What changed in this filing

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Item 9A. Controls and Procedures

2022-03-01 compared with 2021-02-25 · 84 added, 72 removed, 231 unchanged (40% of the section changed)

7 unchanged sentences

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, is responsible for establishing and maintaining adequate internal control over financial reporting.

Internal control over financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Securities Exchange Act of 1934 as a process designed by, or under the supervision of, the Company’s Chief Executive Officer and Chief Financial Officer and effected by the Company’s board of directors, management and other personnel to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America and includes those policies and procedures that:

board of directors, management and other personnel to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America and includes those policies and procedures that:

(1) Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets;

4 unchanged sentences

Management conducted an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2021 based on the criteria set forth in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO.

Based on the assessment, management has concluded that the material weakness in our internal control over financial reporting relating to our inventory process as reported in our Annual Report on Form 10-K for the year ended December 31, 2019 remains un-remediated as of December 31, 2020 and that, our internal control activities over financial reporting as of December 31, 2020 was not effective due to the following material weakness:

the Company did not design and maintain effective controls over the completeness, accuracy and presentation and disclosure of inventory.

Based on the assessment, management has concluded that the material weakness in our internal control over financial reporting relating to our inventory process as reported in our Annual Report on Form 10-K for the year ended December 31, 2020 remains un-remediated as of December 31, 2021 and that, our internal control over financial reporting as of December 31, 2021 was not effective due to the following material weakness:

the Company did not design and maintain effective controls over the completeness, accuracy, existence and presentation and disclosure of inventory.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual or interim consolidated financial statements will not be prevented or detected on a timely basis.

Specifically, we did not maintain effective controls related to (i) the review of inventory reconciliations, (ii) the validation of the inventory costing and (iii) the periodic assessment of excess and obsolete inventory related reserves.

Specifically, we did not maintain effective controls related to (i) the review of inventory reconciliations, (ii) the validation of the inventory costing, (iii) the periodic assessment of excess and obsolete inventory related reserves and (iv) verification that the existence of all inventories subject to physical inventory counts were correctly counted as of December 31, 2021.

Although during 2021 we strengthened our controls related to (i) the review of inventory reconciliations, (ii) the validation of the inventory costing and (iii) the periodic assessment of excess and obsolete inventory related reserves, further remediation is needed.

4 unchanged sentences

• We have designed and implemented more robust controls throughout 2021 and will continue to improve the precision of our controls in 2022.

• We provided training to individuals with internal control responsibilities, including review documentation requirements, during 2020, and will continue to do so in 2021.

• We provided training to individuals within the supply chain, manufacturing, quality and inventory processes, including review documentation requirements, during 2021, and will continue to do so in 2022 including training of all new employees and written standard operating procedures for all key inventory processes.

• We designed controls to address the completeness and accuracy of any key reports utilized in the execution of internal controls.

• Implementing an inventory count policy and standard operating procedures to ensure consistent communication of the inventory count process and adherence to these policies at facilities managed by third party logistics and contract manufacturing organizations.

• We reported regularly during 2021, and will continue to report regularly in 2022, to the audit committee on the progress and results of control remediation.

• We engaged an outside firm to assist with performing sufficient testing in 2020 and executed upon a monitoring protocol to allow the Company to validate the operating effectiveness of certain controls over financial reporting to gain assurance that such controls are present and functioning as designed.

• We continued to engage an outside firm to assist with performing sufficient testing in 2021 and executed upon a monitoring protocol to allow the Company to validate the operating effectiveness of certain controls over financial reporting to gain assurance that such controls are present and functioning as designed.

We will continue to engage an outside firm in 2022 to assist management with performing sufficient testing throughout the year to validate the operating effectiveness of certain controls over financial reporting.

3 unchanged sentences

Changes in Internal Control over Financial Reporting

During the quarter ended December 30, 2020, we implemented certain internal controls in connection with our remediation efforts described above.

