Document:

Softgel Commercial Manufacturing and Packaging Agreement

 Exhibit 10.12 
 ***Text Omitted and Filed Separately 
 with the Securities and Exchange
Commission. 
 Confidential Treatment Requested 
 Under 17 C.F.R. Sections 200.80(b)(4) 
 and 230.406. 

EXECUTION VERSION 
 SOFTGEL COMMERCIAL MANUFACTURING AND PACKAGING AGREEMENT 
 This Softgel Commercial Manufacturing and Packaging Agreement (“Agreement”) is made this 21st day of March, 2011, by and between Catalent
Pharma Solutions, LLC, a Delaware limited liability company, having a place of business at 14 Schoolhouse Road, Somerset, New Jersey 08873 (“Catalent”) and Insys Therapeutics, Inc., a Delaware corporation, having its principal place
of business at 10220 S. 51st Street, Suite 2, Phoenix, AZ
85044 (“Client”). 
 RECITALS 

A.    Catalent provides certain pharmaceutical development, manufacturing, packaging, and analytical testing services
to the pharmaceutical industry; 
 B.    Client has certain technology relating to certain pharmaceutical
products and wants Catalent to assist in the formulation, filling, packaging and testing of such products as provided in this Agreement and the attachments hereto; 
 C.    Client desires to engage Catalent to provide certain services to Client in connection with the processing and packaging of Client’s Product (defined below); and Catalent
desires to provide such services pursuant to the terms and conditions set forth in this Agreement. 
 THEREFORE, in
consideration of the mutual covenants, terms and conditions set forth below, the parties agree as follows: 
 ARTICLE 1

 DEFINITIONS 
 The following terms have the following meanings in this Agreement: 

1.1    “Act” means the U.S. Federal Food, Drug and Cosmetic Act and its amendments. 

1.2    “Affiliate(s)” means, with respect to Client or any third party, any corporation, firm, partnership or other
entity that controls, is controlled by or is under common control with such entity; and with respect to Catalent, any corporation, firm, partnership or other entity controlled by Catalent Pharma Solutions, Inc. For purposes of this definition,
“control” shall mean the ownership of at least 50% of the voting share capital of entity or any other comparable equity or ownership interest. 
 1.2a    “API” means the pharmaceutically active potent, generic compound dronabinol described in Exhibit C that has been released by Client and provided to Catalent,
along with a certificate of analysis, in accordance with the API Specifications and as further provided in this Agreement. The parties acknowledge that the API is a Schedule I controlled substance under Applicable Law, including Drug Enforcement
Agency regulations. 
 1.2b    “API Specifications” means the Specifications set forth on Exhibit C.

 1.3    “Applicable Laws” means all laws, ordinances, rules and
regulations, as amended from time to time, of the Territory applicable to the Processing and Packaging of the Product or any aspect thereof and the obligations of Catalent or Client, as the context requires under this Agreement, including, without
limitation, (A) all applicable federal, state and local laws and regulations of the United States; (B) the Act, and (C) the Good Manufacturing Practices promulgated by the Regulatory Authorities, as amended from time to time
(“GMPs”). 
 1.4    “Batch” means defined quantity of finished drug product that has been
or is in the process of being Processed or Packaged in accordance with the Specifications. 
 1.5    “Calendar
Quarter” means a period of three (3) consecutive months commencing on January 1, April 1, July 1, or October 1 of any calendar year. 
 1.6    “Catalent Defective Packaging” has the meaning set forth in Section 5.1. 
 1.7    “Catalent Defective Processing” has the meaning set forth in Section 5.1. 
 1.8    “Catalent Technology” shall have the meaning set forth in Article 11. 
 1.9    “Change Order” shall have the meaning set forth in Section 4.5A. 
 1.10    “Client Supplied Materials” means any materials to be supplied by or on behalf of Client, including API, to Catalent for Processing or Packaging, as provided
in Exhibit C. 
 1.11    “Commencement Date” means the first date upon which a Regulatory Authority
approves Catalent as the manufacturer of the Product. 
 1.12    “Confidential Information” shall have the
meaning set forth in Section 10.2. 
 1.13    “Contract Year” means each consecutive twelve
(12) month period beginning on the Commencement Date. 
 1.14    “Client Technology” shall have the
meaning set forth in Article 11. 
 1.15    “Defective Packaged Product” has the meaning set forth in
Section 5.1. 
 1.16    “Defective Product” shall have the meaning set forth in Section 5.1.

 1.17    “Dispute” shall have the meaning set forth in Section 18.9. 

1.18    “Dosage Container” means any final dosage form container(s) the parties may agree upon in writing from time
to time. 
 1.18    “Effective Date” means the date this Agreement was fully executed. 

1.20    “Facilities” means Catalent’s facilities located in Somerset, NJ, Philadelphia, PA, or such other
facility as mutually agreed to in writing by the parties. 

 1.21    “FDA” means the United States Food and Drug Administration.

 1.22    “Firm Commitment” shall have the meaning set forth in Section 4.2. 

1.23    “Minimum Requirement” shall have the meaning set forth in Section 4.1. 

1.24    “Package” or “Packaging” means the labeling and packaging of bulk Product into primary and
secondary packaging in accordance with the Packaging Specifications and the terms and conditions of this Agreement. 

1.25    “Packaged Product” means Refrigerated Product or Room Temperature Product (as defined below) that is
Packaged in accordance with the Packaging Specifications and under the terms of this Agreement. 

1.26    “Process” or “Processing” means the compounding, filling, encapsulation, producing and/or
bulk packaging of the API and Raw Materials into Product in accordance with the Specifications and the terms and conditions set forth in this Agreement. 
 1.27    “Processing Date” means the day on which the Product is to be compounded by Catalent. 
 1.28    “Product” means the fully compounded bulk drug product containing the API provided by Client and Processed and bulk packaged in accordance with the
Specifications. The parties also acknowledge that the Product, upon approval of the associated ANDA by the FDA, is a Schedule III controlled substance under Applicable Law, including Drug Enforcement Agency regulations. The Product may be either a
compounded bulk drug product containing the API that requires refrigeration (“Refrigerated Product”) or a compounded bulk drug product containing the API that does not require refrigeration (“Room Temperature
Product”) and references to “Product” hereunder refer to both Refrigerated Product and Room Temperature Product. 

1.29    “Product Maintenance Fee for Processing” shall have the meaning set forth in Section 7.2. 

1.30    “Product Maintenance Fee for Packaging” shall have the meaning set forth in Section 7.2. 

1.31a    “Purchase Order” shall have the meaning set forth in Section 4.3. 

1.31b    “Quality Agreement(s)” shall have the meaning set forth in Section 9.7. 

1.32    “Raw Materials” means all raw materials, supplies, components and packaging necessary to manufacture and
ship the Product in accordance with the Specifications, as provided in Exhibit A, but not including the API. 

1.33    “Recall” shall have the meaning set forth in Section 9.6. 

1.34    “Regulatory Approval” shall have the meaning set forth in Section 7.5. 

  
 3 

 1.35    “Regulatory Authority” means any governmental regulatory
authority within the United States involved in regulating any aspect of the development, manufacture, market approval, sale, distribution, packaging or use of pharmaceutical or medicinal products. 

1.36    “Rolling Forecast” shall have the meaning set forth in Section 4.2. 

1.37    “Softgel Technology” means Catalent’s proprietary technology, whether or not patented or patentable,
for the manufacture of softgels for various uses, including the oral administration of pharmaceutically active ingredients (including health and nutritional substances). The Softgel Technology includes proprietary know-how relating to (i) the
development of fill and shell formulations, (ii) the design and use of the encapsulation process to enhance stability, solubility, bioavailability and manufacturability of active ingredient chemical entities in softgels, (iii) the
selection and preparation of solvents, vehicles, excipients, surfactants, stabilizers, gelatin and gelatin substitutes, plasticizers and other components of the liquid fill and the shell and (iv) certain encapsulation, drying and related
manufacturing techniques and machinery for making experimental, clinical, or commercial quantities of softgels. 

1.38    “Specifications” means the Processing or Packaging procedures, requirements, standards, quality control
testing and other data and the scope of services as set forth in Exhibit A, which are hereby incorporated by reference into this Agreement, along with any valid amendments or modifications thereto, subject to the terms and conditions set
forth in Article 8. 
 1.39    “Term” shall have the meaning set forth in Section 16.1. 

1.40    “Territory” means the United States of America, and its possessions and territories. 

1.41    “Unit Pricing” shall have the meaning set forth in Section 7.1. 

ARTICLE 2 

PROCESSING & RELATED SERVICES 
 2.1    Supply and Purchase of Product. Client will purchase exclusively from Catalent, and Catalent will be the exclusive, supplier to Client for all of Client’s and its
Affiliates’ requirements of Product (Refrigerated Product and Room Temperature Product) and Packaged Product (Refrigerated Product and Room Temperature Product) for the term of this Agreement. Sales of Product and Packaged Product by Affiliates
of Client shall be deemed to be made by Client for this purpose, and Catalent may assign to its Affiliates, as appropriate, responsibilities for compliance or partial compliance with its responsibilities hereunder. 

2.2    Product Maintenance and Other Related Services. During the Term and subject to Client’s payment of the Product
Maintenance Fee for Processing and the Product Maintenance Fee for Packaging as set forth in Section 7.2, Client shall be entitled to the following product maintenance services with respect to Processing: [...***...] access to document
library [...***...]; 

  

					
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 Product document and Sample storage relating to GMP requirements; [...***...] and with respect to
Packaging, [...***...] as applicable. For the avoidance of doubt, the following services are not included in product maintenance services: [...***...] for the Product or the Packaged Product, and Packaged Product [...***...].
Catalent shall provide other services upon terms and conditions agreed to by the parties in writing from time to time. 

ARTICLE 3 

MATERIALS 

3.1    API. 
 A.    Client shall supply to Catalent for Processing, at Client’s sole cost, the API and applicable reference standards in quantities sufficient to meet Client’s requirements
for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Catalent for Processing, Client shall provide to Catalent a copy of the API Material Safety Data Sheet (“MSDS”), as
amended, and any subsequent revisions thereto. Client shall supply the API, reference standards, and certificate of analysis [...***...] the Facility no later than [...***...] before (but not earlier than [...***...] before) the
scheduled Processing Date upon which such API will be used by Catalent for Processing. Client shall be responsible at its expense for securing any necessary DEA, export, or import clearances or permits required in respect of supply to Catalent of
such items. Upon receipt of the API, Catalent shall conduct release testing of the API as per the Specifications. Catalent shall use the API solely and exclusively for Processing under this Agreement. 

B.    All API provided by Client shall meet the API Specifications that apply thereto, and shall be produced in
accordance with all applicable federal, state and local laws and regulations, including, without limitation, cGMPs. 

C.    Catalent shall inspect API as received to verify its identity and shall give Client oral and written notice of
any nonconformity with the API Specifications within [...***...] of receipt of API by Catalent. Catalent shall inform Client of any API nonconformity within [...***...] from receipt of nonconformity testing results. Client shall provide
a certificate of analysis with each delivery of API and such certificate shall be the basis for drug potency. 

D.    Client shall retain title to API at all times and shall bear the risk of loss thereof, subject to the
exceptions set forth in Section 14.1. 
 3.2    Raw Materials. 

A.    Catalent shall be responsible for procuring, inspecting and releasing adequate Raw Materials as necessary to
meet the Firm Commitment, unless otherwise agreed to by the parties in writing. Unless a particular Raw Material can be replaced with the same raw material 

  

					
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from another supplier, Catalent shall not be liable for any delay in delivery of Product or Packaged Product if (1) Catalent is unable to obtain, in a timely manner, a particular Raw
Material necessary to Process or Package the Product, (2) Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitment and (3) such delay did not result, in whole or in part, from the negligence
or willful misconduct of Catalent. 
 B.    In certain instances, Client may require a specific supplier,
manufacturer or vendor (“Supplier”) to be used for a Raw Material. In such an event, (i) such Supplier will be identified in the Specifications, (ii) Client shall be responsible for the timeliness, quantity and quality of
supply of Raw Materials from such Supplier, subject to Catalent’s compliance with its obligations set forth in Section 3.2A, (iii) Catalent shall not be liable for any defects in Raw Materials or in Packaging or Packaged Product as a
result of such defective Raw Materials from such Supplier, or in Product or Packaged Product as a result of such defective Raw Materials, unless Catalent failed to properly perform any testing required by the Specifications, and (iv) the Raw
Materials from such Supplier shall be deemed, for purposes of liability hereunder, Client-supplied Materials. If the cost of the Raw Material from any such Supplier is greater than Catalent’s costs for the same raw material of equal quality
from other suppliers, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Supplier’s cost of the Raw Material to the Unit Pricing. Client will be responsible for all costs associated with qualification of
any such Supplier who has not been previously qualified by Catalent. In the case of Raw Materials in respect of which Client requires a specific Supplier to be used, Catalent shall not be liable for any delay in delivery of Product if Catalent is
unable to obtain, in a timely manner, such particular Raw Material necessary to Manufacture or Package the Product, provided that Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitment. 

3.3    Artwork and Packaging. If applicable, Client shall provide or approve, prior to the procurement of applicable
components, all artwork, advertising and packaging information necessary to Process or Package the Product. Such artwork, advertising and packaging information is and shall remain the exclusive property of Client, and Client shall be solely
responsible for the content thereof. Such artwork, advertising and packaging information or any reproduction thereof may not be used by Catalent following the termination of this Agreement, or during the Term of this Agreement in any manner other
than solely for the purpose of performing its obligations hereunder. 
 3.4    Reimbursement for Materials. In the
event of (A) a Specification change for any reason, (B) termination or expiration of this Agreement; or (C) obsolescence of any Raw Material, Client shall bear the cost of any unused Raw Materials (including packaging materials at
[...***...]), provided that Catalent purchased such Raw Materials in quantities consistent with Client’s most recent Firm Commitment and the supplier’s minimum purchase requirements. 

  

					
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 ARTICLE 4 
 MINIMUM COMMITMENT, PURCHASE ORDERS & FORECASTS 

4.1    Minimum Requirement. During each Contract Year, Client shall purchase the minimum number of units of Product
(“Minimum Requirement”) set forth on Exhibit B. 
 If Client does not purchase such Minimum Requirement during any
Contract Year, within [...***...] after the end of such Contract Year, Client shall pay Catalent the difference between (A) the total amount Client would have paid to Catalent if the Minimum Requirement had been fulfilled for the Product
and (B) the sum of all purchases from Catalent for the Product during the just-concluded Contract Year. 

4.2    Forecast. Client shall provide Catalent with a [...***...] non-binding long range forecast on
the first (1st) day of each Contract Year. On or
before the first (1st) day of each calendar quarter,
beginning at least [...***...] prior to the anticipated Commencement Date, Client shall furnish to Catalent a written [...***...] rolling forecast of the quantities of Product that Client intends to order from Catalent during such period
(“Rolling Forecast”). Such Rolling Forecast shall include detailed ordering requirements for each of Processing and Packaging. With respect to Packaging, Client shall provide detailed instructions as to the packaging configuration
and requested delivery date for Packaged Product. The first [...***...] of such Rolling Forecast shall constitute a binding order for the quantities of Product and Packaged Product specified therein (“Firm Commitment”) and the
following [...***...] of the Rolling Forecast shall be non-binding, good faith estimates. 

4.3    Purchase Orders. Post-approval of the Product by the FDA, on or before the first (1st) day of each calendar quarter, Client shall submit a purchase
order for the Firm Commitment portion of the Processing, which specifies the actual number of Batches to be Processed and Packaged, the approximate number of Dosage Containers in each Batch, and the requested delivery dates for each Batch
(“Purchase Order”). Client shall submit each Purchase Order to Catalent at least [...***...] in advance of the delivery date requested in the Purchase Order; no Purchase Order may be for less than [...***...] per run. If
Catalent accepts a Purchase Order, Catalent shall promptly issue an order acknowledgement (“Acknowledgement”), including the Processing Dates and the expected delivery date. In the event of a conflict between the terms of any
Purchase Order and this Agreement, this Agreement shall control. Upon the request of Client, Catalent shall use commercially reasonable efforts to supply Client with quantities of Product and Packaged Product which are up to [...***...] in
excess of the quantities specified in the Firm Commitment, subject to Catalent’s other supply commitments and manufacturing and equipment capacity; provided, however, that Catalent’s failure to supply Client with quantities in excess of
the quantities specified in the Firm Commitment shall not constitute a breach of this Agreement by Catalent. 

4.4    Catalent’s Cancellation of Purchase Orders. Notwithstanding the terms and conditions set forth in Section 4.5
below, Catalent reserves the right to cancel all, or any part of, a Purchase Order upon written notice to Client, and Catalent shall have no further obligations or liability with respect to such Purchase Order, if Client refuses or fails to make
scheduled deliveries of the API. Any such cancellation of Purchase Orders shall not constitute a breach of this Agreement by Catalent nor shall it absolve Client of its obligations in respect of the Minimum Requirement. 

  

					
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	4.5    Client’s	Modification or Cancellation. 

 A.    Client may modify the delivery date, Specifications or quantity of Product and/or Packaged Product in any Purchase Order only by submitting a written change order
(“Change Order”) to Catalent at least [...***...] in advance of the earliest scheduled Processing Date for the Processing, and at least [...***...] in advance of the earliest scheduled Packaging Date, covered by the
Change Order. Such Change Order shall be effective and binding against Catalent only upon the written approval of Catalent, and notwithstanding the foregoing, Client shall remain responsible for the Firm Commitment portion of the Rolling Forecast.

 B.    Notwithstanding any amounts due to Catalent under Section 4.4 or Section 4.1, if Client
fails to place Purchase Orders sufficient to satisfy the Firm Commitment, Client shall, within [...***...] of receipt of invoice, pay to Catalent the Unit Price for all Units that would have been Processed and Packaged if Client had placed
Purchase Orders sufficient to satisfy the Firm Commitment. 
 C.    Neither the changes nor postponement of
any Batch of Product or Packaged Product, nor the payment of the fees described in this Section 4.5, will reduce or in any way effect Client’s Minimum Requirement obligations set forth in Section 4.1. 

4.6    Unplanned Delay or Elimination of Processing or Packaging. Catalent shall use commercially reasonable efforts to meet
the Purchase Orders, subject to the terms and conditions of this Agreement. Catalent shall provide Client with as much advance notice as possible (and will use its best efforts to provide at least [...***...] advance notice where possible) if
Catalent determines that any Processing or Packaging will be delayed or eliminated for any reason. 
 4.7    Inspection
of Processing or Packaging. Client may base up to [...***...] representatives at the Facilities to observe the Processing and Packaging of Product, for a maximum of [...***...] per year, provided that Client provides Catalent at
least [...***...] days’ advance written notice of the attendance of such Client representatives. Such representatives shall abide by all Catalent safety rules and other applicable employee policies and procedures, and Client shall be
responsible for such compliance. Client shall indemnify and hold harmless Catalent against any damage caused by any action or activity of such representatives while on Catalent’s premises, except to the extent caused by the negligence or
willful misconduct of Catalent. Catalent reserves the right to require such representatives to enter into separate confidentiality agreements prior to entry. 
 ARTICLE 5 
 TESTING; SAMPLES; RELEASE 

5.1    Discrepant Test Results. In the event of a disagreement between the parties regarding whether the Product meets
Specifications, the parties shall cause a mutually agreeable independent third party to review records, test data and to perform comparative tests and/or analyses on samples of the Product or Packaged Product alleged to be non-conforming
(“Defective Product” or “Defective Packaged Product”, as applicable). The independent 

  

					
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party’s results shall be final and binding. Unless otherwise agreed to by the parties in writing, the costs associated with such testing and review shall be borne by the party found
responsible. If the Product is Defective Product or Defective Packaged Product and the cause of the nonconformity is due solely to Catalent’s fault (“Catalent Defective Processing” or “Catalent Defective
Packaging”) then Section 5.2 shall apply. For the avoidance of doubt, where the cause of nonconformity cannot be determined or assigned, it shall not be deemed Catalent Defective Processing or Catalent Defective Packaging. 

