Document:

Exclusive Sublicense Agreement / Novartis AG

 Exhibit 10.27 
  
 EXCLUSIVE SUBLICENSE AGREEMENT 
  
 BETWEEN 
  
 RELIANT PHARMACEUTICALS, LLC 
  
 AND 
  
 NOVARTIS AG

 SUBLICENSE AGREEMENT 
  
 THIS SUBLICENSE AGREEMENT (this “Agreement”) dated as of the 11th day of March, 2003, by and between Novartis AG, a company incorporated under the laws of Switzerland, with a principal place of business located at Postfach
4002, Basel, Switzerland (hereinafter “Novartis”) and Reliant Pharmaceuticals, LLC, a Delaware limited liability company, with its principal place of business at 110 Allen Road, Liberty Corner, New Jersey 07938 (“Reliant”).

  
 WHEREAS, Sandoz Pharma Ltd. (“Sandoz”)
entered into a Development and License Agreement with Alza Corporation (“Alza”) dated January 1, 1991 (the “Alza License”), which Alza License is annexed hereto as Exhibit A; 
  
 WHEREAS, Novartis is a successor to Sandoz and has succeeded to the
rights and obligations of Sandoz under the Alza License; 
  
 WHEREAS, pursuant to the Option and Asset Transfer Agreement (as hereinafter defined) dated as of July 10, 2000, as amended, Reliant has exercised its option to purchase all of Novartis’ right, title and interest in the Assets
(as defined in the Option and Asset Transfer Agreement); and 
  
 WHEREAS, pursuant to the Option and Asset Transfer Agreement, Novartis desires to grant a sublicense of the Alza License to Reliant on the terms and conditions set forth herein; and 
  
 WHEREAS, pursuant to the Option and Asset Transfer Agreement, Reliant
desires to sublicense the Alza License from Novartis on the terms and conditions set forth herein. 
  
 NOW, THEREFORE, in consideration of the foregoing recitals and the mutual promises, representations, warranties, covenants and agreements
hereinafter set forth, and intending to be legally bound, the parties do hereby agree as follows: 
  

 ARTICLE 1 
  

DEFINITIONS 
  
 In this Agreement the following terms shall have the following meanings: 
  
 1.1 “Affiliate” shall mean all corporations or business entities which, directly or indirectly, are controlled by,
control, or are under common control with Novartis 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. 
  
 1.2 “Alza License” shall have the meaning ascribed to it in the Recitals hereof. 
  
 1.3 “Alza Technical Information” shall mean Technical Information
(as defined in the Alza License); but only to the extent such Technical Information relates to Isradipine, DynaCirc CR, or the System (as defined in the Alza License). 
  
 1.4 “Alza Patents” shall mean those patents owned by Alza, and licensed by Novartis pursuant to the Alza License,
set forth on Schedule 1.4 hereto, including, without limitation, reissues, continuations, and continuations in part. 
  
 1.5 “Change of Control” means (i) the sale, lease, exchange, license or other disposition of all or substantially all of a Person’s assets
in one transaction or series of related transactions; (ii) a merger, consolidation, refinancing or recapitalization as a result of which the holders of a Person’s issued and outstanding voting securities immediately before such transaction own
or control less than a majority of the voting securities of the continuing or surviving entity immediately after such transaction and/or (iii) the acquisition (in one or more transactions) by any Person or Persons acting together or constituting a
“group” under Section 

  

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13(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), together with any Affiliates thereof (other than, with respect to
Reliant, members of Reliant as of the date hereof and their respective Affiliates) of beneficial ownership (as defined in Rule 13d-3 under the Exchange Act) or control, directly or indirectly, of a least fifty percent (50%) of the total voting power
of all classes of securities entitled to vote generally in the election of a Person’s board of directors, board of managers or similar governing body. 
  
 1.6 “Consequential Damages” shall mean those types of damages variously referred to under applicable law as “consequential,”
“indirect” or “special,” including, without limitation, lost profits, down time, loss of use and damage to business reputation. 
  
 1.7 “DynaCirc CR” or “Licensed Product” shall mean a controlled release formulation of isradipine capsules (5 mg. and 10 mg.) marketed
pursuant to the NDA under the brand name DynaCirc CR. 
  
 1.8
“Effective Date” shall mean March 11, 2003, the date upon which this Agreement shall become effective. 
  
 1.9 “GAAP” shall have the meaning ascribed to it in Section 7.1(c) hereof. 
  
 1.10 “January 2003 Agreement” shall mean the letter agreement dated as of January 10, 2003 among Novartis, NPC and
Reliant, as amended. 
  
 1.11 “Material Adverse Effect”
shall mean a material adverse effect on the manufacture, marketing, distribution or sale of the Licensed Products. 
  
 1.12 “NDA” shall mean the new drug application 20-336 (DynaCirc CR), as amended and supplemented, for the Licensed Product and as approved by
the FDA, to market the Licensed Product in the Territory and any materials, documents or information referred to or relied upon therein including without limitation all drug master files relating thereto. 
  

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 1.13 “Net Sales” shall have the meaning set forth in Section 1.9 of the Alza License.

  
 1.14 “NPC” shall mean Novartis Pharmaceuticals
Corporation, a Delaware corporation. 
  
 1.15 “Option and
Asset Transfer Agreement” shall mean that certain Option and Asset Transfer Agreement dated July 10, 2000 between Reliant and Novartis and NPC, as amended. 
  