Except as noted in the preceding paragraphs, there have been no changes in the Company’s internal control over financial reporting during the fourth quarter of 2021, as such term is defined in Rules 13a-15(f) and 15(d)-15(f) promulgated under the Exchange Act, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

9 unchanged sentences

The following material weakness has been identified and included in management’s assessment.

We identified deficiencies in internal controls included within the Company's inventory process.

Specifically, the Company did not maintain effective controls related to (i) the review of inventory reconciliations, (ii) the validation of the inventory costing and (iii) the periodic assessment of excess and obsolete inventory related reserves.

Management has identified deficiencies in internal controls included within the Company’s inventory process.

Specifically, the Company did not maintain effective controls related to (i) the review of inventory reconciliations, (ii) the validation of the inventory costing (iii) the periodic assessment of excess and obsolete inventory related reserves and (iv) verification that the existence of all inventories subject to physical inventory counts were correctly counted.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2021 and 2020, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2021, and the related notes.

This material weakness was considered in determining the nature, timing and extent of audit tests applied in our audit of the 2020 consolidated financial statements, and this report does not affect our report dated February 25, 2021, which expressed an unqualified opinion thereon.

This material weakness was considered in determining the nature, timing and extent of audit tests applied in our audit of the 2021 consolidated financial statements, and this report does not affect our report dated March 1, 2022, which expressed an unqualified opinion thereon.

Basis for Opinion

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting.

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the Management’s Annual Report on Internal Control over Financial Reporting.

Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.

6 unchanged sentences

Definition and Limitations of Internal Control Over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally

accepted accounting principles.

A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;

5 unchanged sentences

Boston, Massachusetts

February 25, 2021

March 1, 2022

Other Information

On February 25, 2021, we entered into a royalty interest acquisition agreement, or the Royalty Agreement, with HealthCare Royalty Partners IV, L.P., or HCR, pursuant to which we sold to HCR our right to receive all royalties and sales milestones for vadadustat, collectively the Royalty Interest Payments, in each case, payable to us under our Collaboration Agreement dated December 11, 2015, or the MTPC Agreement, with Mitsubishi Tanabe Pharma Corporation, or MTPC, subject to an annual maximum “cap” of $13.0 million, or the Annual Cap, and an aggregate maximum “cap” of $150.0 million, or the Aggregate Cap.

After HCR receives Royalty Interest Payments equal to the Annual Cap in a given calendar year, we will receive 85% of the Royalty Interest Payments for the remainder of that year.

After HCR receives Royalty Interest Payments equal to the Aggregate Cap, or we pay the Aggregate Cap to HCR (net of the Royalty Interest Payments already received by HCR), the Royalty Interest Payments will revert back to us, and HCR would have no further right to any Royalty Interest Payments.

We received $45.0 million from HCR (net of certain transaction expenses) under the Royalty Agreement, and we are eligible to receive an additional $15.0 million under the Royalty Agreement if specified sales milestones are achieved for vadadustat in the territory covered by the MTPC Agreement, subject to the satisfaction of certain customary conditions.

We retain the right to receive all potential future regulatory milestones for vadadustat under the MTPC Agreement.

The Royalty Agreement will terminate on the earlier of the date on which HCR has received (i) the last Royalty Interest Payment or (ii) payment by us of an amount equal to the Aggregate Cap minus the aggregate amount of all Royalty Interest Payments actually received by HCR.

The Royalty Agreement requires us to take certain actions, including actions with respect to the Royalty Interest Payments, the MTPC Agreement, our agreement with MTPC for the commercial supply of vadadustat drug product, and our intellectual property.

The Royalty Agreement also contains certain representations and warranties, covenants, indemnification obligations, events of default and other provisions that are customary for a royalty monetization transaction of this nature.

In addition, we granted HCR a precautionary security interest in connection with the Royalty Interest Payments.

This summary of the Royalty Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Royalty Agreement, a copy of which we plan to file as an exhibit to our Quarterly Report on Form 10-Q for the quarter ending March 31, 2021.

The foregoing information is included for the purpose of providing the disclosures required under “Item 1.01 – Entry into a Material Definitive Agreement,” of Current Report on Form 8-K.

