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CONFIDENTIAL

Exhibit 10.49

Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential. Triple asterisks denote omissions.

COLLABORATION AGREEMENT
BY AND BETWEEN
AKEBIA THERAPEUTICS, INC.
AND
MITSUBISHI TANABE PHARMA CORPORATION
 
 

CONFIDENTIAL

TABLE OF CONTENTS
 
																		
						
	 	Page
	ARTICLE I. DEFINITIONS	 	1
	 	 	 	 	 	 
	 	Section 1.01	 	“Affiliate”	 	1
	 	Section 1.02	 	“Akebia Inventions”	 	1
	 	Section 1.03	 	“Akebia Know-How”	 	2
	 	Section 1.04	 	“Akebia Patents”	 	2
	 	Section 1.05	 	“Akebia Reserved Dispute”	 	2
	 	Section 1.06	 	“Akebia Technology”	 	2
	 	Section 1.07	 	“Akebia Trademark”	 	2
	 	Section 1.08	 	“API”	 	2
	 	Section 1.09	 	“Business Day”	 	2
	 	Section 1.10	 	“Commercialization” or “Commercialize”	 	2
	 	Section 1.11	 	“Commercialization Plan”	 	2
	 	Section 1.12	 	“Commercially Reasonable Efforts”	 	2
	 	Section 1.13	 	“Confidential Information”	 	3
	 	Section 1.14	 	“Controlled”	 	3
	 	Section 1.15	 	“Cost of Goods Sold” or “COGS”	 	3
	 	Section 1.16	 	“DD-CKD Indication”	 	3
	 	Section 1.17	 	“Development”	 	3
	 	Section 1.18	 	“Development Plan”	 	4
	 	Section 1.19	 	“Distributor”	 	4
	 	Section 1.20	 	“Dollars” or “$”	 	4
	 	Section 1.21	 	“FDA”	 	4
	 	Section 1.22	 	“FD&C Act”	 	4
	 	Section 1.23	 	“Field”	 	4
	 	Section 1.24	 	“First Commercial Sale”	 	4
	 	Section 1.25	 	“Global Phase 3 DD-CKD Study”	 	4
	 	Section 1.26	 	“Global Phase 3 NDD-CKD Study”	 	4
	 	Section 1.27	 	“Global Phase 3 Program”	 	5
	 	Section 1.28	 	“Good Clinical Practices” or “GCP”	 	5
	 	Section 1.29	 	“Good Laboratory Practices” or “GLP”	 	5
	 	Section 1.30	 	“Good Manufacturing Practices” or “GMP”	 	5
	 	Section 1.31	 	“HIF Product”	 	5
	 	Section 1.32	 	“Improvements”	 	5
	 	Section 1.33	 	“IND”	 	5
	 	Section 1.34	 	“Invention(s)”	 	5
	 	Section 1.35	 	“Joint Inventions”	 	5
	 	Section 1.36	 	“Joint Patents”	 	5
	 	Section 1.37	 	“Joint Technology”	 	5
	 	Section 1.38	 	“Know-How”	 	6
	 	Section 1.39	 	“Launch Plan”	 	6
	 	Section 1.40	 	“Licensee Inventions”	 	6

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	 	Section 1.41	 	“Licensee Know-How”	 	6
	 	Section 1.42	 	“Licensee Patents”	 	6
	 	Section 1.43	 	“Licensee Reserved Dispute”	 	6
	 	Section 1.44	 	“Licensee Technology”	 	6
	 	Section 1.45	 	“Licensee Trademark”	 	6
	 	Section 1.46	 	“Licensed Compound”	 	6
	 	Section 1.47	 	“Licensed Product”	 	6
	 	Section 1.48	 	“Medical Affairs”	 	6
	 	Section 1.49	 	“MHLW”	 	6
	 	Section 1.50	 	“NDA”	 	7
	 	Section 1.51	 	“NDD-CKD Indication”	 	7
	 	Section 1.52	 	“Net Sales”	 	7
	 	Section 1.53	 	“Patents”	 	8
	 	Section 1.54	 	“Phase 1 Trial”	 	8
	 	Section 1.55	 	“Phase 2 Trial”	 	8
	 	Section 1.56	 	“Phase 3 Trial”	 	8
	 	Section 1.57	 	“PMDA”	 	8
	 	Section 1.58	 	“Regulatory Approval”	 	8
	 	Section 1.59	 	“Regulatory Authority”	 	8
	 	Section 1.60	 	“Regulatory Filings”	 	9
	 	Section 1.61	 	“Reimbursement Approval”	 	9
	 	Section 1.62	 	“Safety Data Exchange Agreement”	 	9
	 	Section 1.63	 	“sNDA”	 	9
	 	Section 1.64	 	“Territory”	 	9
	 	Section 1.65	 	“Third Party”	 	9
	 	Section 1.66	 	“U.S.”	 	9
	 	Section 1.67	 	“Valid Claim”	 	9
	 	Section 1.68	 	Interpretation	 	11
	 	 	 	 	 	 
	ARTICLE II. LICENSES	 	12
	 	 	 	 	 	 
	 	Section 2.01	 	Grant of License	 	12
	 	Section 2.02	 	Rights to Grant Sublicense	 	12
	 	Section 2.03	 	No Other Rights and Retained Rights	 	12
	 	Section 2.04	 	Knowledge Transfer	 	13
	 	 	 	 	 	 
	ARTICLE III. GOVERNANCE	 	13
	 	 	 	 	 	 
	 	Section 3.01	 	Formation and Purpose of JSC	 	13
	 	Section 3.02	 	Membership	 	13
	 	Section 3.03	 	Meetings	 	13
	 	Section 3.04	 	Decision Making and JSC Dispute Resolution	 	14
	 	Section 3.05	 	Meeting Agendas	 	14
	 	Section 3.06	 	Additional Committees	 	14
	 	Section 3.07	 	Interactions Between Committees and Internal Teams	 	14
	 	Section 3.08	 	Specific Responsibilities of the JSC	 	14
	 	Section 3.09	 	Alliance Managers	 	15

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	ARTICLE IV. DEVELOPMENT	 	16
	 	 	 	 	 	 
	 	Section 4.01	 	Development in the Territory	 	16
	 	Section 4.02	 	Development Plan	 	16
	 	Section 4.03	 	Development Reports	 	16
	 	Section 4.04	 	Standards of Conduct	 	17
	 	Section 4.05	 	Developmental Efforts	 	17
	 	Section 4.06	 	Records	 	17
	 	Section 4.07	 	Medical Affairs	 	17
	 	 	 	 	 	 
	ARTICLE V. REGULATORY	 	17
	 	 	 	 	 	 
	 	Section 5.01	 	Regulatory Filings	 	17
	 	 	 	 	 	 
	ARTICLE VI. COMMERCIALIZATION	 	18
	 	 	 	 	 	 
	 	Section 6.01	 	General	 	18
	 	Section 6.02	 	Commercialization Reports	 	19
	 	Section 6.03	 	Commercialization Efforts	 	19
	 	Section 6.04	 	Standards of Conduct	 	19
	 	Section 6.05	 	Trademarks and International Nonproprietary Name	 	19
	 	 	 	 	 	 
	ARTICLE VII. MANUFACTURING AND SUPPLY	 	20
	 	 	 	 	 	 
	 	Section 7.01	 	Manufacture and Supply of Licensed Products	 	20
	 	Section 7.02	 	Supply Price	 	20
	 	Section 7.03	 	Labeling	 	20
	 	 	 	 	 	 
	ARTICLE VIII. PAYMENTS	 	21
	 	 	 	 	 	 
	 	Section 8.01	 	Upfront License Fee	 	21
	 	Section 8.02	 	Development Costs	 	21
	 	Section 8.03	 	Milestone Payments	 	22
	 	Section 8.04	 	Royalties	 	23
	 	Section 8.05	 	Royalty Payments and Reports	 	24
	 	Section 8.06	 	Accounting	 	24
	 	Section 8.07	 	Currency Conversion	 	25
	 	Section 8.08	 	Methods of Payment	 	25
	 	Section 8.09	 	Taxes	 	25
	 	Section 8.10	 	Late Payments	 	26
	 	 	 	 	 	 
	ARTICLE IX. OWNERSHIP OF INTELLECTUAL PROPERTY	 	26
	 	 	 	 	 	 
	 	Section 9.01	 	Akebia Intellectual Property	 	26
	 	Section 9.02	 	Licensee Intellectual Property	 	26

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	 	Section 9.03	 	Joint Technology and Improvements	 	26
	 	Section 9.04	 	Prosecution of Akebia Patents	 	27
	 	Section 9.05	 	Prosecution of Licensee Patents Covering Improvements	 	27
	 	Section 9.06	 	Prosecution of Joint Patents	 	28
	 	Section 9.07	 	Enforcement and Defense	 	28
	 	Section 9.08	 	Defense of Third Party Infringement Claims	 	29
	 	Section 9.09	 	Patent Term Extensions	 	30
	 	Section 9.10	 	Trademarks	 	30
	 	 	 	 	 	 
	ARTICLE X. INFORMATION AND ADVERSE DRUG EVENTS AND REPORTS	 	30
	 	 	 	 	 	 
	 	Section 10.01	 	Information	 	30
	 	Section 10.02	 	Data Security	 	30
	 	Section 10.03	 	Compliance	 	30
	 	Section 10.04	 	Adverse Drug Events	 	31
	 	 	 	 	 	 
	ARTICLE XI. REPRESENTATIONS, WARRANTIES, AND COVENANTS	 	31
	 	 	 	 	 	 
	 	Section 11.01	 	Mutual Representations and Warranties	 	31
	 	Section 11.02	 	Additional Akebia Warranties	 	32
	 	Section 11.03	 	Additional Licensee Warranties	 	33
	 	Section 11.04	 	Disclaimer	 	34
	 	Section 11.05	 	Limitation of Liability	 	34
	 	 	 	 	 	 
	ARTICLE XII. CONFIDENTIALITY	 	35
	 	 	 	 	 	 
	 	Section 12.01	 	Generally	 	35
	 	Section 12.02	 	Exceptions	 	35
	 	Section 12.03	 	Publicity	 	36
	 	Section 12.04	 	Publications	 	36
	 	Section 12.05	 	Injunctive Relief	 	37
	 	 	 	 	 	 
	ARTICLE XIII. INDEMNIFICATION	 	37
	 	 	 	 	 	 
	 	Section 13.01	 	Indemnification by Akebia	 	37
	 	Section 13.02	 	Indemnification by Licensee	 	37
	 	Section 13.03	 	Procedure	 	38
	 	Section 13.04	 	Insurance	 	38
	 	 	 	 	 	 
	ARTICLE XIV. TERM AND TERMINATION	 	38
	 	 	 	 	 	 
	 	Section 14.01	 	Term	 	38
	 	Section 14.02	 	Termination for Breach	 	38
	 	Section 14.03	 	Termination for Convenience	 	39
	 	Section 14.04	 	Termination for Bankruptcy	 	39
	 	Section 14.05	 	Effect of Termination by Akebia	 	39
	 	Section 14.06	 	Effect of Termination by Licensee	 	40
	 	Section 14.07	 	Survival; Accrued Rights	 	40

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	ARTICLE XV. DISPUTE RESOLUTION; GOVERNING LAW	 	41
	 	 	 	 	 	 
	 	Section 15.01	 	Executive Officers; Disputes	 	41
	 	Section 15.02	 	Arbitration	 	41
	 	Section 15.03	 	Choice of Law	 	42
	 	 	 	 	 	 
	ARTICLE XVI. MISCELLANEOUS	 	42
	 	 	 	 	 	 
	 	Section 16.01	 	Assignment	 	42
	 	Section 16.02	 	Standstill	 	42
	 	Section 16.03	 	Non-Competition	 	42
	 	Section 16.04	 	Additional Collaboration	 	43
	 	Section 16.05	 	Force Majeure	 	43
	 	Section 16.06	 	Entire Agreement	 	43
	 	Section 16.07	 	Severability	 	43
	 	Section 16.08	 	Notices	 	43
	 	Section 16.09	 	Further Assurances	 	44
	 	Section 16.10	 	Agency	 	44
	 	Section 16.11	 	No Waiver	 	44
	 	Section 16.12	 	No Strict Construction	 	45
	 	Section 16.13	 	Cumulative Remedies	 	45
	 	Section 16.14	 	Counterparts	 	45

 
 
 

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COLLABORATION AGREEMENT
THIS COLLABORATION AGREEMENT (this “Agreement”) is made and entered into as of December 11, 2015 (“Effective Date”) between Akebia Therapeutics, Inc., a company organized and existing under the laws of the State of Delaware, United States of America with its principal offices at 245 First Street, Suite 1100, Cambridge, MA 02142, U.S.A. (“Akebia”), and Mitsubishi Tanabe Pharma Corporation, a company organized and existing under the laws of Japan, with its principal offices at 3-2-10 Dosho-machi, Cho-ku, Osaka, Japan (“Licensee”).
Akebia and Licensee may be referred to herein individually as a “Party” and collectively as the “Parties”.
RECITALS
WHEREAS, Akebia is the owner of, or otherwise controls, the Akebia Technology and the Licensed Compound and the Licensed Product in the Territory as defined below;
WHEREAS, Licensee has expertise in the development of biopharmaceutical products and has regulatory and commercial capabilities in the Territory, and is interested in obtaining an exclusive license to Develop and Commercialize the Licensed Compound and the Licensed Product in the Territory; and  
WHEREAS, the Parties desire to [***] for the Licensed Compound and the Licensed Product and collaborate to Develop and Commercialize the Licensed Compound and the Licensed Product in the Territory, and Akebia wishes to grant Licensee an exclusive license to develop, use, sell, offer to sell and import the Licensed Compound and the Licensed Product in the Territory for this purpose.
NOW THEREFORE, the Parties agree as follows:
ARTICLE I.
DEFINITIONS
Section 1.01 “Affiliate” means, with respect to an entity, any corporation or other business entity controlled by, controlling, or under common control with such entity, with “control” meaning direct or indirect beneficial ownership of at least fifty percent (50%) of the voting stock of, or at least a fifty percent (50%) interest in the income of, the applicable entity.  Notwithstanding the foregoing, “Affiliates” shall not include, with respect to an entity, bona fide venture capital investors in such entity or bona fide institutional investors in such entity, which institutional investors routinely make venture capital investments for the potential financial return on such investments and not with any view to acquisition or for any other strategic purpose, or Affiliates of such venture capital or institutional investors.
Section 1.02 “Akebia Inventions” means all Inventions that (a) are made prior to or during the Term by one or more employees of Akebia or any Affiliate of Akebia, or persons contractually required to assign or license patent rights covering such Inventions to Akebia or any Affiliate of Akebia, and (b) are not Joint Inventions.
Section 1.03 “Akebia Know-How” means all Know-How that is both (a) Controlled as of the Effective Date and during the Term by Akebia or any of its Affiliates; and (b) [***]; or (ii) [***].  For the avoidance of doubt, Akebia Know-How shall include any Know-How developed during the Global Phase 3 Program.

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Section 1.04 “Akebia Patents” means all Patents (including any Joint Patents) that both (a) are Controlled as of the Effective Date or during the Term by Akebia or any of its Affiliates in the Territory, and (b) cover a Licensed Compound or a Licensed Product or their respective Development, manufacture, use, design, registration, offer for sale, sale or importation.  All Akebia Patents as of the Effective Date are listed in Exhibit A.
Section 1.05 “Akebia Reserved Dispute” means any dispute with respect to the [***] including any decision that [***] including, without limitation, decisions regarding any [***] of the Licensed Compound or Licensed Product or the [***] of the Licensed Compound or Licensed Product in the Territory.  Notwithstanding the foregoing, once the Joint Steering Committee has determined to [***] any dispute relating to the [***].
Section 1.06 “Akebia Technology” means Akebia Know-How and Akebia Patents.
Section 1.07 “Akebia Trademark” means one or more trademarks selected by Akebia or its licensees under which (i) Akebia or its licensees will market any Licensed Product outside the Territory and/or (ii) Licensee will Commercialize the Licensed Product inside the Territory if the global brand name is used in accordance with Section 6.05 (Trademarks and International Nonproprietary Name) hereof, as well as the trademarks for the Akebia company name and logo, and all trademark registrations and applications therefor, and all goodwill associated therewith.
Section 1.08 “API” means active pharmaceutical ingredient, which is also commonly referred to as drug substance. For the avoidance of doubt, API shall include any prodrug form.
Section 1.09 “Business Day” means a calendar day in which the corporate headquarters of both Akebia and Licensee are open for business.
Section 1.10 “Commercialization” or “Commercialize” means, with respect to a Licensed Product or a Combination Product or Bundled Product, any and all activities directed to the marketing, promotion, distribution, offering for sale, and sale of such Licensed Product, Combination Product, or Bundled Product in the Territory, and interacting with Regulatory Authorities regarding the foregoing.
Section 1.11 “Commercialization Plan” means the annual plan for Commercialization of the Licensed Product, Combination Product and/or Bundled Product in the Territory by Licensee and the activities to be conducted by Licensee relating thereto including, without limitation, detailed plans for sales and marketing after launch.
Section 1.12 “Commercially Reasonable Efforts” means, with respect to the Development and/or Commercialization of a Licensed Compound or Licensed Product, those efforts and resources, including reasonably necessary personnel, equivalent to the efforts that a research-based biopharmaceutical company would typically devote to a product of similar market potential, profit potential and strategic value and at a comparable stage in development or product life to such Licensed Product, based on conditions then prevailing and taking into account issues of safety and efficacy, product profile, difficulty in developing the Licensed Product, competitiveness of alternative Third Party products in the marketplace, the patent or other proprietary position of the Licensed Product, the regulatory structure involved and the potential profitability of the Licensed Product marketed or to be marketed.
Section 1.13 “Confidential Information” means Know-How and any technical, scientific, trade, research, manufacturing, business, financial, marketing, product, supplier, intellectual property and other information that may be disclosed by one Party to the other Party, regardless of whether such information is specifically designated as confidential and regardless of whether such information is in written, oral, electronic, or other form.  

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Section 1.14 “Controlled” means, with respect to a Party or its Affiliate, and any Know-How, Patent or other intellectual property right, that such Party or Affiliate, as the case may be, owns or has a license to such intellectual property right and has the ability to grant to the other Party a license or sublicense to, or a right of access with respect to, such Know-How, Patent or other intellectual property right without violating the terms of any pre-existing agreement or other pre-existing arrangements with any Third Party.
Section 1.15 “Cost of Goods Sold” or “COGS” means the fully burdened cost of all direct materials and labor and fully allocated manufacturing overhead directly attributable to the manufacture, storage, packaging, and shipping of a Licensed Product, calculated in accordance with U.S. GAAP and Akebia’s or its suppliers’, as applicable, then-prevailing standard procedure for calculating COGS as reflected in Akebia’s or its suppliers’, as applicable, audited financial statements. COGS includes, without limitation, all bulk API, work in process (where applicable) and transfer prices paid by Akebia, Licensed Product testing and yield loss costs, quality control, quality assurance, or other testing of Licensed Products, together with all reasonably allocated indirect costs and overhead applicable to manufacturing of Licensed Product, quality control or technical operations functions, less costs of goods returned in accordance with Akebia’s, or its suppliers’, return policy.
Section 1.16 “DD-CKD Indication” means the treatment of anemia in dialysis patients with chronic kidney disease.
Section 1.17 “Development” means all internal and external research, development and regulatory activities regarding a Licensed Compound and Licensed Product, as the case may be.  This includes (a) research, preclinical testing, toxicology, route of synthesis, non-clinical activities, formulation and clinical studies of Licensed Compound and Licensed Product; and (b) preparation, submission, review, and development of data or information for the purpose of submission to a governmental authority to obtain authorization to conduct clinical trials and Regulatory Approval of Licensed Product.  Development shall include development and regulatory activities for additional forms, formulations, or indications for a Licensed Product after Regulatory Approval of such Licensed Product, including clinical trials initiated following receipt of Regulatory Approval or any clinical trial to be conducted after a Regulatory Approval which was mandated by the applicable Regulatory Authority as a condition of such Regulatory Approval with respect to an approved indication.  “Develop”, “Developing” and “Developed” shall be construed accordingly.

Section 1.18 “Development Plan” means the plan setting out activities to be undertaken by Licensee and Akebia, and their Affiliates, licensees and sublicensees, in Developing the Licensed Compound and Licensed Product together with timelines and, in the [***], budgets, for such activities including, without limitation, the proposed clinical trials, regulatory plans, and manufacturing plans as well as outlining the key elements involved in obtaining Regulatory Approval in the Territory.
Section 1.19 “Distributor” means any Third Party appointed by Licensee or its Affiliates to distribute, market, offer for sale and/or sell the Licensed Product  in the Territory.
Section 1.20 “Dollars” or “$” means the legal tender of the U.S.
Section 1.21 “FDA” means the U.S. Food and Drug Administration or any successor agency thereto.
Section 1.22 “FD&C Act” means the U.S. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time.

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Section 1.23 “Field” means the treatment, prevention and/or diagnosis of any diseases or conditions in humans, including, but not limited to, anemia.
Section 1.24 “First Commercial Sale” means, for each Licensed Product in the Territory, the first sale for end use or consumption to a Third Party of such Licensed Product in the Territory by Licensee, its Affiliate or its permitted sublicensee after the granting of Regulatory Approval in the Field for such Licensed Product by the relevant Regulatory Authorities.  First Commercial Sale excludes any sale or other distribution for use in a clinical trial or other Development activity, or for compassionate or named-patient use.
Section 1.25 “Global Phase 3 DD-CKD Study” means the Phase 3 global clinical studies for the DD-CKD Indication, known informally as the INNO2VATE study, consisting of a conversion study and a correction study, and known formally as the “Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat Compared to Epoetin Alfa in the Maintenance Treatment of Anemia of CKD in Subjects with Dialysis-Dependent Chronic Kidney Disease (INNO2VATE – Conversion)” and the “Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects with Incident Dialysis-Dependent Chronic Kidney Disease (INNO2VATE – Correction)”.
Section 1.26 “Global Phase 3 NDD-CKD Study” means the Phase 3 global clinical studies for the NDD-CKD Indication, known informally as the PRO2TECT study, consisting of a conversion study and a correction study, and known formally as the “Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects with Non-Dialysis Dependent Chronic Kidney Disease (PRO2TECT – Conversion)” and the “Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects with Non-Dialysis-Dependent Chronic Kidney Disease (PRO2TECT – Correction)”.

Section 1.27 “Global Phase 3 Program” means the Global Phase 3 NDD-CKD Study and the Global Phase 3 DD-CKD Study collectively, as well as any other studies that (i) generate data required to obtain Regulatory Approval of the Licensed Product both inside and outside of the Territory and that (ii) are approved by the JSC.
Section 1.28 “Good Clinical Practices” or “GCP” means the then-current good clinical practice standards, practices, and procedures promulgated or endorsed by the applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time to time.
Section 1.29 “Good Laboratory Practices” or “GLP” means the then-current good laboratory practice standards, practices, and procedures promulgated or endorsed by the applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time to time.
Section 1.30 “Good Manufacturing Practices” or “GMP” means the then-current good manufacturing practices required by the applicable Regulatory Authority, including the MHLW and PMDA or, solely for Akebia’s obligations, covenants, and representations under this Agreement, by the FDA.
Section 1.31 “HIF Product” means any product or product candidate that is a hypoxia inducible factor (“HIF”) prolyl hydroxylase inhibitor for the treatment of anemia related to 

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chronic kidney disease. For the avoidance of doubt, “HIF Product” shall include, without limitation, [***] and the Licensed Product.
Section 1.32 “Improvements” Section 1.01 means all Inventions or Know-How relating to, arising from the use of, or including the Licensed Compound or Licensed Product or their respective Development, manufacture, use, design, registration, offer for sale, sale or importation that are made during the Term solely by one or more employees of Licensee or any Affiliate of Licensee, or persons contractually required to assign or license patent rights covering such Inventions to Licensee or any Affiliate of Licensee.
Section 1.33 “IND” means an Investigational New Drug application for submission to the FDA or its equivalent in the Territory.
Section 1.34 “Invention(s)” means any process, method, composition of matter, article of manufacture, discovery or finding that is conceived and/or reduced to practice (whether or not patentable).
Section 1.35 “Joint Inventions” means any Inventions that are jointly made during the Term by at least one (1) employee of Akebia or its Affiliate or person contractually required to assign or license patent rights covering such inventions to Akebia and at least one (1) employee of Licensee or its Affiliate or person contractually required to assign or license patent rights covering such inventions to Licensee.
Section 1.36 “Joint Patents” means all Patents claiming Joint Inventions.
Section 1.37 “Joint Technology” means Joint Inventions and Joint Patents.
Section 1.38 “Know-How” means Inventions, discoveries, trade secrets, information, experience, data, formulas, procedures, technology and results (whether or not patentable), including discoveries, formulae, practices, methods, knowledge, know-how, processes, experience and test data (including physical, chemical, biological, toxicological, pharmacological, clinical and veterinary data), dosage regimens, control assays, product specifications, analytical and quality control data, marketing, pricing, distribution cost and sales data or descriptions.
Section 1.39 “Launch Plan” means the strategic plan for the Licensed Product which details the activities to be conducted prior to launch, plans for launch, and activities to be conducted after launch.
Section 1.40 “Licensee Inventions” means all Inventions that (a) are made during the Term by one or more employees of Licensee or any Affiliate of Licensee, or persons contractually required to assign or license patent rights covering such Inventions to Licensee or any Affiliate of Licensee, and (b) are not Joint Inventions.
Section 1.41 “Licensee Know-How” means all Know-How that is both (a) Controlled as of the Effective Date or during the Term by Licensee or any of its Affiliates in the Territory, and (b) is either (i) [***] or (ii) [***].  For the avoidance of doubt, Licensee Know-How shall include any Know-How developed during pre-clinical or clinical studies conducted by Licensee in the Territory.
Section 1.42 “Licensee Patents” means all Patents (excluding any Joint Patents) that are Controlled as of the Effective Date or during the Term by Licensee or any of its Affiliates.

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Section 1.43 “Licensee Reserved Dispute” means any dispute with respect to the [***] and as set forth in the last sentence of Section 1.05 (Akebia Reserved Dispute) hereof.
Section 1.44 “Licensee Technology” means Licensee Know-How and Licensee Patents.
Section 1.45 “Licensee Trademark” means, if the global brand name selected by Akebia for the Licensed Product cannot be used in the Territory pursuant to Section 6.05 (Trademarks and International Nonproprietary Name) hereof, the trademarks approved by the JSC under which Licensee, its Affiliates or its sublicensees will market such Licensed Product in the Territory in the Field, and all trademark registrations and applications therefor, and all goodwill associated therewith.
Section 1.46 “Licensed Compound” means vadadustat, formerly known as AKB-6548.
Section 1.47 “Licensed Product” means any pharmaceutical product, drug product, preparation, formulation, or dosage form that has the Licensed Compound as at least one API.
Section 1.48 “Medical Affairs” means communications with key opinion leaders, medical education, symposia and other medical programs and communications.
Section 1.49 “MHLW” means the Ministry of Health, Labor and Welfare, otherwise referred to as “Koro-Sho,” or any successor thereto.
Section 1.50 “NDA” means a New Drug Application or its equivalent for submission to the FDA or its equivalent in the Territory.
Section 1.51 “NDD-CKD Indication” means the treatment of anemia in non-dialysis patients with chronic kidney disease.
Section 1.52 “Net Sales” means the gross invoice price of Licensed Product sold or otherwise transferred to a Third Party by Licensee, its Affiliates or sublicensees (each, a “Seller”) to independent Third Parties for consideration, reduced by the following amounts to the extent such items are customary under industry practices and to the extent such amounts are included in the gross invoiced sales price:
(a) trade, cash and quantity discounts actually allowed and taken directly with respect to such sales or transfers, and inventory management fees paid to wholesalers and reasonably allocated to such Licensed Product;
(b) tariffs, duties, excises, value added tax and other sales taxes imposed upon and paid with respect to the sale, transportation, delivery, use, exportation, or importation of such Licensed Product (which does not include income, withholding or similar taxes);
(c) amounts actually repaid or credited upon returns, rejections, defects, recalls (due to spoilage, damage, expiration of useful life), price adjustments, billing errors, or trial prescriptions;
(d) invoiced freight, shipping, and insurance expenses specific to the Licensed Product and allocated accordingly;
(e) invoiced amounts that are written off as uncollectible in accordance with Seller’s accounting policies, as consistently applied;

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(f) allowances or credits to customers on account of price reductions affecting the Licensed Product;
(g) rebates, discounts, or charge-backs actually paid or credited to any governmental agency (or branch of government) or to any Third Party payor, administrator or contractee; and
(h) discounts actually paid under state-legislated or Seller-sponsored discount prescription drug programs or reductions or coupon and voucher programs.
If Seller receives [***] Net Sales for such Licensed Product sold or otherwise transferred.
In the event a Licensed Product is sold as part of a Combination Product, the Net Sales from the Combination Product, for the purposes of determining royalty payments, shall be determined by [***], in each case during the applicable royalty reporting period or, [***].  For purposes of this paragraph, a “Combination Product” means any prescription pharmaceutical product which comprises two (2) or more APIs, at least one (1) of which is the Licensed Compound.
If a Licensed Product is sold as part of a Bundled Product, the Seller [***] of the Licensed Product included in such [***].  For purposes of this paragraph, “Bundled Product” means products (including one or more Licensed Product) that are either (A) packaged together for sale or shipment as a single unit or sold at a single price or (B) marketed or sold collectively as a single product.
Section 1.53 “Patents” means (a) all patents and patent applications in any country or  jurisdiction in the Territory, and (b) any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like.
Section 1.54 “Phase 1 Trial” means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. Part 312.21(a) (as amended from time to time) or other comparable regulation imposed by an applicable Regulatory Authority in any country other than the United States, the principal purposes of which are to (a) determine the pharmacokinetics, metabolism, and pharmacologic actions of the drug in humans, (b) determine the side effects associated with increasing doses, and (c) if possible, gain early evidence of effectiveness to permit the design of well-controlled, scientifically valid, Phase 2 trials.  A Phase 1 Trial shall be deemed initiated upon the enrollment of the first subject.
Section 1.55 “Phase 2 Trial” means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. Part 312.21(b) (as amended from time to time) or other comparable regulation imposed by an applicable Regulatory Authority in any country other than the United States, the principal purposes of which are to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug.  A Phase 2 Trial shall be deemed initiated upon the enrollment of the first subject.
Section 1.56 “Phase 3 Trial” means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. Part 312.21(c) (as amended from time to time) or other comparable regulation imposed by an applicable Regulatory Authority in any country other than the United States, the principal purposes of which are to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.  A Phase 3 Trial shall be deemed initiated upon the enrollment of the first subject.

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Section 1.57 “PMDA” means the Pharmaceuticals and Medical Devices Agency in Japan or any successor thereto, which conducts scientific reviews of marketing authorization application for pharmaceuticals and monitoring of their post-marketing safety in Japan.
Section 1.58 “Regulatory Approval” means, with respect to a particular regulatory jurisdiction, all approvals (other than Reimbursement Approvals), product and/or establishment licenses, registrations or authorizations of any Regulatory Authority necessary for the commercial sale of a Licensed Product in such regulatory jurisdiction.
Section 1.59 “Regulatory Authority” means, in a particular country or jurisdiction, any applicable governmental authority involved in granting Regulatory Approval in such country or jurisdiction, including without limitation (a) in the United States, the FDA and any other applicable governmental authority in the United States having jurisdiction of the Licensed Product, (b) in Europe, the European Medicines Agency (“EMA”), and (c) in the Territory, the MHLW, PMDA, and any other applicable governmental authority in the Territory having jurisdiction over the Licensed Product.
Section 1.60 “Regulatory Filings” means all applications, filings, dossiers and the like submitted to a Regulatory Authority for the purpose of obtaining Regulatory Approval from that Regulatory Authority.  Regulatory Filings shall include, but not be limited to, all INDs, NDAs and other Regulatory Approval applications and their equivalents in the Territory.
Section 1.61 “Reimbursement Approval” means an approval, agreement, determination, or other decision by the applicable governmental authority and/or Regulatory Authority that establishes prices at which the Licensed Product will be reimbursed by the governmental authorities and/or Regulatory Authorities in the Territory.
Section 1.62 “Safety Data Exchange Agreement” means that agreement regarding receipt, investigation and reporting of product complaints, adverse events, product recalls, and any other information related to the safety of the Licensed Product as set forth in Section 10.04 (Adverse Drug Events) hereof.
Section 1.63 “sNDA” means supplemental New Drug Application or additional application for a previous New Drug Application (for example, seeking approval for a new indication) or its equivalent, for submission to Regulatory Authorities in the Territory.
Section 1.64 “Territory” means Japan, Taiwan, Indonesia, East Timor, South Korea, Mongolia, the Philippines, Vietnam, Laos, Cambodia, Thailand, Malaysia, Singapore, Burney, Myanmar, Nepal, Sri Lanka, Bangladesh, Bhutan, Maldives, Palau, Tonga and India, and their territories and possessions.
Section 1.65 “Third Party” means any person or entity other than a Party or its Affiliates.
Section 1.66 “U.S.” means the United States of America.
Section 1.67 “Valid Claim” means a claim in any Akebia Patent in the Territory, which claim has not been held invalid or unenforceable by a non-appealed or un-appealable decision of a court or government agency or other appropriate body of competent jurisdiction and has not been admitted invalid or unenforceable through reissue, reexamination or disclaimer, or has not been made unenforceable due to failure to pay maintenance fees.
 

