Document:

Supply Agreement, dated as of September 23, 2003

 Exhibit 10.26 
  
 SUPPLY AGREEMENT 
  
 SUPPLY AGREEMENT (“Agreement”) dated as of September 23, 2003, (“Effective Date”) between RELIANT PHARMACEUTICALS, LLC, a Delaware
limited liability company (“Reliant”), and AUSTIN SHASUN, LLC, an Illinois limited liability company (“ASL”). 
  
 WHEREAS, ASL and Reliant desire to enter into this Agreement which will set forth the terms and conditions under which ASL shall supply to Reliant bulk
quantities of the Active Ingredient (as hereinafter defined) for use in the manufacture of the Products (as hereinafter defined); 
  
 NOW THEREFORE, in consideration of the mutual covenants and consideration set forth herein, the parties hereto agree as follows: 
  
 SECTION 1  
  
 DEFINITIONS 
  
 SECTION 1.1. As used herein, the following defined terms shall have the definitions set forth
below: 
  
 (a) “Act” shall mean the Federal Food Drug
and Cosmetic Act (21 U.S.C. §301 et seq) as amended from time to time and the regulations promulgated thereunder and corresponding legislation in any other country where the Active Ingredient is manufactured. 
  
 (b) “Active Ingredient” or “API” shall mean isradipine.

  
 (c) “Adverse Events” shall mean any serious or
unexpected side effect, injury, toxicity, or sensitivity reaction, or any adverse drug reaction reports and the severity thereof associated with the Product where the term “serious” as used in this Section refers to an experience which
results in death, permanent or substantial disability, a vegetative state, inpatient hospitalization or prolongation of hospitalization, a congenital anomaly, cancer, an overdose, or is life threatening. The term “unexpected” as used in
this definition means an adverse drug experience that is not listed in the then current labeling for the Product and includes an event that may be symptomatically or pathophysiologically related to an event listed in the labeling, but differs from
the event because of greater severity or specificity. 
  
 (d)
“Affiliate” shall mean all corporations or business entities which, directly or indirectly, are controlled by, control or are under common control by any of ASL or Reliant, as the case may be. For this purpose, “control” shall
mean the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person or entity, whether through the ownership of at least fifty percent (50%) of the voting shares or interest of such
person or entity, by contract or otherwise. 
  
 (e)
“Agreement Year” shall mean each twelve (12) month period of the term of this Agreement beginning on the first day of the calendar year except for the “First Agreement Year” 

 
which shall mean the period commencing on the Effective Date and ending on December 31, 2003. 
  
 (f) “Annual Payment Amount” shall have the meaning set forth in Section 2.7(c). 
  
 (g) “Annualized Purchase Amount” shall have the meaning set forth
in Section 2.7(d). 
  
 (h) A “Bankruptcy Event” shall
have occurred when the person or entity in question becomes insolvent, or voluntary or involuntary proceedings by or against such person or entity are instituted in bankruptcy or under any insolvency law, or a receiver or custodian is appointed for
such person or entity, or proceedings are instituted by or against such person or entity for corporate reorganization or the dissolution of such person or entity, which proceedings, if involuntary, shall not have been dismissed within one hundred
and twenty (120) days after the date of filing, or such person or entity makes an assignment for the benefit of its creditors, or substantially all of the assets of such person or entity are seized or attached and not released within one hundred and
twenty (120) days thereafter. 
  
 (i) “Claims” shall
have the meaning ascribed in Section 2.9. 
  
 (j) “Designated
Facility” shall mean a location in the Territory set forth by Reliant in the applicable purchase order. 
  
 (k) “Drug Master File” or “DMF’ means a submission to the FDA by ASL that may be used to provide confidential detailed information
about facilities, processes or articles used in the manufacturing, processing, packaging and storing of the Active Ingredient. 
  
 (l) “DynaCirc” shall mean isradipine capsules (2.5 mg and 5 mg) marketed by Reliant pursuant to the NDA under the brand name DynaCirc®. 
  
 (m) “DynaCirc CR” shall mean controlled release isradipine capsules
(5 mg and 10 mg) marketed by Reliant pursuant to the NDA under the brand name DynaCirc CR®. 
  
 (n) “Effective
Date” shall mean the date first shown above. 
  
 (o)
“FDA” shall mean the United States Food and Drug Administration or any successor entity performing similar functions. 
  
 (p) “First Commercial Sale” shall mean the date on which Reliant (or any Affiliate of Reliant) sells the first Product to an unaffiliated third
party utilizing API supplied by ASL pursuant to this Agreement. 
  
 (q) “GMP” shall mean current Good Manufacturing Practice as defined in 21 CFR §210.211 as may be amended from time to time. 
  
 (r) “Improvements” shall mean any improved Products, line extensions, modified Products or similar items which contain the Active Ingredient and
which Reliant obtains rights to, develops or sells during the course of this Agreement. 
  

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 (s) “Initial Forecast” shall have the meaning ascribed in Section 2.8(a). 
  
 (t) “Initial Products” shall mean DynaCirc and DynaCirc CR
manufactured using bulk amounts of the Active Ingredient supplied by ASL. 
  
 (u) “Losses” shall have the meaning ascribed in Section 3.2. 
  
 (v) “NDA” shall mean the New Drug Applications, 19-596 (DynaCirc) and 20-336 (DynaCirc CR) as amended and supplemented, to market the Products
and any materials, documents or information referred to or relied upon therein. 
  
 (w) “Process Description” shall mean, with respect to the Active Ingredient, good manufacturing procedures (including, but not limited to, FDA quality system requirements and procedures), as well as such
other know-how, technical specifications, instructions, processes and other intellectual property and information Reliant shall possess and as shall be necessary in order to allow ASL to manufacture and/or have manufactured the Active Ingredient.

  
 (x) “Products” shall mean the Initial Products, and
any Improvements thereto including all formulations containing Active Ingredient in all strengths, dosage forms and presentations. 
  
 (y) “Product Quality Complaint” shall mean any complaint that questions the purity, identity, potency or quality of the Active Ingredient.

  
 (z) “Purchase Price” shall have the meaning ascribed
in Section 2.7. 
  
 (z2) “Quality Agreement” refers to
the form of Quality Agreement attached as Exhibit C. 
  
 (z3)
“Quarterly Forecast” shall have meaning ascribed in Section 2.8(a). 
  
 (aa) “Receipt Date” shall mean the earliest date on which a party or its Affiliate first becomes aware of the Adverse Event. 
  
 (bb) “Regulatory Approval” shall mean, with respect to the Products, the FDA’s regulatory approval of the
amendment to the NDA authorizing the use of Active Ingredient manufactured by ASL in the Initial Products. 
  
 (cc) “Regulatory Filings” shall mean all applications, filings, materials, studies, data and documents of any nature whatsoever (including any
supporting information related thereto) filed with, or prepared in connection with, the Regulatory Approval. 
  
 (dd) “Specifications” shall have the meaning ascribed in 2.2. 
  
 (ee) “Term” shall have the meaning ascribed in 3.5. 
  
 (ff) “Territory” shall mean the United States, its territories and possessions including Puerto Rico. 

 

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 SECTION 2 
  
 SUPPLY AGREEMENT 
  
 SECTION 2.1. Supply of the Active Ingredient. 
  
 (a) During the term of this Agreement, and subject to the other terms and conditions hereof, ASL shall supply and sell to Reliant and Reliant shall purchase from ASL all of Reliant’s requirements for the Active
Ingredient pursuant to the terms of this Agreement. Notwithstanding the preceding sentence, Reliant’s obligation to purchase all of its requirements of API from ASL is contingent upon ASL’s ability to manufacture all Reliant’s
requirements, receipt by Reliant of Regulatory Approval and is further subject to Reliant’s obligations to purchase minimum quantities of Active Ingredient from Novartis pursuant to that certain Supply Agreement by and between Reliant and
Novartis dated January 10, 2003. 
  
 (b) During the term of this
Agreement and provided that Reliant complies with its purchase obligations set forth herein, ASL shall not supply or sell the Active Ingredient to any other purchaser in the Territory or outside the Territory for sale of any product containing the
Active Ingredient inside the Territory without the prior written consent of Reliant (provided, however, that nothing herein shall affect ASL’s ability to manufacture products which are not the Active Ingredient). 
  
 (c) ASL shall supply Reliant with Active Ingredient meeting the
Specifications. All Active Ingredient supplied by ASL to Reliant hereunder shall be consistent with the DMF and NDA and produced in a facility and in a manner compliant with GMP and all other applicable laws, and shall not be adulterated or
misbranded within the meaning of the Act and will have expiration dating of at least twenty four (24) months from the date of manufacture. Each shipment of Active Ingredient from ASL to Reliant shall be sampled and analyzed by ASL to determine if
the shipment of Active Ingredient meets the Specifications. ASL shall deliver with each shipment of the Active Ingredient a certificate of analysis stating that the Active Ingredient meets the Specifications. ASL shall not relocate or otherwise
transfer the site of manufacture of API without the express prior written approval of Reliant in the absence of a force majeure event or unremedied audit deficiencies under Section 2.3 below. Upon delivery to the Designated Facility, title to the
Active Ingredient so delivered will be free and clear of any security interest or other encumbrance created by ASL. 
  
 SECTION 2.2. Specifications. 
  
 (a) The specifications (“Specifications”) for the Active Ingredient are set forth on Exhibit A. 
  
 (b) All Active Ingredient supplied to Reliant hereunder shall be supplied in
bulk form in drums and on pallets or as otherwise agreed by the parties. The packaging requirements shall be specified in the Specifications. 
  
 (c) No changes to the Specifications or to the Active Ingredient shall be made by ASL without the prior written approval of Reliant unless expressly
required either under GMP or the Act. In addition, any changes to the Active Ingredient, the Specifications or the 

  

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manufacturing process which may require the submission of any amendment, filing or other documentation with the FDA and could potentially impact the NDA or
other Regulatory Filings shall be identified, reviewed and require the written approval of Reliant. To the extent reasonably practicable, Reliant shall provide a response to any such proposed changes within twenty (20) business days after receipt

  
 SECTION 2.3. Audit of Manufacturing Facility. 
  
 (a) Reliant or its representatives shall have the right, upon not less than
five (5) business days advance notice and during regular business hours, to inspect and audit any facilities being used by ASL and any of its Affiliates, subsidiaries, joint ventures or other entities for the manufacture, production or supply or
storage of the Active Ingredient (“Supply Facilities”) including all documentation related thereto to assure compliance by ASL or its suppliers with the terms of this Agreement, applicable US laws, rules and regulations including GMP and
the prevailing FDA quality system requirements. Such inspection and audit shall be limited to those portions of such Supply Facilities as are involved in the production of the Active Ingredient, and shall be, conducted in a manner so as to minimize
disruption of ASL’s and the inspected facilities’ business operations. ASL shall ensure Reliant has access to all such Supply Facilities (including, but not limited to, any third party facilities) in accordance with the foregoing in order
for Reliant to conduct such audits; provided, however, that Reliant shall be subject to such reasonable confidentiality obligations as may be required by such third party in order to protect any proprietary information. 
  
 (b) If any of such audits reveal that the Supply Facilities do not satisfy
the requirements of this Agreement or the Act, then Reliant shall provide 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 Supply Facilities and, if practicable, those steps which should be undertaken in order to remedy such deficiencies. ASL shall within thirty (30) days remedy any deficiencies from any such audit which have been provided to
ASL in writing. In the event that ASL does not remedy, or is incapable of remedying, any of such deficiencies within such thirty (30) day period, ASL shall have the option to locate and qualify alternate GMP qualified Supply Facilities from which to
perform its supply obligations under this Agreement. Should ALSA not locate and qualify such alternate GMP qualified Supply Facilities within 90 days of receiving Reliant’s notice, then Reliant shall be entitled to terminate this Agreement upon
written notice to ASL, in which event ASL shall provide Reliant at ASL’s cost such assistance and any other information (including the Process Descriptions) as shall be necessary in order for Reliant to manufacture or have manufactured the
Active Ingredient at another facility. 
  
 (c) ASL acknowledges
that the provisions of this Section 2.3 granting Reliant certain audit rights shall in no way relieve ASL of any of its obligations under this Agreement, nor shall such provisions require Reliant to conduct any such audits. 
  
 SECTION 2.4. Notice of Audit. 
  
 (a) Notice. ASL shall give Reliant immediate notice of any impending
FDA or other governmental audit of ASL as it relates to the manufacture, production or testing storage of 

  

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Active Ingredient supplied to Reliant pursuant to this Agreement and shall provide Reliant with any documentation provided to it relating to such audit. ASL
shall provide Reliant the opportunity for a 15-day, or a mutually-agreed timeline for review, prior to submission, any documentation prepared in response to such governmental audit and shall promptly provide Reliant with the results of such audit
following its conclusion. 
  
 (b) Inspection Reports. ASL
shall promptly provide to Reliant copies of any FDA or other US governmental inspection reports it receives from the FDA or other US governmental agency with jurisdiction over the manufacturing facility with respect to the manufacturing facilities
which supply the Active Ingredient. 
  
 (c) Regulatory
Inspections. ASL shall promptly notify Reliant of any FDA or other US regulatory inspections of the facilities which supply the Active Ingredient. 
  
 SECTION 2.5. Notice of Regulatory Action. 
  
 ASL shall provide Reliant with immediate notification of its receipt of any of the following related to the manufacture, production or testing storage of
the Active Ingredient; a copy of any list of observations (Form FD483), Warning Letters, Information Letters, Regulatory Letters or the like issued by the FDA as well as provide Reliant an opportunity to review any written response prior to
submission to the FDA. ASL shall maintain sole responsibility for any matter pertaining to such inspections. 
  
 SECTION 2.6. Recordkeeping. 
  
 ASL shall keep and maintain all production, batch, control laboratory and other records in accordance with all applicable FDA laws, roles and regulations including but not limited to GMP. Such records shall be made available to Reliant or
its representatives upon request. 
  
 SECTION 2.7. Orders, Prices and
Terms. 
  