1.16 “Person” shall mean any individual, corporation (including any non-profit corporation), general or limited partnership, limited
liability company, joint venture, estate, trust, association, organization, labor union, or other entity or governmental body. 
  
 1.17 “Term” shall have the meaning ascribed to it in Article 2.3 hereof. 
  
 1.18 “Territory” shall mean the United States of America and Puerto Rico. 
  
 ARTICLE 2 
  
 GRANT OF SUBLICENSE 
  
 2.1 Grant of Sublicense. Subject to the terms and conditions of this Agreement and the Alza License, Novartis grants to Reliant and Reliant accepts
an exclusive sublicense in the Territory during the Term under the Alza License to utilize the Alza Technical Information and the Alza Patents to make, have made (by a third-party to which Alza has no reasonable objection), use and sell the Licensed
Product. 
  
 2.2 Payment of Earned Royalties. 

 
 (a) In consideration of the sublicense granted to Reliant
under Section 2.1 hereof, Reliant shall pay royalties on Net Sales of the Licensed Product in the Territory to Alza in accordance with the terms and conditions of the Alza License. All royalty payments on Net Sales of the Licensed Product in the
Territory subsequent to the Effective Date due under the Alza License shall be paid by Reliant for the duration of the Term. Payment of the royalties due 

  

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under this sublicense shall be paid to Alza in accordance with the Alza License. Reliant shall provide Novartis with proof of payment within thirty (30) days
of each royalty payment date under the Alza License and at such other times as reasonably requested by Novartis. 
  
 (b) From and after such date as Reliant receives the first shipment of B-1 or B-2 Lots (as such terms are defined in the January 2003
Agreement) and until such time as all of the B-1 and B-2 Lots are sold to third parties, Reliant shall provide Novartis with a report within thirty (30) days following the end of each calendar quarter setting forth for such calendar quarter the
number of units of Licensed Product from the B-1 or B-2 Lots sold to third parties during such calendar quarter (identified by lot). Within thirty (30) days of its receipt of such report, Novartis shall pay to Reliant in respect of royalties under
the Alza License the amount set forth under the heading “Royalty Reimbursement from Novartis Per Unit” on Attachment B-1 or Attachment B-2, as applicable, to the January 2003 Agreement, per unit of Licensed Product from the
B-1 or B-2 Lots sold to third parties during such calendar quarter. With respect to Licensed Product supplied by NPC to Reliant on or prior to the Effective Date, Novartis represents and warrants that it has or will pay royalties due to Alza in
respect of the sale of such Licensed Product by NPC to Reliant pursuant to and in accordance with the Alza License. Except as expressly set forth in this Section 2.2(b), Novartis shall have no further liability or obligation with respect to
royalties payable to Alza in respect of the manufacture, use, or sale of Licensed Product constituting B-1 or B-2 Lots. 
  
 2.3 Term. This Agreement shall commence on the Effective Date and unless sooner terminated shall expire on the date on which the Alza License with
respect to the Territory terminates or expires (the “Term”). Notwithstanding the foregoing, if Reliant is granted a license (including any sublicense by a Person authorized to grant such sublicense) to utilize Alza 

  

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Technical Information and the Alza Patents to make, use and sell the Licensed Product, on terms as or more favorable to Reliant (when taken as a whole) than
those set forth herein, subject to any confidentiality obligation of Reliant, Reliant shall promptly notify Novartis in writing of such arrangement and the parties shall negotiate in good faith the termination of this Agreement. 
  
 2.4 Records. Reliant shall each maintain true and complete books of
account containing an accurate record of all data necessary for the proper computation of payments due or charges made that it is responsible for determining under the provisions of this Agreement or the Alza License. Novartis shall have the right,
through the independent certified public accountant employed by Reliant to conduct its regular annual audit, or through a firm of independent public accountants selected by mutual agreement of the parties, to examine the books of account of Reliant
at any time within two years after the date of the payment to which they relate (but not more than once in each calendar year) for the purpose of verifying the amount of such payments or charges and the accuracy of such books of account. Such
examination shall be made during normal business hours at the place of business of Reliant. The parties agree that information furnished as a result of any such examination shall be limited to a statement by such certified public accountant to the
effect that they have reviewed the books of account of the party being audited and either (i) that the amounts of the payments due or charges made under this Agreement are in conformity with such books of account and the applicable provisions of
this Agreement or (ii) setting forth any required adjustments. The fees and expenses of the accountants performing such verification shall be borne by the party requesting the audit; provided, however, that if the audit is requested in connection
with the audited parties regular annual audit by its independent outside auditors, the cost shall be borne by the party 

  

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being audited. If an audit shows any underpayment or overpayment a refund shall be made within 30 days of receipt of verification by the appropriate party.

  
 ARTICLE 3 
  
 REPRESENTATIONS AND WARRANTIES 
  
 3.1 Representations and Warranties of Novartis. Novartis hereby
represents and warrants to Reliant as of the date hereof as follows: 
  
 (a) Organization. Novartis is (i) a corporation duly organized and validly existing and in good standing under the laws of the state or country of its incorporation, and (ii) has all necessary corporate power
and authority to own its properties and to conduct its business, as currently conducted. 
  
 (b) Authorization. The execution and delivery of this Agreement and the consummation of the transactions contemplated hereby are
within the corporate power of Novartis, have been or will be, on or prior to the Effective Date duly authorized by all necessary corporate proceedings and this such Agreement has been, or will be, prior to the Effective Date duly executed and
delivered by Novartis. 
  