Amendment to Lease Agreement with CLPF One Marina Park Drive LLC

On February 24, 2022, we entered into an Assignment and Assumption Agreement with Keryx, pursuant to which we assumed all of the rights and responsibilities of Keryx with respect to the One Marina Park Drive Office Lease, dated April 29, 2015, by and between Keryx and Fallon Cornerstone One MPD LLC, or Fallon, or the Boston Lease, for the entire twelfth floor of the building located at One Marina Park Drive, Boston, Massachusetts, or the Premises.

On February 24, 2022,we entered into a First Amendment to Lease, or the First Lease Amendment, with CLPF One Marina Park Drive LLC (successor-in-interest to Fallon), or the Landlord, amending the Boston Lease for the Premises.

Pursuant to the First Lease Amendment, we have agreed to extend the term of the Boston Lease, as amended, until July 31, 2031.

The monthly lease payment for the Premises pursuant to the First Lease Amendment will be $200,122.00 commencing on August 1, 2023, with an annual rent escalation of approximately 2% commencing on August 1, 2024.

The First Lease Amendment also includes a Landlord’s allowance for certain leasehold improvements to the Premises in an amount of up to $1,954,680.00, provided that such allowance must be used prior to August 1, 2024.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Not applicable.

Director, Executive Officers and Corporate Governance

14 unchanged sentences

Consolidated Statements of Operations and Comprehensive Loss

Consolidated Statements of Stockholders’ Equity (Deficit)

Consolidated Statements of Stockholders’ Equity

Consolidated Statements of Cash Flows

14 unchanged sentences

4.1 Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1/A (333-193969), filed on March 4, 2014)

4.2 Fourth Amended and Restated Investors’ Rights Agreement, dated March 5, 2014 (incorporated by reference to Exhibit 4.4 to the Company’s 10-K for the year ending December 31, 2014 and filed on March 4, 2015)

4.2 Fourth Amended and Restated Investors’ Rights Agreement, dated March 5, 2014 (incorporated by reference to Exhibit 4.4 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 4, 2015)

Amendment No.

2 unchanged sentences

and Vifor (International) Ltd., dated May 12, 2017 (incorporated by reference to Exhibit 4.1 to the Company’s Quarterly Report on Form 10-Q (001-36352) , filed on August 8, 2017)

4.5*# Investment Agreement between Akebia Therapeutics, Inc.

and Vifor (International) Ltd., dated February 18, 2022

4.6 Common Stock Purchase Warrant between Akebia Therapeutics, Inc.

and Janssen Pharmaceutica NV, dated February 9, 2017 (incorporated by reference to Exhibit 4.1 to the Company’s Quarterly Report on Form 10-Q (001-36352) , filed on May 9, 2017)

Description of Registrant’s Securities

4.7 Description of Registrant’s Securities (incorporated by reference to Exhibit 4.6 to the Company's Annual Report on Form 10-K (001-36352) , filed on February 25, 2021)

Form of Director and Officer Indemnification Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 12, 2018)

1 unchanged sentence

and Akebia Therapeutics, Inc., dated December 3, 2013 (incorporated by reference to Exhibit 10.2 to the Company’s Registration Statement on Form S-1 (333-193969), filed on February 14, 2014)

10.3 First Amendment to Office Lease Agreement Between Jamestown Premier 245 First, LLC and Akebia Therapeutics, Inc., dated December 15, 2014 (incorporated by reference to Exhibit 10.3 to the Company’s 10-K for the year ending December 31, 2014 and filed on March 4, 2015)

10.4 Second Amendment to Office Lease Agreement Between Jamestown Premier 245 First, LLC and Akebia Therapeutics, Inc., dated November 23, 2015 (incorporated by reference to Exhibit 10.4 to the Company’s 10-K for the year ending December 31, 2015 and filed on March 14, 2016)

10.5 Third Amendment to Office Lease Agreement Between Jamestown Premier 245 First, LLC and Akebia Therapeutics, Inc., dated July 25, 2016 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q, filed on November 9, 2016)

