Document:

ex_98728.htm

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Exhibit 10.1

 

Amendment #2 to Manufacturing Services Agreement Between 

Patheon Pharmaceuticals Inc., and AcelRx Pharmaceuticals, Inc.

 

WHEREAS Patheon Pharmaceuticals Inc., (“Patheon”) and AcelRx Pharmaceuticals, Inc., ("Client"), have entered into a Manufacturing Services Agreement effective December 12, 2012 and Amendment #1 effective January 19, 2016 (collectively, the “Agreement”). Patheon and AcelRx are each a “Party” and are collectively the “Parties.”

 

AND WHEREAS the Parties wish to further amend the Agreement.

 

NOW THEREFORE, in consideration of the premises hereof and the mutual covenants and conditions hereinafter set forth and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, hereby agree as follows:

 

	 	
			1.

				
			Article 1, Section 1.1 (Definitions) of the Agreement is amended to add the following definitions:

			

 

	 	
			●

				
			“Bulk Product” means, as described and identified in Schedule A.

			

 

	 	
			2.

				
			Article 1, Section 1.1 (Definitions) is amended as follows:

			

 

	 	
			●

				
			“Finished Product Packaging” means, the product(s) listed and identified in Schedule A.

			

 

	 	
			3.

				
			Section 2.1 (Manufacturing Services), the first paragraph, is deleted in its entirety and replaced with the following: 

			

 

Patheon will perform the Manufacturing Services and supply to Client Product intended for marketing and sale in the Territory for the fees specified in Schedules B and C. Client has the right to purchase Product in Bulk Tablet Packaging from Patheon and to have a third party package the Product into Finished Product Packaging for distribution or sale outside of the Territory. Schedule B sets forth a list of cost items that are included in the Price for Product; all cost items required for the manufacture of Product that are not included in this list are excluded from the Price and are subject to reasonable additional fees to be paid by the Client. All Manufacturing Services will be performed by Patheon at the Manufacturing Site. Patheon may change the Manufacturing Site for the Product only with the prior written consent of Client, this consent not to be unreasonably withheld. 

 

During the period commencing on the Effective Date, Patheon will supply 100% of the Client’s Bulk Product requirements for Product offered for sale by Client in the Territory so long as Patheon is in material compliance with its obligations to Client under this Agreement. But if the Client has provided all Client-supplied materials, including API, per the terms of this Agreement and (a) Patheon fails to meet its supply obligations to Client for three consecutive Firm Orders, (b) in any consecutive six month period, 30% or more of the aggregate quantities of Product to be delivered by Patheon pursuant to Firm Orders during the six month period are not delivered by the due dates specified in the applicable Firm Orders, or (c) Patheon does not fulfill a Firm Order within 90 days after the Delivery Date specified therein then, in each case, Client may obtain up to 20% of its requirements for Product offered for sale in the Territory from an alternate supplier, regardless of whether this is attributable to a Force Majeure Event. 

 

 

 

 

	 	
			4.

				
			Article 2 (Patheon’s Manufacturing Services), new Section 2.3 is added as follows:

			

 

2.3 Quality Control and Quality Assurance Release Testing of ARX-04 Finished Packaged Product: Not excepting anything contained in this Article 2, Patheon will perform release and stability testing of ARX-04 Finished Packaged Product, provided by a third party packager managed by AcelRx, as specified in the Quality Agreement. If testing confirms that the ARX-04 Finished Packaged Product meets all Specifications, Patheon will provide a Certificate of Analysis that contains a statement that the Finished Packaged Product has been tested in accordance with the Specifications and cGMP’s and conforms to the Specifications. Client will have sole responsibility for release of Finished Packaged Product to the market.

 

	 	
			5.

				
			Schedules A, B and C are deleted in their entirety and replaced with the revised Schedules A, B and C attached.

			

 

	 	
			6.

				
			Conflicts, Use of Terms. If there is a conflict between the terms and conditions of the Agreement and the terms and conditions of this Amendment #2, the terms and conditions of this Amendment #2 will control. 

			

 

	 	
			7.

				
			No Other Modifications. Except as provided above, the terms and conditions of the Agreement remain unchanged.

			

 

 

 

IN WITNESS WHEREOF, the Parties have caused this Amendment #2 to be duly executed, effective as of 4 August 2017. The Parties agree that this Amendment #2 may be signed in counterparts.

 

 

ACCEPTED AND ACKNOWLEDGED

 

	
			AcelRx Pharmaceuticals, Inc. 

				
			Patheon Pharmaceuticals Inc.