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	Additional Defined Terms	 	Section
	Agreement	 	Preamble
	Alliance Manager	 	3.09
	Akebia	 	Preamble
	Akebia Indemnitees	 	13.02
	Akebia Regulatory Documents	 	5.01(b)

9
															
	Additional Defined Terms	 	Section
	Arbitration Request	 	15.02(a)
	Bankruptcy Code	 	14.04
	Bankrupt Party	 	14.04
	Breaching Party	 	14.02
	Bundled Product	 	1.52(h)
	Clinical Data	 	5.01(b)
	CMC	 	5.01(b)
	Combination Product	 	1.52(h)
	Competing Product	 	16.03
	Development Cost Pre-Payment	 	8.02(e)
	Developing Party	 	4.02
	Effective Date	 	Preamble
	EMA	 	1.59
	Event of Bankruptcy	 	14.04
	FCPA	 	11.03(b)(i)
	Form 3	 	8.01
	Form 17	 	8.01
	Form 6166	 	8.01
	Generic Product	 	8.04(d)
	Government Official	 	11.03(a)(i)
	[***]	 	[***]
	HIF	 	1.31
	ICH	 	10.03
	Information	 	10.01
	Indemnified Party	 	13.03
	Indemnifying Party	 	13.03
	Joint Publication Plan	 	12.04
	JPC	 	10.03
	JSC	 	3.01
	Lead Co-Chairperson	 	3.02
	Licensed Rights	 	2.01(ii)
	Licensee	 	Preamble
	Licensee Indemnitees	 	13.01
	Licensee Regulatory Documents	 	5.01(b)
	[***]	 	[***]
	Losses	 	13.01
	Non-Breaching Party	 	14.02
	Other Covered Party	 	11.03(a)(ii)
	Other Party	 	14.04

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	Party or Parties	 	Preamble
	Party Vote	 	3.04
	Recipient	 	12.02
	Royalty Term	 	8.04(b)
	Seller	 	1.52
	Sub-Committee	 	3.06
	Supply Price	 	7.02
	Tax Forms	 	8.01
	Term	 	14.01
	Withholding Tax Avoidance Documents	 	8.09
	Withholding Party	 	8.09

 
Section 1.68 Interpretation.  (a) Whenever any provision of this Agreement uses the term “including” (or “includes”), such term shall be deemed to mean “including without limitation” and “including but not limited to” (or “includes without limitations” and “includes but is not limited to”) regardless of whether the words “without limitation” or “but not limited to” actually follow the term “including” (or “includes”); (b) “herein,” “hereby,” “hereunder,” “hereof” and other equivalent words shall refer to this Agreement in its entirety and not solely to the particular portion of this Agreement in which any such word is used; (c) all definitions set forth herein shall be deemed applicable whether the words defined are used herein in the singular or the plural; (d) wherever used herein, any pronoun or pronouns shall be deemed to include both the singular and plural and to cover all genders; (e) the recitals set forth at the start of this Agreement, along with the schedules and the exhibits to this Agreement, and the terms and conditions incorporated in such recitals and schedules and exhibits shall be deemed integral parts of this Agreement and all references in this Agreement to this Agreement shall encompass such recitals and schedules and exhibits and the terms and conditions incorporated in such recitals and schedules and exhibits; provided, that in the event of any conflict between the terms and conditions of this Agreement and any terms and conditions set forth in the recitals, schedules or exhibits, the terms of this Agreement shall control; (f) in the event of any conflict between the terms and conditions of this Agreement and any terms and conditions that may be set forth on any order, invoice, verbal agreement or otherwise, the terms and conditions of this Agreement shall govern; (g) this Agreement shall be construed as if both Parties drafted it jointly, and shall not be construed against either Party as principal drafter; (h) unless otherwise provided, all references to Sections, Articles and Schedules in this Agreement are to Sections, Articles and Schedules of and to this Agreement; (i) any reference to any federal, national, state, local or foreign statute or law shall be deemed to also refer to all rules and regulations promulgated thereunder, unless the context requires otherwise; (j) wherever used, the word “shall” and the word “will” are each understood to be imperative or mandatory in nature and are interchangeable with one another; (k) references to a particular person include such person’s successors and assigns to the extent not prohibited by this Agreement; (l) references to Akebia’s knowledge shall be taken to refer to the knowledge of Akebia’s senior management team as of the Effective Date having made no particular inquiry; and (m) the captions used herein are inserted for convenience of reference only and shall not be construed to create obligations, benefits or limitations.
ARTICLE II.
LICENSES
Section 2.01 Grant of License.  Subject to the terms and conditions of this Agreement, Akebia hereby grants to Licensee, during the Term;

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(i) an exclusive, royalty-bearing license under Akebia Technology and Joint Technology to research, Develop, use, import, offer for sale, and sell the Licensed Compounds and Licensed Products in the Field in the Territory during the Term of this Agreement; and
(ii) a non-exclusive, royalty-bearing license under Akebia Technology and Joint Technology to make and have made the Licensed Compounds and Licensed Products for the purpose of exercising Licensee’s foregoing rights (collectively, the “Licensed Rights”); provided, however, that Licensee may only exercise its right to make and have made Licensed Compounds and Licensed Products in accordance with Section 7.01 (Manufacture and Supply of Licensed Products) hereof.
Section 2.02 Rights to Grant Sublicense.  Subject to the terms and conditions of this Agreement, upon Akebia’s written consent, not to be unreasonably withheld or delayed, Licensee shall have the right to enter into one or more sublicenses under this Agreement with Third Party/ies to research, Develop, use, make, have made, import, offer for sale, and sell the Licensed Compounds and the Licensed Products in the Field in the Territory during the Term of this Agreement; provided, however, that Licensee may only sublicense its right to make and have made Licensed Compounds and Licensed Products in accordance with Section 7.01 (Manufacture and Supply of Licensed Products); provided further, however, that Licensee shall have the right to sublicense to its Affiliates without Akebia’s consent after providing prior written notification to Akebia identifying Licensee’s intention to grant such sublicense, the purpose of such sublicense, and the Affiliate of Licensee to whom Licensee intends to grant such sublicense.  All permitted sublicensees shall hold their rights contingent on the Licensed Rights under this Agreement.  Any loss by Licensee of its rights under this Agreement due to an early termination of this Agreement for Licensee’s breach, pursuant to Article XIV (Term and Termination), or due to any other reason shall automatically cause all of the permitted sublicensees to lose the same rights under any sublicense.  Unless otherwise agreed by Akebia, each sublicense shall require the permitted sublicensee’s management to communicate its plan for the Development and Commercialization of the Licensed Product and implement processes for consistent communication and coordination between the sublicensee and Akebia during the term of the sublicense.  Licensee agrees that it shall be fully responsible and liable for any breach of the terms of this Agreement by any of its permitted sublicensees to the same extent as if Licensee itself has committed any such breach.
Section 2.03 No Other Rights and Retained Rights.  Nothing in this Agreement shall be interpreted to grant Licensee any rights under any Akebia Technology that are not expressly granted herein, whether by implication, estoppel or otherwise.  Any rights not expressly granted to Licensee by Akebia under this Agreement are hereby retained by Akebia. For the avoidance of doubt, Akebia retains the right to make, have made, Develop, use, import and export the Licensed Product in the Field in the Territory in order to fulfill its obligations under this Agreement and/or in order to Develop and Commercialize the Licensed Product outside the Territory.
Section 2.04 Knowledge Transfer (a) .  Within a reasonable time [***] days following the Effective Date hereof, Akebia shall provide to Licensee an initial onboarding information package describing the Development program for the Licensed Product including, but not limited to, non-clinical and clinical data, intellectual property and associated information, regulatory information and market research.  Akebia shall make its qualified personnel reasonably available to Licensee, free of charge to Licensee, at Akebia’s place of business and upon reasonable prior notice for the purpose of discussing such information under this Section 2.04 (Knowledge Transfer).  All further requests for additional information will be addressed through the Alliance Managers.

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ARTICLE III.
GOVERNANCE
Section 3.01 Formation and Purpose of JSC.  Within thirty (30) days after the Effective Date, Licensee and Akebia shall establish the Joint Steering Committee (“JSC”), which shall consist of [***] members, shall coordinate the Parties’ activities hereunder and shall have the additional responsibilities provided for herein.  The JSC will establish a charter that will include details regarding the operation of the JSC consistent with Article III (Governance) hereof.  The JSC will dissolve upon the expiration of the Term.
Section 3.02 Membership.  Each Party shall designate [***] representatives with appropriate knowledge and expertise to serve as members of the JSC.  Each Party may replace its JSC representatives at any time upon written notice to the other Party.  Akebia may designate one (1) of its JSC members as the co-chairperson and Licensee may designate one (1) of its JSC members as the co-chairperson.  [***] “Lead Co-Chairperson”.  The Lead Co-Chairperson shall be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting, and preparing and issuing minutes of each meeting within thirty (30) days thereafter.  Such minutes will not be finalized until all JSC members have had an adequate opportunity to review and confirm the accuracy of such minutes in writing.
Section 3.03 Meetings.  The JSC shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than twice a year.  The JSC shall meet alternatively at Licensee’s facilities in Tokyo, Japan and Akebia’s facilities in Cambridge, Massachusetts, or at such locations as the Parties may otherwise agree.  Other employees of each Party (including without limitation, the Alliance Managers of each Party) involved in the Development or Commercialization of Licensed Product may attend meetings of the JSC as non-voting participants, and, with the consent of each Party, consultants, representatives, or advisors involved in the same activities may attend meetings of the JSC as non-voting observers; provided, however, that such Third Party participants and observers are under obligations of confidentiality and non-use applicable to the Confidential Information of each Party and that are at least as stringent as those set forth in Article XII (Confidentiality).  Each Party shall be responsible for all of its own expenses of participating in any JSC meeting.   Meetings of the JSC may be held by audio or video teleconference with the consent of each Party; provided, however, that at least one (1) JSC meeting per year shall be held in person.
Section 3.04 Decision Making and JSC Dispute Resolution.  Each Party’s representatives on the JSC shall, collectively, have one (1) vote (the “Party Vote”) on all matters brought before the JSC.  The JSC shall operate as to matters within its jurisdiction by [***]; provided, however, that the JSC shall not have the authority to amend or modify, or waive compliance with, this Agreement.  Any disagreement between the representatives of Licensee and Akebia on JSC matters within the JSC’s jurisdiction shall, at the election of either Party, be referred for resolution pursuant to Article XV (Dispute Resolution, Governing Law).
Section 3.05 Meeting Agendas.  Each Party shall disclose to the other Party the proposed agenda items along with appropriate information at least [***] Business Days in advance of each meeting of the JSC; provided that under exigent circumstances requiring JSC input, a Party may provide its agenda items to the other Party within a lesser period of time in advance of the meeting, or may propose that there not be a specific agenda for a particular meeting, so long as such other Party consents to such later addition of such agenda items or the absence of a specific agenda for such JSC meeting.
Section 3.06 Additional Committees.  The JSC shall establish and delegate duties to other committees or ad-hoc sub-committees, including a Development committee and a 

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Commercialization committee (each a “Sub-Committee”), on an as needed basis to oversee particular projects or activities.  Each such Sub-Committee shall be constituted and shall operate as the JSC determines and shall be co-chaired by the Alliance Managers.  Each Sub-Committee and its activities shall be subject to the oversight, review and approval of, and shall report to, the JSC.  The authority of the Sub-Committee cannot exceed that specified for the JSC in this Article III (Governance).
Section 3.07 Interactions Between Committees and Internal Teams.  The Parties recognize that while they will establish the JSC and Sub-Committees under this Agreement, each Party possesses an internal structure (including without limitation various committees, teams and review boards) that will be involved in administering such Party’s activities under this Agreement.  If requested by a Party, the JSC and Sub-Committees shall establish procedures to facilitate communications between the JSC or such Sub-Committee and the relevant internal committee, team or board of the requesting Party.  Such procedures may include, to the extent reasonably necessary, requiring appropriate members of the JSC or Sub-Committee to be available at reasonable times and places and upon reasonable prior notice for making appropriate reports to, and responding to reasonable inquiries from, the relevant internal committee, team or board.
Section 3.08 Specific Responsibilities of the JSC.  In addition to its overall responsibility under this Agreement for the Development and Commercialization of Licensed Compounds and Licensed Products, the JSC shall, in particular:
(a) coordinate the activities of the Parties hereunder;
(b) resolve any disputes or disagreements, including those arising from any Sub-Committee, or submit unresolved disputes or disagreements to the designated executive officers pursuant to Section 3.04 (Decision Making and JSC Dispute Resolution) and Article XV (Dispute Resolution, Governing Law);
(c) support Development and Commercialization efforts for Licensed Compounds and Licensed Products, including reviewing and discussing the strategy for the Development and Commercialization of Licensed Compounds and Licensed Products;
(d) make recommendations for approval by the Parties for [***] programs;
(e) subject to Section 4.02 (Development Plan), review and approve the Development Plan [***];
(f) review and approve any Development in the Territory for [***] of the DD-CKD Indication and NDD-CKD Indication;
(g) subject to Section 6.05 (Trademarks and International Nonproprietary Name), review and discuss the use in the Territory of the [***] for the Licensed Product, which shall be prepared by Akebia, and review and discuss the [***] for each country in the Territory, which shall be prepared by Licensee;
(h) review and discuss a [***] including supporting materials for a [***] for [***] taking into consideration [***] for the [***];
(i) review commercial and sales performance, and sales forecasts, of the Licensed Product in each country in the Territory; and

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(j) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties, including the periodic evaluation of performance against goals.
Section 3.09 Alliance Managers.  Each of the Parties shall appoint a single individual to manage Development and Commercialization obligations between the Parties (each, an “Alliance Manager”).  The role of the Alliance Manager is to act as a single point of contact between the Parties to ensure a successful relationship under this Agreement.  The Alliance Managers may attend all JSC meetings and support their co-chairperson of the JSC in the discharge of his/her responsibilities.  Alliance Managers shall be non-voting participants in such JSC meetings, unless they are also appointed members of the JSC; provided, however, that an Alliance Manager may bring any matter to the attention of the JSC if such Alliance Manager reasonably believes that such matter warrants such attention.  Each Party may change its designated Alliance Manager at any time upon written notice to the other Party.  Any Alliance Manager may designate a substitute to temporarily perform the functions of that Alliance Manager by written notice to the other Party.  Each Alliance Manager will also:  (i) be the point of first referral in all matters of conflict resolution; (ii) provide a single point of communication for seeking consensus between the Parties regarding key strategy and plan issues; (iii) identify and bring disputes to the attention of the JSC in a timely manner; (iv) plan and coordinate cooperative efforts and internal and external communications; (v) co-chair any Sub-Committees established by the JSC pursuant to Section 3.06 (Additional Committees) hereof; and (vi) take responsibility for ensuring that governance activities, such as the conduct of required JSC meetings and production of meeting minutes, occur as set forth in this Agreement, and the relevant action items resulting from such meetings are appropriately carried out or otherwise addressed.
ARTICLE IV.
DEVELOPMENT
Section 4.01 Development in the Territory.  
(a) Clinical Development in Japan.  The Parties intend to use Commercially Reasonable Efforts to include [***] for the [***] based on the [***]. In the event that [***] associated with the [***] as set forth in the Development Plan, subject to Section 5.01 (Regulatory Filings) hereof, and [***]. Without affecting the generality of the foregoing, if either Party becomes aware of an event which would cause a material adverse effect to proceeding with the [***], such Party shall promptly notify the other Party and the Parties shall promptly discuss potential solutions, including that Licensee conducts certain supporting activities of the [***] subject to the approval of JSC.  In the event that [***], Licensee shall be responsible for the [***].
(b) Clinical Development in Countries in the Territory Other Than Japan.  Licensee shall be responsible for the Development of Licensed Compounds and Licensed Products in all countries in the Territory other than Japan and all costs associated therewith; provided, however, that if any such country is [***]. For the avoidance of doubt, Licensee shall be responsible for all other Development in such country.
(c) Non-Clinical Development in the Territory.  For the avoidance of doubt, Licensee shall be solely responsible for all non-clinical Development that is specific to a country in the Territory other than non-clinical activities conducted by Akebia to support approval outside the Territory which will be made available to Licensee pursuant to Section 5.01(b) hereof; [***].  Licensee shall have the right to request that Akebia conduct any other non-clinical studies 

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required for the Territory, subject to reimbursement by Licensee of Akebia’s internal and external costs associated with such non-clinical studies.
Section 4.02 Development Plan.  The Party responsible for Development in a country in the Territory pursuant to Section 4.01 (Development in the Territory) (the “Developing Party”), with the cooperation, support and assistance of the other Party, will prepare the initial Development Plans for such country in the Territory within [***] days of the Effective Date, to be submitted to the JSC.  The JSC will review and approve the initial Development Plan within [***] days of receipt.  The Developing Party will be responsible for preparing subsequent amendments to the Development Plan, which shall be submitted to the JSC for approval.  
Section 4.03 Development Reports.  Within [***] Business Days after the end of each calendar quarter, the Developing Party shall, through the JSC, provide the other Party with a written report that summarizes Development in each country in the Territory performed by the Developing Party, its Affiliates or any sublicensee during the prior calendar quarter, which report shall include the status of each pending and proposed Regulatory Filing for Licensed Products in the Territory.  In addition, the Developing Party shall promptly provide written notice, through the JSC or Alliance Managers, to the other Party of any significant Development events (e.g., clinical trial initiation or completion, clinical holds, Regulatory Filings for the Licensed Product, Regulatory Approvals, or Clinical Data, which, in any case, is significant).
Section 4.04 Standards of Conduct.  Akebia and Licensee shall perform, and shall ensure that its Affiliates, permitted sublicensees and Third Party contractors perform, all Development activities under the Development Plan in a good scientific manner, in accordance with GLP and GCP, as applicable, and in compliance in all material respects with applicable laws, rules and regulations.
Section 4.05 Developmental Efforts.  Each Party, directly or through its Affiliates, permitted sublicensees and Third Party contractors, shall use Commercially Reasonable Efforts to Develop, or support the Development of, Licensed Compounds and Licensed Products in the Territory.  For the avoidance of doubt, each Party shall be permitted to use Third Party contractors to perform its Development obligations hereunder, subject to the terms and conditions of this Agreement.  
Section 4.06 Records.  Licensee and its Affiliates and permitted sublicensees shall maintain written or electronic records in sufficient detail, in a good scientific manner (in accordance with GLP, GCP and GMP, as applicable) and appropriate for regulatory and patent purposes, which are complete and accurate in all material respects and reflect all Development work performed under the Development Plan and results achieved.
Section 4.07 Medical Affairs.  Licensee shall be responsible for Medical Affairs in the Territory, with Akebia’s cooperation, support and assistance.
ARTICLE V.
REGULATORY
Section 5.01 Regulatory Filings.
(a) Under the oversight of the JSC and subject to Section 4.02 (Development Plan), Licensee shall be responsible for preparing and filing, directly or through its Affiliates and permitted sublicensees, all Regulatory Filings and seeking all Regulatory Approvals in the Territory; provided, however, that, unless otherwise agreed upon by the Parties, (i) Akebia shall be responsible for [***], (ii) Licensee shall be responsible for [***] and (iii) the JSC will 

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determine the Parties’ responsibilities for any other Regulatory Filings related to the Global Phase 3 Program in the Territory.  Licensee shall provide Akebia with copies of such draft Regulatory Filings reasonably in advance of filing so that Akebia may review, comment and approve such Regulatory Filings.  Except as otherwise provided in this Section 5.01(a), all Regulatory Filings for Licensed Products in the Territory shall be filed in the name of Licensee (or its Affiliates or permitted sublicensees) and Licensee shall be responsible for all communications and other dealings with the Regulatory Authorities relating to the Licensed Product in the Territory; provided, however, that representatives of Akebia will be invited to attend all meetings, and copied on all written correspondence, with Regulatory Authorities in the Territory.  All Regulatory Filings and Regulatory Approvals in the Territory shall be at Licensee’s sole expense.
(b) In support of Licensee’s preparation and filing of any IND equivalent, amendment thereto, or NDA with respect to any Licensed Product in the Territory, Akebia shall provide Licensee access to a complete electronic copy of all relevant documentation submitted by Akebia to the FDA or EMA that would be necessary or useful to Licensee in preparing its own IND or NDA for a particular Licensed Product for use in the Territory (collectively, the “Akebia Regulatory Documents”).  In support of Akebia’s (or its Affiliates or sublicensees) preparation and filing of any IND equivalent, amendment thereto, or NDA with respect to any Licensed Product outside of the Territory, Licensee shall provide Akebia access to a complete electronic copy of all relevant documentation submitted by Licensee to Regulatory Authorities in the Territory that would be necessary or useful to Akebia in preparing its own IND or NDA for a particular Licensed Product for use outside the Territory (collectively, the “Licensee Regulatory Documents”). Each Party shall make available to the other Party copies of any other documentation related to the Licensed Compound or Licensed Product, including but not limited to research data and reports, material regulatory materials and correspondence (including INDs and NDAs), clinical and preclinical data, and chemistry, manufacturing and controls (“CMC”) data (collectively, the “Clinical Data”) if such Clinical Data is necessary for Licensee to conduct clinical studies and/or obtain Regulatory Approval in the Territory or for Akebia to conduct clinical studies and/or obtain Regulatory Approval outside of the Territory.  Licensee and its Affiliates and permitted sublicensees shall be entitled at no cost to access, use, and reference the Akebia Regulatory Documents and Clinical Data for the Development and Commercialization of the Licensed Compound or Licensed Product in the Territory.  Akebia and its Affiliates and sublicensees shall be entitled at no cost to access, use, and reference the Licensee Regulatory Documents and Clinical Data for the Development and Commercialization of the Licensed Compound or Licensed Product outside of the Territory.  All Regulatory Documents and Clinical Data shall be considered Confidential Information pursuant to Article XII (Confidentiality) hereof.
ARTICLE VI.
COMMERCIALIZATION
Section 6.01 General.  Under the direction of the JSC, Licensee, its Affiliates and permitted sublicensees shall be solely responsible for the Commercialization of the Licensed Product in the Territory. Licensee, its Affiliates and permitted sublicensees shall be responsible for all costs associated with the Commercialization of Licensed Product. Licensee shall prepare a Launch Plan, which shall be reviewed and approved by the JSC no later than [***] after filing the first NDA in the Territory, and an annual Commercialization Plan, which shall be [***] by the JSC no later than [***] following Regulatory Approval of the Licensed Product and annually thereafter.  The Launch Plan shall be a strategic, high-level plan and shall include, without limitation, launch budgets.  The Commercialization Plan shall include, without limitation, the following elements:

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(a) [***] of the Licensed Product by Licensee’s sales representatives during the [***] after First Commercial Sale of the Licensed Product;
(b) [***] who market and sell the Licensed Products;
(c) sales forecasts for the Licensed Products; and
(d) Commercialization budgets.
The Parties shall share their promotional materials for the Licensed Product on a regular basis, and Akebia shall have the right to review such promotional materials prior to their use in the Territory.
Section 6.02 Commercialization Reports.  Within [***] Business Days after the end of each calendar quarter following the First Commercial Sale, Licensee shall provide Akebia with (i) a written report that summarizes Commercialization activities performed during the prior calendar quarter, (ii) detailed sales reports for the Licensed Product for each month of the prior calendar quarter in each country in the Territory, and (iii) quarterly sales forecasts for the Licensed Products in each country in the Territory.
Section 6.03 Commercialization Efforts.  Licensee, directly or through its Affiliates and/or permitted sublicensees, shall use Commercially Reasonable Efforts to obtain Regulatory Approval and Reimbursement Approval in the Territory and thereafter to Commercialize the Licensed Product in the Territory.
Section 6.04 Standards of Conduct.  Licensee shall perform, or shall ensure that its Affiliates, permitted sublicensees and Third Party contractors perform, all Commercialization activities in a professional and ethical business manner and in compliance in all material respects with applicable laws, rules and regulations.
Section 6.05 Trademarks and International Nonproprietary Name.   Licensee shall Commercialize the Licensed Product under the Akebia Trademarks using the global brand name for the Licensed Product selected by Akebia unless prohibited by applicable laws or for other reasons specific to a country in the Territory (e.g., cultural and linguistic differences, varying business practices). In addition, Akebia will reasonably consider Licensee’s comments regarding the use of the global brand name in each country in the Territory, however, Akebia will make the final decision in its sole discretion whether to use the global brand name for the Licensed Product in such country.  If Akebia ultimately determines that the global brand name is not appropriate for use in a particular country, the JSC shall approve an alternative brand name for the Licensed Product for use in that country in the Territory and such brand name shall be a Licensee Trademark.  Akebia will be responsible for the selection and filing of the international nonproprietary name for any Licensed Product or Licensed Compound with the World Health Organization and any Regulatory Authorities in the Territory, which Licensee shall have the right to reference.
ARTICLE VII.
MANUFACTURING AND SUPPLY
Section 7.01 Manufacture and Supply of Licensed Products.  
(a) Subject to the terms and conditions of this Agreement, Akebia shall  be responsible for manufacturing or having manufactured and supplying all reasonable requirements of Licensed Product for clinical and commercial use in the Territory in accordance with GCP and 

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GMP at the same level of diligence [***].  If necessary, the Parties shall agree upon a supply agreement for the clinical supply of the Licensed Product by Akebia to Licensee in the Territory pursuant to which Akebia shall supply Licensed Products at [***].  Prior to commercial launch of the Licensed Product, the Parties shall agree upon a supply agreement for the commercial supply of the Licensed Product by Akebia to Licensee in the Territory, which shall include provisions regarding long-range forecasting of Licensee’s requirements for the Licensed Product.  Promptly after the execution of a supply agreement, the Parties will enter into a mutually acceptable quality agreement, which shall include the Parties’ respective obligations and responsibilities relating to quality assurance requirements for Licensed Products.
(b) After First Commercial Sale of the Licensed Product in the Territory, Licensee shall have the right, but not the obligation, [***]; provided, however, that if Licensee chooses to exercise its [***] it shall also [***].  If Licensee wishes to exercise this right, it shall so notify Akebia, and [***].  For the avoidance of doubt, Licensee shall not be permitted to [***]. Upon the execution of a [***], which shall include the Parties’ respective obligations and responsibilities relating to matters of [***].  If Licensee wishes to [***] pursuant to this Section 7.01(b), Licensee may do so only with Akebia’s prior written consent, not to be unreasonably withheld or delayed, and all other terms of this Section 7.01(b) shall apply.
(c) If, at any time during the Term, Licensee reasonably expects that Akebia will be [***], Licensee may request a discussion with Akebia and the Parties shall promptly discuss a potential resolution, which may include a [***].
Section 7.02 Supply Price.  The supply price for Licensed Products supplied by Akebia to Licensee for commercial use will be equal to [***] (the “Supply Price”).
Section 7.03 Labeling.  Licensed Products shall bear Licensee’s name and Akebia’s company name on the labels, containers, cartons, package inserts and other packaging and labeling to the extent practicable and permitted by applicable laws.  Akebia hereby grants Licensee a fully-paid, non-exclusive license under Akebia’s Trademarks as necessary to effect the co-labeling provided for in this Agreement and to Develop and Commercialize Licensed Products in the Territory. Licensee shall be responsible for packaging and labeling Licensed Products for use in the Territory and for all costs associated therewith.
ARTICLE VIII.
PAYMENTS
Section 8.01 Upfront License Fee.  As consideration for the rights and licenses granted by Akebia to Licensee under this Agreement, within fifteen (15) Business Days of the Effective Date, and provided that Licensee is in receipt of Akebia’s Certificate of Residency from the U.S. Department of Treasury (“Form 6166”), and Application Form for Income Tax Convention (“Form 3”), and Attachment Form for Limitation on Benefits Article (“Form 17”) from the Japanese National Tax Agency (collectively, the “Tax Forms”), Licensee shall pay Akebia a nonrefundable, noncreditable upfront license fee of [***]. If Licensee is not in receipt of Akebia’s Tax Forms within fifteen (15) Business Days of the Effective Date, then the upfront license fee shall be paid by Licensee within fifteen (15) Business Days following receipt of Akebia’s Tax Forms.
Section 8.02 Development Costs.
(a) In the [***], in addition to being responsible for all Development costs for Licensed Products in the Territory outside of Japan pursuant to Section 4.01 (Development in the Territory), Licensee shall be responsible for (i) up to [***] of the total internal and external 

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Development costs associated with Development in the Global Phase 3 Program, including the Global Phase 3 DD-CKD Study and the Global Phase 3 NDD-CKD Study, and (ii) all internal and external Development costs associated with any additional clinical studies performed in the Territory used to obtain Regulatory Approval of the Licensed Product in the Territory, as defined in the initial Development Plan to be approved by the Parties, provided, however, that Licensee’s responsibility for Development costs in the [***] shall not exceed [***].  
(b) In the event that [***], then Licensee shall be responsible for (i) up to [***] of the Global Phase 3 Program costs associated with such indication based on the Development Plan approved by the JSC, and (ii) all internal and external Development costs associated with any additional clinical studies performed in the Territory to support Regulatory Approval of the Licensed Product for such indication in the Territory, up to a maximum amount of [***].  For the avoidance of doubt, Licensee shall be solely responsible for [***].  
(c) [***], the Parties shall discuss in good faith, and include in the Development Plan, the consideration to be paid by Licensee for use of, or reference to, [***].  
(d) Akebia will invoice Licensee for such costs as incurred in accordance with the budgets and payment schedules for such Development costs which will be included in the JSC-approved Development Plan for the Global Phase 3 Program.  Upon the receipt of an undisputed invoice from Akebia with sufficient details and documentation of incurred costs, Licensee shall make a payment to Akebia within forty-five (45) days pursuant to the invoice.
(e) Within fifteen (15) Business Days after the Effective Date, Licensee shall pay Akebia a pre-payment for Development costs in the amount of [***] (“Development Cost Pre-Payment”).  The Development Cost Pre-Payment shall be deducted from the total amount payable by Licensee in accordance with Section 8.02(a) and Section 8.02(b) hereof.  In the event that, ultimately, neither Section 8.02(a) nor Section 8.02(b) hereof is applied, then Akebia shall, at Licensee’s discretion and within [***] days of Licensee’s request, either (i) [***] or (ii) [***].  If Licensee is not in receipt of Akebia’s Tax Forms within fifteen (15) Business Days after the Effective Date, then the Development Cost Pre-Payment shall be paid by Licensee within fifteen (15) Business Days following receipt of Akebia’s Tax Forms.
Section 8.03 Milestone Payments. Licensee shall pay to Akebia the following non-refundable and non-creditable amounts no later than [***] days after the first occurrence of the indicated event for the Licensed Product:
 
Development Milestones
 

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	Event	Payment Amount (in U.S. Dollars)

	[***]	[***]
	[***]	[***]
	[***]	In the [***]:
 
·    [***]
·    [***]
 
In the [***]:
 
·    [***]
 
In the event that Licensee determines, in its sole discretion, to [***], Licensee shall pay Akebia [***] of the above milestone payments for the [***] for the Licensed Product and [***] of the above milestones for the [***] for the Licensed Product.

	[***]	In the [***]:
 
·    [***]
·    [***], in which case the milestone payment shall be
      [***].
 
In the [***]:
 
      [***]
 
In the event that Licensee determines, in its sole discretion, to [***], Licensee shall pay Akebia [***] of the above milestone payments for Regulatory Approval of the Licensed Product for [***] and [***] of the above milestone payments for Regulatory Approval of the Licensed Product for [***].