 (a) Purchase Price. The purchase price
(“Purchase Price”) for the Active Ingredient purchased from ASL for a period of three (3) years from the date of Regulatory Approval for either of the Initial Products (the “Initial Pricing Period”) shall be as set forth on
Exhibit B hereto. In the event that Reliant fails to order at least [***] kgs of Active Ingredient (the “Minimum”) in any year of the Initial Pricing Period (excluding the “First Agreement Year”), and fails to cure such failure
in the Quarterly Forecast for the succeeding Agreement Year, ASL shall have the right to renegotiate the Purchase Price. Price increases will be limited to ASL’s direct incremental price increase for raw materials directly attributable to the
lower than expected volume purchases of raw materials by ASL as demonstrated from ASL’s records. The Purchase Price for each purchase order shall be determined by the relevant Tier on Exhibit B according to the aggregate number of kilograms of
API purchased to date within the relevant Agreement Year. The Purchase Price set forth on Exhibit B may be renegotiated at any time and from time to time after expiration of the Initial Period. Any change in the Purchase Price of Active Ingredient
following expiration of the Initial Pricing Period provided, however, that the Purchase Price for Active Ingredient shall not be increased greater than the annual increase in any Agreement Year during the Term by greater than the annual increase in
the Producer Price Industry Data figure for pharmaceutical preparations [***] as published by the US Department of Labor. 
  
 (b) Effect of Specification Changes on Purchase Price. Notwithstanding the foregoing, in the event that Reliant requests a change to the
Specifications, ASL shall notify Reliant within 30 days of ASL’s receipt of such request whether the requested change will result in a material increase or decrease in the direct cost of manufacture of the Active Ingredient and ASL’s
estimate of the cost of implementing the change. If Reliant then confirms to ASL that it wants to have the change implemented, then Reliant shall reimburse ASL for the estimated costs of implementing the change and pay such increased or decreased
price, as the case may be, for API in an amount that enables ASL to pass through its consequent direct cost increases or decreases 
  
 (c) Quarterly Reconciliation. Within thirty-(30) days of the last day of each calendar quarter, a quarterly reconciliation shall be calculated by
multiplying the total number of kgs purchased by Reliant in such quarter by the cost/kg in the relevant Tier in Exhibit B, and subtracting such amounts invoiced Reliant during such quarter (the difference is the “the Quarterly Payment”).
If the Quarterly Payment Amount is less than zero ($0.00), ASL shall credit Reliant that entire amount by way of a volume rebate in Kgs in the next invoice to Reliant for purchases. 
  

	[***]:	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.

  

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 (d) Annual Reconciliation: During each Agreement Year, ASL shall invoice Reliant for purchases as
set forth in Exhibit B. Within 30-days of the last day of each Agreement Year, an annual reconciliation will be calculated by multiplying the total number of kilograms of API purchased for the relevant agreement year by the relevant price in
appropriate Tier in Exhibit B, and subtracting the total invoiced amount in dollars for such Agreement Year (the difference is the “Annual Payment Amount”). If the Annual Payment Amount is less than zero ($0.00), ASL shall credit Reliant
that entire amount by way of a volume rebate in Kgs (the “Volume Rebate”) in the next invoice to Reliant for purchases. 
  
 (e) Invoices and Payments. ASL will invoice Reliant within thirty-(30) days after delivery and acceptance of each shipment of Active Ingredient to
Reliant or Designated Facility. Reliant shall pay ASL for API accepted within thirty-(30) days of receipt of the relevant invoice. All payments shall be made in U.S. dollars without deduction of any kind such as for withholding taxes or claims of
set-off other than in the case of a bona fide dispute with respect to this Agreement. If Reliant has not paid the invoice within such thirty (30) day period (other than amounts related to amounts subject to bona fide dispute), Reliant shall pay
interest on any unpaid and undisputed amounts at the rate of 1 1⁄2% per month or the maximum rate allowed by law whatever is lower until paid in full, and, if the dispute is resolved in ASL’s favor, Reliant shall pay interest at such rate on
the disputed amount until paid in full. 
  
 SECTION 2.8. Forecasts and Purchase
Orders. 
  
 (a) Following Regulatory Approval of one of the
Initial Products during the term of this Agreement, Reliant shall provide to ASL no later than the first day of the first month of each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s
requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each
Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval. 
  
 (b) Reliant shall place binding purchase orders for Active Ingredient by
written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which shall be placed at least ninety (90) days prior to desired date of delivery. 
  
 (c) ASL shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar
month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered. 
  
 (d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The
Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the
specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with
adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility. 
  
 (e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states
the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or
inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern. 
  

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 (f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a
shipment of Active Ingredient. 
  
 (g) ASL shall not be obligated
to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the
manufacturing, storage and/or transportation requirements of the Act. 
  
 SECTION
2.9. Product Claims. 
  
 (a) After delivery of a shipment
of any Active Ingredient to Reliant, Reliant shall have sixty (60) days to examine the Active Ingredient to determine if it conforms to the Specifications and, on the basis of such examination, to accept or reject such shipment. Any claims for
failure to so conform (“Claims”) shall be made by Reliant in writing within such sixty (60) day period to ASL, indicating the nonconforming characteristics of the Active Ingredient. 
  
 (b) If ASL agrees with such Claim, then as promptly as possible after the
submission of a Claim by Reliant, ASL shall, at Reliant’s option, provide Reliant (i) with a credit against future billings equal to the full amount paid by Reliant for such Active Ingredient or (ii) replacement Active Ingredient free of
charge. ASL shall pay for all shipping costs of returning or destroying Active Ingredient that are the subject of such accepted Claims. ASL shall bear the risk of loss for such Active Ingredient, beginning at such time as they are taken at
Reliant’s premises for return delivery. 
  
 (c) If ASL does
not agree with such Claim, then the parties shall submit the Active Ingredient in question to an independent party with validated analytical methods (such as Metrics, Inc.) of testing the Active Ingredient to determine whether or not it complies
with the Specifications. In the event the parties cannot agree upon such independent party, or in the event it is not possible to acquire the services of such an independent party, then such dispute shall be resolved pursuant to Section 4.15.

  
 SECTION 2.10. Additional Obligations of ASL. 
  
 ASL shall: 
  
 (a) Manufacture the Active Ingredient in accordance with the Specifications and the Quality Agreement for sale to Reliant
taking care to adhere to GMP, and all applicable FDA and other applicable US laws, rules and regulations including but not limited to the Act and FDA Guides to Inspections of Bulk Pharmaceutical Chemicals. 
  
 (b) Ship all Active Ingredient to Reliant with a remaining shelf life of at
least equal to the approved stability dating as set forth in the NDA as may be amended from time to time from date of shipment and perform annual stability testing on the API to support the expiration dating used on the API and affix lot numbers on
the containers of Active Ingredient on each shipping carton in accordance with applicable US laws. Once expiration dating of at least thirty six (36) months is assigned to the Active Ingredient, all Active Ingredient supplied by ASL hereunder will
have a remaining shelf life of at least twenty four (24) months from the date of shipment. 
  

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 (c) On not less than five(5) business days notice, afford representatives of Reliant, the FDA and any
other United States authority access to its facilities and that of its subcontractors for the purpose of inspecting and approving the facilities used to manufacture the Active Ingredient. 
  
 (d) No later than forty five (45) days of completion of test results on thirty (30) day accelerated stability on the first
validation batch of API, ASL will take all actions necessary to establish a DMF with FDA as may be required by the rules and regulations of the FDA and to make all filings necessary to maintain the DMF including, but not limited to, any necessary
updates following the completion of the stability report on the ninety (90) day accelerated stability test on the first validation batch of API. In addition, ASL shall take all action necessary to provide Reliant with access to the DMF such that the
NDA may reference the DMF for the purposes of this Agreement. 
  
 (e) In the event any shipment of the Active Ingredient fails to conform to the Specifications, GMP, or any applicable FDA or other US governmental regulation, ASL shall, without charge, promptly replace any such Active Ingredient with a
non-defective, conforming Active Ingredient. ASL shall promptly investigate the cause of such nonconformance or defect and shall report back to Reliant with respect to such investigation no later than seven (7) calendar days after notification or
discovery of such nonconformance or defect. 
  
 (h) Neither ASL
nor its subcontractors shall initiate any contact with the FDA or any other US regulatory agency in connection with the subject matter of this Agreement without the prior written approval of Reliant. ASL and/or such subcontractor shall inform
Reliant, via same-day telephone and by receipt of written notice within one day thereafter, of any contacts of ASL or such subcontractor by the FDA or any other US regulatory agencies in connection with the subject matter of this Agreement, and ASL
or such subcontractor shall prepare and submit to Reliant for its approval a written record of all such contacts. Reliant shall have the right to have a representative present at any time the FDA or other US governmental authority shall elect to
conduct an inspection of any site at which a manufacturing or other investigation of API is being conducted. ASL or such subcontractor shall forward to Reliant any notice relating to such inspection, immediately upon receipt thereof. 
  
 SECTION 2.11. Adverse Events; FDA Audits; Etc. 
  
 (a) Each party agrees to cooperate with the other party in the exchange of
information concerning Adverse Events associated with the use in humans of the Products which Reliant or any its Affiliates manufactures or has manufactured, markets, and distributes from the Active Ingredient supplied by ASL under this Agreement.
Each party shall notify the designated party of the other set forth in Section 2.13 within one (1) working day of the Receipt Date. Unless otherwise required by law, Reliant will retain exclusive authority and responsibility for the reporting of any
Adverse Events to the FDA. 
  
 (b) Each party shall notify the
designated Quality Assurance Manager of the other by e-mail, fax or by telephone within one (1) working day of receipt of any product complaint report received relating in any manner to the Products which may meet FDA Field-alert Report criteria
codified at 21 CFR 314.81(b)(1)) with an original copy of the report sent by overnight 

  

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courier the same day. ASL shall investigate all such complaints associated with the Active Ingredient and provide a written response to such complaints with
a copy to Reliant. Reliant shall investigate all such complaints associated with Product (other than complaints associated with the Active Ingredient)) and provide a written response to the FDA (if required by applicable laws) to such complaints
with a copy to ASL. Each party shall provide the other with a preview copy of its written responses and consult with the other regarding such responses prior to filing the responses with the FDA. 
  
 (c) Reliant shall have the right to have a representative present at any time
the FDA or other US governmental authority shall elect to conduct an inspection of any site at which a manufacturing or other investigation of the Active Ingredient is being conducted. ASL or such subcontractor shall forward to Reliant any notice
relating to such inspection, immediately upon receipt thereof. 
  
 SECTION 2.12.
Product Quality Complaints. 
  
 (a) Complaints that concern
any incident that causes the Product or its labeling to be mistaken for, or applied to, another article or any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the Product, or any failure of
one or more distributed batches of the Product to meet the Specifications shall be telephoned to both parties promptly upon receipt. 
  
 (b) The relevant contact person with respect to Adverse Events shall be: 
  
 If to ASL: 
  
 Facsimile No.: (847) 520 9160 
 Telephone No.: (847) 520 9600 
 E-mail:
             @austinchemical.com 
  
 If to Reliant: Reliant Medical Affairs 
  
 Fax: 1-877-311-8160 
 Tel: 1-908-580-1200 
         1-877-311-7515 
  
 SECTION 2.13. Government Agency Recalls. 
  
 (a) Each of the parties agree to maintain or cause to be maintained such
traceability records as are necessary to permit a recall, withdrawal, field alert or field correction of Active Ingredient or Product. 
  
 (b) In the event any governmental agency having applicable jurisdiction shall order any corrective action with respect to Product containing Active
Ingredient supplied hereunder such as customer notice, restriction, change, corrective action or market action or any Product change, and the cause of basis of such corrective action is due to the actions or inactions of ASL 

  

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under this Agreement including without limitation the failure of the API to meet the Specifications or a breach by ASL of Section 3.1(a) below, then ASL
shall be liable to Reliant to credit or replace such API as required by Section 2.9(b), including paying all costs of returning or destroying such API. 
  
 (c) Reliant shall have the right to determine that a recall of any portion of Product is necessary or appropriate at any time, and to design, administer
and control the recall process (provided, however, that at the request of ASL, ASL shall have the right to consult with Reliant prior to determining that a recall is necessary). If a recall is determined to be necessary or appropriate due to
ASL’s breach of any of its obligations under this Agreement, ASL shall be liable for replacing the Active Ingredient used to manufacture the recalled Product. For purposes of this Section, “recall” means a firm’s removal or
correction (e.g., repair, modification, adjustment, re-labeling, destruction or inspection (including patient/consumer marketing) of a product without its physical removal to some other location) of a marketed Product that there are reasonable
grounds to believe could be considered by the FDA to be in violation of the Act or against which the FDA could initiate legal action. 
  
 SECTION 2.14. Annual Review. The parties agree to establish an annual business review process pursuant to which the parties will review (either in person, by
telephone, videoconference or other mutually agreeable means) Active Ingredient quality, cycle time, manufacturing capacity, projected market needs, and delivery. 
  
 SECTION 3 
  
 GENERALLY APPLICABLE TERMS 
  
 SECTION 3.1. Representations and Warranties. 
  
