Document:

Manufacturing and Packaging Agreement / Cardinal Health PTS, LLC

 Exhibit 10.33 
  
 MANUFACTURING AND PACKAGING AGREEMENT 
  
 This Manufacturing and Packaging Agreement (“Agreement”) is made this 14th day of April, 2005, by and between Cardinal Health PTS, LLC, having a place of business at 2725 Scherer Drive, St Petersburg, Florida 33716 (“Cardinal
Health”) and Reliant Pharmaceuticals, Inc. (“Reliant”), having its principal place of business at 110 Allen Road, Liberty Corner, New Jersey 07938. 
  
 BACKGROUND 
  
 Cardinal Health provides contract pharmaceutical development, manufacturing, packaging, analytical, and sales and marketing services to the
pharmaceutical industry. 
  
 Reliant has rights to market certain
pharmaceutical products and wants Cardinal Health to assist in the formulation, filling, packaging and testing of such products as provided in this Agreement and the attachments hereto. 
  
 Reliant desires to engage Cardinal Health to provide certain services to Reliant in connection with the processing of
Reliant’s Product (defined below) and Cardinal Health desires to provide such services pursuant to the terms and conditions set forth in this Agreement. 
  
 The parties therefore agree as follows: 
  
 ARTICLE 1 
 DEFINITIONS

  
 The following terms have the following meanings in this
Agreement: 
  
 1.1 “Affiliate(s)” means any corporation, firm,
partnership or other entity that controls, is controlled by or is under common control with a party. For purposes of this definition, “control” shall mean the ownership of at least fifty percent (50%) of the voting share capital of such
entity or any other comparable equity or ownership interest. 
  
 1.2
“API” means the active pharmaceutical ingredient described in the Manufacturing Specifications, which have been released by Reliant and provided to Cardinal Health as raw material, along with a certificate of analysis, as provided in this
Agreement. 
  
 1.3 “Applicable Laws” means all laws, ordinances, rules
and regulations within the Territory applicable to the Manufacturing and Packaging of the Product or any aspect thereof and the obligations of Cardinal Health or Reliant, as the context requires under this Agreement, including, without limitation,
(A) all applicable federal, state and local laws and regulations of each Territory; (B) the U.S. Federal Food, Drug and Cosmetic Act, and (C) the current Good Manufacturing Practices promulgated by the Regulatory Authorities, as amended from time to
time (“cGMPs”). 
  

 1.4 “Batch” means defined quantity of finished drug product that has been or is being Manufactured and 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 “Cardinal Health Technology” shall have the meaning set forth in Article 12. 
  
 1.7 “Change Order” shall have the meaning set forth in Section 4.5(A). 
  
 1.8 “Confidential Information” shall have the meaning set forth in Section 11.2.

  
 1.9 “Contract Year” means each consecutive twelve (12) month period
beginning on July 1, 2005. 
  
 1.10 “Defective Product” shall have the
meaning set forth in Section 5.2. 
  
 1.11 “Delivery Date” shall mean
the date on which Cardinal Health tenders the relevant Batch(es) to the carrier in accordance with Section 6.1. Each Delivery Date shall be specified by Reliant on the relevant Purchase Order and confirmed by Cardinal Health as set forth in Section
4.4. 
  
 1.12 “Dispute” shall have the meaning set forth in Section
19.9. 
  
 1.13 “Effective Date” means the date this Agreement was fully
executed. 
  
 1.14 “Facility or Facilities” means Cardinal Health’s
facilities located in St. Petersburg, Florida or such other facility as agreed by the parties. 
  
 1.15 “FDA” means the United States Food and Drug Administration and any successor agency thereto. 
  
 1.16 “Firm Commitment” shall have the meaning set forth in Section 4.3. 
  

1.17 “Minimum Requirement” shall have the meaning set forth in Section 4.1. 
  
 1.18 “Manufacture” or “Manufacturing” means the compounding, filling, encapsulation, producing and/or inspection of the
API and Raw Materials into Product in accordance with the Specifications and the terms and conditions set forth in this Agreement. 
  
 1.19 “Manufacturing Date” means the day on which the Product is to be compounded by Cardinal Health, which shall not be more than forty-five (45) days prior to
the Delivery Date. 
  
 1.20 “Manufacturing Related Reference Documents”
means (a) all completed production/Batch records; (b) all quality control test/request forms (result worksheets) and 

  

 
associated data; (c) dynamic monitoring performed during processing; (d) any alert/action notifications generated during processing; (e) any planned or
unplanned deviations associated with the Product; (f) any out of Specification result investigations associated with the Product; (g) the Certificate of Analysis for the Batch comparing testing to Specifications; (h) the appropriate disposition
notification for the Batch, and (i) a Yield statement. 
  
 1.21
“Package” or “Packaging” means the labeling and the packaging of the Product onto the bulk product packaging in accordance with the Specifications and the terms and conditions of this Agreement. 
  
 1.22 “Product” means Omacor® as fully compounded API Manufactured and Packaged in accordance with the
Specifications. 
  
 1.23 “Product Maintenance Fee” shall have the
meaning set forth in Section 7.2. 
  
 1.24 “Purchase Order” shall have
the meaning set forth in Section 4.4. 
  
 1.25 “Raw Materials” means all
raw materials, supplies, components and packaging, not including API, necessary to Manufacture, Package and ship the Product in accordance with the Specifications. 
  
 1.26 “Regulatory Authority” means any governmental regulatory authority within a Territory involved in regulating any aspect of
the development, manufacture, market approval, sale, distribution, packaging or use of the Product. 
  
 1.27 “Reliant Technology” shall have the meaning set forth in Article 12. 
  
 1.28 “Review Period” shall have the meaning set forth in Section 5.1. 
  

1.29 “Rolling Forecast” shall have the meaning set forth in Section 4.3. 
  
 1.30 “Sample” shall have the meaning set forth in Section 5.1. 
  
 1.31 “Softgel Technology” means Cardinal Health’s proprietary technology for the manufacture of softgels for the oral
administration of pharmaceutical active ingredients having certain solubility characteristics and includes proprietary know-how including without limitation 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, plasticizers and other components of the liquid fill and the gelatin shell; (iv) certain encapsulation, drying and related manufacturing techniques and machinery for making commercial quantities of softgels, and [***].

  
 1.32 “Specifications” means the procedures, requirements, standards,
quality control testing and other data and the scope of services as set forth in Exhibit A, which are hereby incorporated 
  
  
  
  
  
  
  
  
  
  
  
  

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by reference into this Agreement, along with any valid amendments or modifications thereto, subject to the terms and conditions of Article 9. 
  
 1.33 “Term” shall have the meaning set forth in Section 15.1. 
  
 1.34 “Territory” means the United States of America, its territories and
possessions. 
  
 1.35 “Unit” means each individual unit of Product, as
described more fully in the Specifications. 
  
 1.36 “Unit Pricing”
shall have the meaning set forth in Section 7.1. 
  
 1.37 “Yield” shall
have the meaning set forth in Section 3.4. 
  
 ARTICLE 2

 VALIDATION, MANUFACTURING, PACKAGING & RELATED SERVICES 
  
 2.1 Validation Services. During the Term, Cardinal Health shall perform the qualification and validation services described in
Exhibit D of this Agreement for the prices specified therein. 
  
 2.2
Supply and Purchase of Product. During the Term, Cardinal Health shall Manufacture and Package the Products in accordance with the Specifications, Applicable Laws and the terms and conditions of this Agreement. Reliant shall purchase Product
from Cardinal Health in accordance with the terms and conditions of this Agreement, including but not limited to the obligations set forth in Section 4.1 and Section 4.2 hereof. 
  
 2.3 Product Maintenance Services. During the Term and subject to Reliant’s payment of the Product Maintenance fee as set forth
in section 7.2, Reliant shall be entitled to the following Product Maintenance Services: 
  

	 	•	 	Administration of Foreign Trade Zone; 

  

	 	•	 	One annual audit; 

  

	 	•	 	Annual Product review; 

  

	 	•	 	Access to document library over and above the Quality Agreement, including additional copies of batch paperwork or other batch documentation; 

  

	 	•	 	Annual Drug Master File update; 

  

	 	•	 	Preparation of Product licenses or permits under United States local, state or Federal regulations (in each case as more fully set forth in Article 10); 

  

	 	•	 	Product Document and Sample Storage relating to cGMP requirements; 

  

	 	•	 	Vendor re-qualification; 

  

	 	•	 	Maintenance and storage of Audit Reports; and 

  

	 	•	 	Bulk stability (6 months, warehouse conditions). 

  

 ARTICLE 3 
 MATERIALS 
  
 3.1 API. 

 
 A. Reliant shall supply to Cardinal Health for Manufacturing and
Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference
standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API,
reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct
identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount
reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast. 
  
 B. All API provided by Reliant shall meet applicable 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. Cardinal Health shall inspect API as
received to verify its identity and shall give Reliant oral and written notice of any nonconformity with Specifications within thirty (30) calendar days of receipt of API by Cardinal Health. Reliant shall provide a Certificate of Analysis with each
delivery of API and such certificate shall be the basis for drug potency. 
  
 D. Reliant shall retain title to API at all times and shall bear the risk of loss thereof; provided, however, subject to Section 15.1, from the time API is received at Cardinal Health’s Facility to
the time API is returned (or Product is delivered) to Reliant’s designated carrier at Cardinal Health’s loading dock, Cardinal Health shall bear the risk of loss of API arising from Cardinal Health’s negligence or failure to comply
with cGMPs or failure to comply with all Specifications. 
  
 3.2 Raw
Materials. Cardinal Health 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. All Raw Material supplier changes must
be agreed by the parties by amending the Specifications in writing. 
  
 3.3
Reimbursement for Materials. In the event of (A) a Specification change requested by Reliant or Cardinal Health for Reliant’s benefit and agreed by the parties, or to comply with any new requirement of a Regulatory Authority, (B)
termination of this Agreement by Reliant without cause or expiration of this Agreement; or (C) unforeseeable obsolescence of any Raw 

  

 
Material, Reliant shall bear the cost of any unused Raw Materials that cannot be used by Cardinal Health or returned for credit, provided that Cardinal
Health purchased such Raw Materials in quantities consistent with Reliant’s most recent Firm Commitment and the supplier’s minimum purchase obligations. 
  
 3.4 Yield and Inventory Reconciliation. Cardinal Health will achieve a minimum Yield in Manufacturing the Product. “Yield”
means the relation between the API content of the Product Manufactured over a certain time period and the actual quantity of API used to Manufacture such quantity of Product. The minimum Yield will be determined after the Manufacture of [***] or the
number of batches Manufactured during [***] of production and shall be set forth in Exhibit C. In the event the minimum yield falls below [***] at any time during the Term, the parties agree to discuss remedies to elevate the minimum yield in
good faith and amend the Agreement as the parties deem appropriate, provided, however, the foregoing discussions shall not relieve Cardinal Health of its obligations to pay for quantities of API consumed in excess of the minimum Yield
under this Section 3.4. In the event the parties have not agreed on remedies to elevate the Yield to [***] within three (3) months of determining the minimum Yield as set forth above, the parties expressly agree that for purposes of this Section 3.4
and the obligations set forth herein, the minimum Yield shall be no less than [***], unless the parties discuss and agree that it is commercially impracticable under the circumstances. After the parties have established the minimum Yield, Cardinal
Health shall, after Manufacture of each Batch, compare actual Yield for such batch with the minimum Yield. Cardinal Health shall prepare a quarterly report that sets forth all Yields by lot numbers that exceed the minimum Yield. Cardinal Health will
reimburse or credit Reliant an amount that equals [***] for API consumed in excess of the minimum Yield. The parties agree that for specific written orders Reliant may provide Cardinal Health with instructions for Manufacturing that result in Yields
lower than the minimum Yield. Reliant will not be entitled to reimbursement or credit for API to the extent that API loss is attributable solely to Reliant’s specific instructions. Within three (3) business days of the end of each quarter
Cardinal Health shall notify Reliant of the quantities of API (both raw material and in-process) in inventory. Upon reasonable advance notice to Cardinal Health and at mutually agreeable times but not more than twice in any twelve (12) month period,
Reliant shall be permitted to inspect API inventory at Cardinal Health’s Facility. 
  
 ARTICLE 4 
 MINIMUM COMMITMENT, PURCHASE ORDERS & FORECASTS 
  
 4.1 Minimum Requirement. During each Contract Year, Reliant shall purchase the minimum
dollar volume of Product (“Minimum Requirement”) set forth on Exhibit B. If Reliant does not purchase such Minimum Requirement during any Contract Year, within thirty (30) days after the end of such Contract Year and upon receipt of
an invoice from Cardinal Health, Reliant shall pay Cardinal Health the difference between (A) the Minimum Requirement and (B) the sum of all purchases from Cardinal Health for the Product during the just-concluded Contract Year. 
  
 4.2 Commitment of the Parties. 
  
 (a) Cardinal Health commits to using best commercial efforts to Manufacture
and Package [***], [***] to the finished product packaging contractor designated by Reliant. Reliant 
  
  
  
  
  
  
  
  
  
  
  
  
  

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commits to use its best commercial efforts to perform its obligations with regard to validation and the timelines to be met in connection therewith.

  
 (b) [***]. 
  
 (c) In the event Cardinal Health (i) determines it cannot meet any of
Reliant’s Rolling Forecasts delivered in accordance with Section 4.3 below, or (ii) fails to deliver any Product within [***] of a respective Delivery Date for [***] during the Term, such that at the end of any three month period Cardinal
Health has failed to deliver the total number of lots for which Reliant has issued Purchase Orders, [***], provided, however, Reliant shall use commercially reasonable efforts to [***] following resolution of any technical issues.

  
 (d) Any quantity of Product which is not delivered to Reliant
by Cardinal Health within [***] of any Delivery Date, for any reason whatsoever, during the Term shall give Reliant the option to [***]. 
  
 (e) In the event Cardinal Health’s Facility undergoes expansion and subsequent FDA approval of such expansion, Reliant shall have the option, but not
the obligation, to have its Product Manufactured and Packaged in such new wing, provided, however, that Reliant shall bear the cost of relocating to such new wing, [***]. 
  
 4.3 Forecast. On the Effective Date and on or before the first (1st) day of each calendar month following the Effective Date, Reliant shall furnish to Cardinal Health in writing, an eighteen (18) month rolling forecast of the
quantities of Product that Reliant intends to order from Cardinal Health during such period (“Rolling Forecast”). The first three (3) months of such Rolling Forecast shall constitute a binding order for the quantities of Product specified
therein (“Firm Commitment”) and the following fifteen (15) months of the Rolling Forecast shall be non-binding, good faith estimates. 
  
 4.4 Purchase Orders. On or before the first (1st) day of each calendar month, Reliant shall submit a purchase order for the Firm Commitment, which specifies the actual number of Batches to be Manufactured and Packaged, the approximate number of Units in each Batch, and
the requested Delivery Dates for each Batch (“Purchase Order”). Reliant shall submit each Purchase Order to Cardinal Health at least ninety (90) days in advance of the earliest Delivery Date requested in the Purchase Order. Cardinal Health
shall confirm Delivery Dates to Reliant. In the event of a conflict between the terms of any Purchase Order and this Agreement, this Agreement shall control. Notwithstanding the foregoing, Cardinal Health shall supply Reliant with quantities of
Product that exceed by not more than [***] the quantities specified in the Firm Commitment (“Excess Quantities”), and shall use best commercial efforts to supply additional quantities of Product requested by Reliant (“Additional
Quantities”). Cardinal Health’s supply of Excess Quantities and Additional Quantities are both subject to (i) receipt of a Purchase Order for such Additional Quantities and Excess Quantities at least ninety (90) days in advance of the
requested Delivery Date for such Additional Quantities and Excess Quantities, and (ii) Cardinal Health’s possession of sufficient quantities of API to Manufacture Excess Quantities and Additional Quantities. Cardinal Health’s failure to
supply Reliant with Additional Quantities shall not constitute a failure to supply under Section 2.2 and 4.2. Should Cardinal Health fail to 
  
  
  
  
  
  
  
  
  
  
  
  
  

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supply Reliant with its requirements for the Product, specifically excluding Additional Quantities, for any particular month hereunder, Cardinal Health shall
be required to make up the difference in the immediately subsequent month. 
  
 4.5
Cardinal Health’s Cancellation of Purchase Orders. Notwithstanding the terms and conditions set forth in Section 4.6 below, Cardinal Health reserves the right to cancel all, or any part of, a Purchase Order upon written notice to Reliant
(and Cardinal Health shall have no further obligations or liability with respect to such Purchase Order) if Reliant refuses or fails to make scheduled deliveries of the API. 
  
 4.6 Reliant’s Modification or Cancellation. 
  
 A. Reliant may modify the delivery date, Specifications or quantity of Product in such Purchase Order only by submitting a
written change order (“Change Order”) to Cardinal Health at least thirty (30) business days in advance of the earliest scheduled Manufacturing Date for the Manufacturing and Packaging covered by the change order. Such change order shall be
effective and binding upon Cardinal Health only upon the written acceptance by Cardinal Health and, notwithstanding the foregoing, Reliant shall remain responsible for the Firm Commitment portion of the Rolling Forecast. 
  
 B. Notwithstanding any amounts due to Cardinal Health under Section 4.4 or
Section 4.1, if Reliant fails to place Purchase Orders sufficient to satisfy the Firm Commitment, Reliant shall, within thirty (30) days of receipt of invoice, pay to Cardinal Health the difference between the (i) Unit Price for all Units that would
have been Manufactured and Packaged if Reliant had placed Purchase Orders sufficient to satisfy the Firm Commitment, and (ii) Cardinal Health’s cost of any Raw Materials that would have been used in such Units, provided, however,
that Cardinal Health is not in default of any of its supply obligations hereunder. In the event Cardinal Health has an opportunity to mitigate its damages hereunder, the parties shall meet in good faith to discuss an appropriate reduction.

