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Article I DEFINITIONS

1

Article II LICENSES

22

Article III GOVERNANCE

24

Article IV DEVELOPMENT

34

Article V REGULATORY AFFAIRS

45

Article VI MEDICAL AFFAIRS

48

Article VII COMMERCIALIZATION

49

Article VIII MANUFACTURING AND SUPPLY

53

Article IX PAYMENTS

55

Article X OWNERSHIP OF INTELLECTUAL PROPERTY

62

Article XI INFORMATION; PHARMACOVIGILANCE;

70

PRODUCT WITHDRAWAL AND LIMITED RECALL

70

Article XII REPRESENTATIONS, WARRANTIES, AND COVENANTS

72

Article XIII CONFIDENTIALITY

76

Article XIV INDEMNIFICATION

79

Article XV TERM AND TERMINATION

80

Article XVI DISPUTE RESOLUTION; GOVERNING LAW

84

Article XVII MISCELLANEOUS

86

1.1

“AAA” has the meaning set forth in Section 16.2.3 (Arbitration Procedure).

1.2

“Accounting Standards” means (a) International Financial Reporting Standards, or (b) U.S. GAAP.

1.3

“Acquiror” has the meaning set forth in Section 17.3.1 (Exception for Acquisition by a Third Party).

1.4

“Additional Development” has the meaning set forth in Section 4.3 (Additional Development).

1.5

“Affiliate” means, with respect to a Party, any corporation, or other business entity controlled by, controlling, or under common control with such Party, with “control” meaning (a) direct or indirect beneficial ownership of at least 50% of the voting stock or other ownership interest of, or at least a 50% interest in the income of, the applicable entity, or (b) the possession, directly or indirectly, of the power to direct the management or policies of the applicable entity, whether

through the ownership of voting securities or other equity rights, by contract relating to voting rights or corporate governance, or otherwise.  Notwithstanding the foregoing, “Affiliates” will 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 other strategic purpose, or Affiliates of such venture capital or institutional investors.

1.6

“Akebia Housemarks” means (a) the corporate logo of Akebia, (b) the trademarks “AKEBIA,” “PRO₂TECT,” “INNO₂VATE,” and “O₂XYGEN,” (c) any other trademark, trade name, or service mark (whether registered or unregistered) containing the word “Akebia,” (d) any trademark, trade name, or service mark (whether registered or unregistered) used as the name of any clinical trial for any Licensed Product, (e) any other corporate logo or trademark of Akebia used by Akebia to identify Akebia or its Affiliates, (f) all registrations, applications for registrations, and other intellectual property rights associated with any of the foregoing, and (g) all goodwill associated with any and all of the foregoing in clauses (a) through (f).

1.7

“Akebia Improvement” means any Improvement that is made during the Term in the course of performance of activities undertaken by Akebia pursuant to this Agreement or pursuant to the license grants in Section 2.3 (Grant of Licenses to Akebia), solely by one or more employees of Akebia or any Affiliate of Akebia, or persons contractually required to assign or license such Improvement (or Patents Covering such Improvement) to Akebia or any Affiliate of Akebia, but excluding any Joint Know-How.

1.8

“Akebia Indemnitees” has the meaning set forth in Section 14.2 (Indemnification by Licensee).

1.9

“Akebia Know-How” means all Know-How (excluding Joint Know-How) that (a) is Controlled as of the Effective 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) necessary or reasonably useful for the Development, Packaging, or Commercialization of the Licensed Compound or a Licensed Product in the Field in the Territory.

1.10

“Akebia Patents” means all Patents (excluding Joint Patents) that (a) are Controlled as of the Effective Date or during the Term by Akebia or any of its Affiliates in the Territory, and (b) (i) [***] or (ii) are [***] of the Licensed Compound or a Licensed Product in the Field. Akebia Patents include any and all [***] and all Patents Controlled by Akebia or any of its Affiliates in the Territory that Cover Akebia Improvements. All Akebia Patents as of the Effective Date are set forth on Schedule 1.10.

1.11

“Akebia Reserved Disputes” means any dispute of the [***] with respect to matters within the [***] jurisdiction that is not resolved following escalation to the [***] (if applicable) and the [***] related to (a) the [***] of the Licensed Compound or the Licensed Products in the Territory in accordance with [***], (b) the [***] for each Licensed Product and [***] for use in the Territory, (c) any [***] of the Licensed Compound or the Licensed Products (other than [***]), including (i) whether to [***], and (ii) whether to [***], and (d) [***] only to the extent described in Section 1.11.1 through Section 1.11.4:

1.11.1

prior to the [***], in each case, any [***] of [***] Licensed Product in such indication or such formulation to be [***] that is reasonably likely [***] for such indication or such formulation, including [***]; and

1.11.2

after the [***], in each case, if [***] in effect, then [***] of [***] Licensed Product in such indication or such formulation to be [***] for such indication or such formulation.

1.11.3

prior to the [***]:

(a)

[***] (subject to Section 1.11.1 or Section 1.11.2, as applicable, with respect [***] that is reasonably likely [***] for such indication or such formulation, including [***], and

(b)

[***], in each case, that [***] of any applicable [***] for such indication or such formulation; and

1.11.4

after the [***], in each case, [***] in effect, then [***] of [***] Licensed Product in such indication or such formulation [***] for such indication or such formulation.

1.12

“Akebia Technology” means Akebia Know-How, Akebia Patents, Assigned Product Improvements, Akebia Improvements, and Akebia’s interest in Joint Technology.

1.13

“Alliance Manager” has the meaning set forth in Section 3.9 (Alliance Managers).

1.14

“Anti-Slavery and Human Trafficking Laws” has the meaning set forth in Section 12.4.6 (Additional Covenants).

1.15

“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.

1.16

“Applicable Law” means any applicable law (including common law), statute, rule, regulation, order, judgment, or ordinance of any Governmental Authority (including any Regulatory Authority), including those concerning environmental, health, regulatory, privacy, and safety matters.

1.17

“Approved Labeling” means, with respect to each Licensed Product: (a) the Regulatory Authority-approved full prescribing information for such Licensed Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Licensed Product.

1.18

“Arbitration Request” has the meaning set forth in Section 16.2.1 (Arbitration Request).

1.19

“Assigned Product Improvement Patents” means any Patent that Covers an Assigned Product Improvement.

1.20

“Assigned Product Improvements” means all Licensee Improvements that solely relate to the Licensed Compound or a Licensed Product.

1.21

“Breaching Party” has the meaning set forth in Section 15.2 (Termination for Breach).

1.22

“Business Day” means any day (other than a Saturday or Sunday) on which the banks in Cambridge, Massachusetts, Tokyo, Japan, and London, England are open for business.

1.23

“Clinical Supply Agreement” has the meaning set forth in Section 8.3 (Supply Agreements).

1.24

“Combination Product” means any Licensed Product that is comprised of two or more APIs, at least one of which is the Licensed Compound.

1.25

“Commercial Operations” means, with respect to a country, a country in which Licensee or any of its Affiliates conducts sales activities either itself or jointly with a Third Party.

1.26

“Commercial Supply Agreement” has the meaning set forth in Section 8.3 (Supply Agreements).

1.27

“Commercialization” means, with respect to a Licensed Product, Combination Product, or Co-Packaged Product, any and all activities directed to the marketing, promotion, distribution, pricing, reimbursement, offering for sale, and sale of such Licensed Product, Combination Product, or Co-Packaged Product, and interacting with Regulatory Authorities following Regulatory Approval in the applicable country or region for such Licensed Product, Combination Product, or Co-Packaged Product, regarding the foregoing, including seeking any required Reimbursement Approval, but excluding activities directed to the manufacture (including Packaging) and Development of the Licensed Compound or a Licensed Product. “Commercialize,” “Commercializing,” and “Commercialized” will be construed accordingly.

1.28

“Commercialization Plan” means a [***] plan for the Commercialization of a Licensed Product, Combination Product, or Co-Packaged Product in the Territory that is prepared, updated, and amended by Licensee in accordance with Section 7.2 (Commercialization Plan).

1.29

“Commercially Reasonable Efforts” means, with respect to the Development, manufacture, and Commercialization of the Licensed Compound or a Licensed Product by a Party, those efforts and resources, including reasonably necessary personnel, equivalent to the efforts that a research-

based biopharmaceutical company or a pharmaceutical company that is comparable to such Party 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 all relevant factors, including issues of safety and efficacy, anticipated or actual product labeling, the competitiveness of alternative Third Party products in the marketplace, the nature and extent of expected and actual market exclusivity (including Patent coverage and regulatory exclusivity), the expected likelihood of regulatory approval, the expected and actual reimbursability and pricing, the potential profitability of such Licensed Product marketed or to be marketed, and other relevant scientific, technical, and commercial factors.

1.30

“Comparable Quarter” has the meaning set forth in Section 9.3.3(a) (Sub-Territory A and Sub-Territory B).

1.31

“Competing Product” means a product that is approved by an applicable Regulatory Authority for the treatment of anemia associated with chronic kidney disease, including any HIF Product, but excluding (a) the Licensed Products, (b) all products that [***], and (c) all [***].

1.32

“Confidential Disclosure Agreement” has the meaning set forth in Section 17.7 (Entire Agreement; Amendment).

1.33

“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 Effective Date pursuant to the Confidential Disclosure Agreement or the U.S. Collaboration and License Agreement), regardless of whether such information is specifically designated as confidential and regardless of whether such information is in written, oral, electronic, or other form.

1.34

“Controlled” means, with respect to a Party or its Affiliate, 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 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 other than payment obligations incurred under licenses taken pursuant to Section 10.10.4 (Responsibility for Third Party Licenses).  Notwithstanding the foregoing, no Patent, Know-How, or other intellectual property right will be “Controlled” by either Party hereunder if such Patent, Know-How, or other intellectual property right is owned or in-licensed by a Third Party that becomes an Affiliate of such Party after the Effective Date as a result of such Party being acquired by such Third Party, whether by merger, stock purchase, or purchase of assets; provided that prior to the date of such transaction, neither such Party nor any of its Affiliates had any rights to any such Patent, Know-How, or other intellectual property right. Notwithstanding the foregoing, any such Patent, Know-How, or other intellectual property right that is owned or in-licensed by such an acquiring Third Party and that is necessary for or used following the date of such transaction by such Third Party or acquired Party in connection with the Development, manufacture, or Commercialization of the Licensed Compound or any Licensed Product will be “Controlled” by such Third Party (as an Affiliate) or acquired Party for purposes of this Agreement.

1.35

“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.

1.36

“Cost of Goods Sold” or “COGS” (a) with respect to any Licensed Product in API form, U.S. Finished Form, or Tablet Formulation (in bulk form) that is manufactured and supplied by a Third Party, the actual prices paid by Akebia to such Third Party for released batches of such Licensed Product; and (b) to the extent any Licensed Product in API form, U.S. Finished Form, or Tablet Formulation (in bulk form) is manufactured and supplied by Akebia 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 such Licensed Product, calculated in accordance with the Accounting Standards applicable to Akebia or its Affiliates, including all Licensed Product testing and yield loss costs (to the extent within typical yield loss, as agreed by the Parties and set forth in the Manufacturing Plan or a Supply Agreement), quality control, quality assurance, or other testing of such Licensed Product, together with all reasonably allocated indirect costs and overhead applicable to the manufacturing of such Licensed Product (including internal FTE costs associated with supply thereof), or technical operations functions, less costs of goods returned in accordance with Akebia’s or its Affiliates’ or suppliers’ return policy; provided that, with respect to manufacturing overhead attributable to such Licensed Product, COGS calculated in accordance with clause (b) [***].

1.37

“Cost Share Notice” means the notice provided by Akebia to Licensee under Section 4.1.4(a) (Initial Cost Share Notice) or Section 4.1.4(b) (Cost Share Notices).

1.38

“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.

1.39

“Credit Amount” has the meaning set forth in Section 9.3.4(d) (Maximum Supply Price Reduction).

1.40

“Creditable [***] Costs” has the meaning set forth in Section 4.1.3(b) (Credit for [***] Costs).

1.41

“Current Formulation” means the [***] and any other formulation of a Licensed Product used for any clinical or non-clinical study set forth on Schedule 1.44.

1.42

“Current Global Development Costs” means the fully-allocated internal and external costs incurred by Akebia in implementing the Current Global Development Plan, calculated in accordance with the Accounting Standards applicable to Akebia, consistently applied and reflected in its audited financial statements.

1.43

“Current Global Development Plan” means the plan setting forth the Development activities that have been undertaken and will be undertaken by or on behalf of Akebia, and its Affiliates and licensees (including Licensee, if applicable pursuant to Section 4.1 (Current Global Development)), for the purpose of Developing the Licensed Compound and the Licensed Products and obtaining Regulatory Approval from [***] for the Licensed Products for the DD-CKD Indication and the NDD-CKD Indication [***], together with the budget and timelines for such activities including the proposed clinical trials and regulatory plans, as well as outlining the key elements involved in obtaining Regulatory Approval of the Licensed Products from the [***] in the DD-CKD Indication and the NDD-CKD Indication in the [***], as the same may be amended from time-to-time in accordance with this Agreement.

1.44

“Current Global Development Program” means the Global Phase 3 NDD-CKD Program and the Global Phase 3 DD-CKD Program, the other clinical and non-clinical studies set forth on Schedule 1.44, and any other Development activity for the purpose of obtaining Regulatory Approval from [***] for the Licensed Products for each of the DD-CKD Indication and the NDD-CKD Indication in the [***] that is conducted pursuant the Current Global Development Plan, as the same may be amended in accordance with this Agreement. For clarity, [***] are not included in the Current Global Development Program.

1.45

“DD-CKD Indication” means the treatment of anemia in pediatric and adult dialysis patients with chronic kidney disease.

1.46

“Debarred/Excluded” has the meaning set forth in Section 12.1.11 (Mutual Representations and Warranties).

1.47

“Design-Around Product” means any pharmaceutical product, drug product, preparation, formulation, or dosage form thereof (other than a Licensed Product or a [***]) sold by a Third Party (other than a sublicensee of Licensee) that (a) has the Licensed Compound as [***], and (b) is not Developed, Packaged, or Commercialized by Licensee, or any of its Affiliates or sublicensees.

1.48

“Development” means all internal and external research, development, and regulatory activities regarding the Licensed Compound or the Licensed Products. This includes (a) research, non-clinical testing, toxicology, route of synthesis, non-clinical activities, formulation, and clinical studies of a Licensed Compound or any Licensed Product, and (b) preparation, submission, review, and development of data or information for the purpose of submission to a Regulatory Authority to obtain authorization to conduct clinical trials and to obtain or maintain Regulatory Approval of a Licensed Product. Development will 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 that was mandated by the applicable Regulatory Authority as a condition of such Regulatory Approval with respect to an approved indication (such as post-marketing studies and observational studies, if required by any Regulatory Authority in any country in the Territory to maintain Regulatory Approval for a Licensed Product in such country). “Develop,” “Developing,” and “Developed” will be construed accordingly.

1.49

“Dialysis Organization” means any dialysis organization that conducts activities in the Territory and in the U.S., either itself or through its affiliates or related entities (together with all such affiliates and related entities).

1.50

“Divestiture Notice” has the meaning set forth in Section 17.3.1 (Exception for Acquisition by a Third Party).

1.51

“EMA” means the European Medicines Agency or any successor agency thereto.

1.52

“[***] Plan” has the meaning set forth in Section 4.1.2(a) (Agreement of the JDC).

1.53

“[***]” means any clinical or non-clinical study that is [***] as of the Effective Date and is (a) [***] obtaining Regulatory Approval in [***], or (b) [***], in each case ((a) or (b)), for any Licensed Product for the DD-CKD Indication and the NDD-CKD Indication in the [***].  For clarity, [***] are [***] in [***] or the Current Global Development Program.

1.54

“[***]” means all costs and expenses incurred by or on behalf of a Party in connection with any [***].

1.55

“ESA Hyporesponder” means subjects with (a) [***], or (b) [***] (i) [***], or (ii) [***].

1.56

“Establishing Committee” has the meaning set forth in Section 3.5.3 (Operational Teams).

1.57

“E.U.” means the European Union.

1.58

“Excess COGS” has the meaning set forth in Section 9.3.4(b) (Maximum Supply Price Reduction).

1.59

“Executive Officer” means the chief executive officer of a Party or any of its Affiliates or his or her designee.

1.60

“Expert Reserved Matter” means, (a) after the [***] for a Licensed Product in [***], a disagreement of the [***] that is not resolved following escalation to the [***] (if applicable) and the [***] regarding [***] of a [***] Licensed Product in such indication or such formulation [***] for such indication or such formulation, and (b) after the [***], a disagreement of the [***] or any [***] that is not resolved following escalation to the [***] (if applicable) and the [***] regarding [***] of a [***] Licensed Product in such indication or such formulation [***] for such indication or such formulation.

1.61

“FD&C Act” means the United States Federal Food, Drug and Cosmetic Act, as amended from time-to-time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

1.62

“FDA” means the U.S. Food and Drug Administration or any successor agency thereto.

1.63

“Field” means the treatment, prevention, or diagnosis of any diseases or conditions in humans, including the Initial Indications.

1.64

“Finished Form” means a Licensed Product in the Tablet Formulation in finished form and with all applicable Packaging and Labeling.

1.65

“First Commercial Sale” means, for each Licensed Product in a country in the Territory, the first sale for end use or consumption to a Third Party of such Licensed Product in such country by Licensee, its Affiliates, or its permitted sublicensees after the granting of Regulatory Approval in the Field for such Licensed Product by the relevant Regulatory Authority in such country.  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 sold at or below Seller’s costs.

1.66

“FTE” means the equivalent of the work of one duly qualified employee of a Party full time for one year (consisting of a total of [***] hours per year) carrying out Development, manufacturing, or other regulatory, distribution, scientific, or technical work under this Agreement.  Overtime, and work on weekends, holidays and the like will not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution, and no individual may be charged at greater than one FTE, regardless of that individual’s hours worked during that year.  The portion of an FTE billable by a Party for one employee during a given accounting period will be determined by dividing the number of hours worked directly by such employee on the work to be conducted under this Agreement during such accounting period by the number of FTE hours applicable for such accounting period based on [***] working hours per calendar year.