 (a) ASL to the best of its knowledge represents and warrants to Reliant that: 
  
 (i) the Active IngredientS supplied by ASL will be manufactured in accordance with the Specifications GMP,
the DMF and all applicable FDA and other US governmental regulations; 
  
 (ii) the Active Ingredient supplied by ASL are being sold to Reliant free and clear of all liens, claims and encumbrances of any nature; 
  
 (iii) attached as Exhibit C is a true and correct copy of the Quality Agreement as executed by the parties;

  
 (iv) to the best of its knowledge after
diligent inquiry, the Active Ingredient, and its manufacture or use by ASL, does not violate any patents, patent rights, patent applications, inventions, copyrights, confidential information, trade secrets, proprietary rights or processes of any
other person in the country where such Active Ingredient is manufactured or in the Territory; 
  
 (v) there are no pending or threatened suits, claims, or actions of any type whatsoever against ASL with respect to the Active Ingredient
or the manufacture thereof; 
  

 11 

 (vi) all necessary corporate and other authorizations including all necessary approvals,
licenses and authorizations from FDA or other US governmental entities, consents and approvals which are necessary or required for ASL to enter into this Agreement have been duly obtained and are in and will remain in full force and effect;

  
 (vii) the entering into of this Agreement
(including the Quality Agreement) by ASL 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 ASL, under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement (including the Quality Agreement), contract, purchase order or
other instrument, document or agreement to which ASL is a party or by which it or any of its properties or assets is bound or affected; 
  
 (viii) ASL shall, and shall cause its Affiliates, subcontractors, joint venture partners, and any other person or entity performing
services under this Agreement to, comply with all applicable United States laws, rules and regulations applicable to their manufacture or sale of the Active Ingredient (this warranty does not and is not intended to address third party proprietary
rights); and 
  
 (ix) ASL has not been debarred
and ASL has not and will not use in any capacity in connection with the performance of its obligations under this Supply Agreement the services of any individual or person known by ASL to be debarred in each case by the FDA under the provisions of
the Generic Drug Enforcement Act of 1992, as amended, or other applicable 
  
 The foregoing warranties extend only to Reliant and its Affiliates, contract manufacturers, corporate partners and/or other persons who collaborate with Reliant in the production of Product from the Active Ingredient.
THE FOREGOING WARRANTIES SHALL NOT COVER AND ASL MAKES NO WARRANTIES WITH RESPECT TO: (A) ANY ACTIVE INGREDIENT THAT HAS BEEN SUBJECT TO; (I) ABUSE, MISUSE, MISAPPLICATION, NEGLECT, ALTERATION OR ACCIDENT AFTER DELIVERY AND ACCEPTANCE OF THE API BY
RELIANT: (II) IMPROPER OR INCORRECT STORAGE AFTER DELIVERY AND ACCEPTANCE BY RELIANT; OR (; OR (III) ANY MATERIALS, PARTS, GOODS OR OTHER COMPONENTS NOT SUPPLIED BY ASL WHICH ARE USED BY RELIANT IN CONNECTION WITH THE PRODUCT. 
  
 (b) Reliant represents and warrants to ASL that: 
  
 (i) all necessary corporate and other authorizations,
consents and approvals which are necessary or required for Reliant to enter into this Agreement have been duly obtained; 
  

 12 

 (ii) the entering into of this Agreement (including the Quality Agreement) by Reliant
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 Reliant 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 Reliant is a party or
by which it or any of its properties or assets is bound or affected; 
  
 (iii) Reliant shall not, during the course of any manufacturing, marketing or selling by it of the Products, engage in any act which results in the Products being adulterated or misbranded within the meaning of the
Act, or any regulation promulgated thereunder; 
  
 (iv) Reliant shall comply with all applicable laws, rules and regulations applicable to their importation, manufacture, use or sale of the Product in the Territory; 
  
 (v) To the best of its knowledge, the Product, and its manufacture, use or sale by Reliant and/or its
Affiliates, will not violate any patents, patent rights, patent applications, inventions, copyrights, confidential information, trade secrets, proprietary rights or processes of any other person; 
  
 (c) THE WARRANTIES CONTAINED IN THIS SECTION 3.1 ARE THE EXCLUSIVE WARRANTIES
MADE BY THE PARTIES IN RESPECT OF THE ACTIVE INGREDIENT AND PRODUCT, AND ALL OTHER WARRANTIES RELATING THERETO, EXPRESS, STATUTORY OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE, AND MERCHANTABILITY ARE
HEREBY WAIVED AND EXCLUDED; PROVIDED HOWEVER THAT NOTHING IN THIS SECTION 3.1 SHALL BE DEEMED OR CONSTRUED TO LIMIT ASL’s OBLIGATIONS UNDER SECTION 2.10. 
  

SECTION 3.2. Indemnification. In order to distribute among themselves the responsibility for claims arising out of this Agreement, and except as otherwise
specifically provided for herein, the parties agree as follows: 
  
 (a) ASL shall defend and indemnify and hold Reliant (and its Affiliates, and their respective officers, directors and employees) harmless against any and all claims, suits, proceedings, expenses, recoveries and damages, including court
costs and reasonable attorneys fees and expenses (collectively, “Losses”), arising out of, based on, or caused by (A) the breach by ASL of any representation or warranty contained in this Agreement, (B) any failure of ASL to comply with
any applicable US law in connection with performing its obligations under this Agreement or (C) any negligence or intentional misconduct by ASL in connection with performing its obligations under this Agreement in each case except to the extent that
such 

  

 13 

 
Losses arise from or are aggravated by the grossly negligent acts of or failure to act by Reliant or its Affiliates. Reliant will promptly notify ASL of any
such Losses which come to its attention. 
  
 (b) Reliant shall
defend and indemnify and hold ASL (and its Affiliates, and their respective officers, directors and employees) harmless against any and all Losses, arising out of, based on, or caused by (A) statements, whether written or oral, made or alleged to be
made by Reliant or its Affiliates on the packaging or labeling of any of the Products, or in the advertising, manufacturing (other than the manufacturing of the Active Ingredient), promotion, use or sale of any of the Products, (B) the storage,
sale, shipment, promotion or distribution of the Products by Reliant or its Affiliates, or (C) the breach by Reliant of any representation or warranty contained in this Agreement, in each case except to the extent that such Losses arise from or are
aggravated by the grossly negligent acts of or failure to act by ASL or its Affiliates. ASL will promptly notify Reliant of any such Losses which comes to its attention. 
  
 (c) In the event either party becomes aware of any product liability claims from third parties with respect to the Products
(whether related to the safety or efficacy of the Product, or arising out of alleged defects in materials, design or workmanship of the Product or otherwise, (hereinafter, a “Product Liability Claim”), it shall promptly notify the other of
such matter, and provide copies of any notices, claims, letters or other information which such party has received or possesses in connection with such Product Liability Claim. Each party shall reasonably cooperate with the other with respect to the
defense and resolution of any such Product Liability Claim. Reliant shall have responsibility for controlling any litigation, defense or settlement of any such Product Liability Claims. 
  
 SECTION 3.3. Infringement Indemnification. 
  

(a) ASL shall defend and indemnify and hold Reliant (and its Affiliates and the respective officers, directors and employees) harmless against any and
all claims, suits, proceedings, expenses, recoveries and damages, including court costs and reasonable attorneys fees and expenses arising from or relating to claims that the formulation or manufacture of Active Ingredient or other activities of ASL
under this Agreement infringe on the patent or other intellectual property rights of a third party within the Territory. 
  
 (b) Reliant shall defend and indemnify and hold ASL (and its Affiliates and the respective officers, directors and employees) harmless against any and all
claims, suits, proceedings, expenses, recoveries and damages, including court costs and reasonable attorneys fees and expenses arising from or relating to claims that the Products manufactured using the API supplied or its use or sale infringes on
the patent or other intellectual property rights of a third party. 
  
 SECTION
3.4. Insurance. 
  
 (a) Reliant and ASL shall each at its
own expense obtain and maintain insurance of the type and amount described in Section 3.4(b). Neither party shall do or omit to do any act, matter or thing which could prejudice or render voidable any such insurance. 
  
 (b) The parties agree that each will maintain during the performance of this
Agreement the following insurance in amounts no less than that specified for each type: 
  
 (i) General liability insurance with combined limits of not less than $1,000,000 per occurrence and $1,000,000 per accident for bodily
injury, including death and property damage. 
  

 14 

 (ii) product liability insurance with combined limits of not less than $3,000,000 per
occurrence and $3,000,000 per accident for bodily injury, including death and property damage. 
  
 (c) Each party will provide to the other party evidence of its insurance naming the other as an additional insured and containing a waiver of subrogation against the other and thirty (30) days prior written notice of
any cancellation of its coverage or reduction in coverage from the requirements stated herein. 
  
 SECTION 3.5. Term. 
  
 (a)
This Agreement shall remain in effect from the Effective Date for a period of seven (7) years from the receipt of the first Regulatory Approval for either of the Initial Products (the “Initial Term”). Unless sooner terminated, this
Agreement shall be renewed automatically for successive terms of two (2) years unless either party provides notice to the contrary within one hundred twenty (120) days prior to the end of the Initial Term or any such additional term. 
  
 (b) Notwithstanding any other provision of this Agreement, either Reliant or
ASL may terminate this Agreement by notice in writing to the other upon the occurrence of any of the following events: 
  
 (i) if the other commits a breach of this Agreement (other than a breach by Reliant of Section 2.8 hereof) that the notified party fails
to remedy within thirty (30) days of the receipt by the other of a notice identifying the breach and requiring its remedy; or 
  
 (ii) if the other is subject to a Bankruptcy Event. 
  
 (c) Reliant may terminate this Agreement immediately upon written notice to ASL if: 
  
 (i) the FDA prohibits the Product(s) from being
manufactured, shipped, sold or marketed, in which event all outstanding or unfinished purchase orders (including any firm order obligations pursuant to any forecasts) shall be cancelled; 
  
 (ii) in the absence of a force majeure event under Section 4.10 below, ASL is unable to supply API in
sufficient quantities to meet purchase orders submitted in accordance with Section 2.8 hereunder for a period of six (6) months in any twelve (12) month period or, taking into account any such force majeure event, ASL is unable to meet such purchase
orders for a continuous period of six (6) months; or 
  
 (iii) any representation or warranty made herein by ASL proves to be incorrect in any material respect when made. 
  

 15 

 (d) ASL may terminate this Agreement upon written notice to Reliant if any representation or warranty
made herein by Reliant proves to be incorrect in any material respect when made. 
  
 SECTION 3.6. Effect of Termination. 
  
 (a) If
this Supply Agreement is terminated for any reason other than Reliant’s failure to make payment under this Agreement, ASL shall complete the manufacture of any binding purchase order for Active Ingredient and ship such Active Ingredient
pursuant to the terms of this Agreement. 
  
 (b) The termination
or expiration of this Agreement will not release either party from the obligation to pay any sum that may be owing to the other party (whether then or thereafter due) to operate any liability or obligation that had been incurred by either Party
prior to any such termination. 
  
 SECTION 4 
  
 MISCELLANEOUS 
  
 SECTION 4.1. Confidentiality; Press Releases. 
  
 (a) Reliant and ASL will be exchanging confidential and proprietary
information relating to the Active Ingredient and Products and their respective businesses at the inception of and from time to time during the term of this Agreement. The party receiving such information will maintain the information in confidence
using the same standard of care it uses to maintain its own information in confidence. Such obligation of confidentiality shall not apply to information which (i) is known to the receiving party prior to the disclosure, (ii) is publicly known as of
the date of the disclosure, (iii) becomes publicly known after the date of disclosure through no fault of the receiving party, (iv) is received from a third party who has no obligation of confidentiality to the disclosing party or (v) is developed
independently by or for the receiving party. Such obligation of confidentiality shall continue for a period of five (5) years from the date of termination of this Agreement. 
  
 (b) Notwithstanding the foregoing Section 4.1(a), (i) Reliant shall be permitted to disclose to its manufacturers,
subcontractors, wholesalers, other direct customers, investment bankers and/or financing sources such confidential information relating to the Products and this Agreement as Reliant shall reasonably determine to be necessary in order to effectively
market and distribute the Products or otherwise engage in a bona fide financing transaction and (ii) ASL shall be permitted to disclose to its Affiliates, manufacturers, subcontractors, wholesalers, other direct customers, investment bankers and/or
financing sources such confidential information relating to the Active Ingredient and Products as ASL may reasonably determine to be necessary to perform its obligations under this Agreement, provided that such entities undertake the same
confidentiality obligation as the disclosing party has with respect to the other’s confidential information and provided that ASL and its Affiliates may disclose the fact of the Agreement for purposes of marketing its services. 
  

 16 

 (c) Except as may be required by applicable laws, rules or regulations (including in connection with a
public offering of securities), 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 Products or its services 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 ten (10) business days prior to disclosure. In the
absence of a communication approving or disapproving of the public announcement from the party with the right of approval by the end of such ten (10) day period, such party shall be deemed to have approved the public announcement. 
  
 SECTION 4.2. Survival. Those provisions of this Agreement dealing with rights and
obligations upon and/or after termination of this Agreement including but not limited to Sections 1.1 (to the extent necessary to give effect to the Articles and Sections enumerated in this Section 4.2), 2.6, 2.7(d), 2.8(d), 2.8(e), 2.8(f), 2.10,
2.11.2.12, 2.13, 3.2, 3.3, 3.4, 3.6, 4.3, 4.9, 4.15, 4.16 and 4.17 shall survive termination of this Agreement to the extent necessary to give effect to such provisions. 
  
 SECTION 4.3. Penalties. If either party terminates this Agreement in accordance with the terms herein the terminating party shall owe
no penalty to the terminated party on account of such termination. 
  
 SECTION
4.4. Independent Contractor Status. Neither party shall have any authority to obligate the other in any respect nor hold itself out as having any such authority. All personnel of ASL shall be solely employees of ASL and shall not represent
themselves as employees of Reliant, and all personnel of Reliant shall be solely employees of Reliant and shall not represent themselves as employees of ASL. 
  
 SECTION 4.5. Binding Effect; Benefits. This Agreement shall endure to the benefit of and be binding upon the parties and their respective permitted successors and
assigns. Nothing contained herein shall give to any other person any benefit or any legal or equitable right, remedy or claim. 
  
 SECTION 4.6. Assignment. 
  
 Neither party may assign this Agreement or any of its rights hereunder or delegate its performance of its obligations hereunder without the express prior
written consent of the other party, except that either party may assign or delegate any of its rights or obligations under this Agreement to an Affiliate or subsidiary; provided that the assigning party shall be made liable for all obligations and
liabilities of the assignee following such assignment. Notwithstanding the foregoing (a) each party may assign this Agreement to any purchaser of all or substantially all of its assets or to any successor entity resulting from any merger or
consolidation of such party with or into such entity AND (b) Reliant may assign its rights and obligations hereunder to an 

  

 17 

 
acquirer of all or substantially all of Reliant’s assets relating to one or more of the Products. The (i) conversion of either party from a limited
liability company to a corporation and/or (ii) issuance by either party of securities in connection with any financing transaction or public offering shall not be deemed an assignment and shall be permitted without notice to or consent from the
other party or its Affiliates. My attempted assignment in violation of this provision shall be deemed a material breach of this Agreement. 
  
 SECTION 4.7. Entire Agreement; Amendments. The parties acknowledge that this Agreement sets forth the entire agreement and understanding of the parties as to the
subject matter of this Agreement, and supersedes any prior verbal, written or other understandings of the parties with respect to the subject matter of this Agreement. This Agreement shall not be subject to any change or modification except by the
execution of a written instrument subscribed to by the parties. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this
Agreement shall govern. 
  