  
 4.6 Unplanned Delay or Elimination of Manufacturing and Packaging.
Cardinal Health shall timely fill each Purchase Order, subject to the terms and conditions of this Agreement applicable to both parties. Cardinal Health shall notify Reliant as soon as possible after the receipt of a Firm Commitment or Purchase
Order if Cardinal Health determines that any Manufacturing or Packaging related to the Firm Commitment or Purchase Order will be delayed or eliminated for any reason. Unless agreed to by Reliant in writing, such notice will not relieve Cardinal
Health of any of its obligations in this Agreement, including, but in no way limited to, the provisions of Section 4.2. 
  
 4.7 Inspection of Manufacturing and Packaging. Reliant may base up to two (2) representatives at the Facilities to observe the Manufacturing and Packaging provided
that Reliant provide Cardinal Health at least ten (10) days’ advance written notice of the attendance of such Reliant representatives. Reliant shall indemnify and hold harmless Cardinal Health for any action or activity of such representatives
while on Cardinal Health’s premises. 
  

 ARTICLE 5 
 TESTING; SAMPLES; RELEASE 
  
 5.1
Samples; Testing. Within [***] after Cardinal Health’s completion of Manufacturing and Packaging of each Batch, Cardinal Health shall deliver to Reliant, or its designee, a sample of the Product (“Sample”) and the Manufacturing
Related Reference Documents for such Batch. No later than [***] after receipt of the Sample and a complete set of the Manufacturing Related Reference Documents (“Review Period”), Reliant or its designee shall review the Manufacturing
Related Reference Documents and notify Cardinal Health whether the Sample conforms to the warranty set forth in Section 13.1 of this Agreement. Upon receipt of notice from Reliant that a Batch meets the warranty in Section 13.1, or upon failure of
Reliant to respond by the end of the Review Period, Cardinal Health will invoice Reliant for such Batch in accordance with Section 7.5 below. 
  
 5.2 Non-Conforming Product. If Reliant notifies Cardinal Health during the Review Period that the Sample does not conform to the warranty set forth in Section 13.1
and Cardinal Health agrees with Client’s determination, Client shall not be responsible to pay for such batch (the “Defective Product”), and Cardinal Health shall, at Reliant’s option, either (A) replace any Batch of
non-conforming Product, or (B) credit any payments made by Reliant for such Batch. If Cardinal Health does not agree with Reliant’s determination that such Product fails to meet the warranty set forth in Section 13.1, then after reasonable
efforts to resolve the disagreement, the parties shall cause a mutually acceptable independent third party to review records, test data and to perform comparative tests and/or analyses on the Sample. The results of the independent review 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 non-prevailing party. 
  
 THE OBLIGATION OF CARDINAL HEALTH TO (A) REPLACE DEFECTIVE PRODUCT IN ACCORDANCE WITH THE SPECIFICATIONS OR CREDIT PAYMENTS MADE BY RELIANT
FOR DEFECTIVE PRODUCT AND (B) REIMBURSE RELIANT FOR API LOST IN THE DEFECTIVE BATCH, SUBJECT TO THE LIMITATIONS IN ARTICLE 15.1, SHALL BE RELIANT’S SOLE AND EXCLUSIVE REMEDY (WITHOUT PREJUDICE TO ANY INDEMINIFICATION OBLIGATIONS UNDER SECTION
14.1 OR THE OBLIGATIONS OF SECTION 10.6 (RECALL)) UNDER THIS ARTICLE FOR DEFECTIVE PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED. 
  
 5.3 Supply of Material for Defective Product. In the event Cardinal Health is required to replace Product pursuant to Section 5.2, above, in no instance shall
Cardinal Health be liable for damage in excess of fees paid for Defective Product and API, subject to the limitation of liability in Section 15.1 and the indemnification obligations under Section 14.1. 
  
 ARTICLE 6 
 DELIVERY 
  
 6.1
Delivery. Cardinal Health shall segregate and store all Product until such Product has been Manufactured and Packaged to the Product Specifications. Upon such acceptance, Cardinal 
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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Health shall tender the Product for delivery, F.O.B. the Facility. Reliant shall be responsible for all costs and risk of loss associated with shipment of
the Product. Reliant shall qualify at least one (1) carrier to ship the Product, and if Reliant qualifies more than one carrier Reliant shall designate the priority of such qualified carriers to Cardinal Health. 
  
 6.2 Failure to Take Delivery. If Reliant fails to take delivery within seven (7) days
of any scheduled delivery date solely with respect to Product that has been deemed acceptable by Reliant, Reliant shall be invoiced for such Product pursuant to Section 7.5 On the first day of each subsequent month Reliant shall be invoiced for the
stored Product at a rate of [***] for administration and storage costs. For each such batch of accepted but undelivered Product, Reliant agrees that: (A) Reliant has made a fixed commitment to purchase such Product, (B) title and risk of loss for
such Product passes to Reliant, (C) such 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, Cardinal Health shall have the right to ship the Product to Reliant or
Reliant’s designee within four months after billing, and (E) Reliant will be responsible for any decrease in market value of such Product that relates to factors and circumstances outside of Cardinal Health’s control. Within five (5) days
following a written request from Cardinal Health, Reliant shall provide Cardinal Health with a letter confirming items (A) through (E) of this Section for each Batch of undelivered Product. 
  
 ARTICLE 7 
 PRICING AND PAYMENT 
  
 7.1 Unit Pricing. Reliant shall pay to Cardinal Health the unit pricing set forth on Exhibit B (“Unit Pricing”) for all Product. When a Purchase Order is placed, Reliant shall specify in such Purchase Order whether
each lot is designated for sample or trade product. For lots designated for samples, [***]. The parties shall reconcile all accounts annually, no later than thirty (30) days after the beginning of each Contract Year hereunder, including verification
by Reliant of its sampling program. In the event Reliant shall desire to [***], the parties shall reconcile such transfer and Cardinal Health shall credit the difference to Reliant within thirty (30) days of such notification. [***]. [***]. In the
event Reliant requests services other than Manufacturing and Packaging Product, Cardinal Health shall provide a written quote of the fee for such additional services and Reliant shall advise Cardinal Health whether it wishes to have such additional
services performed by Cardinal Health. 
  
 7.2 Product Maintenance Fee. In
partial consideration of the product maintenance services set forth in Section 2.3, Reliant shall pay Cardinal Health an annual Product Maintenance Fee of [***]. The initial Product Maintenance fee is payable on [***], and thereafter upon each
anniversary of such date during the Term. 
  
 7.3 Price Increase. The Unit
Pricing may be adjusted on an annual basis, effective on each anniversary date of the Effective Date, upon ninety (90) days’ written notice from Cardinal Health to Reliant. Such adjustment shall be based on actual increases or decreases in Raw
Material or Manufacturing and Packaging costs, subject to the following limitations: The Unit Pricing for Product shall include only: (a) the cost of Raw Materials and (b) Cardinal Health’s Manufacturing and Packaging costs, including without
limitation Cardinal Health’s labor, 
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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utilities and overhead. Any price adjustment shall limit the increase in component (b) [***]; provided, however, Cardinal Health shall use its
best commercial efforts to limit any increases hereunder as much as possible and Cardinal Health agrees to provide backup documentation for all annual increases, if any, and such costs and related documentation shall be auditable upon reasonable
notice by an independent third party reasonably acceptable to Cardinal Health and Reliant. Reliant shall bear all costs associated for such audit, unless such audit reveals that Cardinal Health exceeded the permitted increase, in which case Cardinal
Health shall bear the costs of the audit and shall credit such overpayment to Reliant. 
  
 7.4 Taxes; Duty. All taxes, duties and other amounts assessed on the Raw Materials, API or the Product prior to or upon sale to Reliant are the responsibility of Reliant, and Reliant shall reimburse Cardinal Health for any such
taxes, duties or other expenses paid by Cardinal Health, upon receipt of reasonable documentation. 
  
 7.5 Payment Terms. Cardinal Health shall invoice Reliant for all Product as provided in Section 7.1 and for any amounts due pursuant to Sections 4.1, and payment for such undisputed invoices shall be due within
thirty (30) days after the date of such invoice. In the event payment is not received by Cardinal Health on or before the thirtieth (30th) day after the date of the invoice, or in the case of the Product Maintenance Fee, upon the date set forth in Sections 7.2, then such unpaid amounts shall accrue interest at the rate of [***] per month until paid in full.

  
 ARTICLE 8 
 [Article 8 intentionally omitted] 
  
 ARTICLE 9 
 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 Cardinal Health, whether requested by Reliant 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. Cardinal Health shall respond promptly to any request made by Reliant 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. If after initial Product qualification, Reliant requests a change in the Specifications for
its own benefit or to comply with the requirements of a Regulatory Authority, the Specifications shall be amended as soon as possible after a request is made for any change in Specifications, and Cardinal Health shall notify Reliant of the costs
associated with such change and shall provide such supporting documentation as Reliant may reasonably require. Reliant shall pay all costs associated with such Reliant-requested changes or changes required by a Regulatory Authority as may be agreed
upon by the parties. Changes, agreed to between the parties, for the benefit of Cardinal Health, shall be at the expense of Cardinal Health. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this
Agreement shall control. 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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 ARTICLE 10 
 RECORDS; REGULATORY MATTERS 
  
 10.1
Batch Records and Data. Within thirty (30) days following the completion of Manufacturing and Packaging of each batch, Cardinal Health shall provide Reliant with properly completed copies of Manufacturing Related Reference Documents prepared
in accordance with the Specifications; provided, however, that if testing reveals an out-of-Specification result, Cardinal Health shall provide such Batch records within ten (10) days following resolution of the out-of Specification result.

  
 10.2 Recordkeeping. Cardinal Health shall maintain true and accurate
books, records, test and laboratory data, reports and all other information relating to Manufacturing and Packaging under this Agreement, including all information required to be maintained by all Applicable Laws. Such information shall be
maintained in forms, notebooks and records for a period of at least two (2) years from the relevant finished Product expiration date or longer if required under Applicable Laws. 
  
 10.3 Regulatory Compliance. Cardinal Health, with the assistance of Reliant, shall obtain all permits and licenses required by any
United States federal, state or local regulatory agency with respect to the Product and the Manufacturing and Packaging under this Agreement, including any product licenses, applications and amendments in connection therewith. Cardinal Health will
be responsible to maintain all permits and licenses required by any Regulatory Authority with respect to the Facility. During the Term, Cardinal Health will assist Reliant with all regulatory matters relating to Manufacturing and Packaging under
this Agreement, at Reliant’s request and at Reliant’s expense. Each party intends and commits to cooperate to satisfy all Applicable Laws relating to Manufacturing and Packaging under this Agreement. Cardinal Health shall provide a
Certificate of Compliance to Reliant annually during the Term. 
  
 10.4
Governmental Inspections and Requests. Cardinal Health shall immediately advise Reliant if an authorized agent of any Regulatory Authority visits the Facility concerning the Manufacturing or Packaging of the Product. Cardinal Health shall
furnish to Reliant a copy of the report by such Regulatory Authority, if any, within ten (10) days of Cardinal Health’s receipt of such report. Further, upon receipt of a Regulatory Authority request to inspect the Facilities or audit Cardinal
Health’s books and records with respect to Manufacturing or Packaging under this Agreement, Cardinal Health shall immediately notify Reliant, and shall provide Reliant with a copy of any written document received from such Regulatory Authority.
Cardinal Health shall permit Reliant to have a representative present for any such Product-specific Facility inspection unless such presence would be unreasonable under the circumstances. To the extent specifically related to the Manufacturing or
Packaging hereunder, Cardinal Health shall provide Reliant with a copy of any proposed written response prior to submission and a reasonable opportunity for Reliant to review and approve, provided such approval is not unreasonably withheld,
conditioned or delayed. 
  

 10.5 Reliant Inspections and Audits. 
  
 A. Except for circumstances as set forth in Section 10.4, during the term of this Agreement, duly-authorized employees,
agents and representatives of Reliant shall be granted access upon at least twenty-four (24) hours prior notice, unless more time is reasonably requested by Cardinal Health, and at reasonable times during regular business hours to only the portion
of the Facilities where Cardinal Health Manufactures or Packages API for the purpose of inspecting and verifying that Cardinal Health is Manufacturing and Packaging API in accordance with cGMPs, the Specifications and the Product Master Batch
Record. For purposes of this Section 10.5, duly-authorized agents and representatives shall be required to sign Cardinal Health’s standard Confidential Disclosure Agreement prior to being allowed access to Cardinal Health’s Facilities.

  
 B. With due regard to information and operations which
constitute Proprietary Information of Cardinal Health, duly-authorized employees, agents and representatives of Reliant shall have the right to inspect Cardinal Health Batch Records relating to Product and those portions of Cardinal Health’s
Facilities used for Manufacturing and Packaging Product. Reliant’s Quality Assurance Manager will arrange audit visits with Cardinal Health Quality Management. 
  
 10.6 Recall. In the event Cardinal Health believes a recall, field alert, Product withdrawal or field correction may be necessary
with respect to any Product provided under this Agreement, Cardinal Health shall immediately notify Reliant in writing. Cardinal Health will not act to initiate a recall, field alert, Product withdrawal or field correction without the express prior
written approval of Reliant, unless otherwise required by Applicable Laws. In the event Reliant believes a recall, field alert, Product withdrawal or field correction may be necessary with respect to any Product provided under this Agreement,
Reliant shall immediately notify Cardinal Health in writing and Cardinal Health shall provide all necessary cooperation and assistance to Reliant. Reliant shall solely control the implementation of such recall, filed alert, Product withdrawal or
field correction. The cost of any recall, field alert, Product withdrawal or field correction shall be borne by Reliant unless such recall, field alert, Product withdrawal or field correction is caused solely by Cardinal Health’s breach of its
representations, warranties and obligations under this Agreement or Applicable Laws or its negligence or willful misconduct, then such cost shall be borne by Cardinal Health. For purposes hereof, such cost shall be limited to reasonable, actual and
documented administrative costs incurred by Reliant for such recall, withdrawal or correction, and replacement of the Defective Product to be recalled, in accordance with Article 5. 
  
 10.7 Quality Agreements. Within thirty (30) days following the execution of this Agreement, the parties shall execute a Quality
Agreement in substantially the form attached to this Agreement as Exhibit C. The Quality Agreement shall in no way determine liability or financial responsibility of the parties for the responsibilities set forth therein. In the event of a
conflict between the terms of this Agreement and the Quality Agreement, this Agreement shall control. 
  
 10.8 Qualification of Additional Facilities. In the event Reliant requests that Cardinal qualify additional Facilities to Manufacture and Package the Product, Reliant shall be solely responsible for any costs
associated therewith which shall be limited to technology transfer and technology transfer service costs. In the event that Cardinal Health desires to qualify additional Facilities to 

  

 
Manufacture and Package the Product, Cardinal Health shall be solely responsible for any costs associated therewith. 
  
 ARTICLE 11 
 CONFIDENTIAL INFORMATION 
  
 11.1 Confidentiality Agreement. The use and disclosure of confidential information exchanged between the parties shall be governed by the Confidentiality Agreement by and between Cardinal Health, Reliant and Pronova Biocare, a.s.,
dated July 29, 2004 (the “Confidentiality Agreement”). 
  
 11.2 No
Implied License. Except as otherwise set forth herein, the party receiving Confidential Information (as such is defined in the Confidentiality Agreement) 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. 
  
 11.3 Return of Confidential Information. Upon termination or expiration of this Agreement, the party to which Confidential Information has been disclosed will,
upon request, promptly return within thirty (30) days, all such Confidential Information, including any copies thereof, and cease its use or, at the option of the receiving party, promptly destroy the same and certify such destruction to the
disclosing 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. 
  
 11.4 Disclosure of Confidential Information. Notwithstanding the terms set forth this Article 11 or the Confidentiality Agreement,
each of the Parties shall have the right to disclose the existence and terms of this Supply Agreement to those of its directors, managers, officers, employees, accountants, attorneys, advisers, agents, investment bankers, lenders and potential
lenders, financing sources, acquirers or business combination candidates who need to know such terms for the purpose of evaluating or entering into a potential business arrangement (“Third-Parties”); provided, that such Third-Parties are
required to maintain the confidentiality of this Supply Agreement to the same extent as if they were parties hereto Notwithstanding the foregoing, each of the Parties shall have the right to disclose the existence and terms of this Supply Agreement
as may be required by applicable laws or rules of any stock exchange to which a party or any Affiliate of a party is subject, in which case the disclosing party shall provide the non-disclosing party with prompt advance notice of such disclosure so
that the non-disclosing party shall have the opportunity if it so desires to seek a protective order or other appropriate remedy and, in connection with any disclosure required by the Securities and 

  

 
Exchange Commission or the rules of any stock exchange to which a party or any Affiliate of a party is subject, the disclosing party shall use reasonable
efforts to obtain confidential treatment for such disclosure. 
  
 11.5
Survival. The obligations of this Article 11 shall terminate five (5) years from the expiration or termination of this Agreement. 
  
 ARTICLE 12 
 INTELLECTUAL PROPERTY

  
 All Cardinal Health Technology, including, without
limitation, all improvements, developments, derivatives or modifications to the Cardinal Health Technology, shall be owned exclusively by Cardinal Health and, except as set forth herein no right or license in Cardinal Health Technology is
transferred or granted to Reliant. All Reliant Technology, including, without limitation, all improvements, developments, derivatives or modifications to the Reliant Technology shall be owned exclusively by Reliant. Reliant hereby grants to Cardinal
Health a non-exclusive, royalty-free license for the term of this Agreement to use Reliant Technology, but solely for the purpose of carrying out Cardinal Health’s obligations under this Agreement. For purposes hereof, “Cardinal Health
Technology” means all Softgel Technology, Cardinal Health 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 Cardinal Health 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 Cardinal Health. For purposes hereof, “Reliant Technology” means all proprietary
information, intellectual property and developments owned, developed, licensed or used by Reliant relating to the API, including, without limitation, patents, patent applications, know-how, inventions, designs, concepts, improvements, technical
information, trademarks or trade names. 
  