 (c) Execution and
Delivery. Neither the execution of this Agreement nor the consummation of the transactions contemplated herein: (i) requires Novartis to obtain any material approval, consent or withholding of objections on the part of any regulatory or
governmental body; (ii) will result in any violation or breach of any term or provision of Novartis’ internal rules of corporate governance; (iii) will constitute a breach or default under any material indenture, mortgage, deed of trust,
license agreement, or other contract or agreement to which Novartis or any Affiliate of Novartis is a party; or (iv) will violate any 

  

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provision of any judicial, governmental or administrative order, writ, injunction, award, judgment or decree applicable to Novartis or any Affiliate of
Novartis. 
  
 (d) Binding Obligation. As
of the Effective Date, this Agreement has been duly and validly authorized, executed and delivered by Novartis and, when duly executed and delivered to Reliant as provided hereunder, will constitute the valid and binding obligations of Novartis
enforceable against Novartis in accordance with its terms, except as such enforcement may be limited by bankruptcy or other laws of general application affecting creditor rights or general principles of equity. 
  
 (e) Broker. Neither Novartis nor any officer,
director or agent of Novartis has employed any broker, finder, or agent with respect to this Agreement or the transactions contemplated hereby. 
  
 (f) Right to Sublicense; Consents. Except as set forth on Schedule 3.1(f), Novartis has the right to sublicense to Reliant the Alza
License. 
  
 (g) Litigation. Except as set
forth on Schedule 3.1(g), there is no litigation, arbitration or proceeding pending by or against Novartis involving the Alza Technical Information, the Alza Patents, the Alza License or the Licensed Product which would in any way materially impede,
impair, restrict or interfere with the sublicense granted Reliant hereunder. 
  
 (h) No Default. Novartis is not in breach or default, nor has it received written notice of breach or default by Alza, under the Alza License. 
  
 (i) Alza License. Novartis shall comply with the terms of the Alza License during the Term.

  

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 3.2 Representations and Warranties of Reliant. Reliant hereby represents and warrants to Novartis
as of the date hereof as follows: 
  
 (a)
Organization. Reliant (i) is a limited liability company duly organized, validly existing and in good standing under the laws of the state of its formation and (ii) has all necessary power and authority to own its properties and to conduct
its business as presently conducted. 
  
 (b)
Authority. The execution and delivery of this Agreement and the consummation of the transactions contemplated hereby are within the power of Reliant and have been or will be, duly authorized by all necessary proceedings, and this Agreement
has been or will be, on or prior to the Effective Date, duly executed and delivered by Reliant. 
  
 (c) Execution and Delivery. Neither the execution of this Agreement nor the consummation of the transactions contemplated hereby:
(i) requires Reliant to obtain the approval, consent or withholding of objection on the part of any governmental body; (ii) will result in any violation or breach of any term or provision of Reliant’s Certificate of Formation or Operating
Agreement; (iii) will constitute a default under any indenture, mortgage, deed of trust, license, agreement, or other contract or agreement to which Reliant is a party; or (iv) will violate any provision of any judicial, governmental or
administrative order, writ, injunction, award, judgment or decree applicable to Reliant. 
  
 (d) Binding Obligation. This Agreement has been duly and validly authorized, executed and delivered by Reliant, and when duly
executed and delivered by Novartis will constitute valid and binding obligations of Reliant, enforceable against Reliant in accordance with its terms, except as such enforcement may be limited by bankruptcy or other laws of general application
affecting creditor rights or general principles of equity. 
  

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 (e) Broker. Neither Reliant nor any officer, manager or agent of Reliant, has
employed any broker or finder with respect to this agreement or the transactions contemplated hereby. 
  
 (f) Alza License. Reliant shall not take any action or fail to take any action which would cause Novartis to be in breach of the
Alza License. 
  
 (g) Litigation. Except
as set forth on Schedule 3.2(g), there is no litigation, arbitration or proceeding pending by or against Reliant involving the Alza Technical Information, the Alza Patents, the Alza License or the Licensed Product which would in any way materially
impede, impair, restrict or interfere with the performance of Reliant hereunder. 
  
 ARTICLE 4 
  
 TERMINATION

  
 4.1 Prior Termination by Novartis. This Agreement
may be terminated by Novartis whenever any of the following events occur: 
  
 (a) Reliant’s failure or refusal to pay sums due Alza under the Agreement as and when due, which failure is not cured within thirty (30) days after Novartis or NPC has given written notice thereof to Reliant;

  
 (b) Reliant has breached or failed to perform
any of the material obligations under or in connection with the Agreement or the Alza License (if any) and such breach or failure is not cured within thirty (30) days after Novartis has given written notice thereof to Reliant. 
  
 (c) any representation or warranty made herein by Reliant
proves to be incorrect when made which incorrectness would have a material adverse effect on the performance of Reliant’s obligations under this Agreement; 
  

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 (d) a court of competent jurisdiction enters a decree or order of relief appointing a
receiver, liquidator, assignee, trustee or similar official of Reliant or any substantial part of its assets and such decree or order is consented to by Reliant or continuing unstayed and in effect for a period of ninety (90) days; 
  
 (e) Reliant files a voluntary petition or acquiesces in or
fails to contest an involuntary petition under any bankruptcy, insolvency or similar law; 
  
 (f) An insolvency petition is filed against Reliant under any bankruptcy, insolvency or similar law and is not dismissed within ninety
(90) days; 
  
 (g) Reliant makes a general
assignment for the benefit of its creditors; or 
  
 (h) Reliant is dissolved or liquidated other than as permitted by Section 8.9. 
  