10.6 Fourth Amendment to Office Lease Agreement Between CLPF-Cambridge Science Center, LLC and Akebia Therapeutics, Inc., dated May 1, 2017 (incorporated by reference to Exhibit 10.6 to the Company’s 10-K for the year ending December 31, 2017, filed on March 12, 2018)

10.3 First Amendment to Office Lease Agreement Between Jamestown Premier 245 First, LLC and Akebia Therapeutics, Inc., dated December 15, 2014 (incorporated by reference to Exhibit 10.3 to the Company’s Ann ua l Report on Form 10-K (001-36352) , filed on March 4, 2015)

10.4 Second Amendment to Office Lease Agreement Between Jamestown Premier 245 First, LLC and Akebia Therapeutics, Inc., dated November 23, 2015 (incorporated by reference to Exhibit 10.4 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 14, 2016)

Number Description of Exhibit

10.6 Fourth Amendment to Office Lease Agreement Between CLPF-Cambridge Science Center, LLC and Akebia Therapeutics, Inc., dated May 1, 2017 (incorporated by reference to Exhibit 10.6 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 12, 2018)

10.7 Fifth Amendment to Office Lease Agreement Between CLPF-Cambridge Science Center, LLC and Akebia Therapeutics, Inc.

1 unchanged sentence

10.8 Sixth Amendment to Office Lease Agreement Between CLPF-Cambridge Science Center, LLC and Akebia Therapeutics, Inc.

dated November 30, 2020

dated November 30, 2020 (incorporated by reference to Exhibit 10.8 to the Company's Annual Report on Form 10-K (001-36352), filed on February 25, 2021)

10.9 One Marina Park Drive Office Lease dated April 29, 2015, by and between Keryx Biopharmaceuticals, Inc.

and Fallon Cornerstone One MPD LLC (incorporated by reference to Exhibit 10.29 to Keryx Biopharmaceuticals, Inc.’s Annual Report on Form 10-K (00 0-30929 ) , filed on March 1, 2017)

10.10* First Amendment to One Marina Park Drive Office Lease, dated February 24, 2022, by and between Keryx Biopharmaceuticals, Inc.

and CLPF One Marina Park Drive LLC (successor-in-interest to Fallon Cornerstone One MPD LLC)

10.11* Assignment and Assumption Agreement, dated February 24, 2022, by and between Keryx Biopharmaceuticals, Inc.

and Akebia Therapeutics, Inc.

10.12 Sublease, dated as of September 9, 2019, by and between Keryx Biopharmaceuticals, Inc.

8 unchanged sentences

10.17† Form of Non-Statutory Stock Option Agreement for officers (incorporated by reference to Exhibit 10.24 to the Company’s Registration Statement on Form S-1/A (333-193969), filed on March 4, 2014)

10.16† Form of Non-Statutory Stock Option Agreement for N on- E mployee D irectors (incorporated by reference to Exhibit 10.25 to the Company’s Registration Statement on Form S-1/A (333-193969), filed on March 4, 2014)

10.17† Amended and Restated Non-Employee Director Compensation Program, effective January 1, 2018 (incorporated by reference to Exhibit 10.13 to the Company’s 10-K for the year ending December 31, 2017 and filed on March 12, 2018)

10.18† Form of Non-Statutory Stock Option Agreement for Non-Employee Directors (incorporated by reference to Exhibit 10.25 to the Company’s Registration Statement on Form S-1/A (333-193969), filed on March 4, 2014)

10.19† Amended and Restated Non-Employee Director Compensation Program, effective January 1, 2018 (incorporated by reference to Exhibit 10.13 to the Company’s 10-K (001-36352) , filed on March 12, 2018)

10.20† Amended and Restated Non-Employee Director Compensation Program, effective January 30, 2019 (incorporated by reference to Exhibit 10.31 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 26, 2019)

10.19† Non-Employee Director Compensation Program, effective January 26, 2021

Number Description of Exhibit

10.21† Non-Employee Director Compensation Program, effective January 26, 2021 (incorporated by reference to Exhibit 10.19 to the Company's Annual Report on Form 10-K (001-36352) , filed on February 25, 2021)