			
	 	 
	
			By: /s/ Raffi Asadorian                  

				
			By: /s/ Amanda Bosse              

			
	
			
			Name: R. Asadorian                          

			

				
			
			Name: Amanda Bosse              

			

			
	
			Title:   Chief Financial Officer      

				
			Title: VP and GM Cincinnati Regional Operations

			
	
			Date: 8/22/17  

				
			Date: 8/18/17

			

  

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

-2-

 

 

SCHEDULE A

PRODUCT LIST AND SPECIFICATIONS

  

 

Product List

 

Bulk Product:

 

Zalviso® (ARX-01) sufentanil 15 mcg tablets

 

DsuviaTM (ARX-04) sufentanil 30 mcg tablets

 

Finished Product Packaging:

 

ZALVISO® sufentanil 15 mcg tablets, 40 tablets per cartridge, 20 cartridges per carton. US market

 

ZALVISO® sufentanil 15 mcg tablets, 40 tablets per cartridge, 20 cartridges per carton. EU group 1 market 

 

ZALVISO® sufentanil 15 mcg tablets, 40 tablets per cartridge, 20 cartridges per carton. EU group 2 market

 

ZALVISO® sufentanil 15 mcg tablets, 40 tablets per cartridge, 20 cartridges per carton. EU group 3 market

 

ZALVISO® sufentanil 15 mcg tablets, 40 tablets per cartridge, 20 cartridges per carton. EU group 4 market

 

 

*Note: The Zalviso product may also be referred to as ARX-01. The Dsuvia product may also be referred to as ARX-04.

 

 

Specifications

 

Prior to the start of commercial manufacturing of Product under this Agreement, Client will give Patheon the originally executed copies of the Specifications that will be submitted by Client to the FDA for approval. 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.

 

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

-3-

 

 

SCHEDULE B

MINIMUM RUN QUANTITY, ANNUAL VOLUME, AND PRICE

 

 

	
			1.

				Annual Volume Forecasts

 

Zalviso Annual Volume Forecasts

 

AcelRx has provided the following forecast*: 

 

	 	
			[*]

			
	
			Bulk Batches

				
			[*]

			
	
			LG1 (Cartons)

				
			[*]

			
	
			LG2 (Cartons)

				
			[*]

			
	
			LG3 (Cartons)

				
			[*]

			
	
			LG4 (Cartons)

				
			[*]

			

 

*Based on [*].

 

Dsuvia Annual Volume Forecasts

 

AcelRx has provided an annual volume forecast of approximately [*].

 

 

	
			2.

				
			Zalviso Pricing Tables

			

 

Pricing Summary- Pricing is Effective from January 1, 2017 – December 31, 2017 

 

Combined Bulk and Packaging Pricing (To Be Utilized for all 2017 POs):

	
			Product

				
			Annual Volume Tier per SKU

			(Cartons)

				
			Minimum Ordering Quantity

				
			2017 Price per 

			Packaged - Cartridge

			
	
			Material Price

				
			Conversion Price

				
			Full Service Price

			
	
			1 carton of 20 cartridges

			(40 tablets per Cartridge)

				
			[*]

				
			[*] Cartridges

				
			[*]

				
			[*]

				
			[*]

			
	
			1 carton of 20 cartridges

			(40 tablets per Cartridge)

				
			[*]

				
			[*] Cartridges

				
			[*]

				
			[*]

				
			[*]

			
	
			1 carton of 20 cartridges

			(40 tablets per Cartridge)

				
			[*]

				
			[*] Cartridges

				
			[*]

				
			[*]

				
			[*]

			
	
			1 carton of 20 cartridges

			(40 tablets per Cartridge)

				
			[*]

				
			[*] Cartridges

				
			[*]

				
			[*]

				
			[*]

			
	
			1 carton of 20 cartridges

			(40 tablets per Cartridge)

				
			[*]

				
			[*] Cartridges

				
			[*]

				
			[*]

				
			[*]

			

 

 

Note: [*] will be assessed for each [*].

 

Recommended 2017 Pricing Tiers per SKU, based on April 2017 Forecast:

	 	
			●

				
			LG1 – Tier 2 ([*] Cartons)

			

	 	
			●

				
			LG2 – Tier 1 ([*] Cartons)

			

	 	
			●

				
			LG3 – Tier 1 ([*] Cartons)

			

	 	
			●

				
			LG4 – Tier 3 ([*] Cartons)

			

 

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

-4-

 

 

	
			3.

				
			Dsuvia Pricing Tables

			

 

	 	
			3.1.

				
			Commercial Manufacturing Prices – Bulk Tablets 

			

 

	
			Product

				
			Mfg. Campaign Length

			(Batches)

				
			Minimum Ordering Quantity

			(000’s)

				
			 

			Price per 1,000

			
	
			Material Price

				
			Conversion Price

				
			Bulk Price

			
	
			ARX-04 Tablets, [*] Tier

				
			[*]

				
			[*]

				
			[*]

				
			[*]

				
			[*]

			
	
			ARX-04 Tablets, [*] Tier

				
			[*]

				
			[*]

				
			[*]

				
			[*]

				
			[*]

			
	
			ARX-04 Tablets, [*] Tier

				
			[*]

				
			[*]

				
			[*]

				
			[*]

				
			[*]

			

 

	 	
			3.2.

