株探米国株
英語
エドガーで原本を確認する
false0001098972Q2--12-31AGENUS INChttp://fasb.org/srt/2025#ChiefExecutiveOfficerMember0001098972agen:NewSalesAgreementMemberagen:BRileyFBRIncMember2025-01-012025-06-300001098972agen:DebenturesMember2024-12-310001098972us-gaap:AdditionalPaidInCapitalMember2024-12-310001098972us-gaap:EmployeeStockOptionMember2025-01-012025-06-300001098972us-gaap:CommonStockMember2025-06-300001098972agen:EmployeeBonusMember2025-01-012025-06-3000010989722025-03-310001098972us-gaap:IntellectualPropertyMembersrt:MinimumMember2024-12-310001098972agen:SaponiQxIncMember2025-06-3000010989722024-03-310001098972agen:SeriesA1ConvertiblePreferredStockMember2024-12-310001098972us-gaap:SubsequentEventMember2025-07-012025-08-070001098972country:US2025-01-012025-06-300001098972agen:SeriesA1ConvertiblePreferredStockMember2025-01-012025-06-300001098972country:USagen:ClinicalProductRevenueMember2025-04-012025-06-300001098972us-gaap:NonUsMember2024-04-012024-06-300001098972us-gaap:AdditionalPaidInCapitalMember2024-04-012024-06-300001098972us-gaap:SeniorSubordinatedNotesMember2025-02-280001098972us-gaap:OtherIntangibleAssetsMembersrt:MaximumMember2024-12-310001098972agen:MiNKTherapeuticsIncMember2024-12-310001098972country:US2025-04-012025-06-300001098972agen:RevenueMember2024-01-012024-06-300001098972us-gaap:FairValueInputsLevel3Member2025-06-300001098972agen:ClinicalProductRevenueMember2024-01-012024-06-300001098972us-gaap:TreasuryStockCommonMember2025-01-012025-03-310001098972agen:ResearchAndDevelopmentRevenueMember2025-04-012025-06-300001098972agen:NonCashRoyaltyRevenueRelatedToTheSaleOfFutureRoyaltiesMember2024-04-012024-06-300001098972agen:A2009EIPMembersrt:MinimumMember2025-01-012025-06-300001098972us-gaap:RetainedEarningsMember2025-03-310001098972us-gaap:NoncontrollingInterestMember2025-01-012025-03-310001098972agen:MiNKTherapeuticsIncMember2025-06-300001098972us-gaap:SubsequentEventMember2025-07-012025-08-110001098972us-gaap:GeneralAndAdministrativeExpenseMember2025-04-012025-06-300001098972agen:Notes2015Memberus-gaap:SeniorSubordinatedNotesMember2022-11-300001098972us-gaap:EmployeeStockOptionMember2024-01-012024-06-300001098972us-gaap:AdditionalPaidInCapitalMember2024-06-300001098972us-gaap:AccumulatedOtherComprehensiveIncomeMember2025-01-012025-03-310001098972agen:LigandPharmaceuticalsIncorporatedMemberus-gaap:CommonStockMember2024-05-310001098972agen:NonCashRoyaltyRevenueMember2024-01-012024-06-300001098972agen:PromissoryNoteMember2025-06-300001098972agen:ResearchAndDevelopmentRevenueMember2025-01-012025-06-300001098972us-gaap:NonUsMemberagen:OtherMember2025-01-012025-06-300001098972agen:OtherMember2025-04-012025-06-300001098972us-gaap:CommonStockMember2024-12-310001098972us-gaap:RestrictedStockMember2025-06-300001098972agen:Notes2015Memberus-gaap:SeniorSubordinatedNotesMember2015-02-280001098972srt:DirectorMember2025-04-012025-06-300001098972us-gaap:PreferredStockMemberagen:SeriesA1ConvertiblePreferredStockMember2024-12-310001098972us-gaap:EmployeeStockOptionMember2025-01-012025-06-300001098972us-gaap:RestrictedStockMember2025-04-012025-06-300001098972us-gaap:CommonStockMember2024-01-012024-03-310001098972us-gaap:NoncontrollingInterestMember2024-12-310001098972agen:LigandPharmaceuticalsIncorporatedMemberagen:PurchaseAndSaleAgreementMember2025-01-012025-06-300001098972agen:RoyaltyPurchaseAgreementMemberagen:GSKAgreementsMemberagen:HCRMember2018-01-190001098972srt:MaximumMemberus-gaap:SeniorSubordinatedNotesMember2025-02-280001098972country:USagen:ClinicalProductRevenueMember2024-04-012024-06-3000010989722024-04-012024-06-300001098972us-gaap:IntellectualPropertyMember2025-06-300001098972us-gaap:IntellectualPropertyMembersrt:MaximumMember2025-06-3000010989722024-12-310001098972country:US2024-04-012024-06-300001098972us-gaap:SeniorSubordinatedNotesMember2025-02-012025-02-280001098972us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-03-310001098972us-gaap:RestrictedStockMember2024-04-012024-06-300001098972us-gaap:AccumulatedOtherComprehensiveIncomeMember2025-06-300001098972us-gaap:AccumulatedOtherComprehensiveIncomeMember2025-03-310001098972us-gaap:IntellectualPropertyMember2024-12-310001098972agen:SeriesA1ConvertiblePreferredStockMember2024-04-012024-06-300001098972us-gaap:ResearchAndDevelopmentExpenseMember2024-01-012024-06-300001098972country:US2024-01-012024-06-300001098972agen:RevenueMember2025-01-012025-06-300001098972agen:NonCashRoyaltyRevenueMembercountry:US2024-04-012024-06-300001098972agen:EmployeeBonusMember2024-01-012024-06-300001098972agen:OtherMember2025-01-012025-06-300001098972us-gaap:RetainedEarningsMember2025-01-012025-03-310001098972us-gaap:WarrantMember2025-01-012025-06-300001098972us-gaap:NonUsMember2024-01-012024-06-300001098972srt:DirectorMember2024-01-012024-06-300001098972us-gaap:EmployeeStockOptionMember2025-04-012025-06-300001098972us-gaap:PreferredStockMemberagen:SeriesA1ConvertiblePreferredStockMember2023-12-310001098972us-gaap:NonUsMemberagen:OtherMember2025-04-012025-06-300001098972us-gaap:WarrantMember2024-04-012024-06-300001098972us-gaap:PreferredStockMemberagen:SeriesA1ConvertiblePreferredStockMember2024-03-310001098972us-gaap:ResearchAndDevelopmentExpenseMember2024-04-012024-06-300001098972us-gaap:OtherIntangibleAssetsMembersrt:MaximumMember2025-06-300001098972us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-12-310001098972us-gaap:WarrantMember2024-01-012024-06-300001098972srt:MinimumMemberus-gaap:IntellectualPropertyMember2025-06-300001098972us-gaap:AdditionalPaidInCapitalMember2025-03-310001098972us-gaap:RetainedEarningsMember2025-06-300001098972us-gaap:CommonStockMember2024-03-310001098972agen:Notes2015Memberus-gaap:SeniorSubordinatedNotesMember2025-01-012025-06-300001098972us-gaap:RestrictedStockMember2025-01-012025-06-300001098972agen:MiNKTherapeuticsIncMember2024-04-012024-06-300001098972us-gaap:SeniorSubordinatedNotesMember2025-06-300001098972agen:SecuritiesPurchaseAgreementMemberagen:ZynextVenturesUSALLCMember2025-06-032025-06-030001098972agen:NonCashRoyaltyRevenueMembercountry:US2025-01-012025-06-300001098972agen:MiNKTherapeuticsIncMemberus-gaap:AdditionalPaidInCapitalMember2024-04-012024-06-300001098972us-gaap:TreasuryStockCommonMember2025-04-012025-06-300001098972us-gaap:OtherIntangibleAssetsMember2024-12-310001098972agen:PromissoryNoteMember2024-12-310001098972agen:NonCashRoyaltyRevenueMember2025-01-012025-06-300001098972agen:NewSalesAgreementMemberagen:AtMarketIssuanceSalesAgreementMemberagen:BRileyFBRIncMember2025-01-012025-06-300001098972us-gaap:IntellectualPropertyMembersrt:MaximumMember2024-12-310001098972us-gaap:AdditionalPaidInCapitalMember2024-03-310001098972us-gaap:SeniorSubordinatedNotesMember2025-01-012025-06-300001098972agen:TwoThousandFifteenSubordinatedNotesMember2025-06-300001098972us-gaap:NoncontrollingInterestMember2024-03-310001098972us-gaap:CarryingReportedAmountFairValueDisclosureMember2024-12-310001098972us-gaap:CommonStockMember2023-12-310001098972us-gaap:AdditionalPaidInCapitalMember2024-01-012024-03-310001098972country:USagen:ClinicalProductRevenueMember2024-01-012024-06-3000010989722024-01-012024-03-310001098972us-gaap:TrademarksMembersrt:MaximumMember2025-06-300001098972us-gaap:NonUsMember2025-01-012025-06-300001098972agen:A2019EIPMembersrt:MaximumMember2025-06-300001098972agen:LicenseAgreementMemberagen:ZydusPharmaceuticalsIncMember2025-06-032025-06-030001098972us-gaap:CommonStockMember2025-04-012025-06-300001098972agen:MiNKTherapeuticsIncMember2024-05-310001098972agen:NonCashRoyaltyRevenueMembercountry:US2025-04-012025-06-300001098972agen:LigandPharmaceuticalsIncorporatedMemberagen:PurchaseAndSaleAgreementMemberagen:CoveredLicenseAgreementsMember2024-05-012024-05-310001098972us-gaap:TrademarksMember2025-06-300001098972us-gaap:NoncontrollingInterestMember2024-01-012024-03-310001098972agen:SeriesA1ConvertiblePreferredStockMember2025-06-300001098972us-gaap:NonUsMemberagen:OtherMember2024-04-012024-06-300001098972us-gaap:AdditionalPaidInCapitalMember2025-04-012025-06-300001098972us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-12-310001098972us-gaap:SeniorSubordinatedNotesMemberagen:AWarrantsAndBWarrantsMember2025-02-280001098972agen:LigandPharmaceuticalsIncorporatedMemberagen:PurchaseAndSaleAgreementMember2024-05-012024-05-310001098972us-gaap:PreferredStockMemberagen:SeriesA1ConvertiblePreferredStockMember2025-06-300001098972us-gaap:FairValueInputsLevel3Member2024-12-310001098972country:USagen:ClinicalProductRevenueMember2025-01-012025-06-300001098972us-gaap:RetainedEarningsMember2025-04-012025-06-300001098972agen:NonCashRoyaltyRevenueMember2025-04-012025-06-300001098972us-gaap:NoncontrollingInterestMember2024-04-012024-06-300001098972agen:MiNKTherapeuticsIncMemberus-gaap:SubsequentEventMember2025-07-012025-07-310001098972agen:ClinicalProductRevenueMember2024-04-012024-06-300001098972us-gaap:CommonStockMember2024-04-012024-06-300001098972us-gaap:OtherIntangibleAssetsMembersrt:MinimumMember2024-12-310001098972agen:OtherMember2024-01-012024-06-300001098972us-gaap:NonUsMemberagen:OtherMember2024-01-012024-06-300001098972agen:SeriesA1ConvertiblePreferredStockMember2025-04-012025-06-3000010989722024-01-012024-06-300001098972us-gaap:NonUsMember2025-04-012025-06-300001098972us-gaap:FairValueInputsLevel2Member2024-12-310001098972agen:ClinicalProductRevenueMember2025-01-012025-06-300001098972us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-01-012024-03-310001098972agen:NonCashRoyaltyRevenueRelatedToTheSaleOfFutureRoyaltiesMember2025-04-012025-06-300001098972agen:RoyaltyPurchaseAgreementMemberagen:LigandPharmaceuticalsIncorporatedMember2025-01-012025-06-300001098972agen:A2009EIPMembersrt:MaximumMember2025-01-012025-06-3000010989722025-01-012025-06-300001098972us-gaap:ResearchAndDevelopmentExpenseMember2025-01-012025-06-300001098972agen:NonCashRoyaltyRevenueRelatedToTheSaleOfFutureRoyaltiesMember2024-01-012024-06-300001098972us-gaap:OtherIntangibleAssetsMembersrt:MinimumMember2025-06-300001098972agen:OtherMember2025-06-300001098972us-gaap:GeneralAndAdministrativeExpenseMember2025-01-012025-06-3000010989722025-01-012025-03-310001098972us-gaap:RestrictedStockMember2024-01-012024-06-300001098972agen:PromissoryNoteMember2025-03-310001098972agen:Notes2015Memberus-gaap:SeniorSubordinatedNotesMember2025-06-300001098972us-gaap:CommonStockMember2024-06-3000010989722025-04-012025-06-300001098972agen:Notes2015Memberus-gaap:SeniorSubordinatedNotesMember2025-02-012025-02-280001098972us-gaap:ResearchAndDevelopmentExpenseMember2025-04-012025-06-300001098972srt:DirectorMember2024-04-012024-06-300001098972agen:RoyaltyPurchaseAgreementMemberagen:GSKAgreementsMemberagen:HCRMember2025-01-012025-06-300001098972us-gaap:FairValueInputsLevel2Member2025-06-300001098972agen:Notes2015Memberus-gaap:SeniorSubordinatedNotesMember2025-02-280001098972us-gaap:TrademarksMember2024-12-310001098972us-gaap:TrademarksMembersrt:MaximumMember2024-12-310001098972agen:NonCashRoyaltyRevenueRelatedToTheSaleOfFutureRoyaltiesMember2025-01-012025-06-300001098972srt:MinimumMemberus-gaap:TrademarksMember2025-06-300001098972agen:SeriesA1ConvertiblePreferredStockMember2024-01-012024-06-300001098972us-gaap:RetainedEarningsMember2023-12-310001098972agen:A2009EIPMember2025-01-012025-06-300001098972agen:NonCashRoyaltyRevenueMembercountry:US2024-01-012024-06-300001098972agen:A2019ESPPMember2025-01-012025-06-300001098972agen:RevenueMember2025-04-012025-06-300001098972us-gaap:FairValueInputsLevel1Member2025-06-300001098972us-gaap:AccumulatedOtherComprehensiveIncomeMember2025-04-012025-06-300001098972us-gaap:EmployeeStockOptionMember2024-04-012024-06-300001098972us-gaap:RetainedEarningsMember2024-04-012024-06-300001098972us-gaap:PreferredStockMemberagen:SeriesA1ConvertiblePreferredStockMember2025-03-310001098972agen:ResearchAndDevelopmentRevenueMember2024-04-012024-06-300001098972agen:A2019EIPMember2025-01-012025-06-300001098972agen:LigandPharmaceuticalsIncorporatedMemberagen:PurchaseAndSaleAgreementMember2025-06-300001098972us-gaap:NoncontrollingInterestMember2025-06-300001098972us-gaap:GeneralAndAdministrativeExpenseMember2024-04-012024-06-300001098972agen:RevenueMember2024-04-012024-06-300001098972us-gaap:NoncontrollingInterestMember2024-01-012024-12-310001098972us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-06-300001098972us-gaap:RetainedEarningsMember2024-01-012024-03-310001098972agen:PromissoryNoteMember2024-11-300001098972srt:MinimumMemberus-gaap:TrademarksMember2024-12-310001098972us-gaap:CarryingReportedAmountFairValueDisclosureMemberus-gaap:MoneyMarketFundsMember2025-06-300001098972us-gaap:RetainedEarningsMember2024-12-310001098972agen:ClinicalProductRevenueMember2025-04-012025-06-300001098972agen:SaponiQxIncMember2024-12-310001098972us-gaap:EstimateOfFairValueFairValueDisclosureMember2025-06-300001098972us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-04-012024-06-300001098972us-gaap:RetainedEarningsMember2024-03-310001098972us-gaap:MoneyMarketFundsMemberus-gaap:EstimateOfFairValueFairValueDisclosureMember2024-12-310001098972us-gaap:NoncontrollingInterestMember2025-04-012025-06-300001098972agen:NewSalesAgreementMemberagen:AtMarketIssuanceSalesAgreementMemberagen:BRileyFBRIncMember2025-04-012025-06-300001098972us-gaap:NoncontrollingInterestMember2025-03-310001098972us-gaap:AdditionalPaidInCapitalMember2025-06-300001098972us-gaap:AdditionalPaidInCapitalMember2025-01-012025-03-310001098972agen:OtherMember2024-04-012024-06-300001098972us-gaap:NoncontrollingInterestMember2023-12-310001098972agen:NewSalesAgreementMemberagen:AtMarketIssuanceSalesAgreementMember2024-08-080001098972agen:MiNKTherapeuticsIncMember2024-05-012024-05-310001098972us-gaap:RestrictedStockMember2025-01-012025-06-300001098972us-gaap:NoncontrollingInterestMember2024-06-300001098972us-gaap:PreferredStockMemberagen:SeriesA1ConvertiblePreferredStockMember2024-06-300001098972us-gaap:NoncontrollingInterestMember2025-01-012025-06-300001098972agen:OtherMember2024-12-310001098972agen:NonCashRoyaltyRevenueMember2024-04-012024-06-300001098972agen:AtMarketIssuanceSalesAgreementMemberagen:NewSalesAgreementMemberagen:BRileyFBRIncMember2025-06-300001098972us-gaap:EstimateOfFairValueFairValueDisclosureMember2024-12-310001098972us-gaap:GeneralAndAdministrativeExpenseMember2024-01-012024-06-3000010989722024-06-300001098972us-gaap:MoneyMarketFundsMemberus-gaap:EstimateOfFairValueFairValueDisclosureMember2025-06-3000010989722025-08-070001098972us-gaap:RetainedEarningsMember2024-06-300001098972us-gaap:OtherIntangibleAssetsMember2025-06-300001098972us-gaap:AdditionalPaidInCapitalMember2023-12-310001098972srt:DirectorMember2025-01-012025-06-300001098972agen:PurchasedAssetsMemberagen:ZydusPharmaceuticalsIncMemberagen:PurchaseAgreementMember2025-06-032025-06-030001098972agen:DebenturesMember2025-06-3000010989722025-06-300001098972agen:Notes2015Memberus-gaap:SeniorSubordinatedNotesMember2022-11-302022-11-300001098972agen:RoyaltyPurchaseAgreementMemberagen:GSKAgreementsMemberagen:HCRMember2018-01-182018-01-190001098972us-gaap:CommonStockMember2025-01-012025-03-310001098972us-gaap:CarryingReportedAmountFairValueDisclosureMemberus-gaap:MoneyMarketFundsMember2024-12-310001098972us-gaap:CommonStockMember2025-03-310001098972agen:SecuritiesPurchaseAgreementMemberagen:ZynextVenturesUSALLCMember2025-06-030001098972us-gaap:CarryingReportedAmountFairValueDisclosureMember2025-06-300001098972agen:ResearchAndDevelopmentRevenueMember2024-01-012024-06-3000010989722024-01-012024-12-3100010989722023-12-310001098972agen:MiNKTherapeuticsIncMember2025-03-310001098972agen:TwoThousandFifteenSubordinatedNotesMember2024-12-310001098972us-gaap:WarrantMember2025-04-012025-06-300001098972agen:MiNKTherapeuticsIncMemberus-gaap:NoncontrollingInterestMember2024-04-012024-06-300001098972us-gaap:FairValueInputsLevel1Member2024-12-310001098972us-gaap:EmployeeStockOptionMember2025-06-30xbrli:purexbrli:sharesagen:Segmentiso4217:USDxbrli:sharesagen:Actioniso4217:USD

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2025

or

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 000-29089

Agenus Inc.