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

 
Sales Milestones
 
						
		
	Event	Payment Amount (in U.S. Dollars)

	Achievement of [***] of aggregate annual Net Sales of Licensed Products in the Territory	[***]
	Achievement of [***] in aggregate annual Net Sales of Licensed Products in the Territory	[***]
	Achievement of [***] in aggregate annual Net Sales of Licensed Products in the Territory	[***]

 
Each milestone payment shall be paid upon the first occurrence of the event in the Territory and Licensee shall not be obligated to pay each milestone payment more than once unless otherwise indicated.
Section 8.04 Royalties
(a) Licensee shall pay Akebia the following royalties on Net Sales, at an incremental royalty rate determined by aggregate annual Net Sales of each Licensed Product in each calendar year during the Term of this Agreement in the Territory:  
 

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	Portion of Annual Net Sales	Royalty
	Less than [***] Japanese Yen	[***]

	[***] Japanese Yen	[***]

	Greater than [***] Japanese Yen	[***]

 
(b) Running royalties paid by Licensee under Section 8.04 (Royalties) shall be paid on a country-by-country basis from the date of the First Commercial Sale of Licensed Product in a country in the Territory until the later of (i) expiration of the last-to-expire Valid Claim that would, but for the licenses granted hereunder, be infringed by the making, using, selling or importing of such Licensed Product in such country in the Territory, (ii) expiration of marketing or regulatory exclusivity in such country in the Territory, or (iii) if no Valid Claim exists in such country in the Territory, then for ten (10) years from the First Commercial Sale of Licensed Product in such country in the Territory (the “Royalty Term”).
(c) If (i) one or more Generic Products to a Licensed Product is, or are, commercially available in any country in the Territory during the Royalty Term for such Licensed Product in such country, and (ii) Net Sales of such Licensed Product in such country during a calendar quarter decline by [***], as compared with the average Net Sales of such Licensed Product in such country for [***] immediately preceding the calendar quarter in which the first Generic Product is launched in such country, the amount of Net Sales to be utilized for the calculation of royalties provided in Section 8.04 (Royalties) for such Licensed Product shall be reduced in such country by [***] for the calendar quarter in which the applicable decline occurs and for all future calendar quarters.
(d) For the purpose of this paragraph, “Generic Product” means, with respect to a Licensed Product in a particular country, any pharmaceutical product that (A)(1) contains at least one of the same API as such Licensed Product and is approved by the Regulatory Authority in such country for an indication for which such Licensed Product obtained Regulatory Approval from the applicable Regulatory Authority in such jurisdiction; or (2) is approved by the Regulatory Authority in such country as a substitutable generic for such Licensed Product, for an indication for which such Licensed Product obtained Regulatory Approval from the applicable Regulatory Authority in such country, on an expedited or abbreviated basis in a manner that relied on or incorporated data submitted by Licensee or its Affiliate or sublicensee in connection with the Regulatory Approval for the Licensed Product in such jurisdiction; and (B) is sold in such country by a Third Party that is not a sublicensee of Licensee and did not purchase such product in a chain of distribution that included Licensee or its Affiliates or any sublicensees of Licensee.
Section 8.05 Royalty Payments and Reports.
(a) Until the expiration of the Royalty Term, Licensee agrees to provide quarterly written reports to Akebia within [***] days after the end of each calendar quarter, covering all Net Sales of the Licensed Product in the Territory by Licensee, its Affiliates or permitted sublicensees, each such written report stating for the period in question:
(i) the quantity and description of Licensed Product sold during the calendar quarter in the Territory, and
(ii) the calculation of Net Sales in the Territory for such quarter and year-to-date Net Sales in the Territory, and
(iii) the exchange rates used to calculate the royalties payable in U.S. Dollars, and

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(iv) any withholding taxes required to be made from such royalties.
(b) The information contained in each report under Section 8.05 (Royalty Payments and Reports) shall be considered Confidential Information of Licensee. [***] days after the end of each calendar quarter, Licensee shall make the royalty payment due hereunder for the calendar quarter covered by such report.
Section 8.06 Accounting
(a) Licensee shall keep full, clear and accurate records in accordance with Japanese generally accepted accounting principles (if Licensee starts to apply International Financial Reporting Standards (IFRS) to its accounting, IFRS will be applied) consistently applied for a period of at least three (3) years after the relevant payment is owed pursuant to this Agreement, setting forth the sales of Licensed Product in sufficient detail to enable royalties and compensation payable to Akebia hereunder to be determined.  Licensee further agrees to permit its books and records to be examined by an independent accounting firm selected by Akebia to verify reports provided for in Section 8.05 (Royalty Payments and Reports).  Such audit shall not be performed more frequently than once per calendar year.  Such examination is to be made at the expense of Akebia, except in the event that the results of the audit reveal an underpayment by Licensee of five percent (5%) or more during the period being audited, in which case reasonable audit fees for such examination shall be paid by Licensee.
(b) Akebia shall keep full, clear and accurate records in accordance with U.S. GAAP consistently applied for a period of at least three (3) years after the relevant payment is made by Licensee to Akebia pursuant to this Agreement.  Akebia further agrees to permit its books and records to be examined by an independent accounting firm selected by Licensee to verify the accuracy of Development costs for the Global Phase 3 Program and COGS.  Such audit shall not be performed more frequently than once per calendar year.  Such examination is to be made at the expense of Licensee, except in the event that the results of the audit reveal an overcharge by Akebia of five percent (5%) or more over the period being audited, in which case reasonable audit fees for such examination shall be paid by Akebia.
Section 8.07 Currency Conversion.  Wherever it is necessary to convert currencies for Net Sales invoiced in a currency other than the U.S. Dollar, including Japanese Yen, such conversion shall be made into U.S. Dollars after being converted at the rate of Telegraph Transfer Middle Rate announced by The Bank of Tokyo-Mitsubishi UFJ, Ltd. on the last Business Day of the reporting calendar quarter.
Section 8.08 Methods of Payment.  All payments due to Akebia under this Agreement shall be made in U.S. Dollars by wire transfer to a bank account of Akebia designated from time to time in writing by Akebia.
Section 8.09 Taxes.  Akebia will pay any and all taxes levied on account of any payments made to it under this Agreement.  If, under any law or regulation of any country of the Territory, withholding of taxes of any type, levies or other charges is required with respect to any amounts payable hereunder to a Party, the other Party (“Withholding Party”) shall apply the withholding or deduction as so required and shall promptly pay such tax, levy or charge to the proper governmental authority, and shall promptly furnish the Party with proof of such payment.  The Withholding Party shall have the right to withhold or deduct any such tax, levy or charge actually paid from payment due to the Party or be promptly reimbursed by the Party if no further payments are due the Party.  Any amounts so withheld or deducted from the payment due the Party pursuant to the relevant law or regulation shall be deemed paid to such Party for all purposes of this Agreement.  Each Withholding Party agrees to assist the other Party in claiming 

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exemption from (or reduction in) such deductions or withholdings under double taxation or similar agreement or treaty from time to time in force and in minimizing the amount required to be so withheld or deducted.  Notwithstanding the foregoing, all sums payable by either Party pursuant to this Agreement are stated exclusive of any sales tax, value added tax or other similar taxes, assessments and charges imposed by the jurisdiction of the Withholding Party or the payee and any such taxes shall be paid by the Withholding Party.  Notwithstanding anything contrary to the foregoing, at the beginning of each calendar year during the Term, Akebia shall provide Licensee with Akebia’s Tax Forms together with any other documents required to be submitted to respective tax authorities for avoiding withholding taxes applicable to any payments to be paid to Akebia from Licensee (the “Withholding Tax Avoiding Documents”).  If Akebia fails to provide Licensee with the Withholding Tax Avoiding Documents at the beginning of each calendar year, until Akebia provides all of the Withholding Tax Avoiding Documents to Licensee, Licensee may [***].
Section 8.10 Late Payments.  Any amount owed by Licensee to Akebia under this Agreement that is not paid within the applicable time period set forth herein shall accrue interest at the lesser of (a) the London Interbank Offered Rate plus three percent (3%) or (b) the highest rate permitted under applicable law.
ARTICLE IX.
OWNERSHIP OF INTELLECTUAL PROPERTY
Section 9.01 Akebia Intellectual Property.  Ownership of the Akebia Inventions, Akebia Know-How, and Akebia Patents (other than Joint Patents), shall remain vested at all times in Akebia.  
Section 9.02 Licensee Intellectual Property.  Ownership of the Licensee Inventions, Licensee Know-How, Improvements, and Licensee Patents (other than Joint Patents) shall remain vested at all times in Licensee.
Section 9.03 Joint Technology and Improvements
(a) The Parties shall promptly disclose to each other any Joint Inventions or Improvements conceived or reduced to practice, but no later than thirty (30) days after such conception or reduction to practice.
(b) Ownership of Joint Technology shall be vested jointly in Akebia and Licensee.  Licensee hereby grants to Akebia (i) the exclusive, royalty-free, sublicensable, irrevocable right and license to practice, make, have made, use, import, offer for sale or sell any Improvements and Joint Technology outside of the Territory as is necessary in connection with the Development or Commercialization of the Licensed Compound or the Licensed Product; and (ii) the non-exclusive, royalty-free, sublicensable, irrevocable right and license to practice, make, have made, use, import, offer for sale or sell any Improvements and Joint Technology inside the Territory as is necessary for Akebia to perform its obligations under this Agreement.
(c) Licensee hereby grants to Akebia (i) the exclusive, royalty-free, sublicensable, irrevocable right and license to practice, make, have made, use, import, offer for sale or sell any Improvements and Joint Technology relating solely to the Licensed Compound or Licensed Product for any purpose outside of the Territory; and (ii) the non-exclusive, royalty-free, sublicensable, irrevocable right and license to practice, make, have made, use, import, offer for sale or sell all other Improvements and Joint Technology for any purpose outside of the Territory.  During the Term of this Agreement, Licensee [***] without Akebia’s written consent, not to be unreasonably withheld or delayed.

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Section 9.04 Prosecution of Akebia Patents
(a) Akebia shall have the first right, but not the obligation, to prosecute and maintain the Akebia Patents.  On a semiannual basis, Akebia shall provide to Licensee a written summary of the status of all Akebia Patents, including patent applications within Akebia Patents in the Territory.  On the reasonable request of Akebia, Licensee shall cooperate with Akebia in connection with the prosecution of all patent applications included within Akebia Patents.
(b) Licensee undertakes without cost to Akebia to obtain all necessary assignment documents for Akebia, to render all signatures that shall be necessary for such patent filings and to assist Akebia in all other reasonable ways that are necessary for the issuance of the patents involved as well as for the maintenance and prosecution of such patents.  Akebia shall be responsible for [***] of the costs incurred with respect to the prosecution and maintenance of such Akebia Patents.
(c) Should Akebia decide that it is no longer interested in maintaining or prosecuting a particular Akebia Patent in the Territory during the Term, it shall promptly advise Licensee of this decision.  Licensee may, upon written notice to Akebia, assume such prosecution and maintenance at its sole expense.  Akebia shall assign such Akebia Patent to Licensee at no cost to Licensee.  Following such assignment, such patent or patent application shall no longer be considered an Akebia Patent and shall be considered a Licensee Patent.
Section 9.05 Prosecution of Licensee Patents Covering Improvements
(a) Licensee shall have the first right, but not the obligation, to prosecute and maintain the Licensee Patents that cover Improvements.  On a semiannual basis, Licensee shall provide to Akebia a written summary of the status of all Licensee Patents that cover Improvements, including patent applications within Licensee Patents that cover Improvements.  On the reasonable request of Licensee, Akebia shall cooperate with Licensee in connection with the prosecution of all patent applications included within Licensee Patents that cover Improvements.
(b) Akebia undertakes without cost to Licensee to obtain all necessary assignment documents for Licensee, to render all signatures that shall be necessary for such patent filings and to assist Licensee in all other reasonable ways that are necessary for the issuance of the patents involved as well as for the maintenance and prosecution of such patents.  Licensee shall be responsible for [***] of the costs incurred with respect to the prosecution and maintenance of such Licensee Patents that include Improvements.
(c) Should Licensee decide that it is no longer interested in maintaining or prosecuting a particular Licensee Patent that covers Improvements during the Term, it shall promptly advise Akebia of this decision.  Akebia may, upon written notice to Licensee, assume such prosecution and maintenance at its sole expense.  Licensee shall assign such Licensee Patent that covers Improvements to Akebia at no cost to Akebia.  Following such assignment, such patent or patent application shall no longer be considered a Licensee Patent and shall be considered an Akebia Patent.
Section 9.06 Prosecution of Joint Patents
(a) Akebia will have the first right of election to file patent applications for Joint Inventions.  If Akebia declines to file such applications then Licensee may do so.  On a semi-annual basis, Akebia shall provide to Licensee a written summary of the status of all Akebia Patents, including patent applications within Akebia Patents in the Territory.  On the reasonable request of Akebia, Licensee shall cooperate with Akebia in connection with the prosecution of all patent applications included within Joint Patents.

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(b) Licensee undertakes without cost to Akebia to obtain all necessary assignment documents for Akebia, to render all signatures that shall be necessary for such patent filings and to assist Akebia in all other reasonable ways that are necessary for the issuance of the patents involved as well as for the maintenance and prosecution of such patents.  Akebia shall be responsible for [***] of the costs incurred with respect to the prosecution and maintenance of such Joint Patents.
(c) Should Akebia decide that it is no longer interested in maintaining or prosecuting a particular Joint Patent in the Territory during the Term, it shall promptly advise Licensee of this decision. Licensee may, upon written notice to Akebia, assume such prosecution and maintenance at its sole expense Akebia shall assign such Joint Patent to Licensee at no cost to Licensee.  Following such assignment, such patent or patent application shall no longer be considered a Joint Patent and shall be considered a Licensee Patent.
Section 9.07 Enforcement and Defense
(a) If either Party becomes aware of any Third Party activity in the Territory, including any Development activity (whether or not an exemption from infringement liability for such Development activity is available under applicable law) that infringes (or that is directed to the Development of a product that would infringe) an Akebia Patent, a Joint Patent or a Licensee Patent covering Improvements, then the Party becoming aware of such activity shall give prompt written notice to the other Party regarding such alleged infringement.
(b) As to Akebia Patents and Joint Patents, Akebia shall have the first right, but not the obligation, to attempt to resolve such Third Party activity by commercially appropriate steps at its own expense, including the filing of an infringement suit using counsel of its own choice.  If Akebia fails to resolve such Third Party activity or to initiate a suit with respect thereto within [***] days after the notice provided under Section 9.07 (Enforcement and Defense), then, with Akebia’s written consent (which shall not be unreasonably withheld, conditioned or delayed), Licensee shall have the right, but not the obligation, to attempt to resolve such Third Party activity by commercially appropriate steps at its own expense, including the filing of an infringement suit using counsel of its own choice.  As to Licensee Patents that cover Improvements, Licensee shall have the first right, but not the obligation, to attempt to resolve such Third Party activity by commercially appropriate steps at its own expense, including the filing of an infringement suit using counsel of its own choice.  If Licensee fails to resolve such Third Party activity or to initiate a suit with respect thereto within [***] days after the notice provided under Section 9.07 (Enforcement and Defense), then, with Licensee’s written consent (which shall not be unreasonably withheld, conditioned or delayed), Akebia shall have the right, but not the obligation, to attempt to resolve such Third Party activity by commercially appropriate steps at its own expense, including the filing of an infringement suit using counsel of its own choice.
(c) Any amounts recovered by a Party as a result of an action pursuant to this Section 9.07 (Enforcement and Defense), whether by settlement or judgment, shall be allocated, after deducting both Parties’ internal and external costs associated with the enforcement action, as follows:  Licensee shall receive [***] of any amounts recovered and Akebia shall receive [***] of any amounts recovered under this Section 9.07 (Enforcement and Defense).
(d) In any event, at the request and expense of the Party bringing an infringement action under this Section 9.07 (Enforcement and Defense), the other Party shall provide reasonable assistance in any such action (including entering into a common interest agreement if reasonably deemed necessary by any Party) and to be joined as a party to the suit if necessary for the initiating Party to bring or continue an infringement action hereunder.  Neither Party may 

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settle any action or proceeding brought under this Section 9.07 (Enforcement and Defense) in a manner that materially adversely affects the other Party’s interest in the Akebia Patents, Joint Patents or Licensee Patents covering Improvements, or knowingly take any other action in the course thereof, without the written consent of such other Party.  Each Party shall always have the right to be represented by counsel of its own selection and its own expense in any suit or other action instituted by the other Party pursuant to this Section 9.07 (Enforcement and Defense).  
Section 9.08Defense of Third Party Infringement Claims.
(a) If a Third Party asserts that a Patent or other right controlled by it in the Territory is infringed by a Party’s activities or a Party becomes aware of a Patent or other right that might form the basis for such a claim, the Party first obtaining knowledge of such a claim or such potential claim shall immediately provide the other Party with notice thereof and the related facts in reasonable detail.  The Parties shall discuss whether to take commercially appropriate steps to avoid infringement of said Third Party Patent or other right controlled by such Third Party in the Territory.  Akebia will reasonably consider Licensee’s comments regarding the avoidance of infringement in the Territory, however, [***].
(b) Notwithstanding the provision set forth in Section 9.08(a) that states [***], at any time during the Term, [***] during the exercise of the rights herein granted, whether or not there has been the [***], Licensee may request that [***].  Following such request, Akebia shall [***].  
(c) If, during the Term of the Agreement, a Third Party asserts that a Patent or other right controlled by such Third Party is infringed in the Territory by the exercise of the rights herein granted, Akebia will be solely responsible for defending against any such claim at its own expense using Commercially Reasonable Efforts and the counsel of its own choosing.  [***].
(d) At any time during the Term, Akebia may at its sole discretion [***].  Akebia shall invoice Licensee for such amounts on a quarterly basis, and such invoices shall be paid by Licensee within [***] days after receipt.  This Section 9.08 (Defense of Third Party Infringement Claims) shall not be interpreted as placing on either Party a duty of inquiry regarding Third Party intellectual property rights.
Section 9.09 Patent Term Extensions.  Akebia shall be solely responsible for making all decisions regarding patent term extensions, including supplementary protection certificates and any other extensions, that are now available or become available in the future, that are applicable to Akebia Patents and Joint Patents licensed hereunder and that become available directly as a result of the Regulatory Approval of a Licensed Product by Licensee or any of its Affiliates or sublicensees, provided that Akebia shall consult with Licensee with respect to such decisions and shall consider the comments and concerns of Licensee in good faith.
Section 9.10 Trademarks.  Licensee shall be responsible for the registration and maintenance of the Licensee Trademarks throughout the Territory, as well as all expenses associated therewith. Akebia shall be responsible for the registration and maintenance of the Akebia Trademarks throughout the Territory, as well as all expenses associated therewith.
ARTICLE X.
INFORMATION AND ADVERSE DRUG EVENTS AND REPORTS
Section 10.01 Information.  Akebia and Licensee will use Commercially Reasonable Efforts to disclose and make available to each other in a timely manner all Regulatory Information, Clinical Data, commercial and other information concerning the Licensed Product 

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or Licensed Compound, known by Akebia or Licensee at any time during the Term of this Agreement (the “Information”), subject to receipt of any required Third Party consents.  Notwithstanding the foregoing, neither Party shall be obligated to disclose to the other Party confidential information about its products other than the Licensed Product or Licensed Compound.
Section 10.02 Data Security.  During the Term of this Agreement, each Party will maintain (and, as applicable, cause its Affiliates to maintain) environmental, safety and facility procedures, data security procedures and other safeguards against the disclosure, destruction, loss, or alteration of the other Party’s Information in the possession of such Party or its Affiliates which are no less rigorous than those maintained by such Party (or any of its Affiliates) for its own Information of a similar nature.
Section 10.03 Compliance.  Each Party shall maintain a record of all non-medical and medical product-related complaints it receives with respect to any Licensed Product or Licensed Compound.  Each Party shall notify the other Party of any such complaint received by it in sufficient detail and in accordance with the timeframes and procedures for reporting established by the Joint Pharmacovigilance Committee (“JPC”), and in any event in sufficient time to allow the Party that holds the applicable regulatory filing to comply with any and all regulatory requirements imposed upon it in any country within its territory including in accordance with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) guidelines.  The Party that holds the applicable regulatory filing in a particular country shall investigate and respond to all such complaints in such country with respect to any Licensed Product or Licensed Compound as soon as reasonably practicable.  All such responses shall be made in accordance with the procedures established by the JPC pursuant to ICH guidelines.  The Party responsible for responding to such complaint shall promptly provide the other Party a copy of any such response.
Section 10.04 Adverse Drug Events.
(a) [***] days prior to the commencement of any non-clinical or clinical study in the Territory, the Parties shall enter into a Safety Data Exchange Agreement. Such Safety Data Exchange Agreement shall provide for the exchange by the Parties of any information of which a Party becomes aware in the Territory concerning any adverse event experienced by a subject or, in the case of non-clinical studies, an animal in a toxicology study, and the seriousness thereof, whether or not determined to be attributable to any Licensed Product or Licensed Compound, including any such information received by either Party from a Third Party (subject to receipt of any required consents from such Third Party).  It is understood that each Party and its Affiliates or licensees/sublicensees shall have the right to disclose such information if such disclosure is reasonably necessary to comply with applicable laws, regulations, and requirements of Regulatory Authorities within its respective territory with respect to its filings and activities related to the Licensed Compound and Licensed Product.  The Safety Data Exchange Agreement will also detail the Parties’ responsibilities relating to recalls and withdrawals of a Licensed Product.
(b) The Parties shall, within [***] days after execution of this Agreement, form the JPC which shall include [***] members: [***] designated by Akebia and [***] designated by Licensee. [***] shall be one of the Akebia representatives and serve as chairperson of the JPC. The JPC shall establish a charter that governs the operation of the JPC. For the avoidance of doubt, the JPC shall not be a Sub-Committee of the JSC.
ARTICLE XI.
REPRESENTATIONS, WARRANTIES, AND COVENANTS

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Section 11.01 Mutual Representations and Warranties.  Each of Licensee and Akebia hereby represents, warrants and covenants (as to (Section 11.01(h)):
(a) it is a corporation or entity duly organized and validly existing under the laws of the state, municipality, provinces, administrative division or other jurisdiction of its incorporation or formation;
(b) the execution, delivery and performance of this Agreement by it has been duly authorized by all requisite corporate action;
(c) it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder, and such performance does not conflict with or constitute a breach of any of its agreements with Third Parties;
(d) it has the right to grant the rights and licenses described in this Agreement, free and clear of all liens, claims or encumbrances;
(e) it has not made any commitments to Third Parties in conflict with the rights granted by it hereunder and it will not do so during the Term of this Agreement;
(f) to its knowledge, no consent, approval or agreement of any person, party, court, government or entity is required to be obtained in connection with the execution and delivery of this Agreement;
(g) it has not been debarred by the FDA, is not the subject of a conviction described in Section 306 of the FD&C Act, an is not subject to any similar sanction of other governmental authorities outside the Territory, and neither it nor any of its Affiliates has used, in any capacity, any person who either has been debarred by the FDA, is the subject of a conviction described in Section 306 of the FD&C Act or is subject to any such similar sanction.  Neither Party shall engage, in any capacity in connection with this Agreement or any ancillary agreements, any person who either has been debarred by the FDA, is the subject of a conviction described in Section 306 of the FD&C Act or is subject to any such similar sanction. Each Party shall inform the other Party in writing promptly if it or any person engaged by Akebia or any of its Affiliates who is performing services under this Agreement, or any ancillary agreements, is debarred or is the subject of a conviction described in Section 306 of the FD&C Act, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to each Party’s knowledge, is threatened, relating to the debarment or conviction of a Party, any of its Affiliates or any such person performing services hereunder or thereunder; and
(h) it will comply with all applicable laws and regulations in performing its activities hereunder.
Section 11.02 Additional Akebia Warranties.  Akebia hereby represents and warrants as of the Effective Date and covenants (as to Section 11.02(k)) that:
(a) to Akebia’s knowledge, Exhibit A contains a list of all Akebia Patents that are necessary or useful to make, have made, use, import, offer for sale, and sell the Licensed Compounds and Licensed Products in the Field in the Territory;
(b) to Akebia’s knowledge, the Akebia Patents listed in Exhibit A have not expired or been abandoned and Akebia is unaware of any challenge in the Territory to the validity of any of the Akebia Patents listed in Exhibit A;

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(c) to Akebia’s knowledge, the patent applications included in the Akebia Patents as of the Effective Date have been duly filed in the Territory and the filing, prosecution and maintenance of Akebia Patents and patent applications in the Territory has been conducted in accordance with applicable laws and are pending with the applicable governmental agency, and any and all maintenance fees, annuity fees and renewal fees with respect to any of Akebia Patents that are due and payable have been paid;
(d) to Akebia’s knowledge, there is no threatened or pending litigation relating to it or any Affiliate that seeks to invalidate any of the Akebia Patents in the Territory;
(e) to Akebia’s knowledge, Akebia has obtained the assignment of all interests and all rights of any and all Third Parties who are entitled to be named as inventors with respect to the subject matter of the Akebia Patents in the Territory;
(f) to Akebia’s knowledge, there is no use, infringement or misappropriation of the Akebia Technology in the Territory in derogation of the rights granted to Licensee in this Agreement;
(g) to Akebia’s knowledge, there are no investigations, inquiries, actions or other proceedings pending before or threatened by any Regulatory Authority or other government agency in the Territory with respect to the Licensed Product arising from any default by Akebia or a Third Party acting on behalf Akebia in the discovery or Development of the Licensed Compound, and Akebia has not received written notice threatening any such investigation, inquiry, action or other proceeding;
(h) to Akebia’s knowledge, Akebia has taken Commercially Reasonable Efforts to protect the secrecy, confidentiality and value of all Know-How that constitutes trade secrets under applicable law (including requiring all employees, consultants and independent contractors to execute binding and enforceable agreements requiring such employees, consultants and independent contractors to maintain the confidentiality of such Know-How) and, to Akebia’s knowledge, such Know-How has not been used, disclosed to or discovered by any Third Party except pursuant to such confidentiality agreements and there has not been a breach by any party of such confidentiality agreements;
(i) to Akebia’s knowledge, Akebia owns or has licensed the rights, title and interest in and to the Akebia Technology granted to Licensee pursuant to Section 2.01 (Grant of License) of this Agreement;
(j) to Akebia’s knowledge, neither the Akebia Technology nor its use infringes any Patent right of any Third Party in the Territory; and
(k) Akebia and its Affiliates shall not (i) license, sell, assign or otherwise transfer to any Third Party any licensed Akebia Technology (or agree to do any of the foregoing) or (ii) incur or permit to exist, with respect to any licensed Akebia Technology, any lien, encumbrance, charge, security interest, mortgage, liability, grant of license to Third Parties or other restriction (including in connection with any indebtedness), in either case, that would conflict with the rights granted to Licensee hereunder.
Section 11.03 Additional Licensee Warranties.
(a) Anti-Corruption Provisions.  Akebia and Licensee have not, directly or indirectly, offered, promised, paid, authorized or given, and will not in the future, offer, promise, pay, authorize or give, money or anything of value, directly or indirectly, to any Government Official (as defined below) or Other Covered Party (as defined below) for the purpose, pertaining to this 

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Agreement, of:  (i) influencing any act or decision of the Government Official or Other Covered Party; (ii) inducing the Government Official or Other Covered Party to do or omit to do an act in violation of a lawful duty; (iii) securing any improper advantage; or (iv) inducing the Government Official or Other Covered Party to influence the act or decision of a government or government instrumentality, in order to obtain or retain business, or direct business to, any person or entity, in any way related to this Agreement.
For purposes of this Agreement:  (i) “Government Official” means any official, officer, employee or representative of:  (A) any federal, state, provincial, administrative division, county or municipal government or any department or agency thereof; (B) any public international organization or any department or agency thereof; or (C) any company or other entity owned or controlled by any government; and (ii) “Other Covered Party” means any political party or party official, or any candidate for political office.
(b) Anti-Corruption Compliance.
(i) In performing under this Agreement, both Parties and their respective Affiliates agree to comply with all applicable anti-corruption laws, including, without limitation:  the Foreign Corrupt Practices Act of 1977, as amended from time to time (“FCPA”); the anti-corruption laws of the Territory; and all laws enacted to implement the Organization for Economic Co-operation and Development Convention on Combating Bribery of Foreign Officials in International Business Transactions.
(ii) Neither Party is aware of any Government Official or Other Covered Party having any financial interest in the subject matter of this Agreement or in any way personally benefiting, directly or indirectly, from this Agreement.
(iii) No political contributions or charitable donations shall be given, offered, promised or paid at the request of any Government Official or Other Covered Party that is in any way related to this Agreement or any related activity, without the other Party’s prior written approval.
(iv) In the event that a Party violates the FCPA, the anti-corruption laws of the Territory or any applicable anti-corruption law or breaches any provision in this Section, the other Party shall have the right to unilaterally terminate this Agreement pursuant to Section 14.02 (Termination for Breach).
Section 11.04 Disclaimer.  EXCEPT AS EXPRESSLY SET FORTH HEREIN, THE INTELLECTUAL PROPERTY RIGHTS PROVIDED BY AKEBIA ARE PROVIDED “AS IS” AND WITHOUT WARRANTY.  EXCEPT AS EXPRESSLY SET FORTH HEREIN, EACH OF THE PARTIES EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY AND/OR ENFORCEABILITY OF THEIR RESPECTIVE INTELLECTUAL PROPERTY RIGHTS, AND NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, ARISING FROM A COURSE OR DEALING, USAGE OR TRADE PRACTICES, IN ALL CASES WITH RESPECT THERETO.
Section 11.05 Limitation of Liability.  NEITHER OF THE PARTIES SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, INDIRECT, CONSEQUENTIAL OR PUNITIVE DAMAGES OR DAMAGES FOR LOSS OF 

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PROFIT OR LOST OPPORTUNITY IN CONNECTION WITH THIS AGREEMENT, ITS PERFORMANCE OR LACK OF PERFORMANCE HEREUNDER, OR ANY LICENSE GRANTED HEREUNDER.  THE FOREGOING SHALL NOT LIMIT ANY INDEMNIFICATION OBLIGATIONS HEREUNDER.
ARTICLE XII.
CONFIDENTIALITY
Section 12.01 Generally.  During the Term of this Agreement and for a period of five (5) years following the early termination of this Agreement, each Party (a) shall maintain in confidence all Confidential Information of the other Party; (b) shall not use such Confidential Information for any purpose except in connection with the activities contemplated by this Agreement or in order to further the purpose of this Agreement; and (c) shall not disclose such Confidential Information to anyone other than those of its Affiliates, investors, prospective investors, lenders, prospective lenders, prospective acquirers, permitted sublicensees, prospective sublicensees, employees, consultants, financial or legal advisors, agents or subcontractors who are bound by written obligations of nondisclosure and non-use no less stringent than those set forth in this Article XII (Confidentiality) and to whom such disclosure is necessary in connection with such Party’s activities as contemplated in this Agreement or in connection with financing or acquisition activities.  Each Party shall ensure that such Party’s Affiliates, investors, prospective investors, lenders, prospective lenders, acquirors, prospective acquirors, permitted sublicensees, prospective sublicensees, employees, consultants, agents, consultants and subcontractors comply with these obligations.  Each Party shall notify the other Party promptly on discovery of any unauthorized use or disclosure of the other’s Confidential Information, including the other’s trade secrets or proprietary information.  Licensee acknowledges that all information related to Akebia’s and its Affiliates’ and sublicensees’ Development and Commercialization of the Licensed Product constitutes Confidential Information of Akebia.
Section 12.02 Exceptions.  The obligations of confidentiality, non-disclosure, and non-use set forth in Section 12.01 (Generally) shall not apply to the extent the receiving Party (the “Recipient”) can demonstrate that the disclosed information (a) was in the public domain at the time of disclosure to the Recipient by the other Party, or thereafter entered the public domain, in each case other than as a result of actions of the Recipient, its Affiliates, employees, licensees, agents or subcontractors, in breach of this Agreement; (b) was rightfully known by the Recipient or its Affiliates (as shown by its written records) prior to the date of disclosure to the Recipient by the other Party; (c) was received by the Recipient or its Affiliates on an unrestricted basis from a Third Party rightfully in possession of such information and not under a duty of confidentiality to the other Party; or (d) was independently developed by or for the Recipient or its Affiliates without reference to or reliance on the Confidential Information of the other Party (as demonstrated by written records).  Notwithstanding any other provision of this Agreement, Recipient’s disclosure of Confidential Information shall not be prohibited if such disclosure:  (i) is in response to a valid order of a court or other governmental body; or (ii) is otherwise required by applicable law or regulation or rules of a nationally recognized securities exchange.  Further notwithstanding any other provision of this Agreement, either Party may disclose the other Party’s Confidential Information to the extent necessary to exercise the rights granted to or retained by the Recipient under this Agreement, including but not limited in filing or prosecuting patent applications, prosecuting or defending litigation, responding to an investigation by a governmental authority, or otherwise establishing rights or enforcing obligations under this Agreement, making Regulatory Filings with respect to Licensed Product in their respective territories and fields of use, or conducting Development with respect to the Licensed Product.  If a Recipient is required to disclose Confidential Information pursuant to this Section 12.02 (Exceptions), prior to any disclosure the Recipient shall provide the other 

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Party with prior written notice of such disclosure in order to permit the other Party to seek a protective order or other confidential treatment of such Confidential Information.
Section 12.03 Publicity.  The Parties recognize that each Party may from time to time desire to issue press releases and make other public statements or disclosures regarding the terms of this Agreement.  In such event, the Party desiring to issue a press release or make a public statement or disclosure shall provide the other Party with a copy of the proposed press release, statement or disclosure for review and approval as soon as practicable prior to publication, which advance approval shall not be unreasonably withheld, conditioned or delayed.  No other public statement or disclosure of, or concerning, the terms of this Agreement shall be made, either directly or indirectly, by either Party hereto, without first obtaining the written approval of the other Party.  Once any public statement or disclosure has been approved in accordance with this Section 12.03 (Publicity), then either Party may appropriately communicate information contained in such permitted statement or disclosure.  Notwithstanding the foregoing provisions of this Article XII (Confidentiality), a Party may (a) disclose the terms of this Agreement where required, as reasonably determined by the disclosing Party, by applicable law, regulation or legal process or by applicable stock exchange rule (with prompt notice of any such legally required disclosure to the other Party and to the extent practicable an opportunity to comment on such disclosure) and (b) disclose the terms of this Agreement under obligations of confidentiality to such Party’s Affiliates, investors, prospective investors, lenders, prospective lenders, acquirors, prospective acquirors, permitted sublicensees, prospective sublicensees, employees, consultants, agents and subcontractors in connection with such Party’s activities hereunder and in connection with such Party’s financing activities.
Section 12.04 Publications.  The JSC will coordinate the plans of the Parties regarding planned publication in the Territory of Clinical Data or other clinical or preclinical results relating to the Licensed Compound or Licensed Product into a single schedule (“Joint Publication Plan”) that will be shared with the Parties. With respect to publication in any academic journal, authorship of any publication shall be determined based on the accepted standards used in peer-reviewed, academic journals at the time of the proposed publication. Notwithstanding the forgoing, each Party recognizes the mutual interest in obtaining valid Patent protection and in protecting business interests and trade secret information.  Consequently, except for disclosures permitted pursuant to Section 12.02 (Exceptions), if either Party, its employees or consultants wishes to publish or present to any Third Party results of the Development work, or any research results, or any Clinical Data or other clinical information about a Licensed Compound, Licensed Product, Bundled Product, or Combination Product being Developed pursuant to this Agreement, it shall deliver to the other Party a copy of the proposed written publication or an outline of an oral disclosure as soon as practicable prior to submission for publication or presentation.  The reviewing Party shall notify the other Party promptly after of receipt of such proposed publication whether such draft publication contains (i) Confidential Information of the reviewing Party, or (ii) information that if published would have an adverse effect on a Patent.  The reviewing Party shall have the right to (a) propose modifications to the publication or presentation for Patent reasons, trade secret reasons, confidentiality reasons or business reasons and/or (b) request a reasonable delay in publication or presentation in order to protect patentable information.  If the reviewing Party requests a delay to protect patentable information, the publishing Party shall delay submission or presentation for a period not to exceed [***] days to enable Patent applications protecting each Party’s rights in such information to be filed in accordance with the terms of this Agreement.  Upon expiration of such [***] days, the publishing Party shall be free to proceed with the publication or presentation.  If the reviewing Party reasonably requests modifications to the publication or presentation to prevent disclosure of material trade secret or proprietary business information, the publishing Party shall edit such publication to prevent the disclosure of such information prior to submission of the publication or presentation.

