COLLABORATION AGREEMENT

Exhibit 10.1

CONFIDENTIAL
FINAL

COLLABORATION AGREEMENT

UCYCLYD PHARMA, INC.

and

HYPERION THERAPEUTICS, INC.

dated

August 23, 2007

TABLE OF CONTENTS

ARTICLE 1 DEFINITIONS			1
ARTICLE 2 PROMOTION AND DEVELOPMENT ACTIVITIES DURING THE DEVELOPMENT TERM			11
2.1 Promotion of Marketed Products During the Development Term			11
2.1.1 Promotion Rights and License			11
2.1.2 Promotion Plan			12
2.1.3 Promotion Activities			13
2.1.4 Supply and Distribution of the Marketed Products			15
2.1.5 Expansion of Promotion Territory			18
2.1.6 Exclusion or Prohibition Affecting Sales of Marketed Product			19
2.2 Research and Development during the Development Term			19
2.2.1 R&D Rights with Respect to Development Products			19
2.2.2 R&D Rights Outside of the Development Field			20
2.2.3 R&D Rights Outside of the United States			20
2.2.4 Development Plan			20
2.2.5 Research and Development Diligence			21
2.2.6 Transition of Development and Regulatory Program to Hyperion			22
2.2.7 Development Costs			22
2.2.8 Information Exchange			23
2.2.9 Approval of **** Prior to Closing			23
2.2.10 Termination Based on Failure to File NDA			24
2.2.11 Supply of Development Products during Development Term			26
2.2.12 Visit of Facilities			27
2.3 Use of Contractors			27
2.3.1 Right to Engage Subcontractors			27
2.3.2 Subcontracting Agreements			28
2.3.3 Replacement of Subcontractors			28
ARTICLE 3 RIGHTS TO PURCHASE ASSETS			29
3.1 Purchase Rights			29
3.2 Purchase Price			29
3.3 Closing			30

TABLE OF CONTENTS
(continued)

3.3.1 Account for Purchase Payment			30
3.3.2 Closing			30
3.3.3 Delay of Closing Date			31
3.3.4 HSR Act Clearance			31
3.4 Transition at Closing			32
3.4.1 Regulatory Filings and Clinical Data			32
3.4.2 Inventories			32
3.4.3 Technology Transfer			32
3.4.4 Post-Closing Application of Corporate Integrity Agreement			32
3.4.5 Accounts Receivables			33
ARTICLE 4 RIGHTS AND OBLIGATIONS OF THE PARTIES AFTER CLOSING			33
4.1 Rights to Commercialize Product			33
4.1.1 Exclusive Commercialization Rights			33
4.1.2 Commercial Diligence			34
4.1.3 Commercialization Efforts Reporting			34
4.1.4 Pricing, Pricing Approvals and Product Distribution			34
4.1.5 Sales and Inventory			34
4.1.6 Labeling and Promotional Materials			34
4.2 Rights to Develop Products			34
4.2.1 Continued Rights under the Development and Regulatory Program			34
4.2.2 Rights to Develop Products for Other Indications Worldwide			34
ARTICLE 5 REGULATORY AND COMPLIANCE MATTERS			35
5.1 General Compliance			35
5.2 Compliance Program			37
5.3 Screening Requirements			38
5.4 Regulatory Filings and Approvals			39
5.4.1 Marketed Products			39
5.4.2 Development and Regulatory Program			39
5.5 Labeling and Promotional Materials			41

TABLE OF CONTENTS
(continued)

5.6 Adverse Events and Safety Reporting			43
5.7 Communication with Governmental Authorities or Regulatory Agencies			43
5.8 Complaints; Medical Inquiries; Product Information Requests			44
5.9 Regulatory Information			44
5.10 Recalls or Other Corrective Action			45
5.11 Compliance Deficiencies			46
ARTICLE 6 GOVERNANCE			48
6.1 Cooperation			48
6.2 Joint Steering Committee			49
6.2.1 Establishment of the Joint Steering Committee			49
6.2.2 Responsibilities of the Joint Steering Committee			49
6.2.3 Meetings of the Joint Steering Committee			50
6.3 Responsibilities of the Chairperson			51
6.4 Reports to the Joint Steering Committees			51
6.4.1 By Hyperion			51
6.4.2 By Ucyclyd			52
6.5 Minutes			52
6.6 Expenses			52
6.7 Voting			52
6.8 Replacement of Personnel			52
6.9 Delegation			53
ARTICLE 7 PAYMENT TERMS AND OBLIGATIONS			53
7.1 Upfront Payments			53
7.2 Regulatory Milestone Payments			53
7.3 Promotion Commission			53
7.4 Other Ongoing Payments			53
7.5 Assumed Payment Obligations			53
7.6 No Reduction for Generic Equivalents			53
7.7 Promotional, Development, Regulatory and Other Costs and Expenses			53
7.8 Payment Procedure			54

TABLE OF CONTENTS
(continued)

7.9 Currency Conversion			55
7.10 Taxes			55
7.11 Continuing Payment Obligations			55
7.12 Late Payments			55
7.13 No Additional Payment			56
7.14 Financial Audit and Record-Keeping Requirements			56
7.15 Set-Off Rights			56
ARTICLE 8 INTELLECTUAL PROPERTY			56
8.1 Ownership Rights of Intellectual Property			56
8.1.1 Pre-Closing			56
8.1.2 On and Following Closing			58
8.2 Licenses			59
8.2.1 Product Technology and Developed Technology			59
8.3 Licensed Marks, Hyperion Marks, Domain Names and 1-888 Phone Number			61
8.3.1 During the Term			61
8.3.2 On and Following the Term			62
8.3.3 New Trademark Filings			62
8.3.4 Use of Hyperion Marks and Licensed Marks			62
8.3.5 Domain Names and 1-888 Phone Number			63
8.4 No Liens			63
8.5 Co-Exclusive Rights			63
ARTICLE 9 PATENTS AND LICENSED MARKS			64
9.1 Patent Prosecution and Maintenance			64
9.1.1 Hyperion’s Rights Pre-Closing			64
9.1.2 Ucyclyd’s Rights			64
9.2 Enforcement			66
9.2.1 Pre-Closing			66
9.2.2 Post-Closing			66
9.2.3 Settlements			67

TABLE OF CONTENTS
(continued)

9.3 Prosecution and Maintenance of Licensed Marks and Domain Names			67
9.4 Enforcement of Licensed Marks			67
9.5 USPTO Inter Partes Proceedings for Licensed Marks			68
9.6 No Contest			68
9.6.1 For Patents			68
9.6.2 For Licensed Marks and Hyperion Marks			69
ARTICLE 10 REPRESENTATIONS AND WARRANTIES			70
10.1 Mutual Representations and Warranties			70
10.2 Additional Representations of Ucyclyd			70
10.3 Additional Representations and Warranties of Hyperion			72
10.4 Obligation to Update Representations and Warranties			72
10.5 Limitation of Warranties			73
ARTICLE 11 ADDITIONAL COVENANTS			74
11.1 Non-Competition			74
11.1.1 By Hyperion			74
11.1.2 By Ucyclyd			74
11.2 Brusilow License Agreement			74
11.3 No Solicitation			74
11.4 Delivery of Financial Statements			75
11.5 Hyperion’s Financial Resources			75
11.6 Material Adverse Changes			77
11.7 Confidentiality of Hyperion’s Financial Information			77
ARTICLE 12 TERM AND TERMINATION			77
12.1 Term			77
12.2 Termination Rights			77
12.3 Effect of Termination or Expiration			79
12.4 No Prejudice to Rights			79
12.5 Survival			79
ARTICLE 13 CONFIDENTIALITY AND NONDISCLOSURE			79
13.1 Confidential Information			79

TABLE OF CONTENTS
(continued)

13.2 Confidentiality Obligation			80
13.3 Exceptions			80
13.4 Authorized Disclosure			80
13.5 Survival			81
ARTICLE 14 INDEMNIFICATION, INSURANCE AND LIMITATION ON LIABILITY			81
14.1 Third Party Claims			81
14.2 Indemnification			81
14.2.1 Indemnification by Ucyclyd			81
14.2.2 Indemnification by Hyperion			83
14.3 Procedures for Indemnification			85
14.3.1 General			85
14.3.2 Defense Assumed			85
14.3.3 Defense Declined			85
14.3.4 Settlement of Claims			85
14.3.5 Contributory Negligence; Right of Contribution			86
14.4 Insurance			86
14.4.1 Ucyclyd’s Insurance Obligations			86
14.4.2 Hyperion’s Insurance Obligations			86
14.5 Insurance Proceeds			87
14.6 Limitation on Liability			87
ARTICLE 15 DISPUTE RESOLUTION			87
15.1 Governing Law			87
15.2 Dispute Resolution Procedure			88
15.3 Waiver of Jury Trial			89
15.4 Continued Performance			89
ARTICLE 16 MISCELLANEOUS			90
16.1 Relationship of the Parties			90
16.2 Force Majeure			90
16.3 Counterparts			91

CONFIDENTIAL
FINAL

TABLE OF CONTENTS
(continued)

16.4 Notices			91
16.5 Further Actions			92
16.6 Performance by Affiliates			92
16.7 Amendment			93
16.8 Severability			93
16.9 Publicity			93
16.10 Third Party Beneficiaries			94
16.11 Headings			94
16.12 Construction			94
16.13 No Waiver of Rights			95
16.14 Assignment			96
16.15 Entire Agreement			99

SCHEDULES AND EXHIBITS

SCHEDULES
Schedule 1		Index of Defined Terms
Schedule 1.30		Distribution Agreements
Schedule 1.31		Domain Names
Schedule 1.48		Hyperion Marks
Schedule 1.57		Licensed Marks
Schedule 1.60		Manufacturing Agreements
Schedule 2.1.2(a)		Requirements for Promotion Plans
Schedule 2.2.4		Development Plan
Schedule 2.2.6(a)		Close Out Activities
Schedule 2.2.6(b)		R&D Agreements
Schedule 2.2.6(c)		Pending R&D Agreements
Schedule 5.2(b)		Audit and Record Keeping Requirements
Schedule 6.2.1		Executive Steering Committee
Schedule 7		Payment Obligations
Schedule 10.2		Ucyclyd Disclosure Schedule
Schedule 11.3		Ucyclyd Employees
Schedule 11.5		Hyperion’s Financial Resources

EXHIBITS
Exhibit 1-A		Brusilow Original Agreement
Exhibit 1-B		Brusilow Amendment
Exhibit 2		Corporate Integrity Agreement
Exhibit 3		R&D Sublicense Agreement
Exhibit 4		Bill of Sale
Exhibit 5		Technology Assignment Agreement
Exhibit 6		Assignment and Assumption Agreement
Exhibit 7		Licensed Marks Assignment
Exhibit 8		Summar Agreement

     This COLLABORATION AGREEMENT is entered into this 23rd day of August 2007 (“ Effective Date ”), by and between UCYCLYD PHARMA, INC. , a Maryland corporation, with its principal place of business at 8125 North Hayden Road, Scottsdale, AZ 85258-2463 (hereinafter referred to as “ Ucyclyd ”) and HYPERION THERAPEUTICS, INC. , a Delaware corporation, with its principal place of business at 847 Sansome Street, 3rd Floor, San Francisco, CA 94111 (hereinafter referred to as “ Hyperion ”). Ucyclyd and Hyperion are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties .”

RECITALS

      WHEREAS , Ucyclyd promotes, markets, and sells the pharmaceutical products commonly known in the United States as Buphenyl ^® and Ammonul ^® ;

      WHEREAS , Ucyclyd is engaged in the research and development of: (a) the product currently referred to as GT4P for use in the treatments of urea cycle disorder and hepatic encephalopathies; and (b) Ammonul for use in the treatment of hepatic encephalopathies;

      WHEREAS , Ucyclyd considered several proposals from prospective bidders and, based on the experience, understanding and unique capabilities of Hyperion and the financial commitments from Hyperion and its investors, Ucyclyd selected Hyperion to promote Buphenyl ^® and Ammonul ^® in the United States and to continue with the ongoing research and development of GT4P for the treatments of urea cycle disorder and hepatic encephalopathies and Ammonul for hepatic encephalopathies, and Hyperion desires to obtain such rights from Ucyclyd; and

      WHEREAS , Ucyclyd desires to grant rights to Hyperion, exercisable in the future, to purchase certain worldwide rights to develop and commercialize Buphenyl ^® , Ammonul ^® and GT4P, and Hyperion desires to obtain such rights from Ucyclyd.

      NOW, THEREFORE , in consideration of the mutual promises, covenants, and agreements set forth herein, both Parties to the Agreement agree as follows:

ARTICLE 1

DEFINITIONS

     Capitalized terms used in the Agreement shall have the meanings ascribed to them in the body of the Agreement and in the attached Schedules, Exhibits, Attachments, Addenda and other documents attached hereto or as defined below. Schedule 1 (Index of Defined Terms) contains an index of terms that are defined in the body of the Agreement or in the attached Schedules, Exhibits, Attachments, Addenda and other documents attached hereto or thereto.

      1.1 “ Affiliate ” means, with respect to a Party, any person, corporation, partnership or other entity that directly or indirectly controls or is controlled by or is under common control with such Party. For purposes of this definition, the term “control” (including, with correlative meaning, the terms “controlled by” or “under common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of

the management and policies of such entity, whether by the ownership of fifty percent (50%) or more of the voting stock of such entity, or by contract or otherwise.

      1.2 “ Agreement ” means this Collaboration Agreement by and between the Parties, including all Schedules, Exhibits, Attachments, Addenda and other documents attached hereto or thereto or otherwise incorporated by reference, including the Purchase Transaction Documents when such Purchase Transaction Documents become effective in accordance with the Agreement or their respective terms.

      1.3 “ Ammonul ” means the pharmaceutical product marketed by Ucyclyd in the Promotion Territory pursuant to NDA 20-645 and any supplements thereto.

      1.4 “ Ammonul HE ” means any products containing sodium phenylacetate and sodium benzoate (including any salts, analogs, metabolites, prodrugs and other physical forms or derivatives of sodium phenylacetate or sodium benzoate) and all Improvements thereto.

      1.5 “ Assets ” means: (a) : (i) the NDAs and INDs, as applicable, for the Products, (ii) any NDAs resulting from Regulatory Approval of a Development Product in the Development Field under the Agreement, and (iii) any Regulatory Approvals for the Products in the Development Field or the On-Market Field (as the case may be) outside the United States, in each case together with all material documentation as reasonably determined by Ucyclyd and to the extent not already transferred to Hyperion pursuant to Section 5.4.2 (Development and Regulatory Program) ;

      (b) all Inventory;

      (c) the Developed Technology (including all of Ucyclyd’s and its Affiliates’ rights and interests in and to the Developed Patents);

      (d) the Product Technology (including all of Ucyclyd’s and its Affiliates’ rights and interests in and to the Product Patents);

      (e) the Assigned Agreements; and

      (f) any and all other assets identified in the Bill of Sale.

      1.6 “ Assigned Agreements ” means, to the extent any of the following are in effect as of the Closing and are assignable to Hyperion: (a) all Distribution Agreements; (b) all Manufacturing Agreements except for any such agreements to which **** (defined herein) is a party; and (c) the Brusilow License Agreement and the Summar Agreement.

      1.7 “ Brusilow Amendment ” that certain Settlement Agreement and First Amendment dated August 21, 2007, a copy of which is attached hereto as Exhibit 1-B (Brusilow License Agreement)

      1.8 “ Brusilow Intellectual Property ” means the Licensed Know-How and the Patent Rights as those terms are defined in the Brusilow License Agreement.

      1.9 “ Brusilow License Agreement ” means, collectively, the Brusilow Original Agreement and the Brusilow Amendment.

      1.10 “ Brusilow Original Agreement ” means that certain License Agreement, dated April 16, 1999, among Dr. Saul Brusilow, Brusilow Enterprises LLC, and Ucyclyd (as successor in interest to Medicis Pharmaceutical Corporation (“ Medicis ”)), a copy of which is attached hereto as Exhibit 1-A (Brusilow License Agreement) .

      1.11 “ Buphenyl ” means Buphenyl Powder and Buphenyl Tablets.

      1.12 “ Buphenyl Powder ” means the pharmaceutical product marketed by Ucyclyd in the Promotion Territory pursuant to NDA 20-573 and any supplements thereto.

      1.13 “ Buphenyl Tablets ” means the pharmaceutical products marketed by Ucyclyd in the Promotion Territory pursuant to NDA 20-572 and any supplements thereto.

      1.14 “ Business Day ” means a day on which banks are open for business in the State of Arizona.

      1.15 “ Change in Control ” means: (a) any merger, consolidation, business combination or sale of shares of stock other than in a direct issuance of shares of stock by Hyperion for fair value, that, if completed, will result in the stockholders of Hyperion prior to such transaction not having voting control of the surviving entity immediately after the transaction such that they, acting in concert with one another, could not elect a majority of the board of directors of the surviving entity; or (b) the sale, transfer, exchange or other disposition of all or substantially all of Hyperion’s assets or business relating to this Agreement (whether alone or in connection with a sale, transfer, exchange or other disposition of other assets or businesses of Hyperion). Notwithstanding the foregoing, Change in Control shall not include a financing transaction, either in the form of a private equity financing or public offering.

      1.16 “ Closing Date ” means the date on which the Closing occurs in accordance with Section 3.3 (Closing) of the Agreement.

      1.17 “ cGMP ” means: (a) all principles and guidelines of Current Good Manufacturing Practices (including any applicable guidance documents that have been issued (or may be issued in the future) by the FDA), as defined from time to time under the Act, as codified in 21 C.F.R. Parts 210, 211, et seq. and being currently utilized within the pharmaceutical industry to manufacture the applicable type of Product(s); and (b) the ICH guide Q7a “ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” as applied to investigational drugs (Section 19) and being currently utilized within the pharmaceutical industry to manufacture the applicable type of Product(s).

      1.18 “ Commercialization ”, “ Commercialize ” or “ Commercialized ” means all activities that are undertaken for a particular Product that relate to the commercial marketing and sale of such Product including pre-commercialization, advertising, education, planning, marketing, promotion, distribution, market and product support studies and Phase IV Trials.

      1.19 “ Commercially Reasonable Efforts ” means efforts and resources normally used by a company in the specialty pharmaceutical industry for a product owned by such company or to which it has rights, which is of similar market potential at a similar stage in its research and development or Commercialization, as the case may be, proprietary positioning or product life and taking into account its relative importance to that particular company. Without limiting the generality of the foregoing, with respect to the research and development of GT4P, Commercially Reasonable Efforts means, at a minimum, the level of effort required under the Brusilow License Agreement.

      1.20 “ Developed Know-How ” means: (a) any and all technical, scientific, regulatory, clinical, medical, marketing, sales, financial and business information and data, know-how, formulations, trade secrets, techniques, processes, ideas, concepts, designs, original works of authorship, enhancements, derivative works, adaptations, discoveries and unpatented inventions developed, conceived, reduced to practice, originated, prepared, learned, generated, obtained or made by or on behalf of a Party or its Affiliates on and after the Effective Date and relating to the Products or arising out of the Agreement, including all Development Plans, Development Reports, preclinical and clinical data, analytical and quality control data, stability data, studies and procedures, marketing studies, Promotional Materials, customer lists, distribution sources and any records described in Schedule 5. 2(b) (Audit and Record-Keeping Requirements) ; (b) any and all Improvements relating to any of the foregoing; and (c) any and all intellectual property rights in or to any of the foregoing. Developed Know-How does not include any of Manufacturing Know-How, Product Know-How and Licensed Know-How. For the avoidance of doubt, Improvements to any of the Products, Product Technology or the Brusilow Intellectual Property, in either case made by or on behalf of either Party on and after the Effective Date, shall be considered Developed Know-How. For clarity, intellectual property that Hyperion demonstrates was independently developed or acquired by or on behalf of Hyperion shall not be included in Developed Know-How.

      1.21 “ Developed Patents ” means any and all Patents arising out of the Developed Know-How.

      1.22 “ Developed Technology ” means Developed Know-How and Developed Patents.

      1.23 “ Development and Regulatory Program ” means the development activities (such as chemistry, manufacturing, and controls (“ CMC ”), pharmacology and toxicology work and clinical trials in preparation for Commercialization) with respect to any Development Product in order to obtain or maintain Regulatory Approvals in the Development Territory for use in the applicable Development Field.

      1.24 “ Development Field ” means: (a) with respect to GT4P, the treatment of UCD, HE and other forms of Hyperammonemia (individually or collectively) in humans; and (b) with respect to Ammonul HE, the treatment of HE in humans.

      1.25 “ Development Plan ” means the plan prepared by Hyperion pursuant to Section 2.2.4 (Development Plan) as amended from time to time during the Development Term in accordance with Section 2.2.4 (Development Plan) .

      1.26 “ Development Product INDs ” means: (a) with respect to Ammonul HE, IND 73-415; (b) with respect to GT4P for the treatment of UCD in humans, IND 73-480; and (c) any IND submitted to the FDA with respect to GT4P. For the avoidance of doubt, as of the Effective Date, except as set forth in subsection (b) , no other IND has been submitted by Ucyclyd or approved by the FDA with respect to GT4P.