10.22† Form of Executive Severance Agreement for officers (incorporated by reference to Exhibit 10.27 to the Company’s Registration Statement on Form S-1/A (333-193969), filed on March 4, 2014)

4 unchanged sentences

10.25† 2014 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.30 to the Company’s Registration Statement on Form S-1/A (333-193969), filed on March 4, 2014)

10.24† Amended and Restated 2014 Employee Stock Purchase Plan (incorporated by reference to Appendix A to the Company’s Definitive Proxy Statement, filed with the Securities and Exchange Commission on April 26, 2019)

Number Description of Exhibit

10.25† Cash Incentive Plan (incorporated by reference to Exhibit 10.31 to the Company’s Registration Statement on Form S-1/A (333-193969), filed on March 4, 2014)

10.26† Amended and Restated 2014 Employee Stock Purchase Plan (incorporated by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A (001-36352) , filed with the Securities and Exchange Commission on April 26, 2019)

10.27† Cash Incentive Plan , effective February 28, 2014 (incorporated by reference to Exhibit 10.31 to the Company’s Registration Statement on Form S-1/A (333-193969), filed on March 4, 2014)

10.28*† Amended and Restated Cash Incentive Plan, effective January 19, 2022

10.29† Form of Officer Restricted Stock Unit Award Agreement under 2014 Incentive Plan (incorporated by reference to Exhibit 10.18 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 12, 2018)

2 unchanged sentences

10.32† Form of Inducement Award Non-Statutory Stock Option Agreement for non-officers (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-8 (333-222728), filed on January 26, 2018)

Form of Officer Performance-Based Stock Option Award, under the Company's 2014 Incentive Plan, as amended (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (001-36352), filed on November 4, 2021)

10.34† Form of Officer Performance-Based Stock Restricted Stock Unit Award, under the Company's 2014 Incentive Plan, as amended (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q (001-36352) , filed on November 4, 2021)

Form of Officer Cash Bonus Letter Agreement (incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q (001-36352) , filed on November 4, 2021)

10.36† Keryx Biopharmaceuticals, Inc.

4 unchanged sentences

2004 Long-Term Incentive Plan dated April 11, 2006 (incorporated by reference to Exhibit 10.1 to Keryx Biopharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (00 0-30929 ) , filed on August 9, 2006)

Number Description of Exhibit

10.39† Keryx Biopharmaceuticals, Inc.

10 unchanged sentences

10.45† Keryx Biopharmaceuticals, Inc.

Third Amended and Restated Directors Equity Compensation Plan (incorporated by reference to Exhibit 10.1 to Keryx Biopharmaceuticals, Inc.’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2014, filed on August 7, 2014)

Third Amended and Restated Directors Equity Compensation Plan (incorporated by reference to Exhibit 10.1 to Keryx Biopharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (00 0-30929 ) , filed on August 7, 2014)

10.46† Keryx Biopharmaceuticals, Inc.

1 unchanged sentence

10.47† Master Consulting Services Agreement by and between the Company and Jason A.

Amello, dated August 7, 2020 (incorporated by reference to Exhibit 10.

1 to the Company's Quarterly Report on Form 10-Q filed on November 5, 2020)

Amello, dated August 7, 2020 (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (001-36352) , filed on November 5, 2020)

10.48# Master Services Agreement, between Akebia Therapeutics, Inc., and Quintiles, Inc., dated as of June 8, 2015 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q (001-36352) , filed on August 11, 2015)

Number Description of Exhibit

Collaboration Agreement between Akebia Therapeutics, Inc.

and Mitsubishi Tanabe Pharma Corporation, dated December 11, 2015 (incorporated by reference to Exhibit 10.29 to the Company’s 10-K for the year ending December 31, 2015 and filed on March 14, 2016)

and Mitsubishi Tanabe Pharma Corporation, dated December 11, 2015

10.50# Letter Agreement between Akebia Therapeutics, Inc.

2 unchanged sentences

and Otsuka Pharmaceutical Co.