 ARTICLE 13

 REPRESENTATIONS AND WARRANTIES 
  
 13.1 Cardinal Health. Cardinal Health represents and warrants to Reliant 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
Manufactured and Packaged in conformance with the Product Specifications and Applicable Laws; 
  
 B. Cardinal Health will be solely responsible for and will obtain all governmental approvals, permits and licenses necessary or desirable in connection with the Manufacturing and Packaging of the API in the Territory.

  
 C. It has, and shall have, good, complete and valid rights to
utilize the Cardinal Health Technology utilized in connection with the Product and as contemplated by this 

  

 
Agreement. There are no patents owned by others related to the Cardinal Health Technology used with the Product which would be infringed or misused by
Cardinal Health’s performance of the Agreement and, to its knowledge, no trade secrets or other proprietary rights of others related to the Cardinal Health Technology used with the Product which would be infringed or misused by Cardinal
Health’s performance of this Agreement. 
  
 F. THE LIMITED
WARRANTY SET FORTH IN THIS SECTION 13.1 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 13.1,
CARDINAL HEALTH MAKES NO OTHER WARRANTY, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE MANUFACTURING AND PACKAGING OR THE PRODUCT. 
  
 13.2 Reliant. Reliant represents, warrants and covenants to Cardinal Health that: 
  
 A. The API and any other materials supplied by Reliant to Cardinal Health (“Reliant-supplied Materials”) will
comply with all applicable 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 Reliant Technology related to the API or any other Reliant supplied materials; 
  
 C. No specific safe handling instructions are applicable to the Product, the API or any other Reliant supplied materials, except as disclosed to Cardinal Health in writing by the Reliant in sufficient time for review
and training by Cardinal Health prior to delivery; 
  
 D. All
Product delivered to Reliant by Cardinal Health will be held, used and/or disposed of by the Reliant in accordance with all applicable laws, rules and regulations; 
  
 E. Reliant will comply with all laws, rules, regulations and guidelines applicable to Reliant’s performance under this
Agreement and its use of Product provided by Cardinal Health under this Agreement; 
  
 F. If release testing is conducted by Reliant, Reliant will not release any Batch of Product if the required Certificates of Analysis indicate that the Product does not comply with the Specifications; 
  
 G. The content of all artwork provided to Cardinal Health complies with all
Applicable Laws; 
  
 H. Reliant has all necessary authority and
right, title and interest in and to any copyrights, trademarks, trade secrets, patents, inventions and developments related to the API, the manufacture thereof, and any Product artwork; 
  

 I. To the knowledge of Reliant, the work to be performed by Cardinal Health 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. Reliant 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 in the Territory. 
  
 13.2 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 is validly 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 regulations or any material contractual obligation of such party and (2) do not materially conflict with, or constitute a material default or require any consent under, any material contractual obligation of such
party. 
  
 ARTICLE 14 
 INDEMNIFICATION 
  
 14.1 Indemnification by Cardinal Health. Cardinal Health shall indemnify and hold harmless Reliant, its Affiliates, directors, officers, employees and agents from
and against any and all suits, claims, losses, demands, liabilities, damages, costs and expenses (including reasonable attorney’s fees) in connection with any suit, demand or action by any third party (“Losses”) arising out of or
resulting from (A) any breach of its representations, warranties or obligations under this Agreement; (B) any negligence or willful misconduct by Cardinal Health, except to the extent that any of the foregoing arises out of or results from the
negligence, willful 

  

 
misconduct or breach of this Agreement by of Reliant; or (C) any actual or alleged infringement or violation of any patent, trade secret, copyright,
trademark or other proprietary rights used by Cardinal Health in Manufacturing and Packaging the Product, except to the extent such was provided by Reliant. 
  
 14.2 Indemnification by Reliant. Reliant shall indemnify and hold harmless Cardinal Health, its Affiliates, directors, officers, employees and agents from and
against all Losses arising out of or resulting from (A) any breach of its representations, warranties or obligations under this Agreement; (B) any manufacture, sale, promotion, distribution, use (other than by Cardinal Health) of or exposure to the
Product, the API or any Reliant-supplied materials, including, without limitation, product liability or strict liability; (C) Reliant’s exercise of control over the Manufacturing and Packaging under this Agreement, to the extent that
Reliant’s written instructions or directions violate applicable law or regulation; (D) any actual or alleged infringement or violation of any patent, trade secret, copyright, trademark or other proprietary rights provided by Reliant and used by
Cardinal Health in Manufacturing and Packaging the Product; or (E) any negligence or willful misconduct by Reliant, except to the extent that any of the foregoing arises out of or results from the negligence, willful misconduct or breach of this
Agreement by Cardinal Health. 
  
 14.3 Indemnification Procedures. All
indemnification obligations in this Agreement are conditioned upon the party seeking indemnification (the “Indemnified Party”): (A) promptly notifying the indemnifying party (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), provided, however, that failure to provide such notice within a reasonable period of time shall not relieve the
Indemnifying Party of any of its obligations hereunder except to the extent the Indemnifying Party is materially prejudiced by such failure; (B) cooperating with the Indemnifying Party in the defense of any such claim or liability (at the
Indemnifying Party’s expense), and (C) not compromising or settling any claim or liability without prior written consent of the Indemnifying Party. The liability of an Indemnifying Party under this Article XIV with respect to Losses arising
from claims of any Third Party which are subject to the indemnification provided for in this Article XIV (“Third Party Claims”) shall be governed by and contingent upon the following additional terms and conditions. If an
Indemnified Party shall receive notice of any Third Party Claim, the Indemnified Party shall give the Indemnifying Party notice of such Third Party Claim within thirty (30) days of the receipt by the Indemnified Party of such notice;
provided, however, that the failure to provide such notice shall not release the Indemnifying Party from any of its obligations under this Article XIV except to the extent the Indemnifying Party is materially prejudiced by such
failure. The Indemnifying Party shall be entitled to assume and control the defense of such Third Party Claim at its expense and through counsel of its choice if it gives notice of its intention to do so to the Indemnified Party within thirty (30)
days of the receipt of such notice from the Indemnified Party; provided, however, that if there exists a material conflict of interest that would make it inappropriate for the same counsel to represent both the Indemnified Party and
the Indemnifying Party, then the Indemnified Party shall be entitled to retain its own counsel, at the expense of the Indemnifying Party, provided that the Indemnifying Party shall not be obligated to pay the reasonable fees and expenses of more
than one separate counsel for all Indemnified Parties, taken together. In the event the Indemnifying Party exercises 

  

 
the right to undertake any such defense against any such Third Party Claim as provided above, the Indemnified Party shall cooperate with the Indemnifying
Party in such defense and make available to the Indemnifying Party, all witnesses, pertinent records, materials and information in the Indemnified Party’s possession or under the Indemnified Party’s control relating thereto as is
reasonably required by the Indemnifying Party. Similarly, in the event the Indemnified Party is, directly or indirectly, conducting the defense against any such Third Party Claim, the Indemnifying Party shall cooperate with the Indemnified Party in
such defense and make available to the Indemnified Party, all such witnesses, records, materials and information in the Indemnifying Party’s possession or under the Indemnifying Party’s control relating thereto as is reasonably required by
the Indemnified Party. The Indemnifying Party shall not, without the written consent of the Indemnified Party (which shall not be unreasonably withheld or delayed), (a) settle or compromise any Third Party Claim or consent to the entry of any
judgment which does not include as an unconditional term thereof the delivery by the claimant or plaintiff to the Indemnified Party of a written release from all liability in respect of such Third Party Claim or (b) settle or compromise any Third
Party Claim if the settlement imposes equitable remedies or material obligations on the Indemnified Party other than financial obligations for which such Indemnified Party will be indemnified hereunder and which contains no admission of fault or
wrongdoing. No Third Party Claim shall be settled or compromised by the Indemnified Party without the written consent of the Indemnifying Party (which shall not be unreasonably withheld or delayed) if such settlement or compromise would result in an
obligation of the Indemnifying Party to indemnify such Indemnified Party, or would otherwise result in liability of, or have an adverse impact upon, such Indemnifying Party. 
  
 ARTICLE 15 
 LIMITATIONS OF LIABILITY 
  
 15.1 CARDINAL HEALTH’S LIABILITY
UNDER THIS AGREEMENT FOR ANY AND ALL CLAIMS FOR LOST, DAMAGED OR DESTROYED API OR OTHER RELIANT-SUPPLIED MATERIALS WHETHER OR NOT SUCH API OR RELIANT-SUPPLIED MATERIALS ARE INCORPORATED INTO PRODUCT SHALL NOT EXCEED [***] PER BATCH, UP TO [***]. IN
THE EVENT THAT CARDINAL HEALTH LIABILITY FOR LOST API SHALL EXCEED [***] FOR ANY CONTRACT YEAR DURING THE TERM, THE PARTIES SHALL MEET WITHIN THIRTY (30) DAYS FROM THE DATE CARDINAL HEALTH’S LIABILITY FOR LOST API [***], OR (B) [***]. IN THE
EVENT THAT THE PARTIES CANNOT REACH AN AGREEMENT WITH REGARD TO THE FOREGOING SENTENCE WITHIN SUCH THIRTY (30) DAY PERIOD, RELIANT SHALL HAVE THE SOLE OPTION TO (X) [***] (Y) [***]. FOR AVOIDANCE OF DOUBT, ANY AMOUNTS OWING BY CARDINAL HEALTH
HEREUNDER SHALL NOT COUNT AGAINST THE LIABILITY CAP SET FORTH IN SECTION 15.2 BELOW. 
  
 15.2 NOTWITHSTANDING, AND SPECIFICALLY EXCLUDING, ANY AMOUNTS OWED BY CARDINAL HEALTH TO RELIANT UNDER SECTION 15.1 ABOVE, AND SPECIFICALLY EXCLUDING LOSSES RESULTING FROM CARDINAL HEALTH’S 
  
  
  
  
  

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GROSS NEGLIGENCE, FRAUD OR WILLFUL MISCONDUCT, CARDINAL HEALTH’S TOTAL LIABILITY UNDER THIS AGREEMENT OTHER THAN FOR LOST, DAMAGED OR DESTROYED API,
SHALL IN NO EVENT EXCEED [***]. 
  
 15.3 NEITHER PARTY SHALL BE LIABLE TO THE
OTHER PARTY FOR INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES (EXCEPT FOR THOSE INDEMNITY OBLIGATIONS UNDER ARTICLE 14 THAT ARE DEEMED CONSEQUENTIAL DAMAGES) ARISING OUT OF PERFORMANCE UNDER THIS AGREEMENT, INCLUDING WITHOUT LIMITATION,
LOSS OF REVENUES, PROFITS OR DATA, WHETHER IN CONTRACT OR TORT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 
  
 15.4 Limitation of Liability for Operation of Foreign Trade Subzone. Cardinal Health has been granted a special purpose subzone (the “FTZ”) that includes
the main plant of Cardinal Health’s US Facility. Reliant may recognize a number of economic benefits resulting from Cardinal Health’s operation of the FTZ. However, notwithstanding anything to the contrary contained herein, including but
not limited to the provisions of Section 14.1, Cardinal Health’s liability to the Reliant, if any, as a result of any and all liabilities, losses, claims, demands, damages, costs, expenses, settlements made or reasonably approved by Cardinal
Health, and money judgments (including attorneys’ fees and other costs of litigation), related to Cardinal Health’s operation of the FTZ, including, but not limited to: (A) Cardinal Health acting as Reliant’s agent for duty drawback
purposes pursuant to 19 CFR §191.9 with respect to the Product; and (B) the suspension or closing of the FTZ (whether voluntary or not)), incurred by or rendered against the Reliant for personal injury, sickness, disease or death and other
damages shall in no event exceed [***]. 
  
 ARTICLE 16

 INSURANCE 
  
 16.1 Cardinal Health. Cardinal Health 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 and general aggregate limits of not less than $1,000,000; (B) Products and Completed Operations Liability Insurance with per-occurrence and general aggregate limits of
not less than $5,000,000; (C) Workers’ Compensation and Employer’s Liability Insurance with statutory limits for Workers’ Compensation and Employer’s Liability insurance limits of not less than $1,000,000; and (D) Professional
Services Errors & Omissions Liability Insurance with per claim and aggregate limits of not less than $1,000,000 covering sums that Cardinal Health becomes legally obligated to pay as damages resulting from claims made by Reliant for errors or
omissions committed in the conduct of the services outlined in the Agreements. In lieu of insurance, Cardinal Health may self-insure any or a 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 and for a period of not less than three (3) years following the termination or expiration of this Agreement. Cardinal Health shall obtain a waiver from any
insurance carrier with whom Cardinal Health carries Workers’ Compensation insurance releasing its subrogation rights against Reliant. Reliant shall be named as an additional insured under the Commercial 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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General Liability and Products and Completed Operations Liability insurance policies as respects the manufacturing services outlined in this Agreement.
Cardinal Health shall furnish certificates of insurance for all of the above noted policies and required additional insured status to Reliant as soon as practicable after the Effective Date of the Agreement and upon renewal of any such policies.
Each insurance policy that is required under this Section shall be obtained from an insurance carrier with an A.M. Best rating of at least A- VII. 
  
 16.2 Reliant Insurance. Reliant 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) Products and Completed Operations Liability Insurance with per-occurrence and general aggregate limits of not less than $10,000,000; (B) Workers’ Compensation and Employer’s Liability Insurance with statutory limits for
Workers’ Compensation and Employer’s Liability insurance limits of not less than $1,000,000; (C) All Risk Property Insurance in an amount equal to full replacement value covering Reliant’s property while it is at Cardinal
Health’s facility; and (D) transit coverage in an amount not less than $1,000,000 while Reliant’s property is in transit to or from Cardinal Health’s facility. 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 and for a period of not less than three (3) years following the termination or expiration of this Agreement. Reliant shall obtain a waiver from any insurance carrier
with whom Reliant carries Workers’ Compensation insurance releasing its subrogation rights against Cardinal Health. Reliant shall obtain a waiver from any insurance carrier with whom Reliant carries Property Insurance releasing its subrogation
rights against Cardinal Health. Reliant shall not seek reimbursement for any property claim, or portion thereof, which is not fully recovered from Reliant’s Property Insurance policy. Cardinal Health and its Subsidiaries and Parent Corporation
shall be named as additional insureds under the Products and Completed Operations Liability insurance policies as respects the products and completed operations outlined in this Agreement. Reliant shall furnish certificates of insurance for all of
the above noted policies and required additional insured status to Cardinal Health as soon as practicable after the Effective Date of the Agreement and upon renewal of any such policies. Each insurance policy that is required under this Section
shall be obtained from an insurance carrier with an A.M. Best rating of at least A- VII. 
  
 ARTICLE 17 
 TERM AND TERMINATION 
  
 17.1 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 17.2 (the “Initial Term”). After the Initial Term, this Agreement may be automatically extended for further periods of one (1) year each (the “Renewal Term”), unless terminated by either party
upon written notice given to the other party at least twelve (12) months prior to the end of the Initial Term. The Initial Term and any Renewal Term shall constitute the Term. 
  
 17.2 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; provided, 

  

 
however, that failure to pay amounts due under this Agreement within thirty (30) days after such payments are due (as set forth in Section 7.5) more than two
(2) times in any Contract Year shall constitute cause for immediate termination of this Agreement, provided, however, that Reliant’s Chief Operating Officer, or his designee, and Cardinal’s Facility General Manager from each
party shall discuss such nonpayment in advance of termination. 
  
 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. 
  

17.3 Without Cause. Either party may terminate this Agreement without cause upon thirty-six (36) months’ written notice to the other party, following the
date which is twenty-four (24) months from the Effective Date. 
  
 17.4 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, Cardinal Health shall promptly return (1) any remaining inventory of materials received from Reliant, (2) all
remaining inventories of API and Product, and (3) any other Product, or API being stored for Reliant, to Reliant at Reliant’s expense. Cardinal Health shall have no obligation to return the foregoing until all outstanding undisputed invoices
sent by Cardinal Health to Reliant have been paid in full. For termination initiated by Reliant, Reliant shall also be required to pay for (Y) completed but not yet shipped Product and (Z) Product in process and Product shipped but not yet invoiced
in the event that this Agreement is terminated for reasons other than Cardinal Health’s default. In the event Reliant breaches or terminates this Agreement (other than as a result of a breach of this Agreement by Cardinal Health) or if Cardinal
Health terminates this Agreement under Section 17.2 hereof, Reliant will also be required to pay Cardinal Health for its direct cost of all materials purchased by Cardinal Health for Processing. Reliant shall specify the location in the continental
United States to which delivery, at Reliant’s expense, of the foregoing is to be made. 
  

 ARTICLE 18 
 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): 
  

			
	 To Reliant:
	  	Reliant Pharmaceuticals, Inc.
	 	  	110 Allen Road
	 	  	Liberty Corner, NJ 07938
	 	  	Attention: Director Manufacturing and Distribution
	 	  	Facsimile: 908.542.9405
		
	 With a copy to:
	  	Reliant Pharmaceuticals, Inc.
	 	  	110 Allen Road
	 	  	Liberty Corner, NJ 07938
	 	  	Attention: Vice President, Legal Affairs
	 	  	Facsimile: 908.542.9406
		
	 To Cardinal Health:
	  	Cardinal Health PTS, LLC
	 	  	2725 Scherer Drive
	 	  	St. Petersburg, Florida 33716
	 	  	Attention: President, Encapsulation,
	 	  	North America Oral Technologies
	 	  	Facsimile: (727) 803-2224
		
	 With a copy to:
	  	Cardinal Health, Inc.
	 	  	7000 Cardinal Place
	 	  	Dublin, Ohio 43017
	 	  	Attn: Associate General Counsel,
	 	  	Pharmaceutical Technologies and Services
	 	  	Facsimile: (614) 757-5051

  
 ARTICLE 19

 MISCELLANEOUS 
  
 19.1 Entire Agreement; Amendments. This Agreement including the attachments, as well as the Confidentiality Agreement dated July 29, 2004, constitute 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. 
  