 4.2 Prior Termination by Reliant. This Agreement may be terminated by Reliant whenever any of the following events occur: 
  
 (a) Novartis has breached or failed to perform any of the material obligations under or in connection with
this Agreement or the Alza License and such breach is not cured within thirty (30) days after Reliant has given written notice thereof to Novartis; 
  
 (b) any representation or warranty made herein by Novartis proves to be incorrect when made which incorrectness would have a Material
Adverse Effect; 
  
 (c) a court of competent
jurisdiction enters a decree or order of relief appointing a receiver, liquidator, assignee, trustee or similar official of Novartis or any substantial part of its assets and such decree or order is consented to by Novartis or continuing unstayed
and in effect for a period of ninety (90) days; 
  
 (d) Novartis files a voluntary petition or acquiesces in or fails to contest an involuntary petition under any bankruptcy, insolvency or similar law; 
  

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 (e) an insolvency petition is filed against Novartis under any bankruptcy, insolvency or
similar law and is not dismissed within ninety (90) days; 
  
 (f) Novartis makes a general assignment for the benefit of its creditors; or 
  
 (g) Novartis is dissolved or liquidated. 
  
 ARTICLE 5 
  
 INDEMNIFICATION 
  
 5.1 Indemnification of Reliant. Novartis will defend, indemnify and hold harmless Reliant, and its Affiliates and the managers, members, officers, agents, employees, representatives or consultants or of any of
them (individually, a “Reliant Indemnified Party,” and collectively, the “Reliant Indemnified Parties”), from and against any and all liabilities, losses, damages, actions, claims and expenses suffered or incurred by the Reliant
Indemnified Parties (including reasonable attorneys’ fees, court costs and expert witnesses’ fees) (individually, a “Liability,” and collectively, the “Liabilities”) that result from, or arise out of (i) a breach by
Novartis of any representation, warranty, covenant or agreement contained in this Agreement; or (ii) Novartis’ failure to comply with any applicable federal, state or local law, rule or regulation in connection with the performance of its
obligations hereunder. 
  
 5.2 Indemnification of Novartis.
Reliant will defend, indemnify and hold harmless Novartis and its Affiliates and the directors, stockholders, officers, agents, employees, representatives or consultants or any of them (individually, a “Novartis Indemnified Party,” and
collectively, the “Novartis Indemnified Parties”), from and against any and all Liabilities that result from or arise out of: (i) a breach by Reliant of any representation, warranty, covenant or agreement contained in this Agreement; (ii)
Reliant’s failure to comply with any applicable federal, state or local law, rule or regulation in connection with the performance of its obligations 

  

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hereunder or (iii) Reliant’s exercise of its rights under this Agreement, including any breach of the Alza License caused by Reliant. 
  
 5.3 Conditions of Indemnification. The obligations of Novartis and
Reliant under this Article 5 shall be subject to the following terms and conditions: 
  
 (a) The party claiming a right to indemnification shall, within ten (10) business days of receipt of notice of any claim, charge, suit or
other action, give, in accordance with Article 6, written notice to the indemnifying party, of any such claim, charge, suit or other action which is governed by the indemnity obligations of this Agreement but the failure to notify the indemnifying
party will not relieve the indemnifying party of any Liability that it may have to the party claiming a right of indemnification, except to the extent that the defense of such action by the indemnifying party is prejudiced by the failure to give
such notice; 
  
 (b) The indemnifying party shall
conduct, at its own expense, the defense of any and all such claims, charges, suits or other actions by a third-party; 
  
 (c) Each party will offer reasonable assistance to the other party in defending or settling the claim. Neither party shall settle or admit
liability with respect to any such claims, charges, suits or other actions which could result in liability to the other party without the prior written consent of the other party, which consent shall not be unreasonably withheld or delayed; provided
however, neither party may settle a claim or action related to a Liability without the consent of the other party, if such settlement would impose any monetary obligation on the other party or require the other party to submit to an injunction or
otherwise limit the other party’s rights under this Agreement. 
  
 (d) If the indemnifying party does not take the steps necessary against any such claims, charges, suits or other action by a third-party, the party claiming indemnification 

  

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may defend against or settle such claims, charges, suits or other action, provided, that such party may not settle such claims, charges, suits or other
action without the prior written consent of the indemnifying party which consent shall not be unreasonably withheld or delayed; provided however, the defense and/or settlement under this Article 5 shall not act as a waiver of rights to
indemnification under this Agreement or any other rights or remedies of a party claiming indemnification and shall not excuse the indemnifying party from its obligations hereunder, and all reasonable costs and expenses incurred by the party claiming
indemnification shall be subject to indemnity by the indemnifying party. 
  
 5.4 Exclusive Remedy. Notwithstanding any other provision of this Agreement, the indemnification provided in this Article 5 shall be the exclusive remedy and the sole recourse of all Liabilities related to or
arising at law, under any statute or in equity, or otherwise, directly or indirectly, out of this Agreement or the transactions contemplated hereby (other than claims of or causes of action arising from fraud). In furtherance thereof, each party
hereto waives, to the fullest extent permitted by law, any and all rights, claims, actions or causes of action (other than claims of or causes of action arising from fraud), it may have against any other party hereto relating to the subject matter
of this Agreement other than the remedies provided in this Article 5. 
  