(exact name of registrant as specified in its charter)

 

 

Delaware

 

06-1562417

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

3 Forbes Road, Lexington, Massachusetts 02421

(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code:

(781) 674-4400

 

Securities registered or to be registered pursuant to Section 12(b) of the Act.

 

Title of each class

Trading symbol(s)

Name of each exchange on which registered

Common stock, par value $0.01

AGEN

The Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

 

 

 

 

Emerging growth company

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

 

Number of shares outstanding of the issuer’s Common Stock as of August 7, 2025: 31,864,108 shares.

 

 


 

 

Agenus Inc.

Six Months Ended June 30, 2025

Table of Contents

 

 

 

 

Page

PART I

 

 

ITEM 1.

 

Financial Statements:

 

2

 

 

Condensed Consolidated Balance Sheets as of June 30, 2025 (Unaudited) and December 31, 2024

 

2

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2025 and 2024 (Unaudited)

 

3

 

 

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Deficit for the three and six months ended June 30, 2025 and 2024 (Unaudited)

 

4

 

 

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2025 and 2024 (Unaudited)

 

6

 

 

Notes to Unaudited Condensed Consolidated Financial Statements

 

7

ITEM 2.

 

Management's Discussion and Analysis of Financial Condition and Results of Operations

 

20

ITEM 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

25

ITEM 4.

 

Controls and Procedures

 

26

 

 

 

PART II

 

 

ITEM 1.

 

Legal Proceedings

 

27

ITEM 1A.

 

Risk Factors

 

27

ITEM 5.

 

Other Information

 

27

ITEM 6.

 

Exhibits

 

28

 

 

Signatures

 

29

 

 

 

 


 

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

AGENUS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Amounts in thousands, except share and per share amounts)

 

 

June 30, 2025
(unaudited)

 

 

December 31, 2024

 

ASSETS

 

 

 

 

 

 

Cash and cash equivalents

 

$

9,534

 

 

$

40,437

 

Accounts receivable

 

 

709

 

 

 

407

 

Prepaid expenses

 

 

1,337

 

 

 

2,315

 

Other current assets

 

 

1,760

 

 

 

2,415

 

Total current assets

 

 

13,340

 

 

 

45,574

 

Property, plant and equipment, net of accumulated amortization and depreciation of
   $74,782 and $72,553 at June 30, 2025 and December 31, 2024, respectively

 

 

112,722

 

 

 

120,087

 

Operating lease right-of-use assets

 

 

26,421

 

 

 

27,308

 

Goodwill

 

 

24,092

 

 

 

24,092

 

Acquired intangible assets, net of accumulated amortization of $17,156 and
   $16,986 at June 30, 2025 and December 31, 2024, respectively

 

 

3,206

 

 

 

3,376

 

Other long-term assets

 

 

5,440

 

 

 

5,834

 

Total assets

 

$

185,221

 

 

$

226,271

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

Current portion, long-term debt

 

$

10,721

 

 

$

2,698

 

Current portion, liability related to sale of future royalties and milestones

 

 

103,703

 

 

 

111,978

 

Current portion, deferred revenue

 

 

45

 

 

 

31

 

Current portion, operating lease liabilities

 

 

2,496

 

 

 

2,446

 

Accounts payable

 

 

74,396

 

 

 

61,470

 

Accrued liabilities

 

 

39,311

 

 

 

34,961

 

Other current liabilities

 

 

3,891

 

 

 

7,817

 

Total current liabilities

 

 

234,563

 

 

 

221,401

 

Long-term debt, net of current portion

 

 

23,151

 

 

 

30,473

 

Liability related to sale of future royalties and milestones, net of current portion

 

 

208,526

 

 

 

224,389

 

Deferred revenue, net of current portion

 

 

1,143

 

 

 

1,143

 

Operating lease liabilities, net of current portion

 

 

53,394

 

 

 

54,551

 

Other long-term liabilities

 

 

752

 

 

 

738

 

Commitments and contingencies

 

 

 

 

 

 

STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

Series A-1 convertible preferred stock; 31,620 shares designated, issued, and
   outstanding at June 30, 2025 and December 31, 2024; liquidation value
   of $34,209 at June 30, 2025

 

 

0

 

 

 

0

 

Common stock, par value $0.01 per share; 800,000,000 shares authorized;
   30,004,430 and 23,634,670 shares issued and outstanding at
 June 30, 2025 and December 31, 2024, respectively

 

 

300

 

 

 

236

 

Additional paid-in capital

 

 

1,882,704

 

 

 

1,857,662

 

Accumulated other comprehensive loss

 

 

(1,504

)

 

 

(1,398

)

Accumulated deficit

 

 

(2,236,101

)

 

 

(2,182,880

)

Total stockholders’ deficit attributable to Agenus Inc.

 

 

(354,601

)

 

 

(326,380

)

Non-controlling interest

 

 

18,293

 

 

 

19,956

 

Total stockholders’ deficit

 

 

(336,308

)

 

 

(306,424

)

Total liabilities and stockholders’ deficit

 

$

185,221

 

 

$

226,271

 

See accompanying notes to unaudited condensed consolidated financial statements.

2


 

AGENUS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(Amounts in thousands, except per share amounts)

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

334

 

 

$

267

 

 

$

334

 

 

$

267

 

Service revenue

 

 

526

 

 

 

660

 

 

 

1,036

 

 

 

898

 

Non-cash royalty revenue related to the sale of future royalties

 

 

24,831

 

 

 

22,582

 

 

 

48,387

 

 

 

50,349

 

Total revenues

 

 

25,691

 

 

 

23,509

 

 

 

49,757

 

 

 

51,514

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of service revenue

 

 

(243

)

 

 

(115

)

 

 

(380

)

 

 

(222

)

Research and development

 

 

(26,710

)

 

 

(36,771

)

 

 

(48,231

)

 

 

(80,696

)

General and administrative

 

 

(15,518

)

 

 

(16,816

)

 

 

(31,237

)

 

 

(33,672

)

Fair value adjustments

 

 

69

 

 

 

 

 

 

69

 

 

 

 

Operating loss

 

 

(16,711

)

 

 

(30,193

)

 

 

(30,022

)

 

 

(63,076

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Non-operating income (expense)

 

 

(12

)

 

 

7,141

 

 

 

(276

)

 

 

6,036

 

Interest expense, net

 

 

(13,289

)

 

 

(31,745

)

 

 

(26,084

)

 

 

(61,211

)

Net loss

 

 

(30,012

)

 

 

(54,797

)

 

 

(56,382

)

 

 

(118,251

)

Dividends on Series A-1 convertible preferred stock

 

 

(54

)

 

 

(54

)

 

 

(108

)

 

 

(107

)

Less: net loss attributable to non-controlling interest

 

 

(2,057

)

 

 

(1,716

)

 

 

(3,161

)

 

 

(3,284

)

Net loss attributable to Agenus Inc. common stockholders

 

$

(28,009

)

 

$

(53,135

)

 

$

(53,329

)

 

$

(115,074

)

Per common share data:

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss attributable to Agenus Inc. common stockholders

 

$

(1.00

)

 

$

(2.52

)

 

$

(2.03

)

 

$

(5.56

)

Weighted average number of Agenus Inc. common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

28,117

 

 

 

21,062

 

 

 

26,303

 

 

 

20,715

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation income (loss)

 

$

(36

)

 

$

70

 

 

$

(106

)

 

$

(46

)

Other comprehensive income (loss)

 

 

(36

)

 

 

70

 

 

 

(106

)

 

 

(46

)

Comprehensive loss

 

$

(28,045

)

 

$

(53,065

)

 

$

(53,435

)

 

$

(115,120

)

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

3


 

AGENUS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT

(Unaudited)

(Amounts in thousands)

 

 

 

Series A-1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Convertible

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preferred Stock

 

 

Common Stock

 

 

 

 

 

Treasury Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Number of
Shares

 

 

Par
Value

 

 

Number of
Shares

 

 

Par
Value

 

 

Additional
Paid-In
Capital

 

 

Number
of Shares

 

 

Amount

 

 

Accumulated
Other
Comprehensive
Income (Loss)

 

 

Non-controlling
Interest

 

 

Accumulated
Deficit

 

 

Total

 

Balance at December 31, 2024

 

 

32

 

 

$

0

 

 

 

23,635

 

 

$

236

 

 

$

1,857,662

 

 

 

 

 

$

 

 

$

(1,398

)

 

$

19,956

 

 

$

(2,182,880

)

 

 

(306,424

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,104

)

 

 

(25,266

)

 

 

(26,370

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(70

)

 

 

 

 

 

 

 

 

(70

)

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,587

 

 

 

 

 

 

 

 

 

 

 

 

597

 

 

 

 

 

 

3,184

 

Shares sold at the market

 

 

 

 

 

 

 

 

2,783

 

 

 

28

 

 

 

6,315

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,343

 

Payment of CEO payroll in shares

 

 

 

 

 

 

 

 

33

 

 

 

1

 

 

 

88

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

89

 

Issuance of warrants

 

 

 

 

 

 

 

 

 

 

 

 

 

 

398

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

398

 

Issuance of shares for services

 

 

 

 

 

 

 

 

11

 

 

 

 

 

 

39

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

39

 

Issuance of shares in connection with debt agreement

 

 

 

 

 

 

 

 

66

 

 

 

1

 

 

 

219

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

220

 

Vesting of nonvested shares

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options and employee share purchases

 

 

 

 

 

 

 

 

18

 

 

 

 

 

 

43

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

44

 

Issuance of shares for employee salaries

 

 

 

 

 

 

 

 

24

 

 

 

 

 

 

171

 

 

 

(8

)

 

 

(22

)

 

 

 

 

 

 

 

 

 

 

 

149

 

Retirement of treasury shares

 

 

 

 

 

 

 

 

(8

)

 

 

 

 

 

(22

)

 

 

8

 

 

 

22

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at March 31, 2025

 

 

32

 

 

$

0

 

 

 

26,563

 

 

$

266

 

 

$

1,867,500

 

 

 

 

 

$

 

 

$

(1,468

)

 

$

19,450

 

 

$

(2,208,146

)

 

$

(322,398

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,057

)

 

 

(27,955

)

 

 

(30,012

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(36

)

 

 

 

 

 

 

 

 

(36

)

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,438

 

 

 

 

 

 

 

 

 

 

 

 

900

 

 

 

 

 

 

3,338

 

Shares sold at the market

 

 

 

 

 

 

 

 

3,136

 

 

 

31

 

 

 

12,186

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

12,217

 

Payment of CEO payroll in shares

 

 

 

 

 

 

 

 

40

 

 

 

 

 

 

114

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

114

 

Issuance of shares for services

 

 

 

 

 

 

 

 

9

 

 

 

 

 

 

26

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

26

 

Issuance of shares in connection with debt agreement

 

 

 

 

 

 

 

 

179

 

 

 

2

 

 

 

402

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

404

 

Vesting of nonvested shares

 

 

 

 

 

 

 

 

15

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of shares for employee salaries

 

 

 

 

 

 

 

 

91

 

 

 

1

 

 

 

103

 

 

 

(29

)

 

 

(65

)

 

 

 

 

 

 

 

 

 

 

 

39

 

Retirement of treasury shares

 

 

 

 

 

 

 

 

(29

)

 

 

 

 

 

(65

)

 

 

29

 

 

 

65

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30, 2025

 

 

32

 

 

$

0

 

 

 

30,004

 

 

$

300

 

 

$

1,882,704

 

 

 

 

 

$

 

 

$

(1,504

)

 

$

18,293

 

 

$

(2,236,101

)

 

$

(336,308

)

 

See accompanying notes to unaudited condensed consolidated financial statements.

4


 

AGENUS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT

(Unaudited)

(Amounts in thousands)

 

 

 

 

Series A-1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Convertible

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preferred Stock

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Number of
Shares

 

 

Par
Value

 

 

Number of
Shares

 

 

Par
Value

 

 

Additional
Paid-In
Capital

 

 

Accumulated
Other
Comprehensive
Income (Loss)

 

 

Non-controlling
Interest

 

 

Accumulated
Deficit

 

 

Total

 

Balance at December 31, 2023

 

 

32

 

 

$

0

 

 

 

19,718

 

 

$

197

 

 

$

1,796,095

 

 

$

(955

)

 

$

11,949

 

 

$

(1,955,668

)

 

$

(148,382

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,568

)

 

 

(61,886

)

 

 

(63,454

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(116

)

 

 

 

 

 

 

 

 

(116

)

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,477

 

 

 

 

 

 

719

 

 

 

 

 

 

4,196

 

Shares sold at the market

 

 

 

 

 

 

 

 

1,249

 

 

 

13

 

 

 

17,158

 

 

 

 

 

 

 

 

 

 

 

 

17,171

 

Payment of CEO payroll in shares

 

 

 

 

 

 

 

 

7

 

 

 

 

 

 

89

 

 

 

 

 

 

 

 

 

 

 

 

89

 

Vesting of nonvested shares

 

 

 

 

 

 

 

 

8

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options and employee share purchases

 

 

 

 

 

 

 

 

12

 

 

 

 

 

 

166

 

 

 

 

 

 

7

 

 

 

 

 

 

173

 

Balance at March 31, 2024

 

 

32

 

 

$

0

 

 

 

20,994

 

 

$

210

 

 

$

1,816,985

 

 

$

(1,071

)

 

$

11,107

 

 

$

(2,017,554

)

 

$

(190,323

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,716

)

 

 

(53,081

)

 

 

(54,797

)

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

70

 

 

 

 

 

 

 

 

 

70

 

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,449

 

 

 

 

 

 

841

 

 

 

 

 

 

9,290

 

Shares sold at the market

 

 

 

 

 

 

 

 

117

 

 

 

1

 

 

 

1,989

 

 

 

 

 

 

 

 

 

 

 

 

1,990

 

Issuance of warrants, net of expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,983

 

 

 

 

 

 

 

 

 

 

 

 

6,983

 

Vesting of nonvested shares

 

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Payment of CEO payroll in shares

 

 

 

 

 

 

 

 

11

 

 

 

 

 

 

114

 

 

 

 

 

 

 

 

 

 

 

 

114

 

MiNK private placement stock sale

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,434

)

 

 

 

 

 

10,234

 

 

 

 

 

 

5,800

 

Exercise of stock options

 

 

 

 

 

 

 

 

2

 

 

 

 

 

 

28

 

 

 

 

 

 

6

 

 

 

 

 

 

34

 

Balance at June 30, 2024

 

 

32

 

 

$

0

 

 

 

21,126

 

 

$

211

 

 

$

1,830,114

 

 

$

(1,001

)

 

$

20,472

 

 

$

(2,070,635

)

 

$

(220,839

)

 

See accompanying notes to unaudited condensed consolidated financial statements.

5


 

AGENUS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(Amounts in thousands, except per share amounts)

 

 

 

Six Months Ended June 30,

 

 

 

2025

 

 

2024

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(56,382

)

 

$

(118,251

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation and amortization

 

 

6,371

 

 

 

6,737

 

Share-based compensation

 

 

7,067

 

 

 

8,185

 

Non-cash royalty revenue

 

 

(48,387

)

 

 

(50,349

)

Non-cash interest expense

 

 

25,681

 

 

 

61,263

 

Loss on sale or disposal of assets, net

 

 

929

 

 

 

9

 

Gain on lease terminations

 

 

 

 

 

(5,475

)

Other, net

 

 

255

 

 

 

1,056

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

(232

)

 

 

25,121

 

Prepaid expenses

 

 

980

 

 

 

5,890

 

Accounts payable

 

 

12,706

 

 

 

(8,718

)

Deferred revenue

 

 

1

 

 

 

(9

)

Accrued liabilities and other current liabilities

 

 

4,230

 

 

 

(386

)

Other operating assets and liabilities

 

 

941

 

 

 

(1,444

)

Net cash used in operating activities

 

 

(45,840

)

 

 

(76,371

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of plant and equipment

 

 

(6

)

 

 

(496

)

Proceeds from sale of plant and equipment

 

 

282

 

 

 

 

Proceeds from sale of long-term investment

 

 

62

 

 

 

488

 

Net cash provided by (used in) investing activities

 

 

338

 

 

 

(8

)

Cash flows from financing activities:

 

 

 

 

 

 

Net proceeds from sale of equity

 

 

18,560

 

 

 

19,161

 

Net proceeds from sale of subsidiary shares in private placement

 

 

 

 

 

5,800

 

Proceeds from Ligand Purchase Agreement, net of expenses

 

 

 

 

 

73,851

 

Proceeds from employee stock purchases and option exercises

 

 

44

 

 

 

207

 

Proceeds from the issuance of long-term debt, net

 

 

2,500

 

 

 

 

Purchase of treasury shares to satisfy tax withholdings

 

 

(87

)

 

 

 

Payment of long-term debt

 

 

(2,500

)

 

 

 

Payment of finance lease obligation

 

 

(3,981

)

 

 

(5,106

)

Net cash provided by financing activities

 

 

14,536

 

 

 

93,913

 

Effect of exchange rate changes on cash

 

 

63

 

 

 

44

 

Net increase (decrease) in cash, cash equivalents and restricted cash

 

 

(30,903

)

 

 

17,578

 

Cash, cash equivalents and restricted cash, beginning of period

 

 

44,071

 

 

 

79,779

 

Cash, cash equivalents and restricted cash, end of period

 

$

13,168

 

 

$

97,357

 

Supplemental cash flow information:

 

 

 

 

 

 

Cash paid for interest

 

$

645

 

 

$

1,193

 

Supplemental disclosures - non-cash activities:

 

 

 

 

 

 

Insurance financing agreement

 

$

552

 

 

$

612

 

Issuance of stock options for payment of certain employee bonuses

 

 

 

 

 

4,966

 

Issuance of subsidiary stock options for payment of certain employee bonuses

 

 

 

 

 

540

 

Lease right-of-use assets obtained in exchange for new operating lease liabilities

 

 

107

 

 

 

105

 

Lease right-of-use assets obtained in exchange for new finance lease liabilities

 

 

 

 

 

122

 

See accompanying notes to unaudited condensed consolidated financial statements.