				
			Process Validation Batch Price:

			

 

	
			Product

				
			 

			Price per Batch

			 

			
	
			ARX-04 Tablets, Bulk

				
			$[*]

			

 

 

	 	
			3.3.

				
			Costs Included in Price

			

 

	 	
			3.3.1.

				
			Product manufactured according to the approved and registered specifications.

			

 

	 	
			3.3.2.

				
			Estimated material costs. Material costs included in the pricing are best estimates based on Patheon’s current standards and specifications and do not include any extraordinary or custom raw materials. Final material costs will be provided after confirmation of specifications and formal quotations have been received from the suppliers. The cost of materials to AcelRx will be [*]. 

			

 

	 	
			3.3.3.

				
			Procurement, storage, inventory control and Quality Control (“QC”) testing of all required raw materials to supply the Product, including storage of Client-supplied components to meet firm order requirements or such time as agreed between the parties to accommodate long lead time items.

			

 

	 	
			3.3.4.

				
			Qualification and auditing of all raw material (with the exception of Client-supplied raw material).

			

 

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

-5-

 

 

	 	
			3.3.5.

				
			Active Pharmaceutical Ingredients (“API”) identity test. AcelRx will audit and approve the Vendor and ensure cGMP compliance. If Patheon is to release an API or other Client stipulated material based on “ID only”, AcelRx will ensure the required verification testing by an independent laboratory has been completed. 

			

 

	 	
			3.3.6.

				
			Standard certificate of analysis (“COA”) and Standard certificate of compliance (“COC”)

			

 

	 	
			3.3.7.

				
			GMP batch release

			

 

	 	
			3.3.8.

				
			GMP required retention samples and executed batch records retention API, bulk product and finished packaged product retention samples, and completed batch production records, as required by the cGMP Regulations or other governing regulations, for one year past the expiration date of the product.

			

 

	 	
			3.3.9.

				
			Deviation investigations and copies of deviation reports

			

 

	 	
			3.3.10.

				
			Batch Record copies for validation batches, first ten commercial batches, and one commercial batch per Year thereafter.  

			

 

	 	
			3.3.11.

				
			Common HPLC/GC columns, reagents, and lab supplies

			

 

	 	
			3.3.12.

				
			Copy of the Annual Product Review Report. Patheon will supply on an annual basis all Product data in its control, including release test results, complaint test results, and all investigations (in manufacturing, testing, and storage), that Client reasonably requires in order to complete any filing under any applicable regulatory regime, including any Annual Report that Client is required to file with the FDA.

			

 

	 	
			3.3.13.

				
			First Product Approval Inspection (“PAI”) and copy of FDA Report. Additional PAI support will be subject to additional fees.

			

 

	 	
			3.4.

				
			Costs Not Included in Price

			

 

	 	3.4.1.	
			API, reference standards, and Client-supplied materials to be supplied by AcelRx at no cost to Patheon.

			
	 	 	 
	 	
			3.4.2.

				
			API complete QC testing or special API testing requests.  NOTE: This testing will be mandatory if AcelRx has not performed the verification testing specified in 3.3.5.

			

 

	 	
			3.4.3.

				
			Stability testing program − Patheon can store and test in accordance with an agreed protocol and ICH guidelines. See proposal C-CRC-101285-R0.

			

 

	 	
			3.4.4.

				
			Regulatory support and CTD files updating

			

 

	 	
			3.4.5.

				
			Routine periodic auditing of component suppliers not currently on Patheon’s approved list 

			

 

	 	
			3.4.6.

				
			Annual Review (“AR”). Any additional data or report requested by AcelRx beyond the scope of cGMPs and customary FDA or other regulatory agencies requirements will be subject to an additional fee to be agreed upon between Patheon and AcelRx.

			

 

	 	
			3.4.7.

				
			Technology transfer fees including packaging serialization readiness.

			

 

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

-6-

 

 

	 	
			3.4.8.

				
			Artworks origination and update costs including one off costs at suppliers.

			

 

	 	
			3.4.9.

				
			Label copy change and batch record changes initiated by AcelRx.

			

 

	 	
			3.4.10.

				
			Any specific visual inspection of the bulk or of the finished products outside of standard release testing.

			

 

	 	
			3.4.11.

				
			Testing required to support OOS results or stability failures, testing required in support of complaint investigations and testing of products which exceeds routine testing that are not related to Patheon’s performance.

			

 

	 	
			3.4.12.

				
			Copy of the Annual Product Review Report. Pricing of this service will depend on the level of complexity required by AcelRx.

			

 

	 	
			3.4.13.

				
			The impact of new continued process verification (CPV) requirements.

			

 

	 	
			3.5.

				
			Capital Requirements 

			

 

	 	
			3.5.1.

				
			Capital and Reservation Fee will be handled under a separate capital agreement.

			

 

	 	
			3.6.