 SECTION 4.8. Severability. In the event that
any provision of this Agreement would be held in any jurisdiction to be invalid, prohibited or unenforceable for any reason, such provision, as to such jurisdiction, shall be ineffective, without invalidating the remaining provisions of this
Agreement or affecting the validity or enforceability of such provision in any other jurisdiction. Notwithstanding the foregoing, if such provision could be more narrowly drawn so as not to be invalid, prohibited or unenforceable in such
jurisdiction, it shall, as to such jurisdiction, be so narrowly drawn, without invalidating the remaining provisions of this Agreement or affecting the validity or enforceability of such provision in any other jurisdiction. 
  
 SECTION 4.9. Remedies; Etc. Unless otherwise expressly provided, all remedies
hereunder are cumulative, are in addition to any other remedies provided for by law and may, to the extent permitted by law, be exercised concurrently or separately, and the exercise of any one remedy shall not be deemed to be an election of such
remedy or to preclude the exercise of any other remedy. 
  
 SECTION 4.10. Force
Majeure. 
  
 The obligations of ASL and Reliant hereunder
shall be subject to any delays or non-performance caused by acts of God, earthquakes, fires, floods, explosion, sabotage, riot, accidents; orders of, or failure to issue all necessary permits or licenses by, regulatory, governmental, or military
authorities; strikes, lockouts or labor trouble; perils of the sea; or any other similar cause beyond the reasonable control of either party, and each party shall be under no liability to the other for anything which would constitute a breach of
this Agreement arising by reason of such matters. The party which is not performing its obligations under this Agreement as a result of an event of force majeure shall use diligent efforts to resume compliance with this Agreement as soon as
possible. Should the event of force majeure continue unabated for a period of sixty (60) days or more, the parties shall enter into good faith discussions with a view to alleviating its affects or to agreeing upon such alternative arrangements as
may be fair and reasonable having regard to the circumstances prevailing at that time. In the event that such alternative arrangements cannot be agreed upon within thirty (30) days after the expiration of such initial sixty (60) day period, then the
non-performing party shall 

  

 18 

 
continue to diligently attempt to alleviate such event of force majeure until it is removed or eliminated. 
  
 SECTION 4.11. Notices. Any notice, request, consent or communication (collectively, a
“Notice”) under this Agreement shall be effective if it is in writing and (i) personally delivered, (ii) sent by certified or registered mail, postage prepaid, return receipt requested, (iii) sent by an internationally recognized overnight
delivery service, with delivery confirmed, or (iv) e-mail, telexed or facsimile, with receipt confirmed, addressed as set forth in this Section or to such address as shall be furnished by either party hereto to the other party hereto. A Notice shall
be deemed to have been given as of (i) the date when personally delivered, (ii) five (5) business days after being deposited with the United States Postal Service, certified or registered mail, properly addressed, return receipt requested, postage
prepaid, (iii) one business day after being delivered to said overnight delivery service properly addressed, or (iv) confirmation of receipt of the e-mail, telex or facsimile, as the case may be. All Notices shall specifically state: (i) the
provision (or provisions) of this Agreement with respect to which such Notice is given, and (ii) the relevant time period, if any, in which the party receiving the Notice must respond. 
  

			
	If to ASL:	  	Austin Shasun LLC
	 	  	1565 Barclay Boulevard
	 	  	Buffalo Grove, IL 60089-4537
	 	  	Attn:
                                       
 
		
	Facsimile:	  	(847)520 9160
	E-mail:	  	            @austinchemical.com
		
	Telecopier:	  	 

			
		
	if to Reliant to:	  	Reliant Pharmaceuticals, LLC
	 	  	110 Allen Road
	 	  	Liberty Corner, New Jersey 07938
	 	  	Attn: Joseph Krivulka, President
		
	Telephone:	  	(908) 542-4400
	Fax:	  	(908) 542-9406
		
	with a copy to:	  	Reliant Pharmaceuticals, LLC
	 	  	110 Allen Road
	 	  	Liberty Corner, New Jersey 07938
	 	  	Attn: Michael J. Lerner, General Counsel
		
	Telephone:	  	(908) 542-4408
	Fax:	  	(908) 542-9406

  
 SECTION 4.12. Waivers. The
failure of either party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by
the other party. 
  

 19 

 SECTION 4.13. Counterparts. This Agreement may be executed in any number of counterparts, and execution by each of
the parties of any one of such counterparts will constitute due execution of this Agreement. Each such counterpart shall be deemed to be an original instrument, and all such counterparts together shall constitute but one agreement. 
  
 SECTION 4.14. Headings. The article and section headings contained in this Agreement
are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. 
  
 SECTION 4.15. Governing Law; Dispute Resolution. 
  
 (a) This Agreement shall be construed, governed, interpreted and applied in accordance with the laws of the State of New York, U.S.A. without regard to
the conflict of law principles thereof, and the United Nations Convention on Contracts for the International Sale of Goods is expressly disclaimed. 
  
 (b) Excepting only actions and claims relating to actions commenced by a third party against ASL or Reliant (including, without limitation, actions for
injuries caused by a Product, or in respect to a patent infringement claim), any controversy or claim arising out of or relating to this Agreement, or the parties’ decision to enter into this Agreement, or the breach thereof, shall be settled
by arbitration in accordance with the arbitration American Arbitration Association, and judgment upon the award rendered by the arbitrator may be entered in any court having jurisdiction thereof. 
  
 (c) The arbitration shall be held before a single arbitrator, to be selected
by ASL and Reliant or, if ASL and Reliant cannot agree on such arbitrator, in accordance with the applicable arbitration rules provided that the arbitrator shall have significant pharmaceutical manufacturing and supply experience. 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) The
arbitrator shall not award either parties punitive damages and the parties shall be deemed to have waived any right to such damages. 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 

  

 20 

 
expediting the arbitration as much as is deemed reasonable to him, but in all events to effect a final award within three hundred sixty five (365) days of
the arbitrator’s selection or appointment and within twenty (20) days of the close of evidence. 
  
 (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. 
  
 (f) Each party is required to continue to perform its
obligations under this Agreement pending final resolution of any such dispute. 
  
 (g) The procedures specified in this Section 4.15 shall be the sole and exclusive procedures for the resolution of disputes between the parties arising out of or relating to this Agreement; provided however, that a
party, without prejudice to the above procedures, may seek injunctive relief or other provisional judicial relief, if in its sole judgment, such action is necessary to avoid irreparable damage. 
  
 SECTION 4.16. Consequential Damages. Neither Reliant nor ASL (which for the purposes
of this Section 4.16 shall include their respective Affiliates, directors, managers, officers, employees, consultants, equity holders, representatives and agents) shall have any liability to the other for any punitive damages, specialty, incidental,
consequential or indirect damage relating to or arising from the loss of commercial or business opportunity, revenue or profit, in connection with or arising out of this Agreement even if such damages may have been forecasted; providing that such
limitations shall not apply in the case of (a) fraud, (b) intentional misconduct or (c) any damages claimed by or paid to a third party in a third party action. 
  

SECTION 4.17. Limitation of Liability. Except in the cases of fraud, gross negligence or intentional misconduct ASL’s aggregate liability to Reliant under
this Agreement for any calendar year during the term of this Agreement shall not exceed the net amounts paid by Reliant (amounts paid less the Annual Payment Amount rebated) under Section 2.7 above with respect to that calendar year. 
  
 SECTION 4.18 Conversion to Non-Exclusive. Following the Initial Period, in the event
that Reliant fails to purchase the Minimum in any two (2) consecutive calendar quarters pursuant to Section 2.8 hereof, ASL as its sole remedy hereunder shall on thirty (30) days written notice shall be relieved of the restriction on sales to third
parties of Active Ingredient set forth in Section 2.1(b) hereof. Reliant, however, shall have the option during the thirty days following notice from ASL to purchase such amounts of API as necessary to satisfy the Minimum for the calendar quarters
in question in which case the restriction on sales of Active Ingredient to third parties set forth in Section 2.1(b) shall remain in full force and effect. 
  
 [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] 
  

 21 

 IN WITNESS WHEREOF, duly authorized representatives of the parties hereto have duly executed this
Agreement as of the date first above written. 
  

			
	 RELIANT PHARMACEUTICALS, LLC

		
	 By:
	 	 
	 Title:
	 	 
	
	 AUSTIN SHASUN, LLC

		
	 By:
	 	 
	 Title:
	 	 

  

 22 

  
 Exhibit A

  
 SPECIFICATIONS 
  
 [TO BE SUPPLIED] 
  

 23 

  
 Exhibit A 

 
 Isradipine API Specifications 
  

					
	 	  	 Tests

	  	 Limits

	 1
	  	[***]	  	[***]
	 2
	  	[***]	  	[***]
	 3
	  	[***]	  	[***]
	 4
	  	[***]	  	[***]
	 5
	  	[***]	  	[***]
	 6
	  	[***]	  	[***]
	 7
	  	[***]	  	[***]
	 8
	  	[***]	  	[***]
	 9
	  	[***]	  	[***]
	 10
	  	[***]	  	[***]
	 11
	  	[***]	  	[***]

  

	[***]:	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 

  
 Exhibit B 
  
 Pricing 
  
 The purchase price (“Purchase Price”) for Active Ingredient purchased from ASL shall be as follows: 
  
 Non-Commercial Use - $[***] 
  
 Commercial Use: 
  

								
	 Kilos Purchased (Annualized)

	  	Cost/Kg

	 Tier 1
	  	[***]	  	 	  	$	[***]
	 Tier 2
	  	[***]	  	 	  	$	[***]
	 Tier 3
	  	[***]	  	 	  	$	[***]

  

	[***]:	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 

 
 QUALITY AGREEMENT 
  
 [TO BE SUPPLIED] 
  

 2Supply and Packaging Agreement, dated March 19, 2004

 Exhibit 10.28 
  
 SUPPLY & PACKAGING AGREEMENT 
  
 This Supply & Packaging Agreement (“Agreement”) is made and entered into as of the 19th day of March, 2004 by and between Reliant
Pharmaceuticals, LLC, a limited liability company organized under the laws of Delaware (being referred to herein as the “Company”) and Novartis Consumer Health, Inc., a corporation organized under the laws of Delaware
(“Manufacturer”). 
  
 WITNESSETH:

  
 WHEREAS, the Company desires to engage the
Manufacturer to manufacture and/or supply the Products and the Packaged Tablets in the Territory to the Company on the terms and conditions set forth herein; and 
  
 WHEREAS, the Manufacturer wishes to manufacture and/or supply the Products and the Packaged Tablets to the
Company on the terms and conditions set forth herein. 
  
 NOW, THEREFORE, in consideration of the premises and mutual covenants contained herein and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties agree
as follows: 
  
 ARTICLE I 
 DEFINITIONS 
  
 1.1 Definitions. 
  
 As used in this Agreement, the following terms shall have the meanings ascribed to them below: 
  
 (a) “Act” shall mean collectively the Federal
Food, Drug, and Cosmetic Act of 1938, including any amendments thereto, and all regulations, rules, guidelines and procedures promulgated thereunder, and the Federal Controlled Substances Act, including all amendments thereto, and all regulations
rules, guidelines and procedures promulgated thereunder. 
  
 (b) “Affiliate” means, with respect to any Person, any other Person directly or indirectly controlling or controlled by, or under direct or indirect common control with, such Person. For purposes of this
definition, a Person shall be deemed to control another Person if it owns or controls more than fifty percent (5 0%) of the voting equity of the other Person (or other comparable ownership if the Person is not a corporation). 
  
 (c) “Agreement” shall have the meaning set forth
in the introductory paragraph. 
  
 (d)
“API” shall mean Isradipine. 

 (e) “API Specifications” has the meaning set forth in NDA, as amended or
supplemented in accordance with this Agreement. 
  
 (f) “Adverse Reactions” means any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: an adverse event occurring in the course of the use of a drug product in
professional practice; an adverse event occurring from drug overdose, whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of pharmacological action.

  
 (g) “cGMP” shall mean the quality
systems and current good manufacturing practices set forth in 21 C.F.R. (Parts 210 and 211) and all applicable directives, Regulatory Requirements (as defined below) and FDA (as defined below) rules, regulations, guides, guidance, each as amended
from time to time and in effect during the Term of this Agreement. 
  
 (h) “cGMP Requirements” means the requirements of cGMP. 
  
 (k) “Contract Year” means the the twelve (12) month period coinciding with the calendar year. Notwithstanding the foregoing, for
purposes of this Agreement, the first Contract Year of this Agreement shall mean the period from the Effective date to December 31, 2004. Thereafter each Contract Year shall be from January 1 through December 31 of each calendar year during the Term
of this Agreement. 
  
 (l) “Drug Layer
Granulation” shall mean a granulate including API meeting the Product Specifications. 
  
 (m) “Effective Date” or “Commencement Date” means the date set forth in the preamble of this Agreement. 
  
 (n) “FDA” means the United States Food and Drug
Administration or any successor thereof. 
  
 (o)
“Forms” has the meaning set forth in Section 13.5 of this Agreement. 
  
 (p) “Governmental Authority” means any nation or government, any state, regional, local or to her political subdivision thereof,
any supernational organization of sovereign states and any entity, department, commission, bureau, agency, authority, board, court, official or officer, domestic or foreign, exercising judicial, regulatory or administrative, functions of or
pertaining to government. 
  
 (q)
“Granulations” shall mean collectively the Drug Layer Granulations and Osmotic Layer Granulations. 
  
 (r) “Including” or “includes” means “including, without limitation,” or “includes, without limitation.

  
 (s) “IP” has the meaning set forth
in Section 12.2 of this Agreement. 

 (t) “Law” means each provision of any currently existing federal, State, local
or foreign law, statute, ordinance, code, rule, regulation (including without limitation, the Act and cGMP’s), promulgated or issued by any Governmental Authority, as well as any binding judgments, decrees, injunctions or agreements entered
into by any Governmental Authority. 
  
 (u)
“Manufacturing” or “Manufacture” shall mean the activities associated with producing the Product including, but not limited to, Materials acquisition, manufacturing, Packaging, testing and labeling of finished dosage form of the
Product. 
  
 (v) “Manufacturer” has the
meaning set forth in the preamble of this Agreement. 
  
 (w) “Manufacturing Fee” means the fee paid to the Manufacturer for the Products pursuant to Section 6.1 of this Agreement. 
  