 19.2 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. 
  
 19.3 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. 
  

 19.4 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. 
  
 19.5 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. 
  
 19.6 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. 
  
 19.7 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 (which consent shall not be unreasonably withheld, conditioned or delayed), 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 the performance of this
Agreement), or, in the case of Reliant, to a successor to all of the assets relating to the Product. 
  
 19.8 Governing Law. This Agreement shall be governed by and construed under the laws of the State of New York, excluding its conflicts of law provisions. 
  
 19.9 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 Cardinal Health and Reliant 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
(“CPR”), 366 Madison Avenue, New York, NY 10017. Arbitration shall be conducted in New York, New York. 
  
 19.10 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. 
  
 19.11 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 (which shall not be unreasonably withheld, conditioned or delayed), except as
required under applicable law or by any governmental agency, 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 (which shall not be
unreasonably withheld, conditioned or 

  

 
delayed) 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.

  
 19.12 Survival. The rights and obligations of the parties shall
continue under Articles 5 (Testing; Samples; Release), 7 (Payment Terms), 10 (Records; Regulatory Matters), 11 (Confidential Information), 12 (Intellectual Property), 14 (Indemnification), 15 (Limitations of Liability), 16 (Insurance) to the extent
expressly stated therein, 18 (Notice), 19 (Miscellaneous), Section 17.4 (Effect of Termination), and Sections 6.2 and 17.4, \notwithstanding expiration or termination of this Agreement. 
  
 19.13 Force Majeure. Except as to payments required under this Agreement, neither party shall be liable in damages 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, 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 storm, labor disturbances, epidemic,
or 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(s) beyond such party’s reasonable control. The party that may invoke
this section shall use all reasonable endeavors to reinstate its ongoing obligations to the other. If the cause(s) shall continue unabated for sixty (60) days, then both parties shall meet to discuss and negotiate in good faith what modifications to
this Agreement should result from this force majeure. 
  
 The
parties are executing this Agreement on the date stated in the introductory clause. 
  

									
	CARDINAL HEALTH PTS, LLC	 	 	 	RELIANT PHARMACEUTICALS, INC.
					
	 By:
	 	 	 	 	 	 By:
	 	 
	 Name:
	 	 David J. Heyens
	 	 	 	 Name:
	 	 Joseph S. Zakrzewski

	 Its:
	 	 President, Encapsulation North America
	 	 	 	 Its:
	 	 Chief Operating Officer

  

  
 EXHIBIT A 

SPECIFICATIONS 
  

  
 EXHIBIT B 

UNIT PRICING, FEES AND MINIMUM REQUIREMENT 
  

			
	UNIT PRICING – [***]
	 Units (millions)

	  	 Price per thousand Units

	 [***]
	  	[***]
	 [***]
	  	[***]
	 [***]
	  	[***]
	 [***]
	  	[***]
	 [***]
	  	[***]

  

			
	UNIT PRICING – [***]
		
	 Units (millions)

	 	 [***]

	 [***]
	 	 [***]

	 [***]
	 	 [***]

	 [***]
	 	 [***]

	 [***]
	 	 [***]

	 [***]
	 	 [***]

  

					
	 [***]

			
	 [***]
	 	[***]	 	[***]
	 [***]
	 	[***]	 	[***]
	 [***]
	 	[***]	 	[***]

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

	[***]:	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

  
 EXHIBIT C 

 
 MINIMUM YIELD SCHEDULE 
  
 [FORTHCOMING] 
  

  
 EXHIBIT D 

 
 QUALIFICATION, VALIDATION AND STABILITY SERVICES 
  

  
 EXHIBIT E 

 
 FORM OF QUALITY AGREEMENT 
  
 [FORTHCOMING]Manufacturing Services Agreement / Patheon Pharmaceuticals, Inc.

 Exhibit 10.34 
  
 EXECUTION COPY 
  
 MANUFACTURING SERVICES AGREEMENT 
  
 THIS MANUFACTURING SERVICES AGREEMENT (the “Agreement”) made as of the 6th day of April, 2004 
  
 BETWEEN: 
  

			
	 	  	PATHEON PHARMACEUTICALS INC.,
	 	  	a corporation existing under the laws of Delaware
		
	 	  	(hereinafter referred to as “Patheon”),
		
	 	  	 - and -

		
	 	  	RELIANT PHARMACEUTICALS, INC.
	 	  	a corporation existing under the laws of Delaware,
		
	 	  	(hereinafter referred to as the “Client”).

  
 THIS AGREEMENT
WITNESSES THAT in consideration of the rights conferred and the obligations assumed herein, and for other good and valuable consideration (the receipt and sufficiency of which are acknowledged by each party), and intending to be legally bound the
parties agree as follows: 
  
 ARTICLE 1 
  
 INTERPRETATION 
  

	1.1	Definitions. 

  
 The following terms shall, unless the context otherwise requires, have the respective meanings set out below and grammatical variations of such terms
shall have corresponding meanings: 
  
 “Act”
shall mean the Federal Food, Drug and Cosmetics Act, 21 U.S.C. §301 et seq. as may be amended from time to time and the regulations promulgated thereunder; 
  
 “Active Compound” or “API” means Isradipine; 
  
 “Affiliate” means, with respect to any party, any person or
entity that directly or indirectly through one or more intermediaries’ controls, is controlled by, or is under common control with, the person or entity specified. For purposes of this definition, “control” shall mean with respect to
an entity the direct or indirect ownership of 

  

 
(i) greater than fifty percent (50%) or more of the capital stock or share capital entitled to vote for the election of the directors of the entity or (ii)
greater than 50% of the equity or voting interest of the entity or (iii) the ability to otherwise direct the management and operations of the entity; 
  
 “Alza Technical Information” shall mean know how, trade secrets, inventions, data, technology and information relating to the Drug
or Drug Product, or the System which are owned by Alza and sublicensed to Reliant. Technical Information shall include without limitation, processes and analytical methodology used in development, testing, analysis and manufacture and medical,
clinical, toxicological or other scientific data; 
  
 “Applicable Laws” means all applicable laws, ordinances, rules and regulations of any kind whatsoever of any Authority relating to the Manufacturing Services; 
  
 “Authority” means any governmental or regulatory authority, department, body or agency or any court,
tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or municipal in the Territory; 
  
 “Business Day” means a day other than a Saturday, Sunday on which commercial banks are not authorized to close in the states of New
Jersey or Ohio; 
  
 “cGMPs” means current good
manufacturing practices as described in Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations, together with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated,
amended and revised from time to time; 
  
 “Capital
Letter” means the agreement between Patheon and the Client relating to the capital expenditures associated with the acquisition of certain equipment and Facility improvements which agreement shall substantially be in the form attached
hereto as Schedule H; 
  
 “Commencement Date”
means the date on which Patheon and/or Client has satisfied all regulatory requirements including those under the Act necessary for Patheon to commence performance of the Manufacturing Services hereunder; 
  
 “Components” means, collectively, all packaging components,
raw materials and ingredients (including labels, product inserts and other labelling for the Drug Product), required to be used in order to produce the Drug Product in accordance with the Specifications, other than the API or Granulations;

  
 “Components Costs” shall mean the cost of
Components as set forth in Section 2.1(c) hereto. 
  
 “Confidentiality Agreement” means the agreement relating to the non-disclosure of confidential information between Patheon and the Client dated December 9, 2003; 
  
 “Contract Year” means the twelve-month period coinciding with the calendar year. Notwithstanding the
foregoing for purposes of this Agreement the first Contract Year 

  

 2 

 
shall mean the period commencing on the Commencement Date to December 31, 2005. Thereafter each Contract Year shall be from January 1 to December 31 of each
calendar year during the Term of this Agreement; 
  
 “Conversion Costs” shall mean the cost to convert the Granulations into Drug Product as set forth in Section 4.2(a) hereto. 
  
 “Deficiency Notice” shall have the meaning ascribed thereto in Section 6.1(a); 
  
 “Drug” shall mean the pharmaceutical product DynaCirc® CR, whose active ingredient is the Active Compound;

  
 “Drug Layer Granulation” shall mean a
granulation of [***]; 
  
 “Drug Product” shall
mean the Drug to be produced by Patheon in bulk dosage form (DynaCirc® CR tablets 5 mg & 10 mg); 
  
 “Facilities” or singularly, “Facility” means the facility owned and operated by Patheon that is located at 2110 East Gaibraith Road, Cincinnati, Ohio; 
  
 “FCA” means Free Carrier Multimodal, as that term is
defined in INCOTERMS 2000; 
  
 “FDA” means the
United States government department known as the Food and Drug Administration and any successor agency performing similar functions; 
  
 “Firm Orders” has the meaning specified in Section 5.2(b); 
  
 “Granulations” shall mean collectively the Drug Layer Granulation and the Osmotic Layer Granulation

  
 “Intellectual Property” includes, without
limitation, rights in patents, patent applications, formulae, trade-marks, trade-mark applications, trade-names, Inventions, know how, copyright, industrial designs; 
  
 “Invention” means information relating to any innovation, improvement, development, discovery, computer
program, device, trade secret, method, know-how, process, technique or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which it is contained and whether or not patentable or copyrightable;

  
 “Inventory” means all inventories of
Components and work-in-process produced or held by Patheon in connection with the manufacture of the Drug Product but, for greater certainty, does not include Granulations; 
  
 “Manufacturing Services” means the manufacturing, compression, coating, laser drilling and over-coating,
quality control, quality assurance, bulk packaging and related services, as contemplated in this Agreement, required to produce Drug Product from Granulations and Components; 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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 3 

 “Minimum Run Quantity” means the minimum number of batches of the Drug Product to be
produced during the same cycle of manufacturing as set forth in Schedule B hereto; 
  
 “NDA” means the New Drug Application 20-336 as amended and supplemented for the Drug Product and as approved by the FDA to market the Drug Product and any materials, documents or information referred
to or relied upon therein; 
  
 “Novartis” shall
mean Novartis Consumer Health, Inc.; 
  
 “Osmotic Layer
Granulation” shall mean a granulate of polyethylene oxide and hydroxypropyl methylcellulose not including Active Compound produced by Novartis on behalf of Reliant and provided to Patheon for use under this Agreement; 
  
 “Packaged Drug Product” shall mean finished Drug Product
packaged by Novartis Pharmaceutical Corporation; 
  
 “Patheon Manufacturing Responsibilities” means Patheon’s responsibilities and obligations with respect to the provision of Manufacturing Services as set forth in Sections 2.1 and 2.2; 
  
 “Quality Agreement” means the agreement between the parties
hereto setting out the quality assurance standards to be applicable to the Manufacturing Services provided by Patheon which agreement shall substantially be in the form attached hereto as Schedule G; 
  
 “Specifications” means the file, for the Drug Product,
which is provided by the Client to Patheon and which contains documents relating to the Drug Product, including, without limitation: 
  

	 	(a)	specifications for Granulations and Components; 

  

	 	(b)	manufacturing specifications; 

  

	 	(c)	storage requirements; 

  

	 	(d)	all environmental, health and safety information relating to the Drug Product including material safety data sheets; 

  

	 	(e)	the finished Drug Product specifications, packaging specifications (if applicable) and shipping requirements for the Drug Product, which are attached hereto as Schedule A;

  
 and which comply with the NDA, and all as
updated, amended and revised from time to time by the Client in accordance with the terms of this Agreement; 
  
 “System” shall mean an oral osmotic system for the controlled administration of drugs. 
  
 “Technical Dispute” has the meaning specified in Section
12.2; 
  

 4 

 “Term” has the meaning specified in Section 8.1; 
  
 “Territory” means in the geographic area of the United
States, its territories and possessions including Puerto Rico; and 
  
 “Third Party Rights” means the Intellectual Property or any other rights of any third party. 
  

	1.2	Currency. 

  
 Unless otherwise indicated, all monetary amounts are expressed in this Agreement in the lawful currency of the United States of America. 
  

	1.3	Sections and Headings. 

  
 The division of this Agreement into Articles, sections, subsections and Schedules and the insertion of headings are for convenience of reference only and
shall not affect the interpretation of this Agreement. Unless otherwise indicated, any reference in this Agreement to a Section or Schedule refers to the specified Section or Schedule to this Agreement. In this Agreement, the terms “this
Agreement”, “hereof”, “herein”, “hereunder” and similar expressions refer to this Agreement and not to any particular part, Section, Schedule or the provision hereof. 
  

	1.4	Singular Terms. 

  
 Except as otherwise expressly provided herein or unless the context otherwise requires, all references to the singular shall include the plural and vice
versa. 
  

	1.5	Schedules. 

  
 The following Schedules are attached to, incorporated in and form part of this Agreement: 
  
 Schedule A - Drug Product Specifications 
 Schedule B - Minimum Run Quantity, Minimum Annual Volume & Fees 
 Schedule C - Intentionally Deleted

 Schedule D - Active Compound and Granulations 
 Schedule E - Batch Numbering & Expiration Dates 
 Schedule F - Technical Dispute Resolution 

Schedule G - Form of Quality Agreement 
 Schedule H - Capital Letter 
  

 5 

 ARTICLE 2 
  

PATHEON’S MANUFACTURING RESPONSIBILITIES 
  

	2.1	Manufacturing Services. 

  
 Patheon shall provide the Manufacturing Services for the Territory for the fees specified in Schedules B in order to produce Drug Product for the Client.
Subject to Client’s continuing obligation to purchase certain quantities of Packaged Drug Product from Novartis Pharmaceutical Corporation, during the Term and provided that Patheon is not in material default hereunder and is otherwise capable
of meeting all of Client’s demand for the Drug Product in accordance with forecasts and Firm Orders set forth in Section 5.2 hereof Client shall purchase all of its other requirements of Drug Product from Patheon. In providing the Manufacturing
Services, Patheon shall perform each of the following services: 
  

	 	(a)	Conversion of Granulations. Patheon shall convert the Granulations and Components into Drug Product. 

  

	 	(b)	Quality Control and Quality Assurance. Patheon shall perform the quality control and quality assurance testing specified in the Quality Agreement. Each time Patheon ships
Drug Product to the Client or Client’s designee, it shall provide the Client with a certificate of analysis that sets out the test results for each batch of Drug Product, and that certifies that such batch has been evaluated by Patheon’s
Quality Control/Quality Assurance department and that the Drug Product complies with the Specifications and a certificate of conformance certifying that the Drug Product was manufactured in accordance with cGMP’s. 

  

	 	(c)	Components. Patheon shall purchase and test all Components (with the exception of those that are supplied by the Client) at Patheon’s expense (the “Components
Costs”) and as specified by the Specifications. 

  

	 	(d)	Bulk Manufacture. Patheon shall manufacture the Drug Product in bulk in accordance with the terms of this Agreement. 

  
  
 [***] 
  

	2.2	Standard of Performance. 

  
 Patheon shall provide the Manufacturing Services for the Drug Product in accordance with the Specifications, Applicable Laws and cGMPs. Drug Product
manufactured hereunder shall not be adulterated or misbranded within the meaning of the Act. In performing the Manufacturing Services, Patheon shall maintain all necessary licenses, permits and other regulatory approvals necessary to comply with its
obligations hereunder. 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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 6 

	2.3	Exclusivity. 

  

	 	(a)	Patheon agrees that during the Term and [***] Patheon, its Affiliates and any successors thereto shall not manufacture or cause to manufacture for any party in the Territory or for
any party outside the Territory for sale inside the Territory other than Client (i) The Drug Product [***]. 

  

	 	(b)	Patheon further agrees that in the event this Agreement is terminated by Reliant pursuant to Sections 8.2 (a) or 8.2 (b), Patheon shall not manufacture or cause to manufacture for
any party in the Territory or for any party outside the Territory for sale inside the Territory for a period from the date of termination through December 31, 2010 (i) the Drug Product or [***]. 

  

	 	(c)	Notwithstanding section 2.3 (a) above in the event Patheon terminates this Agreement pursuant to sections 8.2(b) or 8.2 (d) hereof, the prohibition set forth in section 2.3(a)(ii)
shall not apply. 

  

	 	(d)	Patheon agrees that it shall not manufacture and cause its Affiliates and any successors not to manufacture any products that are manufactured using the Alza Technical Information
unless such party has a valid and existing license to utilize the Alza Technical Information in the manufacture of the product (s). 

  

	 	(e)	Patheon further agrees it shall not at any time use Client Confidential Information for any purpose other than to perform its obligations under this Agreement.

  
 ARTICLE 3 
  
 CLIENT’S OBLIGATIONS 
  

	3.1	Payment. 

  
 Pursuant to the terms of this Agreement, the Client shall pay Patheon for the provision of the Manufacturing Services according to the fees specified in
Schedule B (such fees being subject to adjustment in accordance with the terms hereof). 
  

	3.2	Granulations. 

  
 The Client shall, at its sole cost and expense, deliver or have delivered the Granulations to Patheon in sufficient quantities and at such times to
facilitate the provision of the Manufacturing Services by Patheon, which Granulations shall be held by Patheon on behalf of the Client on the terms and subject to the conditions herein contained. The parties acknowledge and agree that title to the
Granulations shall at all times belong to and remain the property of the 
  
  
  
  
  

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 7 

 
Client. Patheon agrees that any Granulations received by it shall only be used by Patheon to provide the Manufacturing Services. Patheon’s liability
with respect to any lost or damaged Granulations shall be as set forth in Section 10.2. 
  
 ARTICLE 4 
  
 CONVERSION FEES AND COMPONENT COSTS 
  

	4.1	First Year Pricing. 

  
 The fees for the Manufacturing Services (which fees include Conversion costs and Component costs) listed in Schedule B (the “Manufacturing
Fees”) are intended by the parties to be fixed for the first Contract Year of this Agreement, subject to the amendments to such fees provided for in this Article 4. Manufacturing Fees may be referred to herein as the “Fee” or
“Fees”. 
  