 5.5 Consequential Damages. In no event shall any party hereunder or its Affiliates be liable to any other party hereunder or its Affiliates, whether for breach of contract, in tort (e.g. negligence, strict liability, etc.) or
otherwise, for payment of any punitive damages or Consequential Damages resulting or arising from this Agreement or the transactions contemplated hereby, except for fraud or willful misconduct; provided, however, that any 

  

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damages (including Consequential Damages) claimed by or paid to a third-party in a third-party action shall not be considered Consequential Damages for
purposes of this Agreement. 
  
 ARTICLE 6 
  
 NOTICES 
  
 6.1 Notices. All notices required or permitted hereunder shall be given in writing and sent by facsimile
transmission, mailed postage prepaid by certified or registered mail, or sent by a nationally recognized express courier service or hand-delivered at the following addresses: 
  
 TO RELIANT: at its address shown below or such other address as it may give to Novartis by notice hereunder:

  
 Reliant Pharmaceuticals, LLC 
 110 Allen Road 
 Liberty Corner, New Jersey
07938 
 Attention: President 
 Fax No.: (908) 542-9406 
  
 with copies to: 

 
 Latham & Watkins 
 Sears Tower, Suite 5800 
 Chicago, Illinois
60606 
 Fax No.: (312) 993-9767 
 Attn.: Michael A. Pucker 
  
 TO NOVARTIS, at the
addresses shown below or such other address as it may give to Reliant by notice hereunder: 
  
 Novartis AG 
 Postfach 
 4002 Basel, Switzerland 
 Attention: Jürgen Vierkötter 
 Fax No.: 011-41-61-324-8444 
  

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 with copies to: 
  

Kaye Scholer LLP 
 425 Park Avenue

 New York, New York 10022-3598 
 Attn: Adam H. Golden, Esq. 
  
 All notices shall be
deemed made upon receipt by the addressee as evidenced by the applicable written receipt. 
  
 ARTICLE 7 
  
 PUBLICITY

  
 7.1 (a) Disclosure of Agreement Terms. Novartis and
Reliant agree not to issue any press releases or public announcements concerning this Agreement without the prior written consent of the other party to the form, timing and content of any such release or announcement, except as such release or
announcement may be required by law. A party who desires to issue a press release or make any other public disclosure relating to this Agreement shall notify the other in writing at least seven (7) business days (or such shorter period where legally
required) before the time of the proposed release. Such notice shall include the exact text of the proposed release and the time and manner of the release. Neither party shall unreasonably withhold its consent to any such press release or
announcement. 
  
 (b) Exceptions. Novartis
and Reliant recognize that disclosure of the terms of this Agreement to the IRS and other tax and regulatory authorities may be required, and Novartis and Reliant each waives the requirements of this Section 7.1 with respect to disclosure to such
entities. In disclosing such information as required in this Section 7.1(b), each party will use its reasonable best efforts to secure confidential treatment from the applicable regulatory authority when requested by either party. 
  

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 (c) Disclosure of Financial Terms. Except (i) as required by law, (ii) in
connection with a transaction permitted under Section 8.9(a), and/or (iii) to investment bankers and/or financing sources in connection with bona fide financing transactions involving Reliant or an Affiliate (as defined in Section 8.9(b)), neither
party shall disclose to any third-party, whether publicly or otherwise, any financial terms of this Agreement, which have not been previously disclosed publicly pursuant to this Section 7.1(c) without the prior written consent of the other party,
which consent shall not be unreasonably withheld or delayed. In disclosing any information covered by this Section 7.1(c), (a) pursuant to a requirement of law (including a requirement of law in connection with a transaction permitted under Section
8.9(a)), each party will notify the other of the proposed disclosure and each party will use its reasonable efforts to secure confidential treatment from the applicable governmental authority when requested by such other party and (b) in connection
with disclosure permitted by clauses (ii) and/or (iii) of this Section 7.1(c), Reliant will require the party to whom it discloses such information to enter into a confidentiality agreement including terms with respect to the financial terms of this
Agreement not less strict than those set forth in Schedule 7.1(c) attached hereto for a period of at least two (2) years. Reliant will use reasonable commercial efforts to enforce its rights under any such confidentiality agreement.

  
 ARTICLE 8 
  
 MISCELLANEOUS 
  
 8.1 The Headings. The titles, headings or captions and paragraphs in
this Agreement are for convenience only and do not define, limit, extend, explain or describe the scope or extent of this Agreement or any of its terms or conditions and therefore shall not be considered in the interpretation, construction or
application of this Agreement. 
  

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 8.2 Invalid Provisions. Whenever possible, each clause, subclause, provision or condition of this
Agreement shall be interpreted in such manner as to be effective and valid under applicable law, but if any clause, subclause, provision or condition of this Agreement should be prohibited or invalid under applicable law, such clause, subclause,
provision or condition shall be considered separate and severable from this Agreement to the extent of such prohibition or invalidity without invalidating the remaining clauses, subclauses, provisions and conditions of this Agreement, so long as the
remaining Agreement reflects the economic intentions of the parties as evidenced by this Agreement as a whole. 
  
 8.3 Entire Agreement and the Alza License. This Agreement, the Alza License and the January 2003 Agreement set forth the entire agreement between
the parties hereto pertaining to the subject matter hereof and supersedes all negotiations, preliminary agreements, memoranda or letters of proposal or intent, discussions and understandings of the parties hereto in connection with the subject
matter hereof. All discussions between the parties concerning this sublicense of Alza Technical Information and Alza Patents have been merged into this Agreement, the Alza License and the January 2003 Agreement and neither party shall be bound by
any definition, condition, understanding, representation, warranty, covenant or provision other than as expressly stated in or contemplated by this Agreement, the Alza License and the January 2003 Agreement or as subsequently shall be set forth in
writing and executed by a duly authorized representative of the party to be bound thereby. 
  
 8.4 Amendments. No amendment, change or modification of any of the terms, provisions or conditions of this Agreement shall be effective unless made in writing and signed on behalf of the parties hereto by their
duly authorized representatives. 
  

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 8.5 Counterparts. This Agreement may be executed in one or more counterparts, each of which shall
be deemed to be an original document, but all such separate counterparts shall constitute only one and the same instrument. 
  
 8.6 Waiver. No waiver of any term, provision, or condition of this Agreement, whether by conduct or otherwise, in any one or more instances, shall
be deemed to be or construed as a further or continuing waiver of any such or other term, provision, or condition of this Agreement. 
  
 8.7 Force Majeure. Neither party shall be liable hereunder to the other party nor shall a party be in breach for failure to perform its obligations
caused by circumstances beyond the control of either party, including but not limited to, acts of God; fires; earthquakes; floods; riots; wars; civil disturbances; sabotage; accidents; labor disputes; shortages; or government actions (including but
not limited to, priorities, requisitions, allocations and price restrictions). In the case of any such event, the affected party shall promptly notify the other party and make commercially reasonable efforts to diligently pursue resolution of the
force majeure event. The affected party shall make diligent efforts to resume performance and keep the other party informed thereof. After thirty (30) days of such inability to perform, the parties agree to meet and in good faith discuss how to
proceed. In the event that the affected party is prevented from performing its obligations pursuant to this Agreement for a period of six (6) months, the other party shall have the right to terminate this Agreement. 
  
 8.8 Successors and Assigns. Subject to Article 8.9, this Agreement
shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and assigns permitted under this Agreement. 
  

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 8.9 Assignment. 
  
 (a) Except as otherwise permitted hereby, neither party shall assign or otherwise transfer this Agreement or
any interest herein or right or obligation hereunder without the prior written consent of the other party, and any such purported assignment, transfer or attempt to assign or transfer any interest herein or right hereunder shall be void and of no
effect; provided, however that (i) each party may assign its rights and obligations hereunder to (A) an Affiliate or (B) a transferee or acquiror of, or successor to, its assets or securities in the event of a Change of Control without
the prior written consent of the other party and/or (ii) Reliant may assign its rights and obligations hereunder to an acquiror of all or substantially all of Reliant’s assets relating to one or more of DynaCirc, DynaCirc CR and DynaCirc BXR
without the prior consent of Novartis; provided, further that (A) the assigning party shall remain responsible for all of its obligations and agreements set forth herein, notwithstanding such assignment, and (B) in the case of a Change of
Control, such transferee or successor shall assume in writing the obligations of the party to which it is the transferee or successor. 
  
 (b) For the purposes of the definition of Change of Control in Section 1.5, Section 7.1(c) and this Section 8.9, with respect to Reliant,
the term “Affiliate” shall include any or all of the following Persons, (i) PharmBay Investors, L.L.C., (ii) Bay City Capital Fund II, L.P., Bay City Capital Fund III, L.P. (and their related co-investment and advisory entities), and/or
(iii) (A) all lineal descendants of Nicholas J. Pritzker, deceased, and all spouses and adopted children of such descendants; (B) all trusts for the benefit of any Person described in clause (A) and the trustees of such trusts; (C) all legal
representatives of any Person or trust described in clause (A) or (B); and (D) all Persons controlling, controlled by or under common control with any person trust or entity described in clause (A), (B), (C) or (D). The terms 

  

 20 

 
“controlling,” “controlled” and “common control with” mean the ability, by ownership of voting securities or otherwise,
directly or indirectly, to direct the managerial and operating policies of a Person. 
  
 (c) For the purposes of this Section 8.9, the following transactions shall not constitute an assignment or a transfer (and are therefore
permitted transactions): (i) conversion of Reliant from a limited liability company to a corporation following which the equityholders of Reliant immediately prior to such conversion hold shares in the resulting corporation in approximately the same
relative proportions as they did in the pre-conversion entity, and (ii) issuance by Reliant of debt or equity securities (including convertible or exchangeable securities) in connection with any financing transaction or public offering which does
not constitute a Change of Control. 
  
 (d)
Nothing herein shall preclude Reliant from entering into agreements with third parties to co-promote or assist Reliant in the marketing or promotion of the Licensed Product (or the Products as defined in the Option Agreement), including, without
limitation, engaging a contract sales organization; provided that the foregoing shall not relieve Reliant of any of its obligations hereunder. 
  
 8.10 Survival. The provisions of Articles 2.4 (to the extent pertaining to periods on or prior to termination or expiration of this Agreement) 5,
6, 7, 8.12 and 8.15 shall survive, and remain in effect, after termination or expiration of this Agreement in accordance with their terms. 
  