6


 

AGENUS INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2025

 

Note A – Business, Liquidity and Basis of Presentation

Agenus Inc. (including its subsidiaries, collectively referred to as “Agenus,” the “Company,” “we,” “us,” and “our”) is a clinical-stage biotechnology company specializing in discovering and developing therapies to activate the body's immune system against cancer and infections. Our pipeline includes immune-modulatory antibodies, adoptive cell therapies (via MiNK Therapeutics, Inc. ("MiNK")), and vaccine adjuvants (via SaponiQx, Inc. ("SaponiQx")). Our primary focus is immuno-oncology (“I-O”), and our diverse pipeline is supported by our in-house capabilities, including current good manufacturing practice (“cGMP”) manufacturing and a clinical operations platform. To succeed in I-O, innovation and speed are paramount. We are a vertically integrated biotechnology company equipped with a suite of technology platforms to advance from novel target identification through manufacturing for clinical trials of antibodies and cell therapies. By understanding each patient's cancer, we aim to substantially expand the population benefiting from current I-O therapies. In addition to a diverse pipeline, we have assembled fully integrated end-to-end capabilities including novel target discovery, antibody generation, cell line development and cGMP manufacturing. Leveraging our science and capabilities, we have established strategic partnerships to advance innovation. We believe the next generation of cancer treatment will build on clinically validated antibodies targeting cytotoxic T-lymphocyte antigen 4 (“CTLA-4”) and programmed death receptor-1s (“PD-1”) combined with novel immunomodulatory agents designed to address underlying tumor escape mechanisms.

Our I-O portfolio is driven by several platforms and programs, which we plan to utilize individually and in combination:

Multiple antibody discovery platforms, including proprietary display technologies, to identify future antibody candidates.
Antibody candidate programs, including our lead assets, botensilimab ("BOT") (a multifunctional immune cell activator and human Fc-enhanced CTLA-4 blocking antibody, also known as AGEN1181) and balstilimab ("BAL") (a PD-1 blocking antibody).
Our saponin-based vaccine adjuvant platform, primarily centered around our STIMULON™ cultured plant cell (“cpc”) QS-21 adjuvant (“STIMULON cpcQS-21”).
A pipeline of novel allogeneic invariant natural killer T cell therapies for treating cancer and other immune-mediated diseases, controlled by MiNK.

Our business activities include product research, preclinical and clinical development, intellectual property prosecution, manufacturing, regulatory and clinical affairs, corporate finance and development activities, and support of our collaborations. Our product candidates require successful clinical trials and approvals from regulatory agencies, as well as acceptance in the marketplace. Part of our strategy is to develop and commercialize some of our product candidates through arrangements with academic and corporate collaborators and licensees.

Our cash and cash equivalents at June 30, 2025 were $9.5 million, a decrease of $30.9 million from December 31, 2024. Subsequent to quarter end, we received $5.2 million from sales of our common stock in at the market offerings, and we anticipate receiving $75.0 million upfront plus a $16.0 million equity investment from the closing of our agreements with Zydus Lifesciences Ltd and its affiliates, during the third quarter. Cash and cash equivalents of our subsidiary, MiNK, at March 31, 2025, were $3.2 million. MiNK cash can only be accessed by Agenus through a declaration of a dividend by the MiNK Board of Directors or through settlement of intercompany balances. We have incurred significant losses since our inception in 1994. As of June 30, 2025, we had an accumulated deficit of $2.2 billion and $10.5 million of subordinated notes maturing in June 2026.

Based on our current plans and projections, we believe that our cash resources of $9.5 million at June 30, 2025, along with the post-quarter cash infusions noted above and additional cash inflows from funding we expect to receive in 2025, will be sufficient to satisfy our critical liquidity requirements through 2026. To support operations on an ongoing basis we require additional funding. Since our founding we have financed our operations principally through income and revenues generated from corporate partnerships, advance royalty sales, and proceeds from debt and equity issuances.

Currently we are in discussions with entities including operating companies and financial entities to provide the additional funding necessary to support our operations through our planned registration and launch strategy for botensilimab/balstilimab. However, because the completion of cash funding transactions is not entirely within our control, and in accordance with accounting standards, substantial doubt continues to exist about our ability to continue as a going concern for a period of one year after the date of filing of this Quarterly Report on Form 10-Q. The financial statements have been prepared on a basis that assumes Agenus will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business. Management continues to diligently address the Company’s liquidity needs and has continued to adjust spending in order to preserve liquidity. We expect our sources of funding to include additional out-licensing agreements, asset sales, project financing, and/or sales of equity securities.

7


 

The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with the instructions to Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete annual consolidated financial statements. In the opinion of our management, the condensed consolidated financial statements include all normal and recurring adjustments considered necessary for a fair presentation of our financial position and operating results. All significant intercompany transactions and accounts have been eliminated in consolidation. Operating results for the six months ended June 30, 2025, are not necessarily indicative of the results that may be expected for the year ending December 31, 2025. For further information, refer to our consolidated financial statements and footnotes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”).

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances. Actual results could differ materially from those estimates.

For our foreign subsidiaries, the local currency is the functional currency. Assets and liabilities of our foreign subsidiaries are translated into U.S. dollars using rates in effect at the balance sheet date while revenues and expenses are translated into U.S. dollars using average exchange rates during the period. The cumulative translation adjustment resulting from changes in exchange rates are included in the consolidated balance sheets as a component of accumulated other comprehensive income (loss) in total stockholders’ deficit.

Zydus Transaction

On June 3, 2025, we entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Zydus Pharmaceuticals (USA) Inc. (“Zydus”), a wholly owned subsidiary of Zydus Lifesciences Limited, for the sale to Zydus of substantially all of the assets comprising our manufacturing operations, including both owned and leased assets (the “Purchased Assets”).

As consideration for the sale of the Purchased Assets, Zydus will pay us $75.0 million at closing (less costs related to closing). The Purchase Agreement also includes contingent payments of up to an additional $50.0 million that may be earned based on usage by Agenus of Zydus’ manufacturing business during the 36-month period following the closing.

We also entered into a license agreement with Zydus (the “License Agreement”) under which, upon closing of the Purchase Agreement, Zydus will receive an exclusive license to develop, manufacture and commercialize botensilimab and balstilimab in India and Sri Lanka (the “Territory”) in exchange for a royalty on net sales at a rate of 5%, as may be adjusted by the occurrence of certain contingencies, for a period ending at the later of the expiration of our patent rights in a given country in the Territory or 10 years following first commercial sale in such country.

Additionally, in connection with the Purchase Agreement, we and Zynext Ventures USA LLC (“Zynext”), an indirect wholly-owned subsidiary of Zydus Lifesciences Limited, entered into a Securities Purchase Agreement (the “SPA” and together with the License Agreement and Purchase Agreement the “Zydus Agreements”), pursuant to which Zynext agreed to purchase 2,133,333 shares of our common stock for an aggregate purchase price of approximately $16.0 million, or $7.50 per share.

The Purchase Agreement contains customary representations, warranties and agreements by us and Zydus, indemnification obligations of the parties and certain other obligations of the parties. Closing of the transaction is subject to customary conditions, including receipt of all required government approvals, as well as the entry into a contract manufacturing agreement (under which we will use Zydus for agreed manufacturing needs), the SPA and the License Agreement. We anticipate the Zydus Agreements will close in quarter ending September 30, 2025, as such, the impact of the Zydus Agreements is not reflected in our condensed consolidated financial statements as of and for the three and six months ended June 30, 2025.

We do not currently have title to a substantial portion of leased manufacturing equipment included in the Purchased Assets and as such, the Purchased Assets are not available for immediate sale in their present condition. This precludes the Purchased Assets from being classified as held for sale in our condensed consolidated financial statements as of and for the three and six months ended June 30, 2025. We are currently in active negotiations to obtain title before the closing of the Purchase Agreement.

Note B – Net Loss Per Share

Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding (including common shares issuable under our Amended and Restated Directors’ Deferred Compensation Plan, or “DDCP”). Diluted loss per common share is calculated by dividing loss attributable to common stockholders by the weighted average number of common shares outstanding (including common shares issuable under our DDCP) plus the dilutive effect of outstanding instruments such as warrants, stock options, non-vested shares and convertible preferred stock. Because we reported a net loss attributable to common stockholders for all periods presented, diluted loss per common share is the same as basic loss per common share, as the effect of utilizing the fully diluted share count would have reduced the net loss per common share.

8


 

The following securities (listed on an as-if-converted-to-Common-Stock basis) have been excluded from the computation of diluted weighted average shares outstanding as of June 30, 2025 and 2024, as they would be anti-dilutive (in thousands):

 

 

 

Three and Six Months Ended June 30,

 

 

 

2025

 

 

2024

 

Warrants

 

 

1,032

 

 

 

965

 

Stock options

 

 

5,242

 

 

 

3,367

 

Non-vested shares

 

 

1,313

 

 

 

38

 

Series A-1 convertible preferred stock

 

 

17

 

 

 

17

 

 

Note C – Investments

Cash equivalents consisted of the following as of June 30, 2025 and December 31, 2024 (in thousands):

 

 

June 30, 2025

 

 

December 31, 2024

 

 

 

Cost

 

 

Estimated
Fair Value

 

 

Cost

 

 

Estimated
Fair Value

 

Institutional money market funds

 

$

2,591

 

 

$

2,591

 

 

$

6,954

 

 

$

6,954

 

Total

 

$

2,591

 

 

$

2,591

 

 

$

6,954

 

 

$

6,954

 

As a result of the short-term nature of these investments, there were minimal unrealized holding gains or losses for the three and six months ended June 30, 2025 and 2024.

As of both June 30, 2025 and December 31, 2024, all of the investments listed above were classified as cash equivalents on our condensed consolidated balance sheets.

Note D – Acquired Intangible Assets

Acquired intangible assets consisted of the following as of June 30, 2025 and December 31, 2024 (in thousands):

 

 

As of June 30, 2025

 

 

 

Amortization
period
 (years)

 

Gross carrying
amount

 

 

Accumulated
amortization

 

 

Net carrying
amount

 

Intellectual property

 

7-15 years

 

$

16,841

 

 

$

(15,692

)

 

$

1,149

 

Trademarks

 

4-4.5 years

 

 

882

 

 

 

(882

)

 

 

 

Other

 

2-7 years

 

 

582

 

 

 

(582

)

 

 

 

In-process research and development

 

Indefinite

 

 

2,057

 

 

 

 

 

 

2,057

 

Total

 

 

 

$

20,362

 

 

$

(17,156

)

 

$

3,206

 

 

 

 

As of December 31, 2024

 

 

 

Amortization
period
 (years)

 

Gross carrying
amount

 

 

Accumulated
amortization

 

 

Net carrying
amount

 

Intellectual property

 

7-15 years

 

$

16,841

 

 

$

(15,522

)

 

$

1,319

 

Trademarks

 

4-4.5 years

 

 

882

 

 

 

(882

)

 

 

 

Other

 

2-7 years

 

 

582

 

 

 

(582

)

 

 

 

In-process research and development

 

Indefinite

 

 

2,057

 

 

 

 

 

 

2,057

 

Total

 

 

 

$

20,362

 

 

$

(16,986

)

 

$

3,376

 

 

The weighted average amortization period of our finite-lived intangible assets is 9 years. Amortization expense related to acquired intangibles is estimated at $0.2 million for the remainder of 2025, $0.3 million for the years ending December 31, 2026, 2027 and 2028, and $39,000 for the year ending December 31, 2029.

 

9


 

Note E – Debt

Debt obligations consisted of the following as of June 30, 2025 and December 31, 2024 (in thousands):

 

Debt instrument

 

Principal at
June 30, 2025

 

 

Unamortized
Debt Discount

 

 

Balance at
June 30, 2025

 

Current Portion:

 

 

 

 

 

 

 

 

 

2015 Subordinated Notes

 

$

10,500

 

 

$

(297

)

 

$

10,203

 

Debentures

 

 

146

 

 

 

 

 

 

146

 

Other

 

 

372

 

 

 

 

 

 

372

 

Long-term Portion:

 

 

 

 

 

 

 

 

 

Promissory Note

 

 

24,750

 

 

 

(1,599

)

 

 

23,151

 

Total

 

$

35,768

 

 

$

(1,896

)

 

$

33,872

 

 

Debt instrument

 

Balance at
December 31, 2024

 

 

Unamortized
Debt Discount

 

 

Net balance at
December 31, 2024

 

Current Portion:

 

 

 

 

 

 

 

 

 

2015 Subordinated Notes

 

$

2,471

 

 

$

 

 

$

2,471

 

Debentures

 

 

146

 

 

 

 

 

 

146

 

Other

 

 

81

 

 

 

 

 

 

81

 

Long-term Portion:

 

 

 

 

 

 

 

 

 

2015 Subordinated Notes

 

 

10,500

 

 

 

 

 

 

10,500

 

Promissory Note

 

 

22,000

 

 

 

(2,027

)

 

 

19,973

 

Total

 

$

35,198

 

 

$

(2,027

)

 

$

33,171

 

 

As of June 30, 2025 and December 31, 2024, the principal amount of our outstanding debt balance was $35.8 million and $35.2 million, respectively.

 

Promissory Note

In November 2024, we, through a subsidiary, entered into a promissory note (the “Note”) with Ocean 1181 LLC (the “Lender”) for a loan in an aggregate principal amount of $22.0 million (the “Loan”). The Loan has a two-year term and is principally secured by our manufacturing facility in Berkeley, CA and parcels of land located in Vacaville, CA.

In March 2025, we and the Lender agreed to increase the principal amount under the Note by $2.75 million. As part of the transaction, we reimbursed the Lender for transaction costs and paid a 1% origination fee, totaling approximately $0.3 million. These amounts are presented net of the liability in our condensed consolidated balance sheets and will be amortized to interest expense over the term of the Loan.

Subordinated Notes

In February 2015, we issued subordinated promissory notes in the aggregate principal amount of $14.0 million, of which $10.5 million remains outstanding (the “2015 Subordinated Notes”).

In February 2025, we entered into an Amendment to Notes, Amendment of Warrants and Sale of New Warrants (the “Amendment”) with existing noteholders, pursuant to which we:

extended the maturity date of $10.5 million of the 2015 Subordinated Notes from February 20, 2025 to June 20, 2026;
increased the interest rate under the 2015 Subordinated Notes from 8% to 9% per annum;
secured the obligation to pay the 2015 Subordinated Notes by the grant of a subordinate mortgage on our manufacturing facility in Berkeley, CA and parcels of land located in Vacaville, CA;
extended the expiration date of all 2022 A warrants to purchase shares of the Company’s common stock (the “A Warrants”) and 2022 B warrants to purchase shares of the Company’s common stock (the “B Warrants”) held by such noteholders to purchase a total of 97,500 shares of the Company’s common stock previously issued in 2022 to February 20, 2030 and changed the exercise price to $3.25 per share, which represented a 60-day volume weighted average price as of February 14, 2025 (the “Amended A Warrants” and “Amended B Warrants”); issued to certain noteholders new warrants to purchase 67,500 shares of the Company’s common stock to expire February 20, 2030, and have an exercise price of $3.25 per share, (the “C Warrants” and, together with the Amended A Warrants and the Amended B Warrants, the “New Warrants”);

10


 

committed to registering the New Warrants with the Securities and Exchange Commission within ninety (90) days after February 20, 2025; and
provided that if we conduct a financing of greater than $10.0 million at a price per share below $3.25 before February 20, 2026, the exercise price on the New Warrants will be reduced to the same price at which such financing was conducted.

This Amendment was accounted for as a debt modification. As part of the Amendment, we recorded debt discount of approximately $0.4 million, representing the fair value of the new and modified warrants. This amount is presented net of the liability in our condensed consolidated balance sheets and will be amortized to interest expense over the term of the 2015 Subordinated Notes.

Note F – Liability Related to the Sale of Future Royalties and Milestones

 

The following table shows the activity within the liability account in the six months ended June 30, 2025 (in thousands):

 

 

 

Period from
December 31, 2024 to
June 30, 2025

 

Liability related to sale of future royalties and milestones - beginning balance

 

$

337,539

 

Non-cash royalty revenue

 

 

(48,387

)

Non-cash interest expense recognized

 

 

24,184

 

Liability related to sale of future royalties and milestones - ending balance

 

 

313,336

 

Less: unamortized transaction costs

 

 

(1,107

)

Liability related to sale of future royalties and milestones, net

 

$

312,229

 

 

Healthcare Royalty Partners

In January 2018, we, through our wholly-owned subsidiary Antigenics, LLC (“Antigenics”), entered into a Royalty Purchase Agreement (the “HCR Royalty Purchase Agreement”) with Healthcare Royalty Partners III, L.P. and certain of its affiliates (collectively, “HCR”). Pursuant to the terms of the HCR Royalty Purchase Agreement, we sold to HCR 100% of Antigenics’ worldwide rights to receive royalties from GlaxoSmithKline (“GSK”) on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant. At closing, we received gross proceeds of $190.0 million from HCR. Although we sold all of our rights to receive royalties on sales of GSK’s vaccines containing QS-21, as a result of our obligation to HCR, we are required to account for the $190.0 million in proceeds from this transaction as a liability on our condensed consolidated balance sheet that will be recognized into revenue in proportion to the royalty payments from GSK to HCR over the estimated life of the HCR Royalty Purchase Agreement. The liability is classified between the current and non-current portion of liability related to sale of future royalties and milestones in the condensed consolidated balance sheets based on the estimated royalty payments to be received by HCR in the next 12 months from the financial statement reporting date.