5.2    Catalent Defective Processing or Catalent Defective Packaging. Catalent will, at its option, either replace or
repackage any Defective Product attributable to Catalent Defective Processing or Catalent Defective Packaging or credit any payments made by Client for such Batch. THE OBLIGATION OF CATALENT TO REPLACE CATALENT DEFECTIVE PROCESSING OR CATALENT
DEFECTIVE PACKAGING IN ACCORDANCE WITH THE SPECIFICATIONS OR CREDIT PAYMENTS MADE BY CLIENT FOR CATALENT DEFECTIVE PROCESSING OR CATALENT DEFECTIVE PACKAGING SHALL BE CLIENT’S SOLE AND EXCLUSIVE REMEDY UNDER THIS ARTICLE FOR CATALENT DEFECTIVE
PROCESSING AND CATALENT DEFECTIVE PACKAGING AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED. 
 5.3    Supply of
Material for Defective Product. In the event Catalent replaces Product pursuant to Section 5.2, above, Client shall supply Catalent with sufficient quantities of the API in order for Catalent to complete such replacement. 

ARTICLE 6 

DELIVERY 

6.1    Delivery. Catalent shall tender the Product or Packaged Product as applicable, for delivery, [...***...]
(Incoterms 2000) the Facility. Client shall be responsible for all costs and risk of loss associated with shipment of the Product or Packaged Product, as applicable. Client shall qualify at least [...***...] carriers to ship the Product and
Packaged Product and then designate the priority of such qualified carriers to Catalent. 
 6.2    Failure to Take
Delivery. If Client fails to take delivery of any Product and/or Packaged Product on any scheduled delivery date, then, beginning [...***...] days after the scheduled delivery date, Client shall be invoiced on the first day of the
subsequent month for the stored Product and/or Packaged Product and the first day of each subsequent month for reasonable administration and storage costs. For each such Batch of undelivered Product and/or Packaged Product, Client agrees that:
(A) Client has made a fixed commitment to purchase such Product and/or Packaged Product, (B) title and risk of loss for such Product and/or Packaged Product passes to Client, (C) such Product and/or Packaged Product shall be on a bill
and hold basis for legitimate business purposes, (D) if no delivery date is determined at the time of billing, Catalent shall have the right to ship the Product and/or Packaged Product to Client within one month after billing, and
(E) Client will be responsible for any decrease in market value of such Product and/or Packaged Product that relates to factors and circumstances outside of Catalent’s control. Within [...***...] days following a written request from
Catalent, Client shall provide Catalent with a letter confirming items (A) through (E) of this Section for each Batch of stored Product and/or Packaged Product. 

  

					
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 ARTICLE 7 
 PRICING AND PAYMENT 
 7.1    Unit Pricing. Client shall pay to
Catalent the unit pricing for Product and Packaged Product as set forth on Exhibits B and D (“Unit Pricing”). In the event Client requests services other than Processing or Packaging Product, Catalent shall provide a written
quote of the fee for such additional services and Client shall advise Catalent whether it wishes to have such additional services performed by Catalent. 
 7.2    Product Maintenance Fee. In partial consideration of the product maintenance services set forth in Section 2.2, Client shall pay Catalent an annual Product
Maintenance Fee for Processing of [...***...] per each Refrigerated Product strength and [...***...] per each Room Temperature Product strength (“Product Maintenance Fee for Processing”) and an annual Product Maintenance
Fee for Packaging of [...***...] per each Refrigerated Product strength and [...***...] per each Room Temperature Product Strength (“Product Maintenance Fee for Packaging”). The Product Maintenance Fee for Processing and
the Product Maintenance Fee for Packaging for the Refrigerated Product are payable upon [...***...]. The Product Maintenance Fee for Processing and the Product Maintenance Fee for Packaging for the Room Temperature Product are payable upon
[...***...]. 
 7.3    Price Increase. Product pricing will be subject to [...***...] adjustment on
[...***...] written notice from Catalent. Such pricing adjustment will be effective on [...***...], starting with July 1st, 2011. The pricing adjustment will be limited to [...***...]. 

7.4    Taxes; Duty. All taxes, duties and other amounts assessed on the Raw Materials, API, Product or Packaged Product prior
to or upon sale to Client are the responsibility of Client, and Client shall reimburse Catalent for any such taxes, duties or other expenses paid by Catalent. 
 7.5    Product Approval. Notwithstanding the terms set forth above, Client shall use its best efforts to expedite and obtain all regulatory approvals necessary for Catalent to
commence production at the Facility (“Regulatory Approvals”). 
 7.6    Payment Terms. Catalent
shall invoice Client for all Product or Packaged Product upon delivery as provided in Section 6.1 and for any amounts due pursuant to Section 4.1, and payment for such invoices shall be due within [...***...] after the date of such
invoice. In the event payment is not received by Catalent on or before the [...***...] after the date of the invoice, then Catalent may, in addition to any other remedies available at equity or in law, at its option, elect to do any one or
more of the following: (A) charge interest on the outstanding sum from the due date (both before and after any judgment) at [...***...] until paid in full (or, if less, the maximum amount permitted by Applicable Laws); and
(B) suspend any further performance hereunder until such undisputed amount is paid in full. 

  

					
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 7.7    Client and Third Party Expenses. Except as may be expressly covered by the
Product Maintenance Fee for Processing and the Product Maintenance Fee for Packaging, Client shall be responsible for 100% of its own and all third-party expenses associated with Regulatory Approvals and commercialization of Product, including
regulatory filings and post-approval marketing studies. 
 ARTICLE 8 

CHANGES TO SPECIFICATIONS 
 All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. No change in the Specifications shall be implemented by
Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees
associated with such change. Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely
manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client
shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. 

ARTICLE 9 

RECORDS; REGULATORY MATTERS 
 9.1    Batch Records and Data. Within [...***...] days following the completion of Processing and Packaging of each Batch, Catalent shall provide Client with certificates
of analysis and certificates of conformance. Notwithstanding the foregoing, in the event that there is an investigation of Processing or Packaging, such investigation and the time to provide the applicable certificates referenced herein shall be in
accordance with the Quality Agreement. 
 9.2    Recordkeeping. Catalent shall maintain true and accurate books,
records, test and laboratory data, reports and all other information relating to Processing and Packaging under this Agreement, including all information required to be maintained by all Applicable Laws In accordance with Catalent standard operating
procedures. Such information shall be maintained and retained in accordance with cGMP and the terms of the Quality Agreements. 

9.3    Regulatory Compliance. Client shall be solely responsible for all permits and licenses required by any regulatory
agency with respect to the Product and the Processing and Packaging under this Agreement, including any product licenses, applications and amendments in connection therewith. Catalent will be responsible for maintaining all permits and licenses
required by any Regulatory Authority with respect to the Facilities. During the Term, Catalent will assist Client with all regulatory matters relating to Processing and Packaging under this Agreement, at Client’s request and at Client’s
expense. Each party intends and commits to cooperate to satisfy all Applicable Laws relating to Processing and Packaging under this Agreement. 

  

					
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 9.4    Governmental Inspections and Requests. Catalent shall immediately advise
Client if an authorized agent of any Regulatory Authority visits any of the Facilities concerning or affecting the Processing or Packaging of the Product. Catalent shall furnish to Client a copy of the report by such Regulatory Authority, if any,
within [...***...] days of Catalent’s receipt of such report. Further, upon receipt of a Regulatory Authority request to inspect the Facilities or audit Catalent’s books and records with respect to Processing or Packaging under this
Agreement, Catalent shall immediately notify Client, and shall provide Client with a copy of any written document received from such Regulatory Authority. 
 9.5    Client Inspections and Audits. 

A.    During the Term of this Agreement, duly-authorized employees, agents and representatives of Client shall be
granted access at a mutually agreed upon time during regular business hours to only the portion of the Facilities where Catalent Processes or Packages Product for the purpose of inspecting and verifying that Catalent is Processing or Packaging
Product in accordance with cGMPs, the Specifications and the Product master batch record. For purposes of this Section 9.5, duly-authorized agents and representatives shall be required to sign Catalent’s standard Confidential Disclosure
Agreement prior to being allowed access to Catalent’s Facilities. 
 B.    With due regard for
information and operations which constitute Proprietary Information of Catalent, duly-authorized employees, agents and representatives of Client shall have the right to inspect Catalent Batch records relating to Product and those portions of
Catalent’s Facilities used for Processing and Packaging Product. Client’s Quality Assurance Manager will arrange audit visits with Catalent Quality Management. 
 9.6    Recall. In the event Catalent believes a recall, field alert, Product withdrawal or field correction (“Recall”) may be necessary with respect to any
Product or Packaged Product provided under this Agreement, Catalent shall immediately notify Client in writing. Catalent will not act to initiate a Recall without the express prior written approval of Client, unless otherwise required by Applicable
Laws. In the event Client believes a Recall may be necessary with respect to any Product or Packaged Product provided under this Agreement, Client shall immediately notify Catalent in writing and Catalent shall provide all necessary cooperation and
assistance to Client. The cost of any Recall shall be borne by [...***...] unless such Recall is caused solely by [...***...] breach of its obligations under this Agreement or Applicable Laws or its negligence or willful misconduct, in
which case such cost shall be borne by [...***...]. For purposes hereof, such cost shall be limited to [...***...], in accordance with Article 5; provided, however that, NEITHER PARTY SHALL BE LIABLE IN ANY EVENT FOR SPECIAL, INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST REVENUES OR PROFITS OR DAMAGES TO BUSINESS REPUTATION RESULTING FROM SUCH RECALL. 
 9.7    Quality Agreements. Prior to initiating any Processing or Packaging of the Product, the parties shall execute Quality Agreements for Processing and Packaging (the
“Quality Agreements”). In the event of a conflict between any of the provisions of this Agreement and such Quality Agreements with respect to quality-related activities, including compliance with Good Manufacturing Practices, the
provisions of the Quality Agreements shall govern. In the 

  

					
		  	12	  	***Confidential Treatment Requested

 
event of a conflict between any of the provisions of this Agreement and the Quality Agreements with respect to any commercial matters, including allocation of risk, liability and financial
responsibility, the provisions of this Agreement shall govern. 
 ARTICLE 10 

CONFIDENTIAL INFORMATION 

10.1    Mutual Obligation. Catalent and Client agree that they will not disclose the other party’s Confidential
Information (defined below) to any third party without the prior written consent of the other party except as required by law or regulation; provided, however, that prior to making any such legally required disclosure, the party making such
disclosure shall give the other party as much prior notice of the requirement for and contents of such disclosure as is practicable under the circumstances. Notwithstanding the foregoing, each party may disclose the other party’s Confidential
Information to any of its Affiliates which (A) need to know such Confidential Information for the purpose of performing under this Agreement, (B) are advised of the contents of this Section, and (C) agree to be bound by the terms of
this Section, provided, however, that only an Affiliate to which such Confidential Information is actually disclosed and received will be bound by the terms of this Section. 
 10.2    Definition. As used in this Agreement, the term “Confidential Information” includes all such information furnished by Catalent or Client, or any of
their respective representatives or Affiliates, to the other or its representatives or Affiliates, whether furnished before, on or after the Effective Date of this Agreement and furnished in any form, including but not limited to written, verbal,
visual, electronic or in any other media or manner. Confidential Information includes all proprietary technologies, know-how, trade secrets, discoveries, inventions and any other intellectual property (whether or not patented), analyses,
compilations, business or technical information and other materials prepared by either party, or any of their respective representatives, containing or based in whole or in part on any such information furnished by the other party or its
representatives. Confidential Information also includes the existence of this Agreement and its terms. 

10.3    Exclusions. Confidential Information does not include, however, information concerning Catalent or Client that
(A) is or becomes generally available to the public or within the industry to which such information relates other than as a result of a breach of this Agreement, (B) is already known by the receiving party at the time of disclosure as
evidenced by the receiving party’s written records, (C) becomes available to the receiving party on a non-confidential basis from a source that is entitled to disclose it on a non-confidential basis, or (D) was or is independently
developed by or for the receiving party without reference to the Confidential Information, as evidenced by the receiving party’s written records. 
 10.4    Survival. The obligations of this Article 10 will terminate [...***...] years from the expiration of this Agreement. 

10.5    No Implied License. Except as otherwise set forth herein, the party receiving Confidential Information will obtain no
right of any kind or license under any patent application or patent by reason of this Agreement. All Confidential Information will remain the sole property of the party disclosing such information or data. 

  

					
		  	13	  	***Confidential Treatment Requested

 10.6    Return of Confidential Information. Upon termination of this Agreement,
the party to which Confidential Information has been disclosed will, upon request, promptly return within [...***...] days all such information, including any copies thereof, and cease its use or, at the request of the party transmitting such
Confidential Information, will promptly destroy the same and certify such destruction to the transmitting party; except for a single copy thereof which may be retained for the sole purpose of determining the scope of the obligations incurred under
this Agreement. 
 ARTICLE 11 
 INTELLECTUAL PROPERTY 
 All Catalent Technology, including, without limitation, all
improvements, developments, derivatives or modifications to the Catalent Technology, shall be owned exclusively by Catalent and, except as set forth herein, no right or license in Catalent Technology is transferred or granted to Client. All Client
Technology, including, without limitation, all improvements, developments, derivatives or modifications to the Client Technology shall be owned exclusively by Client. For purposes hereof, “Catalent Technology” means all Softgel
Technology, Catalent Confidential Information, intellectual property, and developments (including, all patents, patent applications, know-how, inventions, designs, concepts, improvements, technical information, manuals, instructions or
specifications), owned, licensed or used by Catalent in developing, formulating, manufacturing, filling, processing or packaging of pharmaceuticals and the packaging equipment, processes or methods of packaging, or any improvements to any of the
foregoing, including any container, pouch, vial, ampoule, blister pack or other form of container developed by Catalent. For purposes hereof, “Client Technology” means all Client Confidential Information, proprietary information,
intellectual property and developments (including, without limitation, patents, patent applications, know-how, inventions, designs, concepts, improvements, technical information, specifications, trademarks or trade names), owned, developed, licensed
or used by Client in connection with its business. Client Technology includes the API, the API bulk container specifications, and the API fill solution preparation, all of which are provided by Client to Catalent in accordance with the API
Specifications. Client hereby grants to Catalent a non-exclusive, royalty-free license to use any and all right, title and interest in the Client Technology as may be necessary for Catalent to perform its obligations under this Agreement. All
inventions relative to generic API shall belong to the party making such inventions. 
 ARTICLE 12 

REPRESENTATIONS AND WARRANTIES 
 12.1    Catalent. Catalent represents and warrants to Client that: 
 A.    at the time of delivery of the Product as provided in Section 6.1, such Product will conform to and will have been Processed and/or Packaged in conformance with the Product
Specifications and Applicable Laws; provided that Catalent shall not be liable for defects attributable to API or other Client supplied materials (including artwork, packaging, and labeling); 

B.    it has, and shall have, good, complete and valid rights to utilize the Catalent Technology utilized in
connection with the Product and as contemplated by this Agreement. To its knowledge, there are no patents owned by others related to the Catalent Technology used with 

  

					
		  	14	  	***Confidential Treatment Requested

 
the Product which would be infringed or misused by Catalent’s performance of the Agreement and, to its knowledge, there are no trade secrets or other proprietary rights of others related to
the Catalent Technology used with the Product which would be infringed or misused by Catalent’s performance of this Agreement; 
 C.    All Products will be Processed and Packaged at the Facilities; and 
 D.    Catalent will comply with all Applicable Laws relative to Catalent’s performance under this Agreement. 

E.    THE LIMITED WARRANTY SET FORTH IN THIS SECTION 12.1 IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING ANY WARRANTY OF MERCHANTABILITY AND ANY WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE. EXCEPT FOR THE WARRANTY EXPRESSED IN THIS SECTION 12.1, CATALENT MAKES NO OTHER WARRANTY, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE PROCESSING OR
THE PRODUCT. IN ADDITION, CATALENT HEREBY DISCLAIMS LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES FOR BREACH OF ANY EXPRESS OR IMPLIED WARRANTY, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY AND ANY IMPLIED WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE WITH RESPECT TO PRODUCT. 
  

	12.2    	Client. Client represents, warrants and covenants to Catalent that: 

 A.    the API and any other materials supplied by Client to Catalent (“Client-supplied Materials”) will comply with all applicable API Specifications, will have been
produced in compliance with the Applicable Laws, and will be provided in accordance with the terms and conditions of this Agreement; 
 B.    it has all necessary authority and all right, title and interest in and to any intellectual property related to the Client-supplied materials; 

C.    no specific safe handling instructions, health and environmental information or material safety data sheets are
applicable to the Product, API, or to and any Client-supplied materials, except as disclosed to Catalent in writing by the Client in sufficient time for review and training by Catalent prior to delivery; 

D.    all Product and Packaged Product delivered to Client by Catalent will be held, used and/or disposed of by the
Client in accordance with all Applicable Laws; 
 E.    Client will comply with all laws, rules, regulations
and guidelines applicable to Client’s performance under this Agreement and its use of Products or Packaged Product provided by Catalent under this Agreement; 
 F.    Client will not release any Batch of Product or Packaged Product if the required certificates of analysis indicate that the Product or Packaged Product does not comply with the
Specifications; 

  
 15 

 G.    the content of all artwork, packaging, and labeling provided to
Catalent complies with all Applicable Laws; 
 H.    Client has all necessary authority and right, title and
interest in and to any copyrights, trademarks, trade secrets, patents, inventions and developments related to the Product and any Product artwork necessary for the performance of this Agreement; 

I.    to the knowledge of Client, the work to be performed by Catalent under this Agreement will not violate or
infringe upon any trademark, tradename, copyright, patent or other rights held by any person or entity; and 

J.    Client shall not market or sell, or license any other party to market or sell, the Product without first making
every reasonable effort to ensure that the Product and Packaged Product is safe and effective for its intended purpose or any other purpose for which such Product or Packaged Product might reasonably be utilized. Client will be solely responsible
for and will obtain all governmental approvals, permits and licenses necessary or desirable in connection with the testing, marketing, sale, advertising or distribution of the Product and Packaged Product in the Territory. 

K.    Client shall have obtained all applicable licenses, permits, and registrations required for the transport and
distribution of API and supplies to Catalent. 
 12.3    Mutual. Each party hereby represents and warrants to the
other party that: 
 A.    such party (1) is duly organized, validly existing and in good standing
under the laws of the state in which it is organized, (2) has the power and authority and the legal right to own and operate its property and assets, and to carry on its business as it is now being conducted, and (3) is in compliance with
all requirements of Applicable Law, except to the extent that any noncompliance would not materially adversely affect such party’s ability to perform its obligations under the Agreement; 

B.    such party (1) has the power and authority and the legal right to enter into this Agreement and to perform
its obligations hereunder and thereunder and (2) has taken all necessary action on its part to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder; 

C.    this Agreement has been duly executed and delivered on behalf of such party, and constitutes a legal, valid,
binding obligation, enforceable against such party in accordance with its terms; 
 D.    all necessary
consents, approvals and authorizations of all agencies and other persons required to be obtained by such party in connection with the Agreement have been obtained; and 
 E.    the execution and delivery of this Agreement and the performance of such party’s obligations hereunder (1) do not conflict with or violate any requirement of Applicable
Laws or any material contractual obligation of such party and (2) do not materially conflict with, or 

  
 16 

 
constitute a material default or require any consent under, any material contractual obligation of such party. 
 ARTICLE 13 
 INDEMNIFICATION 

13.1    Indemnification by Catalent. 
 A.    Catalent shall indemnify and hold harmless Client, its Affiliates, directors, officers, employees and agents from and against any suits, claims, losses, demands, liabilities,
damages, costs and expenses (including costs, reasonable attorney’s fees and reasonable investigative costs) in connection with any suit, demand or action by any third party arising out of or resulting from (i) any negligence, willful
misconduct or breach of this Agreement by Catalent, except to the extent that any of the foregoing arises out of or results from the breach of this Agreement by Client or the negligence or willful misconduct of Client; and (ii) any actual or
alleged infringement or violation of any third party patent, trade secret, copyright, trademark or other proprietary rights by Catalent Technology. 
 B.    Catalent shall indemnify Client against any damages, costs or expenses in connection with any loss, damage or destruction of API to the extent such loss, damage or destruction
arises directly from the willful misconduct of Catalent. This indemnification shall apply to all loss, damage or destruction occurring from the time of receipt of the API by Catalent until delivery of Product to Client [...***...] the Facility as specified hereunder. 

13.2    Indemnification by Client. Client shall indemnify and hold harmless Catalent, its Affiliates, directors, officers
employees and agents from and against all suits, claims, losses, demands, liabilities, damages, costs and expenses (including costs, reasonable attorney’s fees and reasonable investigative costs) in connection with any suit, demand or action by
any third party arising out of or resulting from (A) any breach of its representations, warranties or obligations set forth in this Agreement; (B) any use, manufacture, packaging, sale, promotion or distribution of Product by Client, or
use of, or exposure to, the API or Product, including, without limitation, product liability or strict liability; (C) Client’s exercise of control over the Processing or Packaging under this Agreement, to the extent that Client’s
instructions or directions violate Applicable Law; (D) any actual or alleged infringement or violation of any third party patent, trade secret, copyright, trademark or other proprietary rights by Confidential Information or other information
provided by Client, including Client-supplied materials; or (E) any negligence or willful misconduct by Client, except to the extent that any of the foregoing arises out of or results from the breach by Catalent of this Agreement, or the
negligence or willful misconduct of Catalent. 
 13.3    Indemnification Procedures. All indemnification obligations
in this Agreement are conditioned upon the party seeking indemnification promptly notifying the indemnifying party of any claim or liability of which the party seeking indemnification becomes aware (including a copy of any related complaint,
summons, notice or other instrument), cooperating with the indemnifying party in the defense of any such claim or liability (at the indemnifying party’s expense), and not compromising or settling any claim or liability without prior written
consent of the indemnifying party. 

  

					
		  	17	  	***Confidential Treatment Requested

 ARTICLE 14 
 LIMITATIONS OF LIABILITY 
 14.1    EXCEPT IN THE CASE OF WILLFUL
MISCONDUCT, CATALENT SHALL HAVE NO LIABILITY UNDER THIS AGREEMENT FOR ANY AND ALL CLAIMS FOR LOST, DAMAGED OR DESTROYED API OR OTHER CLIENT-SUPPLIED MATERIALS WHETHER OR NOT SUCH API OR CLIENT-SUPPLIED MATERIALS ARE INCORPORATED INTO PRODUCT.

 14.2    EXCEPT IN THE CASE OF WILLFUL MISCONDUCT, CATALENT’S TOTAL LIABILITY UNDER THIS AGREEMENT IN ANY CONTRACT
YEAR SHALL IN NO EVENT EXCEED FIVE HUNDRED THOUSAND DOLLARS ($500,000). 
 14.3    NEITHER PARTY SHALL BE LIABLE TO THE
OTHER PARTY FOR INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF PERFORMANCE UNDER THIS AGREEMENT, INCLUDING LOSS OF REVENUES, REPUTATION, PROFITS OR DATA, WHETHER IN CONTRACT OR IN TORT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF
THE POSSIBILITY OF SUCH DAMAGES. 
 ARTICLE 15 
 INSURANCE 
 15.1    Catalent. Catalent shall, at its own cost
and expense, obtain and maintain in full force and effect the following insurance during the term of this Agreement: 
  

	 	(A)	Commercial General Liability insurance with a per-occurrence limit of not less than [...***...]; 

 

	 	(B)	Products and Completed Operations Liability Insurance with per-occurrence limit of not less than [...***...]; 

 

	 	(C)	Workers’ Compensation and Employer’s Liability Insurance with statutory limits for Workers’ Compensation and Employer’s Liability insurance limits
of not less than [...***...] per accident; and 

  

	 	(D)	Professional Services Errors & Omissions Liability Insurance with per claim and aggregate limits of not less than [...***...]. 

The parties hereby acknowledge and agree that Catalent may self-insure all or any portion of the above-required insurance. In the event
that any of the required policies of insurance are written on a claims made basis, then such policies shall be maintained during the entire term of this Agreement and for a period of not less than [...***...] years following the termination or
expiration of this Agreement. Catalent shall obtain a waiver from any insurance carrier with whom Catalent carries Workers’ Compensation insurance releasing its subrogation rights against Client. Catalent shall furnish to Customer a certificate
of insurance or other evidence of the required insurance and additional insured status as soon as practicable after the Effective Date and within [...***...] days after renewal of such policies, and such certificate shall provide that the
insurer will give Client at least [...***...] days’ written notice of any material change in or cancellation of such insurance. Each insurance policy which is required under this Agreement, other

  

					
		  	18	  	***Confidential Treatment Requested

 
than self-insurance, shall be obtained from an insurance carrier with an A.M. Best rating of at least A- VII. 
 15.2    Client Insurance. Client shall, at its own cost and expense, obtain and maintain in full force and effect the following insurance during the term of this Agreement:

  

	 	(A)	Commercial General Liability insurance with per-occurrence limit of not less than [...***...]; 

 

	 	(B)	Products and Completed Operations Liability Insurance with per-occurrence limit of not less than [...***...]; 

 

	 	(C)	Workers’ Compensation and Employer’s Liability Insurance with statutory limits for Workers’ Compensation and Employer’s Liability insurance limits
of not less than [...***...] per accident; and 

  

	 	(D)	All risk Property Insurance, including transit coverage, in an amount equal to full replacement value covering Client’s property while it is at Catalent’s
facilities or in transit to, from, or between Catalent’s facilities. 

 Client shall maintain levels of
insurance sufficient to meet its obligations under this Agreement. In the event that any of the required policies of insurance are written on a claims made basis, then such policies shall be maintained during the entire term of this Agreement and
for a period of not less than [...***...] years following the termination or expiration of this Agreement. Client shall obtain a waiver from any insurance carrier with whom Client carries Property Insurance releasing its subrogation rights
against Catalent. Client shall not seek reimbursement for any property claim or portion thereof that is not fully recovered from Client’s Property Insurance policy. Client shall obtain a waiver from any insurance carrier with whom Client
carries Workers’ Compensation insurance releasing its subrogation rights against Catalent. Catalent Pharma Solutions, Inc. and its subsidiaries and Affiliates shall be named as additional insureds under the Products and Completed Operations
Liability insurance policies with respect to the products and completed operations outlined in this Agreement. Client shall furnish certificates of insurance evidencing the required insurance policies and additional insured status to Catalent as
soon as practicable after the Effective Date of the Agreement and within [...***...] days after renewal of such policies, and such certificate shall provide that the insurer will give Catalent at least [...***...] days’ written
notice of any material change in or cancellation of such insurance. Each insurance policy that is required under this Agreement shall be obtained from an insurance carrier with an A.M. Best rating of at least A- VII. 

ARTICLE 16 

TERM AND TERMINATION 

16.1    Term. This Agreement shall commence on the Effective Date and shall continue for a period of five (5) Contract
Years, unless earlier terminated under Section 16.2 (the “Initial Term”). After the Initial Term, this Agreement will be renewed automatically for further periods of two (2) years (each, a “Renewal Term”)
unless and until one party gives the other party at least 12 months’ prior written notice of its desire to terminate as of the end of the then-current Term. The Initial Term and any Renewal Term shall constitute the Term.

  

					
		  	19	  	***Confidential Treatment Requested

 16.2    Termination by Either Party. 

A.    Material Breach. Either party may terminate this Agreement effective upon sixty
(60) days’ prior written notice to the other party, if the other party commits a material breach of this Agreement and fails to cure such breach by the end of such sixty (60) day period. 

B.    Bankruptcy. Either party may terminate this Agreement effective upon written notice to
the other party, if the other party becomes insolvent or admits in writing its inability to pay its debts as they become due, files a petition for bankruptcy, makes an assignment for the benefit of its creditors or has a receiver, trustee or other
court officer appointed for its properties or assets. 
 C.    Termination Without
Cause. Either party may terminate this Agreement upon twenty-four (24) months’ prior written notice to the other party. 

16.3    Effect of Termination. 
 A.    Expiration or termination of this Agreement shall be without prejudice to any rights or obligations that accrued to the benefit of either party prior to such expiration or
termination. 
 B.    In the event of any termination, Catalent shall promptly return (1) any remaining
inventory of materials received from Client, (2) all remaining inventories of API, Product, or Packaged Product and (3) any other API, Product, or Packaged Product being stored for Client, to Client at Client’s expense. Catalent shall
have no obligation to return the foregoing until all outstanding invoices sent by Catalent to Client have been paid in full. Client shall also be required to pay for (X) completed but not yet shipped Product or Packaged Product; and
(Y) Product and Packaged Product in process and Product and Packaged Product shipped but not yet invoiced in the event that this Agreement is terminated for reasons other than Catalent’s default. In the event Client breaches or terminates
this Agreement (other than pursuant to Section 16.2(A) or (B) hereof) or if Catalent terminates this Agreement under Section 16.2(A) or (B) hereof, Client will also be required to pay Catalent for its direct cost of all materials
purchased by Catalent for Processing and Packaging in accordance with the Firm Commitment (including packaging materials at [...***...]). Client shall specify the location in the continental United States to which delivery, at Client’s
expense, of the foregoing is to be made. 
 ARTICLE 17 

NOTICE 

All notices and other communications hereunder shall be in writing and shall be deemed given: (A) when delivered personally;
(B) when delivered by facsimile transmission (receipt verified); (C) when received or refused, if mailed by registered or certified mail (return receipt requested), postage prepaid; or (D) when delivered, if sent by express courier
service, to the parties at the following addresses (or at such other address for a party as shall be specified by like notice; provided, that notices of a change of address shall be effective only upon receipt thereof): 

  

					
		  	20	  	***Confidential Treatment Requested

			
	 To Client:
	  	Insys Therapeutics, Inc.
		  	10220 South 51st Street, Suite 2
		  	Phoenix, AZ 85044
		  	Facsimile: (602) 910-2627
		
	 To Catalent:
	  	Catalent Pharma Solutions, LLC
		  	14 Schoolhouse Rd
		  	Somerset, NJ 08873
		  	Attn: Vice President/General Manager, Pharmaceutical Softgel
		  	Facsimile: (732) 537-6480
		
		  	Catalent Pharma Solutions, LLC
		  	Packaging Services
		  	3001 Red Lion Road
		  	Philadelphia, PA 19114
		  	Attn: President, Packaging
		  	Facsimile: (215) 613-3000
		
	 With a copy to:
	  	Catalent Pharma Solutions, LLC
		  	14 Schoolhouse Road
		  	Somerset, NJ 08873
		  	Attn: Legal Dept.
		  	Facsimile: (732) 537-6491

 ARTICLE 18 
 MISCELLANEOUS 
 18.1    Entire Agreement; Amendments. This
Agreement is the entire understanding between the parties and supersedes any contracts, agreements or understanding (oral or written) of the parties with respect to the subject matter hereof. No term of this Agreement may be amended except upon
written agreement of both parties, unless otherwise provided in this Agreement. 
 18.2    Captions. The captions in
this Agreement are for convenience only and are not to be interpreted or construed as a substantive part of this Agreement 

18.3    Further Assurances. The parties agree to execute, acknowledge and deliver such further instruments and to take all
such other incidental acts as may be reasonably necessary or appropriate to carry out the purpose and intent of this Agreement. 

18.4    No Waiver. Failure by either party to insist upon strict compliance with any term of this Agreement in any one or more
instances will not be deemed to be a waiver of its rights to insist upon such strict compliance with respect to any subsequent failure. 

  
 21 

 18.5    Severability. If any term of this Agreement is declared invalid or
unenforceable by a court or other body of competent jurisdiction, the remaining terms of this Agreement will continue in full force and effect. 

18.6    Independent Contractors. The relationship of the parties is that of independent contractors, and neither party will
incur any debts or make any commitments for the other party except to the extent expressly provided in this Agreement. Nothing in this Agreement is intended to create or will be construed as creating between the parties the relationship of joint
ventures, co-partners, employer/employee or principal and agent. 
 18.7    Successors and Assigns. This Agreement
will be binding upon and inure to the benefit of the parties, their successors and permitted assigns. Neither party may assign this Agreement, in whole or in part, without the prior written consent of the other party, except that either party may,
without the other party’s consent, assign this Agreement to an Affiliate or to a successor to substantially all of the business or assets of the assigning company or the assigning company’s business unit responsible for performance under
this Agreement. 
 18.8    Governing Law. This Agreement shall be governed by and construed under the laws of the
State of New Jersey, excluding its conflicts of law provisions. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement. 
 18.9    Alternative Dispute Resolution. If a dispute, controversy or disagreement (“Dispute”) arises between the parties in connection with this Agreement, then
the Dispute shall be presented to the respective presidents or senior executives of Catalent and Client for their consideration and resolution. If such parties cannot reach a resolution of the Dispute, then such Dispute shall be resolved by binding
alternative dispute resolution in accordance with the then existing commercial arbitration rules of The CPR Institute for Dispute Resolution, 366 Madison Avenue, New York, NY 10017. Arbitration shall be conducted in the jurisdiction of the defendant
party. 
 18.10    Prevailing Party. In any dispute resolution proceeding between the parties in connection with this
Agreement, the prevailing party will be entitled to its reasonable attorney’s fees and costs in such proceeding. 

18.11    Counterparts. This Agreement may be executed in one or more counterparts, each of which will be deemed an original
but all of which together will constitute one and the same instrument. The exchange of copies of this Agreement and of signature pages by facsimile or email (pdf.) transmission shall constitute effective execution and delivery of this Agreement as
to the parties hereto and may be used in lieu of the original Agreement for all purposes. 
 18.12    Publicity.
Neither party will make any press release or other public disclosure regarding this Agreement or the transactions contemplated hereby without the other party’s express prior written consent, except as required under Applicable Laws or by any
governmental agency or by the rules of any stock exchange on which the securities of the disclosing party are listed, in which case the party required to make the press release or public disclosure shall use commercially reasonable efforts to obtain
the approval of the other party as to the form, nature and extent of the press release or public disclosure prior to issuing the press release or making the public disclosure. 

  
 22 

 18.13    Setoff. Without limiting Catalent’s rights under law or in equity,
Catalent and its Affiliates, parent or related entities, collectively or individually, may exercise a right of set-off against any and all amounts due to Catalent from Client. For purposes of this Section, Catalent, its Affiliates, parent or related
entities shall be deemed to be a single creditor. 
 18.14    Survival. The rights and obligations of the parties
shall continue under Sections 9.2 (Recordkeeping) and 9.6 (Recall), and Articles 10 (Confidential Information), 11 (Intellectual Property), 13 (Indemnification), 14 (Limitations of Liability), 15 (Insurance) to the extent expressly stated therein,
16.3 (Effects of Termination), 17 (Notice), and 18 (Miscellaneous), notwithstanding expiration or termination of this Agreement. 

18.15    Force Majeure. Except as to payments required under this Agreement, neither party will be liable for, nor shall this
Agreement be terminable or cancelable by reason of, any delay or default in such party’s performance hereunder if such default or delay is caused by events beyond such party’s reasonable control, including but not limited to, acts of God,
raw material shortage, regulation or law or other action or failure to act of any government or agency thereof, war or insurrection, civil commotion, destruction of production facilities or materials by earthquake, fire, flood, or weather, labor
disturbances, failure of suppliers, public utilities or common carriers; provided, however, that the party seeking relief hereunder shall immediately notify the other party of such cause beyond such party’s reasonable control. The party
invoking this section shall use all reasonable endeavors to reinstate its ongoing obligation to the other party. If the cause shall continue beyond [...***...] in any [...***...] period, then both parties shall meet to discuss and
negotiate in good faith what modifications to this Agreement should result from this force majeure. 
 IN WITNESS
WHEREOF, the parties have caused their duly-authorized representative to execute this Agreement effective as of the date first written above. 
  

									
	CATALENT PHARMA SOLUTIONS, LLC	 		 	INSYS THERAPEUTICS, INC.
					
	Signature:	  	/s/ Aris Gennadios	 		 	Signature:	  	/s/ Michael Babich
					
	Name:	  	Aris Gennadios	 		 	Name:	  	Michael Babich
					
	Title:	  	VP/GM, Pharmaceutical Softgel	 		 	Title:	  	Chief Executive Officer

 Signature Page to Softgel Commercial Manufacturing and Packaging Agreement 

  

					
		  	23	  	***Confidential Treatment Requested

 EXHIBIT A 

PROCESSING SPECIFICATIONS 
 [To be attached] 
 PACKAGING SPECIFICATIONS 

[To be attached] 

  
 24 

 DCU 
  

											
	CATALENT BULK FINISHED PRODUCT
SPECIFICATION	  	 	Page 1 of 3	  

  

									
	Specification
Number: [...***...]	  	Version Number: 
[...***...]
	Product Name: Dronabinol
Capsules USP 10mg
	Product Description:
[...***...]
	Synonyms:
[...***...]
	SAFETY /
HANDLING INFORMATION
	Controlled Substance: x YES, specify schedule: 1
	Compound Categorization Code:
[...***...]
	QC Small Quantity Handling
Precautions: [...***...]
	Storage Conditions:
[...***...]
	SAMPLING /
EXPIRATION INFORMATION
	Release Testing Sample Size:
[...***...]	  	Retain Size: [...***...]
	Microbiological Testing Sample Size:
[...***...]	  	Microbiological Retain Size: [...***...]
	Expiration Date Parameters:
[...***...]

									
	TEST	  	METHOD	  	SPECIFICATION
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]

  

					
		  		  	***Confidential Treatment Requested

 DCU 
  

							
	 CATALENT BULK FINISHED PRODUCT SPECIFICATION
	  	Page 2 of 3

  

							
	 Specification Number: [...***...] 
	  	Version Number: 
[...***...]

							
	 Product Name: Dronabinol Capsules USP 10 mg

	 Product Description: [...***...]

	 	  	 	  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	
[...***...]
	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	
[...***...]
	  	 
	
Formulations Signature: /s/ illegible
	  	Date: 21 Oct
2009

							
	 TEST
	  	METHOD	  	SPECIFICATION
	[...***...]	  	 
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]

  

					
		  		  	***Confidential Treatment Requested

 DCU 
  

											
	CATALENT BULK FINISHED PRODUCT
SPECIFICATION	  	 	Page 3 of 3	  

  

									
	Specification
Number: [...***...] 	 	Version Number: 
[...***...]
	Product Name: Dronabinol
Capsules USP 10mg
	Product Description:
[...***...]
	[...***...]
	[...***...]
	APPROVALS
	Prepared By Signature:  /s/ Irene McGuffy	 	Date: 20 Oct 2009
	Formulations Signature:  /s/ illegible	 	Date: 21 Oct 2009
	Microbiology Signature:  /s/ Donna Fati	 	Date: 30 Oct 2009
	Analytical Services Signature:  /s/ illegible	 	Date: 29 Oct 2009
	             
                Signature: N/A	 	/s/ DJL	 	Date: 04 Nov 2009
	 QA Manager Signature (or
Authorized Designee):  /s/ David J. Lucas
	 	Date: 04 Nov 2009
	Effective
date is date of last signature. File in DCU when complete.

  

					
		  		  	***Confidential Treatment Requested

 DCU 
  

					
	CUSTOMER APPROVAL SPECIFICATION FORM
	Prepared By: Irena McGuffy	  	 	  	 
	Customer
Information
	 Customer Contact Name: Venkat Goskonda

 
 Company: Insys Therapeutics, Inc.

 
 Address:
 10220 South 51 Street
 Phoenix, AZ 85044 
	  	 
	Specification:
[...***...]	  	 
	Version Number: [...***...]	  	Supersedes: [...***...]	  	 
	Material Name: Dronabinol Capsules USP 10mg	  	 
	Material Description: [...***...]	  	 	  	 
	[...***...]	  	 	  	 
	Approvals

	 	 
	 Customer Authorization: /s/
illegible
  
	  	 Date: Oct. 20, 2009

 

	File in DCU
when complete.

  

					
		  		  	***Confidential Treatment Requested

 DCU 
  

									
	 CATALENT BULK FINISHED PRODUCT SPECIFICATION
	  	Page 1 of 
3

  

							
	 Specification Number: [...***...] 
	  	Version Number: 
[...***...]
	 Product Name: Dronabinol Capsules USP 2.5mg

	 Product Description: [...***...]

	 Synonyms: [...***...]

							
	
SAFETY / HANDLING INFORMATION

	 Controlled Substance: x YES, specify schedule: 1

	 Compound Categorization Code: [...***...]

	 QC Small Quantity Handling Precautions: [...***...]

	 Storage Conditions: [...***...]

	
SAMPLING / EXPIRATION INFORMATION

	 Release Testing Sample Size: [...***...]
	  	Retain Size: [...***...]
	 Microbiological Testing Sample Size: [...***...]
	  	Microbiological Retain Size: [...***...]
	 Expiration Date Parameters: [...***...]

							
	
TEST
	  	METHOD	  	SPECIFICATION
	
[...***...]
	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	
[...***...]
	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]

  

					
		  		  	***Confidential Treatment Requested

 DCU 
  

									
	CATALENT BULK FINISHED PRODUCT
SPECIFICATION	  	Page 2 of 3

  

							
	
Specification Number: [...***...]
	  	Version Number: 
[...***...]
	 Product Name: Dronabinol Capsules USP 2.5mg

	 Product Description: [...***...] 

	 	  		  	[...***...]	  	[...***...]
	 	  		  	[...***...]	  	[...***...]
	 	  		  	[...***...]	  	[...***...]
	 	  		  	[...***...]	  	[...***...]
	 	  		  	[...***...]	  	[...***...]
	 	  	 	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]
	 Formulations Signature: /s/
illegible
	  	Date: 21 Oct 2009
	 TEST
	  	METHOD	  	SPECIFICATION
	 Microbiological Testing: [...***...]

	[...***...]	  	[...***...]	  	[...***...]	  	 
	[...***...]	  	[...***...]	  	[...***...]	  	 
	[...***...]	  	[...***...]	  	[...***...]	  	 
	[...***...]	  	[...***...]	  	[...***...]	  	 
	[...***...]	  	[...***...]	  	[...***...]	  	 
	[...***...]	  	[...***...]	  	[...***...]	  	 
	[...***...]

  

					
		  		  	***Confidential Treatment Requested

 DCU 
  

											
	CATALENT BULK FINISHED PRODUCT
SPECIFICATION	  	 	Page 3 of 3	  

  

									
	 	 
	 	  	 
	Specification
Number: [...***...]	  	Version Number: 
[...***...]
	Product Name: Dronabinol
Capsules USP 2.5mg
	Product Description:
[...***...]
	 [...***...]
  

	 History Since Last Change: N/A
 [...***...]

 

	APPROVALS
	Prepared By Signature: /s/ Irena McGuffy	  	Date: 20 Oct 2009
	Formulations Signature: /s/ illegible	  	Date: 21 Oct 2009
	Microbiology Signature: /s/ Donna Fati	  	Date: 30 Oct 2009
	Analytical Services Signature: /s/ illegible	  	Date: 29 Oct 2009
	             
            Signature: N/A	 	/s/ DJL	  	Date: 04 Nov 2009
	 QA Manager Signature (or
Authorized Designee): /s/ David J. Lucas
	  	Date: 04 Nov 2009
	Effective
date is date of last signature. File in DCU when complete.

  

					
		  		  	***Confidential Treatment Requested

 DCU 
  

			
	[...CUSTOMER APPROVAL SPECIFICATION FORM
	Prepared By: Irena
McGuffy
	Customer
Information
	Customer Contact Name: Venkat Goskonda
	 
	Company: Insys Therapeutics, Inc.
	 	 
	 Address:

10220 South 51 Street
 Phoenix, AZ
85044
	  	 
	 
	Specification:
[...***...] 
	 Version Number:
[...***...]
	  	Supersedes: [...***...]
	 Material Name: Dronabinol Capsules USP
2.5mg
	  	 
	 Material Description:
[...***...]
	  	 
	[...***...]	  	 
	Approvals

	 	 
	 Customer Authorization: /s/ illegible
	  	Date: Oct. 20, 2009
	 	 
	 	  	 
	File in DCU
when complete.

  

					
		  		  	***Confidential Treatment Requested

 DCU 
  

											
	CATALENT BULK FINISHED PRODUCT
SPECIFICATION	  	 	Page 1 of 3	  

  

									
	Specification
Number: [...***...] 	  	Version Number: 
[...***...]
	 Product Name: Dronabinol Capsules USP 5mg

	 Product Description: [...***...]

	 Synonyms: [...***...]

	 
	SAFETY /
HANDLING INFORMATION
	 Controlled Substance: x YES, specify schedule: 1

	 Compound Categorization Code: [...***...]

	 QC Small Quantity Handling Precautions: [...***...]

	 Storage Conditions: [...***...]

	SAMPLING /
EXPIRATION INFORMATION
	 Release Testing Sample Size: [...***...]
	  	Retain Size: [...***...]
	 Microbiological Testing Sample Size: [...***...]
	  	Microbiological Retain Size: 
[...***...]
	 Expiration Date Parameters: [...***...]

									
	TEST	  	METHOD	  	SPECIFICATION
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]	  	[...***...]

  

					
		  		  	***Confidential Treatment Requested

 DCU 
  

							
	 CATALENT BULK FINISHED PRODUCT SPECIFICATION
	  	Page 2 of
3

  

							
	 Specification Number: [...***...]
	  	Version Number: 
[...***...]
	 Product Name: Dronabinol Capsules USP 5mg

	 Product Description: [...***...]

	 	  	 	  	 [...***...]
	  	[...***...]
	 	  	 	  	 [...***...]
	  	[...***...]
	 	  	 	  	 [...***...]
	  	[...***...]
	 	  	 	  	 [...***...]
	  	[...***...]
	 	  	 	  	 [...***...]
	  	[...***...]
	 	  	 	  	 [...***...]
	  	[...***...]
	
[...***...]
	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	
[...***...]
	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]	  	[...***...]	  	[...***...]
	[...***...]
	 Formulations Signature: /s/
illegible
	  	Date: 21 Oct 2009

											
	
TEST
	  	 	METHOD	  	  	SPECIFICATION
	 Microbiological Testing : [...***...]

	[...***...]	  	 	[...***...]	  	  	[...***...]
	[...***...]	  	 	[...***...]	  	  	[...***...]
	[...***...]	  	 	[...***...]	  	  	[...***...]
	[...***...]	  	 	[...***...]	  	  	[...***...]
	[...***...]	  	 	[...***...]	  	  	[...***...]
	[...***...]	  	 	[...***...]	  	  	[...***...]
	[...***...]	  	 	 	 	  	 

  

					
		  		  	***Confidential Treatment Requested

 DCU 
  

											
	CATALENT BULK FINISHED PRODUCT
SPECIFICATION	  	 	Page 3 of 3	  

  

					
	Specification Number:
[...***...]	  	Version Number: [...***...]
	Product Name: Dronabinol Capsules USP 5mg	  	 
	Product Description: [...***...]	  	 
	[...***...]	  	 
	[...***...] 	  	 
	APPROVALS

	Prepared By Signature: /s/ Irene McGuffy	  	Date: 20 Oct 2009
	Formulations Signature: /s/ illegible	  	Date: 21 Oct 2009
	Microbiology Signature: /s/ Donna Fati	  	Date: 30 Oct 2009
	Analytical Services Signature: /s/ illegible	  	Date: 29 Oct 2009
	             
        Signature: N/A            /s/ DJL	  	Date: 04 Nov 2009
	QA Manager Signature (or Authorized Designee): /s/ David J. Lucas	  	Date: 04 Nov 2009
	Effective
date is date of last signature. File in DCU when complete.

  

					
		  		  	***Confidential Treatment Requested

 DCU 
  

					
	 CUSTOMER
APPROVAL SPECIFICATION FORM

	 Prepared By: Irena McGuffy

	
Customer Information

	
Customer Contact Name: Venkat Goskonda

	 
	
Company: Insys Therapeutics, Inc.

	 
	
Address:
 10220 South 51 Street
 Phoenix, AZ
85044

	 Specification: [...***...] 

	 Version Number:
[...***...]
	  	Supersedes: [...***...]
	 Material Name: Dronabinol Capsules USP 5mg

	 Material Description: [...***...]

	 [...***...] 

	
Approvals

	 	 
	 Customer Authorization: /s/
illegible
	  	Date: Oct. 20, 2009
	
File in DCU when complete.

  

					
		  		  	***Confidential Treatment Requested

 EXHIBIT B 

UNIT PRICING, FEES AND MINIMUM REQUIREMENT 
  

					
	UNIT PRICING
FOR PROCESSING
	 Refrigerated or
Room
 Temperature Product
	  	Dosage Form	  	Initial Unit Price*
	Dronabinol 2.5 mg	  	 Bulk Softgels
(theoretical
 batch size of [...***...] softgels)
	  	
$[...***...] per thousand shipped
 softgels

	Dronabinol 5 mg	  	 Bulk Softgels
(theoretical
 batch size of [...***...] softgels)
	  	
$[...***...] per thousand shipped
 softgels

	Dronabinol 10 mg	  	
Bulk Softgels (theoretical
 batch size of [...***...] softgels)
	  	 $[...***...] per thousand shipped
 softgels

  

	 	•	 	 The Unit Price for the six (6) initial process validation lots of the Refrigerated Product (three lots of the 5 mg strength, two lots of 2.5 mg
strength, and one lot of the 10 mg strength), but not for any process validation lots of the Room Temperature Product, will be [...***...] per thousand softgels for each strength. Within each Contract Year during the Initial Term, the then
Unit Price for Processing will be reduced by [...***...] percent ([...***...]%) for the incremental volume of bulk softgels exceeding [...***...] invoiced bulk softgels. For example, during the first Contract Year, the Unit Price
for incremental volume of bulk softgels exceeding [...***...] invoiced bulk softgels will be [...***...] per thousand softgels for each of the 2.5 mg and 5 mg strengths, and [...***...] per thousand softgels for the 10 mg strength.
Shipments of both Refrigerated Product and Room Temperature Product will be included in the calculation of the first [...***...] bulk softgels invoiced within each Contract Year. For the avoidance of doubt, the six initial process validation
lots of the Refrigerated Product will not be included in the calculation for the [...***...] bulk softgels invoiced in the first Contract Year. 

  

	 	•	 	 If any lot of API received by Catalent for Processing has a net weight below [...***...], Catalent will invoice Client for the lot of bulk
softgels manufactured with such API lot as follows: i) for resulting lots of the 2.5 mg and 5 mg strengths of bulk softgels, Catalent will invoice Client at the then current price for the number of shipped bulk softgels or for [...***...] bulk
softgels, whichever is greater; and ii) for resulting lots of the 10 mg strength of bulk softgels, Catalent will invoice Client at the then current price for the number of shipped bulk softgels or for [...***...] bulk softgels, whichever is
greater. 

  

					
		  	25	  	***Confidential Treatment Requested

					
	 UNIT PRICING FOR PACKAGING

 

	 Refrigerated or Room

Temperature Product
	 	 Packaging Configuration
	 	 Initial Unit Price

	 Dronabinol 2.5 mg
	 	Bottles	 	See Exhibit D
	 Dronabinol 5 mg
	 	Bottles	 	See Exhibit D
	 Dronabinol 10 mg
	 	Bottles	 	See Exhibit D

  

					
	 MINIMUM REQUIREMENT for PROCESSING (REFRIGERATED OR ROOM

TEMPERATURE PRODUCT COMBINED)

	     Contract Year    
	 	 Product/Dosage Form
	 	 Minimum Requirement (excluding
APMF)

	 Contract Year 1
	 	Bulk Softgels	 	$[...***...] of Processed Product
	 Contract Year 2
	 	Bulk Softgels	 	$[...***...] of Processed Product
	 Contract Year 3
	 	Bulk Softgels	 	$[...***...] of Processed Product
	 Contract Year 4
	 	Bulk Softgels	 	$[...***...] of Processed Product
	 Contract Year 5
	 	Bulk Softgels	 	$[...***...] of Processed Product

  

					
	 MINIMUM REQUIREMENT for PACKAGING (REFRIGERATED OR ROOM

TEMPERATURE PRODUCT COMBINED)

	     Contract Year    
	 	 Packaging Configuration
	 	 Minimum Requirement (excluding
APMF)

	 Contract Year 1
	 	Bottles	 	[...***...] 60-count Bottles
	 Contract Year 2
	 	Bottles	 	[...***...] 60-count Bottles
	 Contract Year 3
	 	Bottles	 	[...***...] 60-count Bottles
	 Contract Year 4
	 	Bottles	 	[...***...] 60-count Bottles
	 Contract Year 5
	 	Bottles	 	[...***...] 60-count Bottles

  

					
	ANNUAL PRODUCT MAINTENANCE FEES
	 APMF for Processing of Refrigerated Product
	 	$[...***...]	 	Per each Refrigerated Product strength
	 APMF for Processing of Room Temperature Product
	 	$[...***...]	 	Per each Room Temperature Product strength
	 APMF for Packaging of Refrigerated Product
	 	$[...***...]	 	Per each Refrigerated Product strength
	 APMF for Packaging of Room Temperature Product
	 	$[...***...]	 	Per each Room Temperature Product strength

  

					
		  	26	  	***Confidential Treatment Requested

			
	 PROJECT
MILESTONE FEE PAYABLE UPON SIGN-OFF OF THE PROCESS
VALIDATION REPORT FOR PROCESSING BY CATALENT AND CLIENT

	
$[...***...]

	  	Per each Refrigerated Product strength
	
$[...***...]
	  	Per each Room Temperature Product strength

  

					
		  	27	  	***Confidential Treatment Requested

 EXHIBIT C 

CLIENT SUPPLIED MATERIALS AND API SPECIFICATIONS 
 [To be attached] 

  
 28 

 DCU 
  

					
	Release Specification	 	 	  	Page 1 of 5
	Specification Number: [...***...]	 	Version Number: [...***...]
	Supersedes: [...***...]	 	[...***...]
	Material Category: [...***...]	 	Material Description; [...***...]
	Material Name: Dronabinol, USP	 	 

  

			
	 Chemical Name & CAS Registry No: [...***...]
	  	Synonyms: [...***...]
	
EMPIRICAL Formula: [...***...]
	  	Molecular Weight: [...***...]

  

					
	Item Number	  	Description	  	Vendor
	[...***...]	  	Dronabinol, USP	  	[...***...]
	 	 	 
	 	  	 	  	 
	 	 	 
	 	  	 	  	 
	 	  	 	  	 

  

			
	Safety / Handling Information
	 Compound Categorization Code: [...***...]
 QC Small Quantity Handling Precautions:
[...***...]
 Dronabinol is a schedule 1 controlled drug substance, handle accordingly.

	Storage Requirements: [...***...]	  	 
	Sampling /
Expiration Information
	Special Sample Requirements: [...***...]
	  	 
	[...***...]	  	[...***...]
	 Retest Date
Parameters: [...***...]
 Expiration Date Parameters: [...***...]
	  	 

  

							
	 Monograph legend:
	  	 	  	 	  	 
	 [...***...]
	  	[...***...]	  	[...***...]	  	[...***...]
	 [...***...]
	  	[...***...]	  	[...***...]	  	[...***...]
	 [...***...]
	  	[...***...]	  	[...***...]	  	[...***...]
	 [...***...]
	  	[...***...]	  	[...***...]	  	[...***...]

  

					
		  		  	***Confidential Treatment Requested

 DCU 
  

					
	 USP/NF Tests:
 ID Tests:
[...***...]
 Full Testing: [...***...]

Test requirements upon retest date: [...***...]

Note: [...***...]
	 	(e.g., “All,” or “Tests 1
through 4 and 7,” etc.)
	 Test
	 	Method	 	Specification
	
[...***...]
	 	[...***...]	 	[...***...]
	
[...***...]
	 	[...***...]	 	[...***...]
	
[...***...]
	 	[...***...]	 	[...***...]
	
[...***...]
	 	[...***...]	 	[...***...]
	
[...***...]
	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]
	 	 	[...***...]
	 	 	[...***...]
	 	 	[...***...]
	 	 	[...***...]
	 	 	[...***...]
	 	 	[...***...]
	 	 	[...***...]
	 	 	[...***...]
	 	 	[...***...]
	 	 	[...***...]

  

					
		  		  	***Confidential Treatment Requested

 DCU 
  

					
	Release
Specification	  	Page 3 of 
5
	
Specification Number: [...***...]
	  	Version Number: [...***...]
	
Supersedes: [...***...]
	  	[...***...]
	 Material
Category: [...***...]
	  	Material Description; [...***...]
	 Material Name: Dronabinol, USP

  

							
	Test	  	Method	  	Specification
	
[...*
***...]
	  	[...***...]	  	[...***...]
	
[...***...]
	  	[...***...]	  	[...***...]
	
[...***...]
	  	[...***...]	  	[...***...]
	
[...***...]
	  	[...***...]	  	[...***...]
	
[...***...]
	  	[...***...]	  	[...***...]
	
[...***...]
	  	[...***...]	  	[...***...]
	
[...***...]
	  	[...***...]	  	[...***...]
	
[...***...]
	  	[...***...]	  	[...***...]
	
[...***...]
	  	[...***...]	  	[...***...]
	
[...***...]
	  	[...***...]	  	[...***...]
	
[...***...]
	  	[...***...]	  	[...***...]
	
[...***...]
	  	[...***...]	  	[...***...]
	
[...***...]
	  	 	  	 

  

					
		  		  	***Confidential Treatment Requested

 DCU 
  

					
	 Release
Specification
	  	Page 4 of 5
	 Specification Number: [...***...]
	  	Version Number:
[...***...]
	 Supersedes: [...***...]
	  	[...****...]
	 Material Category: [...***...]
	  	Material Description;
[...****...]
	 Material Name: Dronabinol,
USP

  

	
	 History since last
Change:
  

[...***...]

  

					
		  		  	***Confidential Treatment Requested

 DCU 
  

							
	 Release
Specification
	  	 	Page 5 of 5	  
	
Specification Number: [...***...]
	  	Version Number: [...***...]	  
	
Supersedes: [...***...]
	  	[...***...]	  
	 Material
Category: [...***...]
	  	Material Description; [...***...]	  
	 Material Name: Dronabinol,
USP
	   

  

			
	
APPROVALS

	 Prepared
By: /s/ illegible
	  	Date: 13 Oct 2009
	 QCU
Manager or Authorized Designee: /s/ illegible
	  	Date: 15 Oct 2009
	
Microbiology Manager or Designee: /s/ Donna Fati
	  	Date: 16 Oct 2009
	 Optional
Approval : /s/ illegible
	  	Date: 21 Oct 2009
	 QAU
Manager or Authorized Designee: /s/ illegible
	  	Date: 21 Oct 2009
	
Effective date is date of last signature. File in DCU when complete.

  

					
		  		  	***Confidential Treatment Requested

 EXHIBIT D 

PACKAGING PRICING and QUOTATION 
 (AS FOLLOWS) 

 Catalent Pharma Solutions, LLC Quotation 

Dronabinal 2.5mg, 5mg and 10 mg 
 Tooling, Validation and Printed Components Prep Work 

QTE-PKG-1445.00 
 DC-LW 
 Confidential for Insys Therapeutics 

Prepared for Venkat Goskonda 
 10220 S. 51st
Street, Suite 2 
 Phoenix, AZ 85044 
 Phone: 602-910-2617 ext [...***...] 
 Prepared by: Louis Weiner 

Phone: [...***...] 
 November 7, 2010 
 

 
  
  

 
 3001 Red Lion Road Ÿ Philadelphia, PA 19114 
 Direct: (215) 613-3522 Ÿ Facsimile: (215) 613-3593 Ÿ www.catalent.com 

  

					
		  		  	***Confidential Treatment Requested

 Dear Venkat, 
 On behalf of Catalent Pharma Solutions, I am pleased to present the following proposal for preparations needed to package your Dronabinol bottles at Catalent’s Philadelphia, PA facility: 

Scope: Catalent Pharma Solutions to supply Tooling for bottles (3 strengths), Prep work and dies for printed components, and validation protocols
for approval. 
 Pricing: 
  

	 	•	 	 Validation- $
[...***...] 

 

	 	•	 	 Tooling-$ [...***...] 

  

	 	•	 	 Carton prep and plate-$ [...***...] 

  

	 	•	 	 Carton dies- $ [...***...] 

  

	 	•	 	 Insert prep and plate-$ [...***...] 

  

	 	•	 	 Label prep and plate-$ [...***...] 

  

	 	•	 	 Label dies- $ [...***...] 

  

	 	•	 	 Storage facility for [...***...] 

 Notes: 
  

	 	•	 	 Price quoted is good for [...***...] from date of quotation. 

 

	 	•	 	 [...***...] 

  

	 	•	 	 Customer is responsible for: 

  

	 	•	 	 providing an approved quotation and Purchase Order 

  

	 	•	 	 specifications and artwork 

Cancellation: 
 [...***...]

 We appreciate your interest in Catalent Pharma Solutions, LLC for this opportunity. Our ultimate goal at Catalent is to provide you with
quality, pharmaceutical experience and timeliness. Incorporating these values into our services has distinguished Catalent as a unique contract manufacturer and packager and true partner in the pharmaceutical development process. If you have any
questions concerning this quotation, please do not hesitate to contact me at [...***...] or [...***...]. 
 Sincerely, 

Catalent Pharma Solutions 
 

 
 Louis Weiner 

Account Director 
  

 
 3001 Red Lion Road Ÿ Philadelphia, PA 19114 
 Direct: (215) 613-3522 Ÿ Facsimile: (215) 613-3593 Ÿ www.catalent.com 

  

					
		  		  	***Confidential Treatment Requested

 Standard Terms and Conditions 
 The Standard Terms and Conditions attached to this Quotation as Exhibit 1 are incorporated herein by reference. In the event of a conflict between the terms of this Quotation and the attached Standard
Terms and Conditions, the Standard Terms and Conditions shall govern. 
 Project Approval and Authorization 

By signing below, Insys Therapuetics agrees to the project details as set forth in this Quotation, including the Terms and Conditions, which are attached
hereto and are a part of that quotation. 
  

					
	Insys Terapuetics	 		 	Catalent Pharma Solutions, LLC
			
	  	 		 	

	Signature	 		 	Signature
			
	  	 		 	Louis Weiner
	Printed Name	 		 	Printed Name
			
	  	 		 	Account Director
	Title	 		 	Title
			
	  	 		 	11/7/10
	Date	 		 	

 Please sign and return a copy of the Quotation Approval Page via fax to 

Louis Weiner at [...***...] or email to [...***...] 

 
  
 3001 Red Lion Road Ÿ Philadelphia, PA 19114 

Direct: (215) 613-3522 Ÿ Facsimile: (215) 613-3593 Ÿ www.catalent.com 

  

					
		  		  	***Confidential Treatment Requested

 Catalent Pharma Solutions, LLC Quotation 

Dronabinal DEA CIII Refrigeration Capacity 
 QTE-PKG-1429.02 
 KR 

Confidential for Insys Therapeutics 
 Prepared for Venkat Goskonda 
 10220 S. 51st Street, Suite 2 

Phoenix, AZ 85044 
 Phone: 602-910-2617 ext [...***...] 
 Prepared by: Louis Weiner 

Phone: [...***...] 
 November 10, 2010 
 

 
  
  

3001 Red Lion Road Ÿ Philadelphia, PA 19114 
 Direct: (215) 613-3522 Ÿ Facsimile: (215) 613-3593 Ÿ www.catalent.com 

  

					
		  		  	***Confidential Treatment Requested

 Dear Venkat, 
 On behalf of Catalent Pharma Solutions, I am pleased to present the following revised proposal for using and maintaining DEA CIII refrigerated space for your Dronabinol bottles at Catalent’s
Philadelphia, PA facility: 
 Scope: 
 Catalent will provide access to Insys to use existing CIII refrigerated cage ([...***...]). This will allow Insys to store up to [...***...] of bulk, WIP and finished goods in a DEA-approved
CIII refrigerated environment. The cage includes [...***...]. 
 As previously discussed with Insys, the construction and monthly rental
of this cage has been paid for by another Catalent customer (“Customer A”). Customer A has given permission to Catalent to let Insys use this cage when it is vacant and isn’t needed for upcoming production for Customer A. Insys
therefore agrees to pay [...***...]. 
 Insys acknowledges that Customer A will have “right of first refusal.” When scheduling
use of this refrigerated space, Customer A will take priority over Insys, and Insys production runs (including launch) may need to be rescheduled based on the availability of the CIII refrigerated cage. 

Project Management Fee (one time cost): 

$ [...***...] 
 Monthly Cost
(recurring): 
 $ [...***...] per month includes [...***...]. 
 Notes: 
  

	 	•	 	 Price quoted is good for [...***...] from date of quotation. 

 

	 	•	 	 Storage of bulk and finished goods will be at [...***...] (refrigerated). 

 

	 	•	 	 Product is a controlled substance (DEA Class III). 

  

	 	•	 	 Monthly storage charges will begin [...***...]. 

 

	 	•	 	 Monthly storage charges will apply for each month thereafter, until [...***...] 

 

	 	•	 	 Customer is responsible for: 

  

	 	•	 	 providing an approved quotation and Purchase Order 

 Cancellation: 
 [...***...] 

 
  
 3001 Red Lion Road Ÿ Philadelphia, PA 19114 

Direct: (215) 613-3522 Ÿ Facsimile: (215) 613-3593 Ÿ www.catalent.com 

  

					
		  		  	***Confidential Treatment Requested

 We appreciate your interest in Catalent Pharma Solutions, LLC for this opportunity. Our ultimate goal at
Catalent is to provide you with quality, pharmaceutical experience and timeliness. Incorporating these values into our services has distinguished Catalent as a unique contract manufacturer and packager and true partner in the pharmaceutical
development process. If you have any questions concerning this quotation, please do not hesitate to contact me at [...***...] or [...***...]. 
 Sincerely, 
 Catalent Pharma Solutions 
 

 
 Louis Weiner 

Account Director 
  

 
  
 3001 Red Lion Road Ÿ Philadelphia, PA 19114 

Direct: (215) 613-3522 Ÿ Facsimile: (215) 613-3593 Ÿ www.catalent.com 

  

					
		  		  	***Confidential Treatment Requested

 Standard Terms and Conditions 
 The Standard Terms and Conditions attached to this Quotation as Exhibit 1 are incorporated herein by reference. In the event of a conflict between the terms of this Quotation and the attached Standard
Terms and Conditions, the Standard Terms and Conditions shall govern. 
 Project Approval and Authorization 

By signing below, Insys Therapuetics agrees to the project details as set forth in this Quotation, including the Terms and Conditions, which are attached
hereto and are a part of that quotation. 
  

					
	 Insys Terapuetics
	 		 	Catalent Pharma Solutions, LLC
			
	  	 		 	

	 Signature
	 		 	Signature
			
	  	 		 	                Louis Weiner
	 Printed Name
	 		 	Printed Name
			
	  	 		 	                Account Director
	 Title
	 		 	Title
			
	  	 		 	                11/10/10
	 Date
	 		 	

 Please sign and return a copy of the Quotation Approval Page via fax to 

Louis Weiner at [...***...] or email to [...***...] 

 
  
  

3001 Red Lion Road Ÿ Philadelphia, PA 19114 
 Direct: (215) 613-3522 Ÿ Facsimile: (215) 613-3593 Ÿ www.catalent.com 

  

					
		  		  	***Confidential Treatment Requested

 Catalent Pharma Solutions, LLC Quotation 

Dronabinal 2.5mg, 5mg and 10 mg 60 Count Bottles 
 QTE-PKG-1378.01 
 081006A/B/C/D 

Confidential for Insys Therapeutics 
 Prepared for Venkat Goskonda 
 10220 S. 51st Street, Suite 2 

Phoenix, AZ 85044 

Phone: 602-910-2617 ext [...***...] 
 Prepared by: Louis Weiner 
 Phone: [...***...] 

Revised November 21, 2010 
 

 
  
  

 
 3001 Red Lion Road Ÿ Philadelphia, PA 19114 
 Direct: (215) 613-3522 Ÿ Facsimile: (215) 613-3593 Ÿ www.catalent.com 

  

					
		  		  	***Confidential Treatment Requested

 Dear Venkat, 
 On behalf of Catalent Pharma Solutions, I am pleased to present the following revised proposal for packaging your Dronabinol bottles at Catalent’s Philadelphia, PA facility: 

MATERIALS: 

[...
***...] 
 Catalent Pharma Solutions to supply: 

[...***...] 
 Assembly: 

[...***...] 
 Pricing: 

 

					
	Total Quantity
Per Campaign
(bottles)	  	Strengths	  	Price per bottle
	[...***...]	  	10mg ([...***...])	  	$ [...***...]
	[...***...]	  	2.5mg ([...***...])	  	$ [...***...]
	[...***...]	  	5mg ([...***...])	  	$ [...***...]
	[...***...]	  	2.5mg ([...***...])	  	$ [...***...]
	[...***...]	  	5mg ([...***...])	  	$ [...***...]
	[...***...]	  	2.5mg ([...***...]) & 5mg ([...***...])	  	$ [...***...]
	[...***...]	  	2.5mg ([...***...]), 5mg ([...***...]) & 10mg
([...***...])	  	$ [...***...]
	[...***...]	  	2.5mg ([...***...]) & 5mg ([...***...])	  	$ [...***...]
	[...***...]	  	2.5mg ([...***...]), 5mg ([...***...]) & 10mg
([...***...])	  	$ [...***...]
	[...***...]	  	2.5mg ([...***...]) & 5mg ([...***...])	  	$ [...***...]
	[...***...]	  	2.5mg ([...***...]), 5mg ([...***...]) & 10mg
([...***...])	  	$ [...***...]

  
  

 
 3001 Red Lion Road Ÿ Philadelphia, PA 19114 
 Direct: (215) 613-3522 Ÿ Facsimile: (215) 613-3593 Ÿ www.catalent.com 

  

					
		  		  	***Confidential Treatment Requested

 Additional cost items: 

 

	 	•	 	 Validation- $
[...***...] 

 

	 	•	 	 Project Management and Engineering- Standard Project Management and Engineering will be provided at [...***...]. 

 

	 	•	 	 Dedicated Customer Service team will be provided to manage your account. 

 

	 	•	 	 Slugs- $[...***...]. 

  

	 	•	 	 Lot change charges – $[...***...]. 

 Notes: 
  

	 	•	 	 Price quoted is good for [...***...] from date of quotation. 

 

	 	•	 	 Pricing is based on a minimum lot size of [...***...] softgels for [...***...], and [...***...]. softgels for [...***...].

  

	 	•	 	 Tooling and prep, plate and dies were quoted under a separate quote (QTE-PKG-1445.00). 

 

	 	•	 	 Refrigerated storage was quoted under a separate quote (QTE-PKG-1429.02). 

 

	 	•	 	 [...***...]. 

  

	 	•	 	 Storage of bulk and finished goods will be at [...***...]. 

 

	 	•	 	 Product is a controlled substance (DEA Class III). 

  

	 	•	 	 Customer is responsible for: 

  

	 	•	 	 providing a rolling twelve (12) month forecast to Catalent. 

 

	 	•	 	 providing an approved quotation and Purchase Order 

  

	 	•	 	 specifications and artwork 

Cancellation: 
 [...***...].

 We appreciate your interest in Catalent Pharma Solutions, LLC for this opportunity. Our ultimate goal at Catalent is to provide you with
quality, pharmaceutical experience and timeliness. Incorporating these values into our services has distinguished Catalent as a unique contract manufacturer and packager and true partner in the pharmaceutical development process. If you have any
questions concerning this quotation, please do not hesitate to contact me at [...***...] or [...***...]. 
  

	
	Sincerely,
	
	Catalent Pharma Solutions
	

	Louis Weiner
	Account Director

  
  
  

 
 3001 Red Lion Road Ÿ Philadelphia, PA 19114 
 Direct: (215) 613-3522 Ÿ Facsimile: (215) 613-3593 Ÿ www.catalent.com 

  

					
		  		  	***Confidential Treatment Requested

 Standard Terms and Conditions 
 The Standard Terms and Conditions attached to this Quotation as Exhibit 1 are incorporated herein by reference. In the event of a conflict between the terms of this Quotation and the attached Standard
Terms and Conditions, the Standard Terms and Conditions shall govern. 
 Project Approval and Authorization 

By signing below, Insys Therapuetics agrees to the project details as set forth in this Quotation, including the Terms and Conditions, which are attached
hereto and are a part of that quotation. 
  

					
	Insys Terapuetics	 		 	Catalent Pharma Solutions, LLC
			
	  	 		 	

	Signature	 		 	Signature
			
	  	 		 	Louis Weiner
	Printed Name	 		 	Printed Name
			
	  	 		 	Account Director
	Title	 		 	Title
			
	  	 		 	11/21/10
	Date	 		 	

 Please sign and return a copy of the Quotation Approval Page via fax to 

Louis Weiner at [...***...] or email to [...***...] 

 
  
 3001 Red Lion Road Ÿ Philadelphia, PA 19114 

Direct: (215) 613-3522 Ÿ Facsimile: (215) 613-3593 Ÿ www.catalent.com 

  

					
		  		  	***Confidential Treatment RequestedManufacturing Agreement

 Exhibit 10.14 
 ***Text Omitted and Filed Separately 
 with the Securities and Exchange
Commission. 
 Confidential Treatment Requested 
 Under 17 C.F.R. Sections 200.80(b)(4) 
 and 230.406 

MANUFACTURING AGREEMENT 
 DPT LAKEWOOD, LLC 
 AND 

INSYS THERAPEUTICS 
 Table of Contents 
  

											
	 I - DEFINITIONS
	  	 	4	  
					
		 	 1.1
	 		  	ACT	  	 	4	  
		 	 1.2
	 		  	FDA	  	 	4	  
		 	 1.3
	 		  	FORECASTED NEEDS	  	 	4	  
		 	 1.4
	 		  	LABEL, LABELED, OR LABELING	  	 	5	  
		 	 1.5
	 		  	MANUFACTURING FEE	  	 	5	  
		 	 1.6
	 		  	LAUNCH YEAR	  	 	5	  
		 	 1.7
	 		  	MATERIALS FEE	  	 	5	  
		 	 1.9
	 		  	PACKAGING	  	 	6	  
		 	 1.10
	 		  	PRODUCT(S)	  	 	6	  
		 	 1.11
	 		  	SPECIFICATIONS	  	 	6	  
		
	 II - PRODUCT MANUFACTURE AND SUPPLY
	  	 	6	  
					
		 	 2.1
	 		  	MANUFACTURE AND PURCHASE	  	 	6	  
		 	 2.2
	 		  	SUPPLY OF MATERIALS	  	 	7	  
		 		 	 (a)
	  	Materials Supplied by COMPANY	  	 	7	  
		 		 	 (b)
	  	Materials Supplied by DPT	  	 	8	  
		 		 	 (c)
	  	Packaging and Labeling	  	 	8	  
		 	 2.3
	 		  	MATERIALS TESTING	  	 	8	  
		 	 2.4
	 		  	MATERIAL SAFETY DATA SHEETS	  	 	9	  
		 	 2.5
	 		  	COMMENCEMENT OF MANUFACTURING FOR NEW PRODUCTS	  	 	9	  
		 	 2.6
	 		  	PURCHASE ORDERS	  	 	9	  
		 		 	 (a)
	  	 Purchase of Products
	  	 	9	  
		 		 	 (b)
	  	 Forecasted Needs
	  	 	9	  
		 		 	 (c)
	  	 Time of Issuance
	  	 	10	  
		 		 	 (d)
	  	 Contents of Purchase Orders
	  	 	10	  
		 	 2.7
	 		  	REJECTED PRODUCTS	  	 	11	  
		 		 	 (a)
	  	Rejection of Product by COMPANY	  	 	11	  
		 		 	 (b)
	  	Replacement of Rejected Product	  	 	11	  
		 		 	 (c)
	  	Responsibility for Costs	  	 	11	  
		 		 	 (d)
	  	Resolution of Conflict	  	 	12	  
		 	 2.8
	 		  	PRODUCT PRICE	  	 	13	  
		 		 	 (a)
	  	Manufacturing Fees	  	 	13	  
		 		 	 (b)
	  	Materials Fees	  	 	13	  
		 	 2.9
	 		  	PAYMENT	  	 	14	  
		 	 2.10
	 		  	LATE PAYMENT	  	 	14	  
		 	 2.11
	 		  	DISPOSAL COSTS	  	 	15	  

							
	 III - SHIPMENT AND RISK OF LOSS
	  	 	15	  
			
	 3.1
	 	SHIPMENT	  	 	15	  
	 3.2
	 	DELIVERY TERMS	  	 	15	  
	 3.3
	 	CLAIMS	  	 	15	  
		
	 IV - TERM AND TERMINATION
	  	 	16	  
			
	 4.1
	 	TERM	  	 	16	  
	 4.2
	 	TERMINATION	  	 	16	  
	 4.3
	 	PAYMENT ON TERMINATION	  	 	16	  
	 4.4
	 	SURVIVAL	  	 	16	  
		
	 V - CERTIFICATES OF ANALYSIS AND MANUFACTURING COMPLIANCE
	  	 	17	  
			
	 5.1
	 	CERTIFICATES OF ANALYSIS	  	 	17	  
	 5.2
	 	STABILITY TESTING	  	 	17	  
	 5.3
	 	VALIDATION WORK OR ADDITIONAL TESTING	  	 	17	  
	 5.4
	 	FDA INSPECTION	  	 	17	  
	 5.5
	 	REGULATORY FILINGS	  	 	18	  
		
	 VI - WARRANTIES
	  	 	18	  
			
	 6.1
	 	CONFORMITY WITH SPECIFICATIONS	  	 	18	  
	 6.2
	 	COMPLIANCE WITH THE ACT	  	 	18	  
	 6.3
	 	CONFORMITY WITH FDA REGULATIONS AND CGMP’S	  	 	18	  
	 6.4
	 	COMPLIANCE OF PACKAGING AND LABELING WITH LAWS AND
REGULATIONS	  	 	18	  
	 6.5
	 	ACCESS TO DPT’S FACILITIES	  	 	19	  
	 6.6
	 	DISCLAIMER	  	 	19	  
		
	 VII - FORCE MAJEURE
	  	 	19	  
		
	 VIII - CHANGES TO PROCESS OR PRODUCT
	  	 	20	  
			
	 8.1
	 	CHANGES BY COMPANY	  	 	20	  
	 8.2
	 	CHANGES BY DPT	  	 	20	  
	 8.3
	 	CHANGES BY REGULATORY AUTHORITIES	  	 	20	  
	 8.4
	 	OBSOLETE INVENTORY	  	 	21	  
		
	 IX - CONFIDENTIAL INFORMATION
	  	 	21	  
			
	 9.1
	 	CONFIDENTIAL INFORMATION	  	 	21	  
	 (a)
	 	Obligations of Confidentiality	  	 	21	  
	 (b)
	 	Exceptions	  	 	22	  
	 (c)
	 	DPT Business Model	  	 	22	  
	 9.2
	 	TRADEMARKS AND TRADE NAMES	  	 	22	  
	 9.3
	 	INVENTIONS AND PATENTS	  	 	23	  
		
	 Section 8 regarding Collaborative Efforts of the Research and Development Services Agreement between DPT and COMPANY dated
April 17, 2009, is hereby incorporated in its entirety by its reference and shall remain in effect for the term of this Agreement.
	  	 	23	  
		
	 X - RESEARCH & DEVELOPMENT SERVICES
	  	 	23	  
			
	 10.1
	 	R&D SERVICES	  	 	23	  
	 (a)
	 	Research Products	  	 	23	  
	 (b)
	 	Project Protocol	  	 	23	  
	 (c)
	 	Costs	  	 	24	  
	 (d)
	 	Obsolete Inventory	  	 	24	  
		
	 XI - INDEMNIFICATION
	  	 	25	  
			
	 11.1
	 	INDEMNIFICATION BY DPT	  	 	25	  
	 11.3
	 	INDEMNIFICATION BY COMPANY	  	 	25	  

  
 2 

							
	 11.6
	 	PATENT AND OTHER INTELLECTUAL PROPERTY RIGHTS	  	 	26	  
	 (a)
	 	Warranty by COMPANY	  	 	26	  
	 (b)
	 	Warranty by DPT	  	 	26	  
	 11.7
	 	CONDITIONS OF INDEMNIFICATION	  	 	26	  
		
	 XII - GENERAL PROVISIONS
	  	 	27	  
			
	 12.1
	 	NOTICES	  	 	27	  
	 12.2
	 	ENTIRE AGREEMENT; AMENDMENT	  	 	27	  
	 12.3
	 	WAIVER	  	 	28	  
	 12.4
	 	OBLIGATIONS TO THIRD PARTIES	  	 	28	  
	 12.5
	 	ASSIGNMENT	  	 	28	  
	 12.6
	 	GOVERNING LAW AND ARBITRATION	  	 	28	  
	 (a)
	 	Governing Law	  	 	28	  
	 (b)
	 	Arbitration	  	 	28	  
	 (c)
	 	Mediation	  	 	30	  
	 (d)
	 	Costs	  	 	32	  
	 12.7
	 	SEVERABILITY	  	 	32	  
	 12.8
	 	HEADINGS, INTERPRETATION	  	 	32	  
	 12.9     COUNTERPARTS
	  	 	32	  
	 12.10   INDEPENDENT CONTRACTOR
	  	 	32	  

  
 3 

 This Manufacturing Agreement (the “Agreement”) is made as of
this 24th day of May, 2011 (the “Effective Date”) by and between Insys Therapeutics, a corporation organized under the laws of the State of Delaware with its principal place of business at 10220 South 51st Street, Suite 2, Phoenix, AZ 85044 (hereinafter referred to as
“COMPANY”) and DPT Lakewood, LLC, a corporation organized under the laws of the State of Delaware with a place of business at 1200 Paco Way, Lakewood, New Jersey, 08701, including its affiliate DPT Laboratories, Ltd. (hereinafter
collectively referred to as “DPT”). 
 WITNESSETH: 

WHEREAS, COMPANY is engaged in the distribution and sale of certain pharmaceutical and/or cosmetic products; and 

WHEREAS, DPT owns and has a broad spectrum of technologies for the development, formulation, testing, control, manufacture,
filling and distribution of pharmaceutical, over-the-counter and cosmetic products; and 
 WHEREAS, COMPANY desires DPT
to manufacture and sell the Products hereinafter defined to COMPANY, and DPT desires to do so. 
 NOW, THEREFORE, in
consideration of the mutual covenants hereinafter expressed, the parties agree as follows: 
 I—DEFINITIONS

  

	1.1	Act 

 “Act”
means the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. 
  

	1.2	FDA 

 “FDA”
means the United States Food and Drug Administration, or any successor entity thereto. 
  

	1.3	Forecasted Needs 

“Forecasted Needs” means COMPANY’s estimate of Products to be ordered from DPT for each of the eighteen (18) months
following the month in which such estimate is provided. 

  
 4 

	1.4	Label, Labeled, or Labeling 

 “Label”, “Labeled”, or “Labeling” means all labels and other written, printed, or graphic matter upon: (i) Product or any container or wrapper utilized with Product or
(ii) any written material accompanying Product. 
  

	1.5	Manufacturing Fee 

“Manufacturing Fee” means the fee paid by COMPANY to DPT for services required to manufacture and package Products. The
Manufacturing Fee is quoted in single final Product unit increments (i.e. by the bottle or tube). The Manufacturing Fee shall include services for incoming inspection and testing of materials, compounding of bulk, packaging Product, testing Product
for release, making Product ready for shipment, and minimum product documentation (one copy of Certificate of Analysis.) The Manufacturing Fee does not include, without limitation, any research & development support, package engineering
studies, validation support, FDA audit support, extensive reporting requirements, or additional laboratory testing performed by an outside testing laboratory or testing beyond that required in the Specifications. These services are in addition to
the Manufacturing Fee and shall be billed by the hour at DPT’s then-prevailing R&D hourly rate in accordance with Section XI contained herein. In addition, the Manufacturing Fee does not include warehousing or distribution of Product, any
materials costs or costs associated with establishing or manufacturing new materials such as art charges, die costs, plate costs, and packaging equipment change parts. 
  

	1.6	Launch Year 

 “Launch
Year” means a period of a variable number of months commencing on the first day of the month following the initial invoicing of Product which has been commercially manufactured by DPT in accordance with the terms and conditions of this
Agreement and ending on December 31 of the year of the initial invoicing. 
  

	1.7	Materials Fee 

“Materials Fee” is quoted in single final Product unit increments and is defined as DPT’s Standard Cost (“Standard
Cost” is the average actual cost to DPT of materials plus incoming freight, scrap/yield loss adjustments and any other recurring costs directly attributable to acquiring the material) [...***...] for administration and carrying costs.
Materials Fee does not include, without limitation, costs associated with establishing, testing or manufacturing components or new materials such as reference standards, reagents, art charges, die costs, mold or tooling

  

					
		  	5	  	***Confidential Treatment Requested

 
costs, plate costs, and packaging equipment change parts. These items will be invoiced to COMPANY at DPT’s cost on a net thirty (30) basis and COMPANY agrees to reimburse DPT for any
such authorized expenditures made on COMPANY’s behalf. 
  

	1.8	Material Safety Data Sheet 

“Material Safety Data Sheet” (“MSDS”) means written or printed material concerning a hazardous chemical which is
prepared in accordance with the regulations promulgated by the Occupational Safety & Health Administration, or any successor entity thereto. 
  

	1.9	Packaging 

“Packaging” means all primary containers, cartons, shipping cases, inserts or any other like material used in packaging, or
accompanying, Product. 
  

	1.10	Product(s) 

“Product(s)” means product(s) (as listed in Schedule A) manufactured, packaged, labeled and/or finished by DPT to meet the
Specifications (as hereinafter defined). 
  

	1.11	Specifications 

“Specifications” means the (i) raw material specifications (including chemical, micro, and packaging specifications);
(ii) sampling requirements (i.e., lab, chemical, and micro); (iii) compounding module, including compounding process and major equipment; (iv) intermediate specifications; (v) packaging module (including packaging procedures,
torque and fill weights); and (vi) finished Product specifications release criteria including DPT’s Acceptable Quality Limits (“AQL’s”). Specifications shall be established and/or amended from time to time upon the written
agreement of both DPT and COMPANY via a Change Control Request (“CCR”) in accordance with Section IX below. 

II—PRODUCT MANUFACTURE AND SUPPLY 
  

	2.1	Manufacture and Purchase 

Subject to the terms and conditions of this Agreement, DPT agrees that it will manufacture for and provide to COMPANY, and COMPANY agrees
that it will purchase from DPT, one hundred percent (100%) of the 

  
 6 

 
COMPANY’s requirements of the Products. COMPANY shall pay DPT for Products according to paragraph 2.8 below. DPT shall manufacture Products in accordance with the Specifications or pursuant
to exceptions approved by COMPANY, and in sufficient quantity to meet COMPANY’s Forecasted Needs for the length of this Agreement. 
  

	2.2	Supply of Materials 

  

	 	(a)	Materials Supplied by COMPANY 

 If COMPANY is to supply any material for manufacture of Products as set forth under this Section, COMPANY shall notify DPT, in writing, specifying which materials it will supply. COMPANY shall provide DPT
with said materials at COMPANY’s expense along with Certificates of Analysis and MSDS sheets relating to same, at a minimum of thirty (30) days prior to DPT’s scheduled production of Product requiring said materials and in sufficient
amounts for DPT’s manufacture of Product but not to exceed quantities necessary to support four (4) months of the most recently supplied Forecasted Needs or the minimum order quantity whichever is greater. COMPANY supplied material in
excess of these amounts shall be either subject to storage fees or returned to COMPANY. All COMPANY supplied material shall be shipped to DPT freight prepaid. In the event COMPANY ships or causes to ship such material freight collect, DPT shall
invoice COMPANY for the cost of the freight plus a reasonable administrative fee which invoice shall be paid promptly upon receipt. DPT is hereby authorized by COMPANY to return any portion of COMPANY supplied material for which no future production
is planned. COMPANY shall be responsible for the quality of all COMPANY-supplied materials. COMPANY shall be responsible for the payment of all personal property and other taxes incident to the storage of COMPANY-owned material at DPT. For each lot
of materials supplied by COMPANY, DPT shall perform the quality control and inspection tests as agreed to in the Specifications unless COMPANY has made arrangements in writing for pre-approved material. DPT shall have the right to reject any
pre-approved material which does not meet the Specifications in accordance with paragraph 2.3 below. DPT warrants that it will maintain, for the benefit of COMPANY, complete and accurate records of the inventory of all such COMPANY-supplied
materials. If requested by COMPANY, DPT will provide to COMPANY a monthly report of ending monthly inventory balance of each COMPANY supplied/owned materials stored at DPT. This reporting will be supplied exclusively on DPT forms. 

  
 7 

	 	(b)	Materials Supplied by DPT 

 DPT shall be responsible for supply, at the expense of COMPANY of all other commodities necessary for the manufacture of Products. All DPT supplied materials will be billed to COMPANY on the respective
invoice for Product, into which the DPT supplied materials was converted, as part of the Materials Fee, and in addition to the Manufacturing Fee, all in accordance with the provisions of paragraph 2.8 below. 

 

	 	(c)	Packaging and Labeling 

 COMPANY shall provide DPT with Specifications (including art proofs) for Packaging and Labeling, and DPT shall purchase, at the expense of COMPANY, Packaging and Labeling in accordance with the
Specifications. 
  

	 	(d)	Additional Charges 

COMPANY shall be responsible for any additional charges (including, but not limited to, items such as brokerage fees, courier expenses,
duty fees payable, etc.) that are incurred in the procurement of any materials and/or Packaging and Labeling components as detailed in the immediately preceding sub-sections (a), (b) and (c); required for the manufacture of the Products,
irrespective of which party to the Agreement is responsible for supplying such items. 
  

	 	(e)	Safety Stock 

 At
least annually, and more frequently depending on business conditions, COMPANY shall determine and inform DPT of the level of safety stock inventory for API and Materials, by Product, that DPT shall hold in its warehouse. COMPANY shall pay for such
safety stock inventory for API and Materials and associated storage fee as agreed upon in writing between the parties. 
  

	2.3	Materials Testing 

 All
materials and packaging supplies shall, when received by DPT, be submitted to analysis and evaluation in accordance with DPT’s SOP’s to determine whether or not said materials meet the Specifications. The

  
 8 

 
cost of all such analyses and evaluations shall be borne by DPT, except as otherwise provided in paragraph 2.2 of this Agreement. DPT agrees to maintain and, if necessary, make available records
of all such analyses and evaluations. 
  

	2.4	Material Safety Data Sheets 

 Prior to DPT’s receipt and testing, and as a condition precedent of any testing or formulation work by DPT pursuant to this Agreement, COMPANY shall provide MSDS sheets to DPT for finished products
and all components necessary for the manufacture of Products. Any components or Products requiring disposal shall be presumed hazardous unless otherwise provided in the MSDS information provided. 

 

	2.5	Commencement of Manufacturing for New Products 

 No later than four (4) months prior to the initial calendar year of a new Product added to this Agreement, COMPANY agrees to notify DPT of its delivery requirements, including firm orders for same,
for the four (4) months and shall provide its Forecasted Needs for the first calendar year in order to ensure timely delivery of Product for initial sale and marketing. 

 

	2.6	Purchase Orders 

  

	 	(a)	Purchase of Products 

 COMPANY agrees to purchase from DPT all Products manufactured for COMPANY by DPT in accordance with COMPANY’s purchase orders or Forecasted Needs to the extent such Products meet the Specifications
or exceptions approved by COMPANY. Products shall be ordered by COMPANY by the issuance of separate, pre-numbered purchase orders in increments of full batches and in minimum order quantities. 

 

	 	(b)	Forecasted Needs 

 COMPANY shall provide DPT with a written, non-binding eighteen (18) month projection with specific data as to its Forecasted Needs. Such Forecasted Needs shall be updated by COMPANY monthly on or
before the 10th day of each calendar month on a rolling
eighteen (18) month basis. It is understood and agreed that with respect to all Forecasted Needs issued to DPT by COMPANY pursuant to the terms hereof, the forecast for the first four (4) months thereof shall constitute a firm order for
Products, regardless of receipt of COMPANY’s actual purchase order. Thereafter, 

  
 9 

 
COMPANY shall provide DPT with a Purchase Order on or before the
10th day of each calendar month. DPT may produce Product
up to thirty (30) days prior to the requested delivery date in order to accommodate fluctuations in production demands. The remaining fourteen (14) months of the Forecasted Needs shall be utilized by DPT for purposes of material
acquisition on behalf of COMPANY and DPT production planning. DPT shall attempt to minimize the material inventory purchased on behalf of COMPANY. Certain materials, however, may have long lead times and/or require a minimum order quantity.
Therefore, DPT may order the chemical and packaging components necessary to support up to six (6) months of COMPANY’s Forecasted Needs, or the applicable minimum order quantity, whichever is greater. Should COMPANY subsequently reduce its
Forecasted Needs, COMPANY will be financially responsible for any material purchased by DPT on COMPANY’s behalf. Any such material which is subsequently rendered in excess of that required to support up to six (6) months of COMPANY’s
Forecasted Needs may be subject to storage and inventory caring fees. DPT may require a deposit for such materials and such materials may also be subject to storage and inventory carrying cost fees. 

 

	 	(c)	Time of Issuance 

COMPANY shall issue written purchase orders for Products to DPT at least one hundred twenty (120) days prior to the requested
delivery dates if the requirements are at or below one hundred twenty-five percent (125%) of the applicable Forecasted Needs, and at least one hundred fifty (150) days prior to the requested delivery dates if the requirements exceed the
Forecasted Needs by more than one hundred twenty-five percent (125%). 
  

	 	(d)	Contents of Purchase Orders 

 COMPANY’s purchase orders shall designate the desired quantities of Products, delivery dates and destinations. This Agreement allows for up to three (3) shipping destinations per batch of
Product. Additional destinations can be accommodated for a shipping preparation fee to be negotiated by DPT and COMPANY. 

  
 10 

	2.7	Rejected Products 

  

	 	(a)	Rejection of Product by COMPANY 

 COMPANY may reject any Product which fails to meet the Specifications, provided that such failure impairs the safety or efficacy of the Product (“Rejected Product”). COMPANY shall, within twenty
(20) days after its receipt of any shipment of Product and related Certificate of Analysis of Product batch (as described in paragraph 5.1 hereof), notify DPT in writing of any claim relating to rejected Product batch and, failing such
notification, shall be deemed to have accepted such Product batch. Such notice to DPT shall specify why the Product batch failed to perform to Specifications. COMPANY shall grant to DPT the right to inspect or test said Product batch. All Products
shall be submitted to inspection and evaluation in accordance with DPT’s SOP’s to determine whether or not said Products meet the Specifications. 
  

	 	(b)	Replacement of Rejected Product 

 As to any Rejected Product pursuant to paragraph 2.7(a) above (including phases of or complete batches of bulk product), DPT shall replace such Rejected Product (in an agreed upon batch order quantity,
but in no event less than full batch increments) promptly after all materials are available to DPT for the manufacture. If requested, DPT shall make arrangements with COMPANY for the return or disposal of Rejected Product. 

 

	 	(c)	Responsibility for Costs 

 For the initial three (3) commercial batches and all validation batches of a Product produced by DPT, or in the event a Rejected Product is due to COMPANY supplied information, formulations or
materials, COMPANY shall bear one hundred percent (100%) of all costs directly related to and invoiced for Rejected Product including cost of destruction of the Rejected Product, which shall be conducted by COMPANY in accordance with all
applicable laws and regulations. Upon the completion of all necessary validation batches and in the event a validated Product is rejected due to DPT’s failure to follow cGMP’s and/or comply with applicable written procedures and such
failure renders the Product unmarketable, DPT shall bear one hundred percent (100%) of the manufacturing fees, costs of all materials (except for the Aptar device) supplied by DPT and cost of destruction. [...***...]. In the

  

					
		  	11	  	***Confidential Treatment Requested

 
event a validated Product does not meet final Specifications and results in a Rejected Product, but such failure is not due to either COMPANY supplied information or DPT’s failure to follow
written procedures, the COMPANY shall bear all Materials Fees with DPT bearing all Manufacturing Fees related to Rejected Product, and with destruction to be paid by the COMPANY. Destruction of Rejected Product shall be in accordance with all
applicable laws and regulations and the party conducting the destruction shall indemnify the other party hereto for any liability, costs or expenses, including attorney’s fees and court costs, relating to a failure to dispose of such Product in
accordance with such laws and regulations. The party conducting the destruction shall also provide to the other party hereto all manifests and other applicable evidence of proper destruction as may be requested by applicable law. 

 

	 	(d)	Resolution of Conflict 

 In the event of a conflict between the test results of DPT and the test results of COMPANY with respect to any shipment of Product batch, a sample of such Product batch shall be submitted by DPT to an
independent laboratory or recognized industry expert acceptable to both parties for testing against the Specifications utilizing the methods set out in the Specifications. The fees and expenses of such laboratory testing shall be borne entirely by
the party against whom such laboratory’s findings are made. If results from the independent laboratory are inconclusive, final resolution will be settled in accordance with paragraph 12.6 (b) below. 