 (x) “Materials” means all ingredients, packaging supplies, printed materials and all other components used to Manufacture the
Products excluding API. 
  
 (y) “NDA”
means the New Drug Application 20-336 as amended and supplemented for the Product and as approved by the FDA to market the Product and any materials, documents or information referred to or relied upon therein. 
  
 (z) “Osmotic Layer Granulation” shall mean a
granulate without API meeting the Product Specifications. 
  
 (aa) “Packaged Tablets” means Tablets as packaged in accordance with the Packaging Specifications. 
  
 (bb) “Packaging” or “Package” means packaging of Tablets. 
  
 (cc) “Packaging Fee” means the fee paid to the
Manufacturer for Packaging pursuant to Section 6.1 of this Agreement. 
  
 (dd) “Packaging Specifications” means the requirements and standards for the Packaging of Tablets as set forth in the NDA, as amended or supplemented in accordance with this Agreement. 
  
 (ee) “Party” means each of the Manufacturer and
the Company. 
  
 (ff) “Product” or
“Products” means the Granulations meeting the Product Specifications. 
  
 (gg) “Product Manufacturing Technology” means all trade secrets in the possession or under the control of the Manufacturer,
including research and development, formulae, test procedures, manufacturing procedures, Product formulations or other technical or proprietary information and knowledge, whether or not patentable, that are necessary for, and used by the
Manufacturer solely and specifically in the manufacture of 

 
the Products in the Territory (excluding, in any event, any plant, tangible property or equipment). 
  
 (hh) “Product Specifications” shall mean those
product, process and Manufacturing specifications used by Manufacturer in the Manufacture of Products in compliance with all applicable Regulatory Requirements, including Product formula and materials required for the Manufacture of the Products
that are to be manufactured, purchased and supplied under this Agreement, as such are in effect as of the Effective Date as set forth in the NDA, which Product Specifications may be amended from time to time by the mutual written agreement of the
Parties. 
  
 (ii) “Recall” has the
meaning set forth in Section 7.4(c) of this Agreement. 
  
 (jj) “Regulatory Authority” shall mean any foreign, federal, state or local, regulatory agency, department, bureau or other governmental entity, including, without limitation, the FDA and the U.S. Drug Enforcement Administration,
which is responsible for issuing approvals, licenses, registrations (including but not limited to, the NDA), permits or authorizations necessary for, or otherwise governs, the Manufacture, handling, use, storage, import, transport, distribution or
sale of Products in the Territory. 
  
 (kk)
“Regulatory Requirements” shall mean all applicable approvals, licenses, registrations (including but not limited to, the NDA), cGMPs, and authorizations and all other requirements of each applicable Regulatory Authority in relation to the
Products, including, but not limited to, each of the foregoing which is necessary for, or otherwise governs, the Manufacture, handling, use, storage, import, transport, distribution or sale of Products 
  
 (ll) “Rolling Monthly Forecast” has the meaning
set forth in Section 3.1 of this Agreement. 
  
 (mm) “Tablets” means fully manufactured tablets of Product as delivered to Manufacturer by the Company or a third party specified by the Company to be packaged by Manufacturer in accordance with this Agreement. 
  
 (nn) “Tablet Specifications” means the
specifications for the Tablets as set forth in the NDA in effect at any relevant time during this Agreement.] 
  
 (oo) “Term” has the meaning set forth in Section 8.1 of this Agreement. 
  
 (pp) “Territory” means United States of America
its territories and possessions including Puerto Rico. 
  
 ARTICLE II 
 MANUFACTURE AND SALE OF PRODUCTS 
  
 2.1 Engagement. During the Term of this Agreement and subject to the terms and conditions set forth herein,
Manufacturer shall Manufacture and Package, sell and deliver Products and Packaged Tablets to Company, and the Company and its Affiliates shall purchase 

 
and take delivery of Products and Packaged Tablets from Manufacturer. The Company shall purchase all of its requirements for Products exclusively from
Manufacturer, subject to certain exceptions set forth herein. Manufacturer shall Manufacture, Package and deliver Products and Packaged Tablets hereunder in material accordance with the (i) Product Specifications; (ii) Packaging Specifications;
(iii) cGMP; (iv) the Act; and (v) all other applicable Regulatory Requirements. During the Term and provided that Manufacturer is not in default of its obligations hereunder, Company shall purchase all of its requirements for the Products and
Packaged Tablets exclusively from the Manufacturer, and Manufacturer shall use commercially reasonable efforts to meet the Company’s orders made in accordance with this Agreement. Notwithstanding the foregoing, in the event that at any time
during the Term (i) Manufacturer advises the Company in writing that Manufacturer is unable to Manufacture, Package and/or deliver in whole or in part, any order made by the Company in accordance with the terms of this Agreement or (ii) the parties
mutually agree based on the Company’s forecasts made in good faith that Manufacturer cannot Manufacture, Package and/or deliver all of the Company’s requirements for Products and or Packaged Tablets in a timely manner as determined by
Company subject to the terms hereof, the Company shall have the right to purchase from a qualified third party (the “Alternative Supplier”) such amount of Products or Packaged Tablets, as the case may be (and only such amount), as
Manufacturer was unable to Manufacture, Package or deliver. In addition, in the event Manufacturer fails (x) [***] in any calendar quarter or (y) [***] in any Contract Year to either (i) deliver Products, at least [***]% of which meet the Product
Specifications, (ii) deliver Products within five (5) days of the agreed upon delivery date as set forth in the Firm Order, (iii) deliver Packaged Tablets, at least [***]% of which meet the Packaging Specifications or (iv) deliver Packaged Tablets
within five (5) days of the agreed upon delivery date as set forth in a Firm Order, the Company shall have the immediate right to purchase its requirements for Products and/or Packaged Tablets from the Alternative Supplier until such a time as
Manufacturer can demonstrate in good faith that the cause for such failures has been cured and that Manufacturer is capable of Manufacturing, Packaging and delivering Products and/or Packaged Tablets meeting the Product Specifications or Packaging
Specifications, as the case may be, in accordance with the terms of this Agreement and subject to the approval of applicable regulatory agencies if necessary. Following Manufacturer’s demonstration of its ability to resume Manufacture and/or
Packaging, Company shall have the right to honor any non-cancellable commitments to the Alternate Supplier including but not limited to taking delivery of all outstanding firm orders for Products and/or Packaged Tablets for a period of ninety (90)
days after the date in which Manufacturer is able to resume Manufacture and/or Packaging pursuant to this Section 2.1. The Manufacturer shall thereafter resume the Manufacture, Packaging and delivery and the Company shall purchase Product and/or
Packaged Tablets from the Manufacturer in accordance with the terms of this Agreement. Failure of Manufacturer to deliver Products meeting the Product Specifications or Packaged Tablets meeting the Packaging Specifications in accordance with the
Company’s orders made consistent with this Agreement shall not constitute a material breach by Manufacturer or give the Company a right to terminate this Agreement but shall give Company the right as set forth above to utilize the services of
the Alternative Supplier to perform the Manufacturing and Packaging services described herein; provided however, that failure by Manufacturer to comply with its “commercially reasonable efforts” diligence requirement set forth above
in this Section 2.1 shall constitute a breach of this Agreement and shall give rise to a right of termination by the Company, subject to the cure provisions set forth Section 8.2(b) hereof. Subject to the terms set forth herein, the Manufacturer
shall be responsible for 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.

 
purchase, at its own expense and for its own account, of all raw materials used by Manufacturer to Manufacture the Products or perform the Packaging, except
that the Company shall be solely responsible for the cost and delivery to Manufacturer of API meeting the API Specifications. 
  
 2.2 Manufacturing of Products. Subject to Article 3 of this Agreement, the Manufacturer shall deliver the Products to the Company or such other
third party as may be directed by the Company to be further manufactured into Tablets which the Company will thereafter cause to be delivered to the Manufacturer for Packaging in accordance with the Packaging Specifications. In accordance with
Section 5.1 of this Agreement, Manufacturer shall perform all necessary testing of the Products prior to their release. Upon release by Manufacturer of Product meeting the Product Specifications as evidenced by the Certificate of Analysis and
Certificate of Conformance delivered to Company, nothing shall excuse the Company of its obligation to accept Products or its payment obligation, except in such instances where there is a bona fide dispute as to whether the Products met the Product
Specifications at the time of their release, in which case such dispute will be resolved in accordance with Section 5.4 hereof. 
  
 2.3 Packaging. In accordance with Section 5.1 herein, Manufacturer shall perform the Packaging of Tablets in accordance with the Packaging
Specifications. In the event that the Packaging is not performed in accordance with the Packaging Specifications, the Manufacturer shall, at the Company’s request, re-perform the Packaging at the Manufacturer’s cost. Except as required by
the NDA and other Regulatory Requirements, Manufacturer shall not be under obligation to inspect or otherwise test Tablets delivered to the Manufacturer for Packaging. In the event Manufacturer performs any such bulk Tablet release testing, the
price therefore shall be set in good faith by Manufacturer and paid by the Company as invoiced. In the event any delivery or portion thereof of Packaged Tablets fails to meet any established specifications as a result of the failure of the Tablets
to meet the Tablet Specifications at the time of delivery to Manufacturer, the Manufacturer shall be under no obligation to reperform the Packaging as provided above in this Section 2.3. 
  
 2.4 Labeling. The Company shall specify all labeling to be used on each Packaged Tablet, including any changes or
modifications to such labels; provided that the Company shall ensure that all such labeling complies with applicable Law and the Packaging Specifications. Each Packaged Tablet and all labeling and packaging used in connection therewith shall include
the trademark associated with such product, in the manner and to the extent specified in the Packaging Specifications. The Manufacturer agrees to use the specified labeling (and only such labeling) on the Packaged Tablets, and not to use such
labeling on any other product. Any change or modification to any label shall be implemented by the Manufacturer (i) as soon as possible if required by Law, or (ii) within a reasonable timeframe to be agreed upon by the Parties, following the
Manufacturer’s receipt of notification of such label changes; provided such changes or modifications meet Regulatory Requirements. The Company shall reimburse the Manufacturer for documented costs incurred in connection with any change made in
accordance with this Section 2.4, including the costs of obsolescence of goods-in-process, packaging materials and supplies, and finished goods not suitable for marketing in the Territory, provided, that the Company shall not be liable for
any goods-in-process, packaging materials and supplies, and finished goods in excess of those quantities necessary for Manufacturer to meet the Company’s requirements, as set forth in the Rolling Monthly Forecast, 

 
for the first three complete calendar months following the date of such change. The Company shall own all IP on and related to such labeling of products.
Notwithstanding the foregoing, to the extent that Manufacturer shall purchase certain packaging materials and supplies having extended lead times in order to satisfy its obligations under the terms of this Agreement, the Company shall purchase at
cost plus fifteen (15%) percent (without additional mark up) all of such materials and supplies owned by Manufacturer at the time of any change made that are made obsolete as a result of such change. 
  
 2.5 Scope of Agreement. This Agreement is intended to cover certain
Manufacturing and Packaging services with respect to Packaged Tablets. The Company has heretofore advised the Manufacturer of its intention to have finished Tablets manufactured in part by a qualified third party. The Company shall contract directly
with such third party as it may select to perform such manufacturing services (the “Tablet Manufacturer”), it being expressly agreed that this Agreement shall not inure to the benefit of such third party. This Agreement shall not apply or
have any effect with respect to orders placed for Product or Packaged Tablets pursuant to the supply arrangement between the Company and Novartis Pharmaceuticals Corporation. 
  
 2.6 Qualification of Secondary Source. The parties agree that at any time during the Term or following termination or
expiration of this Agreement, Company at its sole cost and expense may qualify a source other than Manufacturer to Manufacture Products or perform Packaging services. Manufacture agrees to cooperate with Company in the qualification of the secondary
source and assist in the obtaining of any necessary approvals at the Company’s cost plus $200 per man hour for time spent by Manufacturer’s employees, contractors or representatives in assisting Company in the qualification of such
secondary source. 
  
 ARTICLE III 
 FORECASTS ORDERS AND SHIPMENT 
  
 3.1 Forecasting. In order to assist the planning of production runs for the Products and Packaged Tablets, the Company shall, within thirty (30)
days of the Commencement Date and at least thirty (30) days in advance of the commencement of each calendar month during the Term of this Agreement, provide the Manufacturer with its good faith forecast for each month of the 18 months immediately
following of the quantities of each of the Products and Packaged Tablets that the Company estimates it will be ordering during such months (“Rolling Monthly Forecast”). The Company shall forecast in amounts comprising full batch
quantities, as such quantities are set forth on Schedule 3.1. The Manufacturer shall be entitled to order sufficient quantities of long lead time components to meet the Company’s forecasts. 
  
 3.2 Orders. 
  
 (a) The Company shall place orders for Products and Packaged
Tablets in writing no less than ninety (90) days in advance of the Company’s requested delivery dates, and the Company shall deliver to Manufacturer sufficient quantities of API for such requested delivery meeting the API Specifications no less
than 45 days prior to any such requested delivery date. Orders for Products and for Packaged Tablets shall not be combined into a 

 
single purchase order. Each order shall specifically refer to this Agreement and shall specify the quantity and description of each Product or Packaged
Tablet ordered and the requested delivery date (which delivery dates shall not exceed two (2) times per month unless otherwise agreed to by the parties and shall not be on Saturday, Sunday or holiday). The minimum size of any order placed by the
Company shall be a full batch in accordance with Schedule 3.1, except with the advance approval of the Manufacturer. The order forms shall be delivered to such location as the Manufacturer designates in writing to the Company from time to time. The
date an order shall be deemed placed (the “Order Date”) shall be the earlier of (a) the date that the Manufacturer receives the order form containing said order, or (b) the date of receipt of the telexed or telecopied order. Each
such order shall be a firm order (“Firm Order”) for which the Manufacturer is obligated to Manufacture Product and/or Package Tablets and the Company is obligated to take delivery. The parties agree to negotiate in good faith any
changes proposed by Company to a Firm Order. Company shall be responsible for all costs associated with any changes to a Firm Order requested by Company and agreed to by Manufacturer. To the extent any conflict may exist between the terms of any
purchase order and this Agreement, the terms of this Agreement will control. 
  