				
			Key Technical Parameters

			

 

The following technical parameters apply to the production of ARX-04 Tablets and the materials used therein. Pricing may be adjusted to reflect any technical changes foreseen during the Technology Transfer project or after the manufacture of validation batches to reflect any specification or process changes.

 

	 	
			3.6.1.

				
			Manufacturing Parameters

			

 

	 	
			3.6.1.1.

				
			API – API will be stored under ambient conditions 

			

 

	 	
			3.6.1.2.

				
			Batch Size/Yields - The core tablet weight, theoretical manufacturing batch size and product yields considered by Patheon are summarized in the following table.

			

 

	
			Product

				
			Core Tablet 

			Weight (mg)

				
			Batch Size 

			before losses

			(Tablets)

				
			Batch Size 

			(kg)

				
			Mfg. Yield (%)

				
			Pkg.

			Yield (%)

			
	
			ARX-04 Tablets

				
			[*]

				
			[*]

				
			[*]

				
			[*]

				
			[*]

			

 

	 	
			3.6.1.3.

				
			Manufacturing campaign - The commercial pricing presented considers manufacturing in campaign. PV batches will not be produced in campaign.

			

 

	 	
			3.6.1.4.

				
			Hold times – It is assumed that the process is carried out at room temperature and the holding times throughout the process are suitable for the batch size proposed. It is assumed that amber lighting will be utilized during formulation or bulk packaging in the dedicated suite. Further details on the hold time and stability data for the drug product should be provided by AcelRx.

			

 

	 	
			3.6.1.5.

				
			Cleaning – Full cleaning occurs after each batch.

			

 

	 	
			3.6.1.6.

				
			Visual inspection – 100% visual inspection of the packs has not been included. 

			

 

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

-7-

 

 

	 	
			3.6.1.7.

				
			Finished product storage – Finished product will be stored at room temperature (15-30°C). 

			

 

	 	
			3.6.1.8.

				
			Manufacturing Equipment Train -The following manufacturing equipment train is proposed.

			

 

	
			Process Step

				
			Equipment

			
	
			Granulation & Compressing

				
			AcelRx Suite

			

 

	 	
			3.6.2.

				
			Packaging Parameters

			

 

	 	
			3.6.2.1.

				
			Packaging Components:

			

 

	
			Bulk Tablets 

			
	
			[*]

			

 

	 	
			3.6.2.2.

				
			No serialisation, DataMatrix or aggregation has been considered. If any of these activities are required, they will be subject to further assessment by Patheon.

			

 

	 	
			3.6.2.3.

				
			Assumes current process will be followed until tablets are sealed into 8 in X 9.125 in pouches. These pouches will then be placed into lined bulk drum for shipment to final packager.

			

 

	 	
			3.6.2.4.

				
			Assumes 1 bulk drum per batch.

			

 

	 	
			3.6.3.

				
			Testing Conditions

			

 

	 	
			3.6.3.1.

				
			Testing for raw materials are based on information provided by AcelRx and Patheon’s best estimates.

			

 

	 	
			3.6.3.2.

				
			It is assumed that QC test methods are fully validated and robust at the time of manufacture.

			

 

	 	
			3.6.3.3.

				
			The analytical testing included in the pricing is listed below:

			

 

	
			Testing Requirements

			
	
			[*]

			

 

	 	
			3.6.3.4.

				
			Microbiological testing has not been included.

			

 

	 	
			3.6.3.5.

				
			Testing labour may be subject to change after the final agreements on testing specifications and requirements.

			

 

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

-8-

 

 

	 	
			3.6.4.

				
			Supply Chain

			

 

	 	
			3.6.4.1.

				
			Patheon will procure components and excipients for the manufacture of ARX-04 Tablets from Patheon qualified suppliers. Should AcelRx require Patheon to source any materials from specified suppliers, then these suppliers will remain under the quality audit control of AcelRx unless an agreement is reached for Patheon to take on this responsibility.

			

 

	 	
			3.6.4.2.

				
			Components and excipients will be supplied by Patheon in accordance with the specifications agreed. Patheon will issue formal Patheon specifications for each material.

			

 

	 	
			3.6.4.3.

				
			Each lot of incoming components and excipients will be sampled and tested according to the agreed specifications.

			

 

	 	
			3.6.4.4.

				
			The API will be provided free issue/released to Patheon by AcelRx or its qualified supplier.

			

 

	 	
			3.6.4.5.

				
			The API and all excipients used for the manufacture will be GMP grade and from TSE/BSE certified sources.

			

 

	 	
			3.6.4.6.

				
			Finished product will be made available at [*].

			

 

	 	
			3.6.5.

				
			Business Terms

			

 

	 	
			3.6.5.1.

				
			This pricing is based on product information provided by AcelRx and Patheon’s best estimates.

			

 

	 	
			3.6.5.2.

				
			Pricing may be adjusted after the manufacture of feasibility or validation batches to reflect any specification or process changes.

			

 

	 	
			3.6.5.3.