1.67

“Generic Product” means, on a Licensed Product-by-Licensed Product (including Combination Product-by-Combination Product) and country-by-country basis in a particular country in the Territory, any pharmaceutical product sold by a Third Party in such country that:  (a) contains [***] as the applicable Licensed Product in the same [***] as the applicable Licensed Product, and (b) is categorized by the applicable Regulatory Authority in such country to be [***], or [***], such Licensed Product, such that the pharmaceutical product may be substituted for such Licensed Product at the point of dispensing without any intervention by the prescribing physician in such country.

1.68

“Global Brand Plan” has the meaning set forth in Section 7.8 (Global Brand Plan and Promotional Materials).

1.69

“Global Mark” means any Marks selected by Akebia, its Affiliates, or licensees under which Akebia, its Affiliates, or licensees will market any Licensed Product outside of the Territory in the Field, and all trademark registrations and applications therefor, and all goodwill associated therewith. Global Marks exclude all Local Marks.

1.70

“Global Medical Affairs Plan” has the meaning set forth in Section 6.1 (Medical Affairs Plans).

1.71

“Global Phase 3 DD-CKD Program” means the Phase 3 global clinical studies for the DD-CKD Indication, known informally as the INNO₂VATE studies, 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 Dialysis-Dependent Chronic Kidney Disease (INNO₂VATE – Conversion)” (AKB-6548-CI-0017) 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)” (AKB-6548-CI-0016).

1.72

“Global Phase 3 NDD-CKD Program” means the Phase 3 global clinical studies for the NDD-CKD Indication, known informally as the PRO₂TECT studies, 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)” (AKB-6548-CI-0015) 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)” (AKB-6548-CI-0014).

1.73

“Global Trade Control Laws” means the U.S. Export Administration Regulations, the U.S. International Traffic in Arms Regulations, the economic sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Control, E.U. Council Regulations on export controls, including Nos. 428/2009, 267/2012, other E.U. Council sanctions regulations, as implemented in the E.U. member states, United Nations sanctions policies, and all relevant regulations made under any of the foregoing.

1.74

“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.

1.75

“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.

1.76

“Good Manufacturing Practices” or “GMP” means the then-current good manufacturing 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.

1.77

“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 or Governmental Authority.

1.78

“Governmental Authority” means any court, agency, department, authority, tribunal, or other instrumentality of any supra-national, national, state, provincial, county, city, or other political subdivision. For clarity, Governmental Authorities include all Regulatory Authorities.

1.79

“HIF Product” means any product or product candidate that is a hypoxia-inducible factor prolyl-hydroxylase inhibitor for the treatment of anemia related to chronic kidney disease.  For the avoidance of doubt, “HIF Product” includes [***], and each Licensed Product.

1.80

“Housemarks” means the Akebia Housemarks and the Licensee Housemarks.

1.81

“Hyporesponder Endpoint” means either (a) [***], or (b) [***].

1.82

“Hyporesponder Study” means the study known formally as the “Phase 2, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Treatment of Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease who are Hyporesponsive to Erythropoiesis-Stimulating Agents” (AKB-6548-CI-0018).

1.83

“Improvement” means any Invention relating to, arising from the use of, or including the Licensed Compound or a Licensed Product, including any New Formulation, or its respective Development, manufacture, use, design, registration, offer for sale, sale, or importation.

1.84

“IND” means an Investigational New Drug application required pursuant to 21 C.F.R. Part 312 or any comparable filings outside of the U.S. (such as an application for a Clinical Trial Authorization in the E.U.).

1.85

“Indemnified Party” has the meaning set forth in Section 14.3 (Indemnification Procedure).

1.86

“Indemnifying Party” has the meaning set forth in Section 14.3 (Indemnification Procedure).

1.87

“Information” has the meaning set forth in Section 11.1 (Information).

1.88

“Infringement Claim” has the meaning set forth in Section 10.10.1 (Infringement Claim).

1.89

“Initial Indications” means the DD-CKD Indication and the NDD-CKD Indication, and any other indication in the Field for which the initial label of a Licensed Product is approved based on the data generated from the performance of the Current Global Development Program or any [***].

1.90

“Invention” means any process, method, composition of matter, article of manufacture, discovery, or finding that is conceived or reduced to practice (whether or not patentable).

1.91

“JCC” has the meaning set forth in Section 3.4.1 (Formation and Purpose of the JCC).

1.92

“JDC” has the meaning set forth in Section 3.2.1 (Formation and Purpose of the JDC).

1.93

“JMC” has the meaning set forth in Section 3.3.1 (Formation and Purpose of the JMC).

1.94

“Joint Know-How” means any Know-How that is made during the Term in the course of performance of any activities undertaken pursuant to this Agreement (including under the licenses granted hereunder) jointly by at least one employee of Akebia or its Affiliate or any Third Party contractually required to assign or license such Know-How to Akebia and at least one employee of Licensee or its Affiliate or Third Party contractually required to assign  such Know-How to Licensee, but excluding any Akebia Improvements, Assigned Product Improvements, and Retained Licensee Improvements.

1.95

“Joint Patents” means all Patents that Cover the Joint Know-How.

1.96

“Joint Publication Plan” has the meaning set forth in Section 13.4.2 (After Release of Data by Akebia).

1.97

“Joint Technology” means Joint Know-How and Joint Patents.

1.98

“Jointly-Agreed Regulatory Submissions” means, for each Licensed Product in each Initial Indication, (a) the [***], (b) the [***], (c) the [***], (d) the [***], and (e) [***]  submissions (including [***]), in each case, to be submitted to the EMA, and (f) [***] relating to any of the foregoing submissions.

1.99

“JSC” has the meaning set forth in Section 3.1.1 (Formation and Purpose of the JSC).

1.100

“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 and marketing, pricing and distribution cost, and sales data or descriptions.

1.101

“Knowledge” means, with respect to a Party, the actual knowledge of such Party’s and its European headquarters’ [***] as of the Effective Date, without any inquiry or investigation.  For this purpose, [***] means [***].

1.102

“Launch Countries” has the meaning set forth in Section 7.2 (Launch Sequence and Commercialization Plan).

1.103

“Launch Sequence” has the meaning set forth in Section 7.2 (Commercialization Plan).

1.104

“Licensed Compound” means the API referred to as vadadustat, formerly known as AKB-6548, and any salt or crystal form thereof.  Licensed Compound includes any prodrug form of vadadustat.

1.105

“Licensed Product” means any pharmaceutical product, drug product, preparation, formulation, or dosage form thereof that has the Licensed Compound as at least one API.

1.106

“Licensee Contributed Technology” means (a) any Licensee Patent anywhere in the world that includes one or more claims that Covers a Licensed Product that Licensee Develops, Packages, or Commercializes pursuant to this Agreement, and (b) any Licensee Know-How.

1.107

“Licensee Housemarks” means (a) the corporate logo of Licensee or any of its Affiliates, (b) the trademark “Otsuka,” (c) any other trademark, trade name, or service mark (whether registered or unregistered) containing the word “Otsuka,” and (d) any other corporate logo or trademark used by Licensee to identify Licensee or its Affiliates, (e) all registrations, applications for registrations, and other intellectual property rights associated with any of the foregoing, and (f) all goodwill associated with any and all of the foregoing in clauses (a) through (e).

1.108

“Licensee Improvement” means any Improvement that is made during the Term in the course of performance of activities undertaken by Licensee pursuant to this Agreement or pursuant to the license grants in Section 2.1 (Grant of Licenses to Licensee), solely by one or more employees of Licensee or any Affiliate of Licensee, or persons contractually required to assign or license such Improvement (or Patents Covering such Improvement) to Licensee or any Affiliate of Licensee (including all sublicensees), but excluding any Joint Know-How.

1.109

“Licensee Indemnitees” has the meaning set forth in Section 14.1 (Indemnification by Akebia).

1.110

“Licensee Know-How” means all Know-How (excluding Joint Know-How) that is (a) Controlled as of the Effective Date or during the Term by Licensee or any of its Affiliates, and (b) either (i) disclosed to Akebia or any of its Affiliates pursuant to this Agreement, or (ii) necessary or reasonably useful for the Development, manufacture, or Commercialization of the Licensed Compound or a Licensed Product.

1.111

“Licensee Patents” means all Patents (excluding Joint Patents) that (a) are Controlled as of the Effective Date or during the Term by Licensee or any of its Affiliates in the Territory, and (b) (i) include one or more claims that Cover the Licensed Compound or a Licensed Product or their respective Development, manufacture, or Commercialization, or (ii) are necessary or reasonably useful (or, with respect to patent applications, would be necessary or reasonably useful if such patent applications were to issue as patents) for the Development, manufacture, or

Commercialization of the Licensed Compound or a Licensed Product. Licensee Patents include any and all Retained Licensee Improvement Patents.

1.112

“Licensee R&D Cost Share” has the meaning set forth in Section 4.1.3(a) (Licensee R&D Cost Share).

1.113

“Licensee Reserved Dispute” means any dispute of the [***] with respect to matters within the [***] that is not resolved following escalation to the [***] (if applicable) and the [***] related to (a) [***], (b) [***], (c) [***], and (d) the [***] of a Licensed Product, including any dispute with respect to any [***].

1.114

“Licensee Technology” means Licensee Know-How, Licensee Patents, Retained Licensee Improvement Technology, and Licensee’s interest in Joint Technology.

1.115

“Limited Recall” means a recall or retrieval of a Licensed Product on grounds of product quality or manufacturing defect or public health or safety that is limited as to lots or batches of a Licensed Product.

1.116

“Local Marks” has the meaning set forth in Section 7.9.1 (Brand Name in the Territory).

1.117

“Local Medical Affairs Plan” has the meaning set forth in Section 6.2 (Medical Affairs Activities).

1.118

“Losses” has the meaning set forth in Section 14.1 (Indemnification by Akebia).

1.119

“MAA” means (a) a marketing authorization application filed with (i) the EMA under the centralized EMA filing procedure to gain approval to market a pharmaceutical or diagnostic product in the E.U., or (ii) a Regulatory Authority in any E.U. country if the centralized EMA filing procedure is not used to gain approval to market a pharmaceutical or diagnostic product in the E.U., or (b) any other equivalent or related Regulatory Submissions filed in support of approval to market a pharmaceutical or diagnostic product in any country outside the E.U., and, in each case ((a) and (b)), including any amendments thereto, and supplemental applications, but excluding Reimbursement Approval applications.

1.120

“MACE” means any major adverse cardiovascular event, specifically, [***].

1.121

“Major Countries” means [***].

1.122

“Manufacturing Plan” means the manufacturing plan for Akebia’s supply to Licensee of each Licensed Product in the Territory (a) [***], if applicable, (b) [***], if applicable, and (c) [***] or, solely where required by Applicable Law in a country in the Territory, [***], as such plan may be updated pursuant to this Agreement.

1.123

“Mark” means any trademark, trade name, service mark, service name, product name, brand, domain name, trade dress, logo, slogan, or other indicia of origin or ownership, and (a) all registrations, applications for registrations, and other intellectual property rights associated with any of the foregoing, and (b) the goodwill associated with each of the foregoing.

1.124

“Maximum Supply Price” has the meaning set forth in Section 9.3.4 (Maximum Supply Price Reduction).

1.125

“Medical Affairs” means activities conducted by Akebia’s or Licensee’s medical affairs departments, including communications with key opinion leaders, medical education, symposia, advisory boards (to the extent related to medical affairs or clinical guidance), activities performed in connection with patient registries, and other medical programs and communications, including educational grants, research grants (including conducting investigator-initiated studies), and charitable donations to the extent related to medical affairs and not to other activities that do not involve the promotion, marketing, sale, or other Commercialization of the Licensed Products and are not conducted by Akebia’s or Licensee’s medical affairs departments.

1.126

“National Reimbursement Authorities” means [***], and any other Governmental Authority in a Major Country with the authority to control, approve, recommend, or otherwise determine pricing and reimbursement of pharmaceutical products in such country.

1.127

“NDD-CKD Indication” means the treatment of anemia in pediatric and adult non-dialysis patients with chronic kidney disease.

1.128

“Net Sales” means the gross amounts invoiced by Licensee, its Affiliates, or sublicensees (each, a “Seller”) to Third Parties in the Territory for consideration, reduced by the following amounts to the extent such items are customary under industry practices:

1.128.1

trade, cash, and quantity discounts actually allowed and taken directly with respect to such sales or transfers;

1.128.2

inventory management fees paid to wholesalers and distributors and reasonably allocated to such Licensed Product;

1.128.3

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), to the extent such amounts are included in the gross invoiced sales price;

1.128.4

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;

1.128.5

invoiced freight, shipping, and insurance expenses specific to such Licensed Product and allocated accordingly, to the extent such amounts are included in the gross invoiced sales price;

1.128.6

invoiced amounts that are actually written off as uncollectible in accordance with Seller’s accounting policies, as consistently applied;

1.128.7

allowances or credits actually paid or given to customers on account of price reductions affecting such Licensed Product;

1.128.8

rebates (including mandatory rebates), clawbacks, discounts (including confidential payer discounts), or charge-backs actually paid or credited to any Government Authority, or to any Third Party payor, administrator, or contractee, and including those requested by any Government Authority any time after the actual sale; and

1.128.9

discounts actually paid under state-legislated or Seller-sponsored discount prescription drug programs or reductions or coupon and voucher programs.

1.129

“New Formulation” means any formulation of a Licensed Product other than the Current Formulation.

1.130

“New Indication” means any indication for a Licensed Product other than the Initial Indications.

1.131

“Non-Breaching Party” has the meaning set forth in Section 15.2 (Termination for Breach).

1.132

“OFAC” means the Office of Foreign Assets Control of the United States Department of the Treasury or any successor agency thereto.

1.133

“Ongoing E.U. Opposition Hearings” has the meaning set forth in Section 10.10.2(a) (Initiation).

1.134

“Operational Team” has the meaning set forth in Section 3.5.3 (Operational Teams).

1.135

“Other Component” means other devices or components (besides the Licensed Compound and the Licensed Products).

1.136

“Other Covered Party” means any political party or party official, or any candidate for political office.

1.137

“Other Global Development” means Development activities for the Licensed Products that are conducted pursuant to an Other Global Development Plan, as the same may be amended in accordance with this Agreement. [***] are not included in Other Global Development.

1.138

“Other Global Development Plan” means a plan setting forth the Development activities that are (a) not included in the Current Global Development Plan, (b) not [***], and (c) to be undertaken by or on behalf of Akebia and its Affiliates, licensees (including Licensee, if applicable), and sublicensees in Developing the Licensed Compound and the Licensed Products and obtaining or maintaining Regulatory Approval from [***] for New Indications or New Formulations, as set forth in Section 4.3 (Additional Development), together with the budget and timelines for such activities including the proposed clinical trials and regulatory plans, as well as outlining the key elements involved in obtaining and maintaining Regulatory Approval of the Licensed Products from [***] (other than as contemplated in the Current Global Development Plan or [***] or any [***] Plan).

1.139

“Packaging” or “Package” has the meaning set forth in Section 8.1 (Supply and Purchase Obligations).

1.140

“Packaging and Labeling” means primary, secondary, or tertiary packaging and labeling of a Licensed Product (in its commercial packaging presentation) for sale or use in the Territory, including the Approved Labeling and insertion of materials such as patient inserts, patient medication guides, and professional inserts and any other written, printed, or graphic materials accompanying a Licensed Product and any brand security or anti-counterfeiting measures included in the packaging elements for a Licensed Product considered to be part of the finished packaged Licensed Product, and all testing and release thereof.

1.141

“Party Vote” has the meaning set forth in Section 3.7 (Decision-Making and Committee Dispute Resolution).

1.142

“Patents” means (a) all patents and patent applications in any country or jurisdiction, (b) all patent applications filed either from such patents or patent applications or from an application claiming priority from any of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals, and continued prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications, and (d) any and all substitutions, renewals, registrations, confirmations,  extensions, or restorations, including revalidations, reissues, and re-examinations (including any supplementary protection certificates and the like) of the foregoing patents or patent applications.

1.143

“Pharmacovigilance Agreement” means an agreement regarding receipt, investigation, and reporting of product complaints, adverse events, product recalls, and any other information related to the safety of a Licensed Product in the Territory.

1.144

“Pharmacovigilance Committee” or “PVC” has the meaning set forth in Section 3.5.2 (Pharmacovigilance Committee).

1.145

“Prepayment” has the meaning set forth in Section 4.1.4(a) (Initial Cost Share Notice).

1.146

“Privacy Laws” means all Applicable Laws with respect to the collection, use, transfer, storage, deletion, processing (both by computer and manually), combination, or other use of subject or other personal data.

1.147

“Product Hyporesponder” means subjects [***].

1.148

“Product Marks” means any Mark (whether registered or unregistered) selected in accordance with Section 7.9.1 (Brand Name in the Territory) for use on, with, or to refer to a Licensed Product (other than Akebia Housemarks and Licensee Housemarks) or used with patient support or other information or services or Product Materials associated with a Licensed Product in the Territory during the Term (including all Global Marks and Local Marks), and (a) all registrations, applications for registrations, and other intellectual property rights associated with any of the foregoing, and (b) the goodwill associated with each of the foregoing.

1.149

“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.

1.150

“Product Withdrawal” means removal of a Licensed Product from the market in any country in the Territory on the grounds of public health or safety that results in discontinuation of all or substantially all distribution of such Licensed Product in such country in the Territory.  Product Withdrawal does not include a Limited Recall.

1.151

“Professional Requirements” means (a) the codes and standards of the European Accreditation Council for Continuing Medical Education (EACCME) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), (b) the codes of the Prescription Medicines Code of Practice Authority (PMCPA) and the Association of the British Pharmaceutical Industry (ABPI), and (c) all other accepted national and international pharmaceutical industry codes of practice in and for the relevant countries in the Territory, as any of the foregoing may be amended from time-to-time.

1.152

“Progression of CKD” means the time to [***].

1.153

“Progression of CKD Endpoint” means a [***] in the Progression of CKD in subjects dosed with a Licensed Product as compared to subjects receiving the comparator drug in the Global Phase 3 NDD-CKD Program.

1.154

“Proposing Party” has the meaning set forth in Section 4.3 (Additional Development).

1.155

“Quality Agreement” has the meaning set forth in Section 8.4 (Quality Agreement).

1.156

“Quarterly Report” has the meaning set forth in Section 9.3.5(b) (Quarterly Report).

1.157

“Recall Decision-Makers” has the meaning set forth in Section 11.5.3 (Voluntary Withdrawal or Recall in the Territory).

1.158

“Recipient” has the meaning set forth in Section 13.2 (Exceptions).

1.159

“Regulatory Approval” means, with respect to a particular country or other regulatory jurisdiction, any MAA approval or other approval, product or establishment license, registration, or authorization of any Regulatory Authority necessary for the commercial sale of a Licensed Product in such country or other regulatory jurisdiction, excluding, in each case, Reimbursement Approval.

1.160

“Regulatory Authority” means, in a particular country or jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or jurisdiction, including (a) in the U.S., the FDA and any other applicable Governmental Authority in the U.S. having jurisdiction over the Licensed Products, (b) in the E.U., the EMA and any other applicable Governmental Authority in the countries in the E.U. having jurisdiction over the Licensed Products, and (c) in other countries, other analogous Governmental Authorities having jurisdiction over the Licensed Products.

1.161

“Regulatory Executives” has the meaning set forth in Section 5.7 (Decision-Making and Escalation For Certain Regulatory Matters).

1.162

“Regulatory Responsible Party” means (a) with respect to the E.U., (i) [***] (or its Affiliates), [***] of Regulatory Approval from the EMA for the Licensed Product for each of the DD-CKD Indication and the NDD-CKD Indication, and (ii) [***] (or its Affiliates [***]), [***] Regulatory Approval from the EMA for the Licensed Product for each of the DD-CKD Indication and the NDD-CKD Indication, and (b) [***] (or its Affiliates [***]), with respect to all other countries within the Territory, in each case ((a) and (b)), subject to Akebia’s ongoing Development obligations in the Territory related to the Licensed Products.

1.163

“Regulatory Submissions” means all applications, filings, dossiers, and other documents submitted to a Regulatory Authority in support of Development of the Licensed Compound and the Licensed Products inside and outside of the Territory, including for the purpose of obtaining Regulatory Approval from that Regulatory Authority. Regulatory Submissions include all INDs, MAAs, and other Regulatory Approval applications and their equivalents inside and outside of the Territory.

1.164

“Reimbursement Approval” means an approval, agreement, determination, or other decision by the applicable Governmental Authority that establishes prices charged to end-users for biopharmaceutical products that a Licensed Product will be reimbursed by the Governmental Authorities or Regulatory Authorities in the Territory.

1.165

“Restricted Party” means any individual or entity on one or more of the Restricted Party Lists.

1.166

“Restricted Party List” means the list of sanctioned entities maintained by the United Nations; the Specially Designated Nationals and Blocked Persons List, the Foreign Sanctions Evaders List and the Sectoral Sanctions Identifications List, all administered by OFAC; the U.S. Denied Persons List, the U.S. Entity List, and the U.S. Unverified List, all administered by the U.S. Department of Commerce; and the entities subject to restrictive measures and the consolidated list of Persons, Groups, and Entities Subject to E.U. Financial Sanctions, as implemented by the E.U. Common Foreign & Security Policy.

1.167

“Retained Licensee Improvement” means any Licensee Improvement other than an Assigned Product Improvement.

1.168

“Retained Licensee Improvement Patent” means any Patent Controlled by Licensee or any of its Affiliates during the Term that Covers a Retained Licensee Improvement.

1.169

“Retained Licensee Improvement Technology” means Retained Licensee Improvements and Retained Licensee Improvement Patents.

1.170

“Royalty Amount” has the meaning set forth in Section 9.3.4(a) (Maximum Supply Price Reduction).

1.171

“Royalty Amount Exceeding [***]” has the meaning set forth in Section 9.3.4(c) (Maximum Supply Price Reduction).

1.172

“Royalty Term” means, on a country-by-country basis, the period commencing on the date of First Commercial Sale of a Licensed Product in a country in the Territory and continuing until the latest to occur of (a) the date of expiration of the last-to-expire Valid Claim of any Akebia Patent or Joint Patent that Covers a Licensed Product in the form and for the indication approved by the Regulatory Authority in such country in the Territory, (b) the date of expiration of data or regulatory exclusivity in such country in the Territory, or (c) the date that is 10 years from First Commercial Sale of such Licensed Product in such country in the Territory.

1.173

“Safety Data” has the meaning set forth in Section 11.3 (Pharmacovigilance Agreement).

1.174

“Sale Transaction” has the meaning set forth in Section 17.2 (Standstill).

1.175

“[***]” has the meaning set forth in Section 5.3.1 ([***]).

1.176

“Seller” has the meaning set forth in Section 1.128 (Net Sales).

1.177

“Shared Development Costs” has the meaning set forth in Section 4.1.3 (Development Cost Sharing).

1.178

“SmPC” means the Summary of Product Characteristics that sets forth a description of the manner in which a Licensed Product is to be used for a specific treatment and that is approved in connection with the receipt of Regulatory Approval from the EMA.

1.179

“Statistically Significant” means a p-value [***].

1.180

“Study Data” means all research data and reports, material regulatory materials and correspondence (including INDs and MAAs in the U.S.), clinical and non-clinical data, and chemistry, manufacturing, and controls data.

1.181

“Sub-Committee” has the meaning set forth in Section 3.5.1 (Sub-Committees).

1.182

“Sub-Territory A” means [***].

1.183

“Sub-Territory B” means [***]. The countries included in Sub-Territory B as of the Effective Date are set forth on Schedule 1.183.

1.184

“Sub-Territory C” means all countries in the Territory other than those countries in Sub-Territory A or Sub-Territory B.

1.185

“Supply Agreements” means the Clinical Supply Agreement and the Commercial Supply Agreement.

1.186

“Supply Price” has the meaning set forth in Section 8.3 (Supply Agreements).

1.187

“Supply Price Letter Agreement” has the meaning set forth in Section 9.3.4 (Maximum Supply Price Reduction).

1.188

“Tablet Formulation” means a Licensed Product containing the Licensed Compound as its sole API in the solid, oral tablet form in the dosage strength used in the Current Global Development Program as of the Effective Date or in any other dosage strength of the solid, oral tablet form manufactured by or on behalf of Akebia at any time during the Term.  For clarity, the Tablet Formulation excludes [***].

1.189

“Term” has the meaning set forth in Section 15.1 (Term).

1.190

“Territory” means all of the countries of the world and their territories and possessions, except the U.S., Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Guyana, Paraguay, Peru, Uruguay, Suriname, Venezuela, Costa Rica, Guatemala, Nicaragua, Honduras, El Salvador, Panama, Belize, Mexico, Antigua and Barbuda, Bahamas, Barbados, Cuba, Dominica, Dominican Republic, Grenada, Haiti, Jamaica, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Trinidad and Tobago, [***], and their respective territories and possessions.

1.191

“Territory-Specific Development” means Development activities for the Licensed Compound and the Licensed Products in the [***] solely for the Territory and for obtaining or maintaining Regulatory Approval for the Licensed Product solely from the EMA or any other Regulatory Authority in the Territory that are conducted pursuant to a Territory-Specific Development Plan, as the same may be amended in accordance with this Agreement.

1.192

“Territory-Specific Development Plan” means a plan setting forth the Development activities that are (a) not included in the Current Global Development Plan or in any Other Global Development Plan, (b) not [***], and (c) to be undertaken by or on behalf of Licensee and its Affiliates and permitted sublicensees in Developing the Licensed Compound and the Licensed Products in the [***] solely for the Territory and for obtaining or maintaining Regulatory Approval for the Licensed Products solely from the EMA or any other Regulatory Authority in the Territory, together with timelines for such activities, including the high-level study design of proposed clinical trials, as well as outlining the key elements involved in obtaining and maintaining Regulatory Approval for the Licensed Products from the applicable Regulatory Authorities in the Territory.

1.193

“Third Party” means any person or entity other than a Party or its Affiliates.

1.194

“U.S.” means the United States of America (including all possessions and territories thereof, including Puerto Rico).

1.195

“U.S. Collaboration and License Agreement” has the meaning set forth in the Recitals.

1.196

“U.S. Dollars” or “$” means the legal tender of the U.S.

1.197

“U.S. Finished Form” means the Finished Form of a Licensed Product that is made commercially available in the U.S.

1.198

“Valid Claim” means a claim in any issued and unexpired Akebia Patent or Joint Patent in the Territory, which claim has not lapsed, been cancelled or revoked, become abandoned, or 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 disclaimed or admitted to be invalid or unenforceable through reissue, reexamination, disclaimer, or otherwise, or has not been made unenforceable due to failure to pay maintenance fees.

1.199

“Withholding Party” has the meaning set forth in Section 9.7 (Taxes).

1.200

“Year A” has the meaning set forth in Section 9.3.4 (Maximum Supply Price Reduction).

1.201

“Year B” has the meaning set for in Section 9.3.4 (Maximum Supply Price Reduction).

1.202

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.

2.1

Grant of Licenses to Licensee.  Subject to the terms and conditions of this Agreement (including Section 2.7 (No Other Rights and Retained Rights)), Akebia hereby grants to Licensee and its Affiliates:

2.1.1

an exclusive, royalty-bearing license, with the right to grant sublicenses only as provided in Section 2.2 (Rights of Licensee to Grant Sublicenses), under the Akebia Technology to Develop (solely in accordance with Article IV (Development)) and Commercialize (including to import, export, distribute, offer for sale, and sell), but not [***], the Licensed Compound and the Licensed Products in the Field in the Territory during the Term;

2.1.2

a non-exclusive license, with the right to grant sublicenses only as provided in Section 2.2 (Rights of Licensee to Grant Sublicenses), under the Akebia Technology to [***] the Licensed Products inside and outside of the Territory during the Term, subject to and solely in accordance with Section 8.1 (Supply and Purchase Obligations) and solely for use in exercising the licenses in Section 2.1.1 and Section 2.1.3; and

2.1.3

a non-exclusive license under the Akebia Technology to [***] in the Field outside of the Territory during the Term, solely to the extent that the conduct of such activities is allocated to Licensee under the Current Global Development Plan or any [***] Plan or Other Global Development Plan.

2.2

Rights of Licensee to Grant Sublicenses. Subject to the terms and conditions of this Agreement, upon Akebia’s written consent, [***], Licensee will have the right to enter into one or more sublicenses under this Agreement with Third Parties to Develop (solely in accordance with Article IV (Development)), Commercialize, and [***] the Licensed Products in the Field in the Territory during the Term; provided, however, that Licensee’s right to sublicense to Third Parties, including through multiple tiers, is conditioned on every sublicense agreement with a Third Party entered into after the Effective Date including a sublicenseable license back to Licensee of all Patents made or generated by the sublicensee that are necessary or reasonably useful to manufacture, use, sell, offer for sale, or import the Licensed Compound and the Licensed Products (such that Licensee Controls such Patents for the purposes of this Agreement). Licensee will provide prior written notification to Akebia identifying Licensee’s intention to grant such sublicense, the purpose of such sublicense, and the identity of the Third Party to whom Licensee intends to grant such sublicense. Each sublicensee will hold its rights contingent on the rights licensed to Licensee under the terms of this Agreement and each sublicense will be consistent with the terms and conditions of this Agreement. Any loss by Licensee of its rights under this Agreement due to an early termination of this Agreement pursuant to Article XV (Term and Termination) will cause the permitted sublicensees to [***].

2.3

Grant of Licenses to Akebia.  Subject to the terms and conditions of this Agreement, including Section 15.7.6 (Termination by Licensee for Breach), Licensee hereby grants to Akebia a royalty-free, fully paid-up, perpetual, irrevocable license (with the right to grant sublicenses through multiple tiers, subject to Section 2.4 (Rights of Akebia to Grant Sublicenses)) under (a) Licensee’s interest in Joint Technology, (b) the Retained Licensee Improvement Technology, and (c) any Licensee Contributed Technology solely to:

2.3.1

Develop, manufacture, have manufactured, and Commercialize (including to import, export, distribute, offer for sale, and sell) the Licensed Compound and the Licensed Products outside of the Territory;

2.3.2

Develop, manufacture, and have manufactured the Licensed Compound and the Licensed Products in the Territory for the purpose of obtaining Regulatory Approval and Commercializing the Licensed Products outside of the Territory; and

2.3.3

Develop, manufacture, and have manufactured the Licensed Compound and the Licensed Products in the Territory to perform its obligations under this Agreement.

2.4

Rights of Akebia to Grant Sublicenses. Akebia will have the right to grant sublicenses under the licenses granted in Section 2.3 (Grant of Licenses to Akebia) through multiple tiers without Licensee’s consent; provided that Akebia will, promptly after granting any such sublicense, provide written notification to Licensee identifying Akebia’s grant of such sublicense, the purpose of such sublicense, and the Third Party to whom Akebia has granted such sublicense. All sublicensees will hold their rights contingent on Akebia’s rights under this Agreement. Any termination of the licenses granted to Akebia in Section 2.3 (Grant of Licenses to Akebia) as a result of a termination of this Agreement pursuant to Section 15.7.6 (Termination by Licensee for Breach) will [***].

2.5

Responsibility for Sublicensees.  Each Party agrees that it will be fully responsible and liable for any breach of the terms of this Agreement by any of its sublicensees to the same extent as if such Party itself has committed any such breach.

2.6

Subcontracting. Each Party may subcontract with a Third Party to perform services in connection with the performance of its obligations and exercise of its rights under this Agreement; provided that (a) no such permitted subcontractor will be Debarred/Excluded, (b) no such permitted subcontracting will relieve the subcontracting Party of its obligations under this Agreement or any liability hereunder, and (c) the agreement pursuant to which Licensee engages any Third Party subcontractor must (i) be consistent in all material respects with this Agreement, (ii) contain obligations of confidentiality and non-use no less stringent than the confidentiality terms of this Agreement, and (iii) contain terms that are consistent with the intellectual property provisions set forth in this Agreement.

2.7

No Other Rights and Retained Rights.  Nothing in this Agreement will be interpreted to grant a Party any rights under any intellectual property rights owned or Controlled by the other Party, including Akebia Technology or Licensee Technology, in each case, that are not expressly granted herein, whether by implication, estoppel, or otherwise, and Licensee will not practice the Akebia Technology and Akebia will not practice the Licensee Technology, in each case, other than as expressly licensed and permitted under this Agreement.  Any rights not expressly granted to Licensee by Akebia under this Agreement are hereby retained by Akebia and any rights not

expressly granted to Akebia by Licensee under this Agreement are hereby retained by Licensee.  For clarity, Akebia retains (on behalf of itself and its licensees) the right to Develop, manufacture, and have manufactured the Licensed Compound and the Licensed Products inside the Territory (a) to perform its obligations under this Agreement, and (b) for the purpose of obtaining and maintaining Regulatory Approval and Commercializing the Licensed Compound and the Licensed Products outside of the Territory.

3.1

Joint Steering Committee.

3.1.1

Formation and Purpose of the JSC. The Joint Steering Committee (“JSC”) will coordinate and oversee or monitor the Parties’ activities hereunder in accordance with this Section 3.1 (Joint Steering Committee). As of the Effective Date, the JSC will be the joint steering committee established under the U.S. Collaboration and License Agreement. At any time during the Term the Parties may, and upon the conclusion of the term of the U.S. Collaboration and License Agreement the Parties will, establish a JSC that is separate from the joint steering committee established under the U.S. Collaboration and License Agreement. The JSC will have the responsibilities set forth herein, and, for so long as the JSC is the joint steering committee under the U.S. Collaboration and License Agreement, will also have the responsibilities set forth in the U.S. Collaboration and License Agreement. If the Parties establish a JSC that is separate from the joint steering committee established under the U.S. Collaboration and License Agreement, then the terms of Section 3.1.2 (Membership) will apply to the membership of the JSC and the terms of Section 3.1.3 (Meetings) and Section 3.1.4 (Meeting Agendas) will apply to meetings and minutes of the JSC.  The JSC may establish a charter that will include details regarding the operation of the JSC consistent with this Article III (Governance). The JSC will dissolve upon the expiration of the Term.  Notwithstanding anything to the contrary set forth in this Article III (Governance), during the term of the U.S. Collaboration and License Agreement, at the request of Licensee, the joint steering committee and sub-committees (including the joint development committee and joint commercialization committee) established under the U.S. Collaboration and License Agreement  may oversee, monitor, review, discuss, and to the extent provided herein, approve Licensee’s activities under this Agreement that are conducted in [***].

3.1.2

Membership. Each Party will designate up to three representatives with appropriate knowledge and expertise to serve as members of the JSC. The members of the JSC may also be members of the joint steering committee under the U.S. Collaboration and License Agreement. Each Party may replace its JSC representatives at any time upon written notice to the other Party.  Akebia will designate one of its JSC members as one of the co-chairpersons of the JSC and Licensee will designate one of its members as the other co-chairperson of the JSC. [***] The lead co-chairperson or his or her designee, in collaboration with the Alliance Managers, will be responsible for calling meetings, preparing, and circulating an agenda in advance of each meeting, and preparing and issuing minutes of each meeting within 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.

3.1.3

Meetings.  The JSC will hold meetings at such times as it elects to do so, but in no event will such meetings be held less frequently than quarterly, unless otherwise agreed by the

Parties.  The JSC will meet alternatively at Licensee’s Affiliate’s facilities in the United States or Europe and Akebia’s facilities in Cambridge, Massachusetts, or at such locations as the Parties may otherwise agree.  Meetings of the JSC may be held by audio or video teleconference with the consent of each Party; provided, however, that at least one JSC meeting per year will be held in person. If the members of the JSC and the joint steering committee under the U.S. Collaboration and License Agreement are the same or overlap, then the Parties may hold joint meetings of the JSC and the joint steering committee under the U.S. Collaboration and License Agreement. The Alliance Manager of each Party will attend each meeting of the JSC as [***].  Each Party will be responsible for all of its own expenses of participating in any JSC meeting.

3.1.4

Meeting Agendas.  Each Party will disclose to the other Party the proposed agenda items along with appropriate information at least five 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.

3.1.5

Specific Responsibilities of the JSC.  The responsibilities of the JSC will be to:

(a)

manage the overall strategic alignment between the Parties under this Agreement and maintain the relationship between the Parties;

(b)

[***] any allocation to Licensee of Development activities in the Territory under the Current Global Development Plan, as described in Section 4.1 (Current Global Development);

(c)

[***] the Current Global Development Plan and [***] any material amendments or updates thereto (including any amendments to the budgets set forth therein greater than [***]), in each case, which will be prepared by Akebia, as described in Section 4.1.1 (Current Global Development Plan);

(d)

[***] any determination by the JDC (or attempt to resolve any dispute or disagreement at the JDC) as to whether to conduct any [***] pursuant to Section 3.2.3(c);

(e)

[***] each initial [***] Plan and any material amendments or updates thereto (including any amendments to the budgets set forth therein greater than [***]), as described in Section 4.1.2(a) (Agreement of the JDC) and Section 4.1.2(c) ([***] Plan Amendments);

(f)

[***] the initial [***] Development Plan, as described in Section 4.2.1(a) (Initial [***] Development Plan);

(g)

subject to Section 3.1.5(i) with respect to the non-clinical studies, [***], and, [***], any amendment or update to the Territory-Specific Development Plan (or portion thereof) related to such indication or such formulation, as described in Section 4.2.1(b)(i) (Prior to the Receipt of Regulatory Approval);

(h)

[***] a study design or protocol of any clinical study for a Licensed Product in such Initial Indication in the Current Formulation or New Indication or New Formulation that is [***];

(i)

[***] each non-clinical study to be conducted under any [***] Development Plan for such Licensed Product in such indication or such formulation, and the study design or protocol therefor, as described in Section 4.2.1(b)(ii)(2);

(j)

[***] a study design or protocol of any non-clinical study for a Licensed Product in such Initial Indication in the Current Formulation or New Indication or New Formulation [***];

(k)

[***] any Additional Development of the Licensed Compound or a Licensed Product, including any Other Global Development for any New Indication or New Formulation in the Territory proposed by either Party pursuant to Section 4.3 (Additional Development);

(l)

[***] each Other Global Development Plan and any material amendments or updates thereto (including any amendments to the budgets set forth therein greater than [***]), in each case, which will be prepared by the Proposing Party, as described in Section 4.3.1(d) (Conduct of Additional Development);

(m)

[***] whether to hold any [***], as described in Section 5.3.1 ([***]);

(n)

[***] the Launch Sequence and amendments and updates thereto, in each case, to be prepared by Licensee, subject to and as described in Section 7.2.1 (Launch Sequence);

(o)

[***] Licensee’s decision not to launch or Commercialize a Licensed Product in a Major Country, and the portion of the initial Commercialization Plan or any amendment or update thereto that contemplates not launching or Commercializing a Licensed Product in such country, as described in Section 7.2.2 (Commercialization Plan);

(p)

[***] any matters related to the Commercialization Plan (or any amendment or update thereto) referred to the JSC by either Party’s representatives to the JCC;

(q)

[***] any Territory-specific brand strategy for a Licensed Product, which will be developed by the JCC, subject to and as described in Section 7.2.3 (Consistency with Global Brand Plan);

(r)

[***] the Global Brand Plan and any material amendments or updates thereto, which, in each case, will be prepared by [***], as described in Section 7.8 (Global Brand Plan and Promotional Materials);

(s)

[***] the Manufacturing Plan and any material amendments or updates thereto (including any amendments to the budgets set forth therein greater than [***]), as described in Section 8.2 (Manufacturing Plan; Product Supply);

(t)

attempt to resolve any other disputes or disagreements, including those arising from any Sub-Committee;

(u)

[***] possibility of the Parties [***]; and

(v)

perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties.

3.2

Joint Development Committee.

3.2.1

Formation and Purpose of the JDC. The Joint Development Committee (“JDC”) will be a Sub-Committee of the JSC. As of the Effective Date, the JDC will be the joint development committee established under the U.S. Collaboration and License Agreement. At any time during the Term the Parties may, and upon the conclusion of the term of the U.S. Collaboration and License Agreement the Parties will, establish a JDC that is separate from the joint development committee established under the U.S. Collaboration and License Agreement. The JDC will have the responsibilities set forth herein, and, for so long as the JDC is the joint development committee under the U.S. Collaboration and License Agreement, will also have the responsibilities set forth in the U.S. Collaboration and License Agreement; provided that the JSC established under this Agreement (and not the U.S. Collaboration and License Agreement, if the joint steering committees are not the same committee) will approve or attempt to resolve any dispute related to Territory-Specific Development matters (as applicable). If the Parties establish a JDC that is separate from the joint development committee established under the U.S. Collaboration and License Agreement, then the terms of Section 3.2.2 (Membership and Meetings of the JDC) will apply to the membership and meetings of the JDC. The JDC will dissolve upon completion of all Development activities and Medical Affairs with respect to the Licensed Products in the Territory.

3.2.2

Membership and Meetings of the JDC. Each Party will designate up to three representatives with appropriate knowledge and expertise to serve as members of the JDC. The members of the JDC may also be members of the joint development committee under the U.S. Collaboration and License Agreement. Akebia will designate a co-chairperson of the JDC and Licensee will designate a co-chairperson of the JDC, each of whom will be a Party’s representative who is a member of the JDC. Each Party may replace its JDC representatives and co-chairpersons at any time upon written notice to the other Party. The Alliance Manager of each Party (or his or her designee) will attend each meeting of the JDC as a [***]. The JDC will hold meetings at such times as it elects to do so (but in any event at least quarterly, unless the Parties agree otherwise), and at such locations as the Parties may agree upon or, if agreed by the Parties, by audio or video teleconference.  If the members of the JDC and the joint development committee under the U.S. Collaboration and License Agreement are the same or overlap, then the Parties may hold joint meetings of the JDC and the joint development committee under the U.S. Collaboration and License Agreement.  Each Party will be responsible for all of its own expenses of participating in any JDC meeting.

3.2.3

Specific Responsibilities of the JDC.  The responsibilities of the JDC will be to:

(a)

[***] the roles of the Parties with respect to the activities under the Current Global Development Program and the ways in which Licensee can provide assistance to Akebia with respect to the Current Global Development Program;

(b)

[***] any amendments or updates to the Current Global Development Plan (provided that material amendments or updates will be subject to JSC approval in

accordance with Section 3.1.5(c) (Specific Responsibilities of the JSC)), as described in Section 4.1.1 (Current Global Development Plan);

(c)

[***] any [***], and, if applicable, discuss the Development strategy for each such [***], and the roles and responsibilities of each Party in conducting each such [***] (including which Party will be the sponsor for such study), and the associated budget, in each case, as described in Section 4.1.2 ([***] Plan);

(d)

[***] each [***] Plan and any amendments and updates thereto (provided that each initial [***] Plan and any material amendments or updates will be subject to JSC [***] in accordance with Section 3.1.5(e) (Specific Responsibilities of the JSC)), as described in Section 4.1.2(a) (Agreement of the JDC) and Section 4.1.2(c) ([***] Plan Amendments);

(e)

[***] updates from Akebia of Development, manufacturing, and regulatory activities related to the Licensed Compound and the Licensed Products outside of the Territory, as described in Section 4.1.5 (Global and EMA Development Reports);

(f)

[***], the Current Global Development Plan, the [***] Development Plan, any [***] Plan, and any Other Global Development Plan, including through each Party’s updates of the status of Development in the Territory, as described in Section 4.1.5 (Global and [***] Reports), Section 4.2.2 ([***] Development Reports), and Section 4.3.2 (Additional Development Reports; Information);

(g)

subject to Section 3.2.3(h) with respect to non-clinical studies included in any [***] Development Plan, [***] the initial [***] Development Plan and amendments and updates thereto; provided that:

(i)

[***], the initial [***] Development Plan and material amendments or updates thereto (or portion thereof) related to such indication or such formulation will be subject to JSC [***] in accordance with Section 3.1.5(g) (Specific Responsibilities of the JSC), as described in Section 4.2.1(a) (Initial [***] Development Plan) and Section 4.2.1(b)(i) (Prior to the Receipt of Regulatory Approval); and

(ii)

[***], the study design or protocol of any clinical study for a Licensed Product in such Initial Indication in the Current Formulation or New Indication or New Formulation [***] for such indication or such formulation will, in each case, be subject to JSC [***] in accordance with Section 3.1.5(h) (Specific Responsibilities of the JSC), as described in Section 4.2.1(b)(ii)(1);

(h)

[***] whether to conduct any non-clinical study of a Licensed Product in an Initial Indication in the Current Formulation or in any New Indication or New Formulation, and the study design or protocol therefor included in any Territory-Specific Development Plan; provided that:

(i)

[***], in each case, all non-clinical studies to be conducted under any Territory-Specific Development Plan for such indication or such formulation will be subject to JSC [***] in accordance with Section

3.1.5(i) (Specific Responsibilities of the JSC), as described in Section 4.2.1(b)(ii)(2); and

(ii)

[***], the study design or protocol of any non-clinical study for a Licensed Product in such Initial Indication in the Current Formulation or New Indication or New Formulation [***] for such indication or such formulation will, in each case, be subject to JSC [***] in accordance with Section 3.1.5(j) (Specific Responsibilities of the JSC), as described in Section 4.2.1(b)(ii)(3);

(i)

[***] for [***] in the Territory and other [***];

(j)

[***] Development activities of the Parties related to any Additional Development in the Territory proposed by either Party pursuant to Section 4.3 (Additional Development);

(k)

[***] (at a joint meeting with the JSC) whether to hold any [***], as described in Section 5.3.1 ([***]);

(l)

[***] the Global Medical Affairs Plan and the Local Medical Affairs Plan, and any amendments or updates thereto, as described in Section 6.1 (Medical Affairs Plans);

(m)

[***] updates from the Parties of Medical Affairs and progress under the Global Medical Affairs Plan (with respect to Akebia) and the Local Medical Affairs Plan (with respect to Licensee), as described in Section 6.2 (Medical Affairs Activities);

(n)

[***] the Joint Publication Plan, as described in Section 13.4.2 (After Release of Data by Akebia); and

(o)

perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties.

3.3

Joint Manufacturing Committee.

3.3.1

Formation and Purpose of the JMC. At an appropriate time (but no later than [***] after the Effective Date, or earlier if Akebia is to manufacture and supply to Licensee any Licensed Product for Development purposes), the JSC will establish a Joint Manufacturing Committee (“JMC”), which JMC will be a Sub-Committee of the JSC and will have the responsibilities provided for herein; provided that, if the Parties establish a joint manufacturing committee as a sub-committee of the joint steering committee under the U.S. Collaboration and License Agreement, then, unless the Parties agree otherwise, the JMC under this Agreement will be the same as the joint manufacturing committee established under the U.S. Collaboration and License Agreement. Notwithstanding the foregoing, at any time during the Term the Parties may, and upon the conclusion of the term of the U.S. Collaboration and License Agreement the Parties will, establish a JMC that is separate from the joint manufacturing committee established under the U.S. Collaboration and License Agreement. The JMC will have the responsibilities set forth herein, and, for so long as the JMC is the joint manufacturing committee under the U.S. Collaboration and License Agreement, will also have the

responsibilities delegated to the joint manufacturing committee under the U.S. Collaboration and License Agreement. The JMC will dissolve upon the termination or expiration of the Supply Agreements.

3.3.2

Membership and Meetings of the JMC. Each Party will designate up to three representatives with appropriate knowledge and expertise to serve as members of the JMC. Akebia will designate a co-chairperson of the JMC and Licensee will designate a co-chairperson of the JMC, each of whom will be a Party’s representative who is a member of the JMC. Each Party may replace its JMC representatives and co-chairpersons at any time upon written notice to the other Party. The Alliance Manager of each Party (or his or her designee) will attend each meeting of the JMC as a [***].  The JMC will hold meetings at such times as it elects to do so (but in any event at least two times each year, unless the Parties agree otherwise), and at such locations as the Parties may agree upon or, if agreed by the Parties, by audio or video teleconference. Each Party will be responsible for all of its own expenses of participating in any JMC meeting.

3.3.3

Specific Responsibilities of the JMC.  The responsibilities of the JMC will be to:

(a)

[***] the Manufacturing Plan, and any amendments or updates thereto (provided that the initial Manufacturing Plan and material amendments or updates thereto will be subject to JSC [***] in accordance with Section 3.1.5(s) (Specific Responsibilities of the JSC)), as described in Section 8.2 (Manufacturing Plan; Product Supply);

(b)

[***] the [***] of each contract manufacturing organization that Akebia desires to engage to manufacture and supply the Licensed Products in API form or Tablet Formulation, as described in Section 8.2 (Manufacturing Plan; Product Supply); and

(c)

[***] activities under the Manufacturing Plan related to the manufacture and supply of the Licensed Products for Development and Commercialization purposes, as described in Section 8.7 (Manufacturing Reports).

3.4

Joint Commercialization Committee.

3.4.1

Formation and Purpose of the JCC. At an appropriate time (but at least [***] prior to the anticipated First Commercial Sale of the first Licensed Product in the Territory, unless otherwise agreed by the Parties), the JSC will establish a Joint Commercialization Committee (“JCC”), which JCC will be a Sub-Committee of the JSC and will have the responsibilities provided for herein. The JCC will dissolve upon the completion of all Commercialization activities with respect to the Licensed Products.

3.4.2

Membership and Meetings of the JCC. Each Party will designate up to three representatives with appropriate knowledge and expertise to serve as members of the JCC. Akebia will designate a co-chairperson of the JCC and Licensee will designate a co-chairperson of the JCC, each of whom will be a Party’s representative who is a member of the JCC.  Each Party may replace its JCC representatives and co-chairpersons at any time upon written notice to the other Party. The Alliance Manager of each Party (or his or her designee) will attend each meeting of the JCC as a [***].  The JCC will hold meetings at such times as it elects to do so (but in any event at least two times each year, unless the Parties agree otherwise), and at such locations as the Parties may agree upon

or, if agreed by the Parties, by audio or video teleconference. Each Party will be responsible for all of its own expenses of participating in any JCC meeting.

3.4.3

Specific Responsibilities of the JCC.  The responsibilities of the JCC will be to:

(a)

[***] the Launch Sequence and any amendments or updates thereto prepared by Licensee in accordance with Section 7.2.1 (Launch Sequence);

(b)

[***] the Commercialization Plan and any amendments or updates thereto (provided that any amendment or update that contemplates not launching or Commercializing a Licensed Product in a Major Country will be subject to JSC [***] in accordance with Section 3.1.5(o) (Specific Responsibilities of the JSC)), as described in Section 7.2.2 (Commercialization Plan);

(c)

upon request of a Party, [***] a Territory-specific brand strategy for a Licensed Product, as described in Section 7.2.3 (Consistency with Global Brand Plan);

(d)

[***] Commercialization activities and progress under the Commercialization Plan through Licensee’s updates as described in Section 7.3 (Commercialization Reports);

(e)

[***] the Global Brand Plan and any material amendments or updates thereto, which, in each case, will be prepared by [***], as described in Section 7.8 (Global Brand Plan and Promotional Materials); and

(f)

perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties.

3.5

Additional Committees.

3.5.1

Sub-Committees.  The JSC will establish and delegate specifically-defined duties to the JDC, the JMC, the JCC, the PVC, and other operational committees or ad hoc sub-committees, on an “as needed” basis to oversee particular projects or activities (the JDC, the JMC, the JCC, the PVC, and such other operational committees and sub-committees, each a “Sub-Committee”). Each Sub-Committee may establish a charter that will include details regarding its operation and that is consistent with this Article III (Governance). In addition, the JSC or the co-chairpersons of the JSC may delegate to the JDC, the JMC, or the JCC any responsibilities of the JSC set forth in Section 3.1.5 (Specific Responsibilities of the JSC), and in such case, any agreement reached by unanimous Party Vote of the JDC, the JMC, or the JCC with respect to such delegated responsibilities will be deemed [***] by the JSC (to the extent such [***] is required hereunder).  The JSC or the co-chairpersons of the JSC acting together may also reallocate any responsibility of a Sub-Committee to any other Sub-Committee.  Each such Sub-Committee, other than the JDC, the JMC, the JCC, and the PVC, will be constituted and will operate as the JSC determines. Akebia will designate a co-chairperson of each Sub-Committee and Licensee will designate a co-chairperson of each Sub-Committee, each of whom will be a Party’s representative who is a member of such Sub-Committee. [***]  The lead co-chairperson or his or her designee, in collaboration with the Alliance Managers, will be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting, and preparing and issuing minutes of each meeting within 30 days thereafter.  Such minutes will not be finalized until all Sub-

Committee members have had an adequate opportunity to review and confirm the accuracy of such minutes in writing. Each Party may replace its representatives and co-chairpersons on each such Sub-Committee at any time upon written notice to the other Party.  The Alliance Manager of each Party (or his or her designee) will attend each meeting of each Sub-Committee as a [***]. Each Sub-Committee will hold meetings at such times as it elects to do so (but in any event at least two times each year, unless the Parties agree otherwise), and at such locations as the Parties may agree upon or, if agreed by the Parties, by audio or video teleconference. Each Party will be responsible for all of its own expenses of participating in any Sub-Committee meeting. Each Sub-Committee and its activities will be subject to the oversight of, and will report to, the JSC.  No Sub-Committee’s authority may exceed that specified for the JSC in this Article III (Governance).  Any disagreement between the representatives of the Parties on a Sub-Committee will be referred to the JSC for resolution in accordance with Section 3.7 (Decision-Making and Committee Dispute Resolution).

3.5.2

Pharmacovigilance Committee. Without limiting the generality of, and subject to, Section 3.5.1 (Sub-Committees), the pharmacovigilance committee (the “Pharmacovigilance Committee” or “PVC”) will be a Sub-Committee of the JSC. As of the Effective Date, the PVC will be the pharmacovigilance committee established under the U.S. Collaboration and License Agreement. At any time during the Term the Parties may, and immediately upon the conclusion of the term of the U.S. Collaboration and License Agreement the Parties will, establish a PVC that is separate from the pharmacovigilance committee established under the U.S. Collaboration and License Agreement. If the Parties establish a PVC that is separate from the pharmacovigilance committee established under the U.S. Collaboration and License Agreement, then the Parties will establish such PVC at an appropriate time, but in any event prior to the earlier of (a) [***], or (b) [***]. In addition to any other matters that the JSC may delegate to the PVC, the PVC will provide a forum for the Parties to discuss and share information regarding the safety of the Licensed Products and other pharmacovigilance matters worldwide, including safety and pharmacovigilance matters arising under this Agreement in accordance with the Pharmacovigilance Agreement.

3.5.3

Operational Teams. From time-to-time, the JSC or any Sub-Committee (whether the JSC or any Sub-Committee is the same as the joint steering committee or applicable sub-committee under the U.S. Collaboration and License Agreement) may establish and delegate specific matters or duties within its responsibilities to directed teams (each, an “Operational Team”), the composition, operation, and responsibilities of which will be determined by the JSC or the applicable establishing Sub-Committee (the “Establishing Committee”). Operational Teams may be established on an ad hoc basis for purposes of a specific activity or on such other basis as the applicable Establishing Committee may determine.  Each Operational Team will report to, and its activities will be subject to the oversight of, the applicable Establishing Committee.  No Operational Team’s authority may exceed that specified for the applicable Establishing Committee.  Any disagreement between the representatives of the Parties on any Operational Teams will be referred to the applicable Establishing Committee for resolution in accordance with Section 3.7 (Decision-Making and Committee Dispute Resolution).

3.6

Additional Participants. Regardless of whether the JSC or any Sub-Committee is the same as the joint steering committee or applicable sub-committee under the U.S. Collaboration and License Agreement, (a) at the request of either Party, other employees of such Party or any of its Affiliates involved in the Development, manufacturing, Medical Affairs, or Commercialization of

the Licensed Compound or the Licensed Products may attend meetings of the JSC or any Sub-Committee as [***], and (b) with the consent of each Party, consultants, representatives, or advisors involved in the same activities may attend meetings of the JSC or any Sub-Committee as [***]; provided, however, that such Third Party [***] are under written 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 XIII (Confidentiality).

3.7

Decision-Making and Committee Dispute Resolution.  Each Party’s representatives on the JSC and each Sub-Committee will, [***] (the “Party Vote”) on all matters brought before such committee for a decision by consensus.  The JSC and each Sub-Committee will make decisions as to matters within its jurisdiction by unanimous Party Vote, which may either be reflected in the minutes of the committee meeting or by an action by written consent signed by the co-chairperson appointed by each Party or his or her designee identified in writing; provided, however, that neither the JSC nor any Sub-Committee will have the authority to amend, modify, or waive compliance with this Agreement. Any disagreement between the representatives of Licensee and Akebia with respect to matters within the scope of authority of the Alliance Managers, or any Sub-Committees that cannot be resolved after good faith efforts will, at the election of either Party, be submitted to the JSC for resolution. If, after good faith efforts, the JSC is unable to resolve any such disagreement referred to it by any Sub-Committee or any disagreement with respect to the matters within the scope of the JSC’s authority or any other disagreement between the Parties that may be referred to the JSC within a period of [***], then, except as set forth in Section 7.2.1 (Launch Sequence), and Section 7.2.3 (Consistency with Global Brand Plan), at the election of either Party, a Party may refer such matter to the Party’s respective Executive Officer. The Executive Officers will use good faith efforts to resolve any such disagreement so referred to them as soon as practicable, and any final decision that the Executive Officers agree to in writing will be conclusive and binding on the Parties.  If the Executive Officers are unable to resolve any disagreement so referred within [***] after such matter is referred to them (or such longer period as the Executive Officers may agree upon), then the Parties will continue to operate under existing plans until the Parties reach agreement on the applicable matter; provided, however, that (a) if the disagreement is [***], then the Executive Officer of Akebia will have the final say on such dispute, (b) if the disagreement is [***], then the Executive Officer of Licensee will have the final say on such dispute, and (c) if the disagreement is an Expert Reserved Matter, then such matter will be resolved by binding baseball arbitration pursuant to Section 16.4 (Baseball Arbitration for Expert Reserved Matters).  Notwithstanding the foregoing, neither the JSC, nor the [***] will have the authority to (i) amend or modify, or waive compliance with this Agreement, (ii) obligate either Party to violate Applicable Law or the requirements of any Regulatory Authority, or (iii) impose any obligation on either Party that would be in violation of such Party’s written standard operating procedures, written business policies, or written compliance policies or procedures.  For the avoidance of doubt, matters that are specified in Section 3.1.5 (Specific Responsibilities of the JSC), Section 3.2.3 (Specific Responsibilities of the JDC), Section 3.3.3 (Specific Responsibilities of the JMC), or Section 3.4.3 (Specific Responsibilities of the JCC) to be [***] (as opposed to [***]) do not require any agreement or decision by either Party and are not subject to the voting and decision-making procedures set forth in this Section 3.7 (Decision-Making and Committee Dispute Resolution).

3.8

Interactions Between Committees and Internal Teams. The Parties recognize that while they will establish the JSC, the JDC, the JMC, the JCC, the PVC, and other Sub-Committees under this Agreement, each Party possesses an internal structure (including with 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 any Sub-Committees will establish procedures to facilitate communications between the JSC, the JDC, the JMC, the JCC, the PVC, or such

other 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 any other Sub-Committee to be available at reasonable times and places and upon reasonable prior notice to make appropriate reports to or respond to reasonable inquiries from, the relevant internal committee, team, or board.

3.9

Alliance Managers.  Each of the Parties will appoint a single individual to manage Development and Commercialization obligations between the Parties (each, an “Alliance Manager”), which individual may also be the alliance manager under the U.S. Collaboration and License Agreement.  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 will attend all JSC meetings and the Alliance Managers or their respective designees will attend all Sub-Committee meetings and will support the co-chairpersons of the JSC and each Sub-Committee in the discharge of his or her responsibilities.  Alliance Managers will be [***] in all JSC and Sub-Committee meetings; provided, however, that an Alliance Manager may bring any matter to the attention of the JSC or any Sub-Committee if such Alliance Manager reasonably believes that such matter warrants such attention.  Each Party will designate its initial Alliance Manager promptly after the Effective Date and 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: (a) be the point of first referral in all matters of conflict resolution; (b) provide a single point of communication for seeking consensus between the Parties regarding key strategy and plan issues; (c) identify and bring disputes to the attention of the JSC in a timely manner; (d) plan and coordinate cooperative efforts and internal and external communications; and (e) take responsibility for ensuring that governance activities, such as the conduct of required JSC and Sub-Committee meetings and production of meeting minutes, occur as set forth in this Agreement, and that the relevant action items resulting from such meetings are appropriately carried out or otherwise addressed.

4.1

Current Global Development. Subject to Licensee’s performance of its obligations and fulfillment of its responsibilities, in each case, with respect to regulatory affairs in accordance with Article V (Regulatory Affairs), Akebia will use Commercially Reasonable Efforts to perform the Current Global Development Program, and Licensee will provide assistance reasonably requested by Akebia in connection with the activities under the Current Global Development Plan. If Licensee agrees to perform any activities under the Current Global Development Plan and the JSC [***] the allocation of such activities to Licensee pursuant to Section 3.1.5(b) (Specific Responsibilities of the JSC), then Licensee will use Commercially Reasonable Efforts to perform such activities, and Akebia will provide all assistance reasonably requested by Licensee in connection therewith.

4.1.1

Current Global Development Plan. Prior to the Effective Date, Akebia has provided to Licensee the Current Global Development Plan (including the corresponding budget disclosed by Akebia to Licensee at the meeting of the joint steering committee under the U.S. Collaboration and License Agreement on February 23, 2017). Akebia may prepare amendments or updates to the Current Global Development Plan, including any (a) new protocols proposed by Akebia for any additional clinical or non-clinical study that is not an [***] and is to be included in the Current Global Development Program, and (b) material revisions proposed by Akebia to the protocol of any clinical or non-clinical

study included in the Current Global Development Program as of the Effective Date. Akebia will provide each such amendment or update to the Current Global Development Plan (or corresponding budget) to the JDC for its [***] as set forth in Section 3.2.3(b) (Specific Responsibilities of the JDC), provided that material amendments or updates will be provided to the JSC for its [***] as set forth in Section 3.1.5(c) (Specific Responsibilities of the JSC).  Each such material amendment or update to the Current Global Development Plan (and corresponding budget) will become effective and will supersede the previous Current Global Development Plan (and corresponding budget) upon [***] of the JSC.

4.1.2

[***]. The Parties anticipate that the studies included in the Current Global Development Program as of the Effective Date will be the pivotal studies that are necessary to obtain Regulatory Approval from [***] for the Licensed Product in an Initial Indication in the Current Formulation in [***]

(a)

Agreement of the JDC. If, following completion of the [***], and [***] at the JDC of the advice received from [***] at such meetings, Licensee desires to conduct any [***], then Licensee may propose such [***] to the JDC, and the JDC will [***] such [***] as set forth in Section 3.2.3(c) (Specific Responsibilities of the JDC). If the JDC [***] conduct an [***], then the JDC will [***] the Development strategy for such [***], the roles and responsibilities of each Party in conducting such [***], and the associated budget pursuant to Section 3.2.3(c) (Specific Responsibilities of the JDC). Unless the Parties agree otherwise, Licensee will prepare a development plan for such [***] (each, an “[***] Plan”), which plan will include the protocols for such [***], and the Development strategy, roles and responsibilities of each Party (including which Party will be the sponsor of such study), and associated budget, in each case, for such [***] as discussed by the JDC. Licensee will submit such [***] Plan to the JDC for its [***] as provided in Section 3.2.3(d) (Specific Responsibilities of the JDC), and to the JSC for its [***] as provided in Section 3.1.5(e) (Specific Responsibilities of the JSC).  Thereafter, Licensee may conduct (or if the Parties agree that Akebia will be the sponsor, Akebia will conduct) such [***] pursuant to the [***] Plan, as the same may be amended from time-to-time in accordance with this Agreement.

(b)

Failure of the JDC to Agree. If, after escalation to the JSC and the Executive Officers, the Parties are unable to agree (A) as to [***], or (B) on any [***] (including the roles and responsibilities of each Party in conducting such [***]), then, in either case ((A) or (B)), Licensee may conduct (and will be the sponsor of) such [***] pursuant to an [***] Plan prepared by Licensee and provided to Akebia; provided that, prior to Regulatory Approval from the FDA in the U.S. for a Licensed Product in an Initial Indication in the Current Formulation, Akebia may require Licensee to delay [***]

(c)

[***] Plan Amendments. Licensee may prepare amendments or updates to any [***] Plan, and will provide each such amendment or update to the JDC for its [***] as set forth in Section 3.2.3(d) (Specific Responsibilities of the JDC); provided that material amendments or updates will be provided to the JSC for its [***] as set forth in Section 3.1.5(e) (Specific Responsibilities of the JSC). Each such material amendment or update to an [***] Plan will become effective and will supersede the previous [***] Plan upon [***] of the JSC.

(d)

Performance.  Each Party agrees to use Commercially Reasonable Efforts to perform the activities allocated to such Party under each [***] Plan, and the other Party will provide all assistance reasonably requested by the performing Party in connection therewith.

4.1.3

Development Cost Sharing. Commencing on and after January 1, 2017, Akebia and Licensee will each be responsible for [***]% of all [***] Costs, and Licensee will be responsible for [***]% of all Current Global Development Costs and Akebia will be responsible for the remaining [***]% of all Current Global Development Costs, in each case, incurred on and after January 1, 2017 (the [***] Costs and Current Global Development Costs, collectively, the “Shared Development Costs”), in accordance with the following:

(a)

Licensee R&D Cost Share.  Licensee will be responsible for paying (i) [***]% of all [***] Costs, subject to Licensee’s right to credit Akebia’s [***]% share of such costs as described in Section 4.1.3(b) (Credit for [***] Costs), and (ii) [***]% of all Current Global Development Costs (collectively, the “Licensee R&D Cost Share”, as such definition may be amended pursuant to Section 15.7.7 (Termination for Sub-Territory A)), and Akebia will be responsible for paying [***]% of all Current Global Development Costs, in each case, in accordance with Section 4.1.4 (Payment of Licensee R&D Cost Share). If Licensee agrees to perform any activities under the Current Global Development Plan and the JSC [***] such allocation of activities pursuant to Section 3.1.5(b) (Specific Responsibilities of the JSC), then Licensee will perform such activities in accordance with the estimated budget for such activities, and the costs incurred by Licensee in connection with such activities will be credited against the Licensee R&D Cost Share.  

(b)

Credit for [***] Costs.  Licensee may credit an amount equal to [***]% of the actual [***] Costs incurred by or on behalf of either Party (the “Creditable [***] Costs”) against future payments due to Akebia under this Agreement as follows: (i) first, Licensee may credit $[***] of Creditable [***] Costs incurred against [***] due to Akebia under this Agreement (including the Licensee R&D Cost Share), and (ii) then Licensee may credit any further Creditable [***] Costs (if applicable) only against [***] due to Akebia pursuant to Section [***] and [***] due to Akebia pursuant to Section [***]. Notwithstanding the foregoing, Licensee may not credit any such Creditable [***] Costs against amounts due to Akebia in any calendar quarter to the extent that doing so would cause the amount due to Akebia in such [***] (whether as Licensee R&D Cost Share, milestone payments, or royalties) to be less than [***]% of the amount otherwise due to Akebia for such [***]; provided that Licensee may carry forward any such uncreditable amount of Creditable [***] Costs in any [***] into future [***] and apply such amount against applicable future payments due to Akebia in accordance with this Section 4.1.3(b) (Credit for [***] Costs) in such future [***] until all Creditable [***] Costs are fully credited.

(c)

Report of [***] Costs. On a [***] basis prior to end of each [***] during which Licensee conducts any [***], Licensee will provide Akebia with a written notice that includes (i) the estimated budget for any such [***] for the next [***] following the date of such notice, and (ii) a report of actual [***] Costs incurred by or on behalf of Licensee during the [***].

(d)

Separate Obligations. For clarity, the Licensee R&D Cost Share under this Agreement is in addition to and separate from Licensee’s research and development cost share obligations under the U.S. Collaboration and License Agreement.

4.1.4

Payment of Licensee R&D Cost Share.

(a)

Initial Cost Share Notice. No later than [***], Akebia will provide Licensee with a Cost Share Notice that includes (i) the estimated budget for the Current Global Development Program for the next [***] following the date of such Cost Share Notice, (ii) an invoice for the estimated amount of the applicable Licensee R&D Cost Share for the [***], and (iii) a report of actual Current Global Development Costs incurred by or on behalf of Akebia during the [***].

(b)

Cost Share Notices. Following Akebia’s delivery to Licensee of the initial Cost Share Notice in accordance with Section 4.1.4(a) (Initial Cost Share Notice), on a [***] basis prior to the end of each [***], Akebia will provide Licensee with a Cost Share Notice that includes (i) the estimated budget for the Current Global Development Program and any [***] to be conducted by or on behalf of Akebia for the next [***] following the date of such Cost Share Notice, (ii) an invoice for the estimated amount of the applicable Licensee R&D Cost Share for the [***] following such Cost Share Notice, and (iii) a report of actual [***].

(c)

Prepayment. Within [***] of receipt of each Cost Share Notice, Licensee will pay to Akebia the estimated amount of the Licensee R&D Cost Share for the applicable [***], as set forth in the invoice provided pursuant to Section 4.1.4(a)(ii) (Initial Cost Share Notice) or Section 4.1.4(b)(ii) (Cost Share Notices), as applicable, (the “Prepayment”). If the Prepayment paid by Licensee to Akebia for a [***] exceeds the Licensee R&D Cost Share of the actual Shared Development Costs incurred by Akebia for such [***] (based on the [***] reports provided pursuant to Section 4.1.4(b)(iii) (Cost Share Notices)), then such overpayment will be credited to the next Prepayment, or, if there are no subsequent Prepayments owed to Akebia, then Licensee may credit the amount of such overpayment to [***] due to Akebia under Section 9.2 (Milestone Payments). If the Prepayment paid by Licensee to Akebia is less than the applicable Licensee R&D Cost Share of the actual Shared Development Costs incurred by Akebia for such [***] (based on the [***] reports provided pursuant to Section 4.1.4(b)(iii) (Cost Share Notices)), then Licensee will pay to Akebia the amount of such underpayment within [***] of Akebia’s invoice therefor.

(d)

Current Global Development Costs for First Calendar Quarter of 2017. If the Licensee R&D Cost Share of the actual Current Global Development Costs incurred by Akebia during the [***] (based on the initial Cost Share Notice provided pursuant to Section 4.1.4(b)(iii) (Initial Cost Share Notice)) is greater than $[***], then Licensee will pay to Akebia an amount equal to the difference between the Licensee R&D Cost Share of such actual Current Global Development Costs incurred by Akebia during the first calendar quarter of 2017 and $[***] within [***] of Akebia’s invoice therefor. Likewise, if the Licensee R&D Cost Share of the actual Current Global Development Costs incurred by Akebia during the [***] (based on the initial Cost Share Notice provided pursuant to Section 4.1.4(b)(iii) (Initial Cost Share Notice)) is less than $[***],

then the amount equal to the difference between $[***] and the Licensee R&D Cost Share of such actual Current Global Development Costs incurred during the [***] will be credited to the next Prepayment pursuant to Section 4.1.4(c) (Prepayment).

4.1.5

Global and [***] Development Reports. At each JDC meeting, Akebia and Licensee (if applicable) will each provide the JDC with an update (by means of a slide presentation or otherwise) summarizing the Development activities executed under the Current Global Development Plan and any [***] Plan or Other Global Development Plan for the Territory during the prior [***], including [***] and the ongoing status of [***] under any such plan, the status of each pending and proposed [***] set forth in the Current Global Development Plan, or any [***] Plan or Other Global Development Plan for each Licensed Product for the Territory (to the extent not already provided, and without limiting the obligations under Article V (Regulatory Affairs)). In addition, each Party will promptly provide written notice to the other Party, through the JDC or Alliance Managers, of any significant Development events in the Territory (e.g., clinical trial initiation or completion, clinical holds, Regulatory Approvals, and Study Data) that the reporting Party reasonably believes is of interest to the other Party. In addition to the foregoing, on [***] basis, Akebia will provide the JDC with a written summary of any Development, manufacturing, and regulatory activities related to the Licensed Compound and the Licensed Products outside of the Territory that materially impact the Current Global Development Program. Notwithstanding the foregoing, the Parties acknowledge and agree that any information and updates provided pursuant to this Section 4.1.5 (Global and [***] Development Reports) will be subject to the rules and regulations set forth by the relevant Regulatory Authorities.

4.2

Territory-Specific Development.  Subject to Section 4.1 (Current Global Development) and this Section 4.2 (Territory-Specific Development), [***] will be responsible for all Territory-Specific Development at its [***], including all [***]. Except as may otherwise be permitted under this Agreement (including pursuant to Section 4.3 (Additional Development) and as provided in Section 3.1.5(b) (Specific Responsibilities of the JSC)), [***] will conduct Development of the Licensed Compound and the Licensed Products only (a) in accordance with the applicable Territory-Specific Development Plan that has been [***] by the JDC and the JSC, or, as applicable, any portion thereof that has been [***] by the JSC as set forth in Section 3.1.5(f) (Specific Responsibilities of the JSC), in each case, as required under Section 4.2.1 (Territory-Specific Development Plan), and (b) only for the [***], unless the Parties agree to conduct [***] pursuant to Section 4.3.1 (Approval of Additional Development). [***] will use Commercially Reasonable Efforts to Develop, and obtain and maintain Regulatory Approval and Reimbursement Approval (where required) for, the Licensed Products in the Initial Indications in the Territory. In no event will Akebia have the right or authority, [***] or otherwise, to require Licensee to conduct any [***] Development, but Akebia may [***] Licensee from conducting certain [***] Development pursuant to the exercise of its [***] in accordance with Section 1.11(d) (Akebia Reserved Disputes), in each case, at any time.

4.2.1

Territory-Specific Development Plan.

(a)

Initial Territory-Specific Development Plan. No later than [***] after the Effective Date, [***] will prepare and submit to the JDC for its [***] as set forth in Section 3.2.3(g) (Specific Responsibilities of the JDC), and subsequently to the JSC for its [***] as set forth in Section 3.1.5(f) (Specific Responsibilities of the JSC) the initial Territory-Specific Development Plan that summarizes the

Development activities that [***] or its Affiliates or permitted sublicensees will undertake for each country or region in the Territory for purposes of obtaining Regulatory Approval.

(b)

Amendments and Updates. From time-to-time as necessary (e.g., following receipt of guidance from a Regulatory Authority in the Territory), [***] will prepare amendments or updates to the then-current Territory-Specific Development Plan, including any amendment approved by the JSC pursuant to 3.1.5(g) (Specific Responsibilities of the JSC) that sets forth any Additional Development that is to be conducted as Territory-Specific Development, and provide each such amendment or update to the Territory-Specific Development Plan to the JDC for its [***] as set forth in Section 3.2.3(g) (Specific Responsibilities of the JDC), and subsequently to the JSC for its [***] as set forth in Section 3.1.5(g) (Specific Responsibilities of the JSC), Section 3.1.5(h) (Specific Responsibilities of the JSC), Section 3.1.5(i) (Specific Responsibilities of the JSC) or Section 3.1.5(j) (Specific Responsibilities of the JSC). Each amendment or update to the Territory-Specific Development Plan will become effective and will supersede such previous Territory-Specific Development Plan upon [***], thereof by the JSC.

(i)

Prior to [***]. Prior to [***], the JDC will [***] as set forth in Section 3.2.3(g) (Specific Responsibilities of the JDC), and the JSC will [***] as set forth in Section 3.1.5(g) (Specific Responsibilities of the JSC) any amendment or update to the Territory-Specific Development Plan (or portion thereof) related to such indication or such formulation for which the [***].

(ii)

After [***]. After [***], the JDC and JSC will each [***], but the JSC need not [***], any amendment or update to the Territory-Specific Development Plan (or portion thereof) related to such indication or such formulation for which the [***], unless such amendments or updates (or portions thereof) includes a study design or protocol set forth in the following clauses (1), (2), or (3), in which case such study design or protocol will be subject to [***] by the JSC as set forth in Section 3.1.5(h) (Specific Responsibilities of the JSC), with respect to clinical studies, or Section 3.1.5(i) (Specific Responsibilities of the JSC) or Section 3.1.5(j) (Specific Responsibilities of the JSC), in each case, with respect to non-clinical studies:

(1)

a study design or protocol of any clinical study [***] conducted under the Current Global Development Plan (or any Other Global Development Plan with respect to New Indications or New Formulations) for such indication or such formulation;

(2)

prior to [***] for such Licensed Product in such indication or such formulation; or

(3)

after [***] for such Licensed Product in such Initial Indication in the Current Formulation or New Indication or New Formulation that is [***] conducted under the Current Global Development Plan (or any Other Global Development Plan with respect to

New Indications or New Formulations) for such indication or such formulation.

4.2.2

Territory-Specific Development Reports.  At each meeting of the JDC, [***] will provide [***] with a written update (by means of a slide presentation or otherwise) summarizing the activities executed under the Territory-Specific Development Plan in each country in the Territory during the period since the last JDC meeting, including the status of each pending and proposed Regulatory Submission for the Licensed Products in such countries. In addition, [***] will provide prompt written notice to [***], through the JDC or Alliance Managers, of any significant Development events in the Territory (e.g., clinical trial initiation or completion, clinical holds, Regulatory Submissions for the Licensed Products, Regulatory Approvals, or Study Data that Licensee reasonably believes is of interest to [***]). Notwithstanding the foregoing, the Parties acknowledge and agree that any information and updates provided pursuant to this Section 4.2.2 (Territory-Specific Development Reports) will be subject to the rules and regulations set forth by the relevant Regulatory Authorities.

4.3

Additional Development. If either Party (the “Proposing Party”) desires to conduct Other Global Development or any other additional Development of the Licensed Compound or a Licensed Product in its territory that is not included in any [***] Plan or the then-current Current Global Development Plan or the then-current Territory-Specific Development Plan (including for any New Indication, New Formulation, or any Other Global Development, but excluding any [***], “Additional Development”), then the Proposing Party will present a proposal to the JSC for its [***] pursuant to Section 3.1.5(k) (Specific Responsibilities of the JSC), including a synopsis of the Development activities related to such Additional Development, the potential role of the non-Proposing Party with respect to such Additional Development, the timeline for such Additional Development, and the estimated costs associated with such Additional Development. Notwithstanding the foregoing, if a Regulatory Authority in a country or jurisdiction in the Territory requires a New Formulation for a Licensed Product in order for such Regulatory Authority to grant Regulatory Approval for such Licensed Product in an Initial Indication in such country or jurisdiction, then all Development related to such New Formulation will not be Additional Development and instead will be conducted as Territory-Specific Development pursuant to Section 4.2 (Territory-Specific Development).

4.3.1

[***] Additional Development.

(a)

JSC [***]; Agreement. If the JSC [***] any Additional Development as Other Global Development and both Parties agree to participate in such Additional Development, then the Parties will enter into a co-development agreement (or an amendment to this Agreement) regarding such Additional Development, including the allocation of costs and responsibilities related to such Additional Development and the reporting of information regarding such Additional Development, and each Party will receive a right of reference pursuant to Section 5.5 (Rights of Reference; Further Assurances) to the data generated from such Additional Development for the purposes of obtaining Regulatory Approval and Commercializing the Licensed Product in its territory. If the JSC [***] any Additional Development as new Territory-Specific Development and [***] agrees to conduct such Additional Development, then [***] will receive a right of reference pursuant to Section 5.5 (Rights of Reference; Further Assurances) to the data generated from such Additional Development for the purposes of

obtaining Regulatory Approval and Commercializing the Licensed Product outside of the Territory.

(b)

JSC [***]; Failure to Agree. If the JSC [***] Additional Development and the non-Proposing Party does not agree to participate in such Additional Development, then the Proposing Party may conduct such Additional Development in its own territory as [***] (in the case of [***]) or [***] (in the case of [***]); provided, however, that if [***] is the Proposing Party, then [***] may conduct such Additional Development inside the Territory for the purpose of [***]. Subject to Section 4.3.2 (Additional Development Reports; Information) and Section 4.3.4 (Rights to IP and Data), the non-Proposing Party will not receive a [***] to any data generated from such Additional Development that is conducted as Other Global Development and that the JSC [***], but in which the non-Proposing Party does not agree to participate.

(c)

No JSC [***].

(i)

Licensee Proposal. With respect to any Additional Development proposed by Licensee, if the JSC does not [***] such Additional Development and, after escalation of the dispute to the Executive Officers pursuant to Section 3.7 (Decision-Making and Committee Dispute Resolution), [***] ultimately determines not to [***] such Additional Development [***], then Licensee will not conduct any Development activities related to such Additional Development.

(ii)

Akebia Proposal. With respect to any Additional Development that is conducted as Other Global Development and that is proposed by Akebia, if the Licensee’s representatives on the JSC do not [***] such Additional Development and, after escalation of the dispute to the Executive Officers pursuant to Section 3.7 (Decision-Making and Committee Dispute Resolution), Akebia ultimately determines to [***] such Additional Development [***], then Akebia may [***] such Additional Development inside the Territory for the purpose of [***], in each case, at its cost and expense. Subject to Section 4.3.2 (Additional Development Reports; Information) and Section 4.3.4 (Rights to IP and Data), Licensee will not receive a [***] to any data generated from such Additional Development that is conducted as Other Global Development and that the JSC does not [***] (due to Licensee’s representatives’ disapproval), but that Akebia ultimately determines to conduct.

(d)

Conduct of Additional Development.  In all cases, and subject to a Party’s right to conduct any Additional Development as set forth under this Section 4.3.1 (Approval of Additional Development), the Proposing Party (with respect to Additional Development that is conducted as Other Global Development) and Licensee (with respect to Additional Development that is conducted by Licensee as Territory-Specific Development) will conduct any such Additional Development in accordance with the terms of this Agreement and pursuant to (i) an applicable Other Global Development Plan or amendment thereto that is prepared by the Proposing Party and [***] by the JSC pursuant to Section 3.1.5(l) (Specific Responsibilities of the JSC), or (ii) an applicable Territory-Specific Development Plan or amendment thereto prepared by [***] and

submitted to the JDC for its [***] as set forth in Section 3.2.3(g) (Specific Responsibilities of the JDC), and subsequently to the JSC for its [***] as set forth in Section 3.1.5(g) (Specific Responsibilities of the JSC). In addition, nothing in this Agreement will prevent the non-Proposing Party from [***] with the Proposing Party regarding any [***] generated from any Additional Development (to the extent such non-Proposing Party does not obtain rights thereto pursuant to Section 4.3.3 (Reimbursement for Additional Development)).

4.3.2

Additional Development Reports; Information.

(a)

By Licensee.

(i)

All Additional Development. If Licensee conducts any Additional Development and the Parties do not enter into a co-development agreement (or amendment to this Agreement) with respect to such Additional Development in accordance with Section 4.3.1(a) (JSC [***]; Agreement), then, at each JDC meeting, Licensee will provide the JDC with an update (by means of a slide presentation or otherwise) summarizing the Additional Development in each country performed by Licensee or its Affiliates during the prior [***] (with the level of information set forth in Section 4.2.2 (Territory-Specific Development Reports)). In addition, Licensee will promptly provide written notice, through the JDC, to Akebia of any significant Development events that arise in the course of conducting such Additional Development, and will provide to Akebia copies of all material documentation and information related to such Additional Development, including any research data and reports and Study Data and reports that are necessary or reasonably useful for Akebia to satisfy any reporting obligations with Regulatory Authorities inside or outside of the Territory or to obtain or maintain Regulatory Approval for the Licensed Products outside of the Territory; provided that unless such Additional Development is conducted pursuant to Section 4.3.1(a) (JSC Approval; Agreement), or Akebia [***] in accordance with Section 4.3.3 (Reimbursement for Additional Development) to any Additional Development conducted by Licensee pursuant to Section 4.3.1(b) (JSC Approval; Failure to Agree), Akebia will use such information, data, and reports solely for the foregoing purposes and Akebia will not use such information, data, or reports to [***].

(ii)

Jointly Agreed; Opt-In. In addition, if Licensee conducts Additional Development as Other Global Development pursuant to Section 4.3.1(a) (JSC [***]; Agreement) or if Akebia [***] in accordance with Section 4.3.3 (Reimbursement for Additional Development) to any Additional Development conducted by Licensee pursuant to Section 4.3.1(b) (JSC [***]; Failure to Agree), then Licensee will provide to Akebia any research data and reports and Study Data and reports that are necessary or reasonably useful for Akebia to [***], and to [***], in each case, in accordance with this Agreement, and notwithstanding the restriction in Section 4.3.2(a)(i) (All Additional Development), Akebia may use such information, data, and reports for the foregoing purposes.

(b)

By Akebia.  

(i)

All Additional Development. If Akebia conducts Additional Development that is conducted as Other Global Development and the Parties do not enter into a co-development agreement (or amendment to this Agreement) with respect to such Additional Development in accordance with to Section 4.3.1(a) (JSC [***]; Agreement), then at each JDC meeting, Akebia will provide the JDC with an update (by means of a slide presentation or otherwise) summarizing such Additional Development performed by Akebia or its Affiliates during the prior [***] (with the level of information set forth in Section 4.1.5 (Global and EMA Development Reports)). In addition, Akebia will promptly provide written notice, through the JDC, to Licensee of any significant Development events that arise in the course of conducting such Additional Development, and will provide to Licensee copies of all material documentation and information related to such Additional Development, including any research data and reports and Study Data and reports that are necessary or reasonably useful for Licensee to satisfy any reporting obligations with Regulatory Authorities in the Territory or to obtain or maintain Regulatory Approval for the Licensed Products in the Territory; provided that unless such Additional Development is conducted pursuant to Section 4.3.1(a) (JSC Approval; Agreement) or Licensee [***] in accordance with Section 4.3.3 (Reimbursement for Additional Development) to any Additional Development conducted by Akebia pursuant to Section 4.3.1(b) (JSC [***]; Failure to Agree) or Section 4.3.1(c)(ii) (No JSC [***]; Akebia Proposal), Licensee may use such information, data, and reports solely for the foregoing purposes and Licensee will not use such information, data, or reports to [***].  

(ii)

Jointly Agreed; [***]. In addition, if Akebia conducts Additional Development as Other Global Development pursuant to Section 4.3.1(a) (JSC [***]; Agreement) or if Licensee [***] in accordance with Section 4.3.3 (Reimbursement for Additional Development) to any Additional Development conducted by Akebia pursuant to Section 4.3.1(b) (JSC [***]; Failure to Agree) or Section 4.3.1(c)(ii) (No JSC [***]; Akebia Proposal), then Akebia will provide to Licensee any research data and reports and Study Data and reports that are necessary or reasonably useful for Licensee to [***] in accordance with this Agreement, and notwithstanding the restriction in Section 4.3.2(b)(i) (All Additional Development), Licensee may use such information, data, and reports to [***] in accordance with this Agreement.

4.3.3

Reimbursement for Additional Development.  If (a) the JSC [***] any Additional Development as Other Global Development and the Proposing Party elects to proceed with such Additional Development as permitted under Section 4.3.1(b) (JSC [***]; Failure to Agree) without the non-Proposing Party’s agreement to participate in such Additional Development at such time, or (b) Akebia elects to proceed with any Additional Development, notwithstanding the failure of Licensee’s representatives on the JSC to [***] such Additional Development, as permitted under Section 4.3.1(c)(ii) (No JSC [***]; Akebia Proposal), then, in each case ((a) and (b)), at any time, the non-Proposing Party may request, in its discretion and upon written notice to the Proposing

Party, to [***] with respect to such Additional Development and [***] to compensate the Proposing Party for conducting such Additional Development at risk and for the time value of money at such time. Such [***] will become effective upon the Parties’ agreement to such [***] amount.

4.3.4

Rights to IP and Data. Except as set forth under Section 4.3.2(a)(i) (By Licensee; All Additional Development) and Section 4.3.2(b)(i) (By Akebia; All Additional Development), the non-Proposing Party will not have any rights with respect to any information, data, or intellectual property rights generated from any Additional Development conducted pursuant to Section 4.3.1(b) (JSC [***]; Failure to Agree) or Section 4.3.1(c)(ii) (No JSC [***]; Akebia Proposal), including pursuant to the licenses granted in Article II (Licenses) or the [***] granted in Section 5.5 (Rights of Reference; Further Assurances), unless the non-Proposing Party [***] to such Additional Development in accordance with Section 4.3.3 (Reimbursement for Additional Development). If the non-Proposing Party [***] to any Additional Development conducted pursuant to Section 4.3.1(b) (JSC [***]; Failure to Agree) or Section 4.3.1(c)(ii) (No JSC [***]; Akebia Proposal), then following the non-Proposing Party’s payment of such [***], the Party conducting such Additional Development will provide any information, data, or intellectual property generated from such Additional Development to the other Party in accordance with Section 4.3.2(a)(ii) (Jointly Agreed; [***]) or Section 4.3.2(b)(ii) (Jointly Agreed; [***]), as applicable, and such information, data, and intellectual property will be included in the licenses granted to the non-Proposing Party under Article II (Licenses) and the [***].

4.4

Performance of [***]. [***] will (a) [***] related to the Licensed Compound and the Licensed Products that are not part of the Current Global Development Program that are necessary to obtain or maintain Regulatory Approval for any Licensed Product in the Territory, and (b) use Commercially Reasonable Efforts to perform any other [***] related to the Licensed Compound and the Licensed Products that are not part of the Current Global Development Program. [***] will reimburse [***] for all costs and expenses incurred by or on behalf of [***] in connection with such studies within [***] of receiving [***] invoice therefor.

4.5

Standards of Conduct. Akebia and Licensee will perform, and each will ensure that their Affiliates and licensees and permitted sublicensees (as applicable), and subcontractors perform, all Development activities under the Current Global Development Plan, Other Global Development Plan, Territory-Specific Development Plan, or any [***] Plan, as the case may be, in a good scientific manner, in accordance with GLP, GMP, and GCP, as applicable, and in compliance with Applicable Law.

4.6

Development Efforts.  Akebia and Licensee, each directly or through their Affiliates, licensees (with respect to Akebia), permitted sublicensees (with respect to Licensee), or subcontractors, will use Commercially Reasonable Efforts to Develop, or support the Development of, Licensed Products in the Territory.

4.7

Development Records.  Each Party and its Affiliates will 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, and that are complete and accurate in all material respects and reflect all Development work performed and results achieved, in each case, by or on behalf of such Party and its Affiliates, licensees, or permitted sublicensees (as applicable) under the Current Global Development Plan and any Other Global Development Plan, [***] Plan, or Territory-Specific Development Plan.

5.1

Regulatory Submissions.

5.1.1

Submissions in the E.U. Subject to Section 5.2.2 (Responsibility), until receipt of Regulatory Approval from the EMA for a Licensed Product in each Initial Indication in the Current Formulation, [***] will be responsible in collaboration with a representative from Licensee’s regulatory team for (a) preparing, filing, and submitting, directly or through its Affiliates, all Regulatory Submissions in the E.U. relating to the Current Global Development Program and any [***], and each material amendment or update thereto; provided that [***] for a Licensed Product in each Initial Indication for the E.U. (and each material amendment or update thereto) in the name of [***], and for each such MAA, [***], and (b) preparing briefing packages [***] relating to Regulatory Submissions in the E.U. for such Licensed Product in each Initial Indication (other than the briefing package for any [***]). Following receipt of Regulatory Approval from the EMA for the Licensed Product in each Initial Indication, Licensee will be responsible for preparing, filing, and submitting, directly or through its Affiliates and permitted sublicensees, all Regulatory Submissions in the E.U. relating to the Current Global Development Program.  

5.1.2

Submissions Outside of the E.U. From and after the Effective Date, [***] will be responsible for (a) preparing, filing, and submitting, directly or through its Affiliates and permitted sublicensees, all Regulatory Submissions in all countries and jurisdictions in the Territory outside of the E.U., and each material amendment or update thereto, [***]; provided that, upon [***] request, a representative from [***] regulatory team will provide reasonable assistance to [***] in connection with [***] preparation of each IND and MAA for a Licensed Product in countries and jurisdictions in the Territory outside of the E.U. (including each material amendment or update thereto), and (b) briefing packages for meetings with Regulatory Authorities relating to Regulatory Submissions in each such country and jurisdiction in the Territory for such Licensed Product in each Initial Indication.

5.2

Collaboration With Respect to Regulatory Interactions.

5.2.1

Correspondence. The Parties’ regulatory teams will collaborate with respect to substantive correspondence in support of Jointly-Agreed Regulatory Submissions and other Regulatory Submissions in the E.U. on which the Parties have collaborated pursuant to Section 5.1 (Regulatory Submissions). In addition, the Regulatory Responsible Party will provide the other Party with (a) copies (without translation) of any material written correspondence submitted to or received from (i) the EMA and (ii) Regulatory Authorities in the Major Countries and, (iii) upon [***] request, Regulatory Authorities in other countries in the Territory, and (b) summaries of any material oral communications with (i) the EMA and (ii) Regulatory Authorities in the Major Countries and, (iii) upon [***] request, Regulatory Authorities in other countries in the Territory, in each case ((a) and (b)), relating to Regulatory Submissions or Development of the Licensed Compound or any Licensed Product in such country, reasonably promptly after receipt or delivery by such Regulatory Responsible Party of such correspondence or communication, as the case may be (but in any event, with respect to correspondence or communications with the EMA, no later than [***] after receipt or delivery).

5.2.2

Responsibility. Notwithstanding Section 5.1 (Regulatory Submissions) or Section 5.2.1 (Correspondence), (a) the Regulatory Responsible Party will be responsible for, and will have final decision-making authority on the content of, all Regulatory Submissions, communications, and other dealings with the Regulatory Authorities in the applicable countries in the Territory relating to Development of the Licensed Products; provided that the Parties will agree, and [***], on the content of all Jointly-Agreed Regulatory Submissions, and (b) the Regulatory Responsible Party will not be required to delay any submission, correspondence, or communication with any Regulatory Authorities in the Territory in a manner that affects such Regulatory Responsible Party’s ability to comply with any Regulatory Authority requirement or deadline or Applicable Law in the Territory or that would delay receipt of Regulatory Approval. At a mutually convenient time after the Effective Date as agreed to by the Parties, the Parties’ regulatory teams will meet and agree on the strategy and procedures for authoring, publishing, reviewing, approving, and submitting Jointly-Agreed Regulatory Submissions.

5.3

Regulatory Meetings.

5.3.1

[***]. Prior to [***], either Party may request that the JDC and JSC hold a joint meeting to [***] whether or not to [***] (the “[***]”). Such requested joint meeting of the JDC and JSC will be held [***] after such Party’s request and each Party’s Regulatory Executive will be present at such meeting. If the Parties determine (or [***]) to hold a [***], then, subject to Section 5.7 (Decision-Making and Escalation For Certain Regulatory Matters), the Parties’ regulatory teams will collaborate [***].

5.3.2

Other Regulatory Meetings. The Regulatory Responsible Party will [***] with (a) [***] and (b) [***], in each case ((a) and (b)), to the extent [***]. Without limiting the foregoing, representatives of each Party will [***].

5.4

Additional Development. The Party that is the Regulatory Responsible Party will have those responsibilities allocated to such Party under this Article V (Regulatory Affairs) with respect to any Additional Development conducted by or on behalf of either Party.

5.5

Rights of Reference; Further Assurances.

5.5.1

Rights Granted to Licensee. Subject to Section 4.3.2 (Additional Development Reports; Information) and Section 4.3.4 (Rights to IP and Data), Akebia will provide access to a complete electronic copy of all relevant Regulatory Submissions Controlled by Akebia that are necessary or reasonably useful to Licensee in support of Licensee’s preparation and filing of any Regulatory Submissions with respect to any Licensed Product in the Territory in accordance with this Agreement. Subject to Section 4.3.2 (Additional Development Reports; Information) and Section 4.3.4 (Rights to IP and Data), Akebia will make available to Licensee copies of material documentation related to the Licensed Compound or the Licensed Products, including all Study Data from any [***] and any other Study Data if such other Study Data is necessary or reasonably useful to conduct clinical studies or obtain or maintain Regulatory Approvals for any Licensed Product in the Territory, in each case, in accordance with this Agreement. Subject to Section 4.3.2 (Additional Development Reports; Information) and Section 4.3.4 (Rights to IP and Data), Licensee and its Affiliates and permitted sublicensees will be entitled [***] to access, use, and reference the Regulatory Submissions and Study Data Controlled by Akebia for the Development and Commercialization of the Licensed Compound and the Licensed Products in the Territory. In furtherance of the foregoing, and subject to the

rules of the relevant Regulatory Authority and the terms and conditions of this Agreement, Akebia hereby grants to Licensee a right of reference to any Regulatory Approval Controlled by Akebia during the Term relating to the Licensed Compound or any Licensed Product (including the right to rely upon, access, inspect, copy, and otherwise use all information and data included in or used to support any such Regulatory Approval), solely for Licensee’s or its Affiliates’ or its permitted sublicensees’ use in the [***] of the Licensed Products in the Territory during the Term in accordance with this Agreement.  All Regulatory Submissions and Study Data will be considered Confidential Information of Akebia pursuant to Article XIII (Confidentiality).

5.5.2

Rights Granted to Akebia. Subject to Section 4.3.2 (Additional Development Reports; Information) and Section 4.3.4 (Rights to IP and Data), in support of Akebia’s Development and Commercialization of the Licensed Compound and the Licensed Products outside of the Territory, Licensee will provide access to a complete electronic copy of all relevant Regulatory Submissions that are necessary or reasonably useful to Akebia in preparing its own IND, MAA, or other Regulatory Submissions for a Licensed Product for use outside of the Territory. Subject to Section 4.3.2 (Additional Development Reports; Information) and Section 4.3.4 (Rights to IP and Data), Licensee will make available to Akebia copies of material documentation related to the Licensed Compound and each Licensed Product, including all Study Data from any [***] and any other Study Data if such Study Data is necessary or reasonably useful to conduct clinical studies or obtain or maintain Regulatory Approvals of the Licensed Compound or any Licensed Product outside of the Territory. Subject to Section 4.3.2 (Additional Development Reports; Information) and Section 4.3.4 (Rights to IP and Data), Akebia and its Affiliates, licensees, and sublicensees will be entitled [***] to access, use, and reference the Regulatory Submissions and Study Data Controlled by Licensee for the Development, manufacture, and Commercialization of the Licensed Compound and each Licensed Product outside of the Territory. In furtherance of the foregoing and subject to the rules of the relevant Regulatory Authority and the terms and conditions of this Agreement, Licensee hereby grants to Akebia a right of reference to any Regulatory Approval Controlled by Licensee relating to the Licensed Compound or any Licensed Product (including the right to rely upon, access, inspect, copy, and otherwise use all information and data included in or used to support any such Regulatory Approval), solely for Akebia’s or its Affiliates’, licensees’, or sublicensees’ use in the [***] of the Licensed Products outside the Territory.

5.5.3

Further Assurances. The Party granting rights to the other Party under Section 5.5.1 (Rights Granted to Licensee) and Section 5.5.2 (Rights Granted to Akebia) will take such actions as may be reasonably requested by the other Party to give effect to the intent of such Sections and to give the other Party the benefit of the granting Party’s Regulatory Approvals in the other Party’s territory as provided in this Section 5.5 (Rights of Reference; Further Assurances). Such actions may include providing [***], and that the Regulatory Authority may access, in support of the other Party’s application for Regulatory Approval in its territory or providing any underlying raw data or information submitted by such Party to the Regulatory Authority with respect to any Regulatory Submissions, Regulatory Approval, or other Regulatory Submissions Controlled by such Party or its Affiliates that relates to any Licensed Product.

5.6

Cooperation. The Parties will cooperate with each other to achieve the regulatory objectives contemplated herein in a timely, accurate, and responsive manner. The non-Regulatory Responsible Party will assist the Regulatory Responsible Party, as is reasonably necessary, in

order for such Regulatory Responsible Party to obtain and maintain each applicable MAA for each Licensed Product in the Territory, including in connection with the preparation, filing, and submission of all Regulatory Submissions by such Regulatory Responsible Party.

5.7

Decision-Making and Escalation For Certain Regulatory Matters. Any disagreement between the Parties’ regulatory teams with respect to (a) the contents of the [***] described in Section 5.3.1 ([***]), or (b) the contents of any [***], in each case ((a) and (b)), that cannot be resolved after good faith efforts will, at the election of either Party, be submitted for resolution to [***] (each, a “Regulatory Executive”).  If, after good faith efforts, the [***] are unable to resolve any such disagreement set forth in clauses (a) or (b) within a period of [***], then, at the election of either Party, a Party may refer such matter to the Parties’ respective Executive Officers for resolution in accordance with Section 16.1 (Executive Officers; Disputes). For clarity, neither Party will have [***] on the [***] or on the contents of [***] in the event that the Parties’ Executive Officers do not agree.

6.1

Medical Affairs Plans. Akebia will prepare a reasonably detailed, [***] plan for global Medical Affairs (the “Global Medical Affairs Plan”), and Licensee will prepare a reasonably detailed, [***] plan for Medical Affairs in the Territory (the “Local Medical Affairs Plan”), in each case, no later than [***] following the Effective Date. The strategic objectives in the Local Medical Affairs Plan will be consistent with the strategic objectives in the Global Medical Affairs Plan, unless otherwise agreed by the Parties. In order to ensure consistency between the Global Medical Affairs Plan and the Local Medical Affairs Plan and coordination and alignment between the Parties with respect to the Medical Affairs to be conducted by Akebia in the Territory pursuant to the Global Medical Affairs Plan and by Licensee in the Territory pursuant to the Local Medical Affairs Plan (including with respect to each Party’s communications with key opinion leaders in the Territory), the Global Medical Affairs Plan and the Local Medical Affairs Plan, and any amendments or updates thereto, will be [***] simultaneously by the JDC as provided in Section 3.2.3(l) (Specific Responsibilities of the JDC), with the first such [***] occurring no later than [***] following the Effective Date. Any subsequent [***], to the extent required, will occur [***] thereafter at an appropriate time as agreed by the JDC, or more frequently as may be required during the Term.

6.2

Medical Affairs Activities. Licensee will be responsible for Medical Affairs in the Territory, and will conduct such activities in accordance with the Local Medical Affairs Plan. In addition, each Party will conduct all Medical Affairs in the Territory in a professional and ethical business manner and in compliance with Applicable Law and applicable Professional Requirements. Each Party will provide the other Party with reasonable cooperation, support, and assistance with respect to preparing such Party’s Medical Affairs plan, and conducting activities under each such plan, in order to coordinate Medical Affairs inside and outside of the Territory. In addition, each Party will provide to the JDC an update (by means of a slide presentation or otherwise) summarizing its Medical Affairs and progress under the Global Medical Affairs Plan (with respect to Akebia) and the Local Medical Affairs Plan (with respect to Licensee) during the period since the last JDC meeting as provided in Section 3.2.3(m) (Specific Responsibilities of the JDC).

7.1

General.  Subject to the Launch Sequence and the Commercialization Plan as [***] by the JCC, or [***] by the JSC (if applicable), Licensee and its Affiliates and permitted sublicensees will be solely responsible for the Commercialization of the Licensed Products in the Territory. Licensee and its Affiliates and permitted sublicensees will be responsible for all costs associated with the Commercialization of the Licensed Products in the Territory, and will have sole responsibility and authority for [***] for the Licensed Products, detailing, marketing and promotion activities, booking sales, distributing the Licensed Product, processing, invoicing, and collecting inventory and receivables, and providing customer support.

7.2

Launch Sequence and Commercialization Plan.

7.2.1

Launch Sequence.  No later than [***] following the Effective Date, Licensee will prepare a list of those countries in the Territory in which Licensee intends to commence Commercialization of each Licensed Product within the first [***] after receipt of Regulatory Approval for such Licensed Product from the FDA and the EMA and timelines reflecting potential date ranges for First Commercial Sale following receipt of Regulatory Approval and Reimbursement Approval (if applicable) in such countries, (the “Launch Sequence” and the countries included in the Launch Sequence, the “Launch Countries”). Licensee will amend or update the Launch Sequence [***] thereafter, including updating such sequence with additional countries in the Territory in which Licensee plans to commence Commercialization of a Licensed Product. The Launch Sequence and all amendments and updates thereto will be [***] by the JCC pursuant to Section 3.4.3(a) (Specific Responsibilities of the JCC), and subsequently [***] by the JSC pursuant to Section 3.1.5(n) (Specific Responsibilities of the JSC); provided that if the JSC is unable to [***] the Launch Sequence or any amendment or update thereto, then such matter will not be referred for resolution by the Executive Officers, and instead Licensee’s representatives on the JSC will [***] the Launch Sequence (including the Launch Countries).

7.2.2

Commercialization Plan.  At least [***] prior to the anticipated First Commercial Sale of a Licensed Product in each Launch Country in the Territory, but not earlier than [***] after the Effective Date, Licensee will prepare and submit to the JCC for its [***] pursuant to Section 3.4.3(a) (Specific Responsibilities of the JCC), and, if applicable, to the JSC for its [***] pursuant to Section 3.1.5(o) (Specific Responsibilities of the JSC) an initial Commercialization Plan. Such initial Commercialization Plan will be a [***] for Commercialization in the [***]. At least [***] prior to the anticipated First Commercial Sale of a Licensed Product in each Launch Country, Licensee will prepare and submit to the JCC for its [***] pursuant to Section 3.4.3(a) (Specific Responsibilities of the JCC), and, if applicable, to the JSC for its [***] pursuant to Section 3.1.5(o) (Specific Responsibilities of the JSC) an update to the Commercialization Plan for the launch of each Licensed Product in the [***] that will include an update to the initial [***], the then-current Launch Sequence [***], and general descriptions with respect to [***] for each Licensed Product, [***] of each Licensed Product by Licensee’s [***], [***], and [***] for each Licensed Product.  On [***] basis thereafter, Licensee will prepare and submit to the JCC for its [***] pursuant to Section 3.4.3(a) (Specific Responsibilities of the JCC), and, if applicable, to the JSC for its [***] pursuant to Section 3.1.5(o) (Specific Responsibilities of the JSC) an update to the Commercialization Plan, which update will include the then-current [***]. If the initial Commercialization Plan or any amendment or

update thereto reflects a decision by Licensee not to launch or Commercialize a Licensed Product in a Major Country, then such decision (and the portion of the Commercialization Plan or amendment or update relating thereto) must be [***] by the JSC pursuant to Section 3.1.5(o) (Specific Responsibilities of the JSC). In addition, upon the request of either Party’s JCC representatives, such Party may refer any matter related to the Commercialization Plan (or any amendment or update thereto) to the JSC for [***] pursuant to Section 3.1.5(p) (Specific Responsibilities of the JSC).

7.2.3

Consistency with Global Brand Plan. Following Licensee’s receipt from Akebia of the Global Brand Plan (and any update thereto) pursuant to Section 7.8 (Global Brand Plan and Promotional Materials), Licensee will ensure that the Commercialization Plan is at all times consistent with the then-current version of such Global Brand Plan; provided, however, that if the JCC [***] a Territory-specific [***] for a Licensed Product, including any Licensed Product [***] for the Territory that is inconsistent with the Global Brand Plan pursuant to Section 3.4.3(c) (Specific Responsibilities of the JCC), and the JSC [***] such Territory-specific [***] pursuant to Section 3.1.5(q) (Specific Responsibilities of the JSC), then Licensee will implement such Territory-specific [***] in lieu of the applicable [***] under the Global Brand Plan; provided further that if the JSC [***] on the Territory-specific [***], then such matter will not be referred for resolution by the Executive Officers, and instead Licensee’s representatives on the JSC will [***] the Territory-specific [***].

7.3

Commercialization Reports. At each meeting of the JCC, Licensee will provide to the JCC an update (by means of a slide presentation or otherwise) summarizing its Commercialization activities performed in each Launch Country during the period since the last JCC meeting, and, following First Commercial Sale of a Licensed Product in a country in the Territory, sales performance reports for each such country, as set forth in Section 3.4.3(d) (Specific Responsibilities of the JCC).

7.4

Reimbursement and Information Sharing. Licensee will be responsible for, and will have sole authority and [***] with respect to, any [***] related to obtaining and maintaining Reimbursement Approval in the Territory (where required), and all [***] of Licensed Products in the Territory; provided that (a) upon Licensee’s reasonable request, Akebia will [***] and Licensee will reimburse Akebia’s out-of-pocket costs incurred in connection with [***], and (b) [***], upon Akebia’s reasonable request, Licensee will use reasonable efforts to [***] in such country, and if Akebia is [***] reasonably promptly after such meeting. Upon either Party’s reasonable request, but subject to local anti-competition laws and any obligations of confidentiality between a Party and any Third Party, the Parties will share [***] (or their equivalent), as well as other [***] as may be agreed by the Parties.

7.5

Commercialization Efforts. Licensee, directly or through its Affiliates or permitted sublicensees, will use Commercially Reasonable Efforts to Commercialize the Licensed Product in the Territory and to achieve First Commercial Sale as promptly as practicable after receipt of Regulatory Approval and Reimbursement Approval (if applicable) in each country in the Territory, and, after achieving First Commercial Sale in such country, Commercialize such Licensed Product in such country in the Territory in accordance with the Commercialization Plan.  The Parties acknowledge that it may be consistent with the expenditure of Commercially Reasonable Efforts [***].

7.6

Standards of Conduct; Compliance.  Licensee will perform, or will ensure that each of its Affiliates, permitted sublicensees (as applicable), and subcontractors perform, all

Commercialization activities in a professional and ethical business manner and in compliance with Applicable Law, applicable Professional Requirements, the Approved Labeling, and the Commercialization Plan.

7.7

Commercializing Affiliates. If, after the Effective Date, any Licensee Affiliate commences Commercial Operations in a country that is not included on Schedule 1.183, then Licensee will promptly provide written notice thereof to Akebia and will update Schedule 1.183 to include such country.

7.8

Global Brand Plan and Promotional Materials. No later than [***] prior to the anticipated First Commercial Sale in the Territory, Akebia will submit to the JCC and to the JSC, for [***] pursuant to Section 3.4.3(e) (Specific Responsibilities of the JCC) and Section 3.1.5(r) (Specific Responsibilities of the JSC), a global brand plan, which plan will include the [***] for the Licensed Products (the “Global Brand Plan”). Akebia may amend or update the Global Brand Plan from time-to-time and will submit material amendments and updates to the JCC and to the JSC, for [***] pursuant to Section 3.4.3(e) (Specific Responsibilities of the JCC) and Section 3.1.5(r) (Specific Responsibilities of the JSC). All promotional materials for the Licensed Products used by Licensee or its Affiliates in the Territory must be consistent with the Global Brand Plan (or, if applicable, any Territory-specific [***] determined in accordance with Section 7.2.3 (Consistency with Global Brand Plan)). If Licensee seeks to use any promotional materials for any Licensed Product (whether such materials are considered “core” or country-specific) that have content or messaging that is inconsistent with the Global Brand Plan or any Territory-specific [***] determined in accordance with Section 7.2.3 (Consistency with Global Brand Plan), then, in each case, Licensee will [***]. Upon Akebia’s reasonable request, Licensee will provide samples of Licensee’s promotional materials for the Territory, without translation, [***] determined in accordance with Section 7.2.3 (Consistency with Global Brand Plan), and other content or format approved by Akebia. Upon Licensee’s reasonable request, Akebia will provide to Licensee samples of Akebia’s core promotional materials for the Licensed Products, without translation.

7.9

Trademarks and International Nonproprietary Name.

7.9.1

Brand Name in the Territory. Licensee will Commercialize each Licensed Product under the Global Marks using the global brand name for such Licensed Product selected by Akebia in the Global Brand Plan (which name will be the global brand name agreed to by the Parties pursuant to the U.S. Collaboration and License Agreement for the U.S.) and under the trade dress set forth in the Global Brand Plan, unless Licensee reasonably believes that the use or registration of any Global Mark in a particular country in the Territory (a) [***] or would violate the Applicable Laws of such country, (b) is reasonably likely to be [***], or (c) is in conflict with any [***] in such country. If Licensee is unable to use any Global Mark for any of the foregoing reasons, then Licensee will use one of two alternative Marks (which Marks will include trademarks and trade dress) selected by [***] in the Global Brand Plan, or if such alternative Marks are unacceptable for the reasons set forth in the preceding sentence, then Licensee will use other Marks (including trademarks and trade dress) to be agreed upon by Licensee and Akebia (the “Local Marks”). [***], including all trademark registrations and applications therefor and all goodwill associated therewith.  Once the brand name for a Licensed Product has been selected for a country in the Territory pursuant to this Section 7.9.1 (Brand Name in the Territory), the Regulatory Responsible Party in such country will be responsible for obtaining Regulatory Approval of such brand name for use in the Commercialization of such Licensed Product in such country.

7.9.2

Required Use and Compliance.

(a)

Housemarks.  Licensee will Commercialize the Licensed Products only under the applicable Product Marks and each Party’s Housemarks as set forth herein, and no other Marks.

(b)

Ownership; Use.  Each Party acknowledges that Akebia has sole and exclusive ownership of all rights, title, and interests in and to the Product Marks and Akebia Housemarks. Licensee agrees that it and its Affiliates will: (i) ensure that each use of the Product Marks and the Akebia Housemarks by Licensee is accompanied by an acknowledgement that such Product Marks and Akebia Housemarks are owned by Akebia; (ii) not use such Product Marks or Akebia Housemarks in a way that might materially prejudice their distinctiveness or validity or the goodwill of Akebia therein and includes the trademark registration symbol ® or ™ as appropriate; (iii) not use any trademarks or trade names so resembling any of such Product Marks or the Akebia Housemarks as to be likely to cause confusion or deception; and (iv) place and display the Product Marks and Akebia Housemarks 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; provided, however, that Licensee will not be required to place or display any Akebia Housemark on promotional materials or other Product Materials used to Commercialize the Licensed Products in the Territory, except as provided in Section 8.6 (Approved Labeling).

7.9.3

Trademark Responsibility. [***] will be responsible for (a) registering, prosecuting, protecting, and enforcing the Product Marks in the Territory, (b) preparing any guidelines applicable to the use of Product Marks, (c) registering, in [***] name, at least [***] primary Product Mark and at least [***] alternative Product Marks, (d) if necessary pursuant to Section 7.9.1 (Brand Name in the Territory), registering, prosecuting, and enforcing any Local Marks in the Territory, (e) preparing any guidelines applicable to the use of any Local Mark, and (f) investigating and defending any infringement or threatened infringement relating to any of the foregoing, in each case, including all costs associated therewith.  [***] will cooperate and assist [***] with any of the foregoing activities with respect to all Product Marks, including, if requested by [***], providing any specifications, affidavits, declarations, or other documents necessary for [***] to submit to appropriate Regulatory Authorities in order to register and prosecute Product Marks.  [***] will reimburse [***] for the costs of the activities set forth in clauses (a), (c), (d), (e), and (f) to the extent related to a Product Mark in the Territory. For clarity, [***] will not be responsible for any costs associated with designing or determining any Product Mark. [***] will be responsible for securing and protecting any domain names associated with the Product Marks in [***] name, at [***] cost and expense.  [***] will not obtain or hold any such domain name in its own name. Neither Party will register in its own name any trademark, corporate name, domain name, social media account, or other source identifier containing any trademark owned by the other Party or any word or mark that is confusingly similar to any such trademark. [***] will promptly notify [***] of any infringement or threatened infringement of any of the Product Marks in the Territory of which it becomes aware.

7.9.4

Respect of Marks. Neither Party will, and will ensure that its Affiliates do not (a) attack, challenge, oppose, petition to cancel, or initiate legal action or proceedings in connection with any Product Mark or any Housemark of the other Party during the Term, or

thereafter challenge the registration of any Product Mark or any Housemark of the other Party in any country; (b) file, register, or maintain any registrations for any trademarks or trade names that are confusingly similar to any Product Mark (other than for a Licensed Product) in any country without the express prior written consent of Akebia; or (c) authorize or assist any Third Party to do any of the foregoing.  Licensee will not have, assert, or acquire any rights, title, or interests in or to any Product Marks or Akebia Housemarks or the goodwill pertaining thereto, except in each case for the limited licenses explicitly provided in this Agreement. Akebia will not have, assert, or acquire any rights, title, or interest in or to any Licensee Housemarks or the goodwill pertaining thereto. Licensee will maintain the quality standards of Akebia with respect to use of Product Marks and Akebia Housemarks pursuant to the licenses granted under Section 2.1 (Grant of Licenses to Licensee) and Section 7.9.5 (Trademark License), as applicable, and with respect to the goods it sells and the services it provides in connection with the Product Marks and the Akebia Housemarks hereunder. Each Party recognizes and agrees that no ownership rights are vested or created by the limited licenses granted pursuant to Section 2.1 (Grant of Licenses to Licensee), Section 2.3 (Grant of Licenses to Akebia), or Section 7.9.5 (Trademark License), as applicable, and that all goodwill developed by virtue of the use by Licensee of the Product Marks and the Akebia Housemarks inures to the benefit of Akebia.

7.9.5

Trademark License. Subject to the terms and conditions of this Agreement, Akebia hereby grants and agrees to grant to Licensee an exclusive, royalty-free license, with the right to sublicense to sublicensees in accordance with this Agreement, to use the Product Marks and the Akebia Housemarks solely in connection with the Commercialization of the Licensed Products in the Territory pursuant to this Agreement, including to effect the co-labeling provided for under Section 8.6 (Approved Labeling) and as part of any domain names associated with the Product Marks.

7.9.6

International Non-Proprietary Name.  Akebia will be responsible for the selection and filing of the international nonproprietary name for the Licensed Compound and each Licensed Product with the World Health Organization and any Regulatory Authorities in the Territory, to which names Licensee will have the right to reference.

7.10

Negotiations with [***]. The Parties intend to collaborate and strategize together with respect to any [***] between a Party and any [***] relating to the Territory (including, if applicable, any discussions relating to both inside the Territory and outside of the Territory), and each Party will involve the other Party in [***] upon such other Party’s request.

8.1

Supply and Purchase Obligations. Subject to the terms and conditions of this Agreement, Akebia will use Commercially Reasonable Efforts to manufacture or have manufactured and supply to Licensee the Licensed Products (a) [***], (b) [***], and (c) [***], in each case ((a) through (c)), in the Territory pursuant to the Manufacturing Plan. If Licensee is to perform any non-clinical or clinical studies in the Territory under this Agreement, then Licensee will purchase from Akebia all of Licensee’s requirements of such Licensed Products for such studies, which Licensed Product Akebia will supply [***], as applicable. Subject to the terms and conditions of this Agreement, Licensee will purchase from Akebia all of Licensee’s requirements of each Licensed Product for commercial use in the Territory. Except with respect to any U.S. Finished Form that Akebia supplies to Licensee (where required by Applicable Law in a country in the

Territory), Licensee will be responsible, at its sole cost and expense, for all [***], and other related activities required to convert the Licensed Product supplied by Akebia into Finished Form (such activities, collectively, “Packaging”), including all [***] of the Licensed Products for use in the Territory and for [***] associated therewith. Upon Licensee’s request, Akebia will provide [***] technology transfer to Licensee’s representatives of information necessary or reasonably useful to support Licensee’s [***] of the Licensed Products in furtherance of Licensee’s [***] activities, including providing reasonable assistance to Licensee in connection therewith upon request; provided that Licensee will provide to Akebia any information, data, and reports relating to Licensee’s [***] of the Licensed Products. Licensee will reimburse Akebia for all out-of-pocket costs incurred by or on behalf of Akebia in connection with such technology transfer within [***] of receiving Akebia’s invoice therefor.

8.2

Manufacturing Plan; Product Supply. Akebia will prepare the Manufacturing Plan, and will submit such Manufacturing Plan (and any amendments or updates thereto) to the JMC for its [***] pursuant to Section 3.3.3(a) (Specific Responsibilities of the JMC), and subsequently to the JSC for its [***] pursuant to Section 3.1.5(s) (Specific Responsibilities of the JSC); provided that only the initial Manufacturing Plan and material amendments or updates will be subject to JSC [***]. The Parties will discuss the manufacture and supply of the Licensed Compound and the Licensed Products for Development and Commercialization purposes through the JMC pursuant to the reports provided by Akebia as set forth under Section 8.7 (Manufacturing Reports). In addition, prior to Akebia’s engagement of any contract manufacturing organization for manufacture and supply of the Licensed Products [***], Akebia will reasonably consult with Licensee regarding the [***] of such contract manufacturing organization through the JMC pursuant to Section 3.3.3(b) (Specific Responsibilities of the JMC) and Akebia will include all such contract manufacturing organizations so engaged in the Manufacturing Plan.

8.3

Supply Agreements. If Licensee is to perform any clinical or non-clinical studies in the Territory in accordance with this Agreement, then the Parties will agree upon a supply agreement on reasonable and customary terms for the supply of the Licensed Compound or the Licensed Products by Akebia to Licensee in the Territory at its [***] (the “Clinical Supply Agreement”). Prior to First Commercial Sale of the Licensed Product, the Parties will agree upon a supply agreement on reasonable and customary terms for the commercial supply of such Licensed Product by Akebia to Licensee in the Territory at the Supply Price [***] (the “Commercial Supply Agreement”). The Commercial Supply Agreement will include provisions regarding long-range forecasting of Licensee’s requirements for the Licensed Product, specifications, changes to manufacturing process or specifications, ordering, shipment and delivery, failure to supply (including appropriate remedies in the event of a failure to supply), audit and inspection, shortage allocation, acceptance and rejection, and warranties. The supply price for the Licensed Products [***] supplied by Akebia to Licensee or its manufacturer during the Term for commercial use in the Territory will be equal to [***] plus [***] (the “Supply Price”).

8.4

Quality Agreement.  Prior to delivery of any Licensed Product hereunder or under a Supply Agreement, the Parties will also enter into one or more quality technical agreements (each a “Quality Agreement”) containing reasonable and customary terms and conditions regarding quality assurance and quality control and compliance with GMP and GCP (as applicable).  Each Party agrees to provide information to the other Party regarding quality defects and quality complaints associated with the use of the Licensed Products in accordance with the timeframes and procedures for reporting and other terms and conditions set forth in the Quality Agreements.  The Regulatory Responsible Party will be responsible for the management of all product quality complaints with respect to the Licensed Products in the Territory, and the Quality Agreement will define each Party’s roles and responsibilities with respect to the same.

8.5

Term of Supply Agreements and Quality Agreement. Unless otherwise agreed by the Parties, the term of each Supply Agreement and the Quality Agreement will either (a) [***] upon termination of this Agreement (in the event of any termination of this Agreement pursuant to Section 15.2 (Termination for Breach), Section 15.3 (Termination by Licensee for Convenience), Section 15.4 (Termination by Akebia Upon Patent Challenge by Licensee), or Section 15.5 (Termination by Written Agreement)) or (b) expire [***] after the effective date of expiration of this Agreement (in the event of expiration of this Agreement pursuant to Section 15.1 (Term)).

8.6

Approved Labeling.  The Parties agree that, to the extent permitted under Applicable Law within the Territory, the Approved Labeling will include the Akebia Housemarks and the Licensee Housemarks with equal prominence.

8.7

Manufacturing Reports. At each JMC meeting, Akebia will provide the JMC with an update (by means of a slide presentation or otherwise) summarizing Akebia’s manufacturing activities under the Manufacturing Plan related to supply of the Licensed Products for Development purposes (if Akebia is supplying to Licensee any Licensed Product for clinical Development purposes) and Commercialization purposes as set forth in Section 3.3.3(c) (Specific Responsibilities of the JMC). Notwithstanding the foregoing, the Parties acknowledge and agree that any information and updates provided pursuant to this Section 8.7 (Manufacturing Reports) will be subject to the rules and regulations set forth by the relevant Regulatory Authorities.

9.1

Upfront Payment.  As partial consideration for the rights and licenses granted by Akebia to Licensee under this Agreement, no later than [***] after the Effective Date, Licensee will pay to Akebia a nonrefundable and noncreditable upfront payment of $73,000,000.

9.2

Milestone Payments.  As additional consideration for the rights and licenses granted to Licensee under this Agreement, Licensee will pay to Akebia, in the manner set forth in Section 9.3.5 (Royalty Payments and Reports), the following nonrefundable and noncreditable milestone payments, as applicable, no later than [***] after the first occurrence of the indicated event for the Licensed Products:

9.2.1

NDD-CKD Approval Milestones. Upon Regulatory Approval by [***] of a Licensed Product in the Territory in the NDD-CKD Indication, Licensee will pay to Akebia [***] of the following payment amounts set forth in Table 9.2.1 below, depending upon which of the events #1-#4 in Table 9.2.1 occurs.

Table 9.2.1 – NDD-CKD Approval Milestones

Event

Payment Amount

(in U.S. Dollars)

1.   If such Licensed Product [***]:

$[***]

2.   If such Licensed Product [***]:

$[***]

3.   If such Licensed Product [***]:

$[***]

4.   If such Licensed Product [***]:

$[***]

9.2.2

DD-CKD Approval Milestones.  Upon Regulatory Approval by [***] of a Licensed Product in the Territory in the DD-CKD Indication, Licensee will pay to Akebia [***] of the following payment amounts set forth in Table 9.2.2 below, depending upon which of the events #1-#4 in Table 9.2.2 occurs.

Table 9.2.2 – DD-CKD Approval Milestones

Event

Payment Amount

(in U.S. Dollars)

1.   If such Licensed Product [***]:

$[***]

2.   If such Licensed Product [***]:

$[***]

3.   If such Licensed Product [***]:

$[***]

4.   If such Licensed Product [***]:

$[***]

9.2.3

Data Milestones.  If the following milestone events #1-#3 set forth in Table 9.2.3 below are achieved, then Licensee will pay the applicable corresponding milestone payment (in each case, either (a) or (b)) to Licensee upon the first Regulatory Approval of the Licensed Product in the Territory, in addition to any other approval milestones set forth under Section 9.2.1 (NDD-CKD Approval Milestones) or Section 9.2.2 (DD-CKD Approval Milestones):

Table 9.2.3 – Data Milestones

Event

Applicable Criteria

Payment Amount
(in U.S. Dollars)

1. [***]

(a) [***]

$[***]

(b) [***]

$[***]

2. [***]

(a) [***]

$[***]

(b) [***]

$[***]

3. [***]

(a) [***]

$[***]

(b) [***]

$[***]

9.2.4

Sales Milestones. Upon the first occurrence of each event set forth in Table 9.2.4 below in the Territory during the Term, Licensee will pay to Akebia the corresponding sales milestone set forth in Table 9.2.4. Licensee will not [***].  If in a given calendar year during the Term more than one of the following thresholds for the sales milestones is exceeded with respect to aggregate Net Sales of Licensed Products during the Term, then Licensee will pay to Akebia [***] with respect to each such threshold that is exceeded for the first time in such calendar year.

Table 9.2.4 – Sales Milestones

Event

Payment Amount

(in U.S. Dollars)

Achievement of $[***] of aggregate annual Net Sales of Licensed Products in the Territory during a calendar year

$[***]

Achievement of $[***] of aggregate annual Net Sales of Licensed Products in the Territory during a calendar year

$[***]

Achievement of $[***] of aggregate annual Net Sales of Licensed Products in the Territory during a calendar year

$[***]

Achievement of $[***] of aggregate annual Net Sales of Licensed Products in the Territory during a calendar year

$[***]

Achievement of $[***] of aggregate annual Net Sales of Licensed Products in the Territory during a calendar year

$[***]

Achievement of $[***] of aggregate annual Net Sales of Licensed Products in the Territory during a calendar year

$[***]