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Section 12.05 Injunctive Relief.  Each Party acknowledges and agrees that there may be no adequate remedy at law for any breach of its obligations under this Article XII (Confidentiality), that any such breach may result in irreparable harm to such other Party and, therefore, that upon any such breach or any threat thereof, such other Party may seek appropriate equitable relief in addition to whatever remedies it might have at law, without the necessity of showing actual damages.
ARTICLE XIII.
INDEMNIFICATION
Section 13.01 Indemnification by Akebia.  Unless otherwise provided herein, Akebia shall indemnify, hold harmless and defend Licensee and its Affiliates, directors, officers, employees and agents (the “Licensee Indemnitees”) from and against any and all Third Party suits, claims, actions, demands, liabilities, expenses and/or losses (including reasonable attorneys’ fees, court costs, witness fees, damages, judgments, fines and amounts paid in settlement) (“Losses”) to the extent that such Losses arise out of (a) a breach of this Agreement by Akebia, (b) the Development, manufacture, distribution, storage, transportation, use, testing, promotion, marketing, sale or other disposition of a Licensed Product by or on behalf of Akebia or its sublicensees outside the Territory, or the conduct of the Global Phase 3 Program in the Territory or (c) the negligence or willful misconduct of any Akebia Indemnitee (as defined in Section 13.02 (Indemnification by Licensee)).  Notwithstanding the foregoing, Akebia shall not have any obligation to indemnify the Licensee Indemnitees to the extent that any Losses arise out of the negligence or willful misconduct of any Licensee Indemnitee or any breach of this Agreement by Licensee.
Section 13.02 Indemnification by Licensee.  Unless otherwise provided herein, Licensee shall indemnify, hold harmless and defend Akebia and any its Affiliates, directors, officers, employees and agents (the “Akebia Indemnitees”) from and against any and all Losses, to the extent that such Losses arise out of (a) a breach of this Agreement by Licensee, (b) the Development, manufacture, distribution, storage, transportation, use, testing, promotion, marketing, sale or other disposition of a Licensed Product by or on behalf of Licensee or its sublicensees inside the Territory or (c) the negligence or willful misconduct of any Licensee Indemnitee.  Notwithstanding the foregoing, Licensee shall not have any obligation to indemnify the Akebia Indemnitees to the extent that any Losses arise out of the negligence or willful misconduct of any Akebia Indemnitee or any breach of this Agreement by Akebia.
Section 13.03 Procedure.  In the event of a claim by a Third Party against a Party entitled to indemnification under this Agreement (“Indemnified Party”), the Indemnified Party shall notify the other Party (“Indemnifying Party”) within five (5) Business Days in writing of the claim and the Indemnifying Party shall undertake and solely manage and control, at its sole expense, the defense of the claim and its settlement.  The Indemnified Party shall cooperate with the Indemnifying Party.  The Indemnified Party may, at its option and expense, be represented in any such action or proceeding by counsel of its choice.  The Indemnifying Party shall not be liable for any litigation costs or expenses incurred by the Indemnified Party without the Indemnifying Party’s written consent.  The Indemnifying Party shall not settle any such claim unless such settlement fully and unconditionally releases the Indemnified Party from all liability relating thereto, unless the Indemnified Party otherwise agrees in writing.
Section 13.04 Insurance.  Each Party shall, at its own expense, obtain and maintain insurance with respect to the Development and Commercialization of Licensed Compounds and Licensed Products under this Agreement in such amount and subject to such deductibles and other limitations as biopharmaceutical companies in the Territory customarily maintain with 

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respect to the research, development, and commercialization of similar products.  Each Party shall provide a copy of such insurance policy to the other Party upon request.  
ARTICLE XIV.
TERM AND TERMINATION
Section 14.01 Term.  The term of this Agreement shall begin on the Effective Date and, unless earlier terminated in accordance with the terms of this Article XIV (Term and Termination), will expire upon the expiration of the Royalty Term (the “Term”).  Upon the expiration of this Agreement in accordance with the preceding sentence, the licenses granted pursuant to Section 2.01 (Grant of License) shall become royalty-free, fully paid up licenses with no additional payments and no royalties due hereunder (other than amounts previously accrued prior to the expiration of the Royalty Term).  For clarity, no royalties shall be due under Section 8.04 (Royalties) of this Agreement following the expiration of the Royalty Term.  Notwithstanding the expiration of the Term, any and all supply agreements entered into by the Parties in accordance with Section 7.01 (Manufacture and Supply of Licensed Products) hereof shall continue in accordance with their terms.
Section 14.02 Termination for Breach.  Subject to the terms and conditions of this Section 14.02 (Termination for Breach), a Party (the “Non-Breaching Party”) shall have the right, in addition to any other rights and remedies, to terminate this Agreement in the event the other Party (the “Breaching Party”) is in material breach of its obligations under this Agreement.  The Non-Breaching Party shall first provide written notice to the Breaching Party, which notice shall identify with particularity the alleged breach.  With respect to material breaches of any payment provision hereunder, the Breaching Party shall have a period of [***] days after such written notice is provided to cure such breach.  With respect to all other breaches, the Breaching Party shall have a period of [***] days after such written notice is provided to cure such breach.  If such breach is not cured within the applicable period set forth above, the Non-Breaching Party shall have a period of [***] days to (i) enter into good faith discussions with the Breaching Party regarding potential alternatives to termination, and/or (ii) terminate this Agreement upon written notice to the Breaching Party, unless the Breaching Party has commenced a cure and is diligently pursuing such cure at the end of such period, pursuant to an acceptable plan for such cure approved by the other Party, such approval not to be unreasonably withheld, conditioned or delayed.  Notwithstanding the foregoing, if a Party gives to the other Party a notice pursuant to this Section 14.02 (Termination for Breach) of a material breach by such other Party, and such other Party provides notice during the applicable cure period set forth above that such other Party disputes the basis for termination pursuant to this Section 14.02 (Termination for Breach), then this Agreement shall not terminate unless and until an arbitrator issues a final award pursuant to Section 15.02 (Arbitration) upholding such basis for termination provided that the resolution of such dispute is promptly commenced and diligently pursued by the non-terminating Party.  The waiver by either Party of any breach of any term or condition of this Agreement shall not be deemed a waiver as to any subsequent or similar breach.
Section 14.03 Termination for Convenience.  At any time after the second anniversary of the Effective Date, Licensee shall have the right to terminate this Agreement for convenience upon twelve (12) months prior written notice, which notice period may be shortened by Akebia in its sole discretion.
Section 14.04 Termination for Bankruptcy.  To the extent permitted under applicable laws, if at any time during the Term, an Event of Bankruptcy (as defined below) relating to either Party (the “Bankrupt Party”) occurs, the other Party (the “Other Party”) shall have, in addition to all other legal and equitable rights and remedies available hereunder, the 

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option to terminate this Agreement upon sixty (60) days written notice to the Bankrupt Party.  It is agreed and understood that if the Other Party does not elect to terminate this Agreement upon the occurrence of an Event of Bankruptcy, except as may otherwise be agreed with the trustee or receiver appointed to manage the affairs of the Bankrupt Party, the Other Party shall continue to make all payments required of it under this Agreement as if the Event of Bankruptcy had not occurred, the Bankrupt Party shall not have the right to terminate any license granted herein.  The term “Event of Bankruptcy” means:  (i) filing in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of the Bankrupt Party or of its assets or (ii) being served with an involuntary petition against the Bankrupt Party, filed in any insolvency proceeding, and such petition shall not be dismissed within sixty (60) days after the filing thereof.  Without limitation, the Bankrupt Party’s rights under this Agreement shall include those rights afforded by 11 U.S.C. § 365(n) of the United States Bankruptcy Code (the “Bankruptcy Code”) and any successor thereto.  If the bankruptcy trustee of a Bankrupt Party as a debtor or debtor-in-possession rejects this Agreement under 11 U.S.C. § 365(o) of the Bankruptcy Code, the Other Party may elect to retain its rights licensed from the Bankrupt Party hereunder (and any other supplementary agreements hereto) for the duration of this Agreement and avail itself of all rights and remedies to the full extent contemplated by this Agreement and 11 U.S.C. § 365(n) of the Bankruptcy Code, and any other relevant laws.
Section 14.05 Effect of Termination by Akebia.  In the event of any termination of this Agreement by Akebia pursuant to Section 14.02 (Termination for Breach), the following shall apply:
(a) Licensee shall cease using the Akebia Technology and return all inventory of the Licensed Compound and Licensed Product to Akebia together with all copies of the Akebia Know-How and other Confidential Information in the possession or control of Licensee and its Affiliates and sublicensees;
(b) Akebia shall have, and Licensee hereby grants to Akebia with effect from the date of termination, a non-exclusive, fully paid-up, worldwide right and license, with the right to grant sublicenses in multiple tiers, under all Improvements, Licensee Patents, Licensee Inventions and Licensee Technology originating during the Term to research, develop, make, have made, use, import, offer for sale, sell and otherwise exploit the Licensed Compound in the Field inside and outside the Territory, alone or as incorporated into a Licensed Product, only to the extent necessary or useful to research, develop, make, have made, use, import, offer for sale, sell and otherwise exploit the Licensed Compounds, Licensed Products, Combination Products or Bundled Products in the Field inside and outside the Territory; provided that such license shall exclude any Third-Party owned patents, inventions and technology unless Licensee has rights to grant a license to such intellectual property pursuant to the terms of the license from the Third Party.  If Licensee is unable to sub-license any patents, inventions or know-how owned by Third Parties to Akebia pursuant to this Section 14.05(b) without the consent of the Third Party, Licensee undertakes, on request from Akebia, to use its reasonable endeavors to procure such licenses on behalf of Akebia in as far as they are able to do so and Akebia will pay such fees and agree to be bound by the terms agreed between Akebia and the Third Party licensor;
(c) Licensee shall, at Akebia’s written request, promptly (and in any event within [***] days after Licensee’s receipt of such request): (1) assign and transfer to Akebia all of Licensee right, title, and interest in and to all Regulatory Filings, Regulatory Approvals, clinical trial agreements (to the extent assignable and not cancelled), confidentiality and other agreements and data relating to Development or Commercialization of Licensed Products, including data, materials, and Know-How relating to clinical trials, in each case to the extent in Licensee’s Control and to the extent related to the Licensed Product in the Territory; and 

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(2) disclose to Akebia all documents, which are in Licensee’s Control or which it is able to obtain using reasonable efforts, embodying the foregoing; and
(d) the costs associated with the assignments set forth in Section 14.05(c) shall be borne by Licensee.
Section 14.06 Effect of Termination by Licensee.  In the event of any termination of this Agreement by Licensee pursuant to Section 14.02 (Termination for Breach), the Parties shall enter into good faith discussions regarding a royalty-bearing non-exclusive license from Licensee to Akebia, with the right to grant sublicenses, under all Improvements, Licensee Patents, Licensee Inventions and Licensee Technology to research, develop, make, have made, use, import, offer for sale, sell and otherwise exploit the Licensed Compound in the Field inside and outside the Territory, alone or as incorporated into a Licensed Product, only to the extent necessary or useful to research, develop, make, have made, use, import, offer for sale, sell and otherwise exploit the Licensed Compounds, Licensed Products, Combination Products or Bundled Products in the Field inside and outside the Territory. Section 14.05(a) and Section 14.05(c) shall apply, and the costs associated with the assignments set forth in Section 14.05(c) shall be borne by Akebia.  In the event of any termination of this Agreement by Licensee pursuant to Section 14.03 (Termination for Convenience), Section 14.05(a) through Section 14.05(d) shall apply.
Section 14.07 Survival; Accrued Rights.  The following articles and sections of this Agreement shall survive expiration or early termination for any reason: Article I (Definitions), Article VIII (Payments) (with respect to any payment obligations incurred prior to expiration or termination), Section 9.01 (Akebia Intellectual Property), Section 9.02 (Licensee Intellectual Property), Section 9.03 (Joint Technology and Improvements), Section 9.04 (Prosecution of Akebia Patents), Section 9.05 (Prosecution of Licensee Patents Covering Improvements), Section 9.06 (Prosecution of Joint Patents), Section 9.09 (Patent Term Extensions), Article XI (Representations, Warranties, and Covenants), Article XII (Confidentiality), Article XIII (Indemnification), Section 14.04 (Termination for Bankruptcy), Section 14.05 (Effect of Termination by Akebia), Section 14.06 (Effect of Termination by Licensee), Section 14.07 (Survival: Accrued Rights), Article XV (Dispute Resolution; Governing Law), and Article XVI (Miscellaneous).  In any event, expiration or termination of this Agreement shall not relieve the Parties of any liability which accrued hereunder prior to the effective date of such expiration or termination nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement, nor prejudice either Party’s right to obtain performance of any obligation.
ARTICLE XV.
DISPUTE RESOLUTION; GOVERNING LAW
Section 15.01 Executive Officers; Disputes.  Each Party shall ensure that an executive officer is designated for such Party at all times during the Term of this Agreement for dispute resolution purposes, and shall promptly notify the other Party of any change in its designated executive officer. Unless otherwise set forth in this Agreement, in the event of a dispute arising under this Agreement between the Parties, the Parties shall refer such dispute to the respective executive officers, and such executive officers shall attempt in good faith to resolve such dispute. If the dispute is an Akebia Reserved Dispute, then the executive officer of Akebia shall have the final say on such dispute.  If the dispute is a Licensee Reserved Dispute, then the executive officer of Licensee shall have the final say on such dispute.

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Section 15.02 Arbitration.  If the Parties are unable to resolve a given dispute, other than an Akebia Reserved Dispute or a Licensee Reserved Dispute, [***] days after referring such dispute to the executive officers pursuant to Section 15.01 (Executive Officers; Disputes), then either Party may have the given dispute settled by binding arbitration in the manner described below:
(a) Arbitration Request.  If a Party intends to begin an arbitration to resolve a dispute arising under this Agreement, such Party shall provide written notice (the “Arbitration Request”) to the other Party of such intention and the issues for resolution.  From the date of the Arbitration Request and until such time as the dispute has become finally settled, the running of the time periods as to which a Party must cure a breach of this Agreement becomes suspended as to the subject matter of the dispute.
(b) Additional Issues.  Within ten (10) days after the receipt of the Arbitration Request, the other Party may, by written notice, add additional issues for resolution.
(c) Arbitration Procedure.  Except as expressly provided herein, any dispute, controversy or claim arising out of or in connection with this Agreement, including any question regarding its existence, validity or termination, shall be referred to and finally resolved by arbitration under the London Court of International Arbitration Rules, which rules are deemed to be incorporated by reference into this Section 15.02(c) (Arbitration).  There shall be one arbitrator, and such arbitrator will be chosen pursuant to the London Court of International Arbitration Rules.  The seat, or legal place, of arbitration shall be London, England, or such other venue as the Parties agree.  The language to be used in the arbitral proceedings shall be English.  Nothing in this Agreement shall be deemed as preventing either Party from seeking injunctive relief (or any other provisional remedy) from any court having jurisdiction over the Parties and the subject matter of the dispute as necessary to protect either Party’s name, proprietary information, trade secrets, know-how or any other proprietary right or otherwise to avoid irreparable harm.  If the issues in dispute involve scientific or technical matters, any arbitrator chosen hereunder shall have educational training and/or experience sufficient to demonstrate a reasonable level of knowledge in the field of biotechnology and pharmaceuticals.  Judgment on the award rendered by the arbitrator may be entered in any court having jurisdiction thereof.
Section 15.03 Choice of Law.  This Agreement and all amendments, modifications, alterations, or supplements hereto, and the rights of the Parties hereunder, shall be construed under and governed by the laws of the State of New York, United States, exclusive of its conflicts of laws principles.  This Agreement has been prepared in the English language and the English language shall control its interpretation.  All consents, notices, reports and other written documents to be delivered or provided by a Party under this Agreement shall be in the English language, and in the event of any conflict between the provisions of any document and the English language translation thereof, the terms of the English language translation shall control.
ARTICLE XVI.
MISCELLANEOUS
Section 16.01 Assignment.  Either Party may assign this Agreement and the licenses herein granted (a) to any Affiliate of such Party without the prior written consent of the other Party, provided that such Party remains fully liable for the performance of such Party’s obligations hereunder by such Affiliate and such Party so informs the other Party of the assignment, (b) prior to [***], with the other Party’s prior written consent, (c) [***], with the other Party’s prior written consent unless such assignment is to any Third Party purchaser of all or substantially all of the assets or businesses to which this Agreement relates, in which case the 

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assigning Party will provide prior written notice to the other Party and need not obtain the other Party’s consent.  Any other assignment of this Agreement by a Party requires the prior written consent of the other Party.  Any assignment in violation of this Section 16.01 (Assignment) shall be null and void.  This Agreement shall be binding on and shall inure to the benefit of the permitted successors and assigns of the Parties hereto.
Section 16.02 Standstill.  During the Term, Licensee shall not directly or indirectly, without the prior approval of the Board of Directors of Akebia, acquire common shares of Akebia in the public market or from other shareholders exceeding an aggregate total equity stake of [***] on a fully diluted as converted basis.
Section 16.03 Non-Competition.  During the Term of this Agreement, Licensee shall not [***] (“Competing Product”).  Competing Product shall not include (i) any product set forth in Exhibit B, the contents of which shall be agreed upon by the Parties within thirty (30) days after the Effective Date, or (ii) any product containing [***].  For the avoidance of doubt, this Section 16.03 (Non-Competition) shall not apply to Affiliates of Licensee [***].  Notwithstanding the foregoing, at any time during the Term, if Licensee wishes to promote or sell a Competing Product, Licensee may request Akebia’s consent to promote or sell said Competing Product.  Following the request by Licensee, the Parties shall enter into good faith discussions regarding such request.
Section 16.04 Additional Collaboration.  Within [***] after the Effective Date, the Parties will discuss the [***].
Section 16.05 Force Majeure.  If either Party shall be delayed, interrupted in or prevented from the performance of any obligation hereunder by reason of force majeure including an act of God, fire, flood, earthquake, war (declared or undeclared), public disaster, act of terrorism, strike or labor differences, such Party shall not be liable to the other therefor; and the time for performance of such obligation shall be extended for a period equal to the duration of the force majeure which occasioned the delay, interruption or prevention.  The Party invoking such force majeure rights of this Section 16.05 (Force Majeure) must notify the other Party by courier or overnight dispatch (e.g., Federal Express) within a period of thirty (30) days of both the first and last day of the force majeure unless the force majeure renders such notification impossible in which case notification will be made as soon as possible.  If the delay resulting from the force majeure exceeds [***].
Section 16.06 Entire Agreement.  This Agreement, together with Exhibit A and Exhibit B attached hereto, constitutes the entire agreement between the Parties with respect to the subject matter hereof and shall not be modified, amended or terminated, except as herein provided or except by another agreement in writing executed by the Parties hereto.
Section 16.07 Severability.  If any provision of this Agreement is declared invalid by a court of last resort or by any court or other governmental body from the decision of which an appeal is not taken within the time provided by law, then and in such event, this Agreement will be deemed to have been terminated only as to the portion thereof that relates to the provision invalidated by that decision and only in the relevant jurisdiction, but this Agreement, in all other respects and all other jurisdictions, will remain in force; provided, however, that if the provision so invalidated is essential to the Agreement as a whole, then the Parties shall negotiate in good faith to amend the terms hereof as nearly as practical to carry out the original intent of the Parties, and, failing such amendment, either Party may submit the matter for resolution pursuant to Article XV (Dispute Resolution; Governing Law).

CONFIDENTIAL

Section 16.08 Notices.  Any notice or report required or permitted to be given under this Agreement shall be in writing and shall be mailed by internationally recognized express delivery service, or sent by facsimile and confirmed by mailing, as follows:
If to Akebia:
Akebia Therapeutics, Inc.
245 First Street, Suite 1100
Cambridge, MA 02142, U.S.A.
Attention:  Chief Executive Officer
Facsimile:
With a copy to (which shall not constitute notice for purposes of this Agreement):
Akebia Therapeutics, Inc.
245 First Street, Suite 1100
Cambridge, MA 02142
Attention:  General Counsel
Facsimile:
If to Licensee:
Mitsubishi Tanabe Pharma Corporation
17-10, Nihonbashi-Koamicho,
Chuo-ku, Tokyo 103-8405, Japan
Attention:  General Manager
									
			
	 	Business Development Department	 

Facsimile:
With a copy to (which shall not constitute notice for purposes of this Agreement):
Mitsubishi Tanabe Pharma Corporation
3-2-10 Dosho-machi
Cho-ku, Osaka, Japan
Attention:  General Manager
									
			
	 	Legal Affairs & Intellectual Property Department	 

Facsimile:
Section 16.09 Further Assurances.  The Parties agree to reasonably cooperate with each other in connection with any actions required to be taken as part of their respective obligations under this Agreement, and shall (a) furnish to each other such further information; (b) execute and deliver to each other such other documents; and (c) do such other acts and things (including working collaboratively to correct any clerical, typographical, or other similar errors in this Agreement), all as the other Party may reasonably request for the purpose of carrying out the intent of this Agreement.
Section 16.10 Agency.  Neither Party is, nor will be deemed to be an employee, agent or representative of the other Party for any purpose.  Each Party is an independent contractor, not 

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an employee or partner of the other Party.  Neither Party shall have the authority to speak for, represent or obligate the other Party in any way without prior written authority from the other Party.
Section 16.11 No Waiver.  Any omission or delay by either Party at any time to enforce any right or remedy reserved to it, or to require performance of any of the terms, covenants or provisions hereof, by the other Party, shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement.  Any waiver by a Party of a particular breach or default by the other Party shall not operate or be construed as a waiver of any subsequent breach or default by the other Party.
Section 16.12 No Strict Construction.  This Agreement has been prepared jointly by the Parties and shall not be strictly construed against either Party.
Section 16.13 Cumulative Remedies.  No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.
Section 16.14 Counterparts.  This Agreement may be executed in counterparts, all of which taken together shall be regarded as one and the same instrument.
 
 
 

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IN WITNESS WHEREOF, the Parties have executed this Agreement through their duly authorized representatives to be effective as of the Effective Date.
AKEBIA THERAPEUTICS, INC.
 
																					
	By:	 	/s/ John P. Butler	 	By:	 	/s/ Jason A. Amello
	 	 	 	 	 	 	 
	Name:	 	John P. Butler	 	Name:	 	Jason A. Amello
		 	 	 	 	 	 
	Title:	 	President & Chief Executive Officer	 	Title:	 	Senior Vice President,
Chief Financial Officer & Treasurer

 
MITSUBISHI TANABE PHARMA CORPORATION
 
									
	By:	 	/s/ Masayuki Mitsuka
	 	 	 
	Name:	 	Masayuki Mitsuka
	 	 	 
	Title:	 	President & Representative Director
Chief Executive OfficerDocument

Exhibit 10.54

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Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential. Double asterisks denote omission. 

SECOND AMENDED AND RESTATED LICENSE AGREEMENT

BY AND BETWEEN

AKEBIA THERAPEUTICS, INC.

AND

VIFOR (INTERNATIONAL) LTD.

Dated February 18, 2022

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TABLE OF CONTENTS
Pages
						
	Article 1 DEFINITIONS
	2

	Article 2 GOVERNANCE
	13

	Article 3 LICENSE GRANT
	15

	Article 4 SALES OF LICENSED PRODUCTS
	16

	Article 5 SUPPLY AGREEMENTS
	21

	Article 6 PRICING AND PRICE REPORTING
	28

	Article 7 EXCLUSIVITY
	28

	Article 8 REGULATORY
	30

	Article 9 TRADEMARKS; NAMES
	31

	Article 10 MANUFACTURING AND SUPPLY
	32

	Article 11 PAYMENTS
	33

	Article 12 INFORMATION AND ADVERSE DRUG EVENTS AND REPORTS
	36

	Article 13 REPRESENTATIONS, WARRANTIES, AND COVENANTS
	37

	Article 14 CONFIDENTIALITY
	41

	Article 15 INDEMNIFICATION
	42

	Article 16 TERM AND TERMINATION
	44

	Article 17 DISPUTE RESOLUTION; GOVERNING LAW    
	51

	Article 18 MISCELLANEOUS    
	52

Schedule 1.9 (Akebia Patents)
Schedule 1.11 (Akebia Trademarks)
Schedule 1.61 (Executive Leadership Teams)
Schedule 5.7 (IDO Participation Letter)
Schedule 5.10 (Authorized Dialysis Centers)

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SECOND AMENDED AND RESTATED LICENSE AGREEMENT
THIS SECOND AMENDED AND RESTATED LICENSE AGREEMENT (this “Second Amended Agreement”) is made and entered into as of February 18, 2022 (the “Effective Date”) between Akebia Therapeutics, Inc., a company organized and existing under the laws of the State of Delaware, United States of America with its principal offices at 245 First Street, Cambridge, MA 02142 (“Akebia”), and Vifor (International) Ltd., a corporation established in accordance with Swiss laws and registered in the commercial registry under CH-107.360.718, with its premises at Rechenstrasse 37, 9014 St. Gallen, Switzerland (“Licensee”).
Akebia and Licensee may be referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Akebia is the owner of, or otherwise controls, the Akebia Technology, the Licensed Compound, and the Licensed Products in the Territory;
WHEREAS, as of the Effective Date, the Licensed Product is an investigational agent that has completed Phase 3 clinical trials for the treatment of anemia secondary to chronic kidney disease for which the safety and effectiveness in the Territory has not yet been established, and, as of such date, an NDA has been filed but the Licensed Product has not yet received Regulatory Approval;
WHEREAS, Licensee has commercial capabilities in the Territory, and is interested in obtaining an exclusive license to sell Licensed Products in the Field in the Territory;
WHEREAS, as of the Effective Date, Vifor Pharma Participations Ltd., the parent company of Licensee, and Fresenius Medical Care AG & Co KGaA (“FMC”), the parent company of FMCNA, are joint venture partners of Vifor Fresenius Medical Care Renal Pharma Ltd. (“VFMCRP”), with Vifor Pharma Participations Ltd. owning a controlling interest of VFMCRP; 
WHEREAS, Licensee and its Affiliates (including VFMCRP) are strategic partners of Fresenius Kidney Care Group LLC, a Delaware limited liability company (“FKC”) and FreseniusRx, Inc., (“FreseniusRx”), each of which is an Affiliate of FMCNA; 
WHEREAS, Licensee, indirectly through VFMCRP, has entered into a supply agreement with FKC and intends to enter into supply agreements with one or more approved Specialty Pharmacies (which provide specialty pharmacy services to patients receiving treatment in the DD-CKD Indication), certain approved Third Party Dialysis Organizations, and certain Designated Wholesalers; 
WHEREAS, Licensee, directly or indirectly through VFMCRP, intends to enter into supplier agreements with one or more GPOs and IDO Participation Letters with certain approved Independent Dialysis Organization members of such GPOs, and pursuant to such supplier agreements and IDO Participation Letters, Licensed Products will be supplied to such approved Independent Dialysis Organizations;  
WHEREAS, pursuant to such supply agreement with FKC, FKC will provide such Licensed Products only to Authorized Dialysis Centers (other than TPDO Clinics and IDO Clinics); pursuant to such supply agreement with Specialty Pharmacies, Licensed Products will be supplied to such Specialty Pharmacies; pursuant to such supply agreements with Third Party Dialysis Organizations, such Third Party Dialysis Organizations will provide such Licensed Products only to TPDO Clinics; and pursuant to such IDO Participation Letters, Independent Dialysis Organizations will provide such Licensed Products only to IDO Clinics; 
WHEREAS, Akebia and Licensee are parties to that certain License Agreement dated May 12, 2017 (the “Original Execution Date”, and such agreement, the “Original Agreement”) pursuant to which Akebia granted Licensee an exclusive license to sell Licensed Products to FKC in the Field in the 
1

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Territory, and to that certain Amended and Restated License Agreement dated April 8, 2019 (the “First Amended Agreement”) pursuant to which Akebia granted Licensee certain additional rights, including with respect to sales of Licensed Products to Third Party Dialysis Organizations in the Field in the Territory;
 WHEREAS, Akebia and Licensee now desire to amend and restate the First Amended Agreement by entering into this Second Amended Agreement (the First Amended Agreement, as amended by this Second Amended Agreement, the “Agreement”);
WHEREAS, Licensee acknowledges that Akebia has entered into as of the Effective Date, and may during the Term enter into, other agreements with Third Parties with respect to the Licensed Products in the Territory, including granting such Third Parties rights and licenses to Promote or otherwise commercialize such Licensed Products in the Territory, and Licensee agrees that this Agreement is subject to and will be consistent with such agreements; and
WHEREAS, simultaneously with the execution of this Agreement the Parties are entering into the Stock Purchase Agreement (as defined below) pursuant to which Licensee is making an equity investment in Akebia and a Supply Agreement pursuant to which Akebia will supply Licensed Products to Licensee. 
NOW THEREFORE, the Parties agree to amend and restate the Agreement to read in its entirety as follows:
Article 1