	4.2	Subsequent Years’ Pricing. 

  
 For each Contract Year commencing January 1, 2006 the Fees during the Contract Year shall be determined in accordance with the following: 
  

	 	(a)	Manufacturing Costs. Patheon shall be allowed to adjust the Fees: (i) for costs associated with the conversion of Granulations and Components into Drug Product (the
“Conversion Costs”) in respect of the Drug Product based on the most recently available final Producers’ Price Index for Pharmaceutical Product as published by the U.S. Bureau of Labor Statistics or any governmental successor thereto
(“PPI”) using the procedure set forth in Section 4.3 and (ii) for Component Costs to pass on the actual amount of any increase or decrease in such costs without mark-up. For each Contract Year in which Patheon is entitled to adjust
the Fees Patheon shall provide Client with written notice of any change in the Fees within 30 days of receipt by Patheon of the Annual Forecast. The Parties agree that the Fees shall not be adjusted more than once per Contract Year, however this
limitation shall not include price adjustments under section 4.3 or 4.4. In addition, notwithstanding anything herein to the contrary, Manufacturing Fees associated with Conversion Costs shall not be increased by [***] per annum in any Contract Year
during the Term. There shall be no similar limitation in terms of increases in Component Costs which shall be passed on to Client in an amount equal to the actual increase paid by Patheon without markup. 

  

	 	(b)	Annual Forecast. By July 1st of each Contract Year of this Agreement, the Client shall provide Patheon a yearly volume projection for Drug Product. To the extent that Patheon
reasonably determines that the projections contained in that yearly volume forecast necessitate that an adjustment be made to the Fees for such Contract Year, Patheon shall, within 30 days of receipt by Patheon of the yearly forecast, be entitled to
request an appropriate price adjustment. 

  
  
  
  
  

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 8 

	 	(c)	Pricing Basis. The Client acknowledges that the Fees in any Contract Year are quoted based upon the Minimum Run Quantity and estimated annual volume for the Drug Product
specified in Schedule B or thereafter specified in the forecast provided pursuant to Section 4.2(b) for the Contract Year and is subject to change if the specified Minimum Run Quantity and estimated annual volume is not met. For greater certainty,
if Patheon and the Client agree that the Minimum Run Quantity of the Drug Product shall be reduced whether as a result of a decrease in estimated annual volume or otherwise and, as a result of such reduction, Patheon’s Fees materially increase
on a per unit basis, then subject to the limitation set forth in 4.2(a) above Patheon shall be entitled to an increase in the Fees by an amount sufficient to absorb such increase. 

  
 In connection with a Fee adjustment pursuant to Section 4.2(a), Patheon shall
deliver to the Client a revised Schedule B and a statement outlining the percentage increase in the PPI upon which such Fee adjustment is based. In connection with all Fee adjustment requests pursuant to this Section 4.2(b) and 4.2(c), Patheon shall
deliver to the Client a revised Schedule B and such budgetary pricing information or other documentation reasonably sufficient to demonstrate that a Fee adjustment is justified, provided that Patheon shall have no obligation to provide any
supporting documents to the extent such documents are subject to obligations of confidentiality between Patheon and its suppliers. 
  
 From the date Patheon submits a written request for a price adjustment as per the terms described above, Patheon shall continue to perform the
Manufacturing Services while the parties engage in negotiation of revised Fees. Once a price adjustment has been agreed upon such adjustment shall apply retroactively to the later of the first day of the relevant Contract Year or the date in which
the written request is received by Client unless the Parties otherwise agree. 
  

	4.3	Adjustments to Pricing. 

  
 During any Contract Year of this Agreement, the Fees set out in Schedule B or Schedule C shall be subject to adjustment in accordance with the following:

  

	 	(a)	Volume Reduction. If at any time and from time to time Patheon determines, acting reasonably and based on the forecasts and Firm Orders received from the Client, that the
current yearly volumes (including, without limitation, any permanent reductions in volumes) relating to the Drug Product will constitute no more than [***] of the minimum annual volume for the Drug Product specified in Schedule B hereto or, if
applicable, any revised minimum annual volume hereinafter agreed to by the parties, then Patheon shall be entitled to request an adjustment to the Fees to reflect the demonstrated material increased costs that Patheon will incur as a result of the
reduced volumes. 

  

	 	(b)	Extraordinary Increases in Component Costs. If at any time market conditions result in Patheon’s cost of Components being materially greater than normal forecasted
increases, then Patheon shall be entitled to request an adjustment to the Fees to compensate it for such demonstrated material increased in Component costs. For the purposes of this Section 4.3(b), changes materially greater than

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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 9 

	 	 
normal forecasted increases shall be considered to have occurred if: (i) the cost of a Component increases by [***] of the cost for that Component upon which
the fee quote was based; or (ii) the aggregate cost for all Components required to manufacture the Drug Product increases by [***] of the total Component costs for such Drug Product upon which the fee quote was based. To the extent that Component
costs have been previously adjusted pursuant to Section 4.2(a) or this Section 4.3(b) to reflect an increase in the cost of one or more Components, the adjustments provided for in (i) and (ii) above shall operate based on the costs attributed to
such Component (or Components) at the time the last of such adjustments were made. In the event Component costs decrease so that they are less than the amount forecasted, such cost reductions shall be passed through to Client.

  
 In connection with a Fee adjustment request pursuant to this
Section 4.3, Patheon shall deliver to the Client a revised Schedule B or Schedule C and such budgetary pricing information, adjusted Component costs or other documentation reasonably sufficient to demonstrate that a Fee adjustment is justified,
provided that Patheon shall have no obligation to provide any supporting documents to the extent such documents are subject to obligations of confidentiality between Patheon and its suppliers. Upon delivery of such a request, each of the Client and
Patheon shall forthwith use all reasonable efforts to agree on a revised Fee. 
  
 From the date Patheon submits a written request for a price adjustment as per the terms described above, Patheon shall continue to perform the Manufacturing Services while the parties engage in negotiation of revised
Fees. Once a price adjustment has been agreed upon such adjustment shall apply retroactively to the later of the first day of relevant Contract Year unless the Parties otherwise agree or the date in which the written request is received by Client.

  

	4.4	Adjustments Due to Technical Changes. 

  
 Amendments to the Specifications or the Quality Agreement requested by the Client will only be implemented following a technical and cost review by
Patheon and are subject to the Client and Patheon reaching agreement as to revisions, if any, to the Fees specified in Schedules B or C necessitated by any such amendment. If the Client accepts a proposed fee change, the proposed change in the
Specifications shall be implemented, and the fee change shall become effective only with respect to those orders of Drug Product that are manufactured in accordance with the revised Specifications. In addition, the Client agrees to purchase, at
Patheon’s cost therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Inventory), all Inventory utilized under the “old” Specifications and purchased or maintained by Patheon in order to
fill Firm Orders or in accordance with Section 5.3, to the extent that such Inventory can no longer be utilized under the revised Specifications. Open purchase orders for Components no longer required under any revised Specifications that were
placed by Patheon with suppliers in order to fill Firm Orders or in accordance with Section 5.3 shall be cancelled where possible, and where such orders are not subject to cancellation without penalty, shall be assigned to and satisfied by the
Client. 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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 10 

 ARTICLE 5 
  

ORDERS, DELIVERY, INVOICING, PAYMENT 
  

	5.1	Market Outlook. 

  
 The Client acknowledges that for optimal production planning, Patheon requires an understanding of the Client’s strategic vision for the Drug Product
in the market and agrees, to the extent that such information (including, if any, the Client’s five-year market outlook studies) exists, to share such information with Patheon, provided that such information may not be relied upon by Patheon
for any purpose and further provided that any information so provided shall be subject to the confidentiality provisions of Article 11. 
  

	5.2	Orders and Forecasts. 

  
 (a) Rolling Forecasts. No later than ten (10) days of the Commencement Date, the Client shall provide Patheon with a written non-binding 18 month
forecast of the volume of the Drug Product that the Client then anticipates will be required to be produced and delivered to the Client during each month of that 18 month period. Such forecast will be updated by the Client monthly on a rolling 18
month basis and updated forthwith upon the Client determining that the volumes contemplated in the most recent of such forecasts has changed by more than 20%. The most recent 18 month forecast shall prevail. 
  
 (b) Firm Orders. No later than ten (10) days of the Commencement Date
and on or before the 20th day of each calendar month thereafter, the Client shall issue firm written orders (“Firm Orders”) for the Drug Product to be produced and delivered to the Client on a date not less than 90 days from the
first day of the calendar month immediately following the date that the Firm Order is submitted. Such Firm Orders submitted to Patheon shall specify the Client’s purchase order number, quantities of Drug Product, monthly delivery schedule and
any other elements necessary to ensure the timely production and delivery of the Drug Product. The quantities of Drug Product ordered in such written orders shall be firm and binding on the Client and shall not be subject to reduction by the Client.

  
 (c) Three Year Forecast. No later than fifteen (15)
days of the Commencement Date, and on or before May 1st in each Contract Year thereafter, the Client shall provide Patheon with a written non-binding three-year forecast (broken down by quarters for the second and third years of the forecast) of the
volume of the Drug Product the Client then anticipates will be required to be produced and delivered to the Client during the three-year period. 
  

	5.3	Reliance by Patheon. 

  
 The Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted pursuant to Sections 5.2(a) and (b) in
ordering the Components required to meet such Firm Orders. In addition, the Client understands that to ensure an orderly supply of such Components and to achieve economies of scale in the costs, it may be desirable for Patheon to purchase such
Components in sufficient volumes to meet the production requirements for Drug Product during part or all of the forecasted periods referred to 

  

 11 

 
in Section 5.2(a) or to meet the production requirements of any longer period agreed to by Patheon and the Client. Accordingly, the Client authorizes Patheon
to purchase Components in order to satisfy the production requirements for Drug Product for the first six months contemplated in the most recent forecast provided by the Client pursuant to Section 5.2(a), and agrees that Patheon may make such other
purchases of Components to meet production requirements during such longer periods as may be agreed to in writing from time to time by the Client at the request of Patheon. If Components ordered by Patheon pursuant to Firm Orders or this Section 5.3
are not included in finished Drug Product purchased by the Client within six months after the forecasted month in respect of which such purchases have been made (or such longer period as the parties may agree), the Client shall pay to Patheon its
costs therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Components) and, in the event such Components are incorporated into Drug Product subsequently purchased by the Client or into third party
products manufactured by Patheon and subsequently purchased by a third party, the Client will receive credit for any costs of such Components previously paid to Patheon by the Client. 
  

	5.4	Minimum Orders. 

  
 The Client may only order Drug Product in multiples of the Minimum Run Quantities set out in Schedule B. 
  

	5.5	Shipments. 

  
 Shipments of Client’s Drug Product shall be made FCA (as defined in INCOTERMS 2000) Patheon’s shipping point unless otherwise mutually agreed.
Such title as Patheon has in Drug Product and risk of loss or of damage to Drug Product shall remain with Patheon until Drug Product is loaded onto the carrier’s vehicle by Patheon for shipment at the shipping point at which time title and risk
of loss or damage shall transfer to the Client. Unless otherwise agreed, Patheon shall, in accordance with the Client’s instructions and as agent for the Client, (i) arrange for shipping to be paid by the Client and (ii) at the Client’s
risk and expense, obtain any export licence or other official authorization necessary to export the Drug Product. The Client shall arrange for insurance and shall select the freight carrier used by Patheon to ship Drug Product and may monitor
Patheon’s shipping and freight practices as they pertain to this Agreement. Drug Product shall be transported in accordance with the Specifications. 
  

	5.6	Invoices and Payment. 

  
 Patheon shall submit to the Client, with each shipment of Drug Product, an invoice covering such shipment. Patheon shall also provide the Client with an
invoice covering any Inventory or Components which are to be purchased by the Client pursuant to the terms of this Agreement. Each such invoice shall, to the extent applicable, identify the Client purchase order number, Drug Product numbers, names
and quantities, unit price, freight charges and the total amount to be remitted by the Client. The Client shall pay all such undisputed amounts on invoices within 30 days of the date of the invoice. Any undisputed amounts not paid by Client when due
under this Agreement shall be subject to interest beginning on the date which is thirty (30) days from the date of the invoice and including the date upon which such payment is received at a rate equal to the lesser or (i) one and one half percent
(1 1/2%) per month or (ii) the highest rate permitted by Applicable Laws. In each case, interest shall be
calculated daily on the basis of a 365 day year. 
  

 12 

 ARTICLE 6 
  

PRODUCT CLAIMS AND RECALLS 
  

	6.1	Product Claims. 

  
 (a) Product Claims. The Client has the right to reject any portion of any shipment of Drug Product that deviates from the Specifications, cGMPs, or
Applicable Laws without invalidating any remainder of such shipment. The Client shall inspect the Drug Product manufactured by Patheon upon receipt thereof and shall give Patheon written notice (a “Deficiency Notice”) of all claims
for Drug Product that deviate from the Specifications, cGMPs, or Applicable Laws within 30 days after the Client’s receipt thereof (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Drug Product, within
30 days after discovery thereof by the Client, but in no event after the expiration date of the Drug Product). Should the Client fail to provide Patheon with the Deficiency Notice within the applicable 30-day period, then the delivery shall be
deemed to have been accepted by the Client on the 30th day after delivery or discovery, as applicable. Except as set
out in Section 6.2, Patheon shall have no liability for any deviations for which it has not received notice within the applicable 30-day period. 
  
 (b) Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall have 10 days to advise the Client by notice in writing that it
disagrees with the contents of such Deficiency Notice. If the Client and Patheon fail to agree within 10 days after Patheon’s notice to the Client as to whether any Drug Product identified in the Deficiency Notice deviates from the
Specifications, cGMPs, or Applicable Laws, then the parties shall mutually select an independent laboratory to evaluate if the Drug Product deviates from the Specifications or cGMPs. Such evaluation shall be binding on the parties, and if such
evaluation certifies that Drug Product deviates from the Specifications, cGMPs, or Applicable Laws, the Client may reject those Drug Product in the manner contemplated in this Section 6.1. If such evaluation does not so certify in respect of any
such Drug Product, then the Client shall be deemed to have accepted delivery of such Drug Product on the 40th day
after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Drug Product, on the 40th day after discovery thereof by the Client, but in no event after the expiration date of the Drug Product). 
  
 (c) Patheon Responsibility. In the event the Client rejects Drug Product in accordance with this Section 6.1 and the deviation is determined to
arise from Patheon’s failure to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities, Patheon will credit the Client’s account for Patheon’s invoice price to the Client for such defective
Drug Product. If the Client shall have previously paid for such defective Drug Product, Patheon shall promptly, at the Client’s election, either: (i) refund the invoice price for such defective Drug Product; (ii) offset such amount against
other amounts due to Patheon hereunder; or (iii) replace such Drug Product with conforming Drug Product without the Client being liable for payment therefor under Section 3.1, contingent upon the receipt from the Client 

  

 13 

 
of all Active Compounds or Granulations (as the case may be) (which shall be paid for by Patheon, subject to the limitations set out in Section 10.2)
required for the manufacture of such replacement Drug Product. 
  
 (d) Shortages. Claims for shortages in the amount of Drug Product shipped by Patheon shall be dealt with as may reasonably be agreed to by the parties. 
  

	6.2	Product Recalls and Returns. 

  
 (a) Records and Notice. Patheon and the Client shall each maintain such records as may be necessary to permit a Recall of any Drug Product
delivered to the Client or customers of the Client. Each party shall promptly notify the other by telephone (to be confirmed in writing) of any information, which might affect the marketability, safety or effectiveness of the Drug Product and/or
which might result in the Recall or seizure of the Drug Product. Upon receiving any such notice or upon any such discovery, each party shall cease and desist from further shipments of such Drug Product in its possession or control until a decision
has been made whether a Recall or some other corrective action is necessary. The decision to initiate a Recall or to take some other corrective action, if any, shall be made and implemented by the Client. “Recall” shall mean any action:
(i) by the Client to recover title to or possession of quantities of the Drug Product sold or shipped to third-parties (including, without limitation, the voluntary withdrawal of Drug Product from the market); or (ii) by any regulatory authorities
to detain or destroy any of the Drug Product. “Recall” shall also include any action by either party to refrain from selling or shipping quantities of Drug Product to third-parties which would have been subject to a Recall if sold or
shipped. 
  
 (b) Recalls. In the event (i) any governmental
or regulatory authority issued a directive, order or, following the issuance of a safety warning or alert with respect to Drug Product, a written request that any Drug Product be Recalled, (ii) a court of competent jurisdiction orders such a Recall,
or (iii) the Client determines that any Drug Product should be Recalled or that a “dear doctor” letter is required relating the restrictions on the use of any Drug Product, Patheon will co-operate as reasonably required by the Client,
having regard to all applicable laws and regulations. 
  
 (c)
Product Returns. The Client shall have the responsibility for handling customer returns of the Drug Product. Patheon shall provide the Client with such assistance as the Client may reasonably require handling such returns. 
  
 (d) Patheon’s Responsibility. To the extent that a Recall or
return results from, or arises out of, a failure by Patheon to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities, Patheon shall be responsible for the documented out-of- pocket expenses of such Recall
or return and shall use its commercially reasonable efforts to replace the Recalled or returned Drug Product with new Drug Product, contingent upon the receipt from the Client of all Granulations (which shall be paid for by Patheon, subject to the
limitations set out in herein) required for the manufacture of such replacement Drug Product. In the event that Patheon is unable to replace the Recalled or returned Drug Product (except where such inability results from a failure to receive the
required Granulations), then the Client may request Patheon to reimburse the Client for: (i) the price that the Client paid to Patheon for 

  

 14 

 
manufacturing the affected Drug Product; and (ii) the cost of the Granulations. In all other circumstances, Recalls, returns or other corrective actions
shall be made at the Client’s cost and expense. Patheon’s maximum liability associated with any Recall or return of a Drug Product shall be [***] per Recall or return event. 
  

	6.3	Disposition of Defective or Recalled Drug Product. 

  
 The Client shall not dispose of any damaged, defective, returned or Recalled Drug Product in relation to which it intends to assert a claim against
Patheon without Patheon’s prior written authorization to do so. Alternatively, Patheon may instruct the Client to return such Drug Product to Patheon. Patheon shall bear the cost of disposition with respect to any damaged, defective, returned
or Recalled Drug Product in relation to which it bears responsibility under Section 6.1 or 6.2 hereof. In all other circumstances, the Client shall bear the cost of disposition with respect to any damaged, defective, returned or Recalled Drug
Product. 
  

	6.4	Customer Questions and Complaints. 

  
 The Client shall have the sole responsibility for responding to questions and complaints from the Client’s customers. Questions or complaints
received by Patheon from the Client’s customers shall be promptly referred to the Client. Patheon shall co-operate as reasonably required to allow the Client to determine the cause of and resolve any customer questions and complaints. Such
assistance shall include follow-up investigations, including testing. In addition, within 30 days from the date of request, Patheon shall provide the Client with all necessary information that will enable the Client to respond properly to questions
or complaints relating to the Drug Product. Unless it is determined that the cause of any customer complaint resulted from a failure by Patheon to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities, all
costs incurred in respect of this Section 6.4 shall be borne by the Client. 
  

	6.5	Sole Remedy. 

  
 Except for the Client’s right to terminate this Agreement in accordance with the applicable provisions of Section 8 hereof and the indemnity provided
in Section 10.3 and subject to the limitations set forth in Sections 10.1 and 10.2, the remedies described in this Article 6 shall be the Client’s sole remedy for any failure by Patheon to provide the Manufacturing Services in accordance with
the Patheon Manufacturing Responsibilities. 
  
 ARTICLE 7

  
 CO-OPERATION 
  

	7.1	Quarterly Review. 

  
 Each party shall forthwith upon execution of this Agreement appoint one of its employees to be a relationship manager responsible for liaison between the
parties. The relationship managers shall meet not less than quarterly to review the current status of the business relationship and manage any issues that have arisen. 
  
  
  
  
  
  
  
  
  
  
  

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 15 

	7.2	Governmental Agencies. 

  
 Subject to Section 7.8, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for
granting regulatory approval for the Drug Product, regarding such Drug Product if in the opinion of that party’s counsel, such communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental
order or regulation; provided, however, that unless in the reasonable opinion of its counsel there is a legal prohibition against doing so, such party shall permit the other party to accompany and take part in any communications with the agency, and
to receive copies of all such communications from the agency. 
  

	7.3	Records and Accounting by Patheon. 

  
 Patheon shall keep records of the manufacture, testing and shipping of the Drug Product, and retain samples of such Drug Product as are necessary to
comply with the Act and Applicable Laws applicable to Patheon, as well as to assist with resolving Drug Product complaints and other similar investigations. Copies of such records and samples shall be retained for a period of one year following the
date of Drug Product expiry, or longer if required by Applicable Laws. The Client is responsible for retaining samples of the Drug Product necessary to comply with regulatory requirements and Applicable Laws applicable to the Client. 
  

	7.4	Inspection. 

  
 The Client may inspect Patheon reports and records relating to this Agreement during normal business hours and with reasonable advance notice, provided a
Patheon representative is present during any such inspection. 
  

	7.5	Audit. 

  
 (a) Client or its representatives shall have the right, upon reasonable advance notice, with reasonable frequency and during regular business hours, to
inspect and audit the Facilities being used by Patheon for production or supply of Drug Product including all documentation related thereto to assure compliance by Patheon with the terms of this Agreement, Applicable Laws and cGMP’s. Such
inspection and audit shall be limited to those portions of such facilities as are involved in the production of Drug Product, and shall be, conducted in a manner so as to minimize disruption of Patheon’s business operations. 
  
 (b) If any of such audits reveal that the Facilities do not satisfy the
requirements of this Agreement, Applicable Laws and cGMP’s in any material respect, then Client shall provide Patheon with written notice of such fact, which notice shall contain in reasonable detail (including reference to the applicable
standard or criteria which has not been met) the deficiencies found in the Facilities and, if practicable, those steps which should be undertaken in order to remedy such deficiencies. Patheon shall use its commercially reasonable efforts to remedy,
within the time to be agreed upon between the parties (the “GMP Remediation Period”), any deficiencies which may be noted in any such audit. In the event that Patheon does not remedy, or is incapable of remedying, any of such
material deficiencies within such GMP Remediation Period, then Client shall be entitled to terminate this Agreement immediately upon written notice to Patheon, in which event Patheon shall, at its cost and expense, (i) provide such 

  

 16 

 
reasonable assistance and grant such licenses as shall be necessary in order for Client to transfer the manufacture of the Drug Product to itself or an
alternative manufacturer; Client shall be entitled to deduct and/or set off against any amounts due Patheon under this Agreement any costs or expenses incurred by Client in connection with Client obtaining an alternative manufacturer of Drug
Product, provided that such amounts shall not exceed a commercially reasonable amount in accordance with generally accepted industry standards. 
  
 (c) During the term of this Agreement and for three (3) years after the expiration of the last lot of Drug Product manufactured pursuant to the
Specifications, Client may audit manufacturing process records, and quality assurance/quality control records directly relating to the Manufacturing Services and the Drug Product. To the extent such records are not separable from other Client
records, Patheon shall give reasonable access to an independent auditor selected by Client who shall audit the records pertaining to the Manufacturing Services and may disclose the results of the audit only to the extent it relates to this
Agreement. In no event shall other Client information be disclosed to Client. 
  
 (d) Patheon acknowledges that the provisions of this Section 7.5 granting Client certain audit rights shall in no way relieve Patheon of any of its obligations under this Agreement, nor shall such provisions require
Client to conduct any such audits. 
  
 (e) For greater certainty,
the audit rights provided in this Section 7.5 shall not include a right to audit or inspect Patheon’s financial records. Patheon shall notify the Client of any inspections by any governmental agency involving the Drug Product. 
  

	7.6	Regulatory Compliance. 

  
 (a) Patheon shall advise Client immediately (within 24 hours) if the FDA or other regulatory Authority visits or advises Patheon of its intent to visit
Patheon’s Facility in connection with an inquiry or an inspection related to or affecting the Drug Product. Patheon shall provide Client the opportunity to be present at any visit or inspection relative to the Drug Product and to review prior
to submission any documentation prepared in response to an inquiry relating to the Drug Product and Patheon shall immediately (within 24 hours) provide Client with the final report resulting from any such inspections or inquiries. 
  
 (b) Patheon shall provide Client with immediate notification (within 24
hours) of its receipt of any of the following related to its manufacturing, production or testing activities in connection with or related to the Drug Product: (i) a copy of any list of observations (Form FDA483); Warning Letters; Information
Letters; Regulatory Letters or the like issued by the FDA (collectively “Regulatory Notices”) and, to the extent practicable, shall provide Client an opportunity to review any written response relating to the Drug Product prior to
submission to the issuing agency. Patheon shall provide to Client any additional Regulatory Notices received from the FDA following a response by Patheon to the initial Regulatory Notice. Patheon shall maintain sole responsibility for any matter
pertaining to such inspections. 
  

	7.7	Reports. 

  
 Patheon will supply on an annual basis all Drug Product data, including release test results, complaint test results, all investigations (in
manufacturing, testing and storage), and 

  

 17 

 
the like, that the Client reasonably requires in order to complete any filing under any applicable regulatory regime, including any annual product review
report that the Client is required to file with the FDA. At the Client’s request and subject to an additional fee to be agreed by the parties, Patheon may prepare annual product review reports on behalf of the Client and in accordance with the
Client’s instructions. 
  

	7.8	FDA Filings. 

  
 (a) FDA Filings. The Client shall have the sole responsibility for filing all documents with the FDA and taking any other actions that may be
required for the receipt of FDA Approval for the commercial manufacture of the Drug Product. Patheon shall assist the Client, to the extent consistent with Patheon’s obligations under this Agreement, to obtain FDA Approval for the commercial
manufacture of the Drug Product as quickly as reasonably possible. 
  
 (b) Verification of Data. At least [***] days prior to filing any documents with the FDA that incorporate data generated by Patheon, the Client shall provide Patheon with a copy of the documents incorporating such data so as to give
Patheon the opportunity to verify the accuracy and regulatory validity of such documents as they relate to the Patheon generated data. 
  
 (c) Verification of CMC. At least [***] days prior to filing with the FDA the Chemistry and Manufacturing Controls (“CMC”) of the
New Drug Application (“NDA”) or the Abbreviated New Drug Application (“ANDA”) filing, as the case may be, the Client shall provide Patheon with a copy of the CMC portion that relates to the Manufacturing Services
provided by Patheon as well as all supporting documents which have been relied upon to prepare the CMC portion so as to permit Patheon to verify that the CMC portion accurately describes the work that Patheon has performed and the manufacturing
processes that Patheon will perform pursuant to this Agreement. 
  
 (d) Pre-Approval Inspection. If Client does not provide Patheon with the documentation requested under paragraphs (b) and (c) above within the time stipulated in these paragraphs and if Patheon reasonably believes that Patheon’s
standing with the FDA may be jeopardized, Patheon may, in its sole discretion, delay or postpone the FDA pre-approval inspection (“PAI”) until such time Patheon has reviewed the requested documentation and is satisfied with its
contents. 
  
 (e) Deficiencies. If after discussion with
Client, Patheon reasonably determines that any of the information provided by the Client in accordance with paragraphs (b) and (c) above is inaccurate or deficient in any manner whatsoever (the “Deficiencies”), Patheon shall
promptly notify the Client in writing of such Deficiencies. Until such Deficiencies have been resolved or agreement has been reached with the Client, Patheon reserves the right not to participate in the PAI. In such event, Patheon’s
non-participation in the PAI shall not be construed as a breach of any of its obligations under this Agreement. 
  
 (f) Client Responsibility. For clarity, the parties agree that in reviewing the documents referred to in paragraphs (b) and (c) above,
Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. As such, Patheon shall not assume any responsibility for the accuracy of the NDA or the ANDA, as the 

 
  
  
  
  

	[***]:	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

 18 

 
case may be. The sole responsibility of the preparation and filing of the NDA shall be borne by the Client. 
  
 ARTICLE 8 
  
 TERM AND TERMINATION 
  

	8.1	Initial Term. 

  
 This Agreement shall become effective as of the Commencement Date and shall continue for a period of five (5) years from such date (the “Initial
Term”), unless terminated earlier by one of the parties, in accordance herewith. This Agreement shall automatically continue after the Initial Term for successive terms of two (2) years each unless either party gives written notice to the
other party of its intention to terminate this Agreement at least 18 months prior to the end of the then current term. 
  

	8.2	Termination for Cause. 

  
 (a) Either party at its sole option may terminate this Agreement upon written notice in circumstances where the other party has failed to remedy a
material breach of any of its representations, warranties or other obligations under this Agreement within 60 days following receipt of a written notice (the “Contract Remediation Period”) of said breach that expressly states that
it is a notice under this Section 8.2(a) (a “Breach Notice”). The aggrieved party’s right to terminate this Agreement pursuant to this Section 8.2(a) may only be exercised for a period of 60 days following the expiry of the
Contract Remediation Period (in circumstances where the breach has not been remedied) and if the termination right is not exercised during this period then the aggrieved party shall be deemed to have waived the breach of the representation, warranty
or obligation described in the Breach Notice. 
  
 (b) Either party
at its sole option may immediately terminate this Agreement upon written notice, but without prior advance notice, to the other party in the event that: (i) the other party is declared insolvent or bankrupt by a court of competent jurisdiction; (ii)
a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by such other party; or (iii) this Agreement is assigned by such other party for the benefit of creditors. 
  
 (c) The Client may terminate this Agreement upon 30 days’ prior written
notice in the event that any regulatory Authority takes any action, or raises any objection, that prevents the Client from importing, exporting, purchasing or selling the Drug Product. 
  
 (d) Patheon may terminate this Agreement if Client fails to pay undisputed amounts due hereunder pursuant to Sections 3.1
and 5.6 within thirty (30) days following receipt of written notice from Patheon. 
  

	8.3	Product Discontinuation. 

  
 The Client shall provide at least six months’ advance notice if it intends to no longer order the Drug Product due to its discontinuance in the
market. 
  

 19 

	8.4	Obligations on Termination. 

  
 If this Agreement expires or is terminated in whole or in part for any reason, then (in addition to any other remedies Patheon may have in the event of
default by the Client or Client may have in the event of default by Patheon): 
  

	 	(a)	Unless Patheon has terminated this Agreement pursuant to Section 8.2(d) above, Patheon shall complete manufacturing of all Firm Orders for Drug Product pending as of the date of
expiration or termination and the Client shall take delivery of and pay for all undelivered Drug Product that are manufactured and/or packaged pursuant to a Firm Order, at the price in effect at the time the Firm Order was placed;

  

	 	(b)	the Client shall purchase, at Patheon’s cost (including all costs incurred by Patheon in connection with the purchase and handling of such Inventory), the Inventory applicable
to the Drug Product which was purchased, produced or maintained by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.3 prior to notice of termination being given; 

  

	 	(c)	the Client shall satisfy the purchase price payable pursuant to Patheon’s orders with suppliers of Components, provided such orders were made by Patheon in reliance on Firm
Orders or in accordance with Section 5.3; and 

  

	 	(d)	Patheon shall return to the Client all unused Granulations (with shipping and related expenses, if any, to be borne by the Client). 

  
 Any termination or expiration of this Agreement shall not affect any outstanding obligations
or payments due hereunder prior to such termination or expiration, nor shall it prejudice any other remedies that the parties may have under this Agreement. For greater certainty, termination of this Agreement for any reason shall not affect the
obligations and responsibilities of the parties pursuant to Articles 10 and 11 and Sections 13.1, 13.2, 13.3 and 13.15, all of which survive any termination. 
  
 ARTICLE 9 
  
 REPRESENTATIONS, WARRANTIES AND COVENANTS 
  

	9.1	Authority. 

  
 Each party covenants, represents and warrants that it has the full right and authority to enter into this Agreement and that it is not aware of any
impediment that would inhibit its ability to perform its obligations hereunder. 
  

	9.2	Client. 

  
 The Client covenants, represents and warrants that: 
  

	 	(a)	the Specifications for the Drug Product are its or its Affiliate’s property and that the Client may lawfully disclose the Specifications to Patheon; 

 

 20 

	 	(b)	the Specifications for the Drug Product conform to all cGMPs, and Applicable Laws; 

  

	 	(c)	all Active Compounds or Granulations (as the case may be) and Components supplied by Client hereunder will comply in all material respects with the Specifications, cGMP, the Quality
Agreement, and Applicable Laws; 

  

	 	(d)	it owns or possesses adequate licenses or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware of any
assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided by
Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; 

  

	 	(e)	the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be
required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; 

  

	 	(f)	there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds,
Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; 

  

	 	(g)	the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every
jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; 

  

	 	(h)	the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of
any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or
acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage,
lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and 

  

 21 

	 	(i)	all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtained.

  

	9.3	Patheon. 

  
 Patheon covenants, represents and warrants that: 
  

	 	(a)	all Manufacturing Services hereunder shall be performed in accordance with all Applicable Laws, rules or regulations and that all Drug Product manufactured for Client will comply in
all respects with the Specifications, cGMP’s, the Act and all other Applicable Laws and the Quality Agreement and all Drug Product will not at the time of delivery be adulterated or misbranded within the meaning of the Act;

  

	 	(b)	the entering into of this Agreement by Patheon will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of
any court, administrative agency or other governmental body; or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or
acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Patheon, under its organizational documents, as amended to date, or any material note, indenture, mortgage,
lease, agreement, contract, purchase order or other instrument, document or agreement to which Patheon is a party or by which it or any of its properties or assets is bound or affected; 

  

	 	(c)	it owns or possesses adequate licenses or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware of any
assertion or claim challenging the ownership, use or validity of any intellectual property of Patheon to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided by
Patheon under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; 

  

	 	(d)	it has never been and is not currently debarred under the Act and that it will not in the performance of its obligations under this Agreement use the services of any person debarred
or suspended under 21 U.S.C.§335(a) or (b). Patheon represents that it does not currently have, and covenants that it will not hire, as an officer or an employee any person who has been convicted of a felony under the laws of the United States
for conduct relating to the regulation of any drug product under the United States Food, Drug and Cosmetic Act; 

  

	 	(e)	All necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Patheon have been duly obtained;

  

 22 

	 	(f)	There are no actions or legal proceedings pending or threatened which would limit or prevent Patheon from performing the Manufacturing Services contemplated hereunder; and

  

	 	(g)	It possesses all necessary permits, licenses and other authorizations from any regulatory Authority necessary to perform the Manufacturing Services hereunder.

  

	9.4	Permits. 

  
 The Client shall be solely responsible for obtaining or maintaining, on a timely basis, any permits or other regulatory approvals in respect of the Drug
Product or the Specifications, including, without limitation, all marketing and post-marketing approvals. Patheon shall be responsible for obtaining and maintaining on a timely basis any permits or regulatory approvals in respect of the Facilities
used to perform the Manufacturing Services. 
  

	9.5	Compliance with Laws. 

  
 Each party, in connection with its performance under this Agreement, shall comply with all Applicable Laws. 
  

	9.6	No Warranty. 

  
 PATHEON MAKES NO WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT. PATHEON
MAKES NO WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY OF MERCHANTABILITY WITH RESPECT TO THE DRUG PRODUCT. 
  
 ARTICLE 10 
  
 REMEDIES AND INDEMNITIES 
  

	10.1	Consequential Damages. 

  
 Under no circumstances whatsoever shall either party be liable to the other in contract, tort, negligence, breach of statutory duty or otherwise for any
(direct or indirect) loss of profits, of production, of anticipated savings, of business or goodwill or for any liability, damage, costs or expense of any kind incurred by the other party of an indirect or consequential nature, provided however such
limitation shall not apply with respect to the obligations of either party to indemnify the other in respect of a final judgment or order obtained by a third party where such third party claim arose as a result of the actions of the other party.