      1.27 “ Development Products ” means, collectively: (a) GT4P; and (b) Ammonul HE.

      1.28 “ Development Term ” means the period commencing on the Effective Date and unless earlier terminated in accordance with the Agreement, ending on the Closing Date.

      1.29 “ Development Territory ” means the United States of America and all of its territories and possessions and subject to Section 2.2.3 (R&D Rights Outside of the Development Territory) , those countries outside the United States approved by the JSC.

      1.30 “ Distribution Agreements ” means the agreements identified on Schedule 1.30 (Distribution Agreements) .

      1.31 “ Domain Names ” means the domain names set forth on Schedule 1.31 (Domain Names) .

      1.32 “ Excluded Person ” means an Ineligible Person or a Person on an Exclusion List.

      1.33 “ Exclusion List(s) ” mean the then-current: (a) HHS/OIG List of Excluded Individuals/Entities (available through the Internet at http://www.oig.hhs.gov); (b) General Services Administration’s List of Parties Excluded from Federal Programs (available through the Internet at http://www.epls.gov); and (c) FDA Debarment List (available through the Internet at http://www.fda.gov/ora/compliance_ref/debar/).

      1.34 “ Exclusivity Agreement ” means that certain letter agreement by and between Ucyclyd and Hyperion dated March 14, 2007 and effective as of March 20, 2007, and as amended pursuant to that certain letter amendment dated June 8, 2007.

      1.35 “ Executive Sponsors ” means: (a) with respect to Hyperion, Hyperion’s Chief Executive Officer (or a designee); and (b) with respect to Ucyclyd, Executive Vice President of Product Development of Medicis (or a designee).

      1.36 “ Existing Confidentiality Agreement ” means the confidentiality agreement between Hyperion and Ucyclyd dated January 5, 2007.

      1.37 “ FAC ” means the internal review committee of Ucyclyd and its Affiliates for the review of promotional, training, marketing, sales and other related materials, including any successor thereto.

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

      1.39 “ Financial Commitments ” means the financial resources and commitments reflected in Section 11.5 (Hyperion’s Financial Resources) and Schedule 11.5 (Hyperion’s Financial Resources) and the documents referenced therein.

      1.40 “ GAAP ” means generally accepted accounting principles in effect in the United States at the applicable time. GAAP shall be applied by the Parties in a consistent manner.

      1.41 “ Generic Equivalent ” means, regardless of whether a product is considered generic, branded, private-labeled or otherwise, a product that: (a) contains the same active ingredient(s) as a Product; (b) is identical in strength, dosage form, and route of administration to such Product; and (c) is a Therapeutic Equivalent to such Product.

      1.42 “ Governmental Authority ” means any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of: (a) any government of any country; or (b) a federal, state, province, county, city or other political subdivision thereof.

      1.43 “ GT4P ” means any products containing glyceryl tri-(4phenylbutyrate) (including any analogs, metabolites, prodrugs, salts, isomers, enantiomers and other physical forms and derivatives thereof) and all Improvements thereto.

      1.44 “ GT4P Approval Date ” means the date of the written notification from the FDA approving the NDA for GT4P for the treatment of UCD or HE.

      1.45 “ HE ” means hepatic encephalopathy or hepatic encephalopathies.

      1.46 “ HSR Act ” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (15 U.S.C. § 18a), and the rules and regulations promulgated thereunder.

      1.47 “ Hyperammonemia ” means any clinically significant change in blood ammonia concentration, which includes, in any case, each of UCD and HE.

      1.48 “ Hyperion Marks ” means the trademarks as set forth on Schedule 1.48 (Hyperion Marks) , as may be amended by Hyperion from time to time.

      1.49 “ Hyperion Personnel ” means: (a) any individual that has an ownership interest of five percent (5%) or more of Hyperion; (b) all officers, directors, and employees of Hyperion; and (c) those employees of Hyperion’s contractors, subcontractors, representatives and agents who perform research, development, marketing, sales, pricing, promotion or government contracts on behalf of Hyperion, but excluding any preclinical researchers or clinical investigators. Notwithstanding the foregoing, with respect to an individual under subsection (a) that (i) acquires such ownership interest through public trading and (ii) who is considered Hyperion Personnel solely under subsection (a) , Hyperion shall use **** to obtain such individual’s compliance with those obligations under this Agreement that are applicable to Hyperion Personnel and if Hyperion has used **** but has failed to obtain compliance with those obligations under the Agreement, Hyperion will **** of such obligations.

      1.50 “ Improvements ” means any and all improvements, modifications, replacements or refinements, whether or not patentable, that may be conceived, made, generated, developed or reduced to practice by or on behalf of a Party or its Affiliates including modifications in size, package forms, dosage form or strength, methods for applying, methods for delivering or changes in excipients or actives.

      1.51 “ IND ” means an investigational new drug application submitted by a sponsor to the FDA, or to the extent applicable outside the United States, any other similar application submitted to the appropriate Regulatory Agency in a country or group of countries other than the United States, and any supplements or amendments to any of the foregoing.

      1.52 “ Ineligible Person ” means a Person who: (a) is currently excluded, debarred, suspended, or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or non-procurement programs; (b) has been convicted of a criminal offense that falls within the ambit of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible; or (c) is listed on an Exclusion List.

      1.53 “ Inventory ” or “ Inventories ” means the raw materials for, components of, works in progress of, firm orders for, inventory in transit of and inventory of the Products, including both clinical and commercial supply, that meet all relevant specifications and were manufactured in accordance with all Legal Requirements.

      1.54 Joint Steering Committee ” or “ JSC ” means the body organized and acting pursuant to Section 6.2 (Joint Steering Committee) of the Agreement.

      1.55 “ Legal Requirements ” means: (a) any applicable present and future national, state, local, foreign or similar laws whether under statute, rule, regulation, ordinance or otherwise; (b) applicable requirements under permits, orders, decrees, judgments or directives, and requirements of applicable Regulatory Agencies including cGMPs, the federal anti-kickback statute located at 42 U.S.C. § 1320, the PDM Act, and the Federal Food, Drug and Cosmetic Act; and (c) all regulations and other requirements of the applicable Regulatory Agencies.

      1.56 “ Licensed Know-How ” has the meaning set forth in the Brusilow License Agreement.

      1.57 “ Licensed Marks ” means: (a) the trademarks set forth on Schedule 1.57 (Licensed Marks ) and as may be updated from time to time by Ucyclyd upon written notice to Hyperion prior to the expiration of the Term; and (b) any new trademarks approved for use with the Products during the Term, but excluding Hyperion Marks.

      1.58 “ Lien ” means any mortgage, lien (including mechanics, warehousemen, laborers and landlords liens), pledge, hypothecation, charge, community property interest, equitable interest, security interest, preemptive right, right of first refusal or similar restriction or right, option, judgment or title defect.

      1.59 “ Losses ” means any and all liabilities, costs, damages, fines, fees, penalties, judgments, losses and expenses (including interest, court costs and reasonable fees of attorneys, accountants and other experts).

      1.60 “ Manufacturing Agreement(s) ” means the agreements identified on Schedule 1.60 (Manufacturing Agreements) .

      1.61 “ Manufacturing Know-How ” means any and all technical, scientific, regulatory, clinical, medical, marketing, sales, financial and business information and data, know-how, formulations, trade secrets, techniques, processes, ideas, concepts, designs, original works of authorship, enhancements, derivative works, adaptations, discoveries and unpatented inventions developed, conceived, reduced to practice, originated, prepared, learned, generated, obtained or made by or on behalf of a Party or its Affiliates necessary for the manufacture or supply of either or both of GT4P and Ammonul HE, including (a) any and all documentation, Drug Master Files (individually a “ DMF ” and collectively “ DMFs ”), protocols, manufacturing processes, starting materials, purification technologies and specifications for either or both of such Development Product and that are owned by Ucyclyd prior to the Effective Date or are developed, conceived, reduced to practice, originated, prepared, learned, generated, obtained or made by or on behalf of a Party or its Affiliates on and after the Effective Date and relating to the Products or arising out of the Agreement; (b) any and all Improvements relating to any of the foregoing and necessary or reasonably useful for the manufacture or supply of either or both of GT4P and Ammonul HE; and (c) any and all intellectual property rights in or to any of the foregoing. Notwithstanding the foregoing, Manufacturing Know-How does not include any method of treatment, packaging, drug delivery, composition, formulation or dosage unit of a Development Product, but does include any processes for manufacturing or supplying the method of treatment, packaging, drug delivery, composition, formulation or dosage unit of a Development Product. For clarity, intellectual property that Hyperion demonstrates was independently developed or acquired by or on behalf of Hyperion after the Closing shall not be included as Manufacturing Know-How.

      1.62 “ Manufacturing Patents ” means any and all Patents arising out of the Manufacturing Know-How. Manufacturing Patents do not include any of Developed Patents, Product Patents and Patent Rights.

      1.63 “ Manufacturing Technology ” means Manufacturing Patents and Manufacturing Know-How.

      1.64 “ Marketed Product(s) ” means Buphenyl and Ammonul in finished packaged form.

      1.65 “ NDA ” means any approved new drug application for the applicable Products and all supplements submitted pursuant to the requirements of the FDA.

      1.66 “ On-Market Field ” means: (a) the treatment of UCD; and (b) in the event that **** applies, with respect to Ammonul HE, the treatment of HE.

      1.67 “ Patent Rights ” has the meaning set forth in the Brusilow License Agreement.

      1.68 “ Patents ” means all: (a) U.S. issued patents (including re-examinations, reissues, renewals, and all extensions and term restorations), inventors’ certificates and foreign counterparts thereof; (b) pending applications for U.S. patents, including provisional applications, continuations, continuations-in-part, continued prosecution, divisional and

substitute applications; and (c) non-U.S. counterparts or equivalents of the foregoing in subsections (a) and (b) .

      1.69 “ PDM Act ” means the Prescription Drug Marketing Act of 1987, as amended from time to time, and any regulations promulgated thereunder.

      1.70 “ Person ” means any natural person, corporation, partnership, trust, joint venture, Governmental Authority or other entity or organization.

      1.71 “ Price Approval ” means, with respect to any country in which the price at which the applicable Products are to be sold must be approved by a Regulatory Agency for reimbursement or payment purposes, the receipt of approval by the applicable Regulatory Agency with respect to such price.

      1.72 “ Product Know-How ” means: (a) any and all technical, scientific, regulatory, clinical, medical, marketing, sales, financial and business information and data, know-how, formulations, trade secrets, techniques, processes, ideas, concepts, designs, original works of authorship, enhancements, derivative works, adaptations, discoveries and unpatented inventions developed, conceived, reduced to practice, originated, prepared, learned, generated, obtained or made by or on behalf of Ucyclyd and that: (i) are owned by Ucyclyd as of the Effective Date, or (ii) in licensed by Ucyclyd as of the Effective Date to the extent licensable or assignable to Hyperion but specifically excluding that which is separately licensed to Hyperion under this Agreement (e.g., Brusilow Intellectual Property); and (b) any and all intellectual property rights in or to any of the foregoing. Product Know-How does not include any of Licensed Know-How, Manufacturing Know-How and Developed Know-How.

      1.73 “ Product Patents ” means any and all Patents arising out of the Product Know-How. Product Patents do not include any of Developed Patents, Manufacturing Patents and Patent Rights.

      1.74 “ Product Technology ” means Product Patents and Product Know-How. Product Technology does not include Manufacturing Technology or Developed Technology.

      1.75 “ Products ” means, collectively, the Marketed Products and the Development Products.

      1.76 “ Promote ,” “ Promoting ” or “ Promotion ” means the act of marketing and promoting the Marketed Products in the Promotion Territory.

      1.77 “ Promotion Territory ” means: (a) the United States of America but excluding its territories and possessions such as the Commonwealth of Puerto Rico; or (b) in the event that **** applies, with respect to Ammonul HE, worldwide.

      1.78 “ Promotional Materials ” means any training materials, brochures, Website Content, materials displayed on electronic media (including internet, websites, DVD or audio) or other promotional items or materials that refer to a Product.

      1.79 “ Purchase Transaction ” means: (a) the purchase of all of Ucyclyd’s right, title and interest in and to the Assets; (b) complying with, and consummating the transactions and other obligations set forth in, Section 3.3 (Closing) ; and (c) obtaining the rights and assuming the obligations set forth in Section 3.4 (Transition at Closing) .

      1.80 “ Regulatory Agency ” means, with respect to the United States, the FDA, and, in the case of a country other than the United States, such other appropriate regulatory agency or authority with similar responsibilities.

      1.81 “ Regulatory Approval ” means the approval, license, registration or authorization of any federal, state or local Regulatory Agency, department, bureau or other governmental entity, necessary to lawfully manufacture, import, distribute, promote, sell and administer to humans the applicable Products for the indications permitted by the Agreement in a country or region, but shall not include Price Approval in any country.

      1.82 “ Regulatory Costs ” means all costs and expenses associated with any and all regulatory matters relating to the Products or the Development and Regulatory Program including: (a) filings made in connection with the Products with any Governmental Authority or Regulatory Agency and the fees associated therewith including any filing fees and fees pursuant to the Prescription Drug User Fee Act of 1992, as amended; and (b) any costs and expenses of consultants and legal advisors.

      1.83 “ Sales Forecast ” means a rolling forecast by Hyperion of the Incremental Units (as defined in Schedule 7 (Payment Obligations) ) demand for sales of the Marketed Products for the upcoming **** -period.

      1.84 “ Summar Agreement ” means the Agreement by and between Ucyclyd (as successor in interest to Medicis) and Dr. Marshall L. Summar, dated April 1, 2002.

      1.85 “ Tax ” or “ Taxes ” means all federal, state, local, foreign, and other net income, gross income, gross receipts, sales, use, ad valorem, transfer, franchise, profits, license, lease, service, service use, withholding, payroll, employment, excise, severance, stamp, occupation, premium, property, windfall profits, customs, duties, or other taxes, fees, assessments, or charges of any kind whatever, together with any interest and any penalties, additions to tax, or additional amounts with respect thereto, and the term “Tax” means any one of the foregoing Taxes.

      1.86 “ Therapeutic Equivalent ” has the meaning given to it by the FDA in the current edition of the “Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”) as may be amended from time to time.

      1.87 “ Third Party ” means any Person that is not a Party or an Affiliate of a Party.

      1.88 “ UCD ” means urea cycle disorder as defined on Marketed Products label.

      1.89 “ Ucyclyd’s Actual Knowledge ” means the actual knowledge of a particular fact or other matter being possessed as of the pertinent date by the President and Vice President,

Treasurer, of Ucyclyd and with respect to Section 10.2(i) and Section 10.2(j)(i) only, the President and Vice President, Treasurer, of Ucyclyd and **** , for Medicis and its Affiliates.

      1.90 “ Website Content ” means the content available at the Uniform Resource Locator associated with each Domain Name and any Promotional Materials available at any Uniform Resource Locator associated with each domain name owned by Hyperion, but excluding any Licensed Marks.

ARTICLE 2

PROMOTION AND DEVELOPMENT ACTIVITIES
DURING THE DEVELOPMENT TERM

      2.1 Promotion of Marketed Products During the Development Term .

           2.1.1 Promotion Rights and License .

                (a)  Subject to the terms and conditions of the Agreement, Ucyclyd hereby grants to Hyperion an exclusive (even as to Ucyclyd except as provided in subsections (b) and (d) below and Section 8.2.1 (Product Technology and Developed Technology) ), non-transferable (except as permitted by Section 16.14 (Assignment) ), non-sublicenseable license to Promote during the Development Term for use in the On-Market Field; provided that Hyperion shall have the right to exercise its rights and fulfill its obligations under this Section 2.1 (Promotion of Marketed Products During the Development Term) using contract sales and support personnel in accordance with Section 2.1. 3(b) (Sales Forces) below.

                (b)  Hyperion acknowledges and agrees that, in addition to the other rights of Ucyclyd under this Agreement, Ucyclyd shall have the right to Promote during the Development Term for use in the On-Market Field in accordance with the Promotion Plan (as defined in Section 2.1.2 below), and that the license granted to Hyperion under subsection (a) above is subject to such retained rights of Ucyclyd.

                (c)  During the Development Term, each Party shall exercise Commercially Reasonable Efforts to undertake all matters within the scope of that Party’s responsibility as set forth in the Promotion Plan. In considering matters with respect to the Promotion Plan, whether in its capacity as a member of the JSC or otherwise, representatives of the Parties shall act in good faith and deal fairly and equitably with each other, and further shall render decisions and take actions that in each case represent their best judgment as to how to best maximize the commercial potential and the underlying asset value of the Marketed Products in the Promotion Territory.

                (d)  In the event Hyperion fails to use Commercially Reasonable Efforts to Promote for **** or to comply with the terms of this Article 2 (Promotion and Development Activities During the Development Term) during the Development Term, Ucyclyd shall have the right to provide Hyperion with written notice asserting the specific basis for such alleged failure. Hyperion shall, within **** following receipt of such notice, either remedy the situation as stated in the notice to Ucyclyd’s reasonable satisfaction, or dispute such

alleged failure, which dispute shall be resolved pursuant to Article 15 (Dispute Resolution) below. If: (i) Hyperion does not dispute such assertion within such **** period and fails to remedy such alleged failure within such **** period; or (ii) Hyperion disputes such assertion but such dispute is resolved in Ucyclyd’s favor and Hyperion subsequently fails to remedy such alleged failure within **** of such resolution, then Ucyclyd shall have the right, at Ucyclyd’s sole option, to: (x) convert the license under subsection (a) above to a non-exclusive license; or (y) terminate the license granted to Hyperion and grant such rights to one or more Third Parties. In either case as described in subsection (x) or (y) above, Ucyclyd shall have the right to Promote without restriction and Hyperion’s rights with respect to the purchase of the Assets and the other transactions contemplated by Article 3 (Rights to Purchase Assets) shall not be affected by Ucyclyd’s exercise of such right; provided that, on and following the Closing, Hyperion assumes any and all of the obligations of Ucyclyd under any promotion agreements with Third Parties with respect to the Marketed Products in the Promotion Territory. If Hyperion disputes such alleged failure and such dispute is submitted to the dispute resolution process pursuant to Article 15 (Dispute Resolution) , then Ucyclyd shall have the right to withhold the Promotion Commission (as defined in Schedule 7 (Payment Obligations) ) payable to Hyperion pursuant to Section 7.3 (Promotion Commission) below during such dispute resolution period; provided that Ucyclyd shall deposit all such Commission into an interest-bearing escrow account for the benefit of Hyperion. If Hyperion is determined to have fulfilled its obligations as described under this Section 2.1.1 (Promotion Rights and License) in such dispute resolution proceeding, Ucyclyd shall promptly transfer the entire amount in such account to Hyperion (including interest accrued thereon). If Hyperion is determined not to have fulfilled its obligations as described under this Section 2.1.1 (Promotion Rights and License) in such dispute resolution proceeding, the entire amount in such account (including interest accrued thereon) shall be released to Ucyclyd for Ucyclyd to use as Ucyclyd deems in its sole discretion.

      2.1.2 Promotion Plan .

                (a)  The Parties shall, through the JSC, propose, develop and oversee the implementation of an annual plan for Promotion during the Development Term for use in the On-Market Field and proposed in accordance with the terms and conditions of this Section 2.1.2 (Promotion Plan) (the “ Promotion Plan ”). Hyperion shall have the primary responsibility for the development of the Promotion Plan and shall submit such Promotion Plan for approval by the JSC. Notwithstanding the foregoing, during the Development Term, each Promotion Plan shall be subject to final review and acceptance by Ucyclyd. During the Development Term, Hyperion shall not make any material change in the Promotion Plan without the prior written approval of the JSC and Ucyclyd. Each Promotion Plan, at a minimum, shall:

                     (i)  identify the primary means of Promotion by Hyperion during the period of the Development Term to which the Promotion Plan relates;

                     (ii)  specify the obligations of each Party with respect to each applicable activity within the Promotion Plan;

                     (iii)  specify the measures that Hyperion will take to ensure the activities of Hyperion and its respective representatives comply with the terms and conditions of the Agreement including the provisions under Section 5.2 (Compliance Program) ; and

                     (iv)  include the items specified on Schedule 2.1. 2(a) (Requirements for Promotion Plans) and such other items as may be agreed on by the JSC.

                (b)  The Promotion Plan for the remainder of calendar year 2007 (“ Initial Promotion Plan ”) shall be reviewed and approved by the JSC at the first meeting of the JSC and the Initial Promotion Plan approved by the JSC shall be subject to final review and acceptance by Ucyclyd, which such final review and acceptance shall not be unreasonably withheld, delayed or conditioned.

                (c)  During the Development Term, Hyperion shall submit a Promotion Plan for each subsequent calendar year to the JSC on or before **** of the then-current calendar year for approval by the JSC promptly, but no later than **** of such then-current calendar year. Each such Promotion Plan shall be consistent with the applicable provisions of this Section 2.1.2 (Promotion Plan) .