 8.11 Construction. This Agreement has been prepared jointly and shall not be strictly construed against either party. 
  
 8.12 Governing Law. This Agreement shall be interpreted under and
governed by the internal laws of the State of New Jersey, United States of America. 
  

 21 

 8.13 Dispute Resolution. The parties will use their commercially reasonable efforts to resolve any
disputes arising from this Agreement by good-faith negotiation and mutual discussion for a period of thirty (30) days. Thereafter, each party shall be entitled to seek any remedy with respect to such dispute, whether pursuant to this Agreement, at
law or otherwise. 
  
 8.14 Relationship Between Parties.
Novartis and Reliant agree that in all matters relating to this Agreement they are and shall be acting as independent contractors. Each party shall bear all of their expenses in connection with the negotiation and execution of this Agreement.
Neither Novartis nor Reliant is, and shall not hold itself out as, an agent, partner or joint venturer of the other. Neither Novartis nor Reliant shall have any authority to assume or create any obligation express or implied on behalf of the other.

  
 8.15 Incorporation by Reference; Conflicts. Sections 4,
10.1, 10.2, 10.3 and 12 of the Alza License are hereby incorporated by reference as if fully set forth at length herein. 
  
 The parties acknowledge and agree that this Agreement shall be subject in all respects to and limited by the Alza License and in the event of any
conflict between this Agreement and the Alza License, the provisions of the Alza License will control. 
  
 IN WITNESS WHEREOF, the parties have caused this Agreement to be executed in duplicate on the day and year first above written. 
  

									
	RELIANT PHARMACEUTICALS, LLC	 	 	 	NOVARTIS AG
					
	By: 	 	 	 	 	 	By: 	 	 
					
	 Title: 
	 	 	 	 	 	 Title: 
	 	 

  

 22 

 Schedule 1.4 
  
 U.S. PATENTS COVERING OROS® ISRADIPINE-DYNACIRC 
  

											
	 ARC No./
 Country

	 	 Appln. No.

	 	 Filing Date

	 	 Patent No.

	 	 Issue Date

	 	 Expiration Date

	 United States
	 	 	 	 	 	 	 	 	 	 
	 ARC 1558
	 	07/104,006	 	10/02/87	 	4,816,263	 	03/28/89	 	March 28, 2006
	 ARC 1558 Div. 1
	 	07/267,894	 	11/07/88	 	4,946,687	 	08/07/90	 	Aug. 7, 2007
	 ARC 1558 Div. 2
	 	07/267,904	 	11/07/88	 	4,950,486	 	08/21/90	 	Aug. 21, 2007
	 ARC 1558 Cont. 1
	 	07/516,582	 	04/30/90	 	5,030,456	 	07/09/91	 	July 9, 2008
	 ARC 1019 CIP 6
	 	07/595,140	 	10/09/90	 	5,082,668	 	01/21/92	 	Jan. 21, 2009
	 ARC 1019 CIP 3
	 	06/912712	 	09/29/86	 	4,783,337	 	11/08/88	 	Sept. 16, 2003
	 ARC 1019 CIP 1
	 	06/685092	 	12/21/84	 	4,612,008	 	09/16/86	 	Sept. 16, 2003
	 ARC 667
	 	06/210176	 	11/25/80	 	4,327,725	 	05/04/82	 	May 4, 1999
	 ARC 419 Cont. 1
	 	660219	 	02/23/76	 	4,088,864	 	05/09/78	 	May 9, 1995

  

 23 

 Schedule 3.1(f) 
  
 Exceptions to Right to Sublicense; Consents 
  
 None. 
  

 24 

 Schedule 3.1(g) 
  
 Litigation 
  
 None. 
  

 25 

 Schedule 3.2(g) 
  
 Litigation 
  
 None. 
  

 26 

 Schedule 7.1(c) 
  
 Confidentiality Provisions 
  
 In order to allow you to evaluate a possible negotiated business transaction (a “Transaction”) involving Reliant Pharmaceuticals, LLC, a
Delaware limited liability company (the “Company”), you have requested certain information concerning the Company. 
  
 As a condition to your being furnished such information, you agree to treat any information concerning the Company, its affiliates and subsidiaries that
has been or is furnished to you by or on behalf of the Company, at any time or in any form, together with all notes, interpretations, analyses, compilations, studies or other documents prepared by you or any of your directors, officers, employees,
agents or advisors (including, without limitation, attorneys, accountants, consultants, bankers, financial advisors and any representatives of your advisors) (collectively, “Representatives”) that contain or otherwise reflect or are based,
in whole or in part, on such information (collectively referred to as the “Evaluation Material”), in accordance with the provisions of this agreement. “Evaluation Material” does not include information that (a) was or becomes
generally available to the public other than as a result of a disclosure by you or your Representatives or (b) was or becomes available to you on a non-confidential basis from a source other than the Company, or its advisors, provided that such
source was not known by you to be bound by any agreement with the Company to keep such information confidential or to be otherwise prohibited from transmitting the information to you by a contractual, legal or fiduciary obligation. 
  
 You hereby agree that the Evaluation Material will be used solely for the
purpose of evaluating a possible Transaction and that such information will be kept confidential. You and your Representatives shall not disclose any portion of the Evaluation Material to any person in any manner whatsoever, except to the extent
that disclosure of such information is required by law, regulation, supervisory authority or other applicable judicial or governmental order. You may disclose the Evaluation Material to your Representatives on a need to know basis, however, they
should be informed of and bound to this agreement, and you agree to be responsible for any breach hereof on their part. You agree, at your sole expense, to take all reasonable measures (including but not limited to court proceedings) to restrain
your Representatives from prohibited or unauthorized disclosure or use of the Evaluation Material. 
  