				
			All stated Values / Invoices are in USD ($).

			

 

	 	
			3.6.5.4.

				
			Pricing is subject to annual review.

			

 

	 	
			3.6.5.5.

				
			Invoice payment terms are 30 days from date of invoice.

			

 

 

	 	
			3.7.

				
			Commercial Analytical Testing Prices 

			

 

	
			Product

				
			Mfg. Campaign Length

			(Batches)

				
			 

			Price per Batch

			
	
			ARX-04

				
			[*]

				
			[*]

			

 

	 	
			3.7.1.

				
			Costs Included in Price

			

 

	 	
			3.7.1.1.

				
			Product tested according to the approved and registered specifications.

			

 

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

-9-

 

 

	 	
			3.7.2.

				
			Costs Not Included in Price

			

 

	 	3.7.2.1.	
			Product manufactured and packaged according to the approved and registered specifications.

			
	 	 	 
	 	
			3.7.2.2.

				
			Raw material costs and packaging components. Procurement, storage, inventory control and Quality Control (“QC”) testing of all raw materials & packaging materials.

			

 

	 	
			3.7.2.3.

				
			API, reference standards, and Client-supplied materials to be supplied by AcelRx at no cost to Patheon.

			

 

	 	
			3.7.2.4.

				
			API complete QC testing or special API testing requests.  NOTE: This testing will be mandatory if AcelRx has not performed the verification testing specified.

			

 

	 	
			3.7.2.5.

				
			Annual Review (“AR”). Any additional data or report requested by AcelRx beyond the scope of cGMPs and customary FDA or other regulatory agencies requirements will be subject to an additional fee to be agreed upon between Patheon and AcelRx. 

			

 

	 	
			3.7.2.6.

				
			Testing required to support OOS results or stability failures, testing required in support of complaint investigations and testing of products which exceeds routine testing that are not related to Patheon’s performance.

			

 

	 	
			3.7.3.

				
			Key Technical Parameters

			

 

The following technical parameters apply to the testing of ARX-04.

 

	 	
			3.7.3.1.

				
			Testing Conditions

			

 

	 	
			3.7.3.1.1.

				
			Testing for finished product is based on information provided by AcelRx and existing Patheon methods.

			

 

	 	
			3.7.3.1.2.

				
			It is assumed that QC test methods are fully validated and robust at the time of manufacture.

			

 

	 	
			3.7.3.1.3.

				
			The analytical testing included in the pricing are listed below:

			

 

	
			Finished Product Testing Requirements

			
	
			[*]

			

 

	 	
			3.7.3.1.4.

				
			Microbiological testing has been included.

			

 

	 	
			3.7.3.1.5.

				
			Testing labour may be subject to change after the final agreements on testing specifications and requirements.

			

 

	 	
			3.7.3.2.

				
			Supply Chain

			

 

	 	
			3.7.3.2.1.

				
			AcelRx will provide packaged product from secondary packager for the release/stability testing of ARX-04. Patheon will not source any materials. Each lot of incoming product will be sampled and tested according to the agreed specifications.

			

 

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

-10-

 

 

SCHEDULE C

 

ANNUAL STABILITY TESTING

 

 

	
			1.

				
			Zalviso 2017 Stability Pricing 

			

 

[*]

 

 

	
			2.

				
			Dsuvia 2017 Stability Pricing

			

 

[*]

 

 

	 	
			1.1.

				
			Costs Included in Price

			

 

	 	
			1.1.1.

				
			Stability testing program

			

 

	 	
			1.2.

				
			Costs Not Included in Price

			

 

	 	1.2.1.	
			Product manufactured and packaged according to the approved and registered specifications.

			
	 	 	 
	 	
			1.2.2.

				
			Raw material costs and packaging components. Procurement, storage, inventory control and Quality Control (“QC”) testing of all raw materials & packaging materials.

			

 

	 	
			1.2.3.

				
			API, reference standards, and Client-supplied materials to be supplied by AcelRx at no cost to Patheon.

			

 

	 	
			1.2.4.

				
			API complete QC testing or special API testing requests.  NOTE: This testing will be mandatory if AcelRx has not performed the verification testing specified.

			

 

	 	
			1.2.5.

				
			Any additional data or report requested by AcelRx beyond the scope of cGMPs and customary FDA or other regulatory agencies requirements will be subject to an additional fee to be agreed upon between Patheon and AcelRx.

			

 

	 	
			1.2.6.

				
			Regulatory support (such as preparation of Annual Report and Chemistry, Manufacturing, and Controls (“CMC”) files). Regulatory support work is subject to an additional fee and will be charged at a rate of [*].

			

 

	 	
			1.2.7.

				
			Testing required to support OOS results or stability failures, testing required in support of complaint investigations and testing of products which exceeds routine testing that are not related to Patheon’s performance.

			

 

	 	
			1.3.

				
			Key Technical Parameters

			

 

The following technical parameters apply to the testing of ARX-04.