           2.1.3 Promotion Activities .

                (a) General . Following approval of the Hyperion Compliance Program as described in Section 5.2 (Compliance Program) and following approval of the Initial Promotion Plan by the JSC and Ucyclyd as described in Section 2.1. 2(b) (Promotion Plan) and during the Development Term, Hyperion shall Promote for use only in the On-Market Field in accordance with the following:

                     (i)  Within **** following the approval of the: (A) Hyperion Compliance Program as described in Section 5.2 (Compliance Program) and (B) Initial Promotion Plan as described in Section 2.1.2(b) (Promotion Plan) , all Hyperion Personnel shall have concluded training in accordance with Section 2.1. 3(c) (Training) and Hyperion shall commence Promotion in accordance with the Promotion Plan.

                     (ii)  Hyperion shall: (A) support the Promotion through qualified supervisory staff; (B) not use any Person to Promote except for Hyperion Personnel who have undertaken training in accordance with Section 2.1. 3(c) (Training) ; and (C) shall conduct its Promotion activities using at least the number of Territory Business Managers described in Section 2.1. 3(b) (Sales Forces) .

                     (iii)  Hyperion shall only use a Person to Promote if such Person has agreed to perform in accordance with the Hyperion Compliance Program and all applicable Legal Requirements.

                     (iv)  Hyperion shall Promote for use in the On-Market Field in accordance with: (i) the terms of the Agreement; (ii) the then-current Promotion Plan for the Marketed Products; (iii) all applicable Legal Requirements; and (iv) the Hyperion Compliance Program.

                     (v)  For the avoidance of doubt, Hyperion shall not commence Promotion until the Hyperion Compliance Program has been approved pursuant to Section 5.2 (Compliance Program) and the Initial Promotion Plan has been approved pursuant to Section 2.1. 2(b) (Promotion Plan) .

                (b) Sales Forces .

                     (i)  During the Development Term, Hyperion shall maintain a sales force (including sales management) and supervisory staffs for the Marketed Products in the Promotion Territory sufficient to perform its obligations under the Agreement. Without limiting the generality of the foregoing, no later than **** following the later of: (A) approval of the Promotion Plan as set forth in Section 2.1. 2(b) (Promotion Plan) ; and (B) approval of the Hyperion Compliance Program as set forth in Section 5.2 (Compliance Program) , and in addition to Hyperion’s other obligations under the Promotion Plan and the Agreement, Hyperion shall: (X) hire and train a minimum of **** sales representatives or **** full-time equivalent employees (collectively, “ Territory Business Managers ” or “ TBMs ”) to increase the education, awareness and sales of the Marketed Products; (Y) hire a Director of Reimbursement, Managed Care and Distribution to oversee managed health care and distribution and work to optimize reimbursement and distribution of the Marketed Products; and (Z) hire a Vice President of Sales and a Product Manager focused on the market related to the treatment of UCD.

                     (ii)  All Hyperion personnel and TBMs hired pursuant to Section 2.1. 3(b)(i) (Sales Forces) above shall have documented experience for the promotion of pharmaceutical products. All Hyperion supervisory staff hired pursuant to Section 2.1. 3(b)(i) (Sales Forces) above shall have documented experience for the supervision of promotion of pharmaceutical products.

                     (iii)  Upon written notice to the other Party, each Party shall have the right to use the services of a contract sales force ( i.e ., a Third Party whose primary business is devoted to promoting Third Party products) to assist such Party in satisfying its respective Promotion obligations under the Agreement; provided that each such Third Party agrees to comply with the Hyperion Compliance Program and the terms and conditions of Section 5.2 (Compliance Program) .

                (c) Training .

                     (i)  Hyperion shall train all Hyperion Personnel to comply with: (A) the requirements of Section 2.1.2 (Promotion Plan) ; and (B) the Hyperion Compliance Program, including the proper methods of Promoting in accordance with Federal health care program and FDA requirements as well as all other Legal Requirements. Such training shall include: (X) at least **** of initial training as required by Ucyclyd; (Y) additional compliance training as required by the Hyperion Compliance Program; and (Z) such additional training as designated by a representative of Ucyclyd’s compliance officer (“ Chief Compliance Officer of Medicis ”). In addition to approval of the Hyperion Compliance Program as set forth in Section 5.2 (Compliance Program) , any and all training materials related to the Products to be used by Hyperion must be approved by FAC prior to any such use and any and all training

materials related to general compliance to be used by Hyperion must be approved by the Chief Compliance Officer of Medicis prior to any such use.

                     (ii)  Each individual who is required to receive training shall certify, in writing, or in electronic form, if applicable, that he or she has received the required training. The certification shall specify the type of training received and the date received. The Hyperion Compliance Officer (or designee) (defined in Section 5.1 (General Compliance) ) shall retain the certifications, along with all course materials, and shall make all of the foregoing available to Ucyclyd upon request.

                     (iii)  Persons providing the training shall be knowledgeable about the subject area, including the applicable Federal health care program and FDA requirements as well as all other Legal Requirements.

                     (iv)  Hyperion shall review, and shall permit Ucyclyd to review, the training annually and, where appropriate, update the training to reflect: (A) changes in Federal health care program and FDA requirements as well as all other Legal Requirements; (B) any issues discovered during internal audits or any review by Regulatory Agencies; and (C) any other relevant information.

                     (v)  Hyperion shall pay all of its own costs and expenses associated with training and re-training Hyperion Personnel including the training of any new hires in accordance with the Promotion Plan, all Legal Requirements and the Hyperion Compliance Program.

                (d) Use of Marks in Connection with the Marketed Products during Development Term . During Development Term, Ucyclyd shall not have the obligation to place on, or affix to, the Marketed Products (including any labeling, packaging or package inserts) the Hyperion Marks. Hyperion shall have the right to display Hyperion Marks on all Promotional Materials subject to the terms set forth in Sections 5.5 (Labeling and Promotional Materials) and 8.3.4 (Use of Hyperion Marks and Licensed Marks) .

           2.1.4 Supply and Distribution of the Marketed Products .

                (a) Orders and Terms of Sale . During the Development Term, Ucyclyd shall have the sole responsibility to: (i) receive, accept and fill orders for the Marketed Products; (ii) process invoicing, order processing and collection of accounts receivable for Marketed Product sales based on demand and in accordance with GAAP; and (iii) record Marketed Products sales in Ucyclyd’s books of account in a manner consistent with its standard practices, and in any event in accordance with GAAP. During the Development Term, Ucyclyd may decide in its sole discretion on any changes to the commercial terms and conditions with respect to the sale and distribution of Marketed Products, including matters such as the price at which the Marketed Products will be sold and whether any discounts, rebates or other deductions should be made, paid or allowed. Ucyclyd shall inform Hyperion in advance of material changes to the commercial terms and conditions with respect to the sale and distribution of Marketed Products, including the price at which the Marketed Products will be sold, and, upon Hyperion’s request, which shall be no later than **** prior to the change becoming effective, provide

Hyperion an opportunity to discuss such changes; provided that following the FDA’s acceptance of Hyperion’s filing of the NDA for a Development Product, without Hyperion’s prior written approval, which approval shall not be unreasonably withheld, delayed or conditioned, Ucyclyd shall not (i) increase the price of the Marketed Product corresponding to such Development Product or (ii) make changes to Ucyclyd’s practices with respect to discounts, rebates or other deductions that are not consistent with Ucyclyd’s past practices.

                (b) Forecasting .

                     (i)  Within **** after the later of: (A) approval of the Promotion Plan as set forth in Section 2.1. 2(b) (Promotion Plan) ; and (B) approval of the Hyperion Compliance Program as set forth in Section 5.2 (Compliance Program) , Hyperion shall provide Ucyclyd with the initial Sales Forecast for the **** period commencing upon the date of such Sales Forecast (the “ Initial Sales Forecast ”). Thereafter, during the Development Term, on or before the first Business Day of each month, Hyperion shall provide to Ucyclyd a monthly updated rolling Sales Forecast for the subsequent **** period.

                     (ii)  With respect to the Initial Sales Forecast and each such rolling Sales Forecast, Ucyclyd shall be entitled to rely upon the first **** as firm (the “ Firm Forecast ”). Hyperion shall be responsible for the accuracy of each such Firm Forecast and shall reimburse Ucyclyd for the cost of any and all of the Marketed Product that was made by or on behalf of Ucyclyd based on such Sales Forecast and was not sold on or before the expiration of the shelf life of such Marketed Product determined in accordance with the then-current Ucyclyd returns and disposal policy, which such policy shall be provided to Hyperion, promptly following Hyperion’s request.

                (c) Misdirected Orders . During the Development Term, if, for any reason, Hyperion receives orders for Marketed Products, Hyperion shall forward such orders to Ucyclyd (or if directed by Ucyclyd to Ucyclyd’s wholesalers) as soon as practicable.

                (d) Product Returns . During the Development Term, if any quantities of the Marketed Products are returned to Hyperion, Hyperion shall notify Ucyclyd immediately and ship them to the facility designated by Ucyclyd. Hyperion, at its option, may advise the customer who made the return that the Marketed Products have been returned to Ucyclyd, but shall take no other steps in respect of any return without the prior written consent of Ucyclyd.

                (e) Supply of the Marketed Products . During the Development Term:

                     (i)  Ucyclyd shall use Commercially Reasonable Efforts to manufacture or have manufactured and supply Marketed Products in a consistent fashion and in sufficient quantities to meet the forecasted amounts of Marketed Products in accordance with the then-current Promotion Plan and the Sales Forecast. The Parties shall keep each other timely apprised of the status and any potential delay with respect to the supply of the Marketed Products. Notwithstanding the foregoing, Hyperion acknowledges that Ucyclyd is in the process

of transferring the manufacture of Ammonul from one Third Party manufacturer to another due to the closure of the manufacturing facilities of the existing Third Party manufacturer, and there are certain risks of continuous supply or the ability to meet Sales Forecasts. Ucyclyd shall provide Hyperion with a draft of such new Third Party manufacturing agreement reasonably in advance of its execution for Hyperion to review and comment. Hyperion shall provide comments to such draft within **** following delivery of such draft and Ucyclyd shall consider in good faith but shall not be required to include Hyperion’s comments to such draft. Ucyclyd shall obtain rights under all Third Party manufacturing agreements entered into after the Effective Date to assign such agreements to Hyperion without the consent of such manufacturers, and such agreements shall be deemed a Manufacturing Agreement to be transferred to Hyperion upon Closing. Hyperion agrees not to hold Ucyclyd liable with respect to any inability or shortage solely to the extent attributable to any change of manufacturer, and Ucyclyd agrees not to hold Hyperion liable with respect to any failure to perform its obligations under the Agreement as a result of such inability or shortage of supply.

                     (ii)  Ucyclyd shall promptly advise Hyperion, in writing, if supply will not be available to satisfy any Sales Forecast or if any significant distribution disruptions occur at any time, the estimated duration of the disruption and any resulting shortfall, and Ucyclyd’s undertakings aimed at remedying such shortfall in a timely manner. Promptly after Hyperion’s receipt of such notification, Ucyclyd shall discuss with Hyperion, through the JSC or otherwise, a plan and timeline to remedy such shortfall and adjusting any Sales Forecast, in which case Ucyclyd shall use Commercially Reasonable Efforts to remedy any such shortfall in accordance with such plan.

                     (iii)  At any time after the Effective Date, Hyperion shall have the right to qualify an alternative manufacturer that shall be reasonably acceptable to Ucyclyd. Hyperion may provide a list of such manufacturers to Ucyclyd within **** following the Effective Date and Ucyclyd shall notify Hyperion within **** following Ucyclyd’s receipt of such list whether such manufacturers are acceptable to Ucyclyd. With respect to any qualification hereunder: (A) Hyperion shall be responsible solely for qualifying such alternate manufacturer; (B) Hyperion shall pay all related costs, including all fees associated with obtaining any approvals in accordance with any Legal Requirements; (C) Ucyclyd shall establish with such manufacturer, at Hyperion’s sole cost and expense, the applicable DMFs containing the relevant Manufacturing Technology and, if required for purposes of qualifying and manufacturing the Marketed Products, the Product Technology and such manufacturer shall have a limited, non-transferable (except as permitted by Section 16.14 (Assignment) ) right of reference to such DMFs solely for purposes of manufacturing and supplying the affected Marketed Product to Hyperion; and (D) Hyperion shall not otherwise attempt to develop a separate DMF with such alternate manufacturer.

                     (iv)  Only in the event that Ucyclyd is unable to meet the requirements of a Firm Forecast for a Marketed Product for a period of **** for reasons other than due to a Force Majeure event, Hyperion shall have the right to have the affected Marketed Product manufactured by a Third Party alternate manufacturer who shall be qualified in accordance with the requirements set forth in subsection (iii) above. As soon as Ucyclyd has adequately remedied the deficiencies giving rise to the exercise of the right by Hyperion

hereunder, Ucyclyd shall have the right to resume manufacturing and supply of the affected Marketed Products and Hyperion shall cease manufacturing or having manufactured the Marketed Products.  In the event Hyperion exercises its right to supply the affected Marketed Product under this subsection (iv) , the Parties agree to cooperate with respect to any required filings under applicable Legal Requirements related to any such change in manufacturing and supply.

           2.1.5 Expansion of Promotion Territory .

                (a)  From time to time during the Development Term, the Parties may consider the expansion of the Promotion Territory into other countries or territories. Any request for such expansion will be submitted to the JSC for review and prior written approval. Hyperion shall submit a written proposal for expansion into the applicable country or territory, which proposal will address, at a minimum: (i) the Promotion activities expected of each Party in such country or territory including how Promotion will be handled in such country or territory ( e.g ., by employees of a Party, a contract sales force, etc.); (ii) the Regulatory Approvals required in such country or territory and any other barriers to entry in such country or territory; (iii) the anticipated costs and expenses or other investment by each Party with respect to Promotion and supply efforts in such country or territory; (iv) the impact, if any, on the calculation of the Commission; (v) the other criteria for the Promotion Plan; (vi) how expansion into such country or territory will increase the opportunities for both Parties and not adversely impact Promotion activities in the then-current Promotion Territory; and (vii) the consideration to be paid to either Party with respect to the expanded country or territory.

                (b)  The JSC shall submit a final proposal to Ucyclyd for final approval in Ucyclyd’s sole discretion. If approved by Ucyclyd, the proposal shall become part of the then-current Promotion Plan and the Promotion Territory shall be deemed expanded to include such country or territory without any requirement for a written amendment to the Agreement.

                (c)  Notwithstanding the foregoing, Hyperion acknowledges and agrees that the foregoing shall not require Ucyclyd to terminate, not renew or not enter into, any agreements providing rights to Third Parties relating to the distribution, promotion, marketing or sale of the Marketed Products outside of the then-current Promotion Territory. Ucyclyd shall not share any information related to information by Hyperion or the JSC provided pursuant to this Section 2.1.5 (Expansion of Promotion Territory) with a Third Party without the prior written consent of Hyperion. With respect to any agreements providing rights to Third Parties relating to the distribution, promotion, marketing or sale of the Marketed Products outside of the then-current Promotion Territory to be entered into following the Effective Date (not including any renewals of agreements in effect as of the Effective Date), Ucyclyd shall provide Hyperion with drafts of any such agreements prior to its execution for Hyperion to review and comment, and Ucyclyd shall consider such comments in good faith; provided, however, the incorporation of Hyperion’s comments into such draft shall be in Ucyclyd’s sole discretion. Such agreements shall be deemed Distribution Agreements to be transferred (if assignable) to Hyperion upon Closing.

                (d)  Hyperion acknowledges and agrees that Ucyclyd does not make (and shall not make) any representations or warranties of any kind with respect to Promotion or

other activities outside of the United States and that to the extent Ucyclyd approves expansion of the Promotion Territory, Hyperion’s activities outside the United States shall be at Hyperion’s sole cost, expense and risk. Except as expressly agreed in writing by the Parties, if Ucyclyd approves expansion of the Promotion Territory to include territories or countries outside the United States (“ New Territories ”), Ucyclyd and its Affiliates shall: (A) have no liability whatsoever to Hyperion with respect to activities, Regulatory Approvals or Price Approvals in the New Territory; (B) shall not be obligated to defend, indemnify, or hold harmless any Hyperion Indemnitee with respect to any of the foregoing; and (C) not Promote the Marketed Products in such New Territories.

           2.1.6 Exclusion or Prohibition Affecting Sales of Marketed Product . In the event that: (a) a Marketed Product is excluded from reimbursement from a Federal health care program of the United States or a Governmental Authority prohibits the sale of a Marketed Product within its labeling, in each case caused by the failure of Ucyclyd or one of its Affiliates to comply with **** applicable Legal Requirement (and not as a result of an act or omission by Hyperion, its Affiliates or their respective employees, contractors, agents, representatives or sublicensees); and (b) Hyperion: (i) had previously achieved its Sales Forecast for at least **** prior to such prohibition; or (ii) demonstrates to Ucyclyd’s reasonable satisfaction that any decrease in unit sales of the Marketed Products is directly attributable to such exclusion or prohibition; then for the duration of such exclusion or prohibition and until the earlier of: (x) the reinstatement of the Marketed Product in the applicable Federal health care program, or the termination of the prohibition, as the case may be; and (y) the expiration or termination of the Development Term, Ucyclyd will pay Hyperion an amount equal to **** . Such Commission will be paid in accordance with the payment terms set forth in Section 4 (Promotion Commission) of Schedule 7 (Payment Obligations) . In the event that the duration of the exclusion or prohibition is less than a full Commission Period, any payment due by Ucyclyd to Hyperion will be prorated for such partial Commission Period. Hyperion acknowledges and agrees that payment of the Commission as set forth in this Section shall be Hyperion’s sole and exclusive remedy and the sole and exclusive liability of Ucyclyd and its Affiliates to Hyperion for any failure of Ucyclyd or one of its Affiliates to comply with the CIA or applicable Legal Requirements with respect to Marketed Products. In the event that Ucyclyd grants rights to Hyperion as set forth in Section 2.1.5 (Expansion of Promotion Territory) , the calculation of payments hereunder shall apply only to the United States but excluding its territories and possessions such as the Commonwealth of Puerto Rico.

      2.2 Research and Development during the Development Term .

           2.2.1 R&D Rights with Respect to Development Products . Subject to the terms and conditions of the Agreement, during the Development Term, Hyperion shall have responsibility for, and shall use Commercially Reasonable Efforts to perform and conduct, the Development and Regulatory Program with the goal of obtaining Regulatory Approvals in the Development Territory for use of the Development Products in the Development Field in accordance with the Development Plan. Without limiting the generality of the foregoing, Hyperion acknowledges and agrees that the primary focus of its efforts under the Development and Regulatory Program shall be to obtain Regulatory Approval first in the United States for **** in **** . Notwithstanding the foregoing, Ucyclyd acknowledges that the current

Development Plan contemplates that GT4P in UCD and HE and Ammonul HE for the treatment of HE shall be developed concurrently and that FDA approval of **** for the treatment of **** may occur prior to **** in **** . Accordingly, as long as Hyperion has complied with its obligations under Section 2.2 (Research and Development during the Development Term) with respect to obtaining Regulatory Approval for **** in **** in the United States and has performed development for **** in accordance with the Development Plan, then such Regulatory Approval of **** shall not be considered a breach of the prioritization of efforts specified in this Section 2.2.1 (R&D Rights with Respect to Development Products) .

           2.2.2 R&D Rights Outside of the Development Field .

                (a)  Subject to Section 2.2.1 (R&D Rights with Respect to the Development Products) , during the Development Term, Hyperion may develop the Development Products for uses outside of the Development Field only with the prior written consent of Ucyclyd, which consent Ucyclyd shall have the right to withhold in its sole discretion; provided, however, that investigator sponsored activities or investigator sponsored use of the Development Products outside of the Development Field will be reviewed and approved by the JSC.

                (b)  Hyperion acknowledges that, under the Distribution Agreements, Ucyclyd has granted Third Parties certain rights with respect to development of the Products for uses outside of the Development Field. During the Development Term, Ucyclyd agrees not to grant: (i) such Third Parties any rights for additional uses outside the Territory; and (ii) any other Third Party any right to research or develop any Product for uses outside the Development Field without the prior written consent of Hyperion.

           2.2.3 R&D Rights Outside of the United States .

                (a)  Hyperion acknowledges that, under the Distribution Agreements, Ucyclyd has granted Third Parties certain rights with respect to research and development of the Products outside of the United States (the “ Pre-existing Rights ”). During the Development Term, Hyperion shall have the right to conduct research and development activities outside of the United States in support of Hyperion’s efforts to obtain Regulatory Approval in the United States, except in those jurisdictions where such research and development efforts would conflict with the rights granted to Third Parties pursuant to the Pre-existing Rights.

                (b)  Subject to any Pre-existing Rights, during the Development Term, Hyperion shall have the right to propose to the JSC research and development activities outside of the United States in connection with obtaining Regulatory Approval for the Development Products outside of the United States. Ucyclyd shall advise Hyperion whether the conduct of any such activities would conflict with any rights granted to Third Parties that are in addition to the Pre-existing Rights. To the extent such proposed activities do not conflict with any Third Party rights, Hyperion shall have the right to perform such proposed activities. In the event that Hyperion conducts any research and development activities outside of the United States as permitted in this Section, Hyperion shall coordinate all such activities with Ucyclyd through the JSC during the Development Term.

           2.2.4 Development Plan .

                (a)  Hyperion shall establish a Development Plan for the conduct of the Development and Regulatory Program. The Development Plan shall include: (i) a description of the activities to be conducted by each Party from the Effective Date during the Development Term; (ii) a Development Plan budget for such period; and (iii) an estimated timeline for the performance of activities thereunder. The draft Development Plan is attached hereto as Schedule 2.2.4 (Development Plan) and such draft Development Plan shall be reviewed and approved at the first meeting of the JSC; provided, however, until such meeting, Hyperion may conduct activities in accordance with the draft Development Plan.

                (b)  On an annual basis, the JSC shall review the Development Plan and recommend any amendment, and any changes to the Development Plan shall be subject to the approval of the JSC. The JSC may, from time to time include additional activities to the Development Plan, in response to any request or input from the FDA or otherwise (the “ Additional Activities ”), and if so, the JSC also shall adjust the timelines in the Development Plan that are affected by such inclusion to allow the appropriate time for the completion of such Additional Activities (the “ Additional Period ”).

           2.2.5 Research and Development Diligence .

                (a)  Hyperion shall use Commercially Reasonable Efforts to pursue, perform, develop and fund the Development and Regulatory Program in compliance with: (i) the terms and conditions of the Agreement; (ii) the Development Plan; (iii) all applicable good laboratory practices and applicable cGMP requirements; (iv) all applicable Legal Requirements of each country where the Development and Regulatory Program is conducted; and (v) the terms and conditions under the Brusilow License Agreement with regard to the research and development of GT4P. With respect to the research and development of GT4P, in the event of a conflict between the terms and conditions of the Agreement and those under the Brusilow License Agreement, then the terms and conditions of the Brusilow License Agreement shall govern; provided, however, that the foregoing shall not be construed to expand the rights granted to Hyperion under the Agreement.

                (b)  Hyperion shall, on a quarterly basis, submit to the JSC, two (2) written reports describing Hyperion’s progress with respect to the research and development for each Development Product since the date of the previous written reports (each, a “ Development Report ”). The first report will describe such progress with respect to **** for **** (as applicable) and the second report will describe such progress with respect to **** for the treatment of **** (as applicable). Hyperion shall consider in good faith any comments that Ucyclyd may have with respect to any such Development Report. Ucyclyd shall have the right to disclose any reports with respect to GT4P for UCD, HE and any Other Indications, or any parts thereof, to the licensors or their representatives, agents or consultants under the Brusilow License Agreement (collectively, the “ Brusilow Licensors ”).

                (c)  The Development Plan sets forth the expected time frames for the completion of the Development and Regulatory Program. The Parties recognize, however, that despite their efforts to anticipate both the likely scope of such clinical development activities and

their likely cost, there may be delays, cost overruns and increased costs due to factors beyond the reasonable control of Hyperion; provided that Hyperion uses reasonable precautionary measure or reasonable alternative measures to address such scenario, such as additional development activities not included in the Development and Regulatory Program. The Parties agree that such delay shall not automatically be deemed Hyperion’s breach of its diligence obligations under this Section 2.2.5 (Research and Development Diligence) .

           2.2.6 Transition of Development and Regulatory Program to Hyperion .

                (a)  On and following the Effective Date, Hyperion shall be solely responsible for the Development and Regulatory Program except that Ucyclyd shall use Commercially Reasonable Efforts to complete the activities described in Schedule 2.2. 6(a) (Close-Out Activities) (“ Close-Out Activities ”). Hyperion acknowledges and agrees that the work product or deliverables resulting from such Close-Out Activities shall be provided on an AS-IS/WHEREAS basis without any representations or warranties of any kind, express or implied.

                (b)  Promptly following the Effective Date, Ucyclyd and Hyperion will cooperate to transition to Hyperion the work being performed or to be performed under those agreements set forth on Schedule 2.2. 6(b) (R&D Agreements) (“ R&D Agreements ”). Such transition shall include pursuing a novation of the R&D Agreements with Hyperion assuming the obligations under the R&D Agreements except to the extent of any obligations (together with all potential and actual claims and liabilities from any party under such R&D Agreements resulting therefrom) that Ucyclyd or its Affiliates were required to perform, but failed to perform, prior to the effective date of such novation. To the extent that Ucyclyd is unable to secure a novation under an R&D Agreement but Ucyclyd otherwise has the right to assign the applicable R&D Agreement to Hyperion, Ucyclyd shall assign such R&D Agreement to Hyperion with Hyperion assuming the obligations under the R&D Agreements except to the extent of any obligations (together with all potential and actual claims and liabilities from any party under such R&D Agreements resulting therefrom) that Ucyclyd or its Affiliates were required to perform, but failed to perform, prior to the effective date of such assignment. To the extent that the applicable Third Party does not consent to an assignment and Hyperion desires to continue such work, the Parties shall cooperate to pursue alternatives pursuant to which the work will be continued, it being the intent of the Parties that Hyperion (and not Ucyclyd) shall be responsible for continuing all such work.

                (c)  Hyperion acknowledges and agrees that, as of the Effective Date, Ucyclyd has not completed negotiation of the agreements set forth on Schedule 2.2. 6(c) (Pending R&D Agreements) . Hyperion desires that Ucyclyd introduce Hyperion to the applicable Third Parties under such agreements and reasonably cooperate with Hyperion to transition negotiation of such agreement to Hyperion.

                (d)  In the event that the Agreement is terminated prior to Closing for any reason other than as a result of a material breach of the Agreement by Ucyclyd, Hyperion hereby assigns, and Ucyclyd hereby assumes, all of the rights, duties and obligations of Hyperion that existed under the agreements referenced in this Section 2.2.6 (Transition of Development

and Regulatory Program to Hyperion) except to the extent of any obligations that Hyperion was required to perform under the R&D Agreements, but failed to perform.

           2.2.7 Development Costs . Hyperion shall pay any and all costs and expenses related to the performance of the Development and Regulatory Program and obtaining the Regulatory Approvals in the Development Territory, including any cost overruns and increased costs arising in connection with completing those development activities included in the Development and Regulatory Program or incurred in connection with any Additional Activities. Hyperion shall not be required to pay those costs and expenses incurred by Ucyclyd in preparing or maintaining any DMFs for the Products or any costs or expenses for which Ucyclyd is responsible under the express terms and conditions of the Clinical Supply Agreement.

           2.2.8 Information Exchange .

                (a)  Pursuant to the Exclusivity Agreement and the Existing Confidentiality Agreement between the Parties, Ucyclyd has disclosed to Hyperion, prior to the Effective Date, information pertaining to the Development and Regulatory Program that is necessary or reasonably useful for Hyperion to evaluate such Development and Regulatory Program. Hyperion has reviewed all such information thoroughly and has knowingly assumed the responsibility for the Development and Regulatory Program as required under the Agreement and the Brusilow License Agreement.

                (b)  Upon Ucyclyd’s request, Hyperion shall discuss with representatives of Ucyclyd and Brusilow Licensors Hyperion’s progress toward first commercial sale of GT4P. During the Development Term, without the prior written consent of Ucyclyd, Hyperion shall not disclose the Development Report to **** , or discuss with **** any matter relating to the Development of GT4P under this Agreement. During the Development Term, (i) each Party shall have the right to use the Product Technology, Developed Technology or Manufacturing Technology to the extent necessary for such Party to perform its obligations under this Agreement, including the Development Plan, and (ii) neither Party shall have the right to use such Product Technology, Developed Technology or Manufacturing Technology for any other purpose nor to disclose such Product Technology, Developed Technology or Manufacturing Technology to any Third Party, except with the prior written consent of the other Party or as expressly permitted under this Agreement.

           2.2.9 Approval of **** Prior to Closing . In the event that an NDA for **** for the treatment of **** in humans is approved by the FDA during the Development Term on and following such approval:

                (a)  subject to the terms and conditions of the Agreement and provided that Hyperion is otherwise in compliance with the terms and conditions of the Agreement at the time of such approval, Ucyclyd hereby grants to Hyperion an exclusive (even as to Ucyclyd except as provided in subsections (b) and (d) of Section 2.1.1 (Promotion Rights and License) ), non-transferable, sublicenseable, royalty-bearing, worldwide (subject to any previously granted rights set forth in the agreements listed on Schedule 10.2 (Ucyclyd

Disclosure Schedule) ) license to promote, market, sell, offer for sale, use, import, make or have made, and distribute **** for the applicable On-Market Field;

                (b)  until the earlier of: (i) the Closing, and (ii) the expiration or termination of the Term, with respect to **** , Hyperion shall have the sole responsibility to:

                         (A) receive, accept and fill orders;

                         (B) process invoicing, order processing and collection of accounts receivable for sales based on demand and in accordance with GAAP; and

                         (C) record sales and calculate Net Sales in Hyperion’s books of account in a manner consistent with its standard practices, and in any event in accordance with GAAP.

                (c)  subject to Section 8.2.2 (Manufacturing Technology; Drug Master Files) , Hyperion shall be responsible for procuring commercial supplies of **** ;

                (d)  Ucyclyd shall transfer all raw materials or components thereof within specification, work in process and usable Inventory of **** existing or ordered as of the date of approval to Hyperion or a location designated by Hyperion within **** following the approval and Hyperion shall pay to Ucyclyd an amount equal to Ucyclyd’s actual costs for the foregoing following delivery or receipt of title, as the case may be; provided, however, to the extent that any orders are cancellable by Ucyclyd without penalty or liability to Ucyclyd and Hyperion requests such cancellation, Ucyclyd shall cancel the applicable order.

                (e)  sales of **** sold prior to the approval date of **** will remain the responsibility of Ucyclyd;

                (f)  Hyperion shall determine the overall pricing strategy for **** ;

                (g)  during each calendar quarter, Hyperion shall pay to Ucyclyd an amount equal to **** ;

                (h)  Hyperion shall reimburse Ucyclyd for any applicable payment due under the Summar Agreement (defined on Schedule 7 (Payment Obligations) ) in accordance with Schedule 7 (Payment Obligations) ; and

                (i)  the Parties agree to cooperate with respect to the transition of the obligations described in this Section 2.2.9 (Approval of **** Prior to Closing) and to negotiate in good faith a transition services agreement to effectuate such transition, which agreement will include reasonable compensation to Ucyclyd for providing the transition services described therein.

           2.2.10 Termination Based on Failure to File NDA .

                (a)  During the Development Term, Ucyclyd, at its sole option, shall have the right to terminate the Development and Regulatory Program and the Term of the Agreement at any time after **** following the Transition Date if Hyperion has failed to obtain acceptance from the FDA of the filing for the NDA for **** for the treatment of **** , unless Hyperion is excused from such performance pursuant to subsection (b) below. “ Transition Date ” shall mean the date upon which Ucyclyd fulfills its obligations to deliver copies of NDAs, INDs, regulatory correspondence and periodic and other reports filed with regulatory agencies (including serious adverse events (“ SAEs ”), alert reports and any adverse event reports and the underlying data) and clinical data in connection with the Development Products.

                (b)  If, despite Hyperion’s exercise of Commercially Reasonable Efforts, there is no longer a reasonable scientific or medical basis on which to file an NDA for **** for the treatment of **** , Hyperion shall deliver to Ucyclyd written notice specifying in detail the basis(es) for such claims. If Ucyclyd agrees with Hyperion’s conclusion in such claims, then the Parties will present such claims to **** pursuant to subsection (c) below. If Ucyclyd does not agree with such conclusion, then such claims shall be submitted to an independent Third Party acceptable to both Parties for independent review, with each Party bearing half the costs of such review. If the independent Third Party supports Hyperion’s conclusion in such claims, then the Parties will present such claims to **** pursuant to subsection (c) below. In the event such independent Third Party does not support Hyperion’s conclusion in such claims, then Hyperion may elect within **** following the date of the decision of the independent Third Party: (i) to resume the **** portion of the Development and Regulatory Program, or (ii) not to resume the **** portion of the Development and Regulatory Program, in which case, Ucyclyd shall have the right to terminate immediately this Agreement.

                (c)  In the event that the Parties present claims to **** as set forth in subsection (b) above, the Parties shall cooperate to present such claims to **** . In the event **** do not dispute such claims and such claims relate only to **** (i.e., the Development and Regulatory Program can continue with respect to **** for the treatment of **** ), then Hyperion shall be required to continue its obligations under this Agreement with respect to the research and development of **** . In the event **** dispute such claims, the matter will be submitted for resolution in accordance with the dispute resolution procedures set forth in **** . Any such dispute shall be the responsibility of Hyperion and Hyperion shall defend, indemnify and hold the Ucyclyd Indemnitees harmless with respect to such dispute pursuant to Section 14.2.2 (Indemnification by Hyperion) and Ucyclyd will provide reasonable cooperation in connection therewith, at Hyperion’s sole cost and expense.

                (d)  In the event: (i) Hyperion, Ucyclyd and **** have agreed in writing or any dispute resolution among the Parties and **** has confirmed that there is no longer a reasonable scientific or medical basis on which to file NDAs for **** for **** pursuant to subsection (b ) above; or (ii) **** have not notified Ucyclyd of any dispute within

**** following presentation of the claims to **** pursuant to subsection (c) above, whichever of subsections (i) and (ii) occurs earlier, then Hyperion shall have the right to consummate the Purchase Transaction in accordance with Section 3.1(c) (Purchase Rights) .

                (e)  During the Development Term, if Hyperion was excused from filing an NDA for **** for the treatment of **** , but not excused from filing an NDA for **** for the treatment of **** pursuant to subsection (a) above and Hyperion does not receive Regulatory Approval of an NDA for **** for **** in the United States within **** following the Transition Date, then Ucyclyd, at its sole option, shall have the right to terminate the Term of this Agreement thereafter upon **** written notice to Hyperion.

                (f)  Ucyclyd’s right to terminate under subsections (a) or (e) above shall be tolled by: (i) any applicable Additional Period pursuant to Section 2.2. 4(b) (Development Plan) ; (ii) any period of delay that is outside Hyperion’s reasonable control ( e.g. , delay due to limitation in the supply of the applicable Development Product(s), patient enrollment, safety or efficacy concerns or regulatory requirements); provided that Hyperion has used reasonable efforts to minimize such delay and notified Ucyclyd in writing of the delay and the basis therefor promptly after the event giving rise to the delay; and (iii) the period of time commencing on the date Ucyclyd receives from Hyperion the notice under subsection (b) and continuing until the resolution of all disputes under this Section 2.2.10 (Termination Based on Failure to File NDA) . The Parties further agree that the time periods in subsections (a) and (e) are based on certain assumptions specified in the Development Plan. The Parties will discuss in good faith adjustments to subsections (a) and (e) to the extent such time periods are materially affected as a result of the cumulative impact of any changes in such assumptions.

           2.2.11 Supply of Development Products during Development Term.

                (a)  During the Development Term, Hyperion shall be responsible for procuring clinical supplies of GT4P using Ucyclyd’s existing supplier **** . Hyperion shall be responsible for establishing its own direct supply arrangement with **** with respect to such clinical supplies. Ucyclyd shall maintain and not otherwise materially amend the DMF in a manner that would reasonably be expected to affect the supply or cost of supply to Hyperion from **** without prior consultation with Hyperion and considering in good faith Hyperion’s comments during such consultation. Promptly after the Effective Date, Ucyclyd shall provide to Hyperion Ucyclyd’s usable Inventory of GT4P existing as of the Effective Date. Hyperion shall pay Ucyclyd’s actual cost for the amount of usable Inventory of GT4P transferred where “usable Inventory” is determined according to the Development Plan.

                (b)  During the Development Term, Ucyclyd shall be responsible for procuring clinical supplies of Ammonul HE for Hyperion in a manner consistent with Hyperion’s demands for such Development Products under the Development Plan, and the Parties shall cooperate to develop a process and plan for the manufacture and delivery of such clinical supply under a separate agreement (“ Clinical Supply Agreement ”). Such Clinical Supply Agreement shall contain customary provisions including forecast and supply, return and acceptance, product warranty, remedy in the event of shortfall and manufacturing compliance,

and shall provide that such clinical supply shall be provided to Hyperion: (i) with at least **** of shelf life; and (ii) at a purchase price equal to **** . Stability and testing will be reimbursed by Hyperion to Ucyclyd separately in accordance with the terms and conditions of the Clinical Supply Agreement.

                (c)  Subject to Section 2.2.9 (Approval of **** Prior to Closing) , to the extent requested by Hyperion, during the Development Term, the Parties also shall cooperate to develop a process and plan for manufacturing inventory of the applicable Development Product in preparation for first commercial sale of such Development Product following approval from the FDA.

           2.2.12 Visit of Facilities .

                (a)  Except as otherwise expressly set forth in the Agreement, during the Development Term, Hyperion shall permit Ucyclyd and its representatives to visit its, its Affiliates or subcontractor’s facilities where any activities with respect to the Development and Regulatory Program are being conducted once per calendar year upon reasonable notice and at reasonably acceptable times, provided that Ucyclyd shall have the right to conduct additional visit(s) during the same calendar year: (i) in order to confirm correction of any deficiency or problem identified during an earlier visit upon reasonable notice and at reasonably acceptable times; (ii) as requested by a Governmental Authority or Regulatory Agency; or (iii) as reasonably necessary to ensure Hyperion’s compliance with Hyperion Compliance Program and all Legal Requirements. Any costs and expenses associated with the visits contemplated by this Section 2.2.12 (Visit of Facilities) shall be borne by Ucyclyd.

                (b)  To the extent Ucyclyd is authorized to permit Hyperion to do so under Ucyclyd’s agreements with the applicable manufacturers and suppliers, Hyperion shall have the right to visit, once per calendar year upon reasonable notice and at reasonably acceptable times, the manufacturing facilities where the Development Products are manufactured, filled and finished to the extent allowed by such facilities; provided that Hyperion shall have the right to conduct additional visit(s) during the same calendar year: (i) in order to confirm correction of any deficiency or problem identified during an earlier visit upon reasonable notice and at reasonably acceptable times; or (ii) as requested by a Governmental Authority or Regulatory Agency. Notwithstanding the foregoing, either Party shall be apprised of and have the right to visit or participate in any inspection by a Regulatory Agency at any such manufacturing facility

                (c)  Both Parties shall have the right to be present at any such visit that occurs as set forth in subsections (a) or (b) above.

      2.3 Use of Contractors .

           2.3.1 Right to Engage Subcontractors . Hyperion shall have the right to engage subcontractors to perform any portion of its obligations under this Article 2 (Promotion and Development Activities During the Development Term) ; provided that (i) Hyperion shall provide to Ucyclyd and any Governmental Authority or Regulatory Agency with any information reasonably requested by Ucyclyd or such Governmental Authority or Regulatory

Agency with respect to each such subcontractor; and (ii) any subcontractor engaged in the Promotion of the Marketed Products shall be subject to the prior written approval of the JSC. For the avoidance of doubt, approval of the JSC shall not be required in the event Hyperion engages subcontractors to carry out the preclinical and clinical testing, studies, monitoring and laboratory work, conduct of clinical trials, data management, or other activities under the Development and Regulatory Program. During the Development Term, on or before the anniversary of the Effective Date, Hyperion shall provide to the Chief Compliance Officer of Medicis a complete list of all subcontractors used or then-currently being used by Hyperion with respect to the Promotion of the Marketed Products and in the conduct of the activities under the Development and Regulatory Program.

      2.3.2 Subcontracting Agreements .

                (a)  Hyperion shall be responsible for ensuring that, prior to any such use, any subcontractor is subject to a written agreement that: (i) contains terms and conditions substantially similar to the applicable terms and conditions of the Agreement protecting the rights of the Parties under the Agreement, including obligations of confidentiality on each such subcontractor being no less protective than those obligations of Hyperion under this Agreement applicable to the type of work to be conducted by such subcontractor; (ii) vests ownership of any and all Developed Technology and Manufacturing Technology developed by such subcontractor during the Development Term in the course of performing such subcontracted work in Ucyclyd;; and (iii) contains no payment obligations or liability on Ucyclyd without the prior written consent of Ucyclyd (except for those that arise following the assignment of such agreement pursuant to subsection (b) below).

                (b)  In addition to the requirements under subsection (a) above, Hyperion shall use commercially reasonable efforts to ensure that any such written agreement permits the assignment of such written agreement during the Development Term to Ucyclyd, its Affiliates or any clinical research organization engaged by Ucyclyd or its Affiliates without prior written consent of such subcontractor.

                (c)  Hyperion shall ensure that subcontractors who perform, or are reasonably expected to perform, work related to the Products for more than **** during any calendar year undertake the training and any other requirements of Hyperion Personnel under this Agreement.

           2.3.3 Replacement of Subcontractors . If the use of any subcontractor by Hyperion is not in compliance with any of the material terms and conditions of the Agreement, then Ucyclyd has the right to notify Hyperion in writing of such non-compliance. To the extent the subcontractor is not in compliance with a Compliance Requirement, Hyperion and such subcontractor shall have the right to cure such non-compliance in accordance with the terms of Section 5.11 (Compliance Deficiencies) . With respect to any other non-compliance, Hyperion and such subcontractor shall have **** to cure such non-compliance by the subcontractor. If the subcontractor does not become compliant in accordance with the foregoing provisions, then Ucyclyd shall have the right to require Hyperion to cease use of such subcontractor immediately. The foregoing provisions are not intended to limit the rights of Ucyclyd under Section 12.2 (Termination Rights) .

ARTICLE 3

RIGHTS TO PURCHASE ASSETS

      3.1 Purchase Rights . Subject to the terms and conditions of the Agreement, including payment by Hyperion of any amounts due to Ucyclyd as of the relevant date:

                (a)  Following the GT4P Approval Date, Hyperion shall consummate the Purchase Transaction;

                (b)  If, following the FDA’s acceptance of Hyperion’s filing of the NDA for GT4P in UCD, the FDA issues a not approvable letter (as defined pursuant to 21 C.F.R. § 314.125 or as such definition may be amended from time to time in such regulations) with respect to such filing, then for a period of **** following the date Hyperion receives such letter from the FDA, Hyperion shall have the option (“ Purchase Option #1 ”), exercisable by written notice to Ucyclyd, to consummate the Purchase Transaction. The notice from Hyperion to Ucyclyd shall include a copy of the not approvable letter from the FDA; or

                (c)  If it has been determined in accordance with Section 2.2.10 (Termination Based on Failure to File NDA) that there is no longer a reasonable scientific or medical basis on which to file NDAs for **** for **** , for a period of **** following such final determination, Hyperion shall have the option (“ Purchase Option #2 ”), exercisable by written notice to Ucyclyd, to consummate the Purchase Transaction; provided, however, despite the exercise of the Purchase Option #2, the Closing of the Purchase Transaction shall not occur prior to the date that is the later of: (i) **** following the Effective Date, and (ii) **** following the date of the final determination under Section 2.2.10 (Termination Based on Failure to File NDA) (“ Purchase Option #2 End Date ”). For the avoidance of doubt, once Hyperion has exercised Purchase Option #2, Hyperion shall be required to consummate the Purchase Transaction even if the Closing occurs at a later date.

                (d)  If Hyperion has the right to exercise Purchase Option #1 or Purchase Option #2 set forth in subsection (b) or (c) above and fails to exercise either of the Purchase Options, then the Term of the Agreement shall terminate in accordance with Section 12. 2(d) (Termination Rights) .

      3.2 Purchase Price .

                (a)  If the Purchase Transaction is consummated pursuant to Section 3. 1(a) (Purchase Rights) above, then Hyperion shall pay Ucyclyd an aggregate total purchase price of **** Dollars ($ **** ) (“ Purchase Price ”).

                (b)  If the Purchase Transaction is consummated pursuant to Section 3. 1(b) (Purchase Rights) above, then Hyperion shall pay Ucyclyd an aggregate total purchase price in an amount equal to **** (“ Purchase Option Price #1 ”); provided, however: (i) **** ; and (ii) **** .

                (c)  If the Purchase Transaction is consummated pursuant to Section 3. 1(c) (Purchase Rights) above, then Hyperion shall pay Ucyclyd an aggregate total purchase price in an amount equal to **** (“ Purchase Option Price #2 ”).

      3.3 Closing .

           3.3.1 Account for Purchase Payment . Ucyclyd shall designate an account for the receipt of the Purchase Price, Purchase Option Price #1 or Purchase Option Price #2, as the case may be, and provide Hyperion with written wire instructions to such account no less than **** prior to the Closing Date.

           3.3.2 Closing . The Parties will mutually agree upon a closing date (the “ Closing Date ”), which shall occur not later than **** following, as applicable: (a) the GT4P Approval Date, (b) Hyperion’s exercise of the Purchase Option #1 or (c) the Purchase Option #2 End Date. On the Closing Date:

                (a)  Hyperion shall make the payment of the Purchase Price, Purchase Option Price #1 or the Purchase Option Price #2, as the case may be, via wire transfer in immediately available funds to such account.

                (b)  The Parties shall execute and deliver all documents set forth below (the “ Purchase Transaction Documents ”), under which Ucyclyd shall sell, transfer, assign and convey all Assets to Hyperion:

                     (i)  a Bill of Sale in the form attached to the Agreement as Exhibit 4 (Bill of Sale) , under which Ucyclyd transfers the ownership of certain Assets (including all Inventories) to Hyperion, which shall be signed by both Ucyclyd and Hyperion;

                     (ii)  a Technology Assignment Agreement in the form attached to the Agreement as Exhibit 5 (Technology Assignment Agreement), under which Ucyclyd shall assign all Product Technology and Developed Technology to Hyperion, which shall be signed by Ucyclyd; and

                     (iii)  an Assignment and Assumption Agreement of all Assigned Agreements in the form attached to the Agreement as Exhibit 6 (Assignment and Assumption Agreement) , which shall be countersigned by Ucyclyd and accompanied by all consents required from the applicable Third Parties to such Assigned Agreements to Hyperion as attachments to such Assignment and Assumption Agreement.

           3.3.3 Delay of Closing Date . In the event that Hyperion has not initiated the wire transfer to Ucyclyd for the Purchase Price, Purchase Option Price #1 or Purchase Option Price #2 at the end of the Closing Date, Ucyclyd shall have the right in its sole discretion to delay the Closing Date until: (a) such time as Hyperion has received the wire transfer of such payment; or (b) such earlier time determined by Ucyclyd as confirmed by Ucyclyd in writing to Hyperion.

           3.3.4 HSR Act Clearance .

                (a)  Prior to and as a condition to the Closing, each of Ucyclyd and Hyperion shall file or supply, or cause to be filed or supplied, all notifications and information required to be filed or supplied pursuant to the HSR Act in connection with the transaction contemplated by the Agreement subject to the Parties cooperating to maintain the confidentiality of any such information. Each of Ucyclyd and Hyperion shall furnish to the other such necessary information and reasonable assistance as the other may request in connection with its preparation of any filing or submission which is necessary under the HSR Act. As promptly as practicable, Ucyclyd and Hyperion shall make, or cause to be made, all such other filings and submissions under laws, rules and regulations applicable to them, or to their Affiliates, as may be required for them to consummate the transaction contemplated hereby in accordance with the terms of the Agreement. Ucyclyd and Hyperion shall keep one another appraised of the status of any communications with, and inquiries or requests for additional information from, any Governmental Authority, including the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice, and shall comply promptly with any such inquiry or request. Each Party shall pay its costs and expenses associated with all filing fees under the HSR Act.

                (b)  Hyperion shall: (i) determine the fair market value of the transaction described in the Agreement for HSR Act purposes; (ii) communicate in writing to Ucyclyd the fair market value determination no later than the Effective Date; and (iii) discuss with counsel of Ucyclyd the methodology and evidence Hyperion employed in making such determination not later than the Closing. Each Party shall for its own costs in completing and making any required filings pursuant to subsections (a) and (b) .

                (c)  Each of Ucyclyd and Hyperion shall use commercially reasonable efforts to resolve any objections that may be asserted by a Governmental Authority (including the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice) with respect to the transaction contemplated hereby, and shall cooperate with each other to contest any challenges to the transactions contemplated hereby by any such Governmental Authority. The Parties agree to cooperate and to use their respective commercially reasonable efforts to obtain any government clearances or approvals required under the HSR Act, to respond to any government requests for information under the HSR Act, and to contest and resist any action, including any legislative, administrative or judicial action, and to have vacated, lifted, reversed or overturned any decree, judgment, injunction or other order (whether temporary, preliminary or permanent) that restricts, prevents or prohibits the consummation of the transaction contemplated by the Agreement under the HSR Act or which is otherwise required to consummate the transactions contemplated by the Agreement. Hyperion shall pay the reasonable costs and expenses incurred by Ucyclyd, including attorneys’ fees, in connection with efforts to contest, resist, vacate, lift, reverse or overturn any such decree, judgment, injunction or other order.

                (d)  Notwithstanding the foregoing, in the event a Governmental Authority (including the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice) challenges the transaction on antitrust grounds, and the challenge cannot be resolved by consent decree, the Parties may terminate the Term of the Agreement pursuant to Section 12.2(c) (Termination Rights) .

                (e)  In any event, Closing shall not occur unless and until the expiration or early termination of the waiting period for the HSR Act.

      3.4 Transition at Closing . To the extent the Parties identify activities not covered in this Section 3.4 (Transition at Closing) or otherwise in the Agreement that are to be conducted by the Parties in connection with the transition of the Assets to Hyperion following the Closing, the Parties agree to negotiate in good faith a transition services agreement no later than **** prior to the expected Closing Date.

           3.4.1 Regulatory Filings and Clinical Data . Subject to applicable Regulatory Approvals, Ucyclyd shall, as soon as permissible following the Closing Date, transfer ownership of any NDAs and INDs (including any Development Product INDs) related to the Products to Hyperion and all other regulatory requirements in accordance with the Transition Services Agreement. Within **** following the Closing Date, to the extent not previously provided, Ucyclyd will forward to Hyperion copies of the applicable NDAs, INDs, copies of regulatory correspondence and periodic and other reports (including SAEs, alert reports, and any adverse event reports and the underlying data) with the FDA and all clinical data in connection with the Products in Ucyclyd’s possession.

           3.4.2 Inventories . At Closing, Ucyclyd shall transfer to Hyperion, and Hyperion shall pay Ucyclyd, for all Inventory available not to exceed the quantity that Hyperion is reasonably expected to sell based on the then current Sales Forecast and Ucyclyd’s sales forecasts. Notwithstanding the foregoing, the Inventory transferred to Hyperion hereunder shall include all minimum production runs and any overages based on any changes in the Sales Forecast by Hyperion. Hyperion shall pay Ucyclyd’s actual costs (FOB shipping point) of such transferred Inventory, and Ucyclyd shall fill emergency orders from or transfer all such Inventories to Hyperion or a location designated by Hyperion within **** after the Closing Date.

           3.4.3 Technology Transfer . Ucyclyd shall transfer to Hyperion all Product Know-How not already in Hyperion’s possession at the time of Closing pursuant to the Transition Services Agreement. For the avoidance of doubt, Ucyclyd shall not transfer ownership of any DMF to Hyperion.

           3.4.4 Post-Closing Application of Corporate Integrity Agreement . Hyperion acknowledges that Medicis and its Affiliates are subject to the Corporate Integrity Agreement, attached hereto as Exhibit 2 (Corporate Integrity Agreement) (“ CIA ”). Following the Closing, Hyperion shall have the right to seek guidance from the Office of the Inspector General (“ OIG ”) as to the ongoing applicability of the CIA to Hyperion and the purchased Products with the prior written approval of Ucyclyd and the Chief Compliance Officer of Medicis, Hyperion may seek to obtain such guidance in preparation for Closing but only if an event giving rise to Closing has occurred. Hyperion shall coordinate with Ucyclyd and the Chief Compliance Officer of Medicis prior to seeking any such guidance from the OIG, and the Parties will discuss in good faith: (a) Hyperion’s approach to seeking any such guidance from the OIG; and (b) its potential impact on Ucyclyd and its Affiliates’ relationship with OIG. Ucyclyd shall cooperate reasonably with Hyperion in seeking such guidance from OIG including participating in any

meeting with, or presentation to, OIG; provided that Ucyclyd does not deem any such cooperation to be detrimental to the relationship that Ucyclyd or its Affiliates have with OIG. Hyperion shall provide Ucyclyd promptly with a copy of any correspondence between Hyperion and the OIG. Notwithstanding the foregoing, the Closing shall not be delayed nor Hyperion excused from, consummating the purchase on the basis: (x) that Hyperion has received no guidance or other response from the OIG; or (y) of the content of any guidance from the OIG.

           3.4.5 Accounts Receivables .

                (a)  In the event that following the Closing Date, Ucyclyd or its Affiliates receive any payment relating to any accounts receivable relating to the Assets or the Products that accrued following the Closing Date, such payment will be the property of, and will be promptly forwarded and remitted to, Hyperion. Ucyclyd or its Affiliates will endorse and deliver to Hyperion any cash, checks or other documents received by Ucyclyd or its Affiliates on account of any such accounts receivable and will advise Hyperion of any counterclaims or set-offs that may arise subsequent to the Closing Date with respect to such accounts receivable.

                (b)  In the event that following the Closing Date, Hyperion or its Affiliates receive any payment relating to any accounts receivable that accrued prior to the Closing Date, such payment will be the property of, and will be immediately forwarded and remitted to, Ucyclyd. Hyperion or its Affiliates will promptly endorse and deliver to Ucyclyd any cash, checks or other documents received by Hyperion or its Affiliates on account of any such accounts receivable and will advise Ucyclyd of any counterclaims or set-offs that may arise with respect to such accounts receivable.

ARTICLE 4

RIGHTS AND OBLIGATIONS OF THE PARTIES
AFTER CLOSING

      4.1 Rights to Commercialize Product .

           4.1.1 Exclusive Commercialization Rights . Subject to the terms and conditions of this Agreement, on and following Closing, Hyperion shall have the sole and exclusive rights (even as to Ucyclyd) to Commercialize all Products for any and all indications (including any and all indications in the field of Hyperammonemia) which rights shall include the worldwide manufacture and supply of Products for use in all such Commercialization activities, provided that Hyperion complies with the terms and conditions set forth in Section 8.2.2 (Manufacturing Technology; Drug Master Files) regarding the manufacture and supply of Products. Hyperion shall be solely responsible for all costs and expenses in the Commercialization of Products including the supply and manufacture thereof.

           4.1.2 Commercial Diligence . If a Development Product achieves Regulatory Approval in a particular territory, Hyperion shall use Commercially Reasonable Efforts to maximize the sales in such territory. Ucyclyd acknowledges that Hyperion may use distributors to fulfill its obligations under this Section. If Ucyclyd believes that Hyperion is not complying with the provisions of this Article 4 (Rights and Obligations of the Parties After Closing) ,

then Ucyclyd may submit the matter for resolution under the provisions of Article 15 (Dispute Resolution) .

           4.1.3 Commercialization Efforts Reporting . Hyperion shall keep Ucyclyd informed about Hyperion’s efforts to Commercialize the Development Products, including semi-annual written summaries of Hyperion’s marketing plans (as updated), and developments in the Commercialization of the Development Products (each, a “ Marketing Report ”).

           4.1.4 Pricing, Pricing Approvals and Product Distribution . Hyperion shall determine the overall pricing strategy for all Products on and following Closing. Hyperion shall obtain such Product Price Approvals as may be required and arrange for distribution of each Product in each applicable country.

           4.1.5 Sales and Inventory . On and following Closing, Hyperion shall be responsible for booking sales, stocking inventory and collecting accounts receivable.

           4.1.6 Labeling and Promotional Materials . On and following Closing:

                (a)  Hyperion may, at any time, develop and use Promotional Materials for the Products; provided that all Promotional Materials bearing a Licensed Mark (including the Domain Names and the telephone number 1-888-UCYCLYD (or 1-888-829-2593) (“ 1-888 Phone Number ”)) shall be subject to the terms and conditions of this Agreement and shall comply with all applicable Legal Requirements; and

                (b)  Hyperion shall have the sole authority and responsibility to seek and obtain any necessary FDA approvals of any label, labeling, package inserts and packaging, and Promotional Materials used in connection with the Marketed Products and for determining whether the same requires FDA submission or approval.

      4.2 Rights to Develop Products .

           4.2.1 Continued Rights under the Development and Regulatory Program . On and following Closing, Hyperion shall use Commercially Reasonable Efforts to carry out the activities contemplated under the Development and Regulatory Program pursuant to the Development Plan solely at its expense.

           4.2.2 Rights to Develop Products for Other Indications Worldwide . Subject to Section 4.2.1 (Continued Rights under the Development and Regulatory Program) , on and following Closing, Hyperion shall have the sole right, but not the obligation (subject to the terms below), to conduct development activities with respect to the Products for any and all indications in any country or territory in the world solely at its expenses; provided that Hyperion shall keep Ucyclyd informed on an annual basis of its plans and efforts for such development activities.

ARTICLE 5

REGULATORY AND COMPLIANCE MATTERS

      5.1 General Compliance .

                (a)  Each Party shall comply, in all material respects, with all Legal Requirements applicable to it and its activities under the Agreement.

                (b)  Each Party shall Promote and otherwise perform its obligations under the Agreement in compliance with all Federal health care program and FDA requirements, including the Federal anti-kickback statute, 42 U.S.C. § 1320a-7b(b) and all other Legal Requirements. Hyperion shall ensure that all Hyperion Personnel comply with all Federal health care program and FDA requirements, including the Federal anti-kickback statute, 42 U.S.C. §1320a-7b(b) and all other Legal Requirements.

                (c)  Hyperion shall not Promote nor disseminate information about off-label uses of the Marketed Products except as permitted by applicable FDA policies or court decisions and only by the prior written approval of Ucyclyd, which approval through FAC shall be deemed such approval of Ucyclyd. Hyperion shall implement, as part of the Hyperion Compliance Program, a policy addressing the appropriate handling of unsolicited requests and dissemination of information about non-FDA approved uses of the Products (off-label information). This policy shall provide, among other things, that Hyperion shall not directly or indirectly solicit, encourage, or promote unapproved uses of a Product to physicians, pharmacists or other health care professionals.

                (d)  During the Development Term, Hyperion shall designate an employee who shall serve as its compliance officer (“ Hyperion Compliance Officer ”). The Hyperion Compliance Officer shall: (i) be a member of senior management; (ii) be responsible for developing and implementing policies, procedures and practices designed to ensure compliance with all Legal Requirements, any Federal health care program and FDA requirements with respect to the Marketed Products as well as the Hyperion Compliance Program; (iii) be responsible for monitoring the day-to-day compliance activities in which Hyperion and Hyperion Personnel engage as well as for any reporting obligations under the Agreement including the Hyperion Compliance Program; (iv) be available to meet and discuss with the Chief Compliance Officer of Medicis periodically, but no less than monthly, and in-person upon Ucyclyd’s request, the implementation and operation of the Hyperion Compliance Program and any issues arising thereunder, and during such meeting the Hyperion Compliance Officer will provide the Chief Compliance Officer of Medicis access to any written materials related to such implementation and operation; and (v) make quarterly written reports regarding compliance matters to the JSC, copies of which reports shall be provided to the Chief Compliance Officer of Medicis. Hyperion shall notify Ucyclyd in writing immediately (but no later than **** following any such change) of any changes in the identity or position description of the Hyperion Compliance Officer. At no time during the Development Term shall Hyperion leave vacant the position of Hyperion Compliance Officer.

                (e)  During the Development Term, the Chief Compliance Officer of Medicis and the Hyperion Compliance Officer shall use commercially reasonable efforts to cooperate and in a timely manner coordinate efforts to facilitate the performance of each Party’s regulatory and compliance obligations pursuant to the Agreement, including efforts to: (i) review and approve of the Hyperion Compliance Program and general compliance training materials with a mutually acceptable time frame; and (ii) identify, schedule and complete (or have completed) the training required by Ucyclyd pursuant to Section 2.1. 3(c)(i) (Training) .

                (f)  During the Development Term, Ucyclyd shall, within **** after discovery, notify the Hyperion Compliance Officer, in writing, of any enforcement action (including any warning letter, notice of violation, or untitled letter from FDA), any audit request or inquiry, any ongoing investigation or legal proceeding known to Ucyclyd conducted or brought by a Governmental Entity, a Regulatory Agency or their agents or representatives involving an allegation that Ucyclyd or its contractors has violated or otherwise failed to comply with any law or regulation applicable to any Legal Requirement, Federal health care program or any FDA requirements relating to the Marketed Products.

                (g)  During the Development Term, within **** after discovery, Hyperion shall notify the Chief Compliance Officer of Medicis, in writing, of any enforcement action (including any warning letter, notice of violation, or untitled letter from FDA), any audit request or inquiry, any ongoing investigation or legal proceeding known to Hyperion conducted or brought by a Governmental Entity, a Regulatory Agency or their agents or representatives involving an allegation that Hyperion or Hyperion Personnel have violated or otherwise failed to comply with any Legal Requirement, Federal health care program or any FDA requirements.

                (h)  During the Development Term, within **** after discovery, Ucyclyd shall notify the Hyperion Compliance Officer, in writing, of any enforcement action (including any warning letter, notice of violation, or untitled letter from FDA), any audit request or inquiry, any ongoing investigation or legal proceeding known to Ucyclyd conducted or brought by a Governmental Entity, a Regulatory Agency or their agents or representatives involving an allegation that Ucyclyd has violated or otherwise failed to comply with any Legal Requirement, Federal health care program or any FDA requirements related to the Products. Any notification under subsections (e) or (f) above shall include a description of the allegation, the identity of the Government Entity or Regulatory Agency, and the status of such enforcement action, audit request or inquiry, investigation or legal proceeding.

                (i)  During the Development Term, and thereafter to the extent arising from activities prior to Closing, Ucyclyd shall have the right to control, in its sole discretion, any response regarding any alleged violation or other failure to comply with any Legal Requirements, Federal health care program or applicable FDA requirements related to the Products and will make good faith efforts to consider Hyperion’s input. During the Development Term, each Party also shall provide written notice to the Hyperion Compliance Officer or Chief Compliance Officer of Medicis, as the case may be, within **** following the resolution of the matters described in subsection (e) and (f), as the case may be, and shall provide the Hyperion Compliance Officer or Chief Compliance Officer of Medicis, as the case may be, with a description of the findings or results of the investigation or proceedings, if any.

                (j)  Following Closing, except to the extent arising from activities prior to Closing Hyperion shall have the responsibility to respond regarding any such alleged violation or other failure to comply with any Legal Requirements, Federal health care program or applicable FDA requirements related to the Products; provided that Hyperion shall cooperate with Ucyclyd regarding any such response to any such alleged violation or other failure to comply that may be attributed to activities during the Development Term.

      5.2 Compliance Program .

                (a)  Hyperion agrees to, and shall be responsible to ensure that Hyperion Personnel comply with all of the terms and conditions of Hyperion’s compliance program (“ Hyperion Compliance Program ”). The Hyperion Compliance Program and any revisions thereto shall be drafted by Hyperion. Hyperion shall obtain the prior written approval of, the Chief Compliance Officer of Medicis for the Hyperion Compliance Program and any revisions thereto. The terms and conditions under such Hyperion Compliance Program, at a minimum, shall comply with all terms and conditions of any compliance program of Medicis and its Affiliates, as such terms and conditions may be updated from time to time upon written notice to Hyperion from Ucyclyd or one of its Affiliates, in which event, to the extent such update is not then currently addressed in the Hyperion Compliance Program, Hyperion shall update its Hyperion Compliance Program accordingly within **** after receiving such notice. In any event, changes to and interpretation and enforcement of the Hyperion Compliance Program shall not result in disparate treatment of Hyperion or the Marketed Products as compared to the other licensees or products of Medicis and its Affiliates.

                (b)  The Parties shall comply with the audit and record-keeping requirements set forth on Schedule 5. 2(b) (Audit and Record-Keeping Requirements) .

                (c)  In addition to any other reporting obligations of Hyperion to Ucyclyd under this Agreement, Hyperion shall provide all information to Ucyclyd required by Ucyclyd or its Affiliates to fulfill its required reporting obligations under the CIA as determined solely by Ucyclyd or its Affiliates.

                (d)  In accordance with Section 6032 of the Deficit Reduction Act of 2005, Pub. Law No. 109-171, Medicis and its Affiliates have adopted a policy entitled “Medicis Employee Education Policy Concerning the Prevention and Detection of Fraud, Waste, and Abuse in Government Health Care Programs: Compliance Policy Pursuant to the Deficit Reduction Act of 2005” (“ Deficit Reduction Act Compliance Policy ”), which establishes a written protocol for educating all employees (including management) of Medicis and its Affiliates, and any contractors or agents who may on behalf of Medicis and its Affiliates furnish or authorize the furnishing of health care items or services, perform billing or coding functions, or become involved in monitoring any health care provided by Medicis or its Affiliates (“ Applicable Agents ”), about their internal policies and procedures as well as various federal and state statutes and administrative remedies related to detecting and preventing fraud, waste, and abuse in government health care programs. It is a condition of the Agreement that Hyperion complies with the Deficit Reduction Act and Deficit Reduction Act Compliance Policy, and that Hyperion provides the educational information required under the Deficit Reduction Act to all its Affiliates, employees, or approved subcontractors who bear any responsibility in the

performance of the Agreement. A copy of Deficit Reduction Act Compliance Policy, as well as an addendum entitled “Federal and State Statutes and Administrative Remedies Related to Preventing and Detecting Fraud, Waste, and Abuse in Government Health Care Programs,” is available at www.medicis.com/dra (password: 34589034), and is incorporated herein by reference. Upon request, copies of the Deficit Reduction Act Compliance Policy will be provided to Hyperion. Hyperion represents and warrants that, in connection with performing its obligations under the Agreement, it will comply with the Deficit Reduction Act and the Deficit Reduction Act Compliance Policy.

      5.3 Screening Requirements . Hyperion shall ensure that all Hyperion Personnel are not Ineligible Persons by implementing the following screening requirements:

                (a)  Hyperion shall screen all Hyperion Personnel against the Exclusion Lists prior to engaging their services and, as part of the hiring or contracting process, shall require such Hyperion Personnel to disclose whether they are Ineligible Persons;

                (b)  Hyperion shall screen all Hyperion Personnel against the Exclusion Lists within **** after the Effective Date and on an annual basis thereafter; and

                (c)  Hyperion shall implement a policy requiring all Hyperion Personnel to disclose immediately any debarment, exclusion, suspension or other event that makes that person an Ineligible Person.

                     (i)  Hyperion acknowledges and agrees that items or services furnished by Excluded Persons are not payable by Federal health care programs and that the Parties’ may be liable for overpayments and criminal, civil and administrative sanctions for employing or contracting with an Excluded Person regardless of whether the foregoing requirements have been satisfied. Accordingly, Hyperion shall reimburse Ucyclyd for any and all costs and expenses incurred or otherwise suffered by the Ucyclyd with respect to any of the foregoing.

                     (ii)  If Hyperion has actual notice that any Hyperion Personnel have become Ineligible Persons, Hyperion shall remove such Hyperion Personnel from responsibility for, or involvement with, Hyperion’s business operations related to any Federal health care programs and shall remove such Hyperion Personnel from any position for which the Hyperion Personnel’s compensation or the items or services furnished, ordered, or prescribed by the Hyperion Personnel are paid in whole or part, directly or indirectly, by Federal health care programs or otherwise with Federal funds at least until such time as the applicable Hyperion Personnel is reinstated into participation in Federal health care programs.

                     (iii)  If Hyperion has actual notice that a Hyperion Personnel is charged with a criminal offense that falls within the ambit of 42 U.S.C. §§ 1320a-7(a), 1320a-7(b)(1)-(3), or is proposed for exclusion during the Hyperion Personnel employment or contract term, Hyperion shall take all appropriate actions to ensure that the responsibilities of that Hyperion Personnel have not and shall not adversely affect the quality of care rendered to any beneficiary, patient, or resident, or the accuracy of any claims submitted to any Federal health care program.

      5.4 Regulatory Filings and Approvals .

           5.4.1 Marketed Products . Subject to the terms of Section 5.7 (Communication with Governmental Authorities or Regulatory Agencies) , during the Development Term, Ucyclyd shall have exclusive authority and responsibility to maintain and seek revisions of any FDA approval for the Marketed Products and shall keep Hyperion informed of any such actions and Hyperion shall not file any document with the FDA or any other Governmental Authority or Regulatory Agency relating to any Marketed Product without the prior written consent of Ucyclyd. Subject to the terms of Section 5.7 (Communication with Governmental Authorities or Regulatory Agencies) , on and following Closing, (a) Hyperion shall have exclusive authority and responsibility to maintain and seek revisions of any FDA approval for the Marketed Products and shall keep Ucyclyd informed of any such actions; and (b) Ucyclyd shall not file any document with the FDA or any other Governmental Authority or Regulatory Agency relating to any Marketed Product without the prior written consent of Hyperion; provided that, Hyperion shall not withhold such consent if such filing pertains to Marketed Products that either: (x) entered into commerce during the Development Term; or (y) were manufactured pursuant to an agreement to which Ucyclyd is a party.

           5.4.2 Development and Regulatory Program .

                (a)  Ucyclyd shall: (i) within **** after the Effective Date provide to Hyperion: (A) a copy of the Development Product INDs; and (B) a copy of the letter submitted to the FDA designating Hyperion as the regulatory sponsor of the Development Products INDs; (ii) as soon as reasonably practicable, transfer to Hyperion, the regulatory rights and obligations as regulatory sponsor solely with regard to the Development Product INDs ( subsections (i) and (ii) together referred to as the “ Transferred Regulatory Rights ”); (iii) within **** after the Effective Date, provide to Hyperion a copy of the pre-clinical and clinical development work performed by or on behalf of Ucyclyd that is necessary or useful for the filing of the NDAs for the Development Products in the Development Field; and (iv) complete copies of all material information relating to subsections (i) through (iii) above, including all correspondence and regulatory files, relating to the Transferred Regulatory Rights (the “ Transfer ”).

                (b)  The date on which the FDA cites as the receipt date for such letter identified in Section 5.4. 2(a)(i) (B) (Development and Regulatory Program) above shall be the “ Transfer Date ”.

                (c)  Until the Transfer Date, Ucyclyd shall be the owner and regulatory sponsor of the Development Product INDs and shall have all such rights and obligations relating thereto. Ucyclyd shall diligently work to affect the Transfer in accordance with subsection (a) and shall cooperate with Hyperion during such period of time to make sure that FDA requirements are timely met.

                (d)  After the Transfer Date and prior to Closing, Ucyclyd shall be the owner of the Development Product INDs and Hyperion shall act as the regulatory sponsor of the Development Product INDs and shall take over from Ucyclyd all responsibilities and obligations of sponsors as defined under applicable U.S. Food, Drug, and Cosmetic Act, FDA Regulations and all other applicable Legal Requirements and including such ICH Guidelines or FDA

guidance (insofar as such guidelines and guidance documents contain or may reasonably be interpreted to contain provisions that represent or mandate specific standard, routine or accepted practice in the industry) that represent applicable standards of practice.

                (e)  At all times after the Transfer Date, as between Hyperion and Ucyclyd, Hyperion shall be responsible for the filing of all regulatory documents in compliance with all Legal Requirements including: (i) all associated submissions (e.g., safety alerts, protocol submissions, NDAs, etc.) for responding to inquiries and correspondences from the Regulatory Authorities; (ii) for the establishment of the safety database for the Development Products which, subject to written agreement of the Parties, also may be included with the clinical database; and (iii) for the monitoring of all clinical experiences and submission of all required reports throughout clinical development and Commercialization of any Development Product. Hyperion shall provide information to Ucyclyd and reasonably consult with Ucyclyd regarding any such filings or significant or material notices, actions or requests from or by Regulatory Authorities. Ucyclyd may, at Hyperion’s request, review and comment on filings, submissions and responses to Regulatory Authorities related to such Development Product.

                (f)  Subject to the terms and conditions of the Agreement, during the Development Term, with respect to any Development Products, Ucyclyd shall own any Development Product IND. Hyperion shall be solely responsible as regulatory sponsor for the regulatory activities and strategy with respect to the Development and Regulatory Program for the purpose of obtaining Regulatory Approval from the FDA for the Development Products.

                (g)  With respect to the Development Products for which no IND has been filed, on and after the Effective Date, Hyperion shall have the right, subject to the terms and conditions of the Agreement, to be the regulatory sponsor of such INDs and hereby accepts responsibility for: (i) all of the rights and obligations of the regulatory sponsor under all applicable Legal Requirements; (ii) the regulatory rights and obligations solely with regard to the pre-clinical and clinical development of the Development Products in the Development Field; and (iii) obtaining Regulatory Approval in the United States for the applicable Development Products in the Development Field.

                (h)  During the Development Term, Hyperion shall: (i) consult with Ucyclyd regarding the regulatory strategy in each country of the Development Territory and consider in good faith Ucyclyd’s comments regarding the same; (ii) provide Ucyclyd with summaries or updates of any material conversations or meetings with Regulatory Agencies, and upon written request of Ucyclyd, copies of related correspondence from Regulatory Agencies; and (iii) if requested by Ucyclyd to the extent practicable, allow Ucyclyd to have one (1) representative attend meetings between Hyperion and any Regulatory Authority that affect Ucyclyd’s rights or obligations as owner of the Development Product INDs or as otherwise agreed by the JSC. If requested by Ucyclyd, Ucyclyd shall receive copies of any draft response to correspondence from a Regulatory Agency, and Hyperion should consider in good faith Ucyclyd’s comments thereon prior to filing any such response.

                (i)  Hyperion shall be solely responsible for the preparation of the NDAs for any and all of the Development Products in the Development Field. Ucyclyd shall file each NDA promptly with the FDA. Ucyclyd shall retain ownership of all such NDAs until the

Closing. In the event that the NDA for **** in the treatment of **** is approved by the FDA prior to Closing, Ucyclyd shall appoint Hyperion the regulatory agent for such NDA.

                (j)  In the event the Term of the Agreement is terminated prior to Closing or Hyperion does not purchase the Assets in accordance with the terms and conditions of the Agreement, Hyperion shall transfer immediately to Ucyclyd: (i) any and all INDs, NDAs or other Regulatory Approvals or Price Approvals with respect to the Products; (ii) one (1) copy of all correspondence with the FDA and regulatory files relating to any and all INDs, NDAs or other Regulatory Approvals and Price Approvals with respect to the Products to the extent that Hyperion has not previously provided such correspondence to Ucyclyd or as requested by Ucyclyd; and (iii) all rights and obligations as regulatory sponsor of any such INDs.

                (k)  With respect to any transfers under this Section to either Party, each Party acknowledges and agrees that time is of the essence. The Party responsible for delivery agrees that, in the event there is any material delays in such transfer, the Parties shall discuss in good faith a transfer plan to facilitate the process. If the Parties fail to agree to such a transfer plan within **** following the date on which the applicable transfer should have been completing or delivering Party fails to comply with such agreed upon transfer plan, then the receiving Party shall be entitled to specific performance.

      5.5 Labeling and Promotional Materials .

                (a)  To the extent that Hyperion desires to use any Promotional Materials currently used by Ucyclyd to Promote, such Promotional Materials will be subject to review and approval by Ucyclyd in accordance with subsection (c) below and Hyperion shall reimburse Ucyclyd for the actual costs incurred by Ucyclyd for such Promotional Materials within **** after Hyperion receives such Promotional Materials and an invoice regarding such amount from Ucyclyd. In addition to the foregoing, Hyperion shall have the right to designate any Website Content in use by Ucyclyd as of the Effective Date that Hyperion desires to use in connection with the Domain Names and shall submit such Website Content, as may be modified by Hyperion, for review and approval by Ucyclyd in accordance with subsection (c) below; provided that, Ucyclyd shall have the right, at any time, to remove or have removed any Website Content not submitted by Hyperion for such review and approval. Ucyclyd will inform Hyperion if any such Website Content is removed.

                (b)  Subject to approval as set forth in subsection (c) below, Hyperion may, at any time, develop and use Promotional Materials for the Marketed Products in the Promotion Territory; provided that all such Promotional Materials shall comply with applicable Legal Requirements and the terms and conditions of this Agreement.

                (c)  During the Development Term, Hyperion acknowledges and agrees that all Promotional Materials shall be subject to Ucyclyd’s prior written approval. Hyperion shall submit any proposed Promotional Materials to Ucyclyd in writing, and Ucyclyd shall review such Promotional Materials, in each case in accordance with Ucyclyd’s standard operating procedures for review of such Promotional Materials, which includes review and approval by the FAC, as such operating procedures are updated from time to time by Ucyclyd. Ucyclyd will provide Hyperion with notice of any FAC meetings at which such Promotional

Materials may be reviewed and allow Hyperion to participate in such FAC meetings, via telephone or in-person, solely with respect to such Promotional Materials. Ucyclyd agrees to consider Hyperion’s comments during FAC; provided that Ucyclyd shall maintain at all times its sole discretion and authority to approve or reject such Promotional Materials. In the case that Ucyclyd does not approve any Promotional Materials, Hyperion shall have the right to revise and re-submit any such Promotional Materials as set forth in this subsection (c) .

                (d)  Hyperion acknowledges and agrees that, during the Development Term, any new material, modifications or changes to existing Website Content shall be considered Promotional Materials under this Agreement. Hyperion shall submit any such proposed new material, modifications or changes to the Website Content in writing to Ucyclyd for review by FAC in accordance with the procedures set forth in subsection (c) above.

                (e)  During the Development Term:

                     (i)  Ucyclyd shall have sole authority and responsibility to seek and obtain any necessary FDA approvals of any label, labeling, package inserts and packaging, and Promotional Materials used in connection with the Marketed Products and for determining whether the same requires FDA submission or approval;

                     (ii)  Ucyclyd shall be responsible for submission to FDA of Promotional Materials for the Marketed Products, as applicable, and Hyperion shall not use any Promotional Materials until Hyperion has been notified in writing by Ucyclyd that the FDA submission has been completed;

                     (iii)  any label, labeling, package inserts and packaging, Promotional Materials and Licensed Marks and any use thereof by Hyperion shall be subject to the prior written approval of Ucyclyd;

                     (iv)  Hyperion shall furnish such samples of label, labeling, package inserts and packaging, Promotional Materials and Licensed Marks or any use thereof to Ucyclyd for inspection and analysis; and

                     (v)  Hyperion shall not modify, alter or otherwise change any approved label, labeling, package inserts and packaging, Promotional Materials and Licensed Marks and any use thereof, without the prior written approval of Ucyclyd.

      5.6 Adverse Events and Safety Reporting . As soon as practical after the Effective Date but no later than **** following the Effective Date, the Parties shall enter into, and comply with, the terms and conditions of, a separate pharmacovigilance agreement which shall include a detailed procedure with respect to the Products and the Development and Regulatory Program and at a minimum shall be consistent with the pharmacovigilance procedures for Ucyclyd and its Affiliates. In the event of a conflict between the terms and conditions of the pharmacovigilance agreement and the Agreement with respect to the subject matter of such pharmacovigilance agreement, the terms and conditions of the pharmacovigilance agreement shall govern.

      5.7 Communication with Governmental Authorities or Regulatory Agencies .

                (a)  During the Development Term, except as may be permitted in the pharmacovigilance agreement described in Section 5.6 (Adverse Events and Safety Reporting) , without the prior written consent of Ucyclyd or unless so required by applicable Legal Requirements (and then only pursuant to the terms of this Section 5. 7(a) (Communication with Governmental Authorities or Regulatory Agencies) ), Hyperion shall not correspond or communicate with the FDA or with any other Governmental Authority or Regulatory Agency, whether within the United States or otherwise, concerning the Marketed Products or otherwise take any action concerning any authorization or permission under which the Marketed Products are sold or any application for the same. In addition, during the Development Term, upon receipt of any communication from the FDA or from any other Governmental Authority or Regulatory Agency relating to any Marketed Product, Hyperion shall forward immediately to Ucyclyd a copy or description of the same and respond to all inquiries by Ucyclyd relating thereto. If Hyperion’s counsel recommends that Hyperion communicate with the FDA or with any other Governmental Authority or Regulatory Agency, then Hyperion shall so advise Ucyclyd immediately and, unless the applicable Legal Requirements prohibit, provide Ucyclyd in advance with a copy of any proposed written communication with the FDA or any other Governmental Authority or Regulatory Agency and comply with any and all reasonable direction of Ucyclyd concerning any meeting or written or oral communication with the FDA or any other Governmental Authority or Regulatory Agency.

                (b)  Except as may be permitted in Section 3.4 (Transition At Closing) or the pharmacovigilance agreement described in Section 5.6 (Adverse Events and Safety Reporting) , without the prior written consent of Hyperion or unless so required by applicable Legal Requirements (and then only pursuant to the terms of this Section 5. 7(b) (Communication with Governmental Authorities or Regulatory Agencies) ), Ucyclyd shall not correspond or communicate with the FDA or with any other Governmental Authority or Regulatory Agency, or otherwise take any action concerning any authorization or permission under which the applicable Products are sold or any application for the same with respect to: (i) the Products on and following Closing; or (ii) the Development Products during the Development Term. In addition, on and following Closing, upon receipt of any communication from the FDA or from any other Governmental Authority or Regulatory Agency relating to any Product, Ucyclyd shall forward immediately to Hyperion a copy or description of the same and respond to all inquiries by Hyperion relating thereto. If Ucyclyd is advised by its counsel that it must communicate with the FDA or with any other Governmental Authority or Regulatory Agency, then Ucyclyd shall so advise Hyperion immediately and, unless the applicable Legal Requirements prohibit, provide Hyperion in advance with a copy of any proposed written communication with the FDA or any other Governmental Authority or Regulatory Agency and comply with any and all reasonable direction of Hyperion concerning any meeting or written or oral communication with the FDA or any other Governmental Authority or Regulatory Agency.

                (c)  Notwithstanding the foregoing, each Party shall be responsible for its own compliance with the PDM Act and reporting thereunder, and subject to Section 5.4 (Regulatory Filings and Approvals) , Hyperion will copy Ucyclyd on all such reports regarding the Marketed Products filed with the FDA during the Development Term.

      5.8 Complaints; Medical Inquiries; Product Information Requests .

                (a)  Information concerning any complaints from consumers, physicians or other Persons received by either Party regarding Products shall be forwarded to the other Party within **** of the first Party’s receipt of the request; provided that all complaints concerning suspected or actual Product tampering, contamination or mix-up ( e.g. , wrong ingredients) shall be delivered within **** of such Party’s receipt of the same. Ucyclyd shall have the sole right to respond to any such complaints with respect to the Products except with respect to **** during the Development Term, and Hyperion shall have the sole right to respond to any such complaints with respect to the Products on and following Closing, and with respect to **** at any time during the Term of this Agreement.

                (b)  During the Development Term, Ucyclyd shall respond to all medical inquiries with respect to the Products and Product information requests. The Hyperion Compliance Program shall be consistent with the compliance program of Medicis with respect to addressing inquiries or requests. During the Development Term, Hyperion may submit a request to Ucyclyd that Hyperion assume from Ucyclyd the responsibility to respond to such inquiries or requests and Ucyclyd shall determine in its sole discretion whether to allow Hyperion to assume such responsibility. Hyperion shall have the sole right, authority and responsibility to respond to such inquiries and requests on and following Closing.

                (c)  For the avoidance of doubt, any communications involving adverse events shall be governed by the pharmacoviligance agreement as described in Section 5.6 (Adverse Events and Safety Reporting) .

      5.9 Regulatory Information .

                (a)  Subject to the terms of the pharmacovigilance agreement described in Section 5.6 (Adverse Events and Safety Reporting) and Section 5.7 (Communication with Governmental Authorities or Regulatory Agencies) , each Party shall provide the other Party with all reasonable assistance and take all actions reasonably requested by the other Party that are necessary or desirable to enable the other Party to comply with any Legal Requirements applicable to any Product, including such Party’s meeting its reporting and other obligations to: (i) maintain and update any NDAs for the Products; (ii) report SAEs to the FDA or other Governmental Authority or Regulatory Agency; and (iii) submit or file Product labels, labeling, package inserts or Promotional Materials with the FDA.

                (b)  Notwithstanding any provision of this Agreement, such assistance and actions shall include informing the other Party within **** following notification of any action by, or notification or other information that it receives (directly or indirectly) from, the FDA or any other Governmental Authority or Regulatory Agency that: (i) raises any material concerns regarding the safety or efficacy of any Product; (ii) indicates or suggests a potential material liability for either Party to Third Parties arising in connection with any Product; or (iii) is reasonably likely to lead to a recall or market withdrawal of any Product; provided that neither Party shall be obliged to disclose information in breach of any contractual restriction that it could not reasonably have avoided.

                (c)  Without limiting the provisions of this Section 5.9 (Regulatory Information) , each Party shall inform the other Party, and provide the other Party with a copy, of any and all correspondence it receives from a Governmental Authority or Regulatory Agency including:

                     (i)  governmental or regulatory inspections of manufacturing, distribution or other related facilities;

                     (ii)  inquiries by any Governmental Authority or Regulatory Agency concerning clinical investigation activities (including inquiries of investigators, clinical monitoring organizations and other related Persons);

                     (iii)  any communication from Governmental Authority or Regulatory Agency involving the manufacture, sale, promotion or distribution of Products or any other Governmental Authority or Regulatory Agency reviews or inquiries relating to any of the Products which, in each case, constitute a Material Event;

                     (iv)  any consent decrees with a Governmental Authority or Regulatory Agency relating to the Products;

                     (v)  receipt of any warning letters;

                     (vi)  receipt of any deficiency noted or otherwise referenced in any Form FDA-483 issued to a Party relating to any of the Products; and

                     (vii)  an initiation of any Governmental Authority or Regulatory Agency investigation, detention, seizure or injunction concerning any Product.

      5.10 Recalls or Other Corrective Action .

                (a)  Ucyclyd shall have sole responsibility for, and shall make all decisions with respect to, any recall, market withdrawals or any other corrective action related to the Marketed Products during the Development Term. Ucyclyd shall promptly notify Hyperion of any such actions taken by Ucyclyd that are reasonably likely to result in a material adverse effect on the marketability of such Marketed Product. At Ucyclyd’s request, Hyperion shall provide assistance to Ucyclyd in conducting such recall, market withdrawal or other corrective action and any documented, direct, out-of-pocket costs incurred by Hyperion with respect to participating in such recall, market withdrawal or other corrective action shall be reimbursed by Ucyclyd except to the extent that any such recall, market withdrawal or other corrective action results from Hyperion’s: (i) Promotion in a manner inconsistent with: (A) the Marketed Product’s labeling or package inserts; (B) the approved Promotion Plans; or (C) Promotional Materials provided or approved by Ucyclyd; (ii) failure to comply with the Agreement; or (iii) negligent, reckless or willful acts or omissions, Hyperion shall be responsible for all costs and expenses relating to such recall, market withdrawal and corrective action and shall reimburse Ucyclyd for any and all costs and expenses associated therewith.

                (b)  Hyperion shall have sole responsibility for, and shall make all decisions with respect to, any recall, market withdrawals or any other corrective action related to

the Marketed Products on and following Closing, and to Development Products throughout the Term; provided that during the Development Term, Hyperion shall consider in good faith Ucyclyd’s input with respect to any such recall, market withdrawal or other corrective action related to the Development Products. Hyperion shall promptly notify Ucyclyd of any such actions taken by Hyperion that are reasonably likely to result in a material adverse effect on the marketability of such Marketed Product. At Hyperion’s request, Ucyclyd shall provide assistance to Hyperion in conducting such recall, market withdrawal or other corrective action and any documented, direct, out-of-pocket costs incurred by Ucyclyd with respect to participating in such recall, market withdrawal or other corrective action shall be reimbursed by Hyperion except to the extent that any such recall, market withdrawal or other corrective action results from Ucyclyd’s: (i) Promotion in a manner inconsistent with: (A) the Marketed Product’s labeling or package inserts; (B) the approved Promotion Plans; or (C) Promotional Materials; (ii) failure to comply with the Agreement; or (iii) negligent, reckless or willful acts or omissions, Ucyclyd shall be responsible for all costs and expenses relating to such recall, market withdrawal and corrective action and shall reimburse Hyperion for any and all costs and expenses associated therewith. Hyperion agrees to cooperate with Ucyclyd to mitigate any costs or other risk to Ucyclyd if any such recall, market withdrawal or other corrective action occurs on or following the Closing with respect to the Marketed Products, but relates to activities that occurred or arose prior to Closing and results from the conduct described in subsections (i) and (ii) of this subsection (b) .

      5.11 Compliance Deficiencies .

                (a)  Hyperion acknowledges and agrees that Hyperion’s promotion of, and adherence to, the Hyperion Compliance Program, Article 5 (Regulatory and Compliance Matters) and Legal Requirements applicable to: (i) the Development and Regulatory Program; and (ii) Promotion (collectively, the “Compliance Requirements ”) and Hyperion’s response to addressing Compliance Deficiencies (as defined below) shall be critical elements in evaluating the performance of Hyperion under the Agreement. “ Compliance Deficiencies ” include: (i) one or more deficiencies of Hyperion or any Hyperion Personnel that are likely to result in a violation(s) of any of the Compliance Requirements or the CIA, (ii) an actual violation(s) of any of the Compliance Requirements by Hyperion or any Hyperion Personnel with the exception of those violations described in Section 12. 2(f) (Termination Rights) of the Agreement, and (iii) any act(s) or omission(s) of Hyperion or any Hyperion Personnel that is likely to result in a violation(s) of any of the Compliance Requirements or the CIA with the exception of those violations described in Section 12.2(f) (Termination Rights) of the Agreement. For the avoidance of doubt, the occurrence of the events described in Section 12. 2(f) (Termination Rights) are not subject to the terms or conditions of this Section 5.11 (Compliance Deficiencies) and shall be governed solely by the terms of Section 12. 2(f) (Termination Rights) . Further, the Parties agree that the Chief Compliance Officer of Medicis and the Hyperion Compliance Officer shall discuss in good faith and agree upon the basis and reporting timeframe for assessing the likelihood of a violation under subsections (i) and (iii) from time to time.

                (b)  Unless the Agreement specifies (or the Parties agree as provided under subsection (a)) on another time frame for the reporting of the applicable Compliance Deficiency to Ucyclyd or the Chief Compliance Officer of Medicis, Hyperion shall notify the

Chief Compliance Officer of Medicis promptly of any Compliance Deficiencies, which notice shall be in writing and shall specify in detail the Compliance Deficiencies and Hyperion’s plan for addressing the Compliance Deficiencies to the extent Hyperion has such a plan available at the time of disclosure to the Chief Compliance Officer of Medicis ( i.e. , notice should not be withheld or delayed because the plan is not fully prepared). To the extent the remedial plan is not included with the notice, Hyperion shall provide the Chief Compliance Officer of Medicis with such a plan as soon as reasonably practicable under the circumstances. The notice also shall specify any measures taken by Hyperion to remedy the Compliance Deficiency and shall describe the terms of the proposed remedial plan, if any. To the extent the Compliance Deficiency is identified as the result of an internal or external audit of Hyperion, Hyperion shall provide to the Chief Compliance Officer of Medicis a copy of any report generated in connection therewith including any recommendations and measures to remedy the applicable Compliance Deficiency.

                (c)  To the extent that Ucyclyd discovers, learns or is notified of a Compliance Deficiency other than through notification by Hyperion under subsection (b) above, Ucyclyd shall notify Hyperion in writing and shall specify in detail such Compliance Deficiency. Within **** following Hyperion’s receipt of such notice, Hyperion shall provide to the Chief Compliance Officer of Medicis a written response addressing each of the identified Compliance Deficiencies and, as applicable, a remedial plan for remedying each such Compliance Deficiency.

                (d)  Promptly (but not longer than **** ) following receipt of Hyperion’s notice under subsection (b) or Hyperion’s response under subsection (c) , the Hyperion Compliance Officer and the Chief Compliance Officer of Medicis shall meet to discuss the Compliance Deficiencies and Hyperion’s remedial plan, which remedial plan shall be subject to the reasonable approval of the Chief Compliance Officer of Medicis; provided, however, Hyperion’s implementation of remedial measures shall not be delayed pending such approval, it being the intent of the Parties that Hyperion take all reasonable measures to remedy any Compliance Deficiency as soon as practicable. Promptly following such meeting, Hyperion shall implement any changes to the remedial plan or the remedial measures under such approved remedial plan.

                (e)  Following implementation of the remedial plan, the Hyperion Compliance Officer shall provide written notice to the Chief Compliance Officer of Medicis certifying that the remedial measures have been implemented in accordance with such plan. The Chief Compliance Officer of Medicis shall have the right to review and audit the implementation of the remedial plan so as to verify Hyperion’s compliance therewith.

                (f)  In addition to the foregoing provisions of this Section 5.11 (Compliance Deficiencies) , with respect to any Compliance Deficiency, the Parties shall fully cooperate to provide timely review and input on the efforts and responsibilities of Hyperion to address violations or failures under this Section 5.11 (Compliance Deficiencies) . In addition, Hyperion shall:

                     (i)  fully cooperate to change or modify the Hyperion Compliance Program to address any and all Compliance Deficiencies;

                     (ii)  act in good faith to mitigate or minimize any adverse impact on Ucyclyd or its Affiliates; and

                     (iii)  as applicable: (A) undertake remedial action against any Hyperion Personnel associated or connected with the violation or failure; (B) implement changes to the controls over the environment designed to prevent the reoccurrence of future Compliance Deficiencies; (C) pay or reimburse Ucyclyd for any Stipulated Penalties (as defined in the CIA) or any other out-of-pocket costs to Ucyclyd or its Affiliates associated with any Compliance Deficiency, including any fines imposed by a Governmental Authority or Regulatory Agency.

                (g)  Ucyclyd agrees that the Chief Compliance Officer of Medicis promptly shall provide to Hyperion and the Hyperion Compliance Officer input and responses under this Section 5.11 (Compliance Deficiencies) with respect to (i) Hyperion’s remedial plan, (ii) changes or modifications to the Hyperion Compliance Program to address any and all Compliance Deficiencies, and (iii) inquiries from Hyperion and the Hyperion Compliance Officer regarding the steps taken by Hyperion to implement the approved remedial plan.

                (h)  If Hyperion fails to implement the approved remedial plan described in subsection (d) or fails to comply with its obligations under subsection (f) , the Chief Compliance Officer of Medicis shall notify the Hyperion Compliance Officer of such failure and Hyperion shall have **** to cure such failure. If Hyperion has not cured the identified failure(s), Ucyclyd shall have the right to terminate the Term of the Agreement upon written notice to Hyperion without any further opportunity of Hyperion to remedy such failure.

ARTICLE 6

GOVERNANCE

      6.1 Cooperation . Subject to the other provisions of the Agreement, the Parties agree that the principal objectives of the Parties under the Agreement are to use Commercially Reasonable Efforts to, in accordance with the responsibilities assigned to each as set forth in the Agreement: (a) maximize the market and sales with respect to the Marketed Products; and (b) develop the Development Products for use in the Development Field. The Parties agree that they shall establish a formal framework, as further set forth in this Article 6 (Governance) , which will oversee the Promotion and the Development and Regulatory Program during the Development Term.

      6.2 Joint Steering Committee .

           6.2.1 Establishment of the Joint Steering Committee . The Parties shall establish a JSC, which shall consist of a total of six (6) members, with three (3) members from each Party. The initial members of the JSC are set forth on Schedule 6.2.1 (Joint Steering Committee) to the Agreement. Members of the JSC may be represented at any meeting by a designee appointed by such member for such meeting. The chairperson shall alternate every calendar year, beginning with a person designated by Ucyclyd and identified on Schedule 6.2.1 (Joint Steering Committee) and shall have the rights and responsibilities as set forth in Section 6.3 (Responsibilities of the Chairperson) . The secretary shall alternate every calendar year,

beginning with a person designated by Hyperion and identified on Schedule 6.2.1 (Joint Steering Committee) . Each Party, in its discretion, may invite non-JSC employees of such Party to attend any JSC meeting. The JSC shall remain in place until the expiration and non-renewal or termination of the Term of the Agreement.

           6.2.2 Responsibilities of the Joint Steering Committee . In addition to the responsibilities expressly described elsewhere in the Agreement, the JSC shall, during the Development Term:

                (a)  develop and discuss strategies for Promotion;

                (b)  review and approve any changes to the Promotion Plans (including the sales forecasts, budget, promotional activities and strategies) consistent with the provisions of Article 2 (Promotion and Development Activities During the Development Term) ;

                (c)  review progress against the then-current Promotion Plan (including the sales forecasts, budget, promotional activities and strategies);

                (d)  review progress of Marketed Products sales in the Promotion Territory against the forecast included in the then-current Promotion Plan;

                (e)  review progress with respect to the Development and Regulatory Program including the Development Plan;

                (f)  review changes to the Development Plan and Development Plan budget consistent with the provisions of Article 2 (Promotion and Development Activities During the Development Term) ;

                (g)  review development costs against the budget for such activities in the applicable year;

                (h)  review pricing and distribution strategies;

                (i)  review and coordinate Hyperion’s efforts internationally with respect to the Products;

                (j)  review any development of Products outside of the Development Plan;

                (k)  review the status of intellectual property protection for inventions made under the Development Plan;

                (l)  review potential competition for the Products and discuss related regulatory strategies;

                (m)  perform any other activities related to the Products as the Parties may reasonably request from time to time other than deciding that a Party is in breach of an obligation under this Agreement;

                (n)  in the event of any dispute arising from or in connection with this Agreement or the breach thereof, serve as a forum to settle the dispute by consulting and negotiating in good faith to attempt to reach a solution satisfactory to both Parties and, if the JSC does not reach such solution within **** of written notice by either Party of the existence of a dispute, then, upon written notice by either Party to the other, the Parties shall settle such dispute pursuant to Article 15 (Dispute Resolution) ;

                (o)  review, discuss and confirm Hyperion’s compliance with Article 5 (Regulatory and Compliance Matters) including the Hyperion Compliance Program; provided, however, that (i) the JSC is not authorized to approve changes to the Hyperion Compliance Program or the requirements under Article 5 (Regulatory and Compliance Matters) , and (ii) the Chief Compliance Officer of Medicis shall retain ultimate authority for evaluating and determining issues relating to compliance as set forth in this Agreement;

                (p)  establish and oversee the function of appropriate subcommittees with focus on particular areas of the Development and Regulatory Program or Commercialization activities; and

                (q)  perform such other activities from time to time as agreed upon by the Parties.

For clarity, the JSC, or any subcommittee established by it pursuant to Section 6.9 (Delegation) below, shall not have the right to amend this Agreement; provided, however, the Parties may agree through the JSC to change the Promotion Plan or the Development Plan or approve other activities related to the implementation or fulfillment of each Party’s obligations under this Agreement except that the JSC shall not approve any such changes or activities related to (i) the Hyperion Compliance Program or the requirements under Article 5 (Regulatory and Compliance Matters), and (ii) the Chief Compliance Officer of Medicis shall retain ultimate authority for evaluating and determining issues relating to compliance as set forth in this Agreement.

           6.2.3 Meetings of the Joint Steering Committee . During the Development Term, the JSC shall meet quarterly, and more frequently as the Parties mutually agree is appropriate. Such meetings shall be on such dates and at such times as the Parties shall agree and may be held either in-person or by means of telecommunication or video conference. Any in-person meetings shall alternate between the offices of the Parties unless the Parties otherwise agree. If practicable, the chairperson shall send notice of all meetings to all members of the JSC no less than **** before the date of the meeting. The JSC also may convene, be polled or consulted from time to time by means of electronic correspondence, as deemed necessary or appropriate in order to fulfill its obligations under the Agreement.

      6.3 Responsibilities of the Chairperson . The chairperson of the JSC shall have the following roles and responsibilities:

                (a)  to call meetings, send notice of each such meeting and designate the time, date and place of each such meeting;

                (b)  to convene or poll the members by other permitted means;

                (c)  to establish the agenda for each meeting, subject to the right of any member to add additional agenda items at any meeting;

                (d)  to prepare comments to the draft minutes prepared by the secretary and communicate with the secretary to finalize the draft minutes prior to circulation to all members; and

                (e)  to execute, along with the secretary, the final minutes of the meetings.

      6.4 Reports to the Joint Steering Committees.

             6.4.1 By Hyperion. In addition to the obligations set forth in Section 2.2.5 (Research and Development Diligence) , prior to the first meeting of the JSC for each calendar year during the Development Term, Hyperion shall provide the JSC with:

                (a)  written reports regarding the status of its activities and progress under the Promotion Plan, including any events that may adversely impact the Promotion Plan and the steps Hyperion is taking to mitigate or correct such events;

                (b)  written reports regarding the status of its activities and progress under the Development and Regulatory Program and the Development Plan, including any events that may adversely impact the Development and Regulatory Program or the Development Plan and the steps Hyperion is taking to mitigate or correct such events; and

                (c)  written reports regarding the status of the Marketed Products with Regulatory Agencies or any actions by Regulatory Agencies that might reasonably be expected to impact Marketed Products.

Within **** following the end of the Development Term, Hyperion shall provide the JSC with a final written report of its activities and progress under each of the Promotion Plan, the Development and Regulatory Program and the Development Plan.

           6.4.2 By Ucyclyd . At the first meeting of the JSC for each calendar year during the Development Term, Ucyclyd shall provide the JSC with:

                (a)  an update (oral or written as determined by Ucyclyd) regarding the status of any Ucyclyd activities and progress under the Promotion Plan, such as in the areas of pharmacovigilance and customer services, including any events that may adversely impact the Promotion Plan and the steps Ucyclyd is taking to mitigate or correct such events; and

                (b)  an update (oral or written as determined by Ucyclyd) regarding the status of the Marketed Products with Regulatory Agencies or any actions by Regulatory Agencies that might reasonably be expected to impact Marketed Products.

The Parties acknowledge and agree that Ucyclyd’s obligations under this Section will be deemed fulfilled in the United States if Ucyclyd provides the annual report submitted by Ucyclyd to the FDA with respect to each of the Marketed Products.

      6.5 Minutes . Promptly after each JSC meeting, the secretary of the JSC shall prepare and distribute to the chairperson of the JSC draft minutes of the meeting, which shall provide a description in reasonable detail of the discussions conducted at the meeting and a list of any actions, and decisions or determinations made by the JSC. The chairperson of the JSC may then comment on the draft minutes. The secretary of the JSC shall discuss with the chairperson any comments of the chairperson and circulate a final draft of the minutes to all members of the JSC within **** of the meeting. The final draft minutes will be submitted for the written approval of the members of the JSC at the following JSC meeting. The secretary and chairperson shall each sign and date the final minutes. The signature of the chairperson and the secretary on the final minutes shall indicate each Party’s assent to the minutes.

      6.6 Expenses . Each Party shall be responsible for all travel and related costs and expenses for its members of the JSC, designees and non-JSC invitees to attend, and otherwise participate.

      6.7 Voting .

                (a)  The JSC shall decide by vote on any subject matter within the JSC’s decision-making authority. Each Party shall have only one (1) vote on matters voted on in the JSC. Such decisions shall require that at least one (1) member of each Party is present at such meeting. All decisions of the JSC must be made by the unanimous vote of the Parties and each Party’s vote shall be cast by the member(s) (or their designee(s)) present at any meeting.

                (b)  If the JSC cannot resolve any matter due to a deadlock or otherwise, such matter shall be referred to the Executive Sponsors for resolution. If such Executive Sponsors cannot resolve such matter in **** after the matter is referred to them, then such matter shall be resolved through the dispute resolution mechanism set forth in Article 15 (Dispute Resolution) .

      6.8 Replacement of Personnel . Each Party shall have the right, at any time, to designate by written notice to the other Party a replacement for any of such Party’s members on the JSC, provided that such replacement has a functionally equivalent position (regardless of title) to the Person being replaced.

      6.9 Delegation . The JSC may delegate any portion of its responsibilities to a subcommittee created by it, which subcommittee shall consist of equal number of representatives from each Party and shall make decisions in the same manner as set forth in Section 6.7 (Voting) except that if any subcommittee cannot resolve any matter due to a deadlock or otherwise, such matter shall be referred to the JSC first for resolution and, thereafter, shall be resolved in accordance with Section 6. 7(b) (Voting) .

ARTICLE 7

PAYMENT TERMS AND OBLIGATIONS

      7.1 Upfront Payments . In partial consideration for the rights and licenses granted to Hyperion in the Agreement, within **** following the Effective Date, Hyperion shall pay to Ucyclyd a one-time, non-refundable payment in the amount of Ten Million Dollars ($10,000,000); provided, however, the Parties acknowledge and agree that **** Dollars ($ **** ) has been paid by Hyperion to Ucyclyd pursuant to the Exclusivity Agreement and is credited to this upfront payment.

      7.2 Regulatory Milestone Payments . As further consideration for the rights and licenses granted to Hyperion under the Agreement, Hyperion shall make one-time, non-refundable payments (each, a “ Regulatory Milestone Payment ”) as provided in Schedule 7 (Payment Obligations) .

      7.3 Promotion Commission . In consideration for Hyperion’s Promotion, Ucyclyd shall pay Hyperion a commission as provided in Schedule 7 (Payment Obligations) .

      7.4 Other Ongoing Payments . Hyperion shall make all other ongoing payments as provided in Schedule 7 (Payment Obligations) .

      7.5 Assumed Payment Obligations . In addition to the payments otherwise payable to Ucyclyd under the Agreement, as of the Effective Date, Hyperion hereby assumes the payment obligations to the applicable Persons as set forth on Schedule 7 (Payment Obligations) (“ Assumed Payments ”). Hyperion agrees to pay the Assumed Payments as provided in Schedule 7 (Payment Obligations) .

      7.6 No Reduction for Generic Equivalents . In the event any Person develops, markets, promotes, manufactures, sells, offers to sell, distributes or imports a Generic Equivalent, nothing in the Agreement shall be construed to allow a reduction in any of Hyperion’s payment obligations under the Agreement.

      7.7 Promotional, Development, Regulatory and Other Costs and Expenses .

                (a)  Hyperion shall be solely responsible for any and all: (i) costs and expenses related to the performance by Hyperion of the Development and Regulatory Program on and after the Effective Date; (ii) the Promotional and other activities of Hyperion in furtherance of the obligations of Hyperion under the Agreement; and (iii) Hyperion Regulatory Costs. Hyperion shall be responsible solely for any and all cost and expense overruns arising in connection with the foregoing.

                (b)  Hyperion shall reimburse Ucyclyd and its Affiliates for time spent by employees of Ucyclyd and its Affiliates on and after the Effective Date relating to any research, development, promotion, marketing, sale, regulatory compliance or manufacture of, or with respect to the, Products (“ Ucyclyd Services ”) as follows:

                     (i)  No reimbursement shall be required for Ucyclyd Services provided within **** days following the Effective Date.

                     (ii)  Following such **** period, subject to subsection (iii) below, Ucyclyd shall provide Ucyclyd Services at **** to the extent such Ucyclyd Services do not require material (when considered individually or in the aggregate of all such requests) amounts of time by employees of Ucyclyd and its Affiliates. To the extent that Ucyclyd determines that the requested Ucyclyd Services require material amounts of time, prior to Ucyclyd incurring any such costs or expenses, Ucyclyd shall submit to Hyperion an estimate of the costs for the Ucyclyd Services. Following Hyperion’s approval of such estimate, Ucyclyd shall provide the proposed Ucyclyd Services in accordance with the proposal, and Hyperion shall pay Ucyclyd for the Ucyclyd Services in accordance with the terms of such proposal, or if none are specified, then within **** following Hyperion’s receipt of an invoice from Ucyclyd. The estimate shall be considered a cap on the amount subject to reimbursement by Hyperion unless otherwise approved in writing by Hyperion prior to incurrence of any activity that would result in costs or expenses above such cap.

                     (iii)  Notwithstanding the foregoing, to the extent that other provisions of the Agreement specify the allocation of costs or expenses, such other provisions shall control.

      7.8 Payment Procedure . All payments due under the Agreement shall be paid in United States Dollars by wire transfer, or by such other method mutually agreed upon by the Parties, in each case at the expense of the payor, for value no later than the due date thereof to the following bank accounts or such other bank account or accounts as the payee shall designate in writing within a reasonable period of time prior to such due date:

     If to Hyperion:

		Account Name: Account Number: Hyperion Tax ID: Bank: ABA Number:		**** **** **** **** ****

     If to Ucyclyd, payment will be made to the account below for the benefit of Ucyclyd:

		Account Name: Name: SWIFT Code: ABA/ Routing#: Bank Address: Account #:		**** **** **** **** **** ****

      7.9 Currency Conversion . Monetary conversions from the currency of a foreign country, in which Products are sold, into U.S. currency shall be determined using the Average Exchange Rate. The “Average Exchange Rate” shall be the average of the official exchange rate in force in that country for financial transactions on the first and last business day of the calendar month for which the payments are being paid. If there is no such official exchange rate, the conversion shall be made at the rate for such remittances on the date as published in the United States edition of The Wall Street Journal.

      7.10 Taxes .

                (a)  Each Party will be responsible for any and all Taxes applicable to its own business.

                (b)  Each Party may withhold from payments due to the other Party any withholding tax that is required by law to be paid to any taxing authority with respect to such payments. The Party that has withheld such tax shall provide to the other Party all relevant documents and correspondence and written evidence of the payment of such tax and any other cooperation or assistance as may be reasonably necessary to enable the Party subject to the withholding tax to claim exemption from such tax and to receive a full refund of such tax or claim a foreign tax credit. The Parties also agree to cooperate with each other in the event a Party seeks deductions under any double taxation or other similar treaty or agreement from time to time in force.

                (c)  The Parties will cooperate to more accurately determine and minimize their respective tax liability. Each Party will provide tax information or tax documents reasonably requested by the other Party. Each Party will promptly notify the other of any claim for Taxes asserted with respect to the Agreement by a taxing authority with jurisdiction over either Party. With respect to any claim arising out of a tax form or return signed by a Party to the Agreement, the signing Party may control the response to and settlement of the claim, but the other Party shall have the right to participate to the extent it may be liable.

      7.11 Continuing Payment Obligations . The obligation of each Party to pay any and all payments required under the Agreement shall remain in effect notwithstanding any alleged infringement by any Person of any of the Products, the Product Technology, Developed Technology, Manufacturing Technology or the Brusilow Intellectual Property.

      7.12 Late Payments . Any undisputed payments owed by a Party to the other Party under the Agreement that are not paid on or before the date such payments are due shall accrue daily interest, to the extent permitted by applicable Legal Requirements, at the rate announced by Bank of America (or its successor) as its prime rate in effect on the date that such payment was first due plus **** percent ( **** %).

      7.13 No Additional Payment . Except as expressly set forth in the Agreement, the Parties shall have no obligation under the Agreement to pay or reimburse the other Party for any other amounts, including any other costs or expenses incurred by the other Party in connection with the performance of its obligations under the Agreement. This provision shall in no way

limit a Party’s ability to collect damages for any material breach by the other Party or in any way limit a Party’s indemnification obligations under the Agreement.

      7.14 Financial Audit and Record-Keeping Requirements . The Parties shall comply with the audit and record-keeping requirements set forth on Schedule 5. 2(b) (Audit and Record-Keeping Requirements) .

      7.15 Set-Off Rights . Ucyclyd shall have the right to set off any amounts due to Hyperion against any undisputed damages, charges or other amounts due from Ucyclyd to Hyperion. Hyperion shall not have the right to set off any amounts due to Ucyclyd against any undisputed damages, charges or other amounts due from Hyperion to Ucyclyd except as set forth below. To the extent that Hyperion learns that Ucyclyd is not paying any payments due pursuant to Section 5 of Schedule 7 (Payment Obligations) , Hyperion shall consult with Ucyclyd as to whether such payments are undisputed and due. If Ucyclyd does not dispute such payment and such payment is due and remains unpaid by Ucyclyd, then Hyperion shall have the right to make such payment to the applicable Third Party and set off any such payment against any undisputed damages, charges or other amounts due from Hyperion to Ucyclyd.

ARTICLE 8

INTELLECTUAL PROPERTY

      8.1 Ownership Rights of Intellectual Property . Subject to the terms and conditions of this Agreement, ownership of intellectual property shall be determined as set forth in this Section 8.1 (Ownership Rights of Intellectual Property) .

           8.1.1 Pre-Closing .

                (a) Product Technology . Prior to Closing, Ucyclyd shall remain the sole and exclusive owner of all Product Technology.

                (b) Developed Technology . Prior to Closing, Ucyclyd shall be the sole and exclusive owner of all Developed Technology. Hyperion hereby assigns to Ucyclyd all of its rights, title and interests in, to and under such Developed Technology.

                (c) Manufacturing Technology . Ucyclyd shall remain the sole and exclusive owner of all Manufacturing Technology at all times prior to, on and following Closing. Hyperion hereby assigns to Ucyclyd all of its rights, title and interests in, to and under such Manufacturing Technology.

                (d) Brusilow Intellectual Property . The Brusilow Licensors shall retain ownership of the Brusilow Intellectual Property and during the Development Term, Hyperion shall have the sublicense rights described in Section 8.2.3 (Brusilow Intellectual Property).

                (e) Copyright . Hyperion agrees that all newly created copyrightable aspects of the Developed Technology and Manufacturing Technology shall be considered a “work-made-for-hire” within the meaning of the Copyright Act of 1976, as amended. To the

extent the Developed Technology, Manufacturing Technology or any part thereof, are found by a court of competent jurisdiction not to be a “work-made-for-hire” within the meaning of the Copyright Act of 1976, as amended, Hyperion agrees that all exclusive right, title and interest in and to those newly created copyrightable aspects of the Developed Technology and the Manufacturing Technology are hereby expressly assigned automatically to Ucyclyd without further consideration (the “ Copyrightable Developed Technology ”).

                (f) Hyperion’s Disclosure and Cooperation . During the Term until the Closing of the Purchase Transaction, Hyperion, on behalf of itself and all Affiliates or applicable Third Parties, shall: (i) promptly disclose to Ucyclyd any Developed Technology and Manufacturing Technology not previously disclosed to Ucyclyd by Hyperion under the Agreement or in the possession of Ucyclyd; and (ii) cooperate with Ucyclyd to provide all reasonable assistance to and execute all documents reasonably required by Ucyclyd to establish, assign, perfect and affirm any and all of Ucyclyd’s rights with respect to the Developed Technology and the Manufacturing Technology. If the Term of this Agreement is terminated without the Closing of the Purchased Transaction, Hyperion will cooperate with Ucyclyd with respect to its obligations in subsections (i) above for a period of **** after such termination and with respect to its obligations under subsection (ii) above, any time after such termination; provided that with respect to any such cooperation provided after the **** period following such termination, Ucyclyd agrees to reimburse Hyperion for the actual, documented, out-of-pocket costs and expenses incurred by Hyperion in connection with such cooperation. Ucyclyd shall use commercially reasonable efforts to secure the signature of Hyperion, its Affiliates or applicable Third Parties (as the case may be), to any document required to file, prosecute, register or memorialize the assignment of any rights as set forth in the Agreement; provided, however, if Ucyclyd is unable to secure such signature within **** of any request by Ucyclyd for such signature, Hyperion hereby irrevocably designates and appoints Ucyclyd and Ucyclyd’s duly authorized officers and agents as Hyperion’s agents and attorneys-in-fact to act for and on Hyperion’s behalf and instead of Hyperion to take all lawfully permitted acts to further the filing, prosecution, registration, memorializing of assignment, issuance and enforcement of such rights, all with the same legal force and effect as if executed by Hyperion. The foregoing is deemed a power coupled with an interest and is irrevocable during the Term until the Closing of the Purchase Transaction, and shall terminate at the Closing of the Purchase Transaction.

                (g) Hyperion’s Further Assurances . Hyperion shall take all reasonable steps to ensure that, during the Development Term, all of its employees acting under its authority in the performance of Hyperion’s obligations under the Agreement are and shall be obligated under a binding written agreement or established corporate policy to assign to Hyperion, or as Hyperion shall direct, all Developed Technology and Manufacturing Technology discovered, developed, originated, prepared, learned, obtained, made, conceived or reduced to practice by such employee as a result of such employee’s employment. In the case of all Persons acting on behalf of Hyperion in the performance of Hyperion’s obligations under the Agreement, including consultants, subcontractors, licensees, sublicensees, outside contractors, clinical investigators, agents, or non-employees working for non-profit academic institutions, such Persons also shall be obligated under an agreement that meets the criteria of the preceding sentence and Section 2.3 (Use of Contractors) , unless with Ucyclyd’s prior written approval.

           8.1.2 On and Following Closing.

                (a) Product Technology and Developed Technology . Upon Closing, Ucyclyd shall assign all Product Technology and Developed Technology (including any and all Copyrightable Developed Technology) to Hyperion under the Technology Assignment Agreement. Thereafter, Hyperion shall be the sole and exclusive owner of all such Product Technology and Developed Technology.

                (b) Manufacturing Technology . On and following Closing, Ucyclyd shall remain owner of all Manufacturing Technology and subject to the terms and conditions of this Agreement, shall continue to license the Manufacturing Technology to Hyperion as set forth in Section 8.2.2 (Manufacturing Technology; Drug Master Files) .

                (c) Brusilow Intellectual Property . Upon the Closing, the R&D Sublicense Agreement shall terminate and Ucyclyd shall assign its rights and obligations under the Brusilow License Agreement to Hyperion in accordance with Section 3.3.2 (Closing) and Hyperion will be the licensee under the Brusilow License Agreement.

                (d) Ucyclyd’s Cooperation . On and following Closing, Ucyclyd shall, on behalf of itself and all Affiliates, cooperate with Hyperion to provide all assistance to and execute all documents reasonably required by Hyperion to establish, assign, perfect and affirm any and all of Hyperion’s rights in accordance with this Section 8.1.2 (On and Following Closing) ; provided that, following the first (1st) anniversary of the Closing, Hyperion agrees to reimburse Ucyclyd for the actual, documented, out-of-pocket costs and expenses incurred by Ucyclyd in connection with such cooperation. Ucyclyd shall use commercially reasonable efforts to secure the signature of Ucyclyd or its Affiliates (as the case may be) to any document required to file, prosecute, register or memorialize the assignment of any rights as set forth in this subsection (d) ; provided, however, if Ucyclyd is unable to secure such signature within **** of any request by Ucyclyd for such signature, Ucyclyd hereby irrevocably designates and appoints Hyperion and Hyperion’s duly authorized officers and agents as Ucyclyd’s agents and attorneys-in-fact to act for and on Ucyclyd’s behalf and instead of Ucyclyd to take all lawfully permitted acts to further the filing, prosecution, registration, memorializing of assignment, issuance and enforcement of such rights, all with the same legal force and effect as if executed by Ucyclyd. The foregoing is deemed a power coupled with an interest and is irrevocable.

                (e) Manufacturing Technology Disclosure and Cooperation . On and following Closing, on behalf of itself and all Affiliates or applicable Third Parties, Hyperion shall: (i) promptly disclose to Ucyclyd any Manufacturing Technology not previously disclosed to Ucyclyd by Hyperion under the Agreement or in the possession of Ucyclyd; and (ii) cooperate with Ucyclyd to provide all reasonable assistance to and execute all documents reasonably required by Ucyclyd to establish, assign, perfect and affirm any and all of Ucyclyd’s rights with respect to the Manufacturing Technology. Ucyclyd shall use commercially reasonable efforts to secure the signature of Hyperion, its Affiliates or applicable Third Parties (as the case may be) to any document required to file, prosecute, register or memorialize the assignment of any rights as set forth in the Agreement; provided, however, if Ucyclyd is unable to secure for any reason within **** of any request by Ucyclyd for such signature, Hyperion hereby irrevocably designates and appoints Ucyclyd and Ucyclyd’s duly authorized officers and agents as

Hyperion’s agents and attorneys-in-fact to act for and on Hyperion’s behalf and instead of Hyperion to take all lawfully permitted acts to further the filing, prosecution, registration, memorializing of assignment, issuance and enforcement of such rights, all with the same legal force and effect as if executed by Hyperion. The foregoing is deemed a power coupled with an interest and is irrevocable on and following Closing, and shall terminate at the expiration of the Term.

      8.2 Licenses .

           8.2.1 Product Technology and Developed Technology . Subject to the terms and conditions of the Agreement, Ucyclyd hereby grants to Hyperion an exclusive (except as to Ucyclyd as set forth in Section 2.2.6(a) (Transition of Development and Regulatory Program to Hyperion) ), non-transferable (except as permitted by Section 16.14 (Assignment) ), non-sublicenseable (except as necessary to conduct research and development activities outside of the United States in accordance with in Section 2.2.3 (R&D Rights Outside of the United States) ), fee-earning (to the extent Hyperion is permitted to Commercialize **** prior to Closing in accordance with Section 2.2.9 (Approval of **** Prior to Closing) ) license under the Product Technology and the Developed Technology to research, develop, make, have made, import and use the Development Products to: (a) perform the activities under the Development and Regulatory Program in the Development Field in the Development Territory; (b) perform research and development activities of such Development Products outside the Development Field in the Development Territory only pursuant to Section 2.2.2 (R&D Rights Outside of the Development Field) ; and (c) perform research and development activities of such Development Products outside the Development Territory only pursuant to Section 2.2.3 (R&D Rights Outside of the United States) , in each case for the duration of the Development Term. For clarity, the license granted under this Section 8.2.1 (Product Technology and Developed Technology) does not grant Hyperion the right to Commercialize, promote, market or sell the Development Products, and any rights to Commercialize, promote market or sell the Development Products in the Development Field arise only on and following Closing, or in the case of **** only, may arise in accordance with the terms and conditions set forth in Section 2.2.9 (Approval of **** Prior to Closing) .

           8.2.2 Manufacturing Technology; Drug Master Files .

                (a)  During the Development Term, subject to the terms and conditions of the Agreement, Ucyclyd hereby grants to Hyperion an exclusive (except as to Ucyclyd as set forth in Section 2.2.6(a) (Transition of Development and Regulatory Program to Hyperion) ), non-transferable (except as permitted by Section 16.14 (Assignment) ), non-sublicenseable (except to a contract manufacturer as permitted under the Agreement), fee-earning (to the extent Hyperion is permitted to Commercialize **** prior to Closing in accordance with Section 2.2.9 (Approval of **** Prior to Closing) ) license under the Manufacturing Technology to make or have: (i) clinical supplies for **** ; and (ii) commercial supply of **** , provided that each such supply (clinical and commercial) is subject to the other terms and conditions of this Agreement regarding manufacture and supply of Products.

                (b)  On and after the Closing Date, subject to the terms and conditions of the Agreement, Ucyclyd hereby grants to Hyperion an exclusive (even as to Ucyclyd except as set forth in this subsection (b) ), non-transferable (except as permitted by Section 16.14 (Assignment) ), sublicenseable, fee-earning license under the Manufacturing Technology to make or have made the Products; provided, however, Ucyclyd shall have the right to use the Manufacturing Technology for purposes of the DMFs under this Agreement and fulfilling Ucyclyd’s obligations to Hyperion under the Agreement. Upon expiration of the Term, all right, title, and interest in and to such Manufacturing Technology shall be fully-paid and assigned to Hyperion.

                (c)  Hyperion acknowledges that a DMF exists with respect to sodium benzoate, an active ingredient in Ammonul and Ammonul HE. As soon as reasonably practicable after the Effective Date, Ucyclyd shall prepare and file with the FDA DMFs for GT4P. Upon acceptance of such DMFs by the FDA, Ucyclyd shall instruct the FDA to supersede, and if permitted delete, the information corresponding to such DMFs in the relevant IND or NDA with that of the DMFs. The DMFs and such portion of the NDAs or INDs as would be covered by such DMFs shall remain with, and as between Hyperion and Ucyclyd shall at all times be the sole property of, Ucyclyd or its Affiliates. Ucyclyd shall not make any material amendment to any such DMF without Hyperion’s prior written consent which shall not be unreasonably withheld, delayed or conditioned; provided, however, Ucyclyd shall not be required to disclose to Hyperion the content of the actual amendment. Hyperion acknowledges and agrees that the licenses to Manufacturing Technology as set forth in subsections (b) and (c) above are the subject of the DMFs and right of references granted in subsection (d) below and Hyperion shall not be entitled to take possession or have access to the Manufacturing Know-How that comprises the DMF, other than the rights granted to it under Section 8.2. 2(d) (Manufacturing Technology; Drug Master Files) below.

                (d)  During the Term, Hyperion shall have a right of reference to the NDAs, INDs and the DMFs as necessary to support the regulatory approval, manufacture (including for Hyperion’s back-up manufacturers) and Commercialization of the Development Products. During the Term, Ucyclyd shall provide to Hyperion, and subject to the licenses set forth in subsections (a) and (b) above, Ucyclyd shall be permitted to use, the Manufacturing Know-How other than the Manufacturing Know-How that comprises the DMF.

                (e)  At all times during the Term, to the extent that Hyperion has rights to make or have made Products, Hyperion agrees to use the DMFs established by Ucyclyd in connection with the Products and Hyperion further agrees to use the contract manufacturers at which Ucyclyd has established the DMFs for such Products. Hyperion shall have the right to qualify alternate manufacturers reasonably acceptable to Ucyclyd and to transfer m