 In addition, without the prior written consent of the Company, you will not, and will direct your Representatives not to, disclose to any person (i) that
the Evaluation Material has been made available to you or your Representatives, (ii) that discussions or negotiations are taking place concerning a possible transaction involving the Company and you, or (iii) any terms, conditions or other facts
with respect to any such possible Transaction, including the status thereof. Such facts will be deemed to be included in the Evaluation Material for all purposes of this agreement. 
  
 In the event that you are requested or required by law, regulations or applicable judicial or governmental order to disclose
any Evaluation Material, you will provide the Company with prompt written notice of such request or requirement. If, failing the entry of a protective order, you are, in the reasonable opinion of your counsel, legally compelled to 

  

 27 

 
disclose any portion of the Evaluation Material, you may disclose to the entity compelling such disclosure only that portion of the Evaluation Material that
your counsel advises that you are compelled to disclose, provided that you will exercise reasonable efforts to obtain assurance that confidential treatment will be accorded to that portion of the Evaluation Material that is being disclosed and you
will cooperate with any action by the Company to obtain an appropriate protective order or other reliable assurance that confidential treatment will be accorded the Evaluation Material. 
  
 All Evaluation Material disclosed by or on behalf of the Company shall be and shall remain the property of the Company. As
soon as reasonably practicable after being so requested in writing by the Company, you shall return or destroy all Evaluation Material, whether in printed or electronic form (and any copies thereof). Any destruction of Evaluation Material shall be
confirmed by you in writing to the Company. 
  
 You understand and
acknowledge that any and all information contained in the Evaluation Material is being provided without any representation or warranty, express or implied, as to the accuracy or completeness of the Evaluation Material, on the part of the Company.
You agree that none of the Company or any of its affiliates or representatives shall have any liability to you or any of your Representatives. It is understood that the scope of any representations and warranties to be given by the Company will be
negotiated along with other terms and conditions in arriving at a mutually acceptable form of definitive agreement should discussions progress to such a point and only those representations and warranties shall have any legal effect. 
  
 It is understood and agreed that money damages would not be a sufficient
remedy for any breach of this agreement by you or your Representatives, that any such breach would result in ongoing and irreparable harm to the Company and that the Company shall be entitled to specific performance and injunctive or other equitable
relief as a remedy for any such breach and you further agree to waive any requirement for the security or posting of any bond in connection with any such remedy. Such remedy shall not be deemed to be the exclusive remedy for breach of this agreement
but shall be in addition to all other remedies available at law or equity to the Company. In the event of litigation relating to this agreement, the prevailing party shall be entitled to be paid by the other party all reasonable legal fees and other
expenses such prevailing party has incurred in connection with such litigation, including any appeal therefrom. 
  
 This agreement is governed by the laws of the State of
[                    ] without regard to conflict of laws principles. You hereby irrevocably and unconditionally consent to submit to the
non-exclusive jurisdiction of the courts of the State of [                    ] and the United States of America located in the State of
[                    ] for any action, suit or proceeding arising out of or relating to this letter agreement or the transactions contemplated
hereby. 
  
 This agreement may not be amended except in writing
signed by both parties hereto. No failure or delay by the Company in exercising any right, power or privilege hereunder or any partial exercise thereof shall operate as a waiver thereof or preclude any other or future exercise thereof or the
exercise of any other right, power or privilege hereunder. The invalidity or unenforceability of any provision of this agreement shall not affect the validity or enforceability of any other provisions of this agreement, which shall remain in full
force and 

  

 28 

 
effect. For purposes of this agreement, the term “person” shall be broadly interpreted to include the media and any individual, corporation,
partnership, group or other entity. This agreement may be executed in counterparts, each of which will be deemed to be an original, but all of which constitute the same agreement. Please confirm that the forgoing is in accordance with your
understanding of our agreement by signing and returning to us a copy of this letter. 
  
 This agreement shall terminate and be of no further force or effect from and after [                    ] from the date hereof.

  

 29 

 Exhibit A 
  

Alza License 
  
 [***] [49 pages omitted] 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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

  

 30Supply and Packaging Agreement / Novartis Consumer Health, Inc.

 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 [***]or (y) [***] to either (i) deliver Products, at least [***] of which meet the Product Specifications, (ii) deliver Products within
[***]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 [***] 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 [***] 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 
  
  
  
  
  

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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 [***] 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 [***] (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 [***] of such Monthly Purchase Requirement of Products and Packaged Tablets [***]and (ii) purchases [***] Products
and Packaged Tablets of [***] of the Rolling Monthly Forecast for [***]. 
  
 (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,
[***] 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 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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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 hereinto 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. 
  
  
  
  
  
  
  
  
  
  
  
  
  

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 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 [***] of the Commencement Date (the “Initial Term”). Thereafter, the Agreement shall automatically renew for up to [***] (each one year term after the Initial term a 
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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“Renewal Term”) (the Initial Term and all Renewal Terms collectively, the “Term”) unless either Party gives the other [***] 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. 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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 (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 [***] 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. 
  
  
  
  
  

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 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 [***] 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 [***] 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 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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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

  
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