During the six months ended June 30, 2025, we recognized $48.4 million of non-cash royalty revenue, and we recorded $15.5 million of related non-cash interest expense related to the HCR Royalty Purchase Agreement.

As royalties are remitted to HCR from GSK, the balance of the recorded liability will be effectively repaid over the life of the HCR Royalty Purchase Agreement. To determine the amortization of the recorded liability, we are required to estimate the total amount of future royalty payments to be received by HCR. The sum of these amounts less the $190.0 million proceeds we received will be recorded as interest expense over the life of the HCR Royalty Purchase Agreement. Periodically, we assess the estimated royalty payments to be paid to HCR from GSK, and to the extent the amount or timing of the payments is materially different from our original estimates, we will prospectively adjust the amortization of the liability, and the related recognition of interest expense. During the six months ended June 30, 2025, our estimate of the effective annual interest rate over the remaining life of the agreement decreased to 13.5%, which results in a life of contract interest rate of 23.8%.

Ligand Pharmaceuticals

In May 2024, we and certain wholly-owned subsidiaries, entered into a Purchase and Sale Agreement (the "Ligand Purchase Agreement") with Ligand Pharmaceuticals Incorporated ("Ligand").

11


 

Pursuant to the terms of the Ligand Purchase Agreement, Ligand will receive (i) 31.875% of the development, regulatory and commercial milestone payments we were then eligible to receive under our agreements with Bristol-Myers Squibb Company ("BMS"), UroGen Pharma Ltd., Gilead Sciences, Inc. ("Gilead"), Merck Sharpe & Dohme and Incyte Corporation ("Incyte"), (the “Covered License Agreements”) (ii) 18.75% of the royalties the Company receives under the Covered License Agreements; and (iii) a 2.625% synthetic royalty on worldwide net sales of botensilimab and balstilimab (collectively the “Purchased Assets”). In the event that we relicense the programs in the Covered License Agreements, Ligand would retain its economic interest in any new agreement.

The total amounts payable to Ligand are subject to a 50% reduction in the event total payments to Ligand exceed a specified return hurdle. The synthetic royalty is subject to a reduction if annual worldwide net sales exceed a specified level, and a cap on annual worldwide net sales if annual worldwide net sales exceed a higher specified level. The synthetic royalty can increase by 1% based on the occurrence of certain future events.

In consideration for the sale of the Purchased Assets, we received gross proceeds of $75.0 million, less $0.9 million in reimbursable expenses, on the closing date. In addition, Ligand had a time-based option to invest an additional $25.0 million on a pro rata basis ("Purchaser Upsize Option"), which expired on June 30, 2025.

In connection with the sale of the Purchased Assets, we issued to Ligand a warrant (the "Ligand Warrant") to purchase 867,052 shares of our common stock, at an exercise price equal to $17.30 per share.

The $75.0 million in gross proceeds was allocated to the identified components as follows (in thousands):

Liability related to sale of future royalties and milestones

 

$

63,879

 

Ligand Warrant

 

 

7,098

 

Purchaser Upsize Option

 

 

4,023

 

Total Ligand Purchase Agreement gross proceeds

 

$

75,000

 

As a result of our significant continuing involvement in the generation of the cash flows of the Purchased Assets, we are required to account for $63.9 million of the proceeds from this transaction as a liability on our condensed consolidated balance sheet that will be recognized into revenue in proportion to the royalty and milestone payments paid to Ligand over the estimated life of the Ligand Purchase Agreement.

The Purchaser Upsize Option was considered a freestanding financial instrument as it was separately exercisable and could be legally transferred from the Ligand Purchase Agreement. As such, it was accounted for as a written option which was accounted for as a liability at fair value and remeasured at each balance sheet date with changes in fair value recorded in earnings. The fair value of the Purchaser Upsize Option at June 30, 2025 was nil as it expired unexercised.

The Ligand Warrant is considered a freestanding financial instrument that as it is separately exercisable and can be legally transferred from the Ligand Purchase Agreement, which was determined to be equity-classified under ASC 815.

To allocate the proceeds, the Purchaser Upsize Option liability and equity-classified Ligand Warrants were recognized based on their fair values and the residual was allocated to a liability related to the sale of future royalties and milestones on our condensed consolidated balance sheets.

During the six months ended June 30, 2025, we recorded $8.7 million of non-cash interest expense related to the Ligand Purchase Agreement.

As royalties are remitted to us and milestone and sales are earned from the Purchased Assets, the balance of the recorded liability will be effectively repaid over the life of the Ligand Purchase Agreement. To determine the amortization of the recorded liability, we are required to estimate the total amount of future payments that Ligand is entitled to under the Ligand Purchase Agreement. The sum of these amounts less the $63.9 million proceeds allocated to the liability related to sale of future royalties and milestones will be recorded as interest expense over the life of the Ligand Purchase Agreement. Periodically, we assess the estimated royalty and milestone payments to be received and sales to be earned under the Ligand Purchase Agreement, and to the extent the amount or timing of the payments is materially different from our original estimates, we will prospectively adjust the amortization of the liability, and the related recognition of interest expense. As of June 30, 2025, our estimate of the effective annual interest rate over the life of the Ligand Purchase Agreement decreased to 21.0%, which results in a life of contract interest rate of 21.4%.

 

12


 

Note G – Accrued and Other Current Liabilities

Accrued liabilities consisted of the following as of June 30, 2025 and December 31, 2024 (in thousands):

 

 

June 30, 2025

 

 

December 31, 2024

 

Payroll

 

$

12,126

 

 

$

10,872

 

Professional fees

 

 

5,003

 

 

 

4,695

 

Contract manufacturing costs

 

 

4,636

 

 

 

2,915

 

Research services

 

 

10,223

 

 

 

9,720

 

Other

 

 

7,323

 

 

 

6,759

 

Total

 

$

39,311

 

 

$

34,961

 

 

Other current liabilities consisted of the following as of June 30, 2025 and December 31, 2024 (in thousands):

 

 

 

June 30, 2025

 

 

December 31, 2024

 

Finance lease liabilities

 

$

766

 

 

$

4,702

 

Other

 

 

3,125

 

 

 

3,115

 

Total

 

$

3,891

 

 

$

7,817

 

 

Note H – Fair Value Measurements

Assets and liabilities measured at fair value are summarized below (in thousands):

Description

 

June 30, 2025

 

 

Quoted Prices in
Active
Markets for
Identical Assets
(Level 1)

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents (Note C)

 

$

2,591

 

 

$

2,591

 

 

$

 

 

$

 

Long-term investments

 

 

919

 

 

 

919

 

 

 

 

 

 

 

Total

 

$

3,510

 

 

$

3,510

 

 

$

 

 

$

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Contingent purchase price consideration

 

$

318

 

 

$

 

 

$

 

 

$

318

 

Total

 

$

318

 

 

$

 

 

$

 

 

$

318

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Description

 

December 31, 2024

 

 

Quoted Prices in
Active
Markets for
Identical Assets
(Level 1)

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents (Note C)

 

$

6,954

 

 

$

6,954

 

 

$

 

 

$

 

Long-term investments

 

 

1,006

 

 

 

1,006

 

 

 

 

 

 

 

Total

 

$

7,960

 

 

$

7,960

 

 

$

 

 

$

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Purchaser Upsize Option (Note F)

 

$

69

 

 

 

 

 

 

 

 

$

69

 

Contingent purchase price consideration

 

 

318

 

 

 

 

 

 

 

 

 

318

 

Total

 

$

387

 

 

$

 

 

$

 

 

$

387

 

Long-term investments are included in "Other long-term assets" in our condensed consolidated balance sheets.

We measure our contingent purchase price considerations at fair value. The fair values of our contingent purchase price considerations at both June 30, 2025 and December 31, 2024, of $0.3 million, included in "Other long-term liabilities" in our condensed consolidated balance sheets, are based on significant inputs not observable in the market, which require them to be reported as Level 3 liabilities within the fair value hierarchy. The valuation of these liabilities use assumptions we believe would be made by a market participant and are mainly based on estimates from a Monte Carlo simulation of our share price, as well as other factors impacting the probability of triggering the milestone payments.

13


 

Share price was evolved using a geometric Brownian motion, calculated daily for the life of the contingent purchase price considerations.

The fair value of our outstanding debt balance at June 30, 2025 and December 31, 2024 was $35.5 million and $36.3 million, respectively, based on the Level 2 valuation hierarchy of the fair value measurements standard using a present value methodology that was derived by evaluating the nature and terms of each note and considering the prevailing economic and market conditions at the balance sheet date. The principal amount of our outstanding debt balance at June 30, 2025 and December 31, 2024 was $35.8 million and $35.2 million, respectively.

 

Note I – Revenue from Contracts with Customers

Disaggregation of Revenue

The following table presents revenue (in thousands) for the three and six months ended June 30, 2025 and 2024, disaggregated by geographic region and revenue type. Revenue by geographic region is allocated based on the domicile of our respective business operations.

 

 

 

Three months ended June 30, 2025

 

 

 

United States

 

 

Rest of World

 

 

Total

 

Revenue Type

 

 

 

 

 

 

 

 

 

Clinical product revenue

 

$

334

 

 

$

 

 

$

334

 

Other services

 

 

 

 

 

526

 

 

 

526

 

Non-cash royalties

 

 

24,831

 

 

 

 

 

 

24,831

 

 

 

$

25,165

 

 

$

526

 

 

$

25,691

 

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended June 30, 2024

 

Revenue Type

 

 

 

 

 

 

 

 

 

Clinical product revenue

 

$

267

 

 

$

 

 

$

267

 

Other services

 

 

 

 

 

660

 

 

 

660

 

Non-cash royalties

 

 

22,582

 

 

 

 

 

 

22,582

 

 

 

$

22,849

 

 

$

660

 

 

$

23,509

 

 

 

 

Six months ended June 30, 2025

 

 

 

United States

 

 

Rest of World

 

 

Total

 

Revenue Type

 

 

 

 

 

 

 

 

 

Clinical product revenue

 

$

334

 

 

$

 

 

$

334

 

Other services

 

 

 

 

 

1,036

 

 

 

1,036

 

Non-cash royalties

 

 

48,387

 

 

 

 

 

 

48,387

 

 

 

$

48,721

 

 

$

1,036

 

 

$

49,757

 

 

 

 

 

 

 

 

 

 

 

 

 

Six months ended June 30, 2024

 

Revenue Type

 

 

 

 

 

 

 

 

 

Clinical product revenue

 

$

267

 

 

$

 

 

$

267

 

Other services

 

 

 

 

 

898

 

 

 

898

 

Non-cash royalties

 

 

50,349

 

 

 

 

 

 

50,349

 

 

 

$

50,616

 

 

$

898

 

 

$

51,514

 

Contract Balances

Contract assets primarily relate to our rights to consideration for work completed in relation to our research and development services performed but not billed at the reporting date. The contract assets are transferred to receivables when the rights become unconditional. Currently, we do not have any contract assets which have not transferred to a receivable. We had no asset impairment charges related to contract assets in the period. Contract liabilities primarily relate to contracts where we received payments but have not yet satisfied the related performance obligations. The advance consideration received from customers for research and development services or licenses bundled with other promises is a contract liability until the underlying performance obligations are transferred to the customer.

The following table provides information about contract liabilities from contracts with customers (in thousands):

14


 

 

Six months ended June 30, 2025

 

Balance at beginning of period

 

 

Additions

 

 

Deductions

 

 

Balance at end of period

 

Contract liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Deferred revenue

 

$

1,174

 

 

$

45

 

 

$

(31

)

 

$

1,188

 

During the six months ended June 30, 2025, we did not recognize any revenue from amounts included in the contract asset or the contract liability balances from performance obligations satisfied in previous periods. None of the costs to obtain or fulfill a contract were capitalized.

 

Note J – Share-based Compensation Plans

 

In June 2025, our stockholders approved an amendment to our Amended and Restated 2019 Equity Incentive Plan (the "2019 EIP") that increased the maximum number of shares of our common stock available for issuance under our 2019 EIP by 7.0 million shares.

We primarily use the Black-Scholes option pricing model to value stock options granted to employees and non-employees, including stock options granted to members of our Board of Directors. However, the fair value of stock option market-based awards is calculated based on a Monte Carlo simulation as of the date of issuance. All stock options have 10-year terms and generally vest ratably over a 3 or 4-year period.

A summary of option activity for the six months ended June 30, 2025 is presented below:

 

 

Options

 

 

Weighted
Average
Exercise
Price

 

 

Weighted
Average
Remaining
Contractual
Term
(in years)

 

 

Aggregate
Intrinsic
Value

 

Outstanding at December 31, 2024

 

 

5,242,916

 

 

$

28.76

 

 

 

 

 

 

 

Granted

 

 

495,564

 

 

 

3.05

 

 

 

 

 

 

 

Exercised

 

 

 

 

 

 

 

 

 

 

 

 

Forfeited

 

 

(242,539

)

 

 

10.45

 

 

 

 

 

 

 

Expired

 

 

(253,738

)

 

 

56.68

 

 

 

 

 

 

 

Outstanding at June 30, 2025

 

 

5,242,203

 

 

$

25.76

 

 

 

7.83

 

 

$

4,044,166

 

Vested or expected to vest at June 30, 2025

 

 

5,242,203

 

 

$

25.76

 

 

 

7.83

 

 

$

4,044,166

 

Exercisable at June 30, 2025

 

 

2,741,527

 

 

$

43.79

 

 

 

6.54

 

 

$

317,505

 

 

The weighted average grant-date fair values of stock options granted during the six months ended June 30, 2025 and 2024 were $2.90 and $11.53, respectively.

During the six months ended June 30, 2025, all options were granted with exercise prices equal to the market value of the underlying shares of common stock on the grant date other than certain awards dated June 18, 2025. In May 2025, our Board of Directors approved certain awards subject to forfeiture in the event stockholder approval was not obtained for an amendment to our 2019 EIP. This approval was obtained in June 2025. Accordingly, these awards have a grant date of June 2025, with an exercise price as of the date the Board of Director's approved the awards in May 2025.

As of June 30, 2025, there was approximately $8.6 million of total unrecognized share-based compensation expense related to these stock options and stock options granted under subsidiary plans which, if all milestones are achieved, will be recognized over a weighted average period of 1.2 years.

Certain employees and consultants have been granted non-vested stock. The fair value of non-vested market-based awards is calculated based on a Monte Carlo simulation as of the date of issuance. The fair value of other non-vested stock is calculated based on the closing sale price of our common stock on the date of issuance.

15


 

A summary of non-vested stock activity for the six months ended June 30, 2025 is presented below:

 

 

Non-vested
Shares

 

 

Weighted
Average
Grant Date
Fair Value

 

Outstanding at December 31, 2024

 

 

42,222

 

 

$

17.30

 

Granted

 

 

1,598,322

 

 

 

4.30

 

Vested

 

 

(316,728

)

 

 

3.97

 

Forfeited

 

 

(10,598

)

 

 

22.53

 

Outstanding at June 30, 2025

 

 

1,313,218

 

 

$

4.65

 

 

As of June 30, 2025, there was approximately $1.2 million of unrecognized share-based compensation expense related to these non-vested shares and non-vested shares granted under subsidiary plans which will be recognized over a period of 2.4 years.

During the six months ended June 30, 2025, 18,365 shares were issued under the 2019 Employee Stock Purchase Plan and 94,340 shares were issued as a result of the vesting of non-vested stock.

The impact on our results of operations from share-based compensation for the three and six months ended June 30, 2025 and 2024, was as follows (in thousands):

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Research and development

 

$

778

 

 

$

4,722

 

 

$

1,604

 

 

$

6,036

 

General and administrative

 

 

2,663

 

 

 

4,568

 

 

 

5,170

 

 

 

7,450

 

Total share-based compensation expense

 

$

3,441

 

 

$

9,290

 

 

$

6,774

 

 

$

13,486

 

 

Note K – Restricted Cash

As of both June 30, 2025, and December 31, 2024, we maintained non-current restricted cash of $3.6 million. This amount is included within “Other long-term assets” in our condensed consolidated balance sheets and is comprised of deposits under letters of credit required under our facility leases.

The following table provides a reconciliation of cash, cash equivalents and restricted cash that sums to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands):

 

 

 

Six Months Ended June 30, 2025

 

 

Six Months Ended June 30, 2024

 

 

 

Beginning of Period

 

 

End of Period

 

 

Beginning of Period

 

 

End of Period

 

Cash and cash equivalents

 

$

40,437

 

 

$

9,534

 

 

$

76,110

 

 

$

93,723

 

Restricted cash

 

 

3,634

 

 

 

3,634

 

 

 

3,669

 

 

 

3,634

 

Cash, cash equivalents and restricted cash

 

$

44,071

 

 

$

13,168

 

 

$

79,779

 

 

$

97,357

 

 

Note L – Equity

On March 14, 2024, we filed a Post-effective Amendment to an Automatic Shelf Registration Statement on Form POSASR (file no. 333-272911) and a Post-Effective Amendments for Registration Statement on Form POS AM (file no. 333-272911) (together, the “Registration Statement”). The Registration Statement included both a base prospectus that covered the potential offering, issuance and sale from time to time of up to $300.0 million of common stock, preferred stock, warrants, debt securities and units of Agenus and a prospectus supplement for the potential offer and sale of up to 6,725,642 shares of common stock (the “Initial ATM Shares”) in “at the market” offerings pursuant to an At Market Issuance Sales Agreement by and between Agenus and B. Riley Securities, Inc. (the “Sales Agent”), dated as of July 22, 2020 (the “Sales Agreement”). On August 8, 2024, we filed an additional prospectus supplement for the potential offer and sale of up to an additional 13,834,015 shares of common stock (together with the Initial ATM Shares, the “Placement Shares”) in “at the market” offerings pursuant to the Sales Agreement. Sales pursuant to the Sales Agreement will be made only upon our instruction to the Sales Agent, and we cannot provide assurances that we will issue any additional Placement Shares pursuant to the Sales Agreement.

16


 

During the three and six months ended June 30, 2025, we received net proceeds of approximately $12.2 million and $18.6 million from the sale of approximately 3.1 million and 5.9 million shares, respectively, of our common stock in at-the-market offerings under the Sales Agreement.

Note M – Non-controlling Interest

 

Non-controlling interest recorded in our condensed consolidated financial statements as of June 30, 2025 and December 31, 2024, relates to the following approximate interests in certain consolidated subsidiaries, which we do not own.

 

 

June 30, 2025

 

 

December 31, 2024

 

MiNK Therapeutics, Inc.

 

 

45

%

 

 

45

%

SaponiQx, Inc.

 

 

30

%

 

 

30

%

Changes in non-controlling interest for the periods ended June 30, 2025 and December 31, 2024, were as follows (in thousands):

 

 

June 30, 2025

 

 

December 31, 2024

 

Beginning balance

 

$

19,956

 

 

$

11,949

 

 

 

 

 

 

 

 

Net loss attributable to non-controlling interest

 

 

(3,161

)

 

 

(5,059

)

 

 

 

 

 

 

 

Other items:

 

 

 

 

 

 

Sale of subsidiary shares in private placement

 

 

 

 

 

10,234

 

Issuance of subsidiary shares for employee stock purchase plan and exercise of options

 

 

1

 

 

 

20

 

Subsidiary share-based compensation

 

 

1,497

 

 

 

2,812

 

Total other items

 

 

1,498

 

 

 

13,066

 

 

 

 

 

 

 

 

Ending balance

 

$

18,293

 

 

$

19,956

 

Sale of subsidiary shares in private placement

In May 2024, MiNK entered into a Stock Purchase Agreement with a certain investor (the “Purchaser”), pursuant to which MiNK issued and sold an aggregate of 464,000 shares of its Common Stock (the “MiNK Common Shares”), at a purchase price of $12.50 per share. The aggregate purchase price paid by the Purchaser for the MiNK Common Shares was approximately $5.8 million, net of offering expenses.

Note N – Related Party Transactions

In June 2024, Dr. Jennifer Buell was appointed to our Board of Directors. Dr. Buell's spouse is a partner in the law firm of Wolf, Greenfield & Sachs, P.C. (“Wolf Greenfield”), which provides us legal services. For the three and six months ended June 30, 2025, we expensed Wolf Greenfield fees totaling approximately $66,000 and $162,000, respectively, and for the three and six months ended June 30, 2024, we expensed Wolf Greenfield fees totaling approximately $57,000 and $99,000, respectively. Dr. Buell’s spouse does not receive direct compensation from the fees we pay Wolf Greenfield and the fees we paid to Wolf Greenfield in the period were an insignificant amount of Wolf Greenfield’s revenues. Our Audit and Finance Committee approved these services under its related-party transactions policy.

 

Note O – Segment Information

We are managed and currently operate as four segments. However, we have concluded that our operating segments meet the criteria required by Accounting Standards Codification (“ASC”) 280 to be aggregated into one reportable segment. Our operating segments have similar economic characteristics and are similar with respect to the five qualitative characteristics specified in ASC 280. Accordingly, we have one reportable segment. Our one reportable segment is focused on the discovery, development and manufacturing of a comprehensive pipeline of immunological agents designed to expand patient populations benefiting from cancer immunotherapy.

Our Chief Executive Officer serves as our Chief Operating Decision Maker (“CODM”) and is responsible for reviewing company performance and making decisions regarding resource allocation. Our CODM evaluates company performance based on net loss, as included in the Consolidated Statements of Operations and Comprehensive Loss, ensuring resource allocation decisions support company goals.

17


 

The measure of segment assets is total assets, as included in the Condensed Consolidated Balance Sheets. Refer to the condensed consolidated financial statements for other financial information regarding our single reportable segment.

The following table presents selected financial information related to our single reportable segment for the three and six months ended June 30, 2025 and 2024 (in thousands):

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Revenues

 

$

25,691

 

 

$

23,509

 

 

$

49,757

 

 

$

51,514

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

External expenses

 

 

(22,720

)

 

 

(31,776

)

 

 

(41,739

)

 

 

(68,772

)

Payroll related expenses

 

 

(11,327

)

 

 

(14,866

)

 

 

(23,431

)

 

 

(32,269

)

Other operating expenses

 

 

(8,355

)

 

 

(7,060

)

 

 

(14,609

)

 

 

(13,549

)

Operating loss

 

 

(16,711

)

 

 

(30,193

)

 

 

(30,022

)

 

 

(63,076

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(13,343

)

 

 

(32,284

)

 

 

(26,325

)

 

 

(62,558

)

Interest income

 

 

54

 

 

 

539

 

 

 

241

 

 

 

1,347

 

Other income (expense)

 

 

(12

)

 

 

7,141

 

 

 

(276

)

 

 

6,036

 

Net loss

 

$

(30,012

)

 

$

(54,797

)

 

$

(56,382

)

 

$

(118,251

)

In the table above, “Other operating expenses” includes items such as depreciation and amortization expense, stock-based compensation expense, fair value adjustments and expenses related to certain foreign subsidiaries.

 

Note P – Contingencies

 

In September 2024, a putative securities class action lawsuit captioned In re Agenus Inc. Securities Litigation, No. 1:24-cv-12299, was filed in the U.S. District Court for the District of Massachusetts (the “Court”) against the Company and certain of its executives and directors. The Court appointed a lead plaintiff pursuant to the Private Securities Litigation Reform Act, and the lead plaintiff filed an amended complaint on February 7, 2025. The amended complaint alleges that Agenus, three of its current officers, and one member of its advisory board violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions of material fact related to the efficacy and commercial prospects of botensilimab and balstilimab. The lead plaintiff seeks to represent all persons who purchased or otherwise acquired Agenus securities between January 23, 2023, and July 17, 2024, and seeks damages and interest, and an award of costs, including attorneys’ fees. The defendants filed a motion to dismiss the amended complaint on April 8, 2025, which motion remains pending. We are unable to estimate a range of loss, if any, that could result were there to be an adverse decision in this action.

The Company has been served with four derivative actions filed in the Court between November 2024 and January 2025 by purported stockholders. The actions name certain of the Company’s executives and directors and allege that the defendants made false or misleading statements and omissions of material fact related to the efficacy and commercial prospects of botensilimab and balstilimab. On May 2, 2025, the Court consolidated the four actions in Case No. 1:24-cv-12823 and stayed all deadlines pending future developments in the securities class action. We are unable to estimate a range of loss, if any, that could result were there to be an adverse decision in this action.

In September 2024, we received a subpoena from the Boston Regional Office of the U.S. Securities and Exchange Commission seeking records relating to certain of our product candidates, correspondence with the FDA, public disclosure, and other matters. We have produced records pursuant to the subpoena. We are unable to estimate a range of loss, if any, that could result were there to be an adverse decision in this action.

 

Note Q – Recent Accounting Pronouncements

 

Recently Issued, Not Yet Adopted

In December 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 requires incremental annual disclosures around income tax rate reconciliations, income taxes paid and other related disclosures. For public business entities, ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, and is applicable for disclosures in our Annual Report on Form 10-K beginning with the year ending December 31, 2025. We are currently evaluating the impact that ASU 2023-09 will have on the notes to our consolidated financial statements.

18


 

In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (DISE). This new guidance requires all public entities to incorporate disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. Public entities must adopt ASU 2024-03 prospectively for fiscal years beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption and retrospective application are permitted. We are currently evaluating the impact that ASU 2024-03 will have on our consolidated financial statements.

No other new accounting pronouncement issued or effective during the six months ended June 30, 2025 had or is expected to have a material impact on our consolidated financial statements or disclosures.

 

 

Note R – Subsequent Events

At the Market Offerings

During the period of July 1, 2025 through August 7, 2025, we sold approximately 787,000 shares of our common stock under the Sales Agreement, totaling net proceeds of approximately $5.2 million.

MiNK Therapeutics Ownership

In July 2025, our ownership percentage of MiNK dropped below 50%, resulting in a loss of control. As a result, MiNK will no longer be consolidated in our consolidated financial statements. We are currently evaluating the financial statement impact and expect the loss of control to be reflected in our consolidated financial statements for the period ending September 30, 2025.

19


 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Forward Looking Statements

This Quarterly Report on Form 10-Q and other written and oral statements we make from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). You can identify these forward-looking statements by the fact they use words such as “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will,” “potential,” “opportunity,” “future” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. You can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements relate to, among other things, our business strategy, our research and development, our product development efforts, our ability to commercialize our product candidates, the activities of our licensees, our prospects for initiating partnerships or collaborations, the timing of the introduction of products, the effect of new accounting pronouncements, uncertainty regarding our future operating results and our profitability, anticipated sources of funds as well as our plans, objectives, expectations, and intentions.

More detailed descriptions of these risks and uncertainties and other risks and uncertainties applicable to our business that we believe could cause actual results to differ materially from any forward-looking statements are included in in Part I-Item 1A “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024. We encourage you to read those descriptions carefully. Although we believe we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved. We caution investors not to place significant reliance on forward-looking statements contained in this document; such statements need to be evaluated in light of all the information contained in this document. Furthermore, the statements speak only as of the date of this document, and we undertake no obligation to update or revise these statements.

Agenus, MiNK, Prophage, Retrocyte Display and STIMULON are trademarks of Agenus Inc. and its subsidiaries. All rights reserved.

Overview

We are a clinical-stage biotechnology company specializing in discovering and developing therapies to activate the body's immune system against cancer and infections. Our pipeline includes immune-modulatory antibodies, adoptive cell therapies (via MiNK Therapeutics, Inc. ("MiNK")), and vaccine adjuvants (via SaponiQx, Inc. ("SaponiQx")). Our primary focus is immuno-oncology (“I-O”), and our diverse pipeline is supported by our in-house capabilities, including current good manufacturing practice (“cGMP”) manufacturing and a clinical operations platform. To succeed in I-O, innovation and speed are paramount. We are a vertically integrated biotechnology company equipped with a suite of technology platforms to advance from novel target identification through manufacturing for clinical trials of antibodies and cell therapies. By understanding each patient's cancer, we aim to substantially expand the population benefiting from current I-O therapies. In addition to a diverse pipeline, we have assembled fully integrated end-to-end capabilities including novel target discovery, antibody generation, cell line development and cGMP manufacturing. Leveraging our science and capabilities, we have established strategic partnerships to advance innovation. We believe the next generation of cancer treatment will build on clinically validated antibodies targeting cytotoxic T-lymphocyte antigen 4 (“CTLA-4”) and a programmed death receptor-1 (“PD-1”) combined with novel immunomodulatory agents designed to address underlying tumor escape mechanisms.

Our I-O portfolio is driven by several platforms and programs, which we plan to utilize individually and in combination:

Multiple antibody discovery platforms, including proprietary display technologies, to identify future antibody candidates.
Antibody candidate programs, including our lead assets, botensilimab ("BOT") (a multifunctional immune cell activator and human Fc-enhanced CTLA-4 blocking antibody, also known as AGEN1181) and balstilimab ("BAL") (a PD-1 blocking antibody).
Our saponin-based vaccine adjuvant platform, primarily centered around our STIMULON™ cultured plant cell (“cpc”) QS-21 adjuvant (“STIMULON cpcQS-21”).
A pipeline of novel allogeneic invariant natural killer T cell (“iNKT”) therapies for treating cancer and other immune-mediated diseases, controlled by MiNK.

We regularly evaluate development, commercialization, and partnering strategies for each product candidate based on various factors, including pre-clinical and clinical trial results, competitive positioning, funding requirements, and available resources.

20


 

Our lead program, BOT is progressing through multiple clinical programs as a monotherapy and in combination with BAL. In April 2023, BOT in combination with BAL received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of patients with non-microsatellite instability-high (“MSI-H”) and/or deficient mismatch repair (“dMMR”) metastatic colorectal cancer without active liver involvement. This designation specifically targets patients who are heavily pretreated and have shown resistance or intolerance to standard chemotherapies, including fluoropyrimidine, oxaliplatin, and irinotecan, as well as those who have received a VEGF inhibitor, an EGFR inhibitor, and/or a BRAF inhibitor, if indicated. Based on the BOT/BAL clinical data generated to date, we have developed designs for registration-enabling trials in Microsatellite Stable colorectal cancer across neoadjuvant, first-line, and late-line metastatic colorectal cancer. These trial(s) will launch upon completion of strategic transactions. The options being considered are partnerships, licensing, or joint ventures.

We have entered into collaborations with several companies, including Bristol-Myers Squibb Company (“BMS”), Betta Pharmaceuticals Co., Ltd. (“Betta”), UroGen Pharma Ltd. (“UroGen”), Gilead Sciences, Inc. (“Gilead”), Incyte Corporation (“Incyte”), and Merck Sharp & Dohme (“Merck”). These collaborations, along with our internal programs, have resulted in over a dozen antibody pre-clinical or clinical development programs.

Pursuant to our collaboration agreement with Incyte, we had exclusively licensed to Incyte monospecific antibodies targeting GITR, OX40, TIM-3 and LAG-3, as well as an additional undisclosed target. Under the terms of our agreement, Incyte was responsible for all future development expenses, and we were eligible to receive up to an additional $315.0 million in potential milestone payments plus royalties on any future sales. Incyte has terminated the OX40 program, effective October 2023, and both the GITR program and undisclosed program, effective May 2024. Upon termination, the rights to the OX40, GITR, and undisclosed programs reverted back to us. In July 2024, Incyte announced that it would discontinue further development of the LAG-3 program and TIM-3 program and in February 2025, Incyte notified us of their intent to terminate the entire Collaboration Agreement, effective February 2026. Upon termination, the rights to the remaining programs will revert back to us.

Pursuant to our collaboration and license agreement with Merck, we exclusively licensed to Merck a monospecific antibody targeting ILT4 (MK-4830), which Merck advanced in a Phase 2 clinical trial. Merck is responsible for all future development expenses, and we are eligible to receive up to an additional $85.0 million in potential milestone payments, as well as royalties on future sales. In 2024 Merck notified us that the further clinical development of MK-4830 will be limited to a neoadjuvant ovarian study of MK-4830 in combination with pembrolizumab and chemotherapy with or without bevacizumab that is ongoing.

In September 2018, we, through our wholly-owned subsidiary, Agenus Royalty Fund, LLC, entered into a royalty purchase agreement (the “XOMA Royalty Purchase Agreement”) with XOMA (US) LLC (“XOMA”). Pursuant to the terms of the XOMA Royalty Purchase Agreement, XOMA purchased 33% of all future royalties and 10% of all future milestone payments that we are entitled to receive from Incyte and Merck, net of certain of our obligations to a third party.

In December 2018, we entered into collaboration agreements with Gilead for the development and commercialization of up to five novel I-O therapies (the “Gilead Collaboration Agreements”). Gilead received worldwide exclusive rights to our bispecific antibody, AGEN1423, and the exclusive option to license AGEN1223, a bispecific antibody, and AGEN2373, a monospecific antibody. Gilead elected to return AGEN1423 to us in November 2020 and terminated the license agreement. We ceased development of AGEN1223 in the third quarter of 2021, and the option and license agreement for AGEN1223 was formally terminated in October 2021. In August 2024, Gilead elected not to exercise the option to license AGEN2373 and the option and license agreement was formally terminated.

In November 2019, we entered into a license agreement with UroGen, granting them an exclusive, worldwide license (not including Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions) to develop, manufacture, and commercialize zalifrelimab for the treatment of cancers of the urinary tract via intravesical delivery. We received an upfront payment of $10.0 million and are eligible to receive up to $200.0 million in milestone payments, as well as royalties on future sales.

In June 2020, we entered into a license and collaboration agreement (the “Betta License Agreement”) with Betta, pursuant to which we granted Betta an exclusive license to develop, manufacture and commercialize balstilimab and zalifrelimab in Republic of China, Hong Kong, Macau and Taiwan (“Greater China”). Under the terms of the Betta License Agreement, we received $15.0 million upfront and are eligible to receive up to $100.0 million in milestone payments plus royalties on any future sales in Greater China.

In May 2021, we entered into a License, Development, and Commercialization Agreement with BMS for our pre-clinical anti-TIGIT bispecific antibody program, AGEN1777. BMS received an exclusive worldwide license to develop, manufacture, and commercialize AGEN1777 and its derivatives. We received a non-refundable upfront cash payment of $200.0 million. In October 2021, we achieved a $20.0 million milestone upon the dosing of the first patient in the AGEN1777 Phase 1 clinical trial and in December 2023, we announced that the first patient was dosed in an AGEN1777 Phase 2 clinical trial, triggering the achievement of a $25.0 million milestone.

21


 

We received this milestone in January 2024. On July 30, 2024, we received notice from BMS was voluntarily terminating the BMS License Agreement, effective as of January 26, 2025. Upon termination, BMS returned AGEN1777 to us.

In May 2024, we, and certain wholly-owned subsidiaries, entered into a Purchase and Sale Agreement (the “Ligand Purchase Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”) for the sale to Ligand of (i) 31.875% of the development, regulatory and commercial milestone payments we were then eligible to receive under our agreements with BMS, UroGen, Gilead, Merck and Incyte, (the “Covered License Agreements”) (ii) 18.75% of the royalties we receive under the Covered License Agreements; and (iii) a 2.625% synthetic royalty on worldwide net sales of botensilimab and balstilimab (collectively the “Purchased Assets”). The total amounts payable to Ligand are subject to a 50% reduction in the event total payments to Ligand exceed a specified return hurdle. The synthetic royalty is subject to a reduction if annual worldwide net sales exceed a specified level, and a cap on annual worldwide net sales if annual worldwide net sales exceed a higher specified level. The synthetic royalty can increase by 1% based on the occurrence of certain future events. After taking into account our obligations under the Ligand Purchase Agreement, XOMA Royalty Purchase Agreement and the current status of our collaboration agreements, we remain eligible to receive up to approximately $136.3 million and $49.4 million in potential development, regulatory, and commercial milestones from UroGen and Merck, respectively.

In September 2021, we launched SaponiQx to lead innovation in novel adjuvant discovery and vaccine design, focusing on our saponin-based adjuvants. We are particularly dedicated to the development of the next-generation cultured plant cell QS-21. To support this initiative, we partnered with Ginkgo Bioworks, Inc. to develop SaponiQx’s saponin products from sustainably sourced raw materials. Our goal is to meet the demands of the vaccine industry, especially for pandemic vaccines.

Our bark extract QS-21 adjuvant is partnered with GSK and plays a vital role in multiple GSK vaccine programs. These programs are at various stages, including GSK’s approved shingles and RSV vaccines, SHINGRIX and AREXVY, which received FDA approval in the United States in October 2017 and May 2023, respectively. In January 2018, we entered into a Royalty Purchase Agreement with Healthcare Royalty Partners III, L.P. and certain of its affiliates (together, “HCR”), pursuant to which HCR purchased 100% of our worldwide rights to receive royalties from GSK on GSK’s sales of vaccines containing our QS-21 adjuvant. We do not incur clinical development costs for products partnered with GSK. We were also entitled to receive up to $40.35 million in milestone payments from HCR based on sales of GSK’s vaccines as follows: (i) $15.1 million upon reaching $2.0 billion last-twelve-months net sales any time prior to 2024 (the “First HCR Milestone”) and (ii) $25.25 million upon reaching $2.75 billion last-twelve-months net sales any time prior to 2026 (the “Second HCR Milestone”). We received the First HCR Milestone after GSK’s net sales of Shingrix for the twelve months ended December 31, 2019 exceeded $2.0 billion. The Second HCR Milestone was received in 2022 after GSK’s net sales of Shingrix for the twelve months ended June 30, 2022 exceeded $2.75 billion.

In October 2021, we completed the initial public offering (“IPO”) of MiNK, which trades on the Nasdaq Capital Market under the ticker symbol “INKT.” MiNK is a clinical stage biopharmaceutical company focused on developing allogeneic invariant natural killer T (“iNKT”) cell therapies to treat cancer and other life-threatening immune diseases. MiNK’s most advanced product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy. MiNK is currently expanding its clinical programs, with an externally funded Phase 2 trial in second-line gastric cancer actively enrolling at Memorial Sloan Kettering Cancer Center. Additionally, MiNK is evaluating agenT-797 as a variant-agnostic therapy for patients with viral acute respiratory distress syndrome (“ARDS”) in planning for a randomized Phase 2 study addressing an urgent unmet need in patients with pulmonary dysfunction. In May 2024, MiNK secured a $5.8 million private placement financing at a 25% premium, led by GKCC, LLC. In addition to its lead clinical program, MiNK has announced a collaboration with ImmunoScape, Inc. (“ImmunoScape”) to discover and develop next-generation T-cell receptor therapies targeting novel solid tumor antigens. This partnership leverages MiNK’s proprietary library of T-cell antigens and ImmunoScape’s platform for rapid discovery of novel T-cell receptors.

Our business activities include product research, preclinical and clinical development, intellectual property prosecution, manufacturing, regulatory and clinical affairs, corporate finance and development activities, and support of our collaborations. Our product candidates require successful clinical trials and approvals from regulatory agencies, as well as acceptance in the marketplace. Part of our strategy is to develop and commercialize some of our product candidates through arrangements with academic and corporate collaborators and licensees.

Our common stock is currently listed on The Nasdaq Capital Market under the symbol “AGEN.”

Historical Results of Operations

Three months ended June 30, 2025 compared to the three months ended June 30, 2024

Non-cash royalty revenue related to the sale of future royalties

22


 

In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant to HCR. As described in Note F to our Condensed Consolidated Financial Statements, this transaction has been recorded as a liability that amortizes over the estimated life of our Royalty Purchase Agreement with HCR. As a result of this liability accounting, even though the royalties are remitted directly to HCR, we record these royalties from GSK as revenue. Non-cash royalty revenue related to our agreement with GSK increased $2.2 million, to approximately $24.8 million for the three months ended June 30, 2025, from $22.6 million for the three months ended June 30, 2024, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant.

Research and development expense

Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of consultants, and administrative costs. Research and development expense decreased 27% to $26.7 million for the three months ended June 30, 2025 from $36.8 million for the three months ended June 30, 2024. Decreased expenses in the three months ended June 30, 2025 primarily relate to a $6.6 million decrease in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs, a $2.7 million decrease in personnel related expenses, mainly due to a decrease in headcount, and a $0.8 million decrease in other research and development expenses.

General and administrative expense

General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 8% to $15.5 million for the three months ended June 30, 2025 from $16.8 million for the three months ended June 30, 2024. Decreased expenses in the three months ended June 30, 2025 primarily relate to a $1.8 million decrease in personnel related expenses, mainly due to a decrease in headcount, and a $0.2 million decrease in other general and administrative expenses. These decreases were partially offset by a $0.3 million increase in expenses attributable to the activities of our subsidiaries and a $0.3 million increase in professional fees.

Non-operating income (expense)

Non-operating expense increased to approximately $12,000 for the three months ended June 30, 2025 from income of $7.1 million for the three months ended June 30, 2024, primarily due to de minimis activity in the three months ended June 30, 2025, compared to the recognition of a $5.5 million gain on the early termination of two operating leases and the recognition of R&D tax credits in the UK in the three months ended June 30, 2024.

Interest expense, net

Interest expense, net decreased to approximately $13.3 million for the three months ended June 30, 2025 from $31.7 million for the three months ended June 30, 2024, mainly due to decreased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR, primarily attributable to decreased sales forecasts of GSK’s vaccines containing our STIMULON QS-21 adjuvant, partially offset by an increase of the non-cash interest expense recorded in connection with our Ligand Purchase Agreement.

Six months ended June 30, 2025 compared to the six months ended June 30, 2024

Non-cash royalty revenue related to the sale of future royalties

In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant to HCR. As described in Note F to our Condensed Consolidated Financial Statements, this transaction has been recorded as a liability that amortizes over the estimated life of our Royalty Purchase Agreement with HCR. As a result of this liability accounting, even though the royalties are remitted directly to HCR, we record these royalties from GSK as revenue. Non-cash royalty revenue related to our agreement with GSK decreased $2.0 million, to approximately $48.4 million for the six months ended June 30, 2025, from $50.3 million for the six months ended June 30, 2024, due to decreased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant.

Research and development expense

Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of consultants, and administrative costs. Research and development expense decreased 40% to $48.2 million for the six months ended June 30, 2025 from $80.7 million for the six months ended June 30, 2024. Decreased expenses in the six months ended June 30, 2025 primarily relate to a $22.9 million decrease in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs, a $6.0 million decrease in personnel related expenses, mainly due to a decrease in headcount, a $3.3 million decrease in expenses attributable to the activities of our subsidiaries and a $0.4 million decrease in other research and development expenses.

General and administrative expense

General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 7% to $31.2 million for the six months ended June 30, 2025 from $33.7 million for the six months ended June 30, 2024.

23


 

Decreased expenses in the six months ended June 30, 2025 primarily relate to a $3.3 million decrease in personnel related expenses, mainly due to a decrease in headcount, and a $0.3 million decrease in other general and administrative expenses. These decreases were partially offset by a $1.1 million increase in professional fees and a $0.1 million increase in expenses attributable to the activities of our subsidiaries.

Non-operating income (expense)

Non-operating expense increased to approximately $0.3 million for the six months ended June 30, 2025 from income of $6.0 million for the six months ended June 30, 2024, primarily due to de minimis activity in the six months ended June 30, 2025, compared to the recognition of a $5.5 million gain on the early termination of two operating leases and the recognition of R&D tax credits in the UK in the six months ended June 30, 2024.

Interest expense, net

Interest expense, net decreased to approximately $26.1 million for the six months ended June 30, 2025 from $61.2 million for the six months ended June 30, 2024, mainly due to decreased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR, primarily attributable to decreased sales forecasts of GSK’s vaccines containing our STIMULON QS-21 adjuvant, partially offset by an increase of the non-cash interest expense recorded in connection with our Ligand Purchase Agreement.

Research and Development Programs

 

For the six months ended June 30, 2025, our research and development programs consisted largely of our antibody programs as indicated in the following table (in thousands).

 

 

 

 

Six Months Ended June 30,

 

 

Year Ended December 31,

 

Research and
Development Program

 

Product

 

2025

 

 

2024

 

 

2023

 

 

2022

 

Antibody programs

 

Various

 

$

30,311

 

 

$

113,135

 

 

$

178,445

 

 

$

133,108

 

Vaccine adjuvant

 

STIMULON cpcQS-21

 

 

1,461

 

 

 

1,844

 

 

 

10,296

 

 

 

10,789

 

Cell therapies

 

Various

 

 

3,282

 

 

 

7,558

 

 

 

16,283

 

 

 

24,300

 

Other research and development programs

 

Various

 

 

13,177

 

 

 

32,991

 

 

 

29,545

 

 

 

18,494

 

Total research and development expenses

 

 

 

$

48,231

 

 

$

155,528

 

 

$

234,569

 

 

$

186,691

 

 

Research and development program costs include compensation and other direct costs plus an allocation of indirect costs, based on certain assumptions and our review of the status of each program. Our product candidates are in various stages of development and significant additional expenditures will be required if we start new clinical trials, encounter delays in our programs, apply for regulatory approvals, continue development of our technologies, expand our operations, and/or bring our product candidates to market. The total cost of any particular clinical trial is dependent on a number of factors such as trial design, length of the trial, number of clinical sites, number of patients, and trial sponsorship. The process of obtaining and maintaining regulatory approvals for new therapeutic products is lengthy, expensive, and uncertain. Because of the current stage of our product candidates, among other factors, we are unable to reliably estimate the cost of completing our research and development programs or the timing for bringing such programs to various markets or substantial partnering or out-licensing arrangements, and, therefore, when, if ever, material cash inflows are likely to commence.

Liquidity and Capital Resources

We have incurred annual operating losses since inception, and we had an accumulated deficit of $2.2 billion as of June 30, 2025. We expect to incur significant losses over the next several years as we continue development of our technologies and product candidates, manage our regulatory processes, initiate and continue clinical trials, and prepare for potential commercialization of products. To date, we have financed our operations primarily through corporate partnerships, advance royalty sales and the issuance of equity. From our inception through June 30, 2025, we have raised aggregate net proceeds of approximately $2.03 billion through the sale of common and preferred stock, the exercise of stock options and warrants, proceeds from our Employee Stock Purchase Plan, royalty monetization transactions, and the issuance of convertible and other notes.

We maintain an effective registration statement (the “Registration Statement”) covering up to $300.0 million of common stock, preferred stock, warrants, debt securities and units.

24


 

The Registration Statement includes prospectuses covering the offer, issuance and sale of up to 20.6 million shares of our common stock from time to time in “at-the-market offerings” pursuant to an At Market Issuance Sales Agreement (the “Sales Agreement”) with B. Riley Securities, Inc. as our sales agent. We sold approximately 5.9 million and 0.8 million shares of our common stock pursuant to the Sales Agreement during the six months ended June 30, 2025 and the period of July 1, 2025 through August 7, 2025, respectively, and received aggregate net proceeds totaling $23.8 million. As of August 7, 2025, approximately 11.4 million shares remained available for sale under the Sales Agreement.

Our cash and cash equivalents at June 30, 2025 were $9.5 million, a decrease of $30.9 million from December 31, 2024. Subsequent to quarter end we received $5.2 million from sales of our common stock in at the market offerings, and we anticipate receiving $75.0 million upfront plus a $16.0 million equity investment from the closing of our agreements with Zydus Lifesciences Ltd and its affiliates, during the third quarter. Cash and cash equivalents of our subsidiary, MiNK, at March 31, 2025, were $3.2 million. MiNK cash can only be accessed by Agenus through a declaration of a dividend by the MiNK Board of Directors or through settlement of intercompany balances.

As of June 30, 2025, we had debt outstanding of $35.8 million in principal, $10.5 million is due June 2026, and $24.75 million is due November 2026.

Based on our current plans and projections, we believe our cash resources of $9.5 million as of June 30, 2025, along with the post-quarter cash infusions noted above and additional cash inflows from funding we expect to receive in 2025, will be sufficient to satisfy our critical liquidity requirements through 2026. To support operations on an ongoing basis we require additional funding. Since our founding we have financed our operations principally through income and revenues generated from corporate partnerships, advance royalty sales, and proceeds from debt and equity issuances. We transact at-the-market sales from time to time in order to manage our cash balances. We execute at-the-market offerings based on market conditions and our stock price. We do not have in place a program whereby at-the-market offerings are executed automatically based on our trading volume.

Currently we are in discussions with entities including operating companies and financial entities to provide the additional funding necessary to support our operations through our planned registration and launch strategy for botensilimab/balstilimab. However, because the completion of cash funding transactions is not entirely within our control, and in accordance with accounting standards, substantial doubt continues to exist about our ability to continue as a going concern for a period of one year after the date of filing of this Quarterly Report on Form 10-Q. The financial statements have been prepared on a basis that assumes Agenus will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business. Management continues to diligently address the Company’s liquidity needs and has continued to adjust spending in order to preserve liquidity. We expect our sources of funding to include additional out-licensing agreements, asset sales, project financing, and/or sales of equity securities.

Our future cash requirements include, but are not limited to, supporting clinical trial and regulatory efforts and continuing our other research and development programs. Since inception, we have entered into various agreements with contract manufacturers, institutions, and clinical research organizations (collectively “third party providers”) to perform pre-clinical activities and to conduct and monitor our clinical studies and trials. Under these agreements, subject to the enrollment of patients and performance by the applicable third-party provider, we have estimated our total payments to be $660.7 million over the term of the related activities. Through June 30, 2025, we have expensed $623.3 million as research and development expenses and $571.1 million has been paid under these agreements. The timing of expense recognition and future payments related to these agreements is subject to the enrollment of patients and performance by the applicable third-party provider. We plan to enter into additional agreements with third party providers and we anticipate significant additional expenditures will be required to initiate and advance our various programs.

Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing collaboration arrangements with academic and collaboration partners and licensees and by entering into new collaborations. As a result of our collaboration agreements, we will not completely control the efforts to attempt to bring those product candidates to market.

Net cash used in operating activities for the six months ended June 30, 2025 and 2024 was $45.8 million and $76.4 million, respectively. Our future ability to generate cash from operations will depend on achieving regulatory approval and market acceptance of our product candidates, achieving benchmarks as defined in existing collaboration agreements, and our ability to enter into new collaborations. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Forward Looking Statements” in Part I, Item 2 of this Quarterly Report on Form 10-Q and the risks highlighted in Part I, Item 1A "Risk Factors" of our 2024 Form 10-K.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our primary market risk exposure is foreign currency exchange rate risk. International revenues and expenses are generally transacted by our foreign subsidiaries and are denominated in local currency. Approximately 3.7% and 2.1% of our cash used in operations for the six months ended June 30, 2025 and the year ended December 31, 2024, respectively, was from our foreign subsidiaries.

25


 

We are exposed to foreign currency exchange rate fluctuation risk related to our transactions denominated in foreign currencies. We do not currently employ specific strategies, such as the use of derivative instruments or hedging, to manage these exposures. Our currency exposures vary but are primarily concentrated in the British Pound and Swiss Franc, in large part due to our subsidiaries, Agenus UK Limited and AgenTus Therapeutics Limited, both with operations in England, and Antigenics SA, a company with operations in Switzerland.

We had cash and cash equivalents at June 30, 2025 of $9.5 million, which are exposed to the impact of interest rate changes, and our interest income fluctuates as interest rates change. Additionally, in the normal course of business, we are exposed to fluctuations in interest rates as we seek debt financing and invest excess cash. Due to the short-term nature of our investments in money market funds, our carrying value approximates the fair value of these investments at June 30, 2025.

There has been no material change to our interest rate exposure and our approach toward interest rate and foreign currency exchange rate exposures, as described in our Annual Report on Form 10-K for the year ended December 31, 2024.

We invest our cash and cash equivalents in accordance with our investment policy. The primary objectives of our investment policy are to preserve principal, maintain proper liquidity to meet operating needs, and maximize yields. We review our investment policy periodically and amend it as deemed necessary. Currently, the investment policy prohibits investing in any structured investment vehicles and asset-backed commercial paper. Although our investments are subject to credit risk, our investment policy specifies credit quality standards for our investments and limits the amount of credit exposure from any single issue, issuer, or type of investment. We do not invest in derivative financial instruments. Accordingly, we do not believe that there is currently any material market risk exposure with respect to derivatives or other financial instruments that would require disclosure under this item.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our Principal Executive Officer and Principal Financial Officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) and Rule 15d-15(e) promulgated under the Exchange Act. Based on this evaluation, our Principal Executive Officer and our Principal Financial Officer concluded that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were effective and were designed to ensure that information we are required to disclose in the reports that we file or submit under the Exchange Act is accumulated and communicated to management, including our Principal Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure, and is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms. It should be noted that any system of controls is designed to provide reasonable, but not absolute, assurances that the system will achieve its stated goals under all reasonably foreseeable circumstances. Our Principal Executive Officer and Principal Financial Officer have each concluded that our disclosure controls and procedures as of the end of the period covered by this report are effective at a level that provides such reasonable assurances.

Changes in Internal Control Over Financial Reporting

There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the three months ended June 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

26


 

PART II - OTHER INFORMATION

In September 2024, a putative securities class action lawsuit captioned In re Agenus Inc. Securities Litigation, No. 1:24-cv-12299, was filed in the U.S. District Court for the District of Massachusetts (the “Court”) against the Company and certain of its executives and directors. The Court appointed a lead plaintiff pursuant to the Private Securities Litigation Reform Act, and the lead plaintiff filed an amended complaint on February 7, 2025. The amended complaint alleges that Agenus, three of its current officers, and one member of its advisory board violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions of material fact related to the efficacy and commercial prospects of botensilimab and balstilimab. The lead plaintiff seeks to represent all persons who purchased or otherwise acquired Agenus securities between January 23, 2023, and July 17, 2024, and seeks damages and interest, and an award of costs, including attorneys’ fees. We have not recorded any accrual for a contingent liability associated with these legal proceedings.

The Company has been served with four derivative actions filed in the Court between November 2024 and January 2025 by purported stockholders. The actions name certain of the Company’s executives and directors and allege that defendants made false or misleading statements and omissions of material fact related to the efficacy and commercial prospects of botensilimab and balstilimab. Plaintiffs seek an award of damages and an order directing the Company to reform and improve its corporate governance and internal procedures. On May 2, 2025, the Court consolidated the four actions in Case No. 1:24-cv-12823 and stayed all deadlines pending future developments in the securities class action.

In September 2024, the Company received a subpoena from the Boston Regional Office of the U.S. Securities and Exchange Commission (the “SEC”) seeking records relating to certain of our product candidates, correspondence with the FDA, public disclosure, and other matters. We have produced records pursuant to the subpoena. At this time, the Company cannot predict the outcome of the SEC’s investigation.

We are not currently a party to any other material legal proceedings. From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Regardless of the outcome, litigation can have a material adverse effect on us because of defense and settlement costs, diversion of management resources and other factors.

Item 1A. Risk Factors

Our results of operations and financial condition are subject to numerous risks and uncertainties described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024. There have been no material changes to the risk factors described in Part I, Item 1A "Risk Factors" of our 2024 Form 10-K.

Item 5. Other Information

Trading Plans of Our Directors and Officers

During the quarter ended June 30, 2025, none of our directors or executive officers adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each item is defined in Item 408 of Regulation S-K.

 

27


 

Item 6. Exhibits

 

Exhibit No.

 

Description

 

 

 

10.1*

 

Asset Purchase Agreement dated June 3, 2025 by and among Agenus Inc., Agenus West, LLC and Zydus Pharmaceuticals (USA) Inc. Filed herewith.

 

 

 

10.2*

 

License Agreement dated June 3, 2025 by and between Agenus Inc. and Zydus Life Sciences Limited. Filed herewith.

 

 

 

10.3*

 

Securities Purchase Agreement dated June 3, 2025 by and between Agenus Inc. and Zynext Ventures USA LLC. Filed herewith.

 

 

 

31.1

 

Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended. Filed herewith.

 

 

 

31.2

 

Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended. Filed herewith.

 

 

 

32.1

 

Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Submitted herewith.

 

 

 

101.INS

 

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)

 

 

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document

 

 

 

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document

 

 

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101)

 

 

 

 

 

* Certain portions of this exhibit (indicated by “[***]”) have been omitted in compliance with Regulation S-K Item 601(b)(10)(iv) as the Company determined the omitted information (i) is not material and (ii) is the type that the Company customarily and actually treats as private or confidential.

 

28


 

AGENUS INC.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Date:

 

August 11, 2025

 

AGENUS INC.

 

 

 

 

 

 

 

 

 

/s/ CHRISTINE M. KLASKIN

 

 

 

 

Christine M. Klaskin

VP, Finance, Principal Financial Officer, Principal Accounting Officer

 

 

29


EX-10.1 2 agen-ex10_1.htm EX-10.1 EX-10.1

 

 

Exhibit 10.1

 

Certain portions of this exhibit (indicated by “[***]”) have been omitted in compliance with Regulation S-K Item 601(b)(10)(iv) as the Company determined the omitted information (i) is not material and (ii) is the type that the Company customarily and actually treats as private or confidential.

 

 

ASSET PURCHASE AGREEMENT

This ASSET PURCHASE AGREEMENT (this “Agreement”) is dated June 3, 2025 (the “Effective Date”), by and between Agenus West LLC, a limited liability company organized under the laws of the State of Delaware (“Agenus West”) and Agenus Inc., a Delaware corporation (“Agenus Parent” and together with Agenus West, each a “Seller” and collectively, “Sellers”), on the one hand, and Zydus Pharmaceuticals (USA) Inc., a corporation organized under the laws of the State of New Jersey (“Buyer”), on the other hand. Sellers and Buyer are sometimes referred to herein as the “Parties” and each as a “Party.”

R E C I T A L S

 

A.
Agenus West conducts a business which, among other things, includes a biologics manufacturing business, and Agenus Parent supports the operation of this business by devoting certain resources to the business, including Employees and certain Assumed Contracts (defined herein).
B.
Sellers desires to sell, transfer, and convey, and Buyer wishes to acquire, the Purchased Assets (defined herein), including Agenus Parent with respect to the applicable Assumed Contracts, on the terms and conditions hereinafter set forth.

A G R E E M E N T S

 

NOW, THEREFORE, in consideration of the mutual covenants, promises and conditions contained herein, the Parties agree as follows:

SECTION 1. DEFINITIONS

1.1
The following terms, as used in this Agreement, shall have the meanings set forth in this Section.

“Action” means any action, claim, complaint, counterclaim, suit, litigation, arbitration,

governmental investigation or other legal, administrative or Tax proceeding.

“Ancillary Agreements” means, collectively, as applicable, the bills of sale deliverable pursuant to Section 8.2(a), the Escrow Agreement, the Assignment and Assumption Agreement, Assignment and Assumption of Lease, the License Agreement, the Transition Services Agreement, the Contract Manufacturing Agreement, the deeds deliverable to Buyer pursuant to Section 8.2(f) and any other agreement or instrument executed in connection with the consummation of the transactions contemplated hereby.

 

2


 

“Assumed Contracts” means all rights of a Seller or others for the benefit of the BioCDMO Business under all agreements, contracts or leases, under (i) the agreements, contracts and/or leases described on Schedule 1.1A, and (ii) such other contracts, agreements and/or leases entered into by either Seller related to the BioCDMO Business between the Effective Date and the Closing Date that are either (A) in the ordinary course of business and have an annual value of $10,000 or less, or (B) agreed to in writing by Buyer, but specifically excluding the Non-Assumed Contracts; provided that no agreement, contract, or lease shall be considered an “Assumed Contract” if and for so long as such agreement, contract, or lease is unassigned as set forth in Section 6.15.

“BioCDMO Business” means the biologics contract development and manufacturing business of Agenus West and all operations or services (including those provided through certain Assumed Contracts) related thereto (whether such operations are conducted for internal purposes or at the behest of a third party), including the provisions of contract development and manufacturing services related to: (i) developing biological drugs, including biologics like monoclonal antibodies and vaccines; (ii) conducting pre-formulation-formulation development, analytical testing, process development, scale-up, packaging services, and clinical trials for biological drugs; and/or (iii) commercially manufacturing any biological drugs, including biologics like monoclonal antibodies and vaccines.

“Books and Records” means all of the written and electronic records directly related to the Purchased Assets (other than any Excluded Assets).

“Business Day” shall mean any day, other than a Saturday or a Sunday, on which

commercial banks are required to be open in Gujarat, India.

“Closing” means the consummation of transactions contemplated by this Agreement, including the assignment, sale, transfer, conveyance and delivery of the Purchased Assets, the Purchase Price and other deliverables contemplated herein to be delivered at Closing as contemplated hereunder.

“Closing Date” means the date upon which all conditions set forth in Section 7 and Section 8 are satisfied or waived in writing, or such other date as Buyer and Sellers may agree.

“Code” means the Internal Revenue Code of 1986, as amended.

“Compensation Arrangement” means any plan or compensation arrangement other than an Employee Plan which provides to Employees, former employees, officers, directors or shareholders of any Seller or any ERISA Affiliate thereof, any compensation or other benefits, whether deferred or not, in excess of base salary, sales commissions or wages (excluding overtime pay), including any bonus or incentive plan, stock rights plan, deferred compensation arrangement, life insurance, stock purchase plan, severance pay plan, employment or consulting agreement and any other employee fringe benefit plan.

“Consents” means the consents of other contracting parties to the assignment of the Assumed Contracts requiring such consent, as listed on Schedule 1.1B.

“Contingent Payment” means up to $50,000,000, which amount may be earned by Agenus West as contemplated in Section 2.7.

contemplated in Section 2.7.

 

3


 

 

 

 

“CP Escrow Fund” means the funds deposited with the Escrow Agent by Buyer as “Data Room” means the electronic documentation site established by Agenus Parent on behalf of Sellers containing the documents referenced in the Disclosure Schedules or identified in this Agreement as having been delivered or made available to Buyer and/or its representatives.

“Debt” means: (a) all indebtedness of (i) Agenus West for borrowed money and/or (ii) a Seller for borrowed money secured by the Purchased Assets, whether current or funded, or secured or unsecured, whether evidenced by a credit agreement, facility, note, debenture, bond, or similar instrument; (b) all indebtedness of (i) Agenus West for the deferred purchase price of assets, property, or services and/or (ii) Agenus Parent for the deferred purchase price of the Purchased Assets, represented by a note or other similar instrument (including all obligations under any acquisition agreements for any earn-out, note payable or other contingent payment);

(c) all indebtedness of Agenus West created or arising under any conditional sale or other title retention agreement with respect to property acquired by Agenus West (even though the rights and remedies of any Agenus West or lender under such agreement in the event of default are limited to repossession or sale of such property); (d) all indebtedness of Agenus Parent created or arising under any conditional sale or other title retention agreement with respect to Purchased Assets acquired by Agenus Parent (even though the rights and remedies of any of Agenus Parent or lender under such agreement in the event of default are limited to repossession or sale of such property); (e) all indebtedness of Sellers secured by a purchase money mortgage or other lien to secure all or part of the purchase price of any Purchased Asset subject to such mortgage or lien;

(f) all capitalized lease obligations (or obligations under leases which are required to be, in accordance with GAAP, recorded as capital leases), other than Assumed Liabilities, related to the Purchased Assets and/or the BioCDMO Business in respect of which a Seller is liable as lessee;

(g) any liability of Agenus West in respect of banker’s acceptances, lines of credit, or letters of credit (whether fixed or contingent); (h) any liability of Agenus Parent in respect of banker’s acceptances, lines of credit, or letters of credit (whether fixed or contingent) securing any Purchased Asset; (i) all obligations under any currency or interest rate swap, hedge or similar agreement or arrangement (determined as if such instrument were terminated as of the Closing Date); (j) all accounts payable which either (i) constitute Assumed Liabilities related to pre- Closing periods or (ii) for which the failure to pay would create a Lien upon, or trigger on behalf of any third party a right or interest in (including but not limited to foreclosure or repossession), any Purchased Asset; (k) all accrued but unpaid interest, fees penalties, prepayment premiums, and other expenses owed with respect to the indebtedness referred to above; (l) unfunded amounts under any employee pension or deferred compensation plans with respect to Transferring Employees; (m) all liabilities with respect to any Transferring Employee up to Closing with respect to (1) unpaid bonuses and commissions, (2) payments required under any incentive plans or phantom stock rights, (3) accrued but unused vacation time, (4) accrued but unpaid salary, or (5) any change of control payments, bonuses, severance or termination obligations or similar amounts payable in the future or due by a Seller in connection with the transactions contemplated hereby; (n) any amounts due and payable by a Seller to any warrantor or any of its affiliates or Persons related to such warrantor; and (o) all indebtedness referred to above that is directly or indirectly guaranteed by a Seller or which a Seller has agreed (contingently or otherwise) to purchase or otherwise acquire or in respect of which it has otherwise assured a creditor against loss.

“Disclosure Schedules” means the disclosure schedules delivered by Sellers to Buyer concurrently with the execution and delivery of this Agreement.

 

4


 

 

 

 

“Dollar” or “$” means United States Dollar.

“Employee Plan” means (1) any pension, retirement, profit-sharing, deferred compensation, vacation, severance, bonus, incentive, medical, vision, dental, disability, life insurance, incentive compensation, employment, consulting, excess benefit, equity (or equity like), profits interest, termination, retention, change in control, fringe benefit, paid time off, holiday, supplemental unemployment or other employee benefit or compensation plan, program, policy, agreement or arrangement, whether written or oral, funded or unfunded not covered in subsections (2) and (3) below, (2) an employee benefit plan as defined in Section 3(3) of ERISA (whether or not subject to ERISA), and (3) each “nonqualified deferred compensation plan” (within the meaning of Section 409A of the Code), in each case that is sponsored, maintained, contributed or required to be contributed to by a Seller or any of its ERISA Affiliates for the benefit of any of the current or former directors, managers, officers, employees or independent contractors of a Seller, or the beneficiaries of such individuals, or with respect to which a Seller has or would reasonably be expected to have any other Liability, including by reason of having an ERISA Affiliate.

“Employees” means (i) the persons employed by Agenus West on a full or part time basis and (ii) the persons employed by Agenus Parent that provide substantially all of such persons’ day-to-day services in support of the BioCDMO Business.

“Enforceability Exceptions” means the exceptions or limitations to the enforceability of contracts under bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally, and by the application of general principles of equity.

“Environmental Law” means any Law relating to the environment, natural resources, pollutants, contaminants, wastes, chemicals or public health and safety, including any Law pertaining to: (a) treatment, storage, disposal, generation and transportation of toxic or hazardous substances or solid or hazardous waste; (b) air, water and noise pollution; (c) groundwater or soil contamination; (d) the release or threatened release into the environment of toxic or hazardous substances or solid or hazardous waste, including emissions, discharges, injections, spills, escapes or dumping of pollutants, contaminants or chemicals; (e) manufacture, processing, use, distribution, treatment, storage, disposal, transportation or handling of pollutants, contaminants, chemicals or industrial, toxic or hazardous substances or oil or petroleum products or solid or hazardous waste; (f) underground and other storage tanks or vessels, abandoned, disposed or discarded barrels, containers and other closed receptacles; (g) public health and safety; or (h) the protection of wildlife, marine sanctuaries and wetlands, including all endangered and threatened species.

“Equipment” means all machinery, equipment, furniture, furnishings, fixtures, computer hardware, materials, vehicles, tools, dies, molds and other items of tangible personal property used by a Seller in the BioCDMO Business, and the full benefit of all express or implied warranties by the manufacturers or sellers or lessors of any item or component part thereof, including those set forth on Schedule 1.1D.

“Equipment Leases” refers to all leases that are included in the Assumed Contracts to which a Seller is a party for any Equipment.

 

5


 

 

 

 

“ERISA” means the Employee Retirement Income Security Act of 1974, as amended.

“ERISA Affiliate” means any entity which is (or at any relevant time was) a member of a “controlled group of corporations” with or under “common control” with a Person as defined in Section 414(b) or (c) of the Code.

“Escrow Account” means the escrow account established under the Escrow Agreement, which shall have the following two sub-accounts, the Indemnity Escrow Fund and the CP Escrow Fund.

“Escrow Agent” means Fifth Third Bank, national association.

“Escrow Agreement” means the escrow agreement to be entered into by Buyer, Agenus West, and the Escrow Agent at the Closing, in a form mutually agreed to by the Parties, providing for a twelve (12) month escrow of the Indemnification Escrow Fund.

“Excluded Assets” means (i) cash and cash equivalents of Sellers and all trade accounts receivable and all notes, and other rights to receive payments arising out of sales of Sellers occurring on or before the Closing Date, (ii) refunds or credits (including interest thereon or claims therefrom) of Taxes paid by Sellers prior to the Closing Date, (iii) insurance policies, refunds of premiums paid on, and rights and claims under, insurance policies relating to events occurring prior to the Closing Date, (iv) bonds, letters of credit, surety instruments and other similar items (other than amounts posted by parties to Assumed Contracts as deposits or other security) held by Sellers, (v) Sellers’ company and tax records and returns and the account books of original entry, general ledger and financial records used in connection with the BioCDMO Business (provided that Sellers shall provide Buyer with a copy of any such records related to the BioCDMO Business that Buyer shall reasonably request), (vi) all Employee Plans and all assets owned or held by any Employee Plans, (vii) Sellers’s corporate seals, minute books, stock record books, taxpayer and other identification numbers, and such other books and records as pertain to the organization, existence or share capitalization of Sellers (viii) the Non-Assumed Contracts,

(ix) such additional assets as are set forth on Schedule 1.1E, and (x) all assets of Sellers and its affiliates that are not used in the BioCDMO Business.

“Excluded Liabilities” means any Liabilities of Sellers other than the Assumed Liabilities including but not limited to: (a) any Liabilities arising out of or relating to any Excluded Asset;

(b) all Liabilities for current trade payables and accounts payable; (c) all Liabilities under any Non-Assumed Contract (d) all Liabilities under any Assumed Contract to the extent such Liabilities arise out of or relate to a breach by Sellers of such Contracts prior to Closing; (e) all Liabilities arising out of or relating to Debt; (f) all Liabilities for Taxes arising as a result of the operation by Sellers of the BioCDMO Business or ownership of the Purchased Assets prior to the Closing; (g) any Excluded Tax Liabilities; (h) any Liabilities related to or arising from any clinical trials operated, or otherwise participated in, by Sellers or the Purchased Assets; (i) all Liabilities arising from or under any Environmental Law or Occupational Safety and Health Law arising out of or relating to the operation of the BioCDMO Business or a Seller’s leasing, ownership or operation of real property; (j) all Liabilities arising under claims by employees or former employees of Sellers relating in any way to compensation, bonuses, incentive compensation, benefits (including workers’ compensation and unemployment benefits), termination or continuation of their employment, or lack or delay of any notice relating to their employment; (k) all Liabilities arising out of or resulting from Sellers’ compliance or non- compliance with any Law; (l) all Transaction Expenses; and (m) all other Liabilities arising out of the operation by Sellers of the BioCDMO Business prior to the completion of the Closing.

 

6


 

 

 

 

“Excluded Tax Liabilities” means any Taxes that arise as a result of the sale of the Purchased Assets pursuant to this Agreement and any deferred Taxes of any nature, whether or not related to such sale, except for any real property transfer Tax or similar Tax thereto.

“Fundamental Representations” means the representations and warranties set forth in Sections 3.1 (Organization and Authority), 3.2 (Authorization and Binding Authority), 3.3 (No Contravention; Consents), 3.4 (Title to Purchased Assets), 3.11 (Taxes) and 3.15 (Brokers).

“GAAP” means United States generally accepted accounting principles as currently in

effect.

“Governmental Authority” means any court or any federal, state, county, local or foreign

governmental, legislative or regulatory body, agency, department, authority, instrumentality or other subdivision thereof.

“Governmental Order” means any order, writ, judgment, injunction, decree, stipulation,

determination or award entered by or with any Governmental Authority.

“HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

“Indemnification Escrow Fund” means the [***] deposited with the Escrow Agent at Closing plus any interest or other amounts earned thereon and less any disbursements therefrom in accordance with the Escrow Agreement.

“Inventory” means all inventory (other than any Excluded Assets) held by Sellers related to the BioCDMO Business, including Sellers’ raw materials, works in process, finished products, wrapping, supply, and packaging items related to the BioCDMO Business, in each case wherever the same may be located.

“Knowledge”, “knowledge” or “to the knowledge” of a Party (or similar phrases) means with respect to Sellers the actual or constructive knowledge of key personnel, including but not limited to, Garo Armen, Zachary Armen, Renuka Siverdian, Tracy Mazza Clement, Christine Klaskin, and/or Al Dadson.

“Law” means any statute, ordinance, code, law, rule, regulation, permit or permit condition, or other requirement, standard, policy or procedure enacted, adopted or applied by any Governmental Authority.

“Leased Real Property” means the real property used by one or both Sellers in connection with its BioCDMO Business located at 6455 Christie Avenue, Emeryville, CA.

 

7


 

 

 

 

“Liabilities” means claims, obligations, commitments or liabilities of a Person of any nature, absolute, accrued, contingent or otherwise, known or unknown, whether matured or unmatured, and whether or not required to be disclosed on a balance sheet prepared in accordance with GAAP.

“Licensed Intellectual Property” means all of Sellers’ manufacturing know-how used in connection with the operation by it of the BioCDMO Business, licensed to Buyer and its affiliates pursuant to the manufacturing know-how license agreement contemplated in Section 8.2(c).

“Lien” means any lien, pledge, charge, easement, security interest, mortgage, deed of trust, right-of-way or other encumbrance.

“Losses” means actual out-of-pocket losses, damages, liabilities, costs, expenses, awards, fines, interest or penalties, including reasonable attorneys’ fees.

“Material Adverse Effect” means any event, circumstance or condition that, individually or when aggregated with all other similar events, circumstances or conditions, would reasonably be expected to have a material adverse effect on: (i) with respect to Sellers, the property (including the Licensed Intellectual Property), operations, condition (financial or otherwise) or results of operations of the BioCDMO Business and/or the Purchased Assets, or the ability of Sellers to consummate the transactions contemplated hereby, and, (ii) with respect to Buyer, the ability of Buyer to consummate the transactions contemplated hereby; provided, that Material Adverse Effect shall not include any effect arising out of or resulting from (x) the transactions contemplated hereby, including the effects of taking any action expressly required, or not taking any action expressly prohibited, by this Agreement, or (y) general economic, financial, competitive or market conditions, provided further, however, that any event, occurrence, fact, condition or change referred to in clause (y) immediately above shall be taken into account in determining whether a Material Adverse Effect has occurred or could reasonably be expected to occur to the extent that such event, occurrence, fact, condition or change has a disproportionate effect on the BioCDMO Business and/or the Purchased Assets compared to businesses and/or assets similar thereto.

“Non-Assumed Contracts” means those contracts, agreements, and arrangements not specifically assumed by Buyer at Closing.

“Occupational Safety and Health Law” means any Law designed to provide safe and healthful working conditions and to reduce occupational safety and health hazards, and any program, whether governmental or private (such as those promulgated or sponsored by industry associations and insurance companies), designed to provide safe and healthful working conditions.

“Order” means any order, injunction, judgment, decree, ruling, assessment or arbitration award of any Governmental Authority or arbitrator.

“Payoff Letter” means a customary payoff or termination letter from each holder of Debt incurred solely with respect to a Purchased Asset being acquired hereunder (and not secured by a Lien on any asset other than a Purchased Asset), each in form and substance reasonably acceptable to the Parties.

 

8


 

 

 

 

“Payoff Letter Amount” means the amount required to be paid pursuant to the

instructions contained in such Payoff Letter.

“Permits” means all permits, licenses, franchises, registrations, authorizations, employee visas, consents or approvals that have been issued by any Governmental Authority to a Seller with respect to the BioCDMO Business, as set forth on Schedule 1.1G.

“Permitted Liens” means (i) statutory landlord’s liens and liens for current Taxes not yet due and payable, (ii) mechanics, carriers’, workmen’s, repairmen’s or other like Liens arising or incurred in the ordinary course of business consistent with past practice for amounts that are not delinquent and which are not, individually or in the aggregate, material to the BioCDMO Business or the Purchased Assets, (iii) easements, rights of way, zoning and building ordinances and other similar Liens affecting real property, which are not, individually or in the aggregate, material to the Purchased Assets or the operation thereof, which do not prohibit or interfere with the current operation of any Real Property, and which do not render title to any Owned Real Property unmarketable, (iv) rights of the public in legal highways and (v) any Liens set forth in Schedule 1.1H.

“Person” means any person or entity, whether an individual, trustee, corporation, general partnership, limited partnership, trust, unincorporated organization, business association, firm, joint venture or Governmental Authority.

“Personally Identifiable Information” means any information or data that, alone or in combination with other information held by the Sellers, can be used to specifically identify an individual or that is otherwise considered personally identifiable information or personal data under applicable Law, including an individual’s name, street address, telephone number, e-mail address, photograph, social security or tax identification number, driver’s license number, passport number, credit card number, bank information or account number.

“Privacy and Security Laws” means applicable Laws relating to the collection, access, use, storage, processing, transfer, disclosure and protection of Personally Identifiable Information, including federal, state or foreign applicable Laws or regulations regarding (1) data privacy and information security, (2) data breach notification (as applicable) (3) consumer data protection, and/or (4) trespass, computer crime and other laws governing unauthorized access to or use of electronic data, including: the Privacy Act of 1974, the Federal Trade Commission Act, the CAN-SPAM Act, the Telephone Consumer Protection Act, the Telemarketing and Consumer Fraud and Abuse Prevention Act, Children’s Online Privacy Protection Act, state social security number protection Laws, and Laws concerning requirements for website and mobile application privacy policies and practices, call or electronic monitoring or recording or any outbound communications (including outbound calling and text messaging, telemarketing, and e-mail marketing) and all equivalent Laws of any other jurisdiction.

“Proceeding” means any action, arbitration, audit, examination, investigation, hearing,

litigation, mediation, or suit (whether civil, criminal, administrative, judicial or investigative, whether formal or informal, and whether public or private) commenced, brought, conducted or heard by or before, or otherwise involving, any Governmental Authority, arbitrator or mediator.

 

9


 

 

 

 

“Purchased Assets” means all properties, assets, rights (including but not limited to leasehold rights), benefits and privileges both tangible and intangible, of every kind, nature and description, of Sellers used in the BioCDMO Business and all such assets acquired for use in the BioCDMO Business (at least in part) between the date hereof and the Closing as permitted by and subject to the terms of this Agreement (in each case other than Excluded Assets), including, but not limited to: (i) the Assumed Contracts, and all of Sellers’ rights thereunder, as applicable, relating to periods and events occurring on and after the Closing Date, (ii) the Owned Real Property, (iii) the Equipment, (iv) Inventory, (v) Warranties, (vi) all prepaid expenses, credits, advance payments, claims, security, refunds, rights of recoupment, deposits, causes of action, choses in action, rights of recovery and rights of set-off of any kind relating to the Purchased Assets or the Assumed Liabilities, against any Person, including, without limitation, any liens, security interests, pledges or other rights to payment or to enforce payment in connection with products delivered or services provided by Sellers on or prior to the Closing Date, (vii) Books and Records, (viii) all Permits, (ix) all insurance benefits, including rights and proceeds, arising from or relating to Purchased Assets or the Assumed Liabilities, (x) all goodwill relating to Purchased Assets or the Assumed Liabilities, and (xi) all other assets of Sellers used in the day- to-day operation of the BioCDMO Business as set forth on Schedule 1.1I.

“Real Estate Lease” means that certain real property lease between Agenus Parent and Bay Center Investor LLC dated November 2020 for the Leased Real Property.

“Real Property” means the Owned Real Property and the Leased Real Property.

“Restricted Business” means operating as a biologics contract manufacturing business and all manufacturing operations or services related thereto (whether such operations are conducted for internal purposes or at the behest of a third party), including manufacturing efforts focused on: (i) developing biological drugs, including biologics like monoclonal antibodies and vaccines; (ii) conducting pre-formulation-formulation development, analytical testing, process development, scale-up, packaging services, and clinical trials for biological drugs; and/or (iii) commercially manufacturing any biological drugs, including biologics like monoclonal antibodies and vaccines.

“Taxes” means any taxes, charges, fees, levies or other assessments, including income, excise, use, transfer, payroll, occupancy, property, sales, franchise, unemployment and withholding taxes, penalties and interest imposed by the United States or any state, county, local or foreign government or subdivision or agency thereof.

“Transaction Expenses” means the sum (without duplication) of: (a) the fees, costs, liabilities and obligations of Sellers as of any date and time for unpaid amounts (i) of the fees and expenses of Sellers or its affiliates that are payable or reimbursable by or on behalf of Sellers or its affiliates and were incurred at or prior to the Closing, whether or not billed or invoiced at or prior to the Closing, in connection with the consummation of the transactions contemplated hereby, including all fees (including brokerage fees, commissions, finders’ fees or financial advisory fees) and expenses of professionals or other service providers (including investment bankers, brokers, attorneys, accountants and other advisors) retained by or on behalf of Sellers or its affiliates, and (ii) payable to current or former employees, directors, officers, and consultants of Sellers or any third party, payable upon or in connection with the consummation of the transactions contemplated by this Agreement pursuant to any discretionary, change-in-control, retention, transaction, incentive, stay (unless requested or required by Buyer), severance or similar bonuses or payments established by Sellers prior to the Closing (and the employer portion of any employment, payroll, social security and similar Taxes payable with respect thereto); provided, however, that “Transaction Expenses” shall exclude costs and expenses contemplated to be paid by Buyer or its affiliates pursuant to this Agreement.

 

10


 

 

 

 

“Warranties” means all rights under or pursuant to all warranties, representations, and guarantees made by suppliers in connection with the Purchased Assets or services furnished to Sellers in connection with the BioCDMO Business.

1.2
Terms Defined Elsewhere in this Agreement. The following is a list of defined terms used in this Agreement and not defined in the preamble, recitals and Section 1.1, with reference to the Section in which such term is defined:

 

Term

Section

Acquisition Proposal

5.1(f)(i)

Allocation Schedule

2.8

Assignment and Assumption

8.2(b)

Agreement

 

Assignment and Assumption of Lease

8.2(d)

Assumed Liabilities

2.3

Basket

9.5(c)

Beneficial Rights

6.15

Buyer Indemnified Parties

9.3

Cap

9.5(b)

Claim Notice

9.6(a)

CFIUS

6.5(a)

CFIUS Filing

6.5(a)

CFIUS Regulatory Approval

6.5(a)

Closing Cash Consideration

2.5(a)

Closing Date Certificate

2.6(b)

Closing Debt

2.5(a)

Closing Seller Transaction Expenses

2.5(a)

Contingent Payment Period

2.7(a)

Contract Manufacturing Agreement

8.2(p)

Deductible

9.5(c)

Designated Accounting Firm

2.6(c)

Earnout Dispute Notice

2.7(b)(iv)

Final Cash Consideration

2.6(b)

First Measurement Period

2.7(a)

FMP Deficiency

2.7(a)(i)

FMP PO Excess Revenues

2.7(a)(i)

FMP Work Orders

2.7(a)(i)

 

 

11


 

 

 

 

 

Term

Section

Indemnified Party

9.6(a)

Indemnifying Party

9.6(a)

Initial Cash Consideration

2.6(a)

Initial Closing Date Certificate

2.6(a)

Interim PO Revenue Statement

2.7(b)(i)

License Agreement

8.2(c)

Legal Description

6.14(b)

Material Permits

3.20

Measurement Date Payment Statement

2.7(b)(i)

Objection Notice

2.6(c)

Objection Response

6.14(c)

Objections

6.14(c)

Offer

6.12(b)

Outside Date

10.1(b)(ii)

Owned Real Property

3.7(a)

Permitted Encumbrances

6.14(a)

PO Revenue

2.7(c)(i)

Proposed Transaction

6.5(a)

Purchase Price

2.5

Required Consents

3.3

Restricted Period

6.13(a)

Schedule Supplement

6.6

Second Measurement Period

2.7(a)

Seller Indemnified Parties

9.4

Seller Objections

2.6(c)

Sellers’ Projections

9.2

SMP Deficiency

2.7(a)(ii)

SMP PO Excess Revenues

2.7(a)(ii)

SMP Work Orders

2.7(a)(ii)

Survey

6.14(b)

Survival Expiration Date

9.1

Taking

6.14(f)

Third Measurement Period

2.7(a)

Third Party Claim

9.7(a)

Third-Party Reimbursement

9.5(f)

Title Commitment

6.14(a)

Transferring Employees

6.12(b)

TMP Deficiency

2.7(a)(iii)

TMP PO Excess Revenues

2.7(a)(iii)

TMP Work Orders

2.7(a)(iii)

Transition Services Agreement

8.2(m)

Updated Phase I

6.14(d)

Work Order

2.7(c)(ii)

 

 

12


 

 

 

 

1.3
Clarifications. Words used in this Agreement, regardless of the gender and number specifically used, shall be deemed and construed to include any other gender and any other number as the context requires. As used in this Agreement, the word “including” is not limiting, and the word “or” is both conjunctive and disjunctive. Except as specifically otherwise provided in this Agreement in a particular instance, a reference to a Section, Schedule or Exhibit is a reference to a Section of this Agreement or a Schedule or Exhibit hereto, and the terms “hereof,” “herein,” and other like terms refer to this Agreement as a whole, including the Schedules and Exhibits to this Agreement, and not solely to any particular part of this Agreement. The descriptive headings in this Agreement are inserted for convenience of reference only and are not intended to be part of or to affect the meaning or interpretation of this Agreement.

SECTION 2.

PURCHASE AND SALE

2.1
Agreement to Sell and Buy. Subject to the terms and conditions herein, at the Closing, Sellers shall sell, convey, transfer, assign and deliver to Buyer all of Sellers’ right, title and interest in and to the Purchased Assets, as applicable, and Buyer shall purchase, acquire and accept from Sellers, as applicable, all of the applicable Seller’s right, title and interest in and to the Purchased Assets, free and clear of all Liens, other than Permitted Liens. Schedule 2.1 lists all assets of Sellers used in the BioCDMO Business but not used solely in the BioCDMO Business.
2.2
Excluded Assets. Notwithstanding any provision of this Agreement to the contrary, Buyer shall not acquire and there shall be excluded from the Purchased Assets, all of the Excluded Assets.
2.3
Assumed Liabilities. At and after the Closing, Buyer shall assume and timely pay, discharge and perform when due only the following Liabilities and obligations: (a) those Liabilities attributable to periods after the Closing under or with respect to the Assumed Contracts (except any such Liabilities specifically included in the definition of Excluded Liability) and (b) the obligation to perform the services for the prepaid accounts that are listed on Schedule 2.5 (collectively, the “Assumed Liabilities”).
2.4
Excluded Liabilities. Notwithstanding any other provision of this Agreement or any other writing to the contrary, and regardless of any information disclosed to Buyer, Buyer does not assume and has no responsibility for any Excluded Liabilities.
2.5
Purchase Price. Subject to adjustments in this Section 2.6 below, the aggregate purchase price to be paid by Buyer for the Purchased Assets (the “Purchase Price”) shall be:
(a)
an amount payable in cash (the “Closing Cash Consideration”) equal to:

$75,000,000, minus the amount of Debt immediately prior to the Closing (“Closing Debt”), minus the Seller’s Transaction Expenses that are not paid prior to the Closing (“Closing Seller Transaction Expenses”); and

(b)
the Contingent Payment, to the extent earned by Sellers as provided under Section 2.7.

 

13


 

 

 

 

2.6
Purchase Price Adjustment.
(a)
At least three (3) Business Days prior to the Closing Date, Sellers shall deliver to Buyer a certificate (the “Initial Closing Date Certificate”), certified and executed by each Seller, setting forth Sellers’ good faith estimates of, and sufficient details to support the calculation of, (A) the Closing Debt and (B) the Closing Seller Transaction Expenses. The Closing Cash Consideration payable at Closing (the “Initial Cash Consideration”) shall be the amount set forth in such Initial Closing Date Certificate.
(b)
Not later than 90 calendar days after the Closing Date, Buyer shall cause to be delivered to Sellers a statement (the “Closing Date Certificate”) setting forth Buyer’s calculation of, and sufficient details to support the calculation of, (A) the Closing Debt and (B) the Closing Seller Transaction Expenses, and Buyer’s statement of the Initial Cash Consideration, calculated consistent with 2.6(a), (such adjusted Initial Cash Consideration, the “Final Cash Consideration”). Buyer shall, at Sellers’ request with reasonable advance notice, make available to Sellers for their review all Books and Records used by Buyer to prepare the Closing Date Certificate; provided that Buyer shall not be required to provide Sellers any Books and Records protected by attorney-client privilege.
(c)
Within 45 calendar days after its receipt of the Closing Date Certificate, Sellers shall either inform Buyer in writing (the “Objection Notice”) that the Closing Date Certificate is acceptable or object thereto in writing, setting forth each of its objections (the “Seller Objections”). An Objection Notice must describe in reasonable detail the items contained in the Closing Date Certificate that Sellers dispute and the basis for any such dispute. Any items included in the Closing Date Certificate which are not disputed by Sellers in the Seller Objections shall be deemed agreed to by Sellers. If Sellers fail to deliver any Seller Objections to Buyer within the first 45-day period referred to above, the Closing Date Certificate delivered by Buyer and the calculations set forth therein shall be final and binding on