 

	 	(e)	Recalled Product 

In the event (I) any government authority issues a request, directive or administrative order that Product be recalled, or
(ii) a court of competent jurisdiction orders a Product recall, or (iii) the COMPANY reasonably determines that the Product should be recalled, the parties shall take all appropriate corrective actions which are reasonable under the
circumstances. In the event that such recall results solely from the breach of DPT’s warranties under this Agreement, DPT shall be responsible for the administrative expenses of the recall in any case not to exceed [...***...] per recall
incident as well as for the cost of replacing the recalled Product. In the event the recall results from the breach of COMPANY’s warranties under this Agreement, COMPANY shall be responsible for all of the expenses of the recall. For the
purposes of this Agreement, administrative expenses of the recall shall be the expenses of notification, destruction or return of the recalled Product; including 

  

					
		  	12	  	***Confidential Treatment Requested

 
any reasonable out-of-pocket costs incurred by the parties in connection with any corrective action. 
  

	2.8	Product Price 

  

	 	(a)	Manufacturing Fees 

The initial Manufacturing Fees to be paid by COMPANY to DPT are listed in Schedule A. The parties hereto agree that the Manufacturing Fees
set out in Schedule A shall be re negotiated, in good faith, at the beginning of each calendar year. If the parties are unable to agree on a re-negotiated price at least thirty (30) days prior to the start of a new twelve (12) month
period, then this Agreement, effective the first day of January of the new twelve (12) month period, shall continue in force with prices being adjusted to reflect the change in the most recently published monthly “Producer Price Index for
Pharmaceutical Preparation Manufacturing”, issued by the Bureau of Labor Statistics, US Department of Labor (“PPI”), or comparable successor index, in July of the preceding year as compared to the same month of the year prior thereto
until such time as to when price negotiation can be completed. 
 In addition, Manufacturing Fees are based on annual volumes for
Products. DPT reserves the right to re-evaluate Manufacturing Fees at the beginning of the second calendar year (and each calendar year thereafter) in the event that actual volumes differ from those volumes listed in Schedule A. by more than ten
percent (10%). 
 Prices for new Products or new Product sizes, new batch sizes or product configuration changes not initially
included in Schedule A, shall be negotiated and DPT and COMPANY shall arrive at a mutual agreement with respect to prices at the time said new Products or new Product sizes are added to Schedule A. 

If a negotiated price cannot be agreed upon, final pricing for any of the above will be settled in accordance with paragraph 12.6
(b) below. 
  

	 	(b)	Materials Fees 

The Materials Fee to be paid by COMPANY to DPT shall be listed in Schedule A within one hundred twenty (120) days of commencement of
the initial commercial products of the applicable Product. The Materials Fee will be adjusted once annually at the 

  
 13 

 
beginning of each calendar year and Schedule A shall be amended accordingly based on changes in DPT’s standard costs for materials. In the event, however, the cost of a material increases
during any calendar year greater than ten percent (10%), DPT may promptly upon the effective date of such increase adjust its invoice price for said material to COMPANY to compensate for the increase. 

Material Fees for new Products or new Product sizes, new batch sizes or product configuration changes not initially included in Schedule
A, shall be established at the time of first production. 
  

	2.9	Payment 

 Payment for all
deliveries of Product and services shall be made in U.S. Dollars (USD), net thirty (30) days after the date of DPT’s invoice therefor. Invoices shall be generated upon shipment of Product from DPT. Total invoice price shall be equal to the
quantity of Product times the Total Price per unit effective on the date of Product release, as listed in Schedule A. Payments shall be made by certified check, via wire transfer or through other instrument accepted by DPT. Fund transfers by wire
should be made to the following: 
  

			
	 Account name:
	  	[...***...]
	 Account number:
	  	[...***...]
	 Bank name:
	  	Bank of America
	 ABA routing number:
	  	[...***...]
	 SWIFT code (US$)
	  	[...***...]
	 Bank location:
	  	901 Main Street, 8th Floor Dallas, Texas 75202
	 Contact:
	  	[...***...]
		  	[...***...]

  

	2.10	Late Payment 

 A late fee
of one and one-half percent (1.5%) of total invoice can be added each month for late payments. DPT, at its sole discretion, has the right to discontinue COMPANY’s credit on future orders and to put a hold on any production or shipment of
Product if COMPANY’s account is not current. Such hold on production or shipment shall not constitute a breach of this Agreement by DPT. In the event credit is discontinued, a one hundred percent (100%) material deposit paid by COMPANY to
DPT will be required prior to DPT ordering materials. In addition, a fifty percent (50%) Manufacturing Fee deposit will be required prior to DPT 

  

					
		  	14	  	***Confidential Treatment Requested

 
manufacturing any Product and the balance of the invoice must be paid in full prior to shipment. 
  

	2.11	Disposal Costs 

 DPT
reserves the right to invoice COMPANY for all disposal costs, related to manufacture of the Products, unless the disposal relates to a Rejected Product causes by the failure of DPT to follow established written procedures. 

III—SHIPMENT AND RISK OF LOSS 
  

	3.1	Shipment 

 Shipment of
Product shall be in accordance with COMPANY instructions, provided that shipment is made in accordance with all relevant statutory requirements. Product will be shipped to COMPANY or its designee immediately upon release, freight collect. At
COMPANY’s request, DPT may hold Product in DPT’s warehouse for a storage fee. Product held at DPT will be subject to payment as if the product was shipped in accordance with paragraph 2.9 above. If COMPANY requests DPT to make any
miscellaneous small shipments of Product, material, or other items on COMPANY’s behalf, COMPANY agrees to reimburse DPT for any shipping charges incurred. 
  

	3.2	Delivery Terms 

 The
delivery terms of the Products detailed in Schedule A hereof shall be Ex Works (“EXW” Incoterms 2010) DPT’s plant of manufacture, freight collect. Title to, and risk of loss for, Product, shall transfer from DPT to COMPANY when DPT
makes the Product available to COMPANY at its plant of manufacture. COMPANY shall bear all risk of loss, delay, or damage in transit, as well as cost of freight and insurance. 

 

	3.3	Claims 

 The weights,
tares and tests affixed by DPT’s invoice shall govern unless established to be incorrect. Claims relating to quantity, weight and loss or damage to any Product sold under this Agreement shall be waived by COMPANY unless made within thirty
(30) days of receipt of Product by COMPANY. 

  
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 IV—TERM AND TERMINATION 

 

	4.1	Term 

The initial term of this Agreement shall commence on the Effective Date hereof and will continue until
December 31 of the fifth (5th) calendar year
following the Launch Year, unless sooner terminated pursuant to paragraph 4.2 below. This Agreement shall thereafter automatically renew for periods of twenty-four (24) months, unless any party shall give notice to the other to the contrary at
least twenty four (24) months prior to the expiration of the initial term or any renewal term of the Agreement. 
  

	4.2	Termination 

 This
Agreement may be terminated at any time upon the occurrence of either of the following events: 
  

	 	(a)	The failure of either party to comply with its obligations herein, which failure is not remedied within sixty (60) days after written notice thereof.

  

	 	(b)	Notice by either party to the other upon the insolvency or bankruptcy of the other party. 

 

	4.3	Payment on Termination 

In the event of the termination or cancellation of this Agreement for any reason besides DPT termination, and without prejudice to any
other rights and remedies available to DPT hereunder, COMPANY agrees to reimburse DPT the Materials Fee directly ordered for the manufacture of Products based on COMPANY’s Forecasted Needs as well as for work-in-process and finished Products.

  

	4.4	Survival 

 Termination of
this Agreement under paragraph 4.2 or due to expiration or cancellation shall not relieve either party of obligations or liability for breaches of this Agreement incurred prior to or in connection with termination, expiration or cancellation.
Sections VI, VII, IX, X, XI and XII hereof shall survive the termination or cancellation of this Agreement for any reason. 

  
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 V—CERTIFICATES OF ANALYSIS AND MANUFACTURING COMPLIANCE 

 

	5.1	Certificates of Analysis 

DPT shall test each lot of Product purchased pursuant to this Agreement before delivery to COMPANY. Each Certificate of Analysis shall set
forth the items tested, specifications and test results for each lot delivered. DPT shall send one (1) Certificate of Analysis to COMPANY at the time of the release of Product. Extraordinary reporting or documentation, outside this Agreement,
may be subject to an additional charge by DPT. 
  

	5.2	Stability Testing 

 DPT
shall perform its standard stability test program as defined in DPT’s SOP’s or as separately agreed to in accordance with a CCR for each of the Products contained herein. COMPANY shall receive a copy of DPT’s Annual Product Review for
each Product as long as DPT is continuing to produce such Product for COMPANY and for as long as COMPANY’s account is current. If COMPANY elects to perform its own stability testing on Product, COMPANY agrees to provide DPT with a copy of the
results from such testing on an annual basis. 
  

	5.3	Validation Work or Additional Testing 

 It is understood by the parties hereto that the responsibility for any validation work shall be the sole responsibility of COMPANY. The parties agree that for any validation work or additional testing in
connection with the Product, DPT and COMPANY shall enter into a specific written Project Protocol establishing methodology and pricing for such services. It is understood between the parties hereto that if DPT is required by regulatory authority to
perform validation studies or additional testing in order to legitimately continue to engage in the manufacture of the Product for COMPANY and DPT and COMPANY cannot reach an agreement on a written Project Protocol, then DPT shall be under no
obligation to continue the manufacture of the Product affected by said regulation. 
  

	5.4	FDA Inspection 

 DPT shall
advise COMPANY if an authorized agent of the FDA or other governmental agency visits DPT’s manufacturing facility and requests or requires information or changes which specifically pertain to the Products. FDA audit time specific to Products
will be billed to COMPANY from DPT at the then-prevailing QA hourly rate. 

  
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	5.5	Regulatory Filings 

COMPANY agrees to provide DPT with copies of any sections of NDA’s, ANDA’s, 510(k)’s or other regulatory filings applicable
to the Products manufactured and/or tested by DPT, and copies of any changes in or updates of same as they, from time to time, hereafter occur. 
 VI—WARRANTIES 
  

	6.1	Conformity with Specifications 

 DPT warrants that all Products sold pursuant to this Agreement will have been manufactured in accordance with the Specifications for the release of the Product or pursuant to exceptions approved by
COMPANY at the time of manufacture. 
  

	6.2	Compliance with the Act 

COMPANY shall bear sole responsibility for the validity of all test methods and appropriateness of all Specifications. In addition,
COMPANY shall bear sole responsibility for all regulatory approvals, filings, and registrations and adequacy of all validation, stability, and preservative efficacy studies. COMPANY further warrants that it has obtained any and all necessary
approvals from all applicable regulatory agencies necessary to manufacture and distribute all Products under this Agreement. 
  

	6.3	Conformity with FDA regulations and cGMP’s 

 Subject to the provisions set forth in paragraph 6.2 and 6.4 hereof, DPT warrants that all Products shall have been manufactured by DPT in compliance with applicable FDA regulations and current Good
Manufacturing Practices as that term is defined under the Act. 
  

	6.4	Compliance of Packaging and Labeling with Laws and Regulations 

 COMPANY warrants that all Labeling copy and artwork approved, designated or supplied by COMPANY shall be in compliance with all applicable laws and governmental regulations. Compliance with all federal,
state, and local laws and regulations concerning Packaging and Labeling shall be the sole responsibility of COMPANY, provided that DPT purchases such Packaging and Labeling as provided in paragraph 2.2 (c) hereof. COMPANY hereby represents and
warrants to DPT that all COMPANY designated formulas, components and artwork related to the Product do not violate or infringe any patent, copyright or trademark laws, 

  
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and agrees to indemnify DPT, its employees, officers, directors and representatives for any claim, loss or damage including reasonable attorney’s fees paid or incurred by any of them in
connection therewith. 
  

	6.5	Access to DPT’s Facilities 

 COMPANY shall have access to DPT’s facilities at a mutually agreeable time for the sole purpose of auditing DPT’s compliance with current Good Manufacturing Practices and the Act. Such access
shall in no way give COMPANY the right to any of DPT’s confidential or proprietary information. Further, such audits shall normally be limited to every eighteen (18) months and three (3) employees of COMPANY who are subject to the
same requirements of confidentiality as COMPANY. 
  

	6.6	Disclaimer 

 DPT AND
COMPANY MAKE NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCT, LABELING OR PACKAGING; EXCEPT AS DETAILED HEREIN. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR
A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED. IN NO EVENT WILL DPT BE LIABLE FOR ANY LOSS OF PROFITS, LOSS OF USE, BUSINESS INTERRUPTION, COST OF COVER, OR INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY KIND IN CONNECTION WITH OR
ARISING OUT OF THE PERFORMANCE OF THIS AGREEMENT, WHETHER ALLEGED AS A BREACH OF CONTRACT OR TORTIOUS CONDUCT, INCLUDING NEGLIGENCE, EVEN IF DPT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. DPT’S LIABILITY UNDER THIS AGREEMENT FOR FIRST
PARTY DAMAGES OF ANY KIND, INCLUDING, WITHOUT LIMITATION, RESTITUTION, WILL NOT EXCEED, THE AMOUNT OF MANUFACTURING FEES PAID BY COMPANY TO DPT UNDER THIS AGREEMENT UP TO A MAXIMUM AMOUNT OF FIVE MILLION ($5,000,000) DOLLARS. 

VII—FORCE MAJEURE 
 Failure of either party to perform its obligations under this Agreement shall not subject such party to any liability to the other if such failure is caused by acts such as, but not limited to, acts of
God, acts of terrorism, fires, explosion, flood, drought, war, riot, sabotage, embargo, strikes, compliance with any court order or regulation of any government entity 

  
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acting with color of right or by any other cause beyond the reasonable control of the parties, whether or not foreseeable. 
 VIII—CHANGES TO PROCESS OR PRODUCT 
  

	8.1	Changes by COMPANY 

 If
COMPANY at any time requests a change to Product and DPT agrees such change is reasonable with regard to Product manufacture; (i) such change shall be incorporated within the Master Batch Record and/or Specifications via a written CCR reviewed
and agreed upon by both DPT and COMPANY; (ii) The parties shall adjust the price of Product, if necessary, and Schedule A shall be amended accordingly; and (iii) COMPANY shall pay DPT for the costs associated with such change including,
but not limited to, any additional development or validation work required, charged at DPT’s then-prevailing R&D rates in accordance with Section XI contained herein. 

 

	8.2	Changes by DPT 

 DPT
agrees that any changes developed by DPT, which may be incorporated into the Product shall require the written approval of COMPANY via a CCR prior to such incorporation. At the time of such incorporation, such changes shall become part of the
Specifications. It is also agreed that any regulatory filings incident to any such change shall be the sole responsibility of COMPANY. 
  

	8.3	Changes by Regulatory Authorities 

 The parties agree that any changes required by regulatory authority, shall be incorporated into the Product as evidenced by the written approval of COMPANY via a CCR prior to such incorporation. At the
time of such incorporation, such changes shall become part of the Specifications. If DPT is required by regulatory authority to perform validation studies for purposes of validating new manufacturing process or cleaning procedures or new material
and finished Product assay procedures with respect to Product in order to continue to engage in the manufacture of said Product for COMPANY, such studies shall be conducted in accordance with paragraph 5.3 herein. Any costs to DPT resulting from the
operation of this paragraph shall be reimbursed by COMPANY. 

  
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	8.4	Obsolete Inventory 

 Any
COMPANY-specific inventory including, but not limited to, materials, work-in-process, and Products rendered obsolete as a result of formula, artwork or packaging changes requested by COMPANY or by changes required by regulatory authority shall be
reimbursed to DPT by COMPANY at DPT’s Materials Fee. At such time and unless otherwise instructed by COMPANY agreed by DPT, DPT will ship the obsolete inventory to COMPANY for destruction by COMPANY. COMPANY shall bear one hundred percent
(100%) of all shipping and destruction costs related to said obsolete inventory. The destruction shall be in accordance with all applicable laws and regulations and COMPANY shall indemnify DPT for any liability, costs or expenses, including
attorney’s fees and court costs, relating to COMPANY’s failure to dispose of such inventory in accordance with such laws and regulations. COMPANY shall also provide DPT with all manifests and other applicable evidence of proper destruction
as may be requested by DPT or required by applicable law. If DPT does not receive disposition instructions from COMPANY within ninety (90) days from date of obsolescence, obsolete inventory remaining at DPT’s facilities shall be subject to
a deposit covering the standard cost of the obsolete inventory and storage fees. 
 IX—CONFIDENTIAL INFORMATION

  

	9.1	Confidential Information 

  

	 	(a)	Obligations of Confidentiality 

 All confidential information furnished by COMPANY to DPT, or by DPT to COMPANY, during the term of this Agreement, relating to the subject matter hereof, shall be kept confidential by the party receiving
said confidential information, except for purposes authorized by this Agreement, and shall not be disclosed to any person or firm, unless previously authorized in writing to do so, for a period of not less than five (5) years following the date
of disclosure. The party receiving said confidential information may, however, disclose the same to its responsible officers and employees who require said information for the purposes contemplated by this Agreement, provided that said officers and
employees shall have assumed like obligations of confidentiality. It is understood that all confidential information provided by either party shall be identified or marked as such. Any oral communications which are to be considered confidential
shall be reduced to writing and identified as confidential within thirty (30) days after disclosure. 

  
 21 

	 	(b)	Exceptions 

 Any
other provisions hereof to the contrary notwithstanding, it is expressly understood and agreed by the parties hereto that the obligations of confidence and nonuse herein assumed shall not apply to any information which: 

 

	 	(1)	is at the time of disclosure or thereafter so becomes a part of the public domain; or 

 

	 	(2)	was otherwise in the receiving party’s lawful possession prior to disclosure as shown by its written record; or 

 

	 	(3)	is hereafter disclosed to the receiving party by a third party purporting not to be in violation of an obligation of confidentiality to the disclosing party relative to
said information; or 

  

	 	(4)	is by mutual agreement of the parties hereto released from a confidential status; or 

 

	 	(5)	is required to be disclosed pursuant to regulatory or legal requirements. 

 

	 	(c)	DPT Business Model 

COMPANY acknowledges that as a contract manufacturing organization, DPT’s business involves the application of its expertise,
technology and know-how to numerous pharmaceutical and other products and that DPT retains the right (subject to its obligations under the applicable confidentiality provision or agreement) to apply such expertise, technology and know-how to a
variety of products or services. 
  

	9.2	Trademarks and Trade Names 

  

	 	(a)	Each party hereby acknowledges that it does not have, and shall not acquire any interest in any of the other party’s trademarks or trade names unless otherwise
expressly agreed. 

  

	 	(b)	Each party agrees not to use any trade names or trademarks of the other party, except as specifically authorized by the other party in writing both as to the names or
marks which may be used and as to the manner and prominence of use. 

  
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	9.3	Inventions and Patents 

Section 8 regarding Collaborative Efforts of the Research and Development Services Agreement between DPT and COMPANY dated
April 17, 2009, is hereby incorporated in its entirety by its reference and shall remain in effect for the term of this Agreement. 
 X—RESEARCH & DEVELOPMENT SERVICES 
  

	10.1	R&D Services 

  

	 	(a)	Research Products 

From time to time, COMPANY may request, in writing, that DPT evaluate, develop, manufacture, test and/or provide price quotations for
certain new items which may become Products (hereinafter referred to as “Research Products”) on behalf of COMPANY. If DPT agrees to perform such services, DPT shall so notify COMPANY within sixty (60) days of its receipt of
COMPANY’s request. To the extent that DPT agrees to perform any services hereunder for COMPANY, DPT shall only be obligated to act in good faith and to use reasonable efforts to accomplish the desired results as outlined in a mutually agreed
upon Project Protocol. Nothing herein shall obligate DPT to achieve any specific results and DPT makes no warranties or representations that it will be able to achieve the desired results. 