 

	 	
			1.3.1.

				
			Testing Conditions

			

 

	 	
			1.3.1.1.

				
			Testing for finished product is based on information provided by AcelRx and existing Patheon methods.

			

 

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

-11-

 

 

	 	
			1.3.1.2.

				
			It is assumed that QC test methods are fully validated and robust at the time of manufacture.

			

 

	 	
			1.3.1.3.

				
			The analytical testing included in the pricing are listed below:

			

 

	
			Stability Testing Requirements

			
	
			[*]

			

 

 

	 	
			1.3.1.4.

				
			Microbiological testing has been included.

			

 

	 	
			1.3.1.5.

				
			Testing labour may be subject to change after the final agreements on testing specifications and requirements.

			

 

	 	
			1.3.2.

				
			Supply Chain

			

 

	 	
			1.3.2.1.

				
			AcelRx will provide packaged product from secondary packager for the release/stability testing of ARX-04. Patheon will not source any materials. Each lot of incoming product will be sampled and tested according to the agreed specifications.

			

 

 

[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

-12-Exhibit

EXHIBIT 10.1

RESOLUTE FOREST PRODUCTS EQUITY INCENTIVE PLAN 
STOCK SETTLED RESTRICTED STOCK UNIT AGREEMENT
THIS RESTRICTED STOCK UNIT AGREEMENT, dated as of [November __], 20__, (the “Date of Grant”) is made by and between Resolute Forest Products Inc., a Delaware corporation (the “Company”), and «FIRST» «LAST» (“Participant”).
WHEREAS, the Company has adopted the Resolute Forest Products Equity Incentive Plan (the “Plan”), pursuant to which restricted stock units may be granted in respect of shares of the Company’s common stock, par value $0.001 per share (“Stock”); and
WHEREAS, the Human Resources and Compensation and Nominating and Governance Committee of the Company (the “Committee”) has determined that it is in the best interests of the Company and its stockholders to grant the restricted stock unit award provided for herein to Participant subject to the terms set forth herein.
NOW, THEREFORE, for and in consideration of the premises and the covenants of the parties contained in this Agreement, and for other good and valuable consideration, the receipt of which is hereby acknowledged, the parties hereto, for themselves, their successors and assigns, hereby agree as follows:
1.Grant of Restricted Stock Unit.
(a)    Grant.  The Company hereby grants to Participant «RSUs» restricted stock units (the “RSUs”), on the terms and conditions set forth in this Agreement and as otherwise provided in the Plan (the "Initial Grant").  Each RSU represents the right to receive one share of Stock as of the Settlement Date (defined in Section 2(b)), to the extent the Participant is vested in such RSUs as of the Settlement Date, subject to the terms of this Agreement and the Plan.
(b)    Incorporation by Reference, Etc.  The provisions of the Plan are hereby incorporated herein by reference.  Except as otherwise expressly set forth herein, this Agreement shall be construed in accordance with the provisions of the Plan and any interpretations, amendments, rules and regulations promulgated by the Committee from time to time pursuant to the Plan. Any capitalized terms not otherwise defined in this Agreement shall have the definitions set forth in the Plan.  The Committee shall have final authority to interpret and construe the Plan and this Agreement and to make any and all determinations under them, and its decision shall be binding and conclusive upon Participant and his legal representative in respect of any questions arising under the Plan or this Agreement.
(c)    Acceptance of Agreement.  Unless Participant notifies the Company in writing within 14 days after the Date of Grant that Participant does not wish to accept this Agreement, Participant will be deemed to have accepted this Agreement and will be bound by the terms of the Agreement and the Plan.  Any such notice may be given to the Director, Corporate Compensation at the Company’s principal executive office.
2.    Terms and Conditions.
(a)    Vesting.  Subject to continued employment with the Company or any Affiliate or Subsidiary or in the case of terminations of employment due to Retirement as provided in 

Section 3(a), Section 3(a), the RSUs shall vest ratably in four equal increments (rounded to the nearest whole restricted stock unit) on each of the dates set forth as follows (each such date, a “Vesting Date”):
	
		
	Vesting Date
	Percentage of RSU Vested

	December 1 of first calendar year following the calendar year that includes the  
Date of Grant
	25% (rounded to the nearest whole)

	First anniversary of the first Vesting Date
	25% (rounded to the nearest whole)

	Second anniversary of the first Vesting Date
	25% (rounded to the nearest whole)