DEFINITIONS
1.1    “340B Ceiling Price” means the price calculated pursuant to Section 340B(a) of the Public Health Service Act, 42 U.S.C. § 256b(a).
1.2    “Accounting Standards” means (a) International Financial Reporting Standards, as adopted in Switzerland, (b) U.S. GAAP, or (c) the applicable accounting standards to which the entity making the Net Sales is subject.
1.3    “Additional Working Capital Payment” has the meaning set forth in Section 11.5 (Working Capital Fund).
1.4    “Affiliate” means, with respect to an entity, any corporation, or other business entity controlled by, controlling, or under common control with the first entity, with “control” meaning direct or indirect beneficial ownership of at least 50% of the voting stock of, or at least a 50% interest in the income of, the applicable entity. For clarity, as of the Effective Date, Licensee is not an Affiliate of FMC, FMCNA or any member of the Licensee Supply Group.
1.5    “Agreement” has the meaning set forth in the Recitals.
1.6    “Akebia” has the meaning set forth in the Preamble.
1.7    “Akebia Indemnitees” has the meaning set forth in Section 15.2 (Indemnification by Licensee).
1.8    “Akebia Know-How” means all Know-How that is both (a) Controlled as of the Original Execution Date or during the Term by Akebia or any of its Affiliates, and (b) is either (i) disclosed to Licensee or any of its Affiliates pursuant to this Agreement, or (ii) reasonably necessary for the sale of a Licensed Product.
1.9    “Akebia Patents” means all Patents that both (a) are Controlled as of the Effective Date or during the Term by Akebia or any of its Affiliates in the Territory; and (b) [**]. All Akebia Patents as of the Effective Date are set forth on Schedule 1.9. 
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1.10    “Akebia Technology” means Akebia Know-How and Akebia Patents.
1.11    “Akebia Trademarks” means one or more trademarks selected by Akebia or its Affiliates or licensees under which Akebia or its Affiliates or licensees [**], as well as the Akebia company name and logo, and all trademark registrations and applications therefor, and all goodwill associated therewith. All Akebia Trademarks as of the Effective Date are set forth on Schedule 1.11. 
1.12    “AMP” or “average manufacturer price” has the meaning set forth in 42 U.S.C. § 1396r-8(k)(1).
1.13    “API” means active pharmaceutical ingredient, which is also commonly referred to as drug substance.  For the avoidance of doubt, API will include any prodrug form.
1.14    “Applicable Law” means any applicable law (including common law), statute, rule, regulation, order, judgment, or ordinance of any Governmental Authority (including the FDA), including those concerning environmental, health, regulatory, privacy, and safety matters.
1.15    “ASP” or “average sales price” has the meaning set forth at 42 U.S.C. § 1395w-3a(c) and implementing regulations.
1.16    “Authorized Dialysis Center” means (a) the Majority Owned Clinics, FKC Clinics, TPDO Clinics, and IDO Clinics identified on Schedule 5.10 (as the same may be updated from time to time in accordance with Section 5.10 (Licensee Supply Group)), and (b) home dialysis programs administered through the clinics identified in the foregoing clause (a).  Notwithstanding anything to the contrary set forth in this Agreement, in no event will “Authorized Dialysis Centers” include dialysis clinics owned, operated or affiliated with [**].
1.17    “Best Price” has the meaning set forth in 42 U.S.C. § 1396r-8(c)(1)(C) and implementing regulations.
1.18    “Breaching Party” has the meaning set forth in Section 16.2 (Termination for Breach).
1.19    “Business Day” means any day (other than a Saturday or Sunday) on which the banks in both Cambridge, Massachusetts and Zurich, Switzerland are open for business.
1.20    “Clinical Trial” means any study in humans conducted to obtain information regarding a pharmaceutical or biologic product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging, or efficacy of such pharmaceutical or biologic product.
1.21    “CMS” means the Centers for Medicare & Medicaid Services.
1.22    “Combination Product” means any product that is comprised of two or more APIs, at least one of which is the Licensed Compound, for use in the DD-CKD Indication.  
1.23    “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party with respect to any objective under this Agreement, those efforts and resources that a company within the biopharmaceutical industry of comparable size and resources would typically devote to accomplishing such similar objective under similar circumstances, in each case, with respect to Akebia’s efforts, taking into account the Relevant Factors in effect at the time such efforts are expended.
1.24    “Competing Product” means any product or product candidate that is not a Licensed Product and that (a) [**] and is approved for the DD-CKD Indication or the NDD-CKD Indication, or (b) is based on [**]. For the avoidance of doubt, the Parties acknowledge and agree that [**].
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1.25    “Complete Response Letter” means a complete response letter issued by the FDA in accordance with 21 C.F.R. §314.110.
1.26    “Confidential Information” means Know-How and any technical, scientific, trade, research, manufacturing, business, financial, marketing, product, supplier, intellectual property, and other information that may be disclosed by one Party to the other Party pursuant to this Agreement (including information disclosed prior to the Original Execution Date pursuant to a Confidential Disclosure Agreement between the Parties dated [**], as amended by Amendment No. 1 dated [**]), regardless of whether such information is specifically designated as confidential and regardless of whether such information is in written, oral, electronic, or other form.
1.27    “Controlled” means, with respect to a Party or its Affiliate, any Know-How, Patents, or other intellectual property right that such Party or Affiliate, as the case may be, owns or has a license to and has the ability to grant to the other Party a license or sublicense to, or a right of access with respect to, such Know-How, Patent, or other intellectual property right without violating the terms of any agreement or other arrangements with any Third Party or incurring any additional payment obligations to a Third Party. 
1.28    “Coordination Committee” has the meaning set forth in Section 2.1 (Formation and Purpose of the Coordination Committee).
1.29    “Co-Packaged Product” means a product that contains a Licensed Product and one or more Other Components and that is either (a) packaged together for sale or shipment as a single unit or sold at a single price, or (b) marketed or sold collectively as a single product.
1.30    “Cost of Goods Sold” or “COGS” means, with respect to any Licensed Product in [**] (a) for products and services acquired from or performed by Third Parties, the [**] actual amounts [**] such Third Parties to the extent [**]; and (b) to the extent manufacturing services are performed by [**] or its Affiliates, the fully-burdened cost of all direct materials and labor and fully allocated manufacturing overhead directly attributable to the manufacture, storage, packaging, and shipping of a Licensed Product [**], calculated in accordance with the Accounting Standards provided that for any Licensed Product manufactured by Akebia, [**] will be excluded from the calculation of COGS. In each case ((a) or (b)), COGS includes all [**], Licensed Product testing and yield loss costs, quality control, quality assurance, or other testing of Licensed Products, together with all reasonably allocated indirect costs and overhead applicable to the manufacturing of each Licensed Product, quality control, or technical operations functions, less costs of resalable goods returned in accordance with Akebia’s, or its suppliers’, return policy. 
1.31    “Cover” means with respect to a particular subject matter at issue and a relevant Patent, that the manufacture, use, sale, offer for sale, or importation of the subject matter would fall within the scope of a claim in such Patent. 
1.32    “DD-CKD Indication” means the treatment of anemia in dialysis patients with chronic kidney disease.
1.33    “Designated Wholesalers” means [**]. 
1.34    “Dollars” or “$” means the legal tender of the U.S.
1.35    “Effective Date” has the meaning set forth in the Preamble.
1.36    “Effective Period” has the meaning set forth in Section 3.2.2 (Suspension).
1.37    “ESA” means erythropoiesis stimulating agent.
1.38    “ESRD” means end-stage renal disease.
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1.39    “ESRD PPS Bundled Payment System” means Medicare’s ESRD prospective payment system for a single per-treatment bundled payment that is made for the collection of renal dialysis products and services furnished to individuals for the treatment of ESRD in an ESRD facility or in a patient’s home, as set forth under 42 U.S.C. § 1395rr, as in effect as of the Effective Date.
1.40    “FDA” means the U.S. Food and Drug Administration or any successor agency thereto.
1.41    “Field” means the treatment of anemia in dialysis patients with chronic kidney disease who receive dialysis either at an Authorized Dialysis Center or through a home dialysis program administered by an Authorized Dialysis Center, in each case, with Licensed Product that has received Regulatory Approval in the DD-CKD Indication and that is provided to such dialysis patients either directly by the Authorized Dialysis Center or through a Specialty Pharmacy. 
1.42    “Finished Form” means a Licensed Product containing the Licensed Compound as its sole API in the [**] form in any dosage strength that receives Regulatory Approval in the Territory in the DD-CKD Indication, with all applicable packaging and labeling.
1.43    “First Amended Agreement” has the meaning set forth in the Recitals.
1.44    “First Commercial Sale” means, for each Licensed Product in the Territory, the first sale for end use or consumption to a Third Party of such Licensed Product in the Territory by Licensee or its Affiliates after the granting of Regulatory Approval in the DD-CKD Indication in the Territory for such Licensed Product by the FDA. 
1.45    “FKC” has the meaning set forth in the Recitals.
1.46    “FKC Clinics” means: (a) all dialysis clinics (including home dialysis programs) in the Territory that purchase pharmaceutical products under FMCNA’s or FMCNA’s Affiliates’ formulary guidelines and (b) all dialysis clinics (including home dialysis programs) in the Territory for which FMCNA or its Affiliates provide management or administrative services that include the purchase of pharmaceutical products, but in each case ((a) and (b)) excluding TPDO Clinics and IDO Clinics. 
1.47    “FMC” has the meaning set forth in the Recitals. 
1.47.1    “FMC Contracting Party” has the meaning set forth in Section 5.1.2.
1.48    “FMCNA” or “Fresenius Medical Care North America” means Fresenius Medical Care Holdings, Inc., and any successor entity of all or substantially all of Fresenius Medical Care Holdings, Inc.’s dialysis clinic business in the Territory (by operation of law or by sale, merger, restructuring, or other transfer of direct or indirect ownership of dialysis clinics).  
1.49    “FreseniusRx” has the meaning given to it in the Recitals. 
1.50    “Governmental Authority” means any court, agency, department, authority, or other instrumentality of any national, state, county, city, or other political subdivision.
1.51    “Group Purchasing Organization” or “GPO” means a Third Party organization that (a) manages contracts with its participating members in order to provide pharmaceutical drug purchasing services to its participating members, (b) has entered into a Licensee-GPO Supplier Agreement meeting the requirements set forth in Section 5.6 (Licensee-GPO Supplier Agreement), and (c) has been approved by Akebia and listed on Schedule 5.10 under the heading “Group Purchasing Organizations” (as the same may be updated from time to time in accordance with Section 5.10 (Licensee Supply Group)). 
1.52    “HCPCS Code” means CMS’s Healthcare Common Procedure Coding System.
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1.53    “HIF” means hypoxia-inducible factor.
1.54    “Indemnified Party” has the meaning set forth in Section 15.3 (Indemnification Procedure).
1.55    “Indemnifying Party” has the meaning set forth in Section 15.3 (Indemnification Procedure). 
1.56    “IDO Clinics” means the dialysis clinics (including home dialysis programs) owned by IDOs in the Territory that are identified on Schedule 5.10 under the heading “IDO Clinics” (as the same may be updated from time to time in accordance with Section 5.10 (Licensee Supply Group))
1.57    “IDO Participation Letter” means a letter agreement between Licensee and an IDO described in Section 5.7 (IDO Participation Letter).
1.58    “Independent Dialysis Organization” or “IDO” means an independent Third Party operator of dialysis clinics in the Territory identified on Schedule 5.10 under the heading “Independent Dialysis Organizations” (as the same may be updated from time to time in accordance with Section 5.10 (Licensee Supply Group)) that owns at least one IDO Clinic and (a) is a participating member of a GPO and (b) has executed an IDO Participation Letter in accordance with the requirements of Section 5.7 (IDO Participation Letter). 
1.59    “Initial Working Capital Payment” has the meaning set forth in Section 11.5 (Working Capital Fund).
1.60    “Know-How” means inventions, discoveries, trade secrets, information, experience, data, formulas, procedures, technology and results (whether or not patentable), including practices, knowledge, know-how, experience and test data (including physical, chemical, biological, toxicological, pharmacological, clinical and veterinary data), dosage regimens, control assays, product specifications, analytical and quality control data, marketing, pricing, distribution cost and sales data or descriptions.
1.61    “Knowledge” means the actual knowledge of each Party’s [**], in each case, without any inquiry or investigation. 
1.62    “License” has the meaning set forth in Section 3.1 (Grant of License to Licensee).
1.63    “Licensed Compound” means vadadustat, and any salt or crystal form thereof. Licensed Compound includes any prodrug form of vadadustat.
1.64    “Licensed Product” means any pharmaceutical product, drug product, preparation, formulation, or dosage form thereof that has the Licensed Compound as its API. 
1.65    “Licensed Product Plan” has the meaning set forth in Section 4.7 (Licensed Product Plan).
1.66    “Licensee” has the meaning set forth in the Preamble.
1.67    “Licensee Compliance Program” has the meaning set forth in Section 4.10.1 (Compliance).
1.68    “Licensee Indemnitees” has the meaning set forth in Section 15.1 (Indemnification by Akebia).
1.69    “Licensee Supply Group” means FMCNA, FMCNA’s Affiliates (including FKC), Third Party Dialysis Organizations, IDOs, Authorized Dialysis Centers, and Specialty Pharmacies.
1.70    “Licensee-Designated Wholesaler Supply Agreement” has the meaning set forth in Section 5.8 (Terms of the Licensee-Designated Wholesaler Supply Agreements).
1.71    “Licensee-FKC Supply Agreement” has the meaning set forth in Section 5.1 (Licensee-FKC Supply Agreement).
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1.72    “Licensee-FreseniusRx Supply Agreement” has the meaning set forth in Section 5.3 (Licensee-FreseniusRx Supply Agreement).
1.73    “Licensee-GPO Supplier Agreement” has the meaning set forth in Section 5.6 (Licensee-GPO Supplier Agreement).
1.74    “Licensee-Specialty Pharmacy Supply Agreement” has the meaning set forth in Section 5.4 (Terms of the Licensee-Specialty Pharmacy Supply Agreements).
1.75    “Licensee-TPDO Purchase Agreement” has the meaning set forth in Section 5.3 (Licensee-TPDO Purchase Agreements). 
1.76    “Licensee’s Pre-Termination Sales Volume” has the meaning set forth in Section 16.10.1 (Termination Fee).
1.77    “Licensee’s Tail Period Profit Share” has the meaning set forth in Section 16.10.1 (Termination Fee).
1.78    “Losses” has the meaning set forth in Section 15.1 (Indemnification by Akebia).
1.79    “LSP” has the meaning set forth in Section 5.2.1 (Terms of the Licensee-FKC Supply Agreement).
1.80    “Majority Owned Clinics” means all dialysis clinics in the Territory that are Affiliates of FMCNA.
1.81    “Medical Affairs” means any and all activities appropriately conducted by or on behalf of a Party’s or any of its Affiliates’ medical affairs function including: (i) interacting with physicians or other healthcare professionals who utilize or conduct research related to a drug or biological product, including communications with key opinion leaders, medical education, symposia, advisory boards (to the extent related to medical affairs or clinical guidance), and other medical programs and communications, (ii) activities supporting educational grants and fellowships, research grants, investigator-initiated studies, charitable donations, medical and scientific platform, content development, publications, and communications, KME and KOL engagement, and congress planning, (iii) conducting advisory board meetings or other consultant programs, the purpose of which is to obtain advice and feedback related to the launch of a given product, (iv) activities related to patient registries, (v) physician and nurse education, in each case, to the extent related to medical affairs and not to activities that involve the Promotion, marketing, sale, or other commercialization of Licensed Products.
1.82    “Medical Affairs Committee” has the meaning set forth in Section 2.4.2 (Medical Affairs Committee).
1.83    “NDA” means a New Drug Application or its equivalent for submission to the FDA.
1.84    “NDD-CKD Indication” means the treatment of anemia in non-dialysis patients with chronic kidney disease.
1.85    “Net Sales” means the gross amounts invoiced by Licensee or its Affiliates for the sales of a Licensed Product in the Territory, to the extent recognized and allowed in accordance with the Accounting Standards, as applicable and consistently applied, less the following deductions:   
1.85.1    inventory management fees paid to distributors and reasonably allocated to such Licensed Product, not to exceed [**]% of aggregate Net Sales in the applicable period;
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1.85.2    tariffs, duties, excises, value added tax, and other sales taxes, and other taxes imposed upon and paid with respect to the sale, transportation, delivery, use, exportation, or importation of such Licensed Product (which taxes do not include income taxes); 
1.85.3    amounts actually repaid or credited upon returns, rejections, defects, recalls (due to spoilage, damage, or expiration of useful life), price adjustments, billing errors, or trial prescriptions;
1.85.4    freight, shipping, and insurance expenses specific to such Licensed Product and allocated accordingly;
1.85.5    allowances or credits actually paid or given to customers on account of price reductions affecting such Licensed Product; 
1.85.6    rebates and similar payments made with respect to sales paid for by any governmental or regulatory authority, including interest or penalties thereon, to the extent such rebates or other payments are paid by Akebia and actually reimbursed in full by Licensee to Akebia in accordance with Section 4.5 (Rebates); 
1.85.7    discounts actually paid by Licensee or its Affiliates with respect to sales made by Licensee or its Affiliates to FKC, Specialty Pharmacies, TPDOs, and IDOs under state-legislated or Licensee-sponsored discount prescription drug programs or reductions or coupon and voucher programs;
1.85.8    wholesaler service fees and chargebacks actually paid or credited by Licensee or its Affiliates; 
1.85.9    discounts actually paid or credited by Licensee or its Affiliates for prompt payment; and 
1.85.10    Specialty Pharmacy fees.
Net Sales will be determined from books and records of Licensee or its applicable Affiliate, maintained in accordance with the Accounting Standards, as consistently applied, with respect to sales of any Licensed Product.
The sale of Licensed Products among Licensee or Licensee’s Affiliates that are [**], but in such cases Net Sales will [**] of such Licensed Products to a person or entity who is not an Affiliate.
Net Sales will not include Licensed Products transferred for use in connection with promotional use (including samples).
If Licensee or any of its Affiliates receives [**] for a Licensed Product, then the Net Sales amount for such Licensed Product will be [**]. 
In the event that a Licensed Product is sold as part of a Co-Packaged Product, the Net Sales from the Co-Packaged Product, for the purposes of determining payments hereunder based on Net Sales, will be determined by multiplying the Net Sales of the Co-Packaged Product (as applicable), during the applicable reporting period, by the fraction, A/(A+B), where A is the average sale price of a Licensed Product when sold separately in Finished Form and B is the average sale price of the Other Components included in the Co-Packaged Product when sold separately during the applicable reporting period or, if sales of both such Licensed Product and the Other Components did not occur in such period, then in the most recent reporting period in which sales of both occurred.  In the event that such average sale price cannot be determined for both a Licensed Product and all Other Components included in such Co-Packaged Product, then Net Sales for the purposes of determining payments to Akebia hereunder will be 
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calculated by multiplying the Net Sales of the Co-Packaged Product during the applicable reporting period by the fraction of C/(C+D) where C is the fair market value of a Licensed Product and D is the average sales price of the Other Components included in such Co-Packaged Product when sold separately.  In such event, Licensee will in good faith make a determination of the respective fair market values of such Licensed Product and all Other Components included in the Co-Packaged Product.
If a Licensed Product is sold as part of a Co-Packaged Product, then Licensee or its applicable Affiliate [**]. 
1.86    “NFAMP” or “non-Federal average manufacturer price” has the meaning set forth in 38 U.S.C. § 8126(h)(5).
1.87    “Non-Breaching Party” has the meaning set forth in Section 16.2 (Termination for Breach).
1.88    “Operational Plan” has the meaning set forth in Section 4.8 (Operational Plan).
1.89    “Original Agreement” has the meaning set forth in the Recitals.
1.90    “Original Execution Date” has the meaning set forth in the Recitals.
1.91    “Other Component” means one or more other devices or components.
1.92    “Outstanding CMO Balance” has the meaning set forth in Section 11.5 (Working Capital Fund).
1.93    “Party” and collectively “Parties” has the meaning set forth in the Preamble.
1.94    “Patents” means (a) all patents and patent applications in any country or jurisdiction in the Territory, and (b) any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates, and the like.
1.95    “Payors” has the meaning set forth in Section 4.5 (Rebates).
1.96    “PhRMA Code” has the meaning set forth in Section 4.10.1 (Compliance).
1.97    “Product Materials” means any and all promotional materials, training materials, medical education materials, packaging and labeling, and all other literature or other information related to a Licensed Product.
1.98    “Profit” means, with respect to a Licensed Product in the Territory, the Net Sales or other revenue received for such Licensed Product in the Territory in a given period minus (a) an amount equal to [**] plus [**], minus (b) an amount equal to [**], and minus (c) [**]. 
1.99    “Promote,” “Promotion,” or “Promoting” means to market, detail, advertise, or otherwise promote a Licensed Product, but does not include the sale of, or Medical Affairs activities with respect to, such Licensed Product.
1.100    “Quarterly Report” has the meaning set forth in Section 11.6.2 (Quarterly Reports).
1.101    “Recipient” has the meaning set forth in Section 14.2 (Exceptions).
1.102    “Regulatory Approval” means any NDA approval by the FDA.
1.103    “Regulatory Filings” means all applications, filings, dossiers, and other documents submitted to the FDA in support of research or development of the Licensed Compound and the Licensed 
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Products, including for the purpose of obtaining Regulatory Approval from the FDA.  Regulatory Filings will include all INDs and NDAs.
1.104    “Reimbursement Date” means the later of (a) the date on which a HCPCS Code has been issued by CMS for the Licensed Product and is effective for billing or (b) date on which CMS determines that the Licensed Product is either (i) to be reimbursed using the TDAPA, (ii) included as part of the ESRD PPS Bundled Payment System, or (iii) included under Medicare Part D. 
1.105    “Relevant Factors” means the following factors that may affect the research, development, Regulatory Approval, manufacturing, or commercialization of a Licensed Product (without taking into account any other product or products that Akebia or its Affiliates may be developing, manufacturing, or commercializing): actual issues of safety, efficacy, or stability; product profile (including product modality, category and mechanism of action); stage of development or life cycle status; actual and projected research, development, Regulatory Approval, manufacturing, and commercialization costs; issues regarding the ability to manufacture or have manufactured any Licensed Product; the likelihood of obtaining Regulatory Approvals for any Licensed Product in the Territory and the timing of such Regulatory Approvals; the labeling and anticipated labeling of such Licensed Product; past performance of such Licensed Product or similar products; present and future market potential of such Licensed Product; existing or projected pricing, sales, reimbursement, and profitability of such Licensed Product; pricing or reimbursement changes in relevant countries in the Territory; and proprietary position, strength, and duration of patent protection and anticipated exclusivity of such Licensed Product; and other relevant scientific, technical, operational, and commercial factors.
1.106    “Safety Data” has the meaning set forth in Section 12.2 (Adverse Drug Events).
1.107    “Safety Stock Amount” has the meaning set forth in Section 11.5 (Working Capital Fund).
1.108    “Sale Transaction” has the meaning set forth in Section 18.2 (Standstill).
1.109    “Second Amended Agreement” has the meaning set forth in the Preamble.
1.110    “Specialty Pharmacy” means those specialty pharmacies identified on Schedule 5.10 under the heading “Specialty Pharmacies” (as the same may be updated from time to time in accordance with Section 5.10 (Licensee Supply Group)) that provide pharmaceutical products to dialysis patients of Authorized Dialysis Centers. As of the Effective Date, “Specialty Pharmacies” includes FreseniusRx.
1.111    “Statistically Significant” means a p-value less than [**].
1.112    “Stock Purchase Agreement” means that certain Investment Agreement, dated as of the Effective Date, by and between Akebia and Licensee.
1.113    “Sub-Committee” has the meaning set forth in Section 2.4.1 (Sub-Committees).
1.114    “Supply Agreement” has the meaning set forth in Section 10.2 (Commercial Supply Agreement).
1.115    “Suspension Period” has the meaning set forth in Section 3.2.2 (Suspension).
1.116    “Tail Period” has the meaning set forth in Section 16.10.1 (Termination Fee).
1.117    “TDAPA” means Medicare’s transitional drug add-on payment adjustment as defined under 42 CFR § 413.234(c) and as amended in the Federal Register / Vol. 83, No. 220 / November 14, 2018 and in effect as of the Effective Date.
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1.118    “Term” has the meaning set forth in Section 16.1 (Term).
1.119    “Termination Fee” has the meaning set forth in Section 16.10.1 (Termination Fee).
1.120    “Territory” means the United States of America and its possessions, including Puerto Rico. 
1.121    “Third Party” means any person or entity other than a Party or its Affiliates.
1.122    “Third Party Dialysis Organization” (or “TPDO”) means a Third Party identified on Schedule 5.10 under the heading “Third Party Dialysis Organizations” (as the same may be updated from time to time in accordance with Section 5.10 (Licensee Supply Group)) that owns TPDO Clinics and has entered into a Licensee-TPDO Purchase Agreement meeting the requirements set forth in Section 5.3 (Licensee-TPDO Purchase Agreements). 
1.123    “TIW Modify Trial” means that certain Clinical Trial referred to as the Phase 3b, Randomized, Open-label, Active-controlled Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting from Erythropoiesis-Stimulating Agents (ESAs), Protocol No. 404-201-00012.
1.124    “Total Working Capital Requirement” has the meaning set forth in Section 11.5 (Working Capital Fund).
1.125    “TPDO Clinics” means the dialysis clinics (including home dialysis programs) owned by TPDOs in the Territory that are identified on Schedule 5.10 under the heading “TPDO Clinics” (as the same may be updated from time to time in accordance with Section 5.10 (Licensee Supply Group)). 
1.126    “Transfer Price” has the meaning set forth in Section 11.4 (Transfer Price).
1.127    “True-Up Amount” has the meaning set forth in Section 4.5 (Rebates).
1.128    “Upfront Payment” has the meaning set forth in Section 11.2 (Upfront Payment).
1.129    “U.S.” means the United States of America and its territories and possessions, including Puerto Rico.
1.130    “Valid Claim” means (a) a claim in any issued and unexpired Akebia Patent in the Territory, which claim has not been held invalid or unenforceable by a non-appealed or un-appealable decision of a court or Governmental Authority or other appropriate body of competent jurisdiction and has not been admitted invalid or unenforceable through reissue, reexamination, or disclaimer, or has not been made unenforceable due to failure to pay maintenance fees; or (b) a claim in any pending Akebia Patent in the Territory that has not been abandoned or finally disallowed without the possibility of appeal or re-filing of the application; provided that such claim has not been pending more than seven years from the priority date of such application (but if such pending claim with a pendency of seven years or longer subsequently issues it will be considered a Valid Claim upon issuance). “Valid Claim” does not include any claim in any issued and unexpired Akebia Patent in the Territory Covering an alternative manufacturing process to produce the Licensed Compound or a Licensed Product, including its components (i.e., a manufacturing process other than the manufacturing process used to produce the Licensed Compound or a Licensed Product as of the Effective Date).
1.131    “VFMCRP” has the meaning set forth in the Recitals.
1.132    “Working Capital Fund” has the meaning set forth in Section 11.5 (Working Capital Fund).
1.133    “Working Capital Payment” has the meaning set forth in Section 11.5 (Working Capital Fund).
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Article 2

GOVERNANCE
2.1.    Formation and Purpose of Coordination Committee.  Licensee and Akebia will establish the coordination committee (“Coordination Committee”), which committee will coordinate and oversee the Parties’ activities hereunder and have the additional responsibilities provided for herein. The Coordination Committee will dissolve upon the expiration of the Term. Each Party will designate up to three representatives with appropriate knowledge and expertise to serve as members of the Coordination Committee. Each Party may replace its Coordination Committee representatives at any time upon written notice to the other Party.  
2.2.    Meetings.  The Coordination Committee will hold meetings at such times as it elects to do so, but in no event will such meetings be held less frequently than [**] per calendar year, and such meetings may be held by audio or video teleconference. Other employees of each Party involved in activities under this Agreement may attend meetings of the Coordination Committee as participants, and, with the consent of each Party, consultants, representatives, or advisors involved in the same activities may attend meetings of the Coordination Committee as observers; provided, however, that such Third Party participants and observers are under legally binding obligations of confidentiality and non-use applicable to the Confidential Information of each Party that are at least as stringent as those set forth in Article 14 (Confidentiality).
2.3.    Specific Responsibilities of the Coordination Committee.  The Coordination Committee will:
2.3.1    coordinate the activities of the Parties hereunder;
2.3.2    [**] a Party’s indication of interest in having [**], as described in [**];
2.3.3    [**] whether to add or remove any TPDO, GPO, IDO, or Authorized Dialysis Center to or from Schedule 5.10;
2.3.4    [**] any required revisions to this Agreement in response to any reimbursement system change or other rule change, as described under Section 4.6 (Reimbursement System and Other Changes);
2.3.5    [**] Akebia’s initial Licensed Product Plan or any amendment or update thereto, or any matter related to the Licensed Product Plan referred to the Coordination Committee by either Party, as described under Section 4.7 (Licensed Product Plan);
2.3.6    [**] the Operational Plan and any amendment thereto, as described in Section 4.8 (Operational Plan);
2.3.7    [**] the implementation of the Operational Plan, as described in Section 4.8 (Operational Plan);
2.3.8    [**] the Parties’ respective compliance programs, as described in Section 4.10 (Compliance)
2.3.9    [**] for the Parties to discuss matters relating to the Parties entering into arrangements with a given Specialty Pharmacy, as described in Section 4.11 (Specialty Pharmacies);
2.3.10    [**] conflicts raised by Licensee relating to Akebia’s sales of Licensed Products to wholesalers or distributors, as described in Section 7.1 (Akebia Restrictions);
2.3.11    [**] whether to update the Working Capital Percentage, as described in Section 11.5 (Working Capital Fund);
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2.3.12    [**] supply of the Licensed Products in the Territory;
2.3.13    perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties; and
2.3.14    receive at least on a [**] basis updates regarding Akebia’s [**] of all Licensed Products for the DD-CKD Indication that are [**] as defined in this Agreement [**] in the Territory.
2.4.    Other Committees.  
2.4.1    Sub-Committees.  If agreed by the Parties, the Coordination Committee may form sub-committees or working groups as may be necessary or desirable to facilitate the activities under this Agreement (each, a “Sub-Committee”).  A Party may refer any dispute on a matter within a Sub-Committee’s authority to the Coordination Committee for resolution.  No such Sub-Committees’ authority may exceed that specified for the Coordination Committee in this Article 2 (Governance).
2.4.2    Medical Affairs Committee.  Without limiting the generality of, and subject to, the foregoing, following the Effective Date, the Parties will establish a Medical Affairs committee (the “Medical Affairs Committee”) as a Sub-Committee.  In addition to any other matters that the Coordination Committee may delegate to the Medical Affairs Committee, the Medical Affairs Committee will (a) [**] for the Parties to discuss and share information regarding the Parties’ respective Medical Affairs activities for the Licensed Product in the Territory and (b) [**] any proposed investigator-initiated study for the Licensed Product in the Territory, as described in Section 4.9 (Medical Affairs Activities).
2.5.    Dispute Resolution.  Any decisions by the Coordination Committee [**], with each Party having one vote collectively through its representative members of the Coordination Committee, provided that a quorum must be present for any decision to be made by the Coordination Committee.  The Coordination Committee will use good faith efforts to promptly resolve any such matter for which it has authority. If, after the use of good faith efforts, the Coordination Committee is unable to resolve any matter that is within the scope of the Coordination Committee’s authority or any other disagreement between the Parties that the Parties may agree to refer to the Coordination Committee, in each case, within a period of [**], then a Party may refer such matter for resolution in accordance with Section 17.1 (Executive Officers).
Article 3

LICENSE GRANT
3.1.    Grant of License to Licensee.  Subject to the terms and conditions of this Agreement (including Section 3.2 (Effectiveness and Suspension), Section 3.3 (No Implied Rights), and Section 7.1 (Akebia Restrictions)), Akebia hereby grants to Licensee non-sublicensable, non-transferrable, license under the Akebia Technology to (a) sell the Licensed Products solely to the Licensee Supply Group, (b) sell the Licensed Products to Designated Wholesalers solely for resale to members of the Licensee Supply Group, and (c) conduct Medical Affairs with respect to the Licensed Product solely in accordance with Section 4.9 (Medical Affairs Activities), in each case ((a) through (c)), in the Territory in the Field during the Term, subject to the limitations set forth in Section 3.2 (Effectiveness and Suspension) (the “License”). The License will be exclusive (even as to Akebia) with respect to the foregoing clause (a) (regarding sales to the Licensee Supply Group for use in the Field in the Territory) and clause (b) (regarding sales to the Designated Wholesalers for resale solely to the Licensee Supply Group for use in the Field in the Territory), and co-exclusive (with Akebia) with respect to clause (c) (regarding the conduct of Medical Affairs in the Territory).  
3.2.    Effectiveness and Suspension.  
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3.2.1    Effectiveness.  The License will be effective as of the Effective Date, provided that Licensee covenants and agrees that it will not sell or otherwise supply Licensed Products until the FDA has granted Regulatory Approval for a Licensed Product in the DD-CKD Indication in the Territory and (a) with respect to each particular Third Party Dialysis Organization, until such time as Licensee has entered into a Licensee-TPDO Purchase Agreement with such Third Party Dialysis Organization in accordance with Section 5.10.2 (Addition of TPDOs), (b) with respect to each particular IDO, until such time as Licensee has executed a Licensee-GPO Supplier Agreement with the GPO to which such IDO is a member and Licensee has entered into an IDO Participation Letter with such IDO in accordance with Section 5.7 (IDO Participation Letter), (c) with respect each particular Specialty Pharmacy, until such time as Licensee has entered into a Licensee- Specialty Pharmacy Supply Agreement with such Specialty Pharmacy in accordance with Section 5.4 (Terms of Licensee-Specialty Pharmacy Supply Agreement), and (d) with respect to each particular Designated Wholesaler, until such time as Licensee has entered into a Licensee-Designated Wholesaler Supply Agreement with such Designated Wholesaler in accordance with Section 5.8 (Terms of the Licensee-Designated Wholesaler Supply Agreements).
3.2.2    Suspension.  Following the Effective Date, the License granted in Section 3.1 (Grant of License to Licensee), will remain in effect and exercisable by Licensee except during any period during which the License is suspended pursuant to Section 4.6 (Reimbursement System and Other Changes), or Section 16.7 (Termination or Suspension for Impacts on Pricing) (the “Effective Period”). During any period after the Effective Date during the Term that is not an Effective Period (a “Suspension Period”), the provisions set forth in Section 16.14 (Suspension of Licensed Rights) shall apply. 
3.3.    New Dialysis Indication for Licensed Product. In the event Akebia wishes to pursue an additional development program intended to support Regulatory Approval of the Licensed Product in an indication other than the DD-CKD Indication for the treatment of dialysis patients, the parties will discuss in good faith financial terms in support of such development program and commercialization of such new indication upon Regulatory Approval.  
3.4.    Commercialization of Potential Combination Product(s).  In the event that Akebia develops any Combination Product for the DD-CKD Indication, then, no later than [**] following the NDA submission for such Combination Product, Licensee may notify Akebia of its desire to include such Combination Product under this Agreement.  No later than [**] following Akebia’s receipt of such notice, the Parties will discuss in good faith including such Combination Product under the definition of “Licensed Product” under this Agreement and any related amendments to this Agreement required with respect to the inclusion of such Combination Product hereunder, for a period of [**] (or such long period as the Parties may agree).  If either (a) Licensee does not provide notice of its desire to include such Combination Product under this Agreement within such [**] period or (b) the Parties do not enter into a definitive amendment to this Agreement within the [**] negotiation period (as may be extended by agreement of the Parties), then, in each case ((a) and (b)), notwithstanding anything to the contrary set forth in this Agreement, Akebia will be free to exploit such Combination Product within and outside of the Field in the Territory, alone or with one or more Third Parties, without any further obligation to Licensee.  Notwithstanding anything to the contrary set forth in this Agreement, following the [**] anniversary of the Effective Date, Akebia will have no further obligations and Licensee will have no further rights under this Section 3.4 (Commercialization of Potential Combination Product(s)).
3.5.    No Implied Rights.  Licensee will not practice the Akebia Technology or exploit the Licensed Compound or any Licensed Product other than as expressly licensed and permitted under this Agreement. Nothing in this Agreement will be interpreted to grant Licensee or any of its Affiliates any rights under any intellectual property rights owned or Controlled by Akebia or its Affiliates (including Akebia Technology) that are not expressly granted herein, whether by implication, estoppel, or otherwise. Any rights not expressly granted to Licensee by Akebia under this Agreement are hereby retained by Akebia.  Without limiting the generality of the foregoing, 
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Akebia retains the exclusive right to sell Licensed Products to any Third Party outside of the Field. 
Article 4