 

	 	(b)	Project Protocol 

Should DPT agree to perform any services hereunder, DPT shall submit a written development proposal in the form of a Project Protocol to
COMPANY identifying DPT’s best estimate of the development costs. This estimate shall include, but not be limited to, labor hours for development, testing, scale up, stability, report writing, etc., as well as all reasonably foreseeable
associated tasks and expenses. If this estimate is acceptable to COMPANY and COMPANY so notifies DPT by approving the Project Protocol in writing, DPT shall begin work as outlined in the Protocol. It is understood between both parties that during
any development project unforeseen circumstances may evolve, including, but not limited to, termination of any further activity due to unacceptable results, significant reevaluation due to marginal results, etc. DPT will promptly notify COMPANY of
any such unforeseen circumstances before proceeding at which time either COMPANY or DPT may terminate the project or mutually agree to amend or completely revise the Project Protocol. In the case where the 

  
 23 

 
project is terminated or revised, COMPANY will be obligated to pay for all of the work performed by DPT up to that point. 

 

	 	(c)	Costs 

 Material
costs involved will be billed to COMPANY at DPT’s cost [...***...] for administration and carrying costs. The foregoing development costs shall be paid to DPT in accordance with DPT’s standard invoicing procedures regardless of
whether DPT is able to accomplish the results which COMPANY requested. All invoices shall be paid by COMPANY in accordance with paragraph 2.7 above. On or before sixty (60) days of the development of a finished product prototype (which shall
include final primary container selection filled with Research Product), DPT will provide an estimate of the Manufacturing Fee. DPT may also provide an estimate of the Materials Fee, should specifications be known for these items at such time. The
estimated Manufacturing Fee shall automatically be adjusted annually based upon CPI adjustments pending commencement of Production. 
  

	 	(d)	Obsolete Inventory 

Any COMPANY-specific inventory including, but not limited to, materials, bulk Research Product, waste by-products, testing supplies,
stability samples, work-in-process, and finished goods rendered obsolete at the conclusion, revision or termination of the development project shall be shipped to COMPANY or, at DPT election destroyed by DPT. COMPANY shall bear one hundred percent
(100%) of all destruction costs related to said obsolete inventory. The destruction shall be in accordance with all applicable laws and regulations and COMPANY shall indemnify DPT for any liability, costs or expenses, including attorney’s
fees and court costs, relating to COMPANY’s failure to dispose of such inventory in accordance with such laws and regulations. COMPANY shall also provide DPT with all manifests and other applicable evidence of proper destruction as may be
requested by DPT or required by applicable law. DPT shall notify COMPANY of its intention to dispose of inventory. If DPT does not receive disposition instructions from COMPANY within ninety (90) days from date of obsolescence, obsolete
inventory remaining at DPT’s facilities shall be subject to storage fees. 

  

					
		  	24	  	***Confidential Treatment Requested

 XI—INDEMNIFICATION 

 

	11.1	Indemnification by DPT 

Subject to paragraph 6.6 above, DPT will indemnify and hold COMPANY harmless against any and all liability, damage, loss, cost, or expense
(including reasonable attorney’s fees) resulting from any third party claims made or suits brought against COMPANY which arise from DPT’s breach of its warranties set forth in Section VI hereof, up to the amount of insurance coverage as
provided for herein. 
  

	11.2	Insurance by DPT 

 While
this Agreement is in full force and effect, DPT shall furnish COMPANY with evidence of Commercial General Liability insurance (including endorsements for Products and Contractual Liability) coverage affording a minimum amount of [...***...]
per occurrence combined single limit, bodily injury/property damage and [...***...] aggregate liability limits. Such evidence of insurance coverage can be in the form of the original policy or a Certificate of Insurance which shall name the
COMPANY as an additional insured and provided that DPT has assumed the liability as provided for herein. 
  

	11.3	Indemnification by COMPANY 

COMPANY will indemnify and hold DPT harmless against any and all liability, damage, loss, cost or expense (including reasonable
attorney’s fees) resulting from any third party claims made or suits brought against DPT which are related to the breach of any of COMPANY’s warranties provided for herein or which arise out of the promotion, distribution, use, testing or
sales of Products, including, without limitation, any claims, express, implied or statutory, made as to the efficacy, safety, or use to be made of Products, and claims made by reason of any Product Labeling or any Packaging containing Product
(provided such packaging and Labeling was purchased by DPT as provided in paragraph 2.2 (c) hereof), unless such liability, damage, loss or expense is caused by the breach of DPT’s warranties under Section VI hereof. 

 

	11.4	Insurance by COMPANY 

While this Agreement is in full force and effect, COMPANY shall furnish DPT with evidence of Commercial General Liability insurance
(including endorsements for Products and Contractual Liability) coverage affording a minimum amount of [...***...] per occurrence combined single limit, bodily injury/property damage and

  

					
		  	25	  	***Confidential Treatment Requested

 
[...***...] aggregate liability limits. Such evidence of insurance coverage can be in the form of the original policy or a Certificate of Insurance which shall name DPT as an additional
insured and provide that COMPANY has assumed the liability as provided for herein. 
  

	11.5	Stacking of Insurance 

Neither COMPANY nor DPT intend for their respective insurance policies to stack on top of each other. To that end, both parties agree that
if a loss is incurred, for which DPT has an obligation under Section 11.1 to indemnify COMPANY hereunder, DPT’s policies will be triggered and DPT will defend COMPANY under the additional insured endorsement, Furthermore, if a loss is
incurred for which Company has an obligation under Section 11.3 to indemnify DPT hereunder, then COMPANY’s policies will be triggered and COMPANY will defend DPT under the additional insured endorsement. 

 

	11.6	Patent and Other Intellectual Property Rights 

  

	 	(a)	Warranty by COMPANY 

COMPANY warrants that use of Products or sales of Products will not infringe any patent or other proprietary rights and that COMPANY will
indemnify, defend and hold DPT harmless from any damage, judgment, loss, cost or other reasonable expense (including reasonable attorney’s fees) arising from claims that Products or the use of the Product names and any other trademarks, trade
names, or trade dress used by COMPANY in connection with Products infringes patent or other proprietary rights of a third party. 
  

	 	(b)	Warranty by DPT 

DPT shall indemnify and hold COMPANY harmless from all costs, damages and expense (including reasonable attorney’s fees) arising out
of any suit or action brought against COMPANY based upon a claim that any process or technical data furnished or utilized by DPT infringes any patent or other proprietary rights. 

 

	11.7	Conditions of Indemnification 

 If either party expects to seek indemnification from the other under paragraphs 11.1 or 11.3 hereof, it shall promptly give notice to the other 

  

					
		  	26	  	***Confidential Treatment Requested

 
party of any such claim or suit threatened, made or filed against it which forms the basis for such claim of indemnification and shall cooperate fully with the other party in the defense of all
such claims or suits. No settlement or compromise shall be binding on a party hereto without its prior written consent. 

XII—GENERAL PROVISIONS 
  

	12.1	Notices 

 Any notices
permitted or required by this Agreement shall be sent by certified or registered mail with a copy by fax and shall be effective the earlier of the date received or three (3) days after deposit in the U.S. mail, if sent and addressed as follows
or to such other address as may be designated by either party in writing: 
  

			
	 If to DPT:
	  	DPT Lakewood, LLC
		  	c/o: DPT Laboratories, Ltd.
		  	Attention: President
		  	318 McCullough Ave.
		  	San Antonio, Texas 78215
		  	Fax: (210) 227-6132
		  	with a copy to the General Counsel’s Office

  

			
	 If to COMPANY:
	  	Insys Therapeutics
		  	10220 South 51st Street, Suite 2
		  	Phoenix, AZ 85044
		  	Attention: President
		  	Fax: (602) 910-2627
		  	with a copy to the General Counsel’s Office

  

	12.2	Entire Agreement; Amendment 

 The parties hereto acknowledge that this document sets forth the entire agreement and understanding of the parties and supersedes all prior written or oral agreements or understandings with respect to the
subject matter hereof, and shall supersede any conflicting portions of DPT’s quotation, acknowledgment and invoice forms and COMPANY’s Purchase Order and other written forms. No modification of any of the terms of this Agreement, or any
amendments thereto, shall be deemed to be valid unless in writing and signed by the party against whom enforcement is sought. No course of dealing or usage of trade shall be used to modify the terms and conditions herein. 

  
 27 

	12.3	Waiver 

 No waiver by
either party of any default shall be effective unless in writing, nor shall any such waiver operate as a waiver of any other default or of the same default on a future occasion. 

 

	12.4	Obligations to Third Parties 

 Each party warrants and represents that proceeding herein is not inconsistent with any contractual obligations, express or implied, undertaken with any third party. 

 

	12.5	Assignment 

 This
Agreement shall be binding upon and inure to the benefit of the successors or permitted assigns of each of the parties and may not be assigned or transferred by either party without the prior written consent of the other, which consent will not be
unreasonably withheld. No such assignment shall release the original party hereto from its duties and obligations under this Agreement. 
  

	12.6	Governing Law and Arbitration 

  

	 	(a)	Governing Law 

 The
validity, interpretation and effect of this Agreement shall be governed by and construed under the substantive laws of the State of New Jersey, excluding any conflicts of law provisions contained therein. 

 

	 	(b)	Arbitration 

  

	 	(i)	 ANY DISPUTE, CLAIM OR CONTROVERSY ARISING FROM OR RELATED IN ANY WAY TO THIS AGREEMENT OR THE INTERPRETATION, APPLICATION, BREACH, TERMINATION OR
VALIDITY THEREOF, INCLUDING ANY CLAIM OF INDUCEMENT OF THIS AGREEMENT BY FRAUD OR OTHERWISE, WILL BE SUBMITTED FOR RESOLUTION TO ARBITRATION PURSUANT TO THE COMMERCIAL ARBITRATION RULES THEN PERTAINING OF THE CENTER FOR PUBLIC RESOURCES
(“CPR”), EXCEPT WHERE THOSE RULES CONFLICT WITH THESE PROVISIONS, IN WHICH CASE THESE PROVISIONS CONTROL. SUCH ARBITRATION SHALL BE HELD IN (I) COMPANY’S HOME COUNTY, IF THE DEMAND FOR

  
 28 

	 	ARBITRATION IS INITIATED BY DPT OR (II) OCEAN COUNTY, NEW JERSEY, IF THE DEMAND FOR ARBITRATION IS INITIATED BY COMPANY. 

 

	 	(ii)	The panel shall consist of three arbitrators chosen from the CPR Panels of Distinguished Neutrals each of whom is a lawyer specializing in business litigation with at
least 15 years experience with a law firm of over 25 lawyers or was a judge of a court of general jurisdiction. In the event the aggregate damages sought by the claimant are stated to be less than $5 million, and the aggregate damages sought by the
counterclaimant are stated to be less than $5 million, and neither side seeks equitable relief, then a single arbitrator shall be chosen, having the same qualifications and experience specified above. 

 

	 	(iii)	The parties agree to cooperate (1) to obtain selection of the arbitrator(s) within 30 days of initiation of the arbitration, (2) to meet with the
arbitrator(s) within 30 days of selection and (3) to agree at that meeting or before upon procedures for discovery and as to the conduct of the hearing which will result in the hearing being concluded within no more than 9 months after
selection of the arbitrator(s) and in the award being rendered within 60 days of the conclusion of the hearings, or of any post-hearing briefing, which briefing will be completed by both sides within 20 days after the conclusion of the hearings. In
the event no such agreement is reached, the CPR will select arbitrator(s), allowing appropriate strikes for reasons of conflict or other cause and three peremptory challenges for each side. The arbitrator(s) shall set a date for the hearing, commit
to the rendering of the award within 60 days of the conclusion of the evidence at the hearing, or of any post-hearing briefing (which briefing will be completed by both sides in no more than 20 days after the conclusion of the hearings), and provide
for discovery according to these time limits, giving recognition to the understanding of the parties hereto that they contemplate reasonable discovery, including document demands and depositions, but that such discovery be limited so that the time
limits specified herein may be met without undue difficulty. In no event will the arbitrator(s) allow either side to obtain more than a total of 40 hours of deposition testimony from all witnesses, including both fact and expert witnesses. In the
event multiple hearing days are required, they will be scheduled consecutively to the greatest extent possible. 

  
 29 

	 	(iv)	The arbitrator(s) shall render an opinion setting forth findings of fact and conclusions of law with the reasons therefor stated. A transcript of the evidence adduced
at the hearing shall be made and shall, upon request, be made available to either party. 

  

	 	(v)	To the extent possible, the arbitration hearings and award will be maintained in confidence. 

 

	 	(vi)	Any court of competent jurisdiction may enter judgment upon any award. In the event the panel’s award exceeds $5 million in monetary damages or includes or
consists of equitable relief, then the court shall vacate, modify or correct any award where the arbitrators’ findings of fact are clearly erroneous, and/or where the arbitrators’ conclusions of law are erroneous; in other words, it will
undertake the same review as if it were a federal appellate court reviewing a district court’s findings of fact and conclusions of law rendered after a bench trial. An award for less than $5 million in damages and not including equitable relief
may be vacated, modified or corrected only upon the grounds specified in the Federal Arbitration Act. 

  

	 	(vii)	Each party has the right before or during the arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, preliminary injunction,
replevin, etc. to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration. 

  

	 	(viii)	EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY. 

  

	 	(c)	Mediation 

  

	 	(i)	 ANY DISPUTE, CONTROVERSY OR CLAIM ARISING OUT OF OR RELATED TO THIS AGREEMENT, OR THE INTERPRETATION, APPLICATION, BREACH, TERMINATION OR VALIDITY
THEREOF, INCLUDING ANY CLAIM OF INDUCEMENT BY FRAUD OR OTHERWISE, WHICH CLAIM WOULD, BUT FOR THIS PROVISION, BE SUBMITTED TO ARBITRATION SHALL, BEFORE SUBMISSION TO ARBITRATION, FIRST BE MEDIATED THROUGH NON-BINDING MEDIATION. SUCH MEDIATION SHALL
BE HELD IN (I) COMPANY’S HOME COUNTY, IF THE DEMAND FOR MEDIATION IS INITIATED BY DPT OR 

  
 30 

	 	 
(II) OCEAN COUNTY, NEW JERSEY, IF THE DEMAND FOR MEDIATION IS INITIATED BY COMPANY AND SHALL BE ATTENDED BY A SENIOR EXECUTIVE WITH AUTHORITY TO RESOLVE THE DISPUTE FROM EACH OF THE OPERATING
COMPANIES THAT ARE PARTIES. 

  

	 	(ii)	After written notice of any dispute or controversy arising out of or related to the Agreement, or the interpretation, application, breach, termination or validity
thereof and Written Demand for Mediation (the “Written Demand for Mediation”), the parties shall promptly confer within thirty (30) days in an effort to select a mediator by mutual agreement. In the absence of such an agreement within
sixty (60) days of the date of the Written Demand for Mediation by either of the parties, the mediator shall be selected by the party making the demand for mediation. In the event that the party that has not made the Written Demand for
Mediation refuses to participate in the mediation process for any reason, or mediation is not scheduled within ninety (90) days of the Written Demand for Mediation for any reason, then the part that made the Written Demand for Mediation shall
have the absolute right to proceed to arbitration pursuant to paragraph 12.6(b) of this Agreement. 

  

	 	(iii)	The mediator shall confer with the parties to design procedures to conclude the mediation within no more than 45 days after initiation. Under no circumstances shall the
commencement of arbitration under Section 18(b) above be delayed more than 45 days by the mediation process specified herein. 

  

	 	(iv)	Each party agrees to toll all applicable statutes of limitation during the mediation process and not to use the period or pendency of the mediation to disadvantage the
other party procedurally or otherwise. No statements made by either side during the mediation may be used by the other during any subsequent arbitration. 

  

	 	(v)	Each party has the right to pursue provisional relief from any court, such as attachment, preliminary injunction, replevin, etc., to avoid irreparable harm, maintain
the status quo, or preserve the subject matter of the arbitration, even though mediation has not been commenced or completed 

  
 31 

	 	(d)	Costs 

 The costs
of arbitration and/or mediation, including reasonable attorney’s fees, shall be borne by the losing party. 
  

	12.7	Severability 

 In the
event that any term or provision of this Agreement shall violate any applicable statute, ordinance, or rule of law in any jurisdiction in which it is used, or otherwise be unenforceable, such provision shall be ineffective to the extent of such
violation without invalidating any other provision hereof. 
  

	12.8	Headings, Interpretation 

  

	 	The	headings used in this Agreement are for convenience only and are not a part of this Agreement. 

 

	12.9	Counterparts 

 This
Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same original. 
  

	12.10	Independent Contractor 

In performing its services hereunder, DPT shall act as an independent contractor. 

 

	12.11	Export/Import Laws and Regulations 

 This Agreement is subject to any restrictions concerning the import or export of Product, active pharmaceutical ingredient, chemical or packaging components (or related technical information or data) to
or from the United States as well as the laws and regulations of any other country involved in the import or export of such Product, active pharmaceutical ingredient, chemical or packaging components (or related technical information or data).
COMPANY acknowledges that it shall be solely and exclusively responsible for the preparation of all import and export documentation and compliance with all import and export laws of the United States as well as the laws and regulations of any other
country involved in the import or export of such Product, active pharmaceutical ingredient, chemical or packaging components (or related technical information or data); except as otherwise agreed by the parties in writing. COMPANY shall indemnify
and hold DPT, its officers, directors, employees, shareholders and affiliates harmless, from any and all claims, 

  
 32 

 
losses, liabilities, damages, fines, penalties, costs and expenses (including reasonable attorneys’ fees) arising from, or related to, any breach by COMPANY of its obligations under this
provision. COMPANY shall be the importer or exporter of record for all such import or export activities. COMPANY shall cooperate with DPT as reasonably necessary to permit DPT to comply with the laws and regulations of the United States and any
other country relating to the control of import or export of Product, active pharmaceutical ingredient, chemical or packaging components (or related technical information or data). 

IN WITNESS WHEREOF, the parties hereto have each caused this Agreement to be executed by their duly authorized officers as of the
date first above written. 
  

									
		 	 INSYS THERAPEUTICS
	 		 		  	DPT LAKEWOOD, LLC
					
	 By:
	 	 /s/    Michael
Babich        
	 		 	 By:
	  	/s/    Paul Johnson        
					
	 Its:
	 	 President and CEO
	 		 	 Its:
	  	President and COO

  
 33 

 Schedule A 
 SCHEDULE A – 2011 
 Insys

 Therapeutics 
  

																											
	 PRODUCT

NUMBER
	  	 PRODUCT
 DESCRIPTION
	  	MINIMUM
ANNUAL
VOLUME	 	  	BATCH
SIZE	 	  	UNIT
BATCH
YIELD	 	  	MFG.
FEE	 	  	MATERIAL
FEE	 	  	TOTAL
UNIT
FEE	 
	 [...***...]

[...***...]

[...***...]

[...***...]

[...***...]
	  	
Fentanyl Sub lingual spray
 [...***...]
	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  
	 [...***...]

[...***...]

[...***...]

[...***...]

[...***...]
	  	
Fentanyl Sub lingual spray
 [...***...]
	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  
	 [...***...]

[...***...]

[...***...]

[...***...]

[...***...]
	  	
Fentanyl Sub lingual spray
 [...***...]
	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  	  	 	[...***...]	  
	 	  	 	  	 	[...***...]	  	  	 	 	 	  	 	 	 	  	 	 	 	  	 	 	 	  	 	 	 

  

	1)	Manufacturing and Materials Fee’s are based on [...***...] 

	2)	Effective date for above Fees is [...***...] through [...***...] 

	3)	[...***...] 

	4)	[...***...] 

	5)	[...***...] 

	6)	Pricing does not include [...***...] 

	7)	Materials Fee will be based on [...***...] 

 Initials/Date Insys Therapeutics:    /s/ MB 6/1/11 
 Initials/Date DPT Laboratories:    /s/ PJ 5/31/11] 

  

					
		  	34	  	***Confidential Treatment Requested

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