	Third anniversary of the first Vesting Date
	Remaining 25%

(b)    Settlement.   The obligation to make payments and distributions with respect to RSUs shall only be satisfied through the issuance of one share of Stock for each earned and vested RSU (the “settlement”) and the settlement of the RSUs may be subject to such conditions, restrictions and contingencies as the Committee shall determine.  The Company undertakes and agrees not to exercise its right under the Plan to settle the RSUs in any other means other than Stock.  RSUs shall be settled as soon as practicable after the earliest of (i) the applicable Vesting Date, (ii) an involuntary termination of employment by the Company or any Affiliate or Subsidiary of a Participant who will not attain age 55 at any time before the fourth anniversary of the Date of Grant, (iii) the Vesting Date that immediately follows (A) an involuntary termination of employment by the Company or any Affiliate or Subsidiary of a Participant who otherwise meets the criteria for Retirement at any time before the fourth anniversary of the Date of Grant, but for the receipt of severance, (B) voluntary termination by the Participant on or after age 55 that does not constitute a Retirement, or (C) Retirement (as defined in Section 3(a)) within six months after the Date of Grant, (iv) death, or (v) termination of employment by reason of Disability.  For payment time or events described in clauses (i), (ii), (iv) and (v), settlement shall in no event be later than March 15 of the year following the year of such payment time or event, as applicable.  For purposes of this Agreement, each date on which RSUs are settled pursuant to the preceding sentence shall be a “Settlement Date.”  For purposes of this Agreement and to the extent applicable to the Participant, the term “termination of employment” shall be interpreted to comply with Section 409A of the Internal Revenue Code (“Section 409A”).  To the extent payments are made during the periods permitted under Section 409A (including any applicable periods before or after the specified payment dates set forth in this Section 2(b)), the Company shall be deemed to have satisfied its obligations under the Plan and shall be deemed not to be in breach of its payments obligations hereunder.
(c)    Dividend Equivalents and Voting Rights.  Participant will from time to time be credited with additional RSUs (including a fractional RSU), the number of which will be determined by dividing: 
(i)    The product obtained by multiplying the amount of each dividend (including extraordinary dividend if so determined by the Company) declared and paid by the 

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Company on the Stock on a per share basis during the Vesting Period by the number of RSUs recorded in Participant's account on the record date for payment of any such dividend, by
(ii)    The Fair Market Value of one (1) share of Stock on the dividend payment date for such dividend.
Subject to continued employment with the Company or any Affiliate or Subsidiary or as otherwise provided in Section 3, the additional RSUs shall vest and be settled at the same time and in the same proportion as the Initial Grant.  No additional RSUs shall be accrued for the benefit of Participant with respect to record dates occurring before, or with respect to record dates occurring on or after the date, if any, on which Participant has forfeited the RSUs. Participant shall not be a shareholder of record with respect to the RSUs and shall have no voting rights with respect to the RSUs. 
3.    Termination of Employment with the Company.
(a)    Retirement.  If the Participant’s employment with the Company, Affiliates and Subsidiaries terminates as a result of “Retirement” at any time on or after six months from the Date of Grant has elapsed, then Section 2(a) shall continue to apply to the Participant and the Participant shall receive settlement of RSUs following each Vesting Date, unless Section 3(c) applies.  For purposes of the Agreement, “Retirement” means the Participant terminates employment with the Company, all Affiliates and Subsidiaries under circumstances that do not entitle the Participant to severance either pursuant to an agreement or policy, plan or program and such termination occurs on or after: (i) attaining age 58, (ii) completing at least two years of service, and (iii) having a combined age and years of service (counting partial years) equal to at least 62.5 points.  
(b)    Involuntary Termination and Certain Voluntary Terminations. The Participant shall become vested in a prorated number of RSUs in the following circumstances: (1) the Participant’s employment with the Company or any Affiliate or Subsidiary terminates as a result of Retirement within six months after the Date of Grant, (2) the Participant voluntarily terminates his employment with the Company, Affiliates and Subsidiaries on or after age 55 and the termination does not constitute a Retirement, or (3) the Participant is involuntarily terminated by the Company or any Affiliate or Subsidiary without Cause (whether or not the Participant is eligible for Retirement, regardless of his age at termination and other than due to Disability or death).  For purposes of the preceding, the prorated portion of the RSUs that is vested as of the Participant’s retirement date or date of termination, as applicable, including the portion of the RSUs then already vested, shall be the total number of granted and credited RSUs multiplied by a fraction, the numerator of which shall be the number of full calendar months elapsed from the Date of Grant through the Participant’s retirement date or last day worked (in the case of termination) and the denominator of which shall be 48 (the number of calendar months in the Vesting Period, treating the calendar month following the Date of Grant as the first calendar month). 
(c)    Death. If the Participant’s employment with the Company or any Affiliate or Subsidiary terminates due to the Participant’s death, then, in addition to the RSUs vested as of the date of death under Section 2(a), the RSUs scheduled to vest on the next scheduled Vesting Date shall also vest on the date of death. 