SALES OF LICENSED PRODUCTS
4.1.    No Unauthorized Sales.  Licensee will not, directly or indirectly, import, offer for sale, sell, or distribute the Licensed Compound or any Licensed Product (a) other than as expressly set forth in this Agreement in the Field in the Territory, (b) outside of the Territory, or (c) to any person or entity (i) other than the Licensee Supply Group or Designated Wholesalers or (ii) who uses or who Licensee reasonably expects will use such Licensed Product outside of the Field in the Territory.  Licensee will promptly report to Akebia any unauthorized use, distribution, or transfer of the Licensed Compound or any Licensed Product in the Territory by or on behalf of any member of the Licensee Supply Group or any Designated Wholesaler, any of their respective Affiliates, or any distributor associated with any of the foregoing. Licensee will use Commercially Reasonable Efforts to stop any such unauthorized use, distribution, or transfer of such Licensed Compound or Licensed Product. In addition, if there is any unauthorized use, distribution, or transfer of any Licensed Product by any member of the Licensee Supply Group or any Designated Wholesaler, any of their respective Affiliates, or any distributor associated with any of the foregoing to a Third Party that is not a dialysis patient or Authorized Dialysis Center, then, if Licensee does not cause such unauthorized use, distribution, or transfer to cease or terminate the rights of the applicable member of the Licensee Supply Group or Designated Wholesaler, their Affiliates, or applicable distributor associated with any of the foregoing, in each case, within [**] of the date on which Licensee knows or should have known about such unauthorized use, distribution, or transfer, then the Parties will discuss in good faith an agreeable resolution for a period of [**]. If the Parties do not reach such a resolution during such [**] period, then Akebia may exercise its applicable right of termination with respect to such unauthorized use, distribution, or transfer pursuant to Section 16.4 (Termination for Unauthorized Sales). 
4.2.    Codes, Marks, and Packaging.  Unless otherwise agreed by the Parties, the Licensed Products sold by Licensee to FKC, Specialty Pharmacies, IDOs, Third Party Dialysis Organizations, and Designated Wholesalers under this Agreement will not be resold or distributed under a different labeler code, product code, trade name, trademark, or packaging than units sold by Akebia outside of this Agreement or supplied by Akebia under this Agreement.  Licensee will not change any such code, trade name, trademark, or packaging of any Licensed Product supplied to it under the Supply Agreement and will not affix any label or sticker on any Licensed Product without Akebia’s prior written consent. 
4.3.    Promotion and Detailing.  Akebia retains for itself and on behalf of its Affiliates and licensees (other than Licensee) the [**] right to Promote the Licensed Products, and Licensee and its Affiliates will not, and Licensee will ensure that the entities in the Licensee Supply Group and Designated Wholesalers do not, Promote any Licensed Product.  If either Party desires [**], then such Party will provide such [**] to the other Party in writing and the Parties will [**] such [**] in the Territory through the Coordination Committee pursuant to Section 2.3.2 (Specific Responsibilities of the Coordination Committee). If Akebia agrees, [**], then Licensee will ensure that all such activities are conducted in compliance with the Licensee Compliance Program.  Nothing in this Agreement will prohibit any entity in the Licensee Supply Group from including references to any Licensed Product or otherwise engaging in customary and routine clinical communications with their respective patient care staff regarding any Licensed Product or dosing regimens that include any Licensed Product.  For the avoidance of doubt, unless otherwise agreed in writing by the Parties pursuant to this Section 4.3 (Promotion and Detailing), nothing in this Agreement will prevent Akebia or its Affiliates or licensees (other than Licensee) from Promoting any Licensed Product at any Authorized Dialysis Center. 
4.4.    Licensed Product Prices.  To the fullest extent permitted by Applicable Law, Licensee will not, and will not knowingly permit its Affiliates, the Licensee Supply Group, or Designated 
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Wholesalers to, use or sell (as applicable) any Licensed Product in any manner that would result in [**]. In addition, to the fullest extent permitted by Applicable Law, in a written agreement with each of its Affiliates, any member of the Licensee Supply Group, or any Designated Wholesaler that receives any Licensed Product, Licensee will cause and require such Affiliates, member of the Licensee Supply Group, or Designated Wholesaler not to use or sell (as applicable) such Licensed Product in any manner that would result in [**].  For clarity, this Section 4.4 (Licensed Product Prices) will not prohibit (a) the Licensee Supply Group’s customary dialysis clinic cost reporting to CMS and any other Governmental Authority, (b) a GPO’s customary non-public disclosure of product pricing under GPO contracts solely to its member IDOs, or (c) any other disclosure required by Applicable Law. 
4.5.    Rebates.  If Akebia receives a rebate invoice from (a) a state Medicaid program, (b) a state managed Medicaid entity, or (c) any other payor (collectively, “Payors”) claiming a rebate on a unit of Licensed Product billed to a Payor for the treatment of a dialysis patient of an Authorized Dialysis Center, then Akebia shall pay such rebate and Licensee shall reimburse Akebia an equal amount.  If interest or penalties are due on any such rebate, other than any interest or penalties attributable to Akebia’s negligence or violation of Applicable Law, then Licensee shall reimburse such interest or penalties to Akebia and such amounts shall be deducted from Net Sales.  No later than [**] following the end of each quarter after the Effective Date, Akebia will provide Licensee with a statement, in a format to be agreed upon by the Parties, identifying the units of Licensed Product provided for the treatment of a dialysis patient of an Authorized Dialysis Center for which Akebia paid rebates, interest, or penalties during such calendar quarter and the total amount of such rebates, interest, or penalties (“True-Up Amount”).  Licensee will pay Akebia the True-Up Amount within [**] after receipt of such statement from Akebia.
4.6.    Reimbursement System and Other Changes.  In the event of a proposed rule change (a) to the TDAPA, (b) to the ESRD PPS Bundled Payment System, or (c) that Akebia [**] believes may impact the pricing of the Licensed Product outside of the Field, the Coordination Committee will [**] revisions to this Agreement, if any, in response to such proposed rule change. Following such discussion by the Coordination Committee, the Parties may [**] for the purpose of entering into a written amendment to this Agreement or such other changes to this Agreement as the Parties may agree. If such proposed rule change is not [**] to the TDAPA or the ESRD PPS Bundled Payment System as they exist as of the Effective Date (with respect to pricing or reimbursement of products like the Licensed Product), and if the Parties fail to enter into such a written amendment prior to the effectiveness of such rule change (unless the Parties agree in writing that no amendment is necessary), then Akebia may elect to suspend the License and commence a Suspension Period under Section 3.2.2 (Suspension), which Suspension Period will start no sooner than the effectiveness of such rule change and continue until the Parties enter into such an amendment. 
4.7.    Licensed Product Plan.  [**], Akebia will prepare and submit to the Coordination Committee for its [**], pursuant to Section 2.3.9 (Specific Responsibilities of the Coordination Committee), a plan setting forth [**] (the “Licensed Product Plan”).  The Licensed Product Plan may include information relating to [**].  In any event, the Licensed Product Plan must be [**].  The Parties, working through the Coordination Committee, will [**] the Licensed Product Plan, and Akebia will [**] into a revised Licensed Product Plan.  During the Term, Akebia may prepare and submit to the Coordination Committee for its [**] amendments to the Licensed Product Plan on an as-needed basis, for example [**].  The Parties, working through the Coordination Committee, will [**] such amendments, and Akebia will give due consideration to and use good faith efforts to incorporate any reasonable recommendations of Licensee into such amendments. 
4.8.    Operational Plan.  No later than [**] following Licensee’s receipt of the Licensed Product Plan, Licensee will submit to the Coordination Committee, for [**], an operational plan for Licensee’s and its Affiliates’ launch, commercialization of, and Medical Affairs activities for the Licensed Product in the Field in the Territory (the “Operational Plan”).  The Operational Plan will (a) allocate to Licensee operational roles and responsibilities consistent with those set forth on Schedule 4.8 (Operational Plan Roles and Responsibilities) and (b) include a [**] commercial forecast of its sales of Licensed Products in the Territory. The Operational Plan will be consistent 
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with the Licensed Product Plan in all respects.  Prior to [**] during the Term, Licensee will provide an updated Operational Plan to the Coordination Committee for [**].  Licensee will negotiate the Licensee-FKC Supply Agreement, and any amendments thereto, each Licensee-Specialty Pharmacy Supply Agreement, and any amendments thereto, each Licensee-GPO Supplier Agreement, and any amendments thereto, each Licensee-TPDO Purchase Agreement, and any amendments thereto, and each Licensee-Designated Wholesaler Supply Agreement, and any amendments thereto, with the Licensee Supply Group and Designated Wholesalers, as applicable, in a manner consistent with the Operational Plan, to the extent applicable.  During the Term, Licensee will commercialize the Licensed Product in accordance with the Operational Plan, and the Coordination Committee will review and monitor the implementation thereof to ensure coordination for successful launch and commercialization of the Licensed Product.  Licensee may prepare and submit to the Coordination Committee for its [**] amendments to the Operational Plan on an as-needed basis and the Parties, working through the Coordination Committee, will [**] such amendments.  
4.9.    Medical Affairs Activities.  Licensee will be responsible for conducting those Medical Affairs activities allocated to Licensee under the Operational Plan.  Licensee will ensure that all such activities are conducted in compliance with Applicable Law and the Licensee Compliance Program.  Licensee acknowledges that Akebia independently conducts certain activities, such as the funding of investigator-initiated studies if and as Akebia deems appropriate in accordance with its internal policies and procedures. In the event that any member of the Licensee Supply Group (excluding any Specialty Pharmacy) desires to conduct any investigator-initiated studies for the Licensed Product in the Territory in the Field and communicates such desire to Licensee, Licensee may submit a proposal on behalf of such member of the Licensee Supply Group to the Medical Affairs Committee, which will [**] such proposal. 
4.10.    Compliance.  
4.10.1    As of the Effective Date and throughout the Term, Licensee will maintain and implement an effective healthcare compliance program that: (i) governs all employees and contractors; (ii) is consistent with the current U.S. Federal Sentencing Guidelines standards for effective compliance programs; (iii) complies with the then-current Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (the “PhRMA Code”); and (iv) addresses standards applicable to activities within the scope of this Agreement, including the distribution and promotion of pharmaceutical products, adverse event reporting, data safeguards, privacy and protection (the “Licensee Compliance Program”).  Licensee will send a current copy of any code, policies or other written materials comprising or documenting the Licensee Compliance Program to Akebia and provide Akebia with copies of any later updates.  Such Licensee Compliance Program will be at least as comprehensive and contain standards at least as strict and up-to-date as those maintained by Akebia for its own equivalent activities for the Licensed Product and that, if the Licensee Compliance Program is not so comprehensive and up-to-date, then Licensee will ensure that all such sales and Medical Affairs activities are conducted in accordance with Akebia’s compliance standards (as communicated to Licensee from time to time during the Term).  Throughout the Term and with respect to the commercialization of Licensed Products under this Agreement, Licensee and each of its Affiliates will further operate in strict compliance with Applicable Law, the PhRMA Code, the Licensee Compliance Program and Akebia compliance standards, as applicable.  
4.10.2    Throughout the Term, Licensee will maintain adequate systems, policies, and procedures to screen before hire and annually thereafter all prospective and current employees, contractors, subcontractors, or agents against (i) the List of Excluded Individuals/Entities compiled by the Office of the Inspector General in the Department of Health and Human Services, and (ii) the General Services Administration’s List of Parties Excluded from Federal Programs. Such policies and procedures require Licensee’s prospective and current employees, contractors, subcontractors, or agents to disclose immediately to Licensee any exclusion, debarment, suspension, or declaration of ineligibility from 
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participation in federal health care programs or in federal procurement or non-procurement programs and any investigation or indictment which may result in an exclusion, debarment, suspension, or declaration of ineligibility.
4.10.3    Throughout the Term, Licensee will maintain adequate systems, policies, and procedures to provide training to its employees on a regular basis, which includes training on the Licensee Compliance Program. 
4.10.4    [**], the Coordination Committee will conduct a review of the Parties’ respective compliance programs. 
4.10.5    Licensee and its Affiliates will only use Product Materials that are prepared by Akebia, or otherwise approved in advance in writing by Akebia, in each case, in connection with its sale of such Licensed Products under this Agreement or any Medical Affairs activities with respect to the Licensed Product or any Promotion of any Licensed Product by Licensee in the Field in the Territory that may be agreed to by the Parties in accordance with Section 4.3 (Promotion and Detailing).  Akebia will use Commercially Reasonable Efforts to ensure that the Product Materials meet all applicable requirements under the Federal Food, Drug, and Cosmetic Act and conform to applicable FDA regulations.  In addition, Licensee will ensure that the entities in the Licensee Supply Group only use Product Materials that are consistent with those Product Materials prepared and provided by Akebia.  
4.10.6    Each Party shall have responsibility for tracking and reporting payments or other transfers of value made directly or indirectly to health care professionals or other persons and entities under the so-called federal “sunshine law” or Open Payments (42 U.S.C. §1320a-7a) and analogous state laws in connection with the performance of this Agreement in accordance with their respective compliance policies
4.11.    Specialty Pharmacies.  Subject to Section 5.10.2 (Additions to Schedule 5.10), Licensee will use [**] to enter into and maintain supply agreements with specialty pharmacies to the extent necessary to make the Licensed Product available to all patients who receive dialysis at Authorized Dialysis Centers, and will ensure that the supply agreements that it enters into with Specialty Pharmacies meet the requirements set forth in Section 5.4 (Terms of the Licensee-Specialty Pharmacy Supply Agreements), Section 6.4 (No Effect on Licensed Product Reported Pricing), and Section 13.5.4.  Notwithstanding anything to the contrary set forth in this Agreement, nothing herein will restrict Akebia from entering into a direct or indirect arrangement with any Specialty Pharmacy for the distribution of Licensed Products outside of the Field.  In the event that the Parties each intend to enter into arrangements with the same Specialty Pharmacy, then the Parties will discuss such matter, along with any operational considerations, through the Coordination Committee.  
Article 5

SUPPLY AGREEMENTS
5.1.    Licensee-FKC Supply Agreement.  Licensee has entered into a supply agreement with its Affiliate, VFMCRP, dated as of December 18, 2018, and in turn VFMCRP has entered into an identical supply agreement with FKC with an effective date of December 18, 2018, pursuant to which, after the Effective Date, Licensed Products will be sold by Licensee (either directly or indirectly through VFMCRP) to FKC in an arms-length transaction for use in Authorized Dialysis Centers, other than TPDO Clinics and IDO Clinics (together, the “Licensee-FKC Supply Agreement”), and only pursuant to such agreements. 
5.1.1    Initial Supply Agreement.  Licensee represents and warrants that the Licensee-FKC Supply Agreement satisfies the requirements of Section 5.2 (Terms of the Licensee-FKC Supply Agreement) with the exception of Section 5.2.8, and does not include any terms related to [**] of any Licensed Product.  If the Licensee-FKC Supply Agreement is 
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terminated or expires, then Akebia may terminate this Agreement pursuant to Section 16.6 (Termination by Akebia for Failure to Enter Into or Amend the Licensee-FKC Supply Agreement or Licensee-FreseniusRx Supply Agreement). 
5.1.2    Amendment to Supply Agreement.  No later than [**] after the Reimbursement Date, Licensee (either directly or indirectly through VFMCRP) and FMCNA or any of its Affiliates (hereinafter referred to as “FMC Contracting Party”) will amend the Licensee-FKC Supply Agreement to finalize such agreement in order to satisfy all requirements of Section 5.2 (Terms of the Licensee-FKC Supply Agreement) (to the extent such Licensee-FKC Supply Agreement does not already do so), including Section 5.2.8.  If Licensee (either directly or indirectly through VFMCRP) and FMC Contracting Party do not enter into an amendment of such Licensee-FKC Supply Agreement during such [**] period, then Akebia may terminate this Agreement pursuant to Section 16.6 (Termination by Akebia for Failure to Enter Into or Amend the Licensee-FKC Supply Agreement or Licensee-FreseniusRx Supply Agreement).  Licensee will provide notice to Akebia that the amendments described herein have been executed and delivered by the parties thereto no later than [**] after entering into such amendments, including whether such amendment satisfies the requirements of Section 5.2.8. Notwithstanding anything herein to the contrary, Licensee (or in case the Licensee-FKC Supply Agreement has been entered into by VFMCRP, then VFMCRP) may amend the Licensee-FKC Supply Agreement in such a way that it no longer complies with Section 5.2.8, if so agreed in writing by the Parties.
5.2.    Terms of the Licensee-FKC Supply Agreement.  Licensee will ensure that, throughout the Term, the Licensee-FKC Supply Agreement:  
5.2.1    requires that FMC Contracting Party either (a) use [**] logistic service providers (each, an “LSP”) and/or use a Designated Wholesaler to provide the Licensed Products solely to the Authorized Dialysis Centers (other than TPDO Clinics and IDO Clinics), in which arrangement the LSP will not own or take title to any Licensed Product, or (b) itself directly provide such Licensed Products solely to Authorized Dialysis Centers other than TPDO Clinics and IDO Clinics;  
5.2.2    prohibits FMC Contracting Party from distributing or transferring Licensed Products to any person or entity other than (a) the LSPs or (b) Authorized Dialysis Centers that are not TPDO Clinics or IDO Clinics;
5.2.3    requires that FMC Contracting Party report any unauthorized use, distribution, or transfer of any Licensed Product promptly to Licensee;
5.2.4    names Akebia as an intended third party beneficiary of such Licensee-FKC Supply Agreement with respect to relevant and appropriate provisions of such agreement;
5.2.5    (a) prohibits FMCNA, FMCNA’s Affiliates (including FKC), or Majority Owned Clinics from [**], except as required by Applicable Law), and (b) [**]; 
5.2.6    requires FMC Contracting Party to cause each Authorized Dialysis Center to (a) not distribute or transfer any Licensed Product to any person or entity other than a dialysis patient in the Field in the Territory or another Authorized Dialysis Center in the Territory, (b) use each Licensed Product, and implement reasonable measures to ensure that each Licensed Product is used only for (i) the treatment of dialysis patients in the Field in the Territory, and (ii) delivering clinical treatment consistent with the requirements of Section 4.4 (Licensed Product Prices) and to dialysis patients in the Field in the Territory; (c) report any unauthorized use, distribution, or transfer of any Licensed Product promptly to Licensee; and (d) [**], except as required by Applicable Law and to promptly inform Licensee, FMC Contracting Party, and Akebia if the Authorized Dialysis Center believes that it is required by Applicable Law [**]; 
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5.2.7    contains such additional provisions as may be necessary to ensure Licensee’s compliance with the terms set forth in this Agreement; 
5.2.8     requires that Licensed Products be sold by Licensee (either directly or indirectly through VFMCRP) to FMC Contracting Party in an arms-length transaction, and by FMC Contracting Party directly (or indirectly through FKC or FreseniusRx) to patients who receive dialysis at Authorized Dialysis Centers; and 
5.2.9    in case the Licensee-FKC Supply Agreement includes sales to FreseniusRx, then sub-sections 5.4.1 and 5.4.6 shall be applicable to the Licensee-FKC Supply Agreement.
5.3.    Licensee-FreseniusRx Supply Agreement.  Licensee has entered into a supply agreement with its Affiliate VFMCRP dated as of December 18, 2018, and in turn, in the event the Licensee-FKC Supply Agreement does not include sales to FreseniusRx, VFMCRP will enter into a separate supply agreement with FreseniusRx, or an amendment thereto, pursuant to which, after the Effective Date, Licensed Products will be sold by Licensee (either directly or indirectly through VFMCRP) to FreseniusRx in an arms-length transaction, and by FreseniusRx directly to patients who receive dialysis at Authorized Dialysis Centers (together, the “Licensee-FreseniusRx Supply Agreement”) in compliance with the requirements of Section 5.4 (Terms of the Licensee-Specialty Pharmacy Supply Agreements).  If, in the event the Licensee-FKC Supply Agreement does not include sales to FreseniusRx, and Licensee, VFMCRP, and FreseniusRx do not enter into such an agreement or amendment, as applicable, within [**] after the Reimbursement Date, then Akebia may terminate this Agreement pursuant to Section 16.6 (Termination by Akebia for Failure to Enter Into or Amend the Licensee-FKC Supply Agreement or Licensee-FreseniusRx Supply Agreement).  Licensee will provide notice to Akebia no later than [**] after entering into such agreement or amendment, as applicable. Notwithstanding anything herein to the contrary, Vifor may terminate the Licensee-FreseniusRx Supply Agreement if so agreed in writing by the Parties.
5.4.    Terms of the Licensee-Specialty Pharmacy Supply Agreements.  In addition to the Licensee-FreseniusRx Supply Agreement, Licensee (either directly or indirectly through VFMCRP) will enter into supply agreements with each other Specialty Pharmacy pursuant to which Licensee will sell Licensed Products directly to such Specialty Pharmacy in arms-length transactions for use by patients who receive dialysis at Authorized Dialysis Centers or at home from an Authorized Dialysis Center (together with the Licensee-FreseniusRx Supply Agreement, each such supply agreement, a “Licensee-Specialty Pharmacy Supply Agreement”), and only pursuant to such agreement. Licensee will ensure that, throughout the Term, each Licensee-Specialty Pharmacy Supply Agreement with each Specialty Pharmacy:  
5.4.1    prohibits the Specialty Pharmacy from distributing or transferring Licensed Products to any person or entity other than to dialysis patients for treatment;
5.4.2    requires that the Specialty Pharmacy report any unauthorized use, distribution, or transfer of any Licensed Product promptly to Licensee;
5.4.3    requires the Specialty Pharmacy to (a) implement reasonable measures to ensure that each Licensed Product is used only for (i) the treatment of dialysis patients in the DD-CKD Indication, and (ii) delivering treatment consistent with the requirements of Section 4.4 (Licensed Product Prices); (b) report any unauthorized use, distribution, or transfer of any Licensed Product promptly to Licensee and Akebia; and (c) [**], except as required by Applicable Law, and to promptly inform Licensee and Akebia if the Specialty Pharmacy believes that it is required by Applicable Law [**];
5.4.4    prohibits the Specialty Pharmacy from [**], except as required by Applicable Law;
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5.4.5    names Akebia as an intended third party beneficiary of such Licensee-Specialty Pharmacy Supply Agreement with respect to relevant and appropriate provisions of such agreement;
5.4.6    prohibits the Specialty Pharmacy from changing any labeler code, product code, trade name, trademark, or packaging of any Licensed Product supplied to it under the Licensee-Specialty Pharmacy Supply Agreement and from affixing any label or sticker on any Licensed Product; 
5.4.7    contains such additional provisions as may be necessary to ensure such Specialty Pharmacy’s compliance with the terms set forth in this Agreement.
5.5.    Licensee-TPDO Purchase Agreements.  Licensee will enter into purchase agreements with each Third Party Dialysis Organization pursuant to which, after the Effective Date, Licensee will sell Licensed Products in arms-length transactions to such Third Party Dialysis Organizations for use in TPDO Clinics (each such supply agreement, a “Licensee-TPDO Purchase Agreement”), and only pursuant to such agreement. Licensee will ensure that, throughout the Term, each Licensee-TPDO Purchase Agreement with each Third Party Dialysis Organization:  
5.5.1    requires that the Third Party Dialysis Organization itself directly provide Licensed Products solely to TPDO Clinics that have been approved by Akebia as provided in Section 5.10 (Licensee Supply Group); 
5.5.2    prohibits the Third Party Dialysis Organization from distributing or transferring Licensed Products to any person or entity other than TPDO Clinics approved by Akebia as provided in Section 5.10 (Licensee Supply Group);
5.5.3    requires that the Third Party Dialysis Organization report any unauthorized use, distribution, or transfer of any Licensed Product promptly to Licensee;
5.5.4    names Akebia as an intended third party beneficiary of such Licensee-TPDO Purchase Agreement with respect to relevant and appropriate provisions of such agreement;
5.5.5    (a) prohibits the Third Party Dialysis Organization and its TPDO Clinics from [**], except as required by Applicable Law, and (b) [**];
5.5.6    requires the Third Party Dialysis Organization to (a) not distribute or transfer any Licensed Product to any person or entity other than a dialysis patient in the Field in the Territory or a TPDO Clinic in the Territory, (b) use each Licensed Product, and implement reasonable measures to ensure that each Licensed Product is used only for (i) the treatment of dialysis patients in the Field in the Territory, and (ii) delivering clinical treatment consistent with the requirements of Section 4.4 (Licensed Product Prices); (c) report any unauthorized use, distribution, or transfer of any Licensed Product promptly to Licensee; and (d) [**], except as required by Applicable Law and to promptly inform Licensee, the Third Party Dialysis Organization, and Akebia if such Third Party Dialysis Organization or any of its TPDO Clinics believes that it is required by Applicable Law [**];
5.5.7    permits Akebia to (a) take assignment of the Licensee-TPDO Purchase Agreement in the event this Agreement is terminated by Licensee pursuant to Section 16.9 (Termination for Convenience) and (b) take over Licensee’s supply of Licensed Products under the Licensee-TPDO Purchase Agreement pursuant to Section 16.15 (Suspension of Licensed Rights) in the event of a Suspension Period; and 
5.5.8    contains such additional provisions as may be necessary to ensure Licensee’s compliance with the terms set forth in this Agreement.
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5.6.    Licensee-GPO Supplier Agreement.  Licensee will enter into a supplier agreement with each GPO pursuant to which, after the Effective Date, Licensee will sell Licensed Products in arms-length transactions solely to the IDO members of such GPO via a distributor associated with such GPO (such supplier agreement, the “Licensee-GPO Supplier Agreement”), and only pursuant to such agreement.  Licensee will ensure that, throughout the Term, each Licensee-GPO Supplier Agreement:  
5.6.1    requires that the GPO and its associated distributor provide Licensed Products solely to the GPO’s member IDOs that have executed an IDO Participation Letter with Licensee in accordance with Section 5.7 (IDO Participation Letter); 
5.6.2    prohibits the GPO and any of its associated distributors from distributing or otherwise transferring Licensed Products to any person or entity other than the GPO’s member IDOs that have executed an IDO Participation Letter with Licensee in accordance with Section 5.7 (IDO Participation Letter);
5.6.3    requires the GPO to cause any member independent operator of dialysis clinics that desires to obtain Licensed Products through such GPO to execute an IDO Participation Letter containing the terms set forth in Schedule 5.7 prior to receiving any Licensed Product through such GPO or its associated distributor; 
5.6.4    requires that the GPO report any unauthorized use, distribution, or transfer of any Licensed Product promptly to Licensee;
5.6.5    (a) with the exception of price disclosure by the GPO to its member IDOs, prohibits the GPO and IDOs from [**], except as required by Applicable Law, and (b) [**]; 
5.6.6    requires the GPO to implement reasonable measures to ensure that each Licensed Product is used only for (a) the treatment of dialysis patients in the Field in the Territory, and (b) delivering clinical treatment consistent with the requirements of Section 4.4 (Licensed Product Prices);
5.6.7    names Akebia as an intended third party beneficiary of such Licensee-GPO Supplier Agreement with respect to relevant and appropriate provisions of such agreement;
5.6.8    permits Akebia to take assignment of the Licensee-GPO Supplier Agreement in the event this Agreement is terminated by Licensee pursuant to Section 16.9 (Termination for Convenience) and (b) take over Licensee’s supply of Licensed Products under the Licensee-GPO Supply Agreement pursuant to Section 16.15 (Suspension of Licensed Rights) in the event of a Suspension Period; and 
5.6.9    contains such additional provisions as may be necessary to ensure Licensee’s compliance with the terms set forth in this Agreement.
5.7.    IDO Participation Letter.  Licensee will cause each GPO to require any member IDO that desires to obtain Licensed Products through such GPO to enter into an IDO Participation Letter with Licensee containing the terms set forth in Schedule 5.7, as a condition of such IDO purchasing Licensed Products through such GPO.  
5.8.    Terms of the Licensee-Designated Wholesaler Supply Agreements.  Licensee will enter into supply agreements with each Designated Wholesaler pursuant to which Licensee will sell Licensed Products to such Designated Wholesaler in arms-length transactions solely for sale by such Designated Wholesaler to a member of the Licensee Supply Group other than as Designated Wholesaler (each such supply agreement, a “Licensee- Designated Wholesaler Supply Agreement”), and only pursuant to such agreement. Licensee will ensure that, throughout the Term, each Licensee-Designated Wholesaler Supply Agreement with each Designated Wholesaler:
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5.8.1    requires that such Designated Wholesaler provide Licensed Products solely to members of the Licensee Supply Group under an exclusive distribution account / “chargeback” sales model;  
5.8.2    prohibits such Designated Wholesaler from distributing or transferring Licensed Products to any person or entity other a member of the Licensee Supply Group;
5.8.3    requires that such Designated Wholesaler report any unauthorized use, distribution, or transfer of any Licensed Product promptly to Licensee;
5.8.4    prohibits such Designated Wholesaler from changing any labeler code, product code, trade name, trademark, or packaging of any Licensed Product supplied to it under the Licensee-Designated Wholesaler Supply Agreement and from affixing any label or sticker on any Licensed Product; and
5.8.5    contains such additional provisions as may be necessary to ensure such Designated Wholesaler’s compliance with the terms set forth in this Agreement.
In addition, Licensee will use reasonable efforts to ensure that each Licensee-Designated Wholesaler Supply Agreement with each Designated Wholesaler names Akebia as an intended third party beneficiary of such Licensee-Designated Wholesaler Supply Agreement.
5.9.    Akebia’s Right to Review Agreements.  Upon request, Licensee further agrees to permit (a) an independent auditor or law firm selected by Akebia and approved by Licensee (which approval will not be unreasonably withheld or delayed) or (b) Akebia, upon Licensee’s approval (which may be withheld in its sole discretion), to examine the Licensee-FKC Supply Agreement, each Licensee-Specialty Pharmacy Supply Agreement, each Licensee-GPO Supplier Agreement, each Licensee-TPDO Purchase Agreement, each Licensee-Designated Wholesaler Supply Agreement, and each IDO Participation Letter, or other agreements between Licensee and any member of the Licensee Supply Group, regarding a Licensed Product, in each case, solely to ensure that such agreements are consistent with the terms set forth in this Agreement.  In the event that Akebia is the reviewing party, then Licensee may redact sensitive commercial information from any such agreement to the extent not necessary for Akebia to determine whether such agreement is consistent with the terms set forth in this Agreement.  Any such auditor or law firm will be bound by a legal agreement obligating it to maintain the confidentiality of such information and not to share such information with Akebia or any other person.  Any such auditor or law firm will summarize its findings solely by stating whether or not such agreements are consistent with Licensee’s obligations hereunder, and if such agreements are inconsistent with Licensee’s obligations, identify such inconsistencies to Akebia. Such examination will not be performed more than once per calendar year.  Akebia will be responsible for the expenses incurred in connection with such examination, except in the event that the results of any examination reveal that such agreements are materially inconsistent with the terms set forth in this Agreement, in which case reasonable fees for such examination will be paid by Licensee.  
5.10.    Licensee Supply Group.  
5.10.1    List of Licensee Supply Group.  As of the Effective Date, listed on Schedule 5.10 are (a) all of the Authorized Dialysis Centers (including each FKC Clinic and Majority Owned Clinic, which are each separately identified on Schedule 5.10), (b) each Third Party Dialysis Organization and each TPDO Clinic owned by each such Third Party Dialysis Organization, (c) each GPO, (d) each IDO that has executed an IDO Participation Letter and the IDO Clinics of each such IDO, and (f) the Specialty Pharmacies.  Licensee will provide to the Coordination Committee an updated Schedule 5.10 [**], and on the Effective Date. 
5.10.2    Additions to Schedule 5.10.  In the event Licensee wishes to update Schedule 5.10 to include any entity within the Licensee Supply Group that has not been previously listed on Schedule 5.10, [**], Licensee will promptly provide to the Coordination Committee 
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an updated Schedule 5.10 that the applicable entity under the applicable heading on Schedule 5.10; and provided further that the License granted in Section 3.1 (Grant of License to Licensee) will only become exercisable by Licensee with respect to such entity, and such entity will only be considered a member of the Licensee Supply Group for purposes of this Agreement, when Licensee has entered into a supply agreement with such entity in accordance with the applicable provisions of this Article 5 (Supply Agreements). and only for so long as such supply agreement remains in effect.
5.10.3    Removal of Licensee Supply Group Members by Akebia.  Akebia may provide written notice to Licensee that Akebia proposes to remove any member of the Licensee Supply Group from Schedule 5.10 in the event that such member of the Licensee Supply Group (a) has not sold any Licensed Product within [**] of its inclusion on Schedule 5.10, (b) has not sold any Licensed Product over a consecutive period of at least [**], or (c) in the case of any IDO, does not have access to one or more of Licensee’s marketed products, other than the Licensed Product, through a GPO of which such IDO is a member.  Within [**] following Licensee’s receipt of a written notice that Akebia proposes to remove an Authorized Dialysis Center from Schedule 5.10, which shall explain the reasons therefore, Licensee may object to such removal in writing, following which the Parties will discuss in good faith an agreeable resolution within [**]. If the Parties do not reach such a resolution during such [**] period, then Akebia may remove such member of the Licensee Supply Group from Schedule 5.10, and in such event Licensee will promptly stop the supply of Licensed Products to such member of the Licensee Supply Group.
5.10.4    Schedule 5.9. [**] the Third Party Dialysis Organizations and their TPDO Clinics and (b) the GPOs, IDOs, and their IDO Clinics, as each ((a) and (b)) are set forth on Schedule 5.10 hereto as of the Effective Date. Licensee represents and warrants that the updated version of Schedule 5.10 attached hereto is accurate and complete as of the Effective Date.
Article 6

PRICING AND PRICE REPORTING
6.1.    Pricing.  Other than with respect to (a) the Licensee Supply Group’s customary dialysis clinic cost reporting to CMS and any other Governmental Authority, (b) a GPO’s customary non-public disclosure of product pricing under GPO contracts solely to its member IDOs that have executed an IDO Participation Letter, or (iii) disclosures required by law, Licensee will not, will cause its Affiliates not to, and will require the Licensee Supply Group and Designated Wholesalers not to, disclose [**], and in each case, such information will be Confidential Information subject to the terms of Article 14 (Confidentiality). 
6.2.    Intention Regarding Impacts on Pricing.  Akebia intends, and enters into this Agreement in reliance upon, the Agreement and the supply of Licensed Product by Akebia to Licensee under the Supply Agreement not giving rise to, or otherwise affecting, [**]. Notwithstanding the foregoing, if the administration of a Licensed Product by an Authorized Dialysis Center or Specialty Pharmacy to a dialysis patient gives rise to a rebate obligation under the Medicaid Drug Rebate Program or the Public Health Service Act Section 340B Drug Discount Program, then so long as (a) Licensee reimburses Akebia in accordance with Section 4.5 (Rebates) for any such rebate obligation incurred by Akebia and (b) such rebate does not affect the AMP, Best Price, 340B Ceiling Price, ASP, or NFAMP of any Akebia product outside of the Field or otherwise contravene Section 6.4 (No Effect on Licensed Product Reported Pricing), then such rebate obligation will not violate the intent of this Section 6.2 (Intention Regarding Impacts on Pricing). 
6.3.    Impacts on Pricing.  If, at any time, (a) there has been a breach of Section 6.1 (Pricing) or Section 6.4 (No Effect on Licensed Product Reported Pricing), (b) through the actions by or on behalf of Licensee, any of its Affiliates, any Designated Wholesaler, or any member of the Licensee Supply Group [**], and even if such actions do not constitute a breach by Licensee 
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under Section 4.4 (Licensed Product Prices)), [**], or (d) [**], then, in each case ((a) through (d)), without limiting Akebia’s other rights and remedies under this Agreement, the Parties will [**] an agreeable resolution for a period of [**].  If the Parties do not reach such a resolution during such [**] period, then Akebia may suspend the License or terminate this Agreement pursuant to Section 16.7 (Termination or Suspension by Akebia for Impacts on Pricing).  
6.4.    No Effect on Licensed Product Reported Pricing.  Licensee will, will cause its Affiliates to, and will require the Licensee Supply Group and Designated Wholesalers to, use and sell (as applicable) each Licensed Product solely in the Field in the Territory. To the fullest extent permitted by Applicable Law, Licensee and its Affiliates will not use, sell, transfer, or distribute the Licensed Product (a) to any “Retail Community Pharmacy” (as defined in 42 U.S.C. § 1396r- 8(k)(10)); or (b) to any other customer, or in any manner, that would cause such sale, transfer, or distribution to affect the AMP, Best Price, 340B Ceiling Price, ASP, or NFAMP of any Akebia product. Licensee will provide prompt written notice to Akebia if Licensee or any of its Affiliates uses, sells, transfers, or distributes any Licensed Product in violation of this Section 6.4 (No Effect on Licensed Product Reported Pricing).   
For the avoidance of doubt, the Parties acknowledge and agree that FreseniusRx does not meet the definition of a “Retail Community Pharmacy” under 42 U.S.C. § 1396r-8(k)(10) and implementing regulations.
Article 7

EXCLUSIVITY
7.1.    Akebia Restrictions.  During the Effective Period, Akebia will not, and will cause its Affiliates and licensees (other than Licensee) to not, sell any Licensed Product directly to any member of the Licensee Supply Group for any use in the Field in the Territory; provided, however, that (a) Akebia will not be required to prohibit any Third Party wholesaler or distributor (including any Designated Wholesaler) from selling any Licensed Product to the Licensee Supply Group and (b) Akebia will not be prohibited from selling Licensed Products to any member of the Licensee Supply Group for any use outside of the Field.  In the event that Licensee reasonably believes any sales of Licensed Products by wholesalers or distributors generates conflicts in Licensee’s distribution of Licensed Products, then Licensee may raise such conflict at the Coordination Committee, and Akebia will consider, if feasible, whether steps can be taken with such wholesaler or distributor to address such conflict.  
7.2.    Licensee Restrictions.  Without the prior written consent of Akebia, neither Licensee nor any of its Affiliates will directly or indirectly Promote, sell, or have sold, or enter into any agreement to Promote, sell, or have sold, any Competing Product in the Territory to FKC, any entity in or member of the Licensee Supply Group, any Designated Wholesaler, or any Authorized Dialysis Center.  Notwithstanding the foregoing, if [**]. 
Article 8

REGULATORY
Akebia will use Commercially Reasonable Efforts to (a) prepare the NDA in the Territory for each Licensed Product based on its global development plan for such Licensed Product, and (b) obtain and maintain Regulatory Approval in the DD-CKD Indication in the Territory for each Licensed Product. Akebia will be responsible for preparing, filing, and submitting, directly or through its Affiliates or licensees, all Regulatory Filings and correspondence with the applicable regulatory authorities for each Licensed Product at its sole cost and expense.
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Article 9