  

	10.2	Limitation of Liability. 

  
 (a) Active Compound and Granulations. Under no circumstances whatsoever shall Patheon reimburse Client for the cost of the Granulations or the
Active Compound contained within the Granulations (the “Patheon Reimbursement”) unless the loss of such Granulations 

  

 23 

 
occurred as a result of (i) Patheon’s Negligence, as defined in subsection (f) below; or (ii) Patheon’s gross negligence, intentional misconduct or
fraud. 
  
 (b) Subject to subsections (c), (d) and (e), the amount
of the Patheon Reimbursement shall be [***] for each lost batch of Drug Product. 
  
 (c) Notwithstanding subsection (b) above, if (i) the Fees in the Contract Year in which the loss occurred were less than [***], and (ii) the loss of the Granulations was as a result of Patheon’s Negligence, then
the Patheon Reimbursement amount shall be [***] for each lost batch of Drug Product. 
  
 (d) If Patheon reimburses the Client [***] for one or more lost batches of Drug Product in any Contract Year due to Patheon’s Negligence and, subsequently, it is determined that the Fees in that Contract Year
were less than [***], then Client shall credit Patheon for the difference between [***] per each batch of Drug Product lost due to Patheon’s Negligence. 
  
 (e) The maximum Reimbursement amount Patheon shall pay to Client for all lost batches in any Contract Year shall be [***] in aggregate in all
circumstances. 
  
 (f) [***] 
  
 (g) The Parties shall work together using commercially reasonable efforts to
develop in-process and other controls to limit or avoid, to the extent feasible, any financial loss for either Party due to the loss of Granulations and Active Compounds during processing, including the use of Process Analytical Technologies
(“PAT”) where possible. 
  
 (h) Drug
Product. Except to the extent that Patheon has failed to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities and as set forth in section 6.2 hereof, Patheon shall not be liable nor have any
responsibility for any deficiencies in, or other liabilities associated with, any Drug Product manufactured by it, including, without limitation, the costs and expenses of any Recall (collectively, “Drug Product Claims”). For
greater certainty, Patheon shall have no obligation for any Drug Product Claims to the extent such Drug Product Claim (i) is caused by deficiencies with respect to the Specifications, the safety, efficacy or marketability of the Drug Product or any
distribution thereof, (ii) results from a defect in a Component that is not reasonably discoverable using the test methods set forth in the Specifications, (iii) results from a defect in the Active Compounds or Granulations (as the case may be) or
Components supplied by the Client, (iv) is caused by actions of third-parties occurring after such Drug Product is shipped by Patheon pursuant to Section 5.5, (v) is caused by actions or omissions of third party suppliers of Components in which
deficiencies or defects were not detected or were not detectable by Patheon after 
  
  

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  

	[***]:	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

 24 

 
conducting tests in accordance with the Specifications, (vi) is due to packaging or labelling defects or omissions for which Patheon has no responsibility,
or (vii) is due to any other breach by the Client of its obligations under this Agreement. 
  

	10.3	Indemnification of Client. 

  
 Subject to Sections 10.1 and 10.2, Patheon agrees to defend, indemnify and hold the Client, its officers, employees and agents harmless against any and
all losses, damages, costs, claims, demands, judgments and liability to, from and in favour of third-parties (other than Affiliates) resulting from, or relating to any claim of personal injury or property damage to the extent that such injury or
damage is the result of a failure by Patheon to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities except to the extent that any such losses, damages, costs, claims, demands, judgments and liability are
due to the negligence, wrongful act(s) or breach of this Agreement by the Client, its officers, employees or agents or Affiliates. 
  
 In the event of a claim, the Client shall: (a) promptly notify Patheon of any such claim; (b) use commercially reasonable efforts to mitigate the effects
of such claim; (c) reasonably cooperate with Patheon in the defence of such claim; (d) permit Patheon to control the defence and settlement of such claim, all at Patheon’s cost and expense. 
  

	10.4	Indemnification of Patheon. 

  
 Subject to Sections 10.1 and 10.2, the Client agrees to defend, indemnify and hold Patheon, its officers, employees and agents harmless against any and
all losses, damages, costs, claims, demands, judgments and liability to, from and in favour of third-parties (other than Affiliates) resulting from, or relating to any claim of infringement or alleged infringement of any Third Party Rights in
respect of the Drug Product, and any claim of personal injury or property damage to the extent that such injury or damage is the result of a breach of this Agreement by the Client, including, without limitation, any representation or warranty
contained herein, except to the extent that any such losses, damages, costs, claims, demands, judgments and liability are due to the negligence, wrongful act(s) or breach of this Agreement by Patheon, its officers, employees or agents. 

 
 In the event of a claim, Patheon shall: (a) promptly notify the Client of
any such claims; (b) use commercially reasonable efforts to mitigate the effects of such claim; (c) reasonably cooperate with the Client in the defence of such claim; (d) permit the Client to control the defence and settlement of such claim, all at
the Client’s cost and expense. 
  

	10.5	Reasonable Allocation of Risk. 

  
 The parties acknowledge and agree that the provisions of this Agreement (including, without limitation, this Article 10) are reasonable and create a
reasonable allocation of risk having regard to the relative profits the parties respectively expect to derive from the Drug Product, and that Patheon, in its Fees for the provision of the Manufacturing Services, has not accepted a greater degree of
the risks arising from the manufacture, distribution and use of the Drug Product, based on the fact that the Client has developed and holds the marketing approval for the Drug Product and requires Patheon to manufacture and label the Drug Product

  

 25 

 
strictly in accordance with the Specifications, and that the Client and not Patheon is in a position to inform and advise potential users of the Drug Product
as to the circumstances and manner of use of the Drug Product. 
  
 ARTICLE 11 
  
 CONFIDENTIALITY

  

	11.1	Confidentiality. 

  
 Subject to Section 11.2 below, the parties agree that the provisions of the Confidentiality Agreement shall apply to all confidential information
disclosed by the parties under this Agreement, which agreement remains in effect in accordance with its terms; provided, however, that in the event the Confidentiality Agreement expires or is terminated prior to the expiration or termination of this
Agreement, the terms of the Confidentiality Agreement shall continue to govern the parties’ obligations of confidentiality with respect to any confidential or proprietary information disclosed by the parties hereunder, for the term of this
Agreement, as though such agreement remained in full force and effect. 
  

	11.2	Publicity. 

  
 Except as may be required by Applicable Laws, rules or regulations neither party will originate any publicity, news release, or other public announcement,
written or oral, whether to the public press or otherwise, relating to this Agreement, any amendment hereto or to performance hereunder, or the existence of an arrangement between the parties, without the prior written approval of the other party,
which consent shall not be unreasonably withheld or delayed (it being understood that such obligation is not intended to restrict either party’s ability to promote, market and sell the Drug Product in a commercially reasonable manner). In the
event disclosure is required by applicable law, rules or regulations, then the party required to so disclose such information shall, to the extent possible, provide to the other party for its approval (such approval not to be unreasonably withheld)
a written copy of such public announcement at least three (3) business days prior to disclosure. Client agrees that Patheon may refer to Client as a customer in public documents but without information as to the nature and extent of the services
provided to Client. 
  
 ARTICLE 12 
  
 DISPUTE RESOLUTION 
  

	12.1	Commercial Disputes. 

  
 In the event of any dispute arising out of or in connection with this Agreement (other than a dispute determined in accordance with Section 6.1(b) or a
Technical Dispute), the parties shall first try to solve it amicably. In this regard, any party may send a notice of dispute to the other, and each party shall appoint, within 10 Business Days from receipt of such notice of dispute, a single
representative having full power and authority to solve the dispute. The representatives so designated shall meet as necessary in order to solve such dispute. If these 

  

 26 

 
representatives fail to solve the matter within one month from their appointment, or if a party fails to appoint a representative within the 10 Business Day
period set forth above, such dispute shall immediately be referred to the Chief Operating Officer or Executive Vice President, Operations (or such other officer as they may designate) of each party who will meet and discuss as necessary in order to
try to solve the dispute amicably. Should the parties fail to reach a resolution under this Section 12.1, their dispute will be referred to the arbitration in accordance with Section 13.15. 
  

	12.2	Technical Dispute Resolution. 

  
 In the event of a dispute (other than disputes in relation to the matters set out in Sections 6.1(b) and 12.1) between the parties that is exclusively
related to technical aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage or other activities under this Agreement (a “Technical Dispute”), the parties shall make all reasonable efforts to
resolve the dispute by amicable negotiations. In this regard, senior representatives of each party shall, as soon as practicable and in any event no later than 10 Business Days after a written request from either party to the other, meet in good
faith to resolve any Technical Dispute. If, despite such meeting, the parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within 30 Business Days of such written request, the Technical Dispute shall, at the
request of either party, be referred for determination to an expert in accordance with the provisions of Schedule F. In the event that the parties cannot agree whether a dispute is a Technical Dispute, Section 12.1 shall prevail. For greater
certainty, the parties agree that the release of the Drug Product for sale or distribution pursuant to the applicable marketing approval for such Drug Product shall not by itself indicate compliance by Patheon with its obligations in respect of the
Manufacturing Services and further that nothing in this Agreement (including Schedule F) shall remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Drug Product is to be
released for sale or distribution. 
  
 ARTICLE 13

  
 MISCELLANEOUS 
  

	13.1	Inventions. 

  
 (a) All Inventions relating to the Drug Product which are conceived, reduced to practice, or created solely by Patheon and/or its Affiliates or agents in
the course of performing the Manufacturing Services under this Agreement (including any pre-existing technology of Patheon which Patheon so employs without use of any of Client’s Confidential Information or AlzaTechnical Information), shall be
owned by Patheon (“Patheon Owned Invention”). Patheon shall and hereby does grant to the Client and its Affiliates a perpetual, royalty-free, non- exclusive, worldwide, irrevocable license to use and/or practice all such
Patheon-owned Inventions (which are used by Patheon hereunder to supply Drug Product to the Client) to manufacture the Drug Product and to use and sell the same, with the right to sub-license to any third party with whom the Client or an Affiliate
contracts to manufacture the Drug Product using, any such Patheon Owned Invention. 
  

 27 

 (b) All Inventions relating to the Drug Product which are conceived, reduced to practice, or created
solely by the Client and/or its Affiliates or agents (including any pre-existing technology of the Client which the Client shares with Patheon hereunder), shall be owned by the Client (“Client Owned Invention”). The Client shall and
hereby does grant to Patheon and its Affiliates a limited royalty-free, non-exclusive license during the term of this Agreement, without the right to sublicense, to use and/or practice all such Client Owned Inventions solely to manufacture the Drug
Product hereunder. 
  
 (c) All Inventions relating to the Drug
Product which are conceived, reduced to practice, or created jointly by: (i) the Client and/or its Affiliates or agents; and (ii) Patheon and/or its Affiliates or agents pursuant to this Agreement shall be owned be a Client Owned Invention, unless
the parties have agreed to a different arrangement in another consulting or services agreement which is more specific to the services provided by Patheon in connection with such Invention. The Client shall and hereby does grant to Patheon and its
Affiliates a perpetual, royalty-free, non-exclusive, worldwide, irrevocable license during the term of this Agreement, without the right to sublicense, to use and /or practise such Client Owned Invention solely to manufacture the Drug Product
hereunder. 
  
 (d) All Inventions created while performing the
Manufacturing Services which are conceived, reduced to practice, or created jointly by: (i) the Client and/or its Affiliates or agents; and (ii) Patheon and/or its Affiliates or agents pursuant to this Agreement which are independent of the Drug
Product or the Granulations, and have application to drug product manufacturing or delivery systems shall be owned by the Client (“Broader Inventions”). Subject to the limitations set forth in Section 2.3 hereof, the Client shall
and hereby does grant to Patheon and its Affiliates a perpetual, royalty-free, non-exclusive, worldwide, irrevocable license to use and/or practise such Broader Inventions with the right to sublicense to any third party. 
  
 (e) Each party shall be solely responsible for the costs of filing,
prosecution and maintenance of patents and patent applications on its own Inventions. 
  
 (f) Either party shall give the other party written notice, as promptly as practicable, of all Inventions which can reasonably be deemed to constitute improvements or other modifications of the Drug Product or
processes or technology owned or other wise controlled by such party. 
  

	13.2	Intellectual Property. 

  
 Subject to Section 13.1, all Intellectual Property of the Client shall be owned by the Client and all Intellectual Property of Patheon shall be owned by
Patheon. The Client and Patheon hereby acknowledge that neither party has, nor shall it acquire, any interest in any of the other party’s Intellectual Property unless otherwise expressly agreed to in writing. Each party agrees not to use any
Intellectual Property of the other party, except as specifically authorized by the other party or as required for the performance of its obligations under this Agreement. 
  

	13.3	Insurance. 

  
 Each party shall maintain commercial general liability insurance, including blanket contractual liability insurance covering the obligations of that party
under this 

  

 28 

 
Agreement through the term of this Agreement and for a period of 1 year after the expiration date of the Drug Product produced under this Agreement, which
insurance shall afford limits of not less than (i) $5,000,000 for each occurrence for personal injury or property damage liability and (ii) $5,000,000 in the aggregate per annum with respect to product and completed operations liability. If
requested each party will provide the other with a certificate of insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date and the limits of liability. The insurance
certificate shall further provide for a minimum of 30 days’ written notice to the insured of a cancellation of, or material change in, the insurance. If a party is unable to maintain the insurance policies required under this Agreement through
no fault on the part of such party, then such party shall forthwith notify the other party in writing and the parties shall in good faith negotiate appropriate amendments to the insurance provision of this Agreement in order to provide adequate
assurances. 
  

	13.4	Independent Contractors. 

  
 The parties are independent contractors and this Agreement shall not be construed to create between Patheon and the Client any other relationship such as,
by way of example only, that of employer-employee, principal agent, joint-venturer, co-partners or any similar relationship, the existence of which is expressly denied by the parties hereto. 
  

	13.5	No Waiver. 

  
 Either party’s failure to require the other party to comply with any provision of this Agreement shall not be deemed a waiver of such provision or
any other provision of this Agreement. 
  

	13.6	Assignment. 

  

	 	(a)	Patheon may not assign this Agreement or any of its rights or obligations hereunder except with the written consent of the Client, such consent not to be unreasonably withheld;
provided, however, that Patheon may arrange for subcontractors to perform specific single tests on excipients and/or compendial products testing services arising under this Agreement without the consent of the Client provided that Patheon shall
remain primarily liable to Client, and such subcontracted testing shall be in accordance with the terms of this Agreement. 

  

	 	(b)	The Client may assign this Agreement or any of its rights or obligations hereunder without approval from Patheon; provided, however, that: i) the Client shall give prior written
notice of any assignment to Patheon; ii) any assignee shall covenant in writing with Patheon to be bound by the terms of this Agreement; and iii) such Assignee has a market capitalization or net worth of not less than $300 million dollars. In all
other cases, Client may assign this Agreement with the consent of Patheon, which consent shall not be unreasonably withheld. 

  
 For purposes of this Section 13.6(b), none of the following shall constitute an assignment by Client: (a) conversion of Client from a limited liability
company to a corporation (whether such conversion is effected by statutory conversion 

  

 29 

 
provisions, merger or otherwise) or (b) the issuance of debt or equity securities by Client in connection with any financing transaction. 
  

	 	(c)	Notwithstanding the foregoing provisions of this Section 13.6, either party may assign this Agreement to any of its Affiliates or to a successor to or purchaser of all or
substantially all of its business or in the case of Client to a purchaser of the Drug Product, provided that such assignee executes an agreement with the non-assigning party hereto whereby it agrees to be bound hereunder. 

 

	13.7	Force Majeure. 

  
 Neither party shall be liable for the failure to perform its obligations under this Agreement if such failure is occasioned by a cause or contingency
beyond such party’s reasonable control, including, but not limited to, strikes or other labour disturbances, lockouts, riots, quarantines, communicable disease outbreaks, wars, acts of terrorism, fires, floods, storms, interruption of or delay
in transportation, defective equipment, lack of or inability to obtain fuel, power or components or compliance with any order or regulation of any government entity acting within colour of right (a “Force Majeure Event”). A party
claiming a right to excused performance under this Section 13.7 shall immediately notify the other party in writing of the extent of its inability to perform, which notice shall specify the occurrence beyond its reasonable control that prevents such
performance. Neither party shall be entitled to rely on a Force Majeure Event to relieve it from an obligation to pay money (including any interest for delayed payment) which would otherwise be due and payable under this Agreement. 
  

	13.8	Additional Product. 

  
 Additional product may be added to this Agreement and such additional products shall be governed by the general conditions hereof with any special terms
(including, without limitation, price) governed by an addendum hereto. 
  

	13.9	Notices. 

  
 Any notice, approval, instruction or other written communication required or permitted hereunder shall be sufficient if made or given to the other party
by personal delivery, by telecopier or facsimile communication or by sending the same by first class mail, postage prepaid to the mailing address or telecopier number set forth below: 
  
 If to the Client: 
  
 Reliant Pharmaceuticals, LLC 
 Attn: Mr.
Joseph Krivulka, President 
 110 Allen Road 
 Liberty Corner, NJ 07938 
  
 Telecopier No.: 908-542-9405 
  

 30 

			
	 With a copy to:
	  	General Counsel (same contact information)

  
 If to Patheon:

  
 Patheon Pharmaceuticals Inc. 
 2110 East Gaibraith Road 
 Cincinnati, Ohio

 Attention: Site Director 
 Telecopier No.: 513-948-7854 
  

			
	 With a copy to:
	  	 President, Patheon North America
 by telecopier:
905-812-6705

  
 or to such other addresses or
telecopier numbers provided to the other party in accordance with the terms of this Section 13.9. Notices or written communications made or given by personal delivery or by telecopier number shall be deemed to have been sufficiently made or given
when sent (receipt acknowledged), or if mailed, five days after being deposited in the United States or Canadian mail, postage prepaid or upon receipt, whichever is sooner. 
  

	13.10 	Severability. 

  
 If any provision of this Agreement is determined by a court of competent jurisdiction to be invalid, illegal or unenforceable in any respect, such
determination shall not impair or affect the validity, legality or enforceability of the remaining provisions hereof, and each provision is hereby declared to be separate, severable and distinct. 
  

	13.11 	Entire Agreement. 

  
 This Agreement, together with the Quality Agreement, the Capital Letter and the Confidentiality Agreement, constitutes the full, complete, final and
integrated agreement between the parties hereto relating to the subject matter hereof and supersedes all previous written or oral negotiations, commitments, agreements, transactions or understandings with respect to the subject matter hereof. Any
modification, amendment or supplement to this Agreement must be in writing and signed by authorized representatives of both parties. In case of conflict, the prevailing order of documents shall be this Agreement, the Quality Agreement, the Capital
Letter and the Confidentiality Agreement. 
  

	13.12 	Other Terms. 

  
 The parties agree that no terms, provisions or conditions of any purchase order or other business form or written authorization used by the Client or
Patheon will have any effect on the rights, duties or obligations of the parties under or otherwise modify this Agreement, regardless of any failure of the Client or Patheon to object to such terms, provisions, or conditions unless such document
specifically refers to this Agreement and is signed by both parties. 
  

 31 

	13.13 	No Third Party Benefit or Right. 

  
 For greater certainty, nothing in this Agreement shall confer or be construed as conferring on any third party any benefit or the right to enforce any
express or implied term of this Agreement. 
  

	13.14 	Execution in Counterparts. 

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

	13.15 	Governing Law & Venue. 

  
 (a) This Agreement shall be construed in accordance with and governed by the laws of the State of New York excluding the conflict of laws rules thereof.

  
 (b) Any disputes or disagreements between Client and Patheon
under this Agreement except as set forth below, shall be submitted to arbitration pursuant to the commercial arbitration rules of the American Arbitration Association and judgment upon the award rendered by the arbitrator may be entered in any court
having jurisdiction thereof. Notwithstanding the foregoing, to the extent either Party, in its sole discretion, determines that it needs injunctive relief such party may seek such injunctive relief in a court of competent jurisdiction applying the
substantive law of the state of New York. 
  
 (c) The arbitration
shall be held before a single arbitrator, to be selected by Patheon and Client or, if Patheon and Client cannot agree on such arbitrator, in accordance with the applicable arbitration rules. Arbitration shall be in the State of New York, and the
arbitrator shall apply the substantive law of the State of New York. It shall be the duty of the arbitrator to set dates for preparation and hearing of any dispute and to expedite the resolution of such dispute. The arbitrator shall permit and
facilitate discovery, taking into account the needs of the parties and the desirability of making discovery expeditious and cost-effective. The arbitrator will set a discovery schedule with which the parties will comply and attend depositions if
requested by either party. The arbitrator will entertain such presentation of sworn testimony or evidence, written briefs and/or oral argument as the parties may wish to present; however, no testimony or exhibits will be admissible unless the
adverse party was afforded an opportunity to examine such witness and to inspect and copy such exhibits during the pre-hearing discovery phase. The arbitrator shall among his other powers and authorities, have the power and authority to award
interim or preliminary relief. 
  
 (d) A qualified court reporter
will record and transcribe the proceedings. The decision of the arbitrator will be in writing and judgment upon the award by the arbitrator may be entered into any court having jurisdiction thereof. Prompt handling and disposal of the issue is
important, accordingly, the arbitrator is instructed to assume adequate managerial initiative and control over discovery and other aspects of the proceeding to schedule discovery and other activities for substantially continuous work, thereby
expediting the arbitration as much as is deemed reasonable to him, but in all events to effect a final award within 365 days of the arbitrator’s selection or appointment and within 20 days of the close of evidence. 
  

 32 

 (e) The proceedings shall be confidential and the arbitrator shall issue appropriate protective orders to
safeguard both parties’ Confidential Information. The fees of the arbitrator shall be paid by the losing party which shall be designated by the arbitrator. If the arbitrator is unable to designate a losing party, he shall so state and the fees
shall be split equally between the parties. 
  
 IN WITNESS
WHEREOF, the duly authorized representatives of the parties have executed this Agreement as of the date first written above. 
  

			
	PATHEON PHARMACEUTICALS INC.
		
	By  	 	 
	
	RELIANT PHARMACEUTICALS, LLC
		
	By	 	 
		
	By	 	 

  

 33 

 SCHEDULE A 
  
 [***] [44 pages omitted] 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

	[***]:	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

 SCHEDULE B 
  
 Minimum Run Quantity, Minimum Annual Volume & Fees 
  
 Pricing is based on the following annual requirements, in no. of bulk batches, provided by
Reliant: 
  

							
	 	  	 Theoretical Batch Size
 (Tablets)

	  	 [***]

	  	 [***]

	 	  	 	  	[***]	  	[***]
	 [***]
	  	[***]	  	[***]	  	[***]
	 [***]
	  	[***]	  	[***]	  	[***]

  
 Phase 1 – Bulk Tablets

  

					
	 Strength

	  	 5 mg

	  	 10 mg

	 [***]
	  	[***]	  	[***]
	 [***]
	  	[***]	  	[***]
	 [***]
	  	[***]	  	[***]
	 [***]
	  	[***]	  	[***]

  
 Manufacturing Assumptions

  

	 	1.	The commercial process at Patheon will closely follow the manufacturing information provided by Reliant. 

  

	 	2.	The proposed theoretical batch sizes are [***]. 

  

	 	3.	A manufacturing campaign of [***] is assumed for [***]. 

  
 Granulation 
  

	 	4.	Drug and Osmotic granulations will be furnished by Reliant. 

  
 Compression 
  

	 	5.	The target [***]. 

  
 [***] 
  
 General Assumptions, Terms &
Conditions 
  

	 	1.	Commercial unit pricing is based on the annual volumes provided and run quantities noted in the Pricing Tables. 

  
  
  
  
  
  
  
  
  
  

	[***]:	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

	 	2.	Each price includes the costs of raw materials and applicable packaging components. Drug arid Osmotic granulations will be furnished by Reliant during Phase 1.

  

	 	3.	Process qualification and validation costs are not included in this proposal. 

  

	 	4.	Post-commercial stability cost is not included in these prices. 

  

	 	5.	Reliant will be responsible for the art work related charges, such as die, film and plate costs. 

  

	 	6.	Unit pricing will be subject to review and change upon finalization of product and component specifications, manufacturing and packaging processes, and equipment run rates.

  

 36 

 SCHEDULE C 
  
 INTENTIONALLY DELETED 
  

 SCHEDULE D 
  
 ACTIVE COMPOUNDS GRANULATIONS 
  

			
	 Granulations

	  	 Supplier

	 [***]
	  	[***]
	 [***]
	  	[***]

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

	[***]:	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

 SCHEDULE E 
  
 BATCH NUMBERING AND EXPIRATION DATES 
  
 Drug Product manufactured at Patheon will bear lot numbers as described in Patheon SOP H045 and will have expiry dates as described in
Patheon SOP Q100. 
  

 SCHEDULE F 
  
 TECHNICAL DISPUTE RESOLUTION 
  
 Technical Disputes which cannot be resolved by negotiation as provided in Section 12.2 shall be resolved in the following
matter: 
  
 1. Appointment of Expert. Within 10 Business Days after
a party requests pursuant to Section 12.2 that an expert be appointed to resolve a Technical Dispute, the parties shall jointly appoint a mutually acceptable expert with experience and expertise in the subject matter of the dispute. If the parties
are unable to so agree within such 10 Business Day period, or in the event of disclosure of a conflict by an expert pursuant to paragraph 2 hereof which results in the parties not confirming the appointment of such expert, then an expert (willing to
act in that capacity hereunder) shall be appointed by an experienced arbitrator on the roster of the American Arbitration Association. 
  
 2. Conflicts of Interest. Any person appointed as an expert shall be entitled to act and continue to act as such notwithstanding that at the time of his
appointment or at any time before he gives his determination, he has or may have some interest or duty which conflicts or may conflict with his appointment provided that before accepting such appointment (or as soon as practicable after he becomes
aware of the conflict or potential conflict) he fully discloses any such interest or duty and the parties shall after such disclosure have confirmed his appointment. 
  
 3. Not Arbitrator. No expert shall be deemed to be an arbitrator and the provisions of the American Arbitration Act or
of any other applicable statute (foreign or domestic) and the law relating to arbitration shall not apply to any such expert or the expert’s determination or the procedure by which the expert reaches his determination to be made pursuant to
this Schedule F. 
  
 4. Procedure. Where an expert is appointed:

  

	 	(a)	Timing. The expert shall be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from
the parties and that he issues such authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 Business Days (or such other
date as the parties and the expert may agree) after receipt of all information requested by him pursuant to paragraph 4(b) hereof. 

  

	 	(b)	Disclosure of Evidence. The parties undertake one to the other to provide to any expert all such evidence and information within their respective possession or control as the
expert may reasonably consider necessary for determining the matter before him which they shall disclose promptly and in any event within five Business Days of a written request from the relevant expert to do so. 

  

	 	(c)	 Advisors. Each party may appoint such counsel, consultants and advisors as it feels appropriate to assist the expert in his determination and so as to
present their 

  

	 	 
respective cases so that at all times the parties shall co-operate and seek to narrow and limit the issues to be determined. 

  

	 	(d)	Appointment of New Expert. If within the time specified in paragraph 4(a) above the expert shall not have rendered a decision in accordance with his appointment, a new expert
may (at the request of either party) be appointed and the appointment of the existing expert shall thereupon cease for the purposes of determining the matter at issue between the parties save that if the existing expert renders his decision with
full reasons prior to the appointment of the new expert, then such a decision shall have effect and the proposed appointment of the new expert shall be withdrawn. 

  

	 	(e)	Final and Binding. The determination of the expert shall, save in the event of fraud or manifest error, be final and binding upon the parties. 

  

	 	(f)	Costs. Each party shall bear its own costs in connection with any matter referred to an expert hereunder and, in the absence of express provision in the Agreement to the
contrary, the costs and expenses of the expert shall be shared equally by the parties. 

  
 For greater certainty, the parties agree that the release of the Drug Product for sale or distribution pursuant to the applicable marketing approval for such Drug Product shall not by itself indicate compliance by
Patheon with its obligations in respect of the Manufacturing Services and further that nothing in this Agreement (including this Schedule F) shall remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement)
to determine whether the Drug Product are to be released for sale or distribution. 
  

 SCHEDULE G 
  
 FORM OF QUALITY AGREEMENT 
  
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	[***]:	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

			
	 March, 2004
	 	Page 1 of 1

 SCHEDULE H 
  
 CAPITAL LETTER AGREEMENT 
  
                             , 2004 
  
 Reliant Pharmaceuticals, LLC 
 110 Allen Road

 Liberty Corner, NJ 
 U.S.A. 07938 
  
 Attention: 
  
 Dear : 
  

	Re:	Capital Expenditure for Commercial Manufacture of DynaCirc CR 

  
 Reliant Pharmaceuticals, LLC (“RELIANT”), and Patheon Pharmaceuticals Inc. (“Patheon”) have entered into a Manufacturing Services
Agreement dated March         , 2004 (the “MSA”) whereby Patheon agreed, among other things, to provide certain manufacturing services (the “Services”) with respect to
DynaCirc CR (the “Product”). 
  
 In order for Patheon to perform
the Services, certain capital equipment will be provided by RELIANT and installed at Patheon’s Cincinnati Operations facility (the “Facility”). As well, certain modifications will be made to the Facility to accommodate such
equipment. 
  
 The purpose of this Letter Agreement is to set out the
parties’ mutual agreement with respect to the equipment and capital expenditures required under the MSA. 
  

	1.	Equipment 

  
 Until this Letter Agreement is terminated in accordance with paragraph 7 below, the Parties agree to purchase certain manufacturing equipment (the
“Equipment”) and to implement certain facility upgrades for use in connection with the manufacture of the Product in accordance with the terms of this Letter Agreement. 
  
 A detailed description of the Equipment is outlined in Schedule A attached hereto. 
  

	2.	Expenditures 

  
 The responsibility for the payment of the estimated costs associated with the Equipment and the Facility Modifications (the “Capital
Expenditures”) will be allocated between Patheon and RELIANT in the manner set out in Schedule A hereto. 
  
 Each Party shall make all necessary arrangements, at its sole expense, for the purchase and shipping of the Equipment it has agreed to purchase, as
indicated on Schedule A, to the Facility. 
  

 To the extent possible (i.e. where Equipment is not being physically installed at the Facility) all
Equipment for which RELIANT is responsible under Schedule A shall be purchased by way of purchase order with instructions indicating that the Equipment be shipped to Reliant Pharmaceuticals, LLC Headquarters and billed to Accounts Payable, Reliant
Pharmaceuticals, LLC. 
  
 Where certain Equipment cannot be
shipped to Reliant Pharmaceuticals, LLC Headquarters, the invoice may be billed to Patheon and RELIANT agrees to forward payment for the invoice to Patheon by wire transfer within the payment terms indicated by the supplier of the Equipment which
shall be forward to RELIANT by Patheon. 
  
 Notwithstanding the
above, RELIANT agrees to pay Patheon directly by wire transfer for the costs associated with Item 12 under Schedule A (Coating Pan) as Patheon has already purchased this particular piece of Equipment. 
  
 Patheon shall make all necessary arrangements for the installation,
qualification and testing of the Equipment at the Facility. Patheon represents that it shall install and test the Equipment in a good and workmanlike manner, including following the manufacturer’s written instructions. 
  
 Patheon warrants that the Equipment shall be cleaned in a good and
workmanlike manner, in accordance with cGMP (as such term is defined in the Agreement) and applicable Laws (as such term is defined in the Agreement). 
  

	3.	Facility Modifications 

  
 Certain modifications must be made to the Facility in order to accommodate the Equipment and are listed on Schedule A attached hereto. 
  

	4.	Maintenance of Equipment 

  

	 	(a)	Patheon shall operate and use the Equipment in accordance with the instructions set forth in the Equipment manufacturer’s service manual provided by RELIANT, if any.

  

	 	(b)	While the Equipment is in Patheon’s possession, Patheon shall assume the costs for all routine and preventative maintenance of the Equipment. 

  

	 	(c)	The costs of any repairs required as a result of the use of the Equipment for RELIANT products, other than routine and preventative maintenance costs, not covered by applicable
manufacturer warranties [***]. In the event of any such repairs, Patheon shall promptly provide written notice of estimated cost of the repairs [***] within 10 business days of RELIANT’s receipt of such notice. 

  
  
  
  
  

	[***]:	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

	 	(d)	In the event of any repairs required as a result of the use of the Equipment for products of other clients of Patheon not covered by applicable manufacturer warranties shall be the
responsibility of Patheon. 

  

	5.	Title, Risk of Loss and Insurance 

  
 The parties agree that title to the Equipment shall reside with the Party who has paid for such Equipment and the other Party shall have no legal or
equitable interest in such Equipment whatsoever. The Equipment shall be clearly marked to indicate the ownership of the Equipment and shall not be subject to the liens or claims of the other Party’s creditors. While the Equipment is in
Patheon’s possession, risk of loss shall reside with Patheon and Patheon shall insure the Equipment under its policy of standard all-risk insurance and name Reliant as the loss-payee. 
  
 Notwithstanding the above, title to the Abatement Equipment listed under
Schedule A shall reside with Patheon once it has been installed at the Facility. 
  

	6.	Warranty 

  
 RELIANT represents and warrants that: (i) RELIANT is the sole legal and beneficial owner of the Equipment it has purchased as set out in Schedule A
hereto; (ii) RELIANT has the full right and authority to loan the Equipment to Patheon in accordance with the terms and conditions hereof; and (iii) prior to delivery of the Equipment to Patheon, such Equipment was in good working order. 

 

	7.	Indemnification 

  
 Patheon shall indemnify, defend and hold RELIANT harmless from and against any claims, damages, expenses or liabilities to, from and in favor of
third-parties (other than affiliates) (“Claims”) resulting from Patheon’s use of the Equipment while such Equipment is situated at the Facility other than those Claims that arise from a defect in the Equipment. 
  

	8.	Return of Equipment 

  
 If, after the expiry of the Term of the MSA or after the MSA has been terminated in accordance with Article 8 of the MSA, RELIANT desires the return of
the Equipment it has purchased under this Letter Agreement, then RELIANT shall notify Patheon in writing at least six months prior to the effective date of removal and, following delivery of the Equipment, within forty-five (45) days of the invoice,
RELIANT shall pay Patheon for all reasonable costs relating to: 
  

	 	(a)	disconnecting, packaging and shipping the Equipment in a good and workmanlike manner; 

  

	 	(b)	repairing any damage resulting from such removal; and 

  

	 	(c)	restoring the Facility to remove the modifications made hereunder. 

  

	9.	Reimbursement 

  
 [***] 
  

	10.	Currency 

  
 All monetary amounts are expressed in the lawful currency of the United States of America. 
  
  
  
  
  

	[***]:	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

	11.	Incorporation of Agreement 

  
 The Equipment shall be deemed to be part of the “Approved Facility” (as such term is defined in the Agreement) and Patheon shall comply with the
terms of the Development Agreement and the MSA in performing services for RELIANT’s on the Equipment as part of the Project. In the event of any inconsistency between the terms of the MSA and the terms of this Letter Agreement, the terms of
this Letter Agreement shall govern with respect to the subject matter hereof. 
  
 This Letter Agreement may be signed by facsimile or in two counterparts, each of which when executed and delivered or transmitted, shall be considered an original and both of which together shall constitute one and the same instrument. This
Letter Agreement shall be governed by and construed in accordance with the laws of the State of New York. 
  
 If the above terms are acceptable to you, please indicate your acceptance below. 
  
 Yours truly, 
  

	
	PATHEON PHARMACEUTICALS INC.
	
	  
	 Ronald B. Mitchell

	 Sr. VP, Finance & Treasurer

  
 ACCEPTED and AGREED to this
         day of March, 2004. 
  

	
	RELIANT PHARMACEUTICALS, LLC
	
	  
	 Name:

	 Title:

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