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(d)    Disability. If the Participant becomes eligible for long-term disability benefits under a  plan sponsored by the Company, an Affiliate or a Subsidiary, then, in addition to the RSUs then vested, the RSUs scheduled to vest on the next scheduled Vesting Date shall also vest on the first date of the long-term disability period.  For the avoidance of doubt, RSUs shall continue to vest during any short-term disability period. 
(e)    Other Termination. If the Participant’s employment with the Company, all Affiliates and Subsidiaries terminates for Cause or resignation (before attainment of age 55 and before Retirement eligibility) then all outstanding RSUs, whether vested but unsettled or unvested, shall immediately terminate.
Notwithstanding anything contained to the contrary in this Section 3, in no event shall any RSUs be settled before the applicable Vesting Date except if otherwise determined by the Company.
4.    Compliance with Legal Requirements.  The granting and settlement of the RSUs, and any other obligations of the Company under this Agreement, shall be subject to all applicable federal, provincial, state, local and foreign laws, rules and regulations and to such approvals by any regulatory or governmental agency as may be required.  
(a)    Transferability.  Unless otherwise provided by the Committee in writing, the RSUs shall not be transferable by Participant other than by will or the laws of descent and distribution.
(b)    No Rights as Stockholder.  The Participant shall not be deemed for any purpose to be the owner of any shares of Stock subject to RSUs.
(c)    Tax Withholding.  All distributions under the Plan are subject to withholding of all applicable federal, state, provincial, local and foreign income taxes and social contributions (the “Withholding Obligation”). The Company may satisfy such Withholding Obligation by any means whatsoever, including withholding cash from any other payment or amounts due to the Participant. Unless otherwise determined by the Committee, the Company will satisfy its Withholding Obligation by issuing, upon the settlement of the RSUs, a net number of Stocks to the Participant equal to the number of Stocks that the Participant would otherwise be entitled to receive on the Settlement Date minus such number of Stocks with a value determined on that date equal to any amount required to satisfy the Withholding Obligation.
5.    Miscellaneous.
(a)    Waiver.  Any right of the Company contained in this Agreement may be waived in writing by the Committee.  No waiver of any right hereunder by any party shall operate as a waiver of any other right, or as a waiver of the same right with respect to any subsequent occasion for its exercise, or as a waiver of any right to damages.  No waiver by any party of any breach of this Agreement shall be held to constitute a waiver of any other breach or a waiver of the continuation of the same breach.
(b)    Notices.  Any written notices provided for in this Agreement or the Plan shall be in writing and shall be deemed sufficiently given if either hand delivered or if sent by fax or 

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overnight courier, or by postage paid first class mail.  Notices sent by mail shall be deemed received three business days after mailing but in no event later than the date of actual receipt.  Notices shall be directed, if to the Participant, at the Participant’s address indicated by the Company’s records, or if to the Company, to the attention of the Director, Corporate Compensation at the Company’s principal executive office.  
(c)    Severability. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement, and each other provision of this Agreement shall be severable and enforceable to the extent permitted by law.
(d)    No Rights to Employment.  Nothing contained in this Agreement shall be construed as giving Participant any right to be retained, in any position, as an employee, consultant or director of the Company or its Affiliates or shall interfere with or restrict in any way the right of the Company or its Affiliates, which are hereby expressly reserved, to remove, terminate or discharge Participant at any time for any reason whatsoever.
(e)    Beneficiary.  The Participant other than a Participant residing in the Province of Québec, may file with the Committee a written designation of a beneficiary on such form as may be prescribed by the Committee and may, from time to time, amend or revoke such designation.  Any notice should be made to the attention of the Corporate Secretary of the Company at the Company’s principal executive office.  If no designated beneficiary survives the Participant, the Participant’s estate shall be deemed to be Participant’s beneficiary.
(f)    Québec Participant.  The Participant residing in the Province of Québec may only designate a beneficiary by will. Upon the death of the Participant residing in the Province of Québec, the Company shall settle the RSUs pursuant to Section 2(b) of this Agreement to the liquidator, administrator or executor of the estate of the Participant.
(g)    Successors.  The terms of this Agreement shall be binding upon and inure to the benefit of the Company and its successors and assigns, and of the Participant and the beneficiaries, executors, administrators, heirs and successors of the Participant.
(h)    Entire Agreement.  This Agreement and the Plan contain the entire agreement and understanding of the parties hereto with respect to the subject matter contained herein and supersede all prior communications, representations and negotiations in respect thereto.  No change, modification or waiver of any provision of this Agreement shall be valid unless the same be in writing and signed by the parties hereto, except for any changes permitted without consent under Section 9 of the Plan.
(i)    Governing Law.  This Agreement shall be construed and interpreted in accordance with the laws of the State of Delaware without regard to principles of conflicts of law thereof, or principles of conflicts of laws of any other jurisdiction which could cause the application of the laws of any jurisdiction other than the State of Delaware.
(j)    Headings.  The headings of the Sections hereof are provided for convenience only and are not to serve as a basis for interpretation or construction, and shall not constitute a part, of this Agreement.

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                                                 *    *    *
[signature page follows]
IN WITNESS WHEREOF, the Company has executed this Agreement as of the day first written above.
RESOLUTE FOREST PRODUCTS INC. 

By: _____________________________________
    

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