TRADEMARKS; NAMES
9.1.    Trademark Responsibility.  Akebia will be responsible for (a) registering, prosecuting, maintaining, and enforcing the Akebia Trademarks in the Territory, (b) preparing any guidelines applicable to the use of the Akebia Trademarks, and (c) investigating and defending any infringement or threatened infringement relating to any of the foregoing, in each case, at its sole cost and expense.  Licensee will cooperate and assist Akebia with any of the foregoing activities with respect to all Akebia Trademarks, including, if requested by Akebia, providing any specifications, affidavits, declarations, or other documents necessary for Akebia to submit to appropriate Governmental Authorities in order to register and prosecute the Akebia Trademarks.  Akebia will own and be responsible for securing any domain names associated with the Akebia Trademarks, and will be responsible for the costs associated with protecting such domain names.  Neither Licensee nor any of its Affiliates will obtain or hold any such domain name in its own name.  
9.2.    Trademark License.  Subject to the terms and conditions of this Agreement, effective as of the Effective Date, Akebia hereby grants and will grant to Licensee and its Affiliates a non-exclusive non-sublicensable, non-transferrable, royalty-free license to use the Akebia Trademarks solely in connection with the sale, and, [**], of the Licensed Products in the Field in the Territory in accordance with this Agreement. Licensee will maintain the quality of the Licensed Products in accordance with this Agreement and the Supply Agreement. Licensee additionally will assure at all times that the Licensed Products are sold in accordance with Applicable Law. 
9.3.    Trademark Ownership and Cooperation.  Each Party acknowledges that Akebia has sole and exclusive ownership of all rights, title, and interests in and to the Akebia Trademarks. Licensee will not, and will cause its Affiliates and the entities in the Licensee Supply Group not to, register in their own name any trademark, corporate name, domain name, social media account, or other source identifier containing any trademark owned by Akebia or any word or mark that is confusingly similar to any such trademark.  All use of any Akebia Trademark and all goodwill and benefit arising from such use will inure to the sole and exclusive benefit of Akebia.  Licensee will place and display the Akebia Trademarks on and in connection with the Licensed Products only in such form and manner as specified in the guidelines adopted from time-to-time by Akebia and provided to Licensee.  Except as otherwise expressly provided in this Agreement, Licensee is not granted any license under, and will not use, any trademarks of Akebia in connection with any Licensed Product.
9.4.    Defense of Third Party Infringement Claims. 
9.4.1    Notice; Akebia Initiation.  Licensee will immediately provide written notice to Akebia if a Third Party asserts that a Patent or other right controlled by such Third Party is or will be infringed by Licensee’s activities under this Agreement or Licensee becomes aware of a Patent or other right that might form the basis for such a claim, which notice will include all facts related to such claim in reasonable detail. [**]. 
9.4.2    Right to Defend.  If, during the Term of the Agreement, a Third Party asserts that a Patent or other right controlled by such Third Party is infringed or will be infringed in the Territory by Licensee’s exercise of the rights granted to it under this Agreement, then: 
(a)    [**] in the Territory, [**] will defend [**] against any such claim at its own expense using the counsel of its own choosing, so long as [**] is in breach of any of its obligations under this Agreement. [**] will be responsible for [**]% of the amounts owed to any Third Party directly related to such claim, whether by settlement or judgment; and 
(b)    [**] in the Territory, [**] will have the right, but not the obligation, to defend any such claim at its own expense using the counsel of its own choosing. If [**] 
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exercises such right to defend, then it will be responsible for [**]% of the amounts owed to any Third Party directly related to such claim, whether by settlement or judgment. 
In addition, with respect to any such claim by a Third Party that a Patent or other right controlled by such Third Party is infringed or will be infringed as a result of Licensee’s activities under this Agreement in the Territory (whether or not [**]), the Parties will reasonably assist each other and cooperate and share information related to any such claim.
9.4.3    Responsibility for Third Party Licenses.  If at any time during the Term, Akebia believes that it is necessary or advisable to seek to acquire or obtain a license from any Third Party in order to avoid infringement of Patents owned or controlled by such Third Party as a result of Licensee’s activities under this Agreement, whether or not such Third Party has instituted an infringement claim, then Akebia will have the sole right, but not the obligation, [**] under such Patents from such Third Party. [**]. This Section 9.4.3 (Responsibility for Third Party Licenses) will not be interpreted as placing on either Party a duty of inquiry regarding Third Party intellectual property rights. 
Article 10

MANUFACTURING AND SUPPLY
10.1.    Commercial Supply.  Subject to the terms and conditions of this Agreement and the Supply Agreement, Licensee will purchase from Akebia all of Licensee’s requirements of the Licensed Products in Finished Form for sale in the Territory.
10.2.    Commercial Supply Agreement.  The Parties will use good faith efforts to negotiate and enter into a supply agreement for the commercial supply to Licensee of the Licensed Products in Finished Form (the “Supply Agreement”) within [**] following the execution of this Agreement. The Supply Agreement will provide that, following acceptance by Akebia of a purchase order for Licensed Products, Akebia will invoice Licensee for the Transfer Price for such Licensed Products (as further described in Section 11.4 (Transfer Price)) at the time of delivery, payable within [**] following delivery.  
Article 11

PAYMENTS
11.1.    Profit Share.  Subject to the provisions of this Agreement, as partial consideration for the License, Licensee will pay to Akebia 66.6% of the Profit accrued by Licensee or its Affiliates with respect to the sale of Licensed Products. Licensee will make such payment to Akebia in the manner described in Section 11.4 (Transfer Price). 
11.2.    Upfront Payment.  Subject to the provisions of this Agreement, including Section 4.6 (Reimbursement System and Other Changes), as further consideration for the License, Licensee will pay to Akebia a non-creditable, nonrefundable payment of $25,000,000 (the “Upfront Payment”) no later than [**] following the Effective Date.
11.3.    Equity Investment.  Licensee will purchase shares of common stock of Akebia for an aggregate purchase price of $20,000,000 at the purchase price and in accordance with the terms and conditions set forth in the Stock Purchase Agreement.
11.4.    Transfer Price.  Akebia will supply Licensed Products to Licensee under the Supply Agreement at a per-unit transfer price equal to [**] plus [**] plus [**] (the “Transfer Price”).  At least [**] prior to the anticipated First Commercial Sale of the Licensed Product in the Territory, the Parties, through the Coordination Committee, will determine, for purposes of calculating the Transfer Price, the [**] for the calendar quarter following the First Commercial Sale.  For each 
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subsequent calendar quarter, [**] will be determined based on the [**] in the most recently available calendar quarter, unless the Parties agree otherwise.  Beginning from the First Commercial Sale, within [**] following the end of each calendar quarter, the Parties will reconcile the aggregate Transfer Price paid for Licensed Products against the [**] and [**] recorded in such calendar quarter. If Licensee has underpaid for such calendar quarter (i.e., the aggregate Transfer Price paid is less than the sum of [**] plus [**] and [**] sold in such calendar quarter), then Licensee will make a true-up payment to Akebia in the amount of such underpayment. If Licensee has overpaid for such calendar quarter (i.e., the aggregate Transfer Price paid is greater than the sum of [**] plus [**] and [**] sold in such calendar quarter), then Akebia will make a true-up payment to Licensee in the amount of such overpayment. 
11.5.    Working Capital Fund.  Within [**] after the Effective Date, Licensee will pay Akebia $40,000,000 (the “Initial Working Capital Payment”) to be used as a working capital fund to finance the manufacture of Licensed Products (the “Working Capital Fund”), representing [**]% of the amount of purchase orders that Akebia has placed with its contract manufacturer for the supply for the Territory of Licensed Product [**].  On a [**] basis, Akebia will notify Licensee of (a) all new purchase orders placed with Akebia’s contract manufacturer in such [**] for Licensed Product scheduled to be delivered within the following [**], (b) following the Reimbursement Date, all purchase orders that have been fulfilled in the preceding [**], (c) the total amount of all outstanding purchase orders that Akebia has placed with its contract manufacturers as of the end of such [**], in each case, for the Territory (the “Outstanding CMO Balance”), (d) with respect to Akebia’s inventory of Licensed Product drug substance, bulk drug product and finished goods as of the end of each [**] (the “Safety Stock Amount”), and (e) the sum of the Outstanding CMO Balance and the Safety Stock Amount (“Total Working Capital Requirement”), provided that, for the purpose of calculating the payments required by this Section 11.5 (Working Capital Fund), the Safety Stock Amount, when calculated as the number of months of forward coverage for the Territory, shall not exceed [**] for drug substance and [**] for the sum of bulk drug product and finished goods, unless the Parties explicitly agree to exceed such cap. Provided further, that such cap on the sum of bulk drug product and finished goods inventory shall not apply until [**] post Reimbursement Date. For clarity, nothing herein shall be construed as restricting the actual amount of Licensed Product inventory Akebia may maintain at any given time during the Term, or otherwise impacting Akebia’s inventory management.  Within [**] of receiving such notice, Licensee will contribute an additional amount (each such payment, an “Additional Working Capital Payment,” and together with the Initial Working Capital Payment, the “Working Capital Payments”), to the Working Capital Fund, equal to the positive difference (if any) between (A) the Working Capital Percentage (defined below) multiplied by the Total Working Capital Requirement, minus (B) the current balance of the Working Capital Fund (i.e., the total amount of all Working Capital Payments previously paid by Licensee to Akebia minus any refunds of such payments from Akebia to Licensee), provided that such Additional Working Capital Payment is greater than $[**], otherwise no additional contribution shall be due in that [**]. For clarity, if such difference is negative, then no payment from Licensee to Akebia shall be due.  If, for a given [**], the Working Capital Fund exceeds the Working Capital Percentage multiplied by the Total Working Capital Requirement by an amount greater than $[**], then Akebia will refund to Licensee their entirety of such excess amount following such [**].  Upon any termination or expiration of this Agreement for any reason other than for convenience by Licensee pursuant to Section 16.9 (Termination by Licensee for Convenience), Akebia will refund to Licensee the then-outstanding balance of the Working Capital Fund, net of any amounts owed by Licensee to Akebia under the Agreement as of the effective date of such termination or expiration.  The “Working Capital Percentage” will be [**]% as of the Effective Date, but the Coordination Committee will evaluate the Working Capital Percentage on a [**] basis during the Term, and will update it as appropriate to account for any substantial change in 
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the percentage of Licensee’s share of overall purchase orders for Licensed Products for the Territory.
11.6.    Sales Reports. 
11.6.1    Monthly Reports.
(a)    Within [**] after the end of each month in which Licensee or its Affiliates sell a Licensed Product to FMCNA, FMCNA’s Affiliates, Majority Owned Clinics, or FKC Clinics, Licensee will provide to Akebia a report setting forth, (i) the number of units of Licensed Products sold by Licensee or its Affiliate to FMCNA, FMCNA’s Affiliates, Majority Owned Clinics, or FKC Clinics, (ii) the actual gross sales of all Licensed Products sold by Licensee or its Affiliates to FMCNA, FMCNA’s Affiliates, Majority Owned Clinics, or FKC Clinics in the Territory in such month; and (iii) the estimated total aggregate Net Sales of the Licensed Products sold by Licensee or its Affiliates to FMCNA, FMCNA’s Affiliates, Majority Owned Clinics, or FKC Clinics in the Territory in such month.  
(b)    Within [**] after the end of each month in which Licensee or its Affiliate sells any Licensed Product to any Designated Wholesaler, Specialty Pharmacy or Authorized Dialysis Center (other than Majority Owned Clinics or FKC Clinics), Licensee will provide to Akebia a written report that sets forth: (i) the number of units of each Licensed Product supplied directly to any Designated Wholesaler, Specialty Pharmacy or Authorized Dialysis Center (other than Majority Owned Clinics or FKC Clinics), (ii) the gross sales for all Licensed Product supplied directly to any Designated Wholesaler, Specialty Pharmacy or Authorized Dialysis Center (other than Majority Owned Clinics or FKC Clinics), (iii) the Net Sales for all Licensed Product supplied directly to any Designated Wholesaler, Specialty Pharmacy or Authorized Dialysis Center (other than Majority Owned Clinics or FKC Clinics), (iv) the number of units of each Licensed Product held in inventory by any wholesaler, and (v) on a facility level, the number of units of each Licensed Product sold from Designated Wholesalers directly to Authorized Dialysis Centers (other than Majority Owned Clinics or FKC Clinics). 
(c)    Licensee will use Commercially Reasonable Efforts to negotiate the purchase of data from FMCNA, or relevant Specialty Pharmacy, in order to be able to report, on a facility level, the number of units of each Licensed Product distributed by FKC to FKC Clinics, or by Specialty Pharmacies to Authorized Dialysis Centers.  Licensee shall confer with Akebia regarding terms of such agreement, prior to execution, and shall implement Akebia’s reasonable comments with respect thereto.  Akebia shall reimburse Licensee for [**]% of all documented costs associated with the purchase of such data, provided that Akebia has consented to the terms of such Agreement prior to its execution, provided further, that the Parties agree that Licensee’s share of all documented costs associated with the purchase of such data shall not exceed [**] dollars ($[**]).   
11.6.2    Quarterly Reports.  In addition to the reports to be provided in accordance with Section 11.6.1 (Monthly Reports), (a) within [**] after the end of each calendar quarter in which Licensee or its Affiliate sells any Licensed Product, Licensee will provide to Akebia a written sales report that sets forth Net Sales of Licensed Products sold directly to FMCNA or any of its Affiliates including FKC, any Designated Wholesaler, each Specialty Pharmacy, each IDO, and each Third Party Dialysis Organization during such calendar quarter and the Profit in such calendar quarter from such sales, together with all calculations used to determine such Net Sales and Profit, and (b) within [**] after the end of each calendar quarter in which Licensee or its Affiliate sells any Licensed Product, Licensee will provide to Akebia a detailed written sales report (each, a “Quarterly Report”) that sets forth (i) the units of each Licensed Product purchased directly by 
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FMCNA or any of its Affiliates including FKC, any Designated Wholesaler, any Specialty Pharmacy, the IDO members of each GPO, and each Third Party Dialysis Organization, and (ii) the number of units of each Licensed Product held in inventory by FMCNA or any of its Affiliates including FKC, each Specialty Pharmacy, each Designated Wholesaler, and any distributor of Licensee that distributes Licensed Products to IDOs or Third Party Dialysis Organizations, which, in each case ((i) and (ii)), will be broken down on a monthly and quarterly basis. In addition, on an annual basis, Licensee will provide to Akebia the annual Net Sales and Profit forecasts for each Licensed Product to be sold by Licensee under the License in the upcoming calendar year.  The Parties will seek to resolve any questions or issues related to a Quarterly Report within [**] following receipt by Akebia of such Quarterly Report.   
11.6.3    Provisional Quarterly Reports.  Akebia may request Licensee to provide, within [**] after the end of each calendar quarter in which Licensee or its Affiliate sells any Licensed Product, a provisional report of the information described in Section 11.6.2 (Quarterly Reports), with the understanding that the information in such reports (each, a “Provisional Quarterly Report”) is not official and will be subject to change.
11.7.    Accounting.  Licensee agrees to keep full, clear, and accurate records in accordance with the Accounting Standards consistently applied for a period of at least three years after the relevant payment is owed pursuant to this Agreement in sufficient detail to enable compensation payable to Akebia hereunder to be determined.  Licensee further agrees to permit its books and records to be examined by an independent accounting firm selected by Akebia and approved by Licensee, which approval will not be unreasonably withheld or delayed, to verify the reports provided in Section 11.4 (Sales Reports). Such auditor will be bound by a legal agreement obligating it to maintain the confidentiality of such information and to not share it with Akebia. The auditor’s report will be provided simultaneously to both Licensee and Akebia, will be limited to a disclosure of the extent of any underpayment or overpayment by Licensee in sufficient detail to allow Akebia and Licensee to understand the source of any error. Such audit will not be performed more frequently than once per calendar year.  Such examination is to be made at the expense of Akebia, except in the event that the results of the audit reveal an underpayment by Licensee of [**]% or more during the period being audited, in which case reasonable audit fees for such examination will be paid by Licensee.
11.8.    Methods of Payment.  All payments due to Akebia under this Agreement will be made in U.S. Dollars by wire transfer to a bank account of Akebia designated from time-to-time in writing by Akebia.
11.9.    Late Payments.  Any amount owed by Licensee to Akebia under this Agreement that is not paid within the applicable time period set forth herein will accrue interest at the lesser of (a) the then current prime rate quoted by Citibank in New York City plus [**]%, or (b) the highest rate permitted under Applicable Law. If a Party disputes an invoice or other payment obligation under this Agreement, then such Party will timely pay the undisputed amount of the invoice or other payment obligation, and the Parties will resolve such dispute in accordance with Article 17 (Dispute Resolution; Governing Law).
Article 12

INFORMATION AND ADVERSE DRUG EVENTS AND REPORTS
12.1.    Data Security.  During the Term of this Agreement, Licensee will maintain and, as applicable, cause its Affiliates to maintain, environmental, safety, and facility procedures, data security procedures and other safeguards against the disclosure, destruction, loss, or alteration of any clinical data, post-marketing data, commercialization information, or any other information concerning the Licensed Compound or the Licensed Products known by Licensee or any of its Affiliates at any time during the Term that are no less rigorous than those maintained by Licensee (or any of its Affiliates) for its own information of a similar nature. 
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12.2.    Adverse Drug Events.  Licensee will provide to Akebia any information that it becomes aware of in the Territory concerning any adverse event relating to the Licensed Compound or any Licensed Product, whether or not determined to be attributable to the Licensed Compound or any Licensed Product, including any such information received by either Party from a Third Party (subject to receipt of any required consents from such Third Party) (such information, the “Safety Data”) no later than [**] after becoming aware of any such Safety Data.  Akebia will own all of the Safety Data, and the global safety database associated with the Licensed Products will be owned and maintained by Akebia. [**] will have the sole right and responsibility to administer and otherwise make decisions with respect to recalls and withdrawals of a Licensed Product, and [**] will, [**], provide assistance and cooperation reasonably requested by [**] in connection with any such recall or withdrawal. 
Article 13

REPRESENTATIONS, WARRANTIES, AND COVENANTS
13.1.    Mutual Representations and Warranties.  Each of Licensee and Akebia hereby represents and warrants to the other Party as of the Effective Date that:
13.1.1    (a) It is a corporation or entity duly organized and validly existing under the laws of the state, municipality, provinces, administrative division, or other jurisdiction of its incorporation or formation, and (b) it has full power and authority and the legal right to own and operate property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement.
13.1.2    The execution, delivery and performance of this Agreement by it has been duly authorized by all requisite corporate action.
13.1.3    This Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, and binding obligation of such Party and is enforceable against such Party in accordance with its terms, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity.
13.1.4    It has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder, and such performance does not conflict with or constitute a breach of any of its agreements with Third Parties.
13.1.5    It has obtained all necessary consents, approvals, and authorizations of all Governmental Authorities and other Third Parties required to be obtained in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder.
13.1.6    The execution and delivery of this Agreement and the performance of its obligations hereunder (a) do not conflict with or violate any requirement of Applicable Law or any provision of its articles of incorporation, bylaws, limited partnership agreement, or any similar instrument, as applicable, and (b) do not conflict with, violate, or breach or constitute a default or require any consent under, any Applicable Law or any contractual obligation or court or administrative order by which it is bound.
13.1.7    It has the right to grant the rights and licenses described in this Agreement.
13.2.    Additional Mutual Representations and Warranties.  Each of Licensee and Akebia represents and warrants as of the Effective Date that it has not been debarred by the FDA, is not the subject of a conviction described in Section 306 of the FD&C Act, and is not subject to any similar sanction of other Governmental Authorities outside of the Territory, and neither it nor any of its Affiliates has used, in any capacity, any person who either has been debarred by the FDA, is the 
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subject of a conviction described in Section 306 of the FD&C Act, or is subject to any such similar sanction.  
13.3.    Additional Akebia Representations and Warranties.  Akebia hereby represents and warrants as of the Effective Date that: 
13.3.1    The Akebia Patents and the Akebia Trademarks have been duly filed in the Territory. 
13.3.2    All applicable filing, maintenance, and other fees have been timely paid for all of the Akebia Patents set forth on Schedule 1.9 and the Akebia Trademarks set forth on Schedule 1.11, and, to Akebia’s Knowledge, all of the Akebia Patents set forth on Schedule 1.9 that are issued patents and the Akebia Trademarks set forth on Schedule 1.11 that are registered trademarks, in each case, are in full force and effect.
13.3.3    There is no pending or, to Akebia’s Knowledge, threatened (in writing) re-examination, opposition, interference, inter partes review, or claim challenging the inventorship, ownership, validity, enforceability, or patentability of the Akebia Patents or other litigation or proceeding in the Territory relating to any of the Akebia Patents. 
13.3.4    The sale of the Licensed Products does not and will not infringe any valid Patent or other intellectual property rights of any Third Party in the Territory.  
13.3.5    Akebia has received no written notice of any claim that a patent or trade secret owned or controlled by a Third Party is or would be infringed or misappropriated by the sale of the Licensed Products in the Territory.  
13.3.6    To Akebia’s Knowledge, there is no use, infringement, or misappropriation of the Akebia Technology in the Territory in derogation of the rights granted to Licensee in this Agreement. 
13.3.7    There are no investigations, inquiries, actions, or other proceedings pending before or to Akebia’s Knowledge threatened by the FDA or other Governmental Authority in the Territory with respect to the Licensed Products arising from any default by Akebia or a Third Party acting on behalf Akebia in the research or development of the Licensed Compound, and Akebia has not received written notice threatening any such investigation, inquiry, action or other proceeding. 
13.3.8    Akebia owns or has licensed the rights, title, and interests in and to the Akebia Technology granted to Licensee pursuant the License.
13.3.9    The research, development, and manufacture of the Licensed Products conducted by Akebia or its Affiliates has been conducted in compliance with Applicable Law and, to Akebia’s Knowledge, the research, development, and manufacture of the Licensed Products conducted by Akebia’s Third Party contractors has been conducted in compliance with Applicable Law. 
13.4.    Additional Licensee Representations and Warranties.  Licensee hereby represents and warrants as of the Effective Date that:
13.4.1    Vifor Pharma Participations Ltd. and Fresenius Medical Care AG & Co KGaA are the joint venture partners of VFMCRP, with Vifor Pharma Participations Ltd. owning a controlling interest of VFMCRP and Fresenius Medical Care AG & Co KGaA owning the remaining interest.
13.4.2    FKC is an Affiliate of FMCNA and a strategic partner of Licensee. 
13.4.3    FreseniusRx is an Affiliate of FMCNA.  
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13.4.4    Licensee is not an Affiliate of FMC, FMCNA or any member of the Licensee Supply Group.
13.4.5    Licensee is a drug manufacturer that is not engaged in the wholesale distribution of prescription drugs to “retail community pharmacies” (as that term is defined in 42 U.S.C. § 1396r-8(k)(10)).
13.4.6    The transmission of all information required to be included in each Quarterly Report and Monthly Reports pursuant to this Agreement is consistent with Applicable Law and Licensee’s contractual obligations with Third Parties.
13.5.    Additional Covenants.  
13.5.1    Each Party covenants that it will not engage, in any capacity in connection with this Agreement or any ancillary agreements, any person who either has been debarred by the FDA, is the subject of a conviction described in Section 306 of the FD&C Act, or is subject to any such similar sanction. Each Party will inform the other Party in writing promptly if it or any person engaged by it or any of its Affiliates who is performing services under this Agreement, or any ancillary agreements, is debarred or is the subject of a conviction described in Section 306 of the FD&C Act, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending or, to each Party’s knowledge, is threatened, relating to the debarment or conviction of a Party, any of its Affiliates, or any such person performing services hereunder or thereunder.
13.5.2    Each Party covenants that it will comply with all Applicable Laws in performing its activities hereunder.
13.5.3    If either Party determines, based on reasonable advice of counsel, that its compliance with this Agreement will violate Applicable Law, then the Parties will negotiate to amend this Agreement as necessary to ensure that the terms hereof to permit such Party to comply with Applicable Law and this Agreement during the Term. 
13.5.4    Licensee covenants that throughout the Term it will not, and will cause each of its Affiliates that are involved in the supply or distribution of any Licensed Product to not, engage in the wholesale distribution of prescription drugs to “retail community pharmacies” (as that term is defined in 42 U.S.C. § 1396r-8(k)(10)) in the Territory.
13.5.5    Licensee covenants that throughout the Term it will provide prompt written notice to Akebia in the event that any of its Affiliates intends to engage, or has engaged, in the wholesale distribution of prescription drugs to “retail community pharmacies” (as that term is defined in 42 U.S.C. § 1396r-8(k)(10)) in the Territory.
13.5.6    Licensee covenants that, throughout the term, Licensee will not provide to FreseniusRx any preferential discounts or rebates that Licensee does not also make available to all other Specialty Pharmacies.
13.5.7    Neither Party will enter into any agreement or contractual obligation with a Third Party that conflicts with or is inconsistent with this Agreement or requires the consent of any Third Party for such Party to perform its obligations under this Agreement.
13.5.8    On the Effective Date, Akebia will provide to Licensee an updated Schedule 1.9 that includes all Akebia Patents as of the Effective Date, and an updated Schedule 1.11 that includes all Akebia Trademarks as of the Effective Date.
13.6.    Disclaimer.  EXCEPT AS EXPRESSLY SET FORTH HEREIN, INCLUDING THE WARRANTIES SET FORTH IN SECTION 13.3 (ADDITIONAL AKEBIA REPRESENTATIONS AND WARRANTIES), THE INTELLECTUAL PROPERTY RIGHTS 
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PROVIDED BY AKEBIA ARE PROVIDED “AS IS” AND WITHOUT WARRANTY.  EXCEPT AS EXPRESSLY SET FORTH HEREIN, INCLUDING THE WARRANTIES SET FORTH IN SECTION 13.3 (ADDITIONAL AKEBIA REPRESENTATIONS AND WARRANTIES), AKEBIA EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY, OR ENFORCEABILITY OF ITS RESPECTIVE INTELLECTUAL PROPERTY RIGHTS, AND NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, ARISING FROM A COURSE OF DEALING, USAGE, OR TRADE PRACTICES, IN ALL CASES WITH RESPECT THERETO.
13.7.    Limitation of Liability.  NEITHER OF THE PARTIES WILL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, INDIRECT, CONSEQUENTIAL, OR PUNITIVE DAMAGES OR DAMAGES FOR LOSS OF PROFIT OR LOST OPPORTUNITY IN CONNECTION WITH THIS AGREEMENT, ITS PERFORMANCE OR LACK OF PERFORMANCE HEREUNDER, OR ANY LICENSE GRANTED HEREUNDER, EXCEPT TO THE EXTENT THE DAMAGES RESULT FROM A PARTY’S WILLFUL MISCONDUCT, OR INTENTIONAL BREACH OF ITS OBLIGATIONS UNDER THIS AGREEMENT, A BREACH OF THE OBLIGATIONS OF A PARTY UNDER [**], A VIOLATION BY A PARTY OR ITS AFFILIATES OF [**]. 
Article 14

CONFIDENTIALITY
14.1.    Generally.  During the Term and for a period of seven years following the early termination of this Agreement, each Party (a) will maintain in confidence all Confidential Information of the other Party; (b) will not use such Confidential Information for any purpose except in connection with the activities contemplated by this Agreement or in order to further the purpose of this Agreement; and (c) will not disclose such Confidential Information, except that each Party may disclose such Confidential Information to its Affiliates, investors, prospective investors, lenders, prospective lenders, financing sources, prospective financing sources (including, in each case, in connection with any royalty factoring or similar transaction), prospective acquirers, licensees, sublicensees, prospective sublicensees, employees, consultants, financial or legal advisors, agents, or subcontractors who are bound by obligations of nondisclosure and non-use no less stringent than those set forth in this Article 14 (Confidentiality) and to whom such disclosure is reasonably necessary or advisable in connection with such Party’s activities as contemplated in this Agreement or in connection with financing or acquisition activities (including its right to assign its rights hereunder pursuant to Section 18.1 (Assignment) as part of a royalty factoring or other similar transaction). Each Party will ensure that its Affiliates, investors, prospective investors, lenders, prospective lenders, acquirors, licensees, sublicensees, prospective acquirors, licensees, sublicensees, prospective sublicensees, employees, consultants, agents, consultants, and subcontractors comply with these obligations.  Each Party will notify the other Party promptly on discovery of any unauthorized use or disclosure of the other Party’s Confidential Information, including the other Party’s trade secrets or proprietary information.  Licensee acknowledges that all (i) Safety Data, (ii) Akebia Know-How, and (iii) other information related to Akebia’s and its Affiliates’, licensees’, and sublicensees’ development and commercialization of the Licensed Compound and the Licensed Products constitutes Confidential Information of Akebia. The terms of this Agreement will be the Confidential Information of each Party. 
14.2.    Exceptions.  The obligations of confidentiality, non-disclosure, and non-use set forth in Section 14.1 (Generally) will not apply to the extent the receiving Party (the “Recipient”) can demonstrate that the disclosed information (a) was in the public domain at the time of disclosure to the Recipient by the other Party, or thereafter entered the public domain, in each case, other than as a result of actions of the Recipient, its Affiliates, employees, licensees, agents, or subcontractors, in breach of this Agreement; (b) was rightfully known by the Recipient or its Affiliates (as shown by its written records) prior to the date of disclosure to the Recipient by the other Party; (c) was received by the Recipient or its Affiliates on an unrestricted basis from a 
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Third Party rightfully in possession of such information and not under a duty of confidentiality to the other Party; or (d) was independently developed by or for the Recipient or its Affiliates without reference to or reliance on the Confidential Information of the other Party (as demonstrated by written records).  Notwithstanding any other provision of this Agreement, the Recipient’s disclosure of Confidential Information will not be prohibited if such disclosure: (i) is in response to a valid order of a court or other Governmental Authority; or (ii) is otherwise required by Applicable Law or regulation or rules of a nationally recognized securities exchange.  Further notwithstanding any other provision of this Agreement, Akebia may disclose Licensee’s Confidential Information to the extent disclosure is required in connection with the filing or prosecuting patent applications, prosecuting, or defending litigation, responding to an investigation by a Governmental Authority, or otherwise establishing rights or enforcing obligations under this Agreement, making Regulatory Filings with respect to the Licensed Products, or conducting research, development, or clinical studies with respect to the Licensed Products. If a Recipient is required to disclose Confidential Information pursuant to this Section 14.2 (Exceptions), then prior to any disclosure the Recipient will provide the other Party with prior written notice of such disclosure in order to permit the other Party to seek a protective order or other confidential treatment of such Confidential Information.
14.3.    Publicity.  The Parties recognize that each Party may from time-to-time desire to issue press releases and make other public statements or disclosures regarding the terms of this Agreement.  In such event, the Party desiring to issue a press release or make a public statement or disclosure will provide the other Party with a copy of the proposed press release, statement, or disclosure for review and approval as soon as practicable prior to publication, which advance approval will not be unreasonably withheld or delayed.  No other public statement or disclosure of, or concerning, the terms of this Agreement will be made, either directly or indirectly, by either Party, without first obtaining the written approval of the other Party.  Once any public statement or disclosure has been approved in accordance with this Section 14.3 (Publicity), then either Party may appropriately communicate information contained in such permitted statement or disclosure.  Notwithstanding the foregoing provisions of this Article 14 (Confidentiality), a Party may disclose the terms of this Agreement where required, as reasonably determined by the disclosing Party, by Applicable Law, regulation or legal process, or by applicable stock exchange rule (with prompt notice of any such legally required disclosure to the other Party and, to the extent practicable, sufficient opportunity for the other Party to review and comment on such required disclosure and request confidential treatment thereof or a protective order therefor).
14.4.    Publications.  If, [**], Licensee, its Affiliates, FMCNA, the Licensee Supply Group, or any healthcare professional having an investigator initiated trial agreement in place with any of the previously listed entities desires to publish any clinical data or other clinic results from the administration of the Licensed Compound or any Licensed Product, then Licensee will, will cause its Affiliates to, and will cause FMCNA, the Licensee Supply Group, and such healthcare professionals to, in each case, [**].  If Akebia determines that any such proposed publication contains patentable subject matter requiring protection, then Akebia may require the delay of such publication for a period of time not to exceed an additional [**] to pursue such protection or negotiate with such healthcare professional.  If Akebia determines that the proposed publication contains Confidential Information, then Akebia may require such Confidential Information to be deleted from such publication.  If, [**], Licensee, its Affiliates, FMCNA, or the Licensee Supply Group desires to publish any preclinical or non-clinical results from the research and development of the Licensed Compound or any Licensed Product, then Licensee will, will cause its Affiliates to, and will cause FMCNA and the Licensee Supply Group to, in each case, [**].
Article 15

INDEMNIFICATION
15.1.    Indemnification by Akebia.  Unless otherwise provided herein, Akebia will indemnify, hold harmless, and defend Licensee and its Affiliates and their respective, directors, officers, employees, and agents (the “Licensee Indemnitees”) from and against any and all Third Party suits, claims, actions, demands, liabilities, expenses, or losses (including reasonable attorneys’ 
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fees, court costs, witness fees, damages, judgments, fines, and amounts paid in settlement) (“Losses”) to the extent that such Losses arise out of (a) a breach of this Agreement by Akebia, (b) [**] of a Licensed Product by or on behalf of Akebia or its Affiliates or licensees (other than Licensee, the LSP, Designated Wholesalers, or a member of the Licensee Supply Group), or (c) the negligence or willful misconduct of any Akebia Indemnitee (as defined in Section 15.2 (Indemnification by Licensee)). Notwithstanding the foregoing, Akebia will not have any obligation to indemnify the Licensee Indemnitees to the extent that any Losses arise out of the negligence or willful misconduct of any Licensee Indemnitee or any breach of this Agreement by Licensee.
15.2.    Indemnification by Licensee.  Unless otherwise provided herein, Licensee will indemnify, hold harmless, and defend Akebia and its Affiliates and their respective directors, officers, employees, and agents (the “Akebia Indemnitees”) from and against any and all Losses, to the extent that such Losses arise out of (a) a breach of this Agreement by Licensee, (b) [**], in each case, of a Licensed Product by or on behalf of Licensee, the LSP, Designated Wholesalers, or the Licensee Supply Group (including any communications regarding such Licensed Product by Licensee, the LSP, or the Licensee Supply Group), or (c) the negligence or willful misconduct of any Licensee Indemnitee.  Notwithstanding the foregoing, Licensee will not have any obligation to indemnify the Akebia Indemnitees (i) to the extent that any Losses arise out of the negligence or willful misconduct of any Akebia Indemnitee or any breach of this Agreement by Akebia, or (ii) for any [**] of any Licensed Product, other than any [**] of any Licensed Product by or on behalf of Licensee, the LSP, Designated Wholesalers, or the Licensee Supply Group. 
15.3.    Indemnification Procedure.  Each Party, if seeking indemnification under this Article 15 (Indemnification) (the “Indemnified Party”), will give [**] written notice of the claim to the other Party (the “Indemnifying Party”); provided, however, that any failure or delay in providing such notice will not relieve the Indemnifying Party of its indemnification obligation, except to the extent it is actually prejudiced by such failure or delay.  Each Party will promptly furnish to the other Party copies of all papers and official documents received in respect of any Losses.  The Indemnifying Party will have the right, exercisable by written notice to the Indemnified Party, to assume and control the defense of the indemnification claim at its own expense with counsel selected by the Indemnifying Party and reasonably acceptable to the Indemnified Party; provided, however, that an Indemnified Party will have the right to retain its own counsel, at its own expense, except that the fees and expenses of the Indemnified Party’s counsel will be paid by the Indemnifying Party if representation of such Indemnified Party by the counsel retained by the Indemnifying Party would be inappropriate due to actual or potential differing interests between the Indemnified Party and any other party represented by such counsel in such proceedings. If the Indemnifying Party does not assume the defense of the indemnification claim as described in this Section 15.3 (Indemnification Procedure), then the Indemnified Party may defend the indemnification claim but will have no obligation to do so.  The Indemnified Party will not settle or compromise the indemnification claim without the prior written consent of the Indemnifying Party, and the Indemnifying Party will not settle or compromise the indemnification claim in any manner that would have an adverse effect on the Indemnified Party’s interests (including any rights under this Agreement or the scope or enforceability of any Patents, Confidential Information, or other rights licensed to Licensee by Akebia hereunder), without the prior written consent of the Indemnified Party, which consent, in each case (by the Indemnifying Party or Indemnified Party, as the case may be), will not be unreasonably withheld or delayed.  The Indemnified Party will reasonably cooperate with the Indemnifying Party at the Indemnifying Party’s expense and will make available to the Indemnifying Party all pertinent information under the control of the Indemnified Party, which information will be subject to Article 14 (Confidentiality). The Indemnifying Party will provide periodic updates to the Indemnified Party (and its counsel, if applicable) regarding its defense of the action with immediate notice regarding any material developments. The Indemnifying Party will not be liable for any settlement or other disposition of Losses by the Indemnified Party if such settlement is reached without the written consent of the Indemnifying Party pursuant to this Section 15.3 (Indemnification Procedure). 
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15.4.    Reimbursement of Additional Expenses.  Notwithstanding any provision to the contrary set forth in this Agreement, Licensee will reimburse Akebia for all reasonable actual out-of-pocket expenses (including, but not limited to, attorneys’ fees and costs, and all other expenses) incurred by Akebia in connection with responses to subpoenas, government investigations and other similar legal orders and legal and regulatory processes issued to Akebia with respect to Licensee or any of its Affiliates or Designated Wholesalers, the Licensee Supply Group, or the subject matter of this Agreement. Licensee, however, shall have no obligation to reimburse Akebia for any such expenses directly arising out of, in connection with or otherwise relating to actions or omissions of Akebia or its employees, officers, directors or Affiliates that violate this Agreement or Applicable Law.
15.5.    Insurance.  Akebia and Licensee will each, at their own expense, obtain and maintain insurance with respect to the use and sale of the Licensed Products under this Agreement in such amount and subject to such deductibles and other limitations as biopharmaceutical companies in the Territory customarily maintain with respect to the use and sale of similar products.  Each Party will provide a copy of such insurance policy to the other Party upon request. 
Article 16