Ltd., dated December 18, 2016 (incorporated by reference to Exhibit 10.26 to the Company’s 10-K for the year ending December 31, 2016 and filed on March 6, 2017)

Ltd., dated December 18, 2016 (incorporated by reference to Exhibit 10.26 to the Company’s Annual Report on Form 10-K (001-36352) and filed on March 6, 2017)

10.52# Collaboration and License Agreement between Akebia Therapeutics, Inc.

3 unchanged sentences

and Janssen Pharmaceutica NV, dated February 9, 2017 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q (001-36352) , filed on May 9, 2017)

Amended and Restated License Agreement, dated April 8, 2019, by and between Akebia Therapeutics, Inc.

Second Amended and Restated License Agreement, dated February 18, 2022, by and between Akebia Therapeutics, Inc.

and Vifor (International) Ltd.

(incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q, filed on August 8, 2019)

Number Description of Exhibit

10.55 Amended and Restated Controlled Equity Offering SM Sales Agreement, dated November 12, 2019, by and between Akebia Therapeutics, Inc.

1 unchanged sentence

(incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K (001-36352) , filed on November 12, 2019)

10.50 Reserved

10.51 Reserved

Second Amended and Restated License Agreement dated April 17, 2019, by and between Akebia Therapeutics, Inc.

4 unchanged sentences

Master Manufacturing Services Agreement by and between Keryx Biopharmaceuticals, Inc.

and Patheon Manufacturing Services LLC and certain of its affiliates, dated September 27, 2016, and related Product Agreement dated September 27, 2016, and related Product Agreement dated October 12, 2016 (incorporated by reference to Exhibit 10.12 to Keryx Biopharmaceuticals, Inc.’s Annual Report on Form 10-K, filed on March 1, 2017)

10.59# Product Agreement, dated August 29, 2017, by and between Keryx Biopharmaceuticals, Inc.

6 unchanged sentences

1 to Master Manufacturing Services and Supply Agreement, dated as of December 21, 2020, by and between Siegfried Evionnaz SA and Keryx Biopharmaceuticals, Inc.

(incorporated by reference to Exhibit 10.58 to the Company's Annual Report on Form 10-K (001-36352), filed on February 25, 2021)

10.62 Amendment No.

2 to Master Manufacturing Services and Supply Agreement, dated as of January 29, 2021, by and between Siegfried Evionnaz SA and Keryx Biopharmaceuticals, Inc.

Number Description of Exhibit

(incorporated by reference to Exhibit 10.58 to the Company's Annual Report on Form 10-K (001-36352) , filed on February 25, 2021)

Amendment No.

3 to Master Manufacturing Services and Supply Agreement, dated as of February 11, 2021, by and between Siegfried Evionnaz SA and Keryx Biopharmaceuticals, Inc.

(incorporated by reference to Exhibit 10.59 to the Company's Annual Report on Form 10-K (001-36352), filed on February 25, 2021)

10.64* Amendment No.

4 to Master Manufacturing Services and Supply Agreement, dated as of December 17, 2021, by and between Siegfried Evionnaz SA and Keryx Biopharmaceuticals, Inc.

10.65# Exclusive Distribution Agreement between Keryx Biopharmaceuticals, Inc.

and Cardinal Health 105, Inc., dated October 16, 2014 and Amendment to Exclusive Distribution Agreement between Keryx Biopharmaceuticals, Inc.

and Cardinal Health 105, Inc., dated October 16, 2014 and First Amendment to Exclusive Distribution Agreement between Keryx Biopharmaceuticals, Inc.

and Cardinal Health 105, Inc., dated April 14, 2015 (incorporated by reference to Exhibit 10.60 to the Company’s Annual Report on Form 10-K (001-36352) , filed on March 26, 2019)

6 unchanged sentences

Loan Agreement, dated November 11, 2019, by and among the Company, Keryx Biopharmaceuticals, Inc., Biopharma Credit plc and Biopharma Credit Investments V (Master) LP (incorporated by reference to Exhibit 10.62 to the Company's Annual Report on Form 10-K (001-36352) , filed on March 12, 2020)

Number Description of Exhibit

10.69!* First Amendment and Waiver, dated February 18, 2022, by and among the Company, Biopharma Credit p l c, BCPR Limited Partnership and Biopharm a Credit Investments V (Master ) LP

Guaranty and Security Agreement, dated November 25, 2019, by and between the Company, Keryx Biopharmaceuticals, Inc.

