Topsert, Combined PI/Med guide (perfed)
    	
 
    	
Topsert, Combined PI/Med guide (perfed)
    
	
 
    	
 
    	
 
    
	
Shrink Wrap, 9-1/4” Wide
    	
 
    	
Shrink Wrap, 9-1/4” Wide
    
	
 
    	
 
    	
 
    
	
Shipper, 24/100cc
    	
 
    	
Shipper, 24/100cc
    
	
 
    	
 
    	
 
    
	
Shipper Label
    	
 
    	
Shipper Label
    
	
 
    	
 
    	
 
    
	
Pallet, ISPM 15 Standard 48” x 40”
    	
 
    	
Pallet, ISPM 15 Standard 48” x 40”
    
	
 
    	
 
    	
 
    
	
Slip Sheet, Fiber 44” x 52”
    	
 
    	
Slip Sheet, Fiber 44” x 52”
    

 

·                  The packaging component specifications assumed for this Pricing have been estimated by Patheon. Changes to the specifications will result in a review of the final Pricing.

 

Testing Assumptions

 

·                                          Testing for raw materials, packaging components and finished product are based on information provided by Osmotica and Patheon’s best estimates.

 

·                                          It is assumed that the Patheon will complete ID/COA release testing of incoming API.

 

·                                          it is assumed that QC test methods are fully validated and robust.

 

·                                          Micro testing has not been included on the finished product.

 

8

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Cleaning Assumption®

 

·                                          It is assumed that Patheon’s current cleaning procedures are adequate and full cleaning occurs after each campaign.

 

Supply Chain Assumptions

 

·                                          The quoted raw materials and bulk packaging components are assumed to be supplied from standard Patheon suppliers. This will need to be reviewed upon the detailed specifications of these materials. Patheon will procure components (raw materials and primary packaging materials) for the manufacture of Venlafaxine Tablets from Patheon qualified suppliers. Should Osmotica require Patheon to source any materials from specified suppliers, then these suppliers will remain under the Quality audit control of Osmotica unless it is agreed that Patheon will take on this responsibility. Components and excipients to be supplied by Patheon in accordance with Osmotica’s specifications. Patheon will issue formal Patheon specifications for each component following Osmotica component requirements. Each lot of incoming components will be sampled and tested according to the agreed specifications. If different component specifications for primary packaging are required, these will be subjected to a further evaluation and assessment by Patheon.

 

·                                          API would be provided free issue by Osmotica and released by Osmotica. The API and all excipients used for tea manufacture will be GMP grade and from TSE/BSE certified sources.

 

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

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

9

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

The following cost items are not Included In the Price for the Products:

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

·                                          [***]

 

10

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

SCHEDULE C

 

ANNUAL STABILITY TESTING (if applicable)

 

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

 

11

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

SCHEDULE D

 

ACTIVE MATERIALS

 

	
Active Materials
    	
 
    	
Supplier
    
	
Venlafaxine   Hydrochloride USP
    	
 
    	
AARTI   INDUSTRIES, LTD.
    

 

Active Materials Credit Value

 

The Active Materials Credit Value will be as follows:

 

	
PRODUCT
    	
 
    	
ACTIVE MATERIALS
    	
 
    	
ACTIVE MATERIALS
   CREDIT VALUE
    
	
Venlafaxine Tablets
    	
 
    	
Venlafaxine Hydrochloride USP
    	
 
    	
Client’s actual cost for Active Materials not to   exceed [***] per kilogram
    

 

MAXIMUM CREDIT VALUE

 

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

 

	
PRODUCT
    	
 
    	
MAXIMUM CREDIT VALUE
    
	
Venlafaxine Tablets
   (4 strengths)
    	
 
    	
[***] of revenues per Year to   Patheon under this Product Agreement
    

 

12

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

SCHEDULE E

 

Following the transition Year 2016, Patheon will be the sole manufacturer of Products offered for sale by Client in the Territory.

 

If the volumes are greater than [***] and less than [***] tablets per Year, the following prices will apply.

 

30ct Bottles

 

	
Product
    	
 
    	
Minimum
   Ordering
   Quantify
   (Bottles)
    	
 
    	
Material
   price
    	
 
    	
Conversion
   Price
    	
 
    	
Full Service
   Price
    
	
Venlafaxine Tablets 37.5mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Venlafaxine Tablets 75mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Venlafaxine Tablets 150mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Venlafaxine Tablets 225mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

90ct Bottles

 

	
Product
    	
 
    	
Minimum
   Ordering
   Quantify
   (Bottles)
    	
 
    	
Material
   price
    	
 
    	
Conversion
   Price
    	
 
    	
Full Service
   Price
    
	
Venlafaxine Tablets 37.5mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Venlafaxine Tablets 75mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Venlafaxine Tablets 150mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
Venlafaxine Tablets 225mg
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

13

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00287-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00287-of-00352.parquet"}]]