TERM AND TERMINATION
16.1.    Term.  The term of this Agreement will begin on the Original Execution Date and, unless earlier terminated in accordance with the terms of this Article 16 (Term and Termination), will extend until the later of (a) expiration of the last-to-expire Valid Claim [**] that would, but for the licenses granted hereunder, be infringed by the making, using, selling, or importing of such Licensed Product in the Territory, or (b) expiration of marketing or regulatory exclusivity in the Territory (the “Term”). 
16.2.    Termination for Breach.  Subject to the terms and conditions of this Section 16.2 (Termination for Breach), a Party (the “Non-Breaching Party”) will have the right, in addition to any other rights and remedies, to terminate this Agreement in its entirety in the event the other Party (the “Breaching Party”) is in material breach of any of its obligations under this Agreement.  The Non-Breaching Party will first provide written notice to the Breaching Party, which notice will identify with particularity the alleged breach and state the Non-Breaching Party’s intent to terminate this Agreement if such breach is not cured.  With respect to material breaches of any payment provision hereunder, the Breaching Party will have a period of [**] after such written notice is provided to cure such breach.  With respect to all other breaches, the Breaching Party will have a period of [**] after the Non-Breaching Party provides written notice to cure such breach. Notwithstanding the foregoing, if a Non-Breaching Party provides notice to the Breaching Party pursuant to this Section 16.2 (Termination for Breach) of an alleged material breach by such Breaching Party, and such Non-Breaching Party provides notice during the applicable cure period set forth above that such Non-Breaching Party disputes the basis for termination pursuant to this Section 16.2 (Termination for Breach) and initiates the dispute resolution procedure set forth in Article 17 (Dispute Resolution; Governing Law) during the applicable cure period, then the cure periods set forth in this Section 16.2 (Termination for Breach) for the alleged material breach will run from the date that such written notice is first provided to the Breaching Party through the resolution of such dispute pursuant to Article 17 (Dispute Resolution; Governing Law) and it is understood and acknowledged that, during the pendency of a dispute pursuant this Section 16.2 (Termination for Breach), all of the terms and conditions of this Agreement will remain in effect, and the Parties will continue to perform all of their respective obligations under this Agreement. The waiver by either Party of any breach of any term or condition of this Agreement will not be deemed a waiver as to any subsequent or similar breach. 
16.3.    Termination for Bankruptcy.  Subject to the terms and conditions of this Agreement, either Party may terminate this Agreement upon notice to the other Party should the other Party: (a) consent to the appointment of a receiver or a general assignment for the benefit of creditors of the other Party that is not discharged within [**], or (b) file a petition under any bankruptcy or 
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insolvency law or have any such petition filed against it that has not been stayed within [**] of such filing.
16.4.    Termination by Akebia for Unauthorized Sales.  
16.4.1    Termination of the Agreement for Unauthorized Sales.  If the Parties do not reach a resolution of a matter under discussion pursuant to Section 4.1 (No Unauthorized Sales) during the [**] period for the Parties to reach a resolution as set forth therein, or Licensee does not (a) [**] any unauthorized use, distribution, or transfer of the Licensed Compound or any Licensed Product by Licensee, FKC, any Specialty Pharmacy, the LSP, a TPDO, any Authorized Dialysis Center, any Designated Wholesaler, or any distributor associated with any of the foregoing, or (b) [**] of Licensed Products to FKC, Specialty Pharmacy, LSP, TPDO, Authorized Dialysis Center, or Designated Wholesaler that is using, distributing, or transferring the Licensed Compound or any Licensed Product other than as expressly permitted under this Agreement, then, in each case ((a) and (b)), Akebia may terminate this Agreement with immediate effect upon written notice to Licensee. 
16.4.2    Termination of GPO or IDO for Unauthorized Sales.  Notwithstanding Section 16.4.1 (Termination of the Agreement for Unauthorized Sales), if the applicable matter under discussion pursuant to Section 4.1 (No Unauthorized Sales) relates to any unauthorized use, distribution, or transfer of any Licensed Product by any distributor used by a GPO, IDO, or IDO Clinic, and the Parties do not reach a resolution of the applicable matter during the [**] period for the Parties to reach a resolution as set forth under Section 4.1 (No Unauthorized Sales), or Licensee does not (a) [**] such unauthorized use, distribution, or transfer of the Licensed Compound or any Licensed Product by such distributor used by a GPO, IDO, IDO Clinic, as applicable, or (b) Licensee does not [**] of Licensed Product to such distributor used by a GPO, IDO, IDO Clinic, as applicable, then Akebia may, in its sole discretion and without limiting its rights set forth in Section 16.4.1 (Termination of the Agreement for Unauthorized Sales), elect to either (i) [**] to sell the Licensed Products, indirectly through a distributor, to such GPO’s IDO members with immediate effect upon written notice to Licensee, in which case Licensee will immediately stop supplying Licensed Products, directly or indirectly through a distributor, to such GPO’s IDO members and terminate the Licensee-GPO Supplier Agreement or (ii) in the case of any unauthorized use, distribution, or transfer of any Licensed Product by any IDO, [**], in which case Licensee will cause the applicable GPO and any distributor that supplies such GPO to (x) [**] of Licensed Products to such IDO and (y) cause such GPO to [**] such IDO’s right to purchase Licensed Products with immediate effect upon written notice to Licensee. 
16.5.    Termination by Akebia Upon Occurrence of Certain Events.  If any of the following events occur, then Akebia may terminate this Agreement with immediate effect upon written notice to Licensee:
16.5.1    Licensee or its Affiliate involved in the supply or distribution of any Licensed Product becomes an Affiliate of FMC, FMCNA or any member of the Licensee Supply Group; or
16.5.2    There is no affiliation or other strategic relationship between Licensee or its Affiliate involved in the supply or distribution of any Licensed Product and FMC or FMCNA.
16.6.    Termination by Akebia for Failure to Enter Into or Amend the Licensee-FKC Supply Agreement or Licensee-FreseniusRx Supply Agreement.  Akebia may terminate this Agreement with immediate effect upon written notice to Licensee if (a) Licensee (either directly or indirectly through VFMCRP) does not enter into an amendment of the Licensee-FKC Supply Agreement in accordance with Section 5.1.2 (Amendment to Supply Agreement) within [**] after the Reimbursement Date,  (b) in the event the Licensee-FKC Supply Agreement does not include sales to FreseniusRx, Licensee (either directly or indirectly through VFMCRP) does not enter into 
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the Licensee-FreseniusRx Supply Agreement, or an amendment thereto, in accordance with Section 5.3 (Licensee-FreseniusRx Supply Agreement) within [**] after the Reimbursement Date, or (c) the Licensee-FKC Supply Agreement or Licensee-FreseniusRx Supply Agreement is terminated or expires, unless, solely as it relates to  termination of the Licensee-FreseniusRx Supply Agreement, the Parties agree in writing to the termination of such agreement in accordance with Section 5.3.
16.7.    Termination or Suspension by Akebia for Impacts on Pricing.  If, at any time, (a) there has been a breach of Section 6.1 (Pricing) or Section 6.4 (No Effect on Licensed Product Reported Pricing), (b) through the actions by or on behalf of Licensee, any of its Affiliates, any Designated Wholesaler, or any member of the Licensee Supply Group (even if pursuant to Licensee Supply Group’s customary dialysis clinic cost reporting to CMS or any other Governmental Authority, and even if such actions do not constitute a breach by Licensee under Section 4.4 (Licensed Product Prices)), any Third Party purchaser or potential purchaser (other than either Party’s Affiliates or FMCNA, FMCNA’s Affiliates (including FKC and FreseniusRx), or Majority Owned Clinics) becomes aware of the price at which Licensee, any of its Affiliates, any Designated Wholesaler, or any member of the Licensee Supply Group acquired any Licensed Product, or the price at which such entity sells any Licensed Product to any purchaser (even if pursuant to Licensee Supply Group’s customary dialysis clinic cost reporting to CMS or any other Governmental Authority), (c) [**], or (d) Licensee or any of its Affiliates sells, or plans to sell, any Licensed Product in any manner that [**], and, in each case ((a) through (d)), the Parties do not reach an agreeable resolution within [**] after Akebia notifies Licensee of its intent to terminate based on such condition, then, in either case, Akebia may elect to either (i) terminate this Agreement or (ii) suspend the License and commence a Suspension Period under Section 3.2.2 (Suspension), in each case ((i) and (ii)), with immediate effect upon written notice to Licensee. If Akebia elects to suspend the License, Akebia may reinstate the License (such reinstatement resuming the Effective Period) at any time during the Term upon written notice to Licensee.
16.8.    Termination by Akebia for Patent Challenge.  Akebia may terminate this Agreement with immediate effect upon written notice to Licensee if Licensee or any of its Affiliates contests the validity or enforceability of any Patent Controlled by Akebia or any of its Affiliates that Covers a Licensed Product or its manufacture, use, sale, or importation, in any court, arbitration proceeding, or other tribunal, including the United States Patent and Trademark Office and the United States International Trade Commission.  As used in this definition, the term “contest” includes (a) filing an action under 28 U.S.C. §§ 2201-2202 seeking a declaration of invalidity or unenforceability of any such Patent; (b) filing, or joining in, a petition under 35 U.S.C. § 311 to institute inter partes review of any such Patent; (c) filing, or joining in, a petition under 35 U.S.C. § 321 to institute post-grant review of any such Patent or any portion thereof; (d) filing or commencing any opposition, nullity, or similar proceedings challenging the validity of any such Patent in any country, or (e) any foreign equivalent of clauses (a), (b), (c), or (d). 
16.9.    Termination by Licensee for Convenience.  At any time after the first anniversary of the receipt of Regulatory Approval for the Licensed Product in the DD-CKD Indication, Licensee may terminate this Agreement in its entirety by providing written notice to Akebia thereof, which termination will be effective 30 months following the date of such notice; provided, however, that (a) such 30-month notice period may be shortened by written agreement of both Akebia and Licensee and (b) in the event that the FDA issues a Complete Response Letter in response to the NDA for the Licensed Product, then Licensee may terminate this Agreement at any time within 30 days of receiving notice of such Complete Response Letter from Akebia by providing written notice of termination to Akebia, which termination will be effective 30 days after Licensee provides such termination notice to Akebia, provided that in such event any payments required to be made to Akebia prior to the effective date of such termination will continue to be due and upon receipt by Akebia will be non-refundable and non-creditable. 
16.10.    Termination by Akebia for Convenience.  Akebia may terminate this Agreement in its entirety for convenience at any time following the earlier of (a) 18 months following the later of (i) the 
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Reimbursement Date and (ii) the date of the topline data readout of the TIW Modify Trial or (b) the second anniversary of the receipt of Regulatory Approval for the Licensed Product from the FDA.  Any such termination by Akebia in accordance with this Section 16.10 (Termination by Akebia for Convenience) will be effective six months after the date on which Akebia provides written notice of such termination to Licensee.  
16.10.1    Termination Fee.  If Akebia terminates this Agreement in accordance with Section 16.10 (Termination by Akebia for Convenience), then Akebia will pay to Licensee a termination fee based on the volume of Licensed Product sold by Licensee prior to the date of such termination and the profit generated by Akebia following the date of such termination.  Within [**] following each calendar quarter during the Tail Period, Akebia will pay to Licensee a fee equal to [**] (such payments, collectively, the “Termination Fee”).  For purposes of the Termination Fee:
    “Licensee’s Pre-Termination Average Sales Volume” means: [**].  Notwithstanding the foregoing, if Akebia materially breaches the Supply Agreement during the [**] period prior to that date of Akebia’s notice of such termination, and such material breach results in a material disruption in the supply of Licensed Products to Licensee, then Licensee’s Pre-Termination Average Sales Volume will be calculated [**].
  
    “Tail Period” means the [**] period following the effective date of such termination.  

    “Licensee’s Tail Period Profit Share” means, for a given calendar quarter during the Tail Period, an amount equal to [**]% of Akebia’s average per-unit Profit during such calendar quarter, with Akebia calculating its per-unit Profit mutatis mutandis in the same manner that Licensee did prior to such termination.  

16.10.2    Commercialization of Competing Product.  If Akebia terminates this Agreement pursuant to Section 16.10 (Termination by Akebia for Convenience), then Licensee may Promote, sell or have sold a Competing Product in the Field in the Territory at any time after the date of termination of this Agreement.  If Licensee or any of its Affiliates Promotes, sells or has sold a Competing Product in the Field in the Territory at any time during the Tail Period, then Akebia will have no further obligation to pay any amount of the Termination Fee yet unpaid as of the date Licensee commences Promoting, selling, or having sold a Competing Product in the Territory. 
16.11.    Termination Following Bundle Exclusion.  If CMS determines that the Licensed Product is excluded from the ESRD PPS Bundled Payment System and TDAPA, then, during the [**] period after Akebia is notified of such determination by CMS, Akebia may terminate this Agreement effective upon not less than [**] prior written notice to Licensee.  If Akebia terminates this Agreement in accordance with this Section 16.11 (Termination Following Bundle Exclusion), then Akebia will (a) repay the Upfront Payment to Licensee, (b) pay an amount equal to [**] (as defined in the Stock Purchase Agreement) (i.e., the per-share premium above the trading average of the market value of such shares as of the Closing Date (as defined in the Stock Purchase Agreement) multiplied by number of shares acquired by Licensee), and (c) pay Licensee [**].
16.12.    Termination Based on Written Agreement of the Parties.  This Agreement may be terminated in its entirety upon the written agreement of both Akebia and Licensee.  
16.13.    Effects of Termination.  In the event of any expiration or termination of this Agreement in its entirety, the following will apply:
16.13.1    Termination of Licenses.  Except as expressly set forth in this Section 16.13 (Effects of Termination), and subject to Section 16.16 (Survival; Accrued Rights), all rights and licenses granted to Licensee under this Agreement will automatically terminate. 
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16.13.2    Return of Confidential Information.  Licensee will cease using the Akebia Technology and will return to Akebia all copies of any documents containing any Akebia Know-How. Each Party will return or destroy all Confidential Information of the other Party in its possession upon expiration or termination of this Agreement at the disclosing Party’s election and written request.  The Recipient will provide a written confirmation of such destruction within [**] of such request; provided, however, that the foregoing will not apply to any Confidential Information that is necessary to allow such Party to perform its obligations or exercise any of its rights that expressly survive the termination or expiration of this Agreement, provided, further, that [**].
16.13.3    Cessation of Sales.  Except for sales made in accordance with Section 16.13.4(a)(i) (Termination Other than for Cause by Akebia), Licensee will cease all sales of Licensed Product in the Territory. 
16.13.4    Sell-Off or Buy-Back.  
(a)    Termination Other than for Cause by Akebia.  If this Agreement is terminated by Licensee pursuant to Section 16.3 (Termination for Bankruptcy), Section 16.10 (Termination by Akebia for Convenience), or Section 16.11 (Termination Following Bundle Exclusion) then, after the effective date of such termination: (i) Licensee may continue to sell the Licensed Products for a period of [**] after the effective date of such termination in order to fill existing binding orders and commitments, and (ii) following such [**] period, at Akebia’s option and in its sole discretion, [**] for such Licensed Products by Licensee or its Affiliates. Licensee will destroy, or cause to be destroyed, all Licensed Products remaining in inventory that [**] following such [**] period, at Licensee’s cost and expense. 
(b)    Termination for Cause by Akebia.  If this Agreement is terminated by Akebia pursuant to Section 16.2 (Termination for Breach), Section 16.4.1 (Termination of the Agreement for Unauthorized Sales), Section 16.5 (Termination by Akebia Upon Occurrence of Certain Events), Section 16.6 (Termination by Akebia for Failure to Enter Into or Amend the Licensee-FKC Supply Agreement or Licensee-FreseniusRx Supply Agreement), Section 16.7 (Termination or Suspension by Akebia for Impacts on Pricing), or Section 16.8 (Termination by Akebia for Patent Challenge), then, after the effective date of such termination, at Akebia’s option in its sole discretion, [**] for such Licensed Products by Licensee or its Affiliates. Licensee will destroy, or cause to be destroyed, all Licensed Products remaining in inventory as of the effective date of termination that [**], at Licensee’s cost and expense. 
16.14.    Effects of Termination With Respect to GPO or TPDO.  If this Agreement is terminated with respect to one or more GPOs or TPDOs, then the following will apply: 
16.14.1    Termination of License Rights.  Licensee’s right to sell Licensed Products to the terminated TPDOs, the terminated GPO, or the IDOs that are members of the terminated GPO will terminate, and without limitation, for the purposes of this Agreement: (a) TPDO Clinics of the terminated TPDO will cease to be Authorized Dialysis Centers; (b) IDOs that are members of the Terminated GPO will cease to be IDOs, and IDO Clinics of such IDOs will cease to be Authorized Dialysis Centers.
16.14.2    Cessation of Sales.  Licensee will cease all sales of Licensed Product to the terminated TPDO and its TPDO Clinics and to the terminated GPO, its IDO members, and the IDO Clinics of such IDO members.
16.15.    Suspension of Licensed Rights.  Promptly following the commencement of any Suspension Period (as set forth under Section 3.2.2 (Suspension)), Licensee will [**].  During any Suspension Period the Articles and Sections set forth in Section 16.16 (Survival; Accrued Rights) will survive.  Upon the commencement of any Suspension Period, if and only if sales of Licensed 
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Products have commenced, Akebia will [**] at a [**] of [**]% of [**]. Except as provided in this Section 16.14 (Suspension of Licensed Rights) and Section 16.16 (Survival; Accrued Rights), during the Suspension Period, all other rights and obligations of the Parties pursuant to the License will be suspended and be of no force and effect.  
16.16.    Survival; Accrued Rights.  The following Articles and Sections of this Agreement will survive suspension of the License or expiration or early termination of the Agreement for any reason: Section 9.1 (Trademark Responsibility), Section 9.3 (Trademark Ownership and Cooperation), Section 11.4 (Sales Reports), but only with respect to Net Sales made during the Term, Section 11.7 (Accounting), Section 11.8 (Methods of Payment), Section 11.9 (Late Payments), Section 13.7 (Limitation of Liability), Article 14 (Confidentiality), Article 15 (Indemnification), other than Section 15.5 (Insurance), Section 16.10.1 (Termination Fee), Section 16.10.2 (Commercialization of Competing Product), Section 16.11 (Termination Following Bundle Exclusion) (with respect to payment obligations set forth therein), Section 16.13 (Effects of Termination), this Section 16.16 (Survival; Accrued Rights), Article 17 (Dispute Resolution; Governing Law), and Article 18 (Miscellaneous). In any event, suspension of the License or expiration or termination of this Agreement will not relieve the Parties of any liability that accrued hereunder prior to the effective date of such suspension, expiration or termination (including Licensee’s obligation to pay Akebia pursuant to Article 11 (Payments) with respect to sales made prior to such suspension, expiration or termination), nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement, nor prejudice either Party’s right to obtain performance of any obligation. 
Article 17

DISPUTE RESOLUTION; GOVERNING LAW
17.1.    Executive Officers.  Unless otherwise set forth in this Agreement, in the event of a dispute arising under this Agreement between the Parties, the Parties will refer such dispute to their respective chief executive officers, and such chief executive officers will attempt in good faith to resolve such dispute. 
17.2.    Litigation.  Any unresolved dispute which was subject to Section 17.1 (Executive Officers) must be brought exclusively in a court of competent jurisdiction, federal or state, located in the State of New York, and in no other jurisdiction. Each Party hereby consents to personal jurisdiction and venue in, and agrees to service of process issued or authorized by, such court. 
17.3.    Jurisdiction.  Each Party to this Agreement, by its execution hereof, (a) hereby irrevocably submits to the exclusive jurisdiction of the United States District Court for the Southern District of New York and state courts located in New York, New York for the purpose of any and all unresolved disputes which were subject to Section 17.1 (Executive Officers), (b) hereby waives to the extent not prohibited by Applicable Law, and agrees not to assert, by way of motion, as a defense or otherwise, in any such action, any claim that it is not subject personally to the jurisdiction of the above-named courts, that its property is exempt or immune from attachment or execution, that any such action brought in one of the above-named courts in such jurisdiction should be dismissed on grounds of forum non conveniens, should be transferred to any court other than one of the above-named courts, or should be stayed by reason of the pendency of some other proceeding in any other court other than one of the above-named courts, or that this Agreement or the subject matter hereof may not be enforced in or by such court, and (c) hereby agrees not to commence any such action other than before one of the above-named courts nor to make any motion or take any other action seeking or intending to cause the transfer or removal of any such action to any court other than one of the above-named courts whether on the grounds of inconvenient forum or otherwise.  Notwithstanding the foregoing, application may be made to any court of competent jurisdiction with respect to the enforcement of any judgment or award.
17.4.    Governing Law.  This Agreement will be governed by and construed in accordance with the laws of the State of New York, without reference to conflict of law principles.
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17.5.    Injunctive Relief.  Notwithstanding the foregoing, in the event of an actual or threatened breach hereunder, the aggrieved Party may seek equitable relief (including restraining orders, specific performance, or other injunctive relief) in any court or other forum, without first submitting to the dispute resolution procedures set forth in Section 17.1 (Executive Officers).
Article 18

MISCELLANEOUS
18.1.    Assignment.  Neither Party may assign this Agreement and the licenses herein granted without the other Party’s prior written consent, except that (a) Vifor may assign this Agreement to VFMCRP effective upon not less than [**] prior written notice to Akebia; or (b) either Party may assign this Agreement in its entirety in writing to a Third Party successor or purchaser of all or substantially all of the assets or businesses to which this Agreement relates whether pursuant to a sale of assets, merger, or other transaction, in which case the assigning Party will provide prior written notice to the other Party and need not obtain the other Party’s consent; provided that the permitted assignee must assume all obligations of the assigning Party under the Agreement in writing and the assigning Party will remain fully liable for the performance of its obligations hereunder by such permitted assignee. In addition, and notwithstanding the foregoing, Akebia may assign its right to receive payments under this Agreement as part of a royalty factoring or other similar transaction undertaken for bona fide financing purposes. Any other assignment of this Agreement by a Party requires the prior written consent of the other Party.  Any assignment in violation of this Section 18.1 (Assignment) will be null, void, and of no legal effect.  This Agreement will be binding on and will inure to the benefit of the permitted successors and assigns of the Parties. 
18.2.    Standstill.  Except in connection with the acquisition of shares by Licensee pursuant to the terms of the Investment Agreement dated as of the Original Execution Date by and between the Parties, Licensee will not, without the written consent of Akebia, acquire directly or indirectly, in a public or private transaction, including by purchase in the open market, any common stock of Akebia if the Licensee’s beneficial ownership of the common stock of Akebia would thereafter exceed [**]%. In addition, unless approved in advance in writing by Akebia, Licensee will not, directly or indirectly:
(a)    Make any statement or proposal to Akebia, other than a non-public statement or proposal delivered directly to the chief executive officer or chairman of the board of directors, or to any of Akebia’s stockholders regarding, or make any public announcement, proposal, or offer (including a “solicitation” of “proxies” as such terms are defined or used in Regulation 14A of the Exchange Act) with respect to, or otherwise solicit, seek, or offer to effect (including, for the avoidance of doubt, indirectly by means of communication with the press or media) (i) any business combination, merger, tender offer, exchange offer, or similar transaction involving Akebia, (ii) any restructuring, recapitalization, liquidation, or similar transaction involving Akebia, (iii) any acquisition of any of Akebia’s equity securities or assets or rights or options to acquire equity securities or assets, (iv) any proposal to seek representation on the board of directors of Akebia or otherwise seek to control or influence the management, board of directors, or policies of Akebia, or (v) any proposal, arrangement, or other statement that is inconsistent with this Section 18.2 (Standstill);
(b)    Instigate, encourage, or assist any Third Party (including forming a “group” with any such Third Party) to do, or enter into any discussions or agreements with any Third Party with respect to, any of the actions set forth in Section 18.2 (Standstill); or
(c)    Take any action that would reasonably be expected to require Akebia or any of its Affiliates to make a public announcement regarding any of the actions set forth in Section 18.2 (Standstill).
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Notwithstanding the foregoing provisions, the restrictions set forth in this Section 18.2 (Standstill) will terminate and be of no further force and effect (a) [**], provided that the provisions of this Section 18.2 (Standstill) will be revived if such [**]; or (b) upon the expiration or termination of this Agreement. For the avoidance of doubt, nothing in this Section 18.2 (Standstill) will prohibit Licensee from acquiring beneficial ownership of the common stock of Akebia to the extent such ownership remains less than [**]% of Akebia’s total outstanding common stock.  For purposes of this Section 18.2 (Standstill), “Sale Transaction” means a transaction between Akebia and a Third Party (i) involving the direct or indirect acquisition by such Third Party of [**]% or more of Akebia’s outstanding shares of common stock or consolidated assets (including assets held by subsidiaries), excluding a transaction in which (A) [**], or (B) [**], or (ii) involving the sale of substantially all of Akebia’s rights with respect to the Licensed Products.
18.3.    Force Majeure.  If either Party will be delayed, interrupted in, or prevented from the performance of any obligation hereunder by reason of any cause beyond its reasonable control, including an act of God, fire, flood, earthquake, war (declared or undeclared), public disaster, epidemic, act of terrorism, or strikes (other than strikes of a Party’s own employees), then such Party will not be liable to the other therefor; and the time for performance of such obligation will be extended for a period equal to the duration of the force majeure that occasioned the delay, interruption, or prevention.  The Party invoking such force majeure rights of this Section 18.3 (Force Majeure) must notify the other Party by courier or overnight dispatch (e.g., Federal Express) no later than 30 days after each of the first and last day of the force majeure unless the force majeure renders such notification impossible, in which case notification will be made as soon as possible.  If the delay resulting from the force majeure exceeds three months, then the Party not affected by the force majeure will have the right to terminate this Agreement forthwith pursuant to Section 16.2 (Termination for Breach) with the consequences set out in Section 16.13 (Effects of Termination), as if the Party affected by the force majeure were in material breach of this Agreement.
18.4.    Entire Agreement.  This Agreement, together with exhibits and schedules attached hereto, (a) constitutes the entire agreement between the Parties with respect to the subject matter hereof, (b) amends and restates the First Amended Agreement in its entirety, and (c) supersedes all prior understandings of the Parties with respect thereto (including the Original Agreement, the First Amended Agreement and that certain Confidential Disclosure Agreement between the Parties dated [**], as amended by Amendment No. 1 dated [**]) and will not be modified, amended, or terminated, except as herein provided or except by another agreement in writing executed by the Parties.
18.5.    Severability.  If any provision of this Agreement is declared invalid by a court of last resort or by any court or other governmental body from the decision of which an appeal is not taken within the time provided by law, then and in such event, this Agreement will be deemed to have been terminated only as to the portion thereof that relates to the provision invalidated by that decision and only in the relevant jurisdiction, but this Agreement, in all other respects and all other jurisdictions, will remain in force; provided, however, that if the provision so invalidated is essential to the Agreement as a whole, then the Parties will negotiate in good faith to amend the terms hereof as nearly as practical to carry out the original intent of the Parties, and, failing to agree to such amendment, then either Party may submit the matter for resolution pursuant to Article 17 (Dispute Resolution; Governing Law). 
18.6.    Notices.  Any notice or report required or permitted to be given under this Agreement will be in writing and will be mailed by internationally recognized express delivery service, or sent by email or facsimile and confirmed by mailing, as follows:
If to Akebia:
Akebia Therapeutics, Inc. 
245 First Street
Cambridge, MA  02142 
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Attention:  Chief Executive Officer 
Facsimile:  [**]
Email:  [**]

With copies to (which will not constitute notice for purposes of this Agreement):
Akebia Therapeutics, Inc. 
245 First Street
Cambridge, MA  02142 
Attention:  Senior Vice President, Chief Legal Officer and Secretary
Facsimile:  [**]
Email:  [**]

and
Ropes & Gray LLP 
Prudential Tower, 800 Boylston Street 
Boston, MA  02199-3600 
Attention:  [**] 
Facsimile:  [**]
Email:  [**]

If to Licensee:
Vifor Pharma Management Ltd.
Flughofstrasse 61, 8152 Glattbrugg, Switzerland
Attention:  [**] 
Facsimile:  [**]
Email:  [**]

With a copy to (which will not constitute notice for purposes of this Agreement):
Vifor Pharma Management Ltd
Flughofstrasse 61, 8152 Glattbrugg, Switzerland 
Facsimile:  [**] 
Attention:  [**]
Email:  [**] 

18.7.    Further Assurances.  The Parties agree to reasonably cooperate with each other in connection with any actions required to be taken as part of their respective obligations under this Agreement, and will (a) furnish to each other such further information; (b) execute and deliver to each other such other documents; and (c) do such other acts and things (including working collaboratively to correct any clerical, typographical, or other similar errors in this Agreement), all as the other Party may reasonably request for the purpose of carrying out the intent of this Agreement.
18.8.    Agency.  Neither Party is, nor will be deemed to be an employee, agent, or representative of the other Party for any purpose.  Each Party is an independent contractor, not an employee or partner of the other Party.  Neither Party will have the authority to speak for, represent, or obligate the other Party in any way without prior written authorization from the other Party.
18.9.    No Waiver.  Any omission or delay by either Party at any time to enforce any right or remedy reserved to it, or to require performance of any of the terms, covenants, or provisions hereof, by the other Party, will not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement.  Any waiver by a Party of a particular breach or default by the other Party will not operate or be construed as a waiver of any subsequent breach or default by the other Party.
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18.10.    Interpretation.  (a) Whenever any provision of this Agreement uses the term “including” (or “includes”), such term will be deemed to mean “including without limitation” and “including but not limited to” (or “includes without limitations” and “includes but is not limited to”) regardless of whether the words “without limitation” or “but not limited to” actually follow the term “including” (or “includes”); (b) “herein,” “hereby,” “hereunder,” “hereof,” and other equivalent words will refer to this Agreement in its entirety and not solely to the particular portion of this Agreement in which any such word is used; (c) all definitions set forth herein will be deemed applicable whether the words defined are used herein in the singular or the plural; (d) wherever used herein, any pronoun or pronouns will be deemed to include both the singular and plural and to cover all genders; (e) the recitals set forth at the start of this Agreement, along with the schedules and exhibits to this Agreement, and the terms and conditions incorporated in such recitals and schedules and exhibits will be deemed integral parts of this Agreement and all references in this Agreement to this Agreement will encompass such recitals and schedules and exhibits and the terms and conditions incorporated in such recitals and schedules and exhibits; provided that in the event of any conflict between the terms and conditions of this Agreement and any terms and conditions set forth in the recitals, schedules, or exhibits, the terms of this Agreement will control; (f) in the event of any conflict between the terms and conditions of this Agreement and any terms and conditions that may be set forth on any order, invoice, verbal agreement, or otherwise, the terms and conditions of this Agreement will govern; (g) this Agreement will be construed as if both Parties drafted it jointly, and will not be construed against either Party as principal drafter; (h) unless otherwise provided, all references to Sections, Articles, and Schedules in this Agreement are to Sections, Articles, and Schedules of and to this Agreement; (i) any reference to any federal, national, state, local, or foreign statute or law will be deemed to also refer to all rules and regulations promulgated thereunder, unless the context requires otherwise; (j) wherever used, the word “shall” and the word “will” are each understood to be imperative or mandatory in nature and are interchangeable with one another; (k) the word “or” will not be exclusive; (l) references to a particular person include such person’s successors and assigns to the extent not prohibited by this Agreement; and (m) the section headings and captions used herein are inserted for convenience of reference only and will not be construed to create obligations, benefits, or limitations.
18.11.    Cumulative Remedies.  No remedy referred to in this Agreement is intended to be exclusive, but each will be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.
18.12.    Counterparts.  This Agreement may be executed in counterparts, all of which taken together will be regarded as one and the same instrument. This Agreement may be executed by facsimile, .pdf, or other electronically transmitted signatures and such signatures will be deemed to bind each Party hereto as if they were the original signatures.
[Remainder of page intentionally left blank; signature page follows.]
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IN WITNESS WHEREOF, the Parties have executed this Second Amended Agreement through their duly authorized representatives to be effective as of the Effective Date.
AKEBIA THERAPEUTICS, INC.    VIFOR (INTERNATIONAL) LTD.

By:  __/s/ John P. Butler ________________    By:  _/s/ Dr. Christoph Springer_______
Name:  __John P. Butler________________    Name:  Dr. Christoph Springer
Title:  _President and Chief Executive Officer     Title:  Chief Strategy Officer

    VIFOR (INTERNATIONAL) LTD.

    By:  _/s/ Dr. Oliver P. Kronenberg_______
    Name:  Dr. Oliver P. Kronenberg
    Title:  Group General Counsel

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