2 unchanged sentences

and Patheon, Inc.

(incorporated by reference to Exhibit 10.

1 to the Company's Quarterly Report on Form 10-Q filed on May 5, 2020)

(incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (001-36352) , filed on May 5, 2020)

Supply Agreement, dated as of April 2, 2020, by and between Akebia Therapeutics, Inc.

and STA Pharmaceutical Hong Kong Limited (incorporated by reference to Exhibit 10.

2 to the Company's Quarterly Report on Form 10-Q filed on August 10, 2020)

and STA Pharmaceutical Hong Kong Limited (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q (001-36352) , filed on August 10, 2020)

Amendment #1 to the Supply Agreement, dated as of April 15, 2021, by and between Akebia Therapeutics, Inc, and STA Pharmaceutical Hong Kong Limited (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q (001-36352), filed on August 5, 2021)

Amended and Restated Product Manufacture and Supply and Facility Construction Agreement between BioVectra, Inc.

and Keryx Biopharmaceuticals, Inc., dated September 4, 2020 (incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K (001-36352) , filed on September 11, 2020)

21.1* List of Subsidiaries

Supply Agreement, dated February 10, 2021, by and between the Company and STA Pharmaceutical Hong Kong Limited (incorporated by reference to Exhibit 10.4 to the Company's Quarterly Report on Form 10-Q (001-36352), filed on May 10, 2021)

Royalty Interest Acquisition Agreement, dated February 25, 2021, by and between the Company and HealthCare Royalty Partners IV, L.P.

(incorporated by reference to Exhibit 10.5 to the Company's Quarterly Report on Form 10-Q ( 001-36352) , filed on May 10, 2021)

21.1 List of Subsidiaries (incorporated by reference to Exhibit 21.1 to the Company's Annual Report on Form 10-K (001-36352), filed on February 25, 2021)

23.1* Consent of Ernst & Young LLP

7 unchanged sentences

101.LAB* Inline XBRL Taxonomy Extension Labels Linkbase Document

Number Description of Exhibit

101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document

Number Description of Exhibit

104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

8 unchanged sentences

AKEBIA THERAPEUTICS, INC.

February 25, 2021 By:

March 1, 2022 By:

President and Chief Executive Officer

Pursuant to the requirements of the Securities Exchange Act of 1934, this report was signed by the following persons on behalf of the registrant and in the capacities and on the date indicated.

February 25, 2021 By:

March 1, 2022 By:

Director, President and Chief Executive Officer (Principal Executive Officer)

February 25, 2021 By:

March 1, 2022 By:

Senior Vice President, Chief Financial Officer and Treasurer (Principal Financial Officer)

February 25, 2021 By:

March 1, 2022 By:

/s/ Violetta Cotreau

1 unchanged sentence

Senior Vice President, Chief Accounting Officer (Principal Accounting Officer)

February 25, 2021 By:

March 1, 2022 By:

/s/ Adrian Adams

February 25, 2021 By:

Chairperson and Director

March 1, 2022 By:

/s/ Ron Frieson

March 1, 2022 By:

/s/ Steven C.

February 25, 2021 By:

/s/ Maxine Gowen

February 25, 2021 By:

March 1, 2022 By:

/s/ Michael T.

February 25, 2021 By:

March 1, 2022 By:

/s/ Michael Rogers

Michael Rogers

February 25, 2021 By:

March 1, 2022 By:

/s/ Cynthia Smith

Cynthia Smith

February 25, 2021 By:

March 1, 2022 By:

/s/ Myles Wolf

February 25, 2021 By:

March 1, 2022 By:

/s/ LeAnne M.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures