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Item 9A. Controls and Procedures

2024-03-15 compared with 2023-03-06 · 78 added, 21 removed, 164 unchanged (38% of the section changed)

1 unchanged sentence

(a) Evaluation of Effectiveness of Disclosure Controls and Procedures

We carried out an evaluation, under the supervision of our Chief Executive Officer and our Chief Financial Officer, and evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of the end of the period covered by this Annual Report on Form 10-K.

Based on that evaluation, our President and Chief Executive Officer and our Chief Financial Officer have concluded that, as of the end of the period covered by this Annual Report on Form 10-K, our disclosure controls and procedures were, in design and operation, effective.

We carried out an evaluation, under the supervision of our Chief Executive Officer and our Interim Chief Financial Officer, and evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of the end of the period covered by this Annual Report on Form 10-K.

Based on that evaluation, our President and Chief Executive Officer and our Interim Chief Financial Officer have concluded that, as of the end of the period covered by this Annual Report on Form 10-K, our disclosure controls and procedures were, in design and operation, effective.

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and that such information is accumulated and communicated to our management, including our chief executive officer, principal financial officer and principal accounting officer, as appropriate, to allow for timely decisions regarding required disclosure.

14 unchanged sentences

(the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on the COSO criteria.

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, 2022 and 2021, and the related consolidated statements of operations, comprehensive (loss) income, stockholders’ equity (deficit) and cash flows for each of the three years in the period ended December 31, 2022, and the related notes and our report dated March 6, 2023 expressed an unqualified opinion thereon.

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, 2023 and 2022, and the related consolidated statements of operations, comprehensive loss, stockholders’ equity (deficit) and cash flows for each of the three years in the period ended December 31, 2023, and the related notes and our report dated March 15, 2024 expressed an unqualified opinion thereon.

Basis for Opinion

20 unchanged sentences

Other Information

Not applicable.

Item 1.01 Entry into a Material Definitive Agreement

Amendment No.

2 to Collaboration Agreement

On February 1, 2021, we announced that we had entered into the Collaboration Agreement with Junshi Biosciences for the co-development and commercialization of toripalimab, Junshi Biosciences’ anti-PD-1 antibody in the United States and Canada.

We entered into an amendment and waiver under the Collaboration Agreement on October 25, 2023 (Amendment No.

1 to Collaboration Agreement”).

On March 13, 2024, we and Junshi Biosciences entered into Amendment No.

2 to the Collaboration Agreement (“Amendment No.

2 to Collaboration Agreement”).

Under Amendment No.

2 to Collaboration Agreement, we agreed with Junshi Biosciences to change the $25.0 million milestone payment to Junshi Biosciences that became due in connection with the approval by the FDA of toripalimab for the treatment of patients with NPC in the first quarter of 2024.

We agreed to split the $25.0 million milestone payment into two equal installments of $12.5 million each, one due in the second quarter of 2024 and one due in the first quarter of 2025.

We also agreed to pay approximately $2.5 million in the first quarter of 2024 to Junshi Biosciences for routine expenses incurred pursuant to the Collaboration Agreement.

The foregoing summary of Amendment No.

2 to Collaboration Agreement does not purport to be complete and is qualified in its entirety by the full text of the Amendment No.

2 to Collaboration Agreement, a copy of which will be filed as an exhibit to our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2024.

Item 2.05 Costs Associated with Exit or Disposal Activities

In addition to our 35 former employees who transferred to Sandoz in connection with the closing of the Sale Transaction, on March 11, 2024 we committed to a plan to reduce our workforce (the “Plan”) by approximately 26 employees effective March 18, 2024 to focus resources on strategic priorities including the research, development and commercialization of innovative cancer treatments and the commercialization of our portfolio of FDA-approved oncology products.

One-time restructuring charges associated with the Plan are expected to be approximately $1.5 million, primarily consisting of personnel expenses such as salaries, one-time severance payments, and other benefits.

Cash payments related to these expenses will be paid out and the Plan is expected to be completed in the first half of 2024.

The estimated costs that we expect to incur in connection with the Plan are subject to a number of assumptions, and actual results may differ significantly from these estimates.

We may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the Plan.

(b) During the three months ended December 31, 2023, neither we nor any of our directors or officers adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each such term is defined in Item 408(a) of Regulation S-K.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Not applicable.

Certain information required by Part III is omitted from this Annual Report on From 10-K because the Company will file a Definitive Proxy Statement (the “Proxy Statement”) with the Securities and Exchange Commission within 120 days after the end of our fiscal year ended December 31, 2022.

Certain information required by Part III is omitted from this Annual Report on From 10-K because we will file a Definitive Proxy Statement (the “Proxy Statement”) with the Securities and Exchange Commission within 120 days after the end of our fiscal year ended December 31, 2023.

Directors, Executive Officers and Corporate Governance

27 unchanged sentences

and Coherus BioSciences, Inc.

Commercial License Agreement, effective June 25, 2012, by and between Selexis SA and Coherus BioSciences, Inc.

Standard Industrial/Commercial Multi-tenant Lease-Gross, effective December 5, 2011, by and between Howard California Property Camarillo 5 and BioGenerics, Inc.

12 unchanged sentences

and each of its directors, officers and certain employees.

Incorporated by Reference

Exhibit Description

Master Services Agreement, effective January 23, 2012, by and between Medpace, Inc.

and BioGenerics, Inc.

Incorporated by Reference

Exhibit Description

New Office Lease, effective July 6, 2015, by and between Hudson 333 Twin Dolphin Plaza, LLC and Coherus BioSciences, Inc.

24 unchanged sentences

Loan Agreement dated as of January 5, 2022 among Coherus BioSciences, Inc., the Guarantors, the Collateral Agent and the Lenders party thereto.

Letter Agreement, dated January 9, 2022, between Coherus BioSciences, Inc.

and Shanghai Junshi Biosciences, Co., Ltd.

Incorporated by Reference

Exhibit Description

Letter Agreement, dated February 9, 2022, between Coherus BioSciences, Inc.

1 unchanged sentence

First Amendment to Loan Agreement dated as of April 7, 2022, among Coherus BioSciences, Inc., the Collateral Agent and the Lenders party thereto.

Incorporated by Reference

Exhibit Description

License Agreement, dated June 22, 2022, among Coherus BioSciences, Inc., Bioeq AG and Genentech Inc.

Second Amendment and Waiver to Loan Agreement dated as of February 6, 2023, among Coherus BioSciences, Inc., the Collateral Agent and the Lenders party thereto.

Executive Change in Control and Severance Plan, effective January 1, 2023.

Letter Agreement between Coherus BioSciences, Inc.

and Vladimir Vexler, dated as of March 27, 2023.

Amendment No.

1 to Sales Agreement between Coherus BioSciences, Inc.

and Cowen and Company, LLC, dated May 15, 2023.

Agreement and Plan of Merger, by and among Coherus BioSciences, Inc., Crimson Merger Sub I, Inc., Crimson Merger Sub II, LLC and Surface Oncology, Inc., dated June 15, 2023 (Form of CVR Agreement included as Exhibit A thereto)

Settlement and License Agreement among Coherus BioSciences, Inc., AbbVie Inc.

and AbbVie Biotechnology Ltd dated January 24, 2019.

Amendment No.

2 to Sales Agreement between Coherus BioSciences, Inc.

and Cowen and Company, LLC dated September 11, 2023.

First Amended and Restated Development and Option Agreement between Adimab, LLC and Surface Oncology, Inc., dated October 3, 2018.

Collaboration Agreement between Novartis Institutes for BioMedical Research, Inc.

and Surface Oncology, Inc., dated January 9, 2016, as amended on May 6, 2016, as further amended on July 14, 2017, and as further amended on September 18, 2017.

Amendment No.

4 to the Collaboration Agreement between Novartis Institutes for BioMedical Research, Inc.

and Surface Oncology, Inc., dated October 9, 2018.

License Agreement, dated as of December 16, 2020, by and between Surface Oncology, Inc.

and GLAXOSMITHKLINE INTELLECTUAL PROPERTY (No.

Amendment No.

1, dated as of August 11, 2021, to License Agreement, dated as of December 16, 2020, by and between Surface Oncology, Inc.

and GLAXOSMITHKLINE INTELLECTUAL PROPERTY (No.

Sixth Amendment, effective October 24, 2023, by and between Hudson 333 Twin Dolphin Plaza, LLC and Coherus BioSciences, Inc.

Amendment to and Waiver, dated October 25, 2023, under the Exclusive License and Commercialization Agreement, dated February 1, 2021, by and between Coherus Biosciences, Inc.

and Shanghai Junshi Biosciences, Co.

Incorporated by Reference

Exhibit Description

Coherus BioSciences, Inc.

Insider Trading Compliance Policy and Procedures, effective February 27, 2023.

Letter Agreement between Coherus BioSciences, Inc.

and McDavid Stilwell, dated as of December 11, 2023.

Exclusive Product License Agreement, dated March 23, 2021, by and between Vaccinex, Inc.

and Surface Oncology, Inc.

Subsidiaries of Coherus BioSciences, Inc.

Consent of Independent Registered Public Accounting Firm.

3 unchanged sentences

Certification of Principal Executive Officer and Principal Financial Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C.

Coherus BioSciences, Inc.

Clawback Policy, effective December 1, 2023.

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

18 unchanged sentences

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Dennis M.

Lanfear and McDavid Stilwell, his or her attorneys-in-fact, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the U.S.

Lanfear and Bryan McMichael, his or her attorneys-in-fact, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the U.S.

Securities and Exchange Commission, hereby ratifying and confirming all that said attorneys-in-fact, or their substitute, may do or cause to be done by virtue thereof.

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

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

/s/ Dennis M.

2 unchanged sentences

March 15, 2024

/s/ McDavid Stilwell

McDavid Stilwell

Chief Financial Officer

(Principal Financial Officer)

March 6, 2023

/s/ Bryan McMichael

Bryan McMichael

Senior Vice President, Accounting and Corporate Controller

(Principal Accounting Officer)

Interim Chief Financial Officer, Executive Vice President, Accounting and Corporate Controller

(Principal Financial Officer and Principal Accounting Officer)

March 15, 2024

/s/ Georgia Erbez

Georgia Erbez

March 15, 2024

/s/ Charles Newton

4 unchanged sentences

March 15, 2024

/s/ Michael Ryan

March 15, 2024

/s/ Kimberly J.

4 unchanged sentences

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