 (b) During any month during the Term, the Manufacturer shall not be required to supply more than one hundred twenty percent (120%) of the forecasted quantity of any Product or Packaged Tablet set forth in the most
recent Rolling Monthly Forecast provided by the Company pursuant to Section 3.2(a) hereof for any monthly order. Provided that Manufacturer has the capacity and is not in default of its obligations hereunder, the Company shall purchase at least
eighty percent (80%) (the “Monthly Purchase Requirement”) of the forecasted quantity of Products or Packaged Tablets set forth in the most recent Rolling Monthly Forecast provided by the Company pursuant to Section 3.2(a) for the
applicable month. In the event Company fails to purchase the Monthly Purchase Requirement in any given month, it shall not be a default hereunder provided that Company (i) purchases at least fifty (50%) percent of such Monthly Purchase Requirement
of Products and Packaged Tablets every month and (ii) purchases a cumulative quantity of Products and Packaged Tablets of at least eighty (80%) per cent of the Rolling Monthly Forecast for the applicable month and subsequent two (2) months.

  
 (c) Within fifteen days of the Effective
Date, Company shall submit to Manufacturer the initial Firm Order from the Commencement Date until June 30, 2004. 
  
 3.3 Delivery. 
  
 (a) The Manufacturer shall Manufacture and supply the Products and Packaged Tablets in response to Firm Orders placed by the Company,
within 95% to 105% of the quantities ordered in each Firm Order in accordance with the terms of this Agreement, and the Company shall accept delivery of same. Delivery dates as set forth in any Firm Order or confirmation thereof shall be deemed to
be estimated only but shall become binding upon acceptance of the Firm Order by Manufacturer, provided that the Company has delivered to Manufacturer API in accordance with Section 3.2(a) hereof. The Manufacturer shall not be required to fill orders
during any calendar quarter that exceed the Firm Orders placed by the Company prior to the commencement of such calendar quarter but shall make commercially reasonable efforts to do so. Each shipment of Products and Packaged Tablets shall be
accompanied by a Certificate of Compliance (“COC”), in a form 

 
reasonably acceptable to both Parties which hereafter shall be attached hereto as Exhibit 3.3 and other documents as defined in the Quality Agreement between
the Parties. Manufacturer shall be under no obligation to warehouse any Products, Tablets or Packaged Tablets after their release by Manufacturer, or any API, except for API to be used in the manufacture of Products within the following 90 days.

  
 (b) All Products and Packaged Tablets shipped
under this Agreement shall be shipped FCA Manufacturer’s shipping dock. The Company shall pay all freight, insurance charges, taxes, import and export duties, inspection fees and other charges applicable to the sale and transport of Products
and Packaged Tablets purchased by the Company. Title and risk of loss and damages to Products purchased by the Company shall pass to the Company upon delivery to the carrier. In the event of damage or loss to the Products after delivery to the
carrier, the Company shall be responsible to file claims with the carrier. The Manufacturer shall cooperate with the Company in the filing of such claims. 
  
 ARTICLE IV 
 REPRESENTATIONS AND
WARRANTIES 
  
 4.1 Representations, Warranties and
Covenants of Manufacturer. The Manufacturer hereby represents, warrants and covenants to the Company: 
  
 (a) Products. Provided that the API delivered by the Company to Manufacturer meets all of the API Specifications, all Products and
Packaged Tablets delivered pursuant to the terms hereof by the Manufacturer (or any subcontractor thereof) to the Company during the Term will at delivery be in compliance with the Product Specifications and the Packaging Specifications
respectively, cGMP, Regulatory Requirements and any other applicable Law and, at the time of delivery of the Products and the Packaged Tablets respectively, and the Products and the Packaged Tablets will be free from defects in materials and
workmanship and shall not be adulterated or misbranded within the meaning of the Act. Manufacturer shall not willfully or intentionally disrupt or cause the disruption of the supply of Product or Packaged Tablets to Company. 
  
 (b) Authorization. This Agreement has been duly
executed and delivered by the Manufacturer and constitutes valid and binding obligations of the Manufacturer, enforceable against the Manufacturer in accordance with its terms, except as enforceability may be limited by bankruptcy, fraudulent
conveyance, insolvency, reorganization, moratorium and other Laws relating to creditors’ rights generally and by general equitable principles. The execution, delivery and performance of this Agreement have been duly authorized by all necessary
corporate action on the part of the Manufacturer. 
  
 (c) Absence of Conflicts. The execution, delivery and performance of this Agreement by the Manufacturer does not conflict with or constitute a default under any agreement, instrument or understanding, oral or written to which it is a
party or by which it may be bound, does not conflict with any provision of any organizational document of the Manufacturer and does not conflict with or violate any applicable Law. 

 (d) Organization and Standing. The Manufacturer is a corporation, duly organized,
validly existing and in good standing under the Laws of the State of Delaware. 
  
 (e) Power and Authority. The Manufacturer has corporate power and authority to execute, deliver and perform this Agreement and to
consummate the transactions contemplated hereby. 
  
 (f) EXCEPT AS EXPRESSLY STATED TN THIS AGREEMENT, THE MANUFACTURER MAKES NO EXPRESS OR IMPLIED WARRANTY AS TO THE MERCHANTABILITY OF THE PRODUCTS, OR AS TO THEIR FITNESS FOR A PARTICULAR PURPOSE AND DISCLAIMS ALL OTHER WARRANTIES, EXPRESS
OR IMPLIED. 
  
 4.2 Representations, Warranties and Covenants
of the Company. The Company hereby represents, warrants and covenants to the Manufacturer: 
  
 (a) Authorization. This Agreement has been duly executed and delivered by the Company and constitutes valid and binding obligations
of the Company, enforceable against the Company in accordance with its terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other Laws relating to or affecting creditors’
rights generally and by general equitable principles. The execution, delivery and performance of this Agreement has been duly authorized by all necessary action on the part of the Company, its officers and directors. 
  
 (b) Absence of Conflicts. The execution, delivery and
performance of this Agreement by the Company does not conflict with or constitute a default under any agreement, instrument or understanding, oral or written to which it is a party or by which it may be bound, does not conflict with any provision of
any organizational document of the Company and does not conflict with or violate any applicable Law. 
  
 (c) Organization and Standing. The Company is a limited liability company, duly organized, validly existing and in good standing
under the Laws of Delaware. 
  
 (d) Power and
Authority. The Company has full corporate power and authority to execute, deliver and perform this Agreement and to consummate the transactions contemplated hereby. 
  
 (e) Compliance with Law. The Company covenants that the sale and distribution of the Products and the
Packaged Tablets will be conducted in accordance with all applicable Law, including without limitation, as permitted in the NDA. 

 ARTICLE V 
 QUALITY ASSURANCE 
  
 5.1 Manufacturer’s Covenants. The Manufacturer hereby covenants during the Term it shall: 
  
 (a) manufacture, test and release the Products in conformity with the Product Specifications and all material applicable Law; 

 
 (b) perform the Packaging in conformity with the NDA, the
Packaging Specifications and all material applicable Law; 
  
 (c) maintain during the Term and for a period thereafter consistent with Manufacturer’s policies and standard cGMP requirements all records as are necessary and appropriate to demonstrate compliance with the Act,
applicable cGMP requirements and any other quality control standards of any Regulatory Authority in the Territory; and 
  
 (d) grant the Company the right, on reasonable advance notice and during normal business hours during the Term of this Agreement no more
than twice per year, to inspect and audit the facilities and operations of the Manufacturer directly related to the Manufacture and supply of the Products and the Packaging in order to confirm compliance with the covenants contained in this
Agreement; provided, however, the Manufacturer reserves the right to refuse access to any facilities where there is a risk to health or safety or to the security or quality of the Products, the Tablets, or any other products of the
Manufacturer or its contractors. 
  
 (e) it will
enter into all necessary compliance agreements designated by the Company and required by Law, including but not limited to agreements to cover adverse incident reporting; 
  
 5.2 The Company’s Covenants. The Company hereby covenants during the Term that: 
  
 (a) all API delivered to Manufacturer shall be in compliance
with the API Specifications at the time of delivery to Manufacturer and shall include a COA from the supplier thereof; 
  
 (b) all Tablets shall have been tested by the Company and/or Tablet Manufacturer and shall be in compliance with the Tablet Specifications
at the time of delivery to Manufacturer; 
  
 (c)
it will hold, store, handle, ship, deliver, distribute and/or sell the Packaged Tablets in accordance with the Act, applicable cGMP requirements and material applicable Laws; 
  
 (d) it will enter into all necessary compliance agreements designated by the Manufacturer and required by
Law, including but not limited to agreements to cover adverse incident reporting; and 

 (e) except as provided in this Agreement, upon delivery of the Products to the Company or
its third party designee, and except for time in which Tablets are at the Manufacturer’s facility being Packaged, the Company shall be solely responsible for compliance with all quality control testing and other testing requirements set forth
in this Agreement and all applicable Laws with respect to such Products, Tablets and Packaged Tablets. 
  
 5.3 Non-Conforming Products. (a) By Manufacturer. Notwithstanding any other provisions of this Agreement, the Company agrees, if so
requested after being advised of the basis on which Manufacturer has requested return of the Products to return to the Manufacturer, at the Manufacturer’s expense, any Products that are, or are claimed to be, damaged or defective, or otherwise
to dispose of such Products as the Manufacturer may direct. Upon such return, Manufacturer shall Manufacture at no cost to Company such quantity of Products alleged by Manufacturer to be damaged or defective and subject to Section 13.1 hereof
reimburse Company for the loss or damage to the API arising from Manufacturer’s negligence, which negligence shall be limited to (i) mishandling or improper storage of the API, excipients, packaging materials, Granulations or containers in
which any of the foregoing are stored or transported; (ii) mishandling, improper operation of or failure to maintain equipment; (iii) failure to follow batch records, standard operating procedures, Company’s written instructions or (iv) such
other conduct determined to be negligent by a court of competent jurisdiction. 
  
 (b) By Company. Company shall have a period of thirty (30) days (forty-five (45) days if an outside testing laboratory is used)
after the date of its receipt of a shipment of Products to inspect and accept or reject such shipment for non conformance with the Product Specifications or due to deviation from cGMPs, Regulatory Requirements or any material applicable Law in the
Manufacture of the Product. If Company rejects such delivery of Product, it shall promptly notify Manufacturer and the Parties shall thereafter in good faith attempt to determine whether the Products did or did not conform to the Product
Specifications and shall reasonably cooperate with each other for such purpose (including but not limited to providing the other party with reasonable access to all documents, filings and other materials in such Party’s possession or reasonably
accessible to such Party and the Company’s provision to Manufacturer of samples of such delivery for testing). If either Company or Manufacturer determines that such shipment did not conform to the Product Specifications, either party may, if
such party determines it to be relevant, submit samples to an independent laboratory of nationally recognized standing for testing and acceptable to both Parties. If such independent laboratory determines that the shipment conformed in all respects
to the Product Specifications, Company shall bear all expenses of shipping and testing such shipment samples and shall be obligated to accept and pay for such shipment of Product. If such independent laboratory confirms that such shipment did not
meet the Product Specifications in all respects, Seller shall, subject to the limitations of Section 13.1 relating to API, replace at no cost to Company, that portion of the Product shipment that does not conform to the Product Specifications, and
shall bear all expenses of shipping and testing the shipment samples, including any costs incurred by Buyer in returning such Product to Seller or its nominee. 
  

(c) During the Term, to the extent necessary to comply with applicable Laws or as approved in writing by the Company, the Company shall
reimburse Manufacturer for the 

 
actual cost of validation and qualification, including analytic method testing of Manufacturer’s facility to the extent such costs relate to the
services being provided by Manufacturer hereunder. 
  
 5.4
Rejection of Delivered Packaged Tablets. Within 30 days of receipt of any Packaged Tablet (forty-five (45) days if an outside laboratory is used), the Company shall perform such samplings and tests using validated test methods described in
the applicable NDA, or equivalent filing, for the packaging of Packaged Tablets, to determine whether the Packaged Tablets meet the Packaging Specifications. It is understood and agreed that the Company will not perform sampling and testing until it
has validated its-test methods. Any Product not refused within 30 days shall be deemed accepted. If the Company wishes to refuse acceptance, the Company shall, within such 30-day period, inform the Manufacturer of its refusal to accept the lot(s)
and the reason therefore. In the event that the Company refuses or revokes acceptance, the Manufacturer, upon confirmation of the reasons for refusal of the Product, shall re-perform the Packaging. If the Manufacturer and the Company do not agree on
the refusal or rejection of Packaged Tablets for reason of failure to meet the Packaging Specifications, then either party may refer the matter for final analysis to a specialized laboratory of national reputation acceptable to both parties for the
purpose of determining the results. Any determination by such laboratory shall be final and binding upon the parties hereto and shall be paid for by the Party whose determination was not in accordance with the finding of such specialized laboratory.

  
 5.5 Sample Retention. Manufacturer on behalf of both
Company and Manufacturer shall retain representative samples and associated documentation from each lot of finished Product and Packaged Tablets for period required by applicable Regulatory Requirements and applicable Law. 
  
 ARTICLE VI 
 PRICE AND PAYMENTS 
  
 6.1 Manufacturing Fee. The prices for the supply of each Product (the “Manufacturing Fee”) and Packaged Tablets (the “Packaging Fee”) shall be equal to the prices set forth in Schedule 6.1;
provided, however, the price for the Products and Packaged Tablets set forth in Schedule 6.1 shall be modified at the commencement of each Contract Year after the initial Contract Year as set forth in Section 6.2. 
  
 6.2 Fee Adjustment. Commencing on January 1, 2005 and, on each
anniversary of the Effective Date thereafter, the price for both Products and Packaged Tablets for each Contract Year shall be increased to reflect all demonstrated increases in the cost to the Manufacturer of manufacturing the Products and the
Packaging of Tablets. Notwithstanding anything herein to the contrary, the annual price increase for both Products and Packaged Tablets shall not exceed [***]%. 
  

6.3 Invoices. Upon (i) delivery of each shipment of Products in accordance with Section 3.3 of this Agreement to the Tablet Manufacturer and
(ii) delivery of Packaged Product to Company, the Manufacturer shall promptly invoice the Company for such delivery. The Manufacturer shall send all invoices to a single Company address. 

	[***]:	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.

 6.4 Manner of Payment. 
  
 (a) The Company shall make all payments for Products and Packaged Product sold hereunder pursuant to this
Article VI by check or by wire transfer in United States currency, without any offset or deduction of any nature whatsoever, within thirty (30) days after the date of the invoice (which shall not precede delivery) provided that this obligation shall
not apply to any Products or Packaged Products that are rejected pursuant to Section 5.4 hereof until Company’s receipt of conforming replacement product in accordance with the terms of such section. All payments shall be made to such account
as the Manufacturer shall have specified in writing to the Company with written confirmation of payment sent by facsimile to such address as the Manufacturer shall have specified in writing to the Company. If the Company fails to pay any invoiced
amount when due, a service charge will be imposed by the Manufacturer equal to the lesser of one and one-half percent (11⁄2%) or the highest rate permitted by Law of the outstanding amount for each month or portion thereof that such amount is
overdue. 
  
 (b) Each shipment of Products to the
Company shall constitute a separate sale, obligating the Company to pay therefor, whether said shipment be in whole or only partial fulfillment of any order or confirmation issued in connection therewith. 
  
 (c) The Company agrees not to make any deductions of any
kind from any payments becoming due to the Manufacturer unless the Company shall have received written authorization from the Manufacturer authorizing such deduction. 
  
 6.5 Taxes. The Company shall bear solely the cost of any taxes, levies, duties or fees of any kind, nature or
description whatsoever applicable to the sale and transportation of any Products sold by the Manufacturer to the Company, and the Company shall forthwith pay to the Manufacturer all such sums upon demand. The Company shall provide to the
Manufacturer any applicable sales, use or resale tax exemption certificates prior to shipment of any Products. 
  
 ARTICLE VII 
 REGULATORY MATTERS; RECORDS 
  
 7.1 Inspections. The Manufacturer shall be responsible at its sole
expense for handling and responding to any FDA or other Governmental Entity inspections with respect to its Manufacture of the Products or Packaging of the Packaged Tablets during the Term of this Agreement. The Manufacturer shall provide to the
Company with prompt notice (not to exceed two (2) business days) of any FDA or other Regulatory Authority inspections of the facility and notify Company of any material observations made during such inspection. Manufacturer shall provide to the
Company any information reasonably requested by the Company and all information requested by any Regulatory Authority concerning any governmental inspection related to the Products or Packaged Tablets. To the extent the Manufacturer requires the
assistance of the Company in order to fulfill its obligations pursuant to this Section 7.1, the Company agrees to fully cooperate and assist the Manufacturer at the Manufacturer’s expense. Notwithstanding any provision herein to the contrary,
Manufacturer shall provide Company with the opportunity to comment to Manufacturer on any filings, notices or other correspondence with 

 
any regulatory Authority that relates to or reasonable could affect the Manufacture, Packaging or supply of Products or Packaged Tablets hereunder.

  
 7.2 Reporting. Except as to responsibilities which
Manufacturer may not as a matter of law transfer, during the Term of this Agreement, the Company will be responsible for any reporting of matters regarding the Manufacture, Packaging and supply of the Products and/or Packaged Tablets to the FDA or
other Regulatory Authority, as the case may be, in accordance with applicable Law, provided that Manufacturer provides Company all information in its possession or control required to prepare any such reports. Manufacturer shall promptly furnish
copies of such reports to the Company. The Manufacturer shall also advise the Company of any occurrences or information that arises out of the manufacturing activities of the Manufacturer or its contractors that have or could reasonably be expected
to have adverse regulatory compliance or reporting consequences concerning the Products and/or Packaged Tablets. 
  
 7.3 Permits, Licenses and Approvals. During the Term of this Agreement, the Manufacturer shall have primary responsibility to and shall maintain
all regulatory and governmental permits, licenses and approvals that are necessary for the Manufacture, Packaging and shipment of the Products and/or Packaged Tablets to the Company; provided, however, that the Parties understand and agree
that the Company owns the NDA and, as a result, the Company will be responsible for any and all NDA-related filings required pursuant to this Section 7.3. Each Party agrees that, to the extent required to fulfill their respective obligations under
this Section 7.3, each Party will reasonably cooperate and assist the other party at the requesting Party’s expense. 
  
 7.4 Complaints; Recalls; Market Withdrawals; Adverse Reactions. 
  
 (a) Complaints. Product complaint reports concerning the Manufacture or supply of Products or
Packaged Tablets received by the recipient will be faxed within two (2) Business Days after receipt to the other party to: 
  
 Novartis Consumer Health, Inc. 
 200 Kimball
Drive 
 Parsippany, New Jersey 
 Attn: Director of Quality Assurance 
 Fax: 973-503-8413 
  
 Reliant Pharmaceuticals, LLC 
 110 Allen Road 
 Liberty Corner, New Jersey 07938 
 Attn: Quality Assurance Department 
 Fax:
908-542-9405 

 The Parties shall cooperate with each other to investigate all complaints associated with the Products or Packaged
Tablets and complete a written report reasonably satisfactory to both parties. 
  
 (b) Recalls. In the event that either party shall be required to initiate a Recall (as defined herein) with respect to any Product
or Packaged Tablet provided under this Agreement, the party shall promptly notify the other party in writing. Except where one party is required by Law to do so, Company shall have the sole and exclusive right to initiate the Recall and shall
provide Manufacturer with written notice thereof. In the event of such a recall, the provisions of Section 7.4(c) shall be applicable. 
  
 (c) Cost of Recall. In the event that any Product, Tablet or Packaged Tablet Manufactured or Packaged hereunder is quarantined or
recalled, or is subject to field alert, product withdrawal or stop-sale action, whether voluntary or by governmental action (collectively, a “Recall”), it is agreed and understood that any expenses, including reasonable fees of any
experts or attorneys that may be utilized by either party, government fines or penalties, related to such recall, quarantine or stop-sale, shall be borne by the Company unless it is determined that the sole cause necessitating such a Recall is that
either (i) the Products at issue are non-compliant with the Product Specifications at the time that such Products are released by Manufacturer, except to the extent that such non-compliance should reasonably have been detected in connection with the
bulk tablet release testing, or (ii) the Packaged Tablets at issue are non- compliant with the Packaging Specifications at the time that such Packaged Tablets are released by Manufacturer and such non-compliance is not due to the negligence or
intentional malfeasance of any party other than the Manufacturer, in which case Manufacturer shall be liable for up to the limits set forth in Section 13.1 hereof. 
  
 7.5 Adverse Reactions. The Company and the Manufacturer shall observe the procedures and notification requirements
with respect to Adverse Reactions described in Schedule 7.5 attached hereto. 
  
 7.6 Insurance. At all times during the Term of this Agreement, both the Company and Manufacturer shall each maintain, or self-insure for, product liability insurance and recall insurance written on a
claims-made basis in an amount of not less than $5,000,000 annual aggregate. 
  
 7.7 Quality Agreement. Within at least thirty (30) days following the Effective Date of this Agreement, the Parties shall mutually agree upon a Quality Agreement which will appropriately address regulatory,
operational and quality responsibilities (the “Quality Agreement”). The Quality Agreement will include a key contact list for each party. 
  
 ARTICLE VIII 
 TERM AND TERMINATION

  
 8.1 Term. This Agreement shall commence as of
the Commencement Date and shall expire on the fifth (5th) Anniversary of the Commencement Date (the “Initial Term”). Thereafter, the Agreement shall automatically renew for up to three (3) successive one (1) year renewal terms (each one
year term after the Initial term a 

 
“Renewal Term”) (the Initial Term and all Renewal Terms collectively, the “Term”) unless either Party gives the other twelve (12) months
prior written notice of its intention not to renew. 
  
 8.2
Termination. Subject to the Manufacturer’s obligations under Section 8.4 below, either Party shall have the right to terminate this Agreement with immediate effect upon written notice to the other upon the occurrence of either of the
following: 
  
 (a) the other Party files a
petition in bankruptcy, or enters into an agreement with its creditors, or applies for or consents to the appointment of a receiver or trustee, or makes an assignment for the benefit of creditors, or becomes subject to involuntary proceedings under
any bankruptcy or insolvency Law; or 
  
 (b) the
other Party fails to cure any noncompliance with any of the terms and conditions hereof within sixty (60) days prior written notice delivered to the non- compliant Party by the other Party. 
  
 8.3 Effect of Termination. If this Agreement is terminated pursuant to
Section 8.2: 
  
 (a) Termination of this
Agreement shall not affect any obligations of either party incurred prior to its termination including without limitation, each party’s obligation with respect to any Firm Orders that have been submitted. 
  
 (b) If the Company shall default in the payment of any
indebtedness to the Manufacturer when and as the same shall become due and payable, and if such default shall continue for a period of ten (10) days after written notice of such default shall have been given to the Company, then all of the
liabilities and obligations of the Company to the Manufacturer, whether then due or not, shall become immediately due and payable. 
  
 (c) The termination of this Agreement shall not release the Company from the obligation to pay any sum that may be owing to the
Manufacturer (whether then or thereafter due to the Manufacturer) or operate to discharge any liability or obligation that had been incurred by either party prior to any such termination. 
  
 (d) During the period between the giving of any notice of
termination pursuant to this Article VIII and the effective date of the termination as set forth in such notice, all Products shall be delivered to the Company solely on a C.O.D. basis. 
  
 8.4 Termination or Expiration of Agreement Validation and Qualification Costs. 
  
 (a) Upon the termination or expiration of this Agreement,
the Manufacturer shall transfer, or shall cause to be transferred at the Company’s sole expense, all remaining API, Products, Packaged Tablets and raw materials (including artwork and film pertaining to the labeling of boxes, cartons and
prescribing information) relating to the Products then owned or held by the Manufacturer and acquired in reasonable quantities during the Term of this Agreement to fulfill the Manufacturer’s obligations hereunder. Such raw materials shall be
invoiced to the Company at cost, plus 15%, and such Products and Packaged Tablets shall be invoiced at the then-current price. 

 (b) It is understood and agreed that the Company shall be responsible for all
Manufacturing of the Products and Packaging of Tablets after the earlier of the termination or expiration of this Agreement or in connection with the use of an Alternate Supplier. In addition, it is understood and agreed that the Company shall be
responsible, at its sole expense, for the validation and qualification, including analytic method testing, of any manufacturing facility to be used by the Company during or after the term of this Agreement. For purposes of this Section 8.4(b),
“manufacturing” shall mean the manufacture of Products, including mix, fill and finish, and the manufacture of active bulk components and Packaging of Tablets. Manufacturer shall cooperate and assist Company in the transfer of
Manufacturing to a third party during the Term or following termination or expiration of this Agreement at the Company’s cost plus $200 per man hour for time spent by Manufacturer’s employees, contractors or representatives; provided
however, the Company shall not be invoiced for the first 125 man hours if the Company terminates this Agreement in accordance with Section 8.2(b). 
  
 (c) To facilitate the Company’s use of the Product Manufacturing Technology subsequent to the termination or expiration of this
Agreement, upon such termination, expiration or earlier upon the reasonable request of the Company, the Manufacturer agrees to provide, and use commercially reasonable efforts to cause its contractors to provide, the Company with (i) reasonable
access to the facilities of the Manufacturer and its contractors and (ii) for a period of 60 days after such termination or expiration, reasonable access to the personnel of the Manufacturer and its contractors, in any case limited to those
facilities or personnel directly responsible for the manufacturing of the Products. The Company hereby agrees to reimburse the Manufacturer or its contractors, as the case may be, for all out-of-pocket expenses incurred in connection with personnel
of the Manufacturer or its contractors assisting the Company at any location other than such person’s regular place of work and to pay the Manufacturer an amount equal to $200 per man hour for time spent by Manufacturer’s employees,
contractors or representatives. 
  
 (d)
Termination or expiration of this Agreement shall not relieve the Parties of any obligation accruing prior to such termination. The rights and obligations of the Parties under Sections 8.3, 8.4, 10.1, Article VI, Article XI and Article XIII of this
Agreement shall survive the expiration or termination of this Agreement. 
  
 (e) Upon the expiration or termination of this Agreement, the Manufacturer and the Company shall promptly return all confidential information that it was provided by the other Party pursuant to this Agreement.

  
 8.5 Termination Rights Construction. For the purposes
of interpreting termination rights hereunder, the Manufacture of Products on the one hand and the Packaging of Tablets on the other hand shall be deemed to be separate services such that a right to terminate one such set of services by either Party
shall not create or result in a right to terminate the other. 

 ARTICLE IX 
 FORCE MAJEURE 
  
 9.1 Force Majeure. Except as otherwise expressly set forth in this Agreement, neither Party shall be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term or provision of
this Agreement (other than the payment of money) when such failure or delay shall be caused (directly or indirectly) by fire; flood; accident; explosion; equipment or machinery breakdown; sabotage; strike or any labor disturbance; civil commotions;
riots; invasions; acts of terrorism; wars; acts, restraints, requisitions, regulations, or directions of any Governmental Entity; compliance by the either party with any request of any Governmental Entity; compliance by either party with any request
for material represented to be for purposes of (directly or indirectly) producing articles for national defense or national defense facilities; shortage of labor, fuel, power or raw materials; inability to obtain supplies; failure of normal sources
of supply; inability to obtain or delays of transportation facilities; any act of God; or any cause (whether similar or dissimilar to the foregoing) beyond the reasonable control of the other party. The party claiming an event of force majeure shall
promptly notify the other party in writing and provide full particulars of the cause or event and also keep the other party informed of any further developments. The party so affected shall use commercially reasonable efforts to remove the cause of
the non-performance and resume performance hereunder. If by reason of such causes the Manufacturer’s supply of any products shall be limited which requires an allocation to be made, Manufacturer shall meet the needs of Company on a basis no
less favorable than pro rata on a volume basis to its own internal needs. If the period of non-performance as result of a force majeure event exceeds an aggregate of ninety (90) days within a six (6) month period, either party may terminate this
Agreement. 
  
 ARTICLE X 
 CONFIDENTIALITY 
  
 10.1 Nondisclosure and Nonuse Obligation. Either party (the “Disclosing Party”) or its contractors may, from time to time, give the other
party (the “Recipient”) valuable information of a technical or non-technical nature that is not generally known to the trade or public. Both parties agree that they will not disclose to anyone in any manner whatsoever (except as authorized
in writing by the Disclosing Party) any such information, including information relating in any way to the Products, processes, and services of Disclosing Party or its contractors, which becomes known to the Recipient during the period that this
Agreement is in effect. The obligations of this Article X shall not apply to information (i) that is known to the Recipient as shown by written records prior to its disclosure by Disclosing Party or its contractors; (ii) that becomes public
information or is generally available to the public other than by an unauthorized act or omission of Recipient; or (iii) that is received by the Recipient from third-parties who are in rightful possession of such information and who are lawfully
entitled to disclose such information to the Recipient. Upon termination of this Agreement, both parties shall return to the other all documents that include confidential information of the other or its contractors, including all copies of such
documents, and shall make no further use of such information. 

 ARTICLE XI 
 INDEMNIFICATION 
  
 11.1 By Manufacturer. Except as may be limited by Section 13.1 of this Agreement, from and after the Effective Date, the Manufacturer shall indemnify, defend and hold harmless the Company and its Affiliates and their respective
officers, directors, employees, agents, advisors and shareholders (“Company Indemnified Parties”) from and against any and all suits, claims, judgments, losses, liabilities, costs or expenses (including reasonable attorneys fees) and
damages of any kind or character (“Losses”) which any Company Indemnified party may suffer or incur either directly or indirectly or in connection with any suits, claims, demands, actions, causes of action, liabilities, proceedings,
investigations, inquiries, injunctions or regulatory actions by a third party to the extent such Losses arise from or arising solely from a breach by the Manufacturer of any of its representations, warranties, agreements, covenants or obligations
contained in or made pursuant to this Agreement. 
  
 11.2 By
The Company. From and after the Effective Date, the Company shall indemnify, defend and hold harmless the Manufacturer and its Affiliates and their respective officers, directors, employees, agents, advisors and shareholders (“Manufacturer
Indemnified Parties”) from and against any and all Losses which any Manufacturer Indemnified Party may suffer or incur either directly or indirectly in connection with any suits, claims, demands, actions, causes of action, liabilities,
proceedings, investigations, inquiries, injunctions or regulatory actions by a third party to the extent such Losses by a third party arise from product liability claims brought by third-parties or a breach by the Company of any of its
representations, warranties, agreements, covenants or obligations contained in or made pursuant to this Agreement, except where such Losses arise from the negligence or willful misconduct of the Manufacturer or solely from a breach by the
Manufacturer of any of its representations, warranties, agreements, covenants or obligations under this Agreement. 
  
 ARTICLE XII 
 INTELLECTUAL PROPERTY RIGHTS 
  
 12.1 License. The Company hereby grants to the Manufacturer, and to
each contractor which the Manufacturer may cause to manufacture and supply Products or Packaged Tablets, (as provided in Section 13.2A below) for the Term of this Agreement, a limited royalty-free, nontransferable right and license under the Product
Intellectual Property, such license to be nonexclusive in the Territory to Manufacture, Package and supply the Products and/or Packaged Tablets to and for the Company without limitation to the purchase obligations of the Company and its Affiliates
under Section 2.1 hereof. 
  
 12.2 Inventions. Each Party
shall own all right, title to and interest in any inventions, discoveries or innovations, whether patentable or not, that such Party or its employees or agents may make in performing such Party’s obligations hereunder (the “IP”).

 ARTICLE XIII 
 MISCELLANEOUS 
  
 13.1 LIMITATION ON LIABILITY. 
  
 NOTWITHSTANDING
ANYTHING TO THE CONTRARY HEREIN, NONE OF THE MANUFACTURER, THE COMPANY OR THEIR RESPECTIVE AFFILIATES SHALL BE LIABLE TO THE OTHER FOR PUNITIVE OR EXEMPLARY DAMAGES WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE,
ARISING OUT OF OR RELATING TO THIS AGREEMENT. IN ADDITION, NONE OF THE MANUFACTURER, THE COMPANY OR THEIR RESPECTIVE AFFILIATES SHALL BE LIABLE TO THE OTHER FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER IN CONTRACT, WARRANTY,
NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF OR RELATING TO THIS AGREEMENT; PROVIDED, HOWEVER, IN THE EVENT OF FRAUD OR INTENTIONAL MALFEASANCE (WHICH SHALL NOT BE DEEMED TO INCLUDE BREACH OF CONTRACT CLAIMS) THE
INJURED PARTY SHALL BE ENTITLED TO COLLECT SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES IF AWARDED BY A COURT OF COMPETENT JURISDICTION, BUT UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR PUNITIVE OR EXEMPLARY
DAMAGES. THE FOREGOING EXCLUSIONS ARE NOT INTENDED TO, NOR SHALL, EXCLUDE ACTUAL OR COMPENSATORY DAMAGES. COMMENCING AS OF THE EFFECTIVE DATE AND CONTINUING UNTIL THE FIRST ADJUSTMENT DESCRIBED IN SECTION 13.2 HEREIN, MANUFACTURER’S LIABILITY
TO THE COMPANY FOR THE REPLACEMENT COST OF API PURSUANT TO THIS AGREEMENT, SHALL BE LIMITED TO $200,000 PER BATCH. EXCEPT IN THE CASE OF FRAUD OR INTENTIONAL MALFEASANCE WHICH SHALL NOT BE SUBJECT TO ANY LIMITATION OF LIABILITY EXCEPT AS EXPRESSLY
PROVIDED ABOVE IN THIS SECTION 13.1, MANUFACTURER’S AGGREGATE LIABILITY FOR ALL OTHER CLAIMS HEREUNDER SHALL NOT EXCEED $5,000,000, EXCLUSIVE OF ANY LIABILITY FOR THE REPLACEMENT COST OF API PURSUANT TO THE SENTENCE IMMEDIATELY PRECEDING.

  
 13.2 Adjustment of Liability Limit. On January 1 of
each Contract Year after the first Contract Year, Company shall have the option on written notice to Manufacturer to adjust the limit of liability for API that Manufacturer assumes hereunder for such Contract Year, it being the express understanding
of the parties that the price that the Company pays per batch for Product shall be increased or decreased, as the case may be, such that the cost of Products per batch is equal to $[***] (plus any adjustments made pursuant to section 6.2 hereof),
plus [***] ([***]%) percent of the adjusted per event liability limit. 
  
 13.3. Assignment. Neither party shall assign or otherwise transfer this Agreement or any interest herein or any right hereunder without the prior written consent of the other party which consent shall not be unreasonably withheld,
delayed or conditioned and any such purported assignment, transfer, or attempt to assign or transfer any interest or right hereunder without the prior written consent of the other party shall be null, void and of no effect 

	[***]:	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.

 
provided however that either party may assign and delegate its rights and duties hereunder without obtaining such consent (a) to any Affiliate of such party
or (b) to any person or entity that acquires substantially all of the business or assets of such party to which this Agreement relates. For purposes of this Section 13.2, none of the following shall constitute an assignment by Company: (a)
conversion of Company from a limited liability company to a corporation (whether such conversion is effected by statutory conversion provisions, merger or otherwise), or (b) the issuance of debt or equity securities by Company in connection with any
financing transaction. 
  
 13.4. Subcontractors.
Manufacturer shall not engage any third party to perform any of the Manufacturing, Packaging, or other services required in the Manufacture or Packaging of the Products or Packaged Tablets without the prior written consent of the Company, which
consent will not be unreasonably withheld, delayed or conditioned. Such consent is not required if the third party contractor (i) is listed in the Product’s approved NDA on file with the FDA, or (ii) performs any of the services required in the
manufacture of the Products, as of the Commencement Date. In any instance where Manufacturer utilizes a third party to perform any of the services hereunder, Manufacturer shall continue to be primarily liable to Company hereunder. 
  
 13.5. Severability. If any provision of this Agreement is held to be
illegal, invalid or unenforceable by any Law or public policy, the remaining provisions of this Agreement shall nevertheless remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its
severance herefrom so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to any party. Upon such determination that any term or other provision is invalid, illegal or
unenforceable, the parties shall negotiate in good faith to modify this Agreement so as to effect the original intent of the parties as closely as possible in an acceptable manner in order that the transactions contemplated hereby are consummated as
originally contemplated to the greatest extent possible. 
  
 13.6.
Notices. All notices or other communications which are required or permitted hereunder shall be in writing and delivered personally, sent by telecopier (and promptly confirmed by personal delivery, registered or certified mail or overnight
courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, addressed as follows: 
  
 If to the Manufacturer, to: 
  
 Novartis Consumer Health, Inc. 
 200 Kimaball
Drive 
 Parsippany, New Jersey 07054 
 Attention: Vice President of Supply and Logistics 
  
 with a copy (which shall not constitute notice) to: 
  
 General Counsel (same address) 

 If to the Company, to: 
  
 Reliant Pharmaceuticals, LLC 
 110 Allen Road 
 Liberty Corner, New Jersey 07938 
 Attn: President 
  
 with a copy (which shall not constitute notice) to: 
  
 General Counsel (same address) 
  
 or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such communication shall
be deemed to have been given when delivered. It is understood and agreed that this Section 13.4 is not intended to govern the ordinary course of business communications necessary between the Parties in performing their duties, in due course, under
the terms of this Agreement, including the placement of orders and the delivery of forecasts. 
  
 13.7. Applicable Law. This Agreement shall be governed by and construed in accordance with the Laws of the State of New York, without giving effect to principles of conflict of Laws thereof. 
  
 13.8. Entire Agreement. This Agreement and the attached Schedules and
Exhibits, which are incorporated herein, constitute the entire agreement between the Parties with respect to the subject matter hereof and all prior agreements with respect hereto are superseded. Each Party confirms that it is not relying on any
representations, warranties, covenants or understandings of any kind, nature or description whatsoever of the other Party, except such as are as specifically set forth herein, except that nothing herein shall be construed as intended to relieve or
release the Company from its obligation to make payment of monies or satisfy any other obligations which the Company may owe to the Manufacturer. No amendment or modifications hereof shall be binding upon the Parties unless set forth in a writing
specified to be an explicit amendment to this Agreement duly executed by authorized representatives of both Parties. The parties recognize that, during the Term of this Agreement, a purchase order, acknowledgement form or similar routine document
(collectively “Forms”) may be used to implement or administer provisions of this Agreement. Therefore, the parties agree that the terms of this Agreement shall prevail in the event of any conflict between this Agreement and the printed
provision of such Forms, or typed provisions of Forms that add to, vary, modify or are at conflict with the provisions of this Agreement with respect to the Products sold during the Term of this Agreement. 
  
 13.9 Headings. The headings used in this Agreement are intended for
convenience only and shall not be considered part of the written understanding between the Parties and shall not affect the construction of this Agreement. 
  
 13.10. Independent Contractors. The relationship between the Manufacturer and the Company is solely that of buyer and seller. It is expressly
agreed that the Manufacturer, on the one hand, and the Company, on the other hand, shall be independent contractors and that neither the relationship between the Parties nor this Agreement shall be construed as creating a 

 
partnership, joint venture or agency. Neither the Manufacturer, on the one hand, nor the Company, on the other hand, shall have the authority to make any
statements, representations or commitments of any kind, or to take any action or to incur any liability or obligation which shall be binding on the other, without the prior consent of the other Party to do so. All persons employed by a Party shall
be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party. 
  
 13.11 Waiver. The waiver by either Party of any right hereunder or the failure to perform or of a breach by the other
Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise. 
  

13.12 Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. 
  
 13.13.
No Benefit to Third-Parties. The representations, warranties, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and nothing herein, express or implied, is
intended to or shall confer upon any person or entity any legal or equitable rights, benefits or remedies. 
  
 13.14. New Supplier of API. The Manufacturer shall use commercially reasonable efforts to assist the Company, during the Term to (i) locate and
qualify a new supplier of API that meets cGMP Requirements, the API Specifications and applicable Law (“Compliant API”) for the Products and (ii) provide such documents and take such other actions as are necessary to allow the Company to
list and obtain FDA approval for the new supplier as an alternate supplier of API in the NDA. The Company shall have the responsibility of locating and qualifying a new supplier of Compliant API for use in manufacturing the Products, provided that
whether or not the Company is successful in doing so during the Term shall not be a basis for force majeure to apply for the benefit of the Manufacturer during the Term, or excuse or delay Manufacturer’s obligations to deliver Products pursuant
to this Agreement. 
  
 [SIGNATURE PAGE FOLLOWS] 

 IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized
representatives as of the date first above written. 
  

									
	 Reliant Pharmaceuticals, LLC
	 	 	 	 Novartis Consumer Health, Inc.

					
	By:	 	 	 	 	 	By:	 	 
					
	Name:	 	 	 	 	 	Name:	 	 
					
	Title:	 	 	 	 	 	Title:	 	 

  
 SCHEDULE 6.1

  
 Manufacturing Fees 
  

			
	 Item

	  	 Cost Per Granulation

		
	 Drug Granulation
	  	[***]
		
	 Osmotic Granulation
	  	[***]

  
 Packaging Fees 
  

						
	 	  	Tablets Made From NCH Granulations	  	 	 
			
	 Item No.

	  	 Item Description

	  	Cost Per Unit

			
	 923501 & 923601
	  	DynaCirc CR 5mg 7’s & DynaCirc CR 10mg 7’s	  	$	[***]
			
	 23515 & 23615
	  	DynaCirc CR 5 mg 30’s & DynaCirc CR 10 mg 30’s	  	$	[***]
			
	 23505 & 23605
	  	DynaCirc CR 5 mg 100’s & DynaCirc CR 10mg 100’s	  	$	[***]
	
	Tablets Made From Granulations Other Than NCH
			
	 Item No.

	  	 Item Description

	  	Cost Per Unit

			
	 923501 & 923601
	  	DynaCirc CR 5m&7’s & DynaCirc CR 10mg 7’s	  	$	[***]
			
	 23515 & 23615
	  	DynaCirc CR 5 mg 30’s & DynaCirc CR 10 mg 30’s	  	$	[***]
			
	 23505 & 23605
	  	DynaCirc CR 5 mg 100’s & DynaCirc CR 10mg 100’s	  	$	[***]

  
 The prices for the supply of each
Product (the “Manufacturing Fee”) and Packaged Tablets (the “Packaging Fee”) shall be equal to the prices set forth in Schedule 6.1 of the supply agreement; provided however, the price for the Products and Packaged Tablets
set forth in Schedule 6.1 shall be modified at the commencement of each Contract Year after the initial Contract Year as set forth in Section 6.2, Fee Adjustment, of the supply agreement. 

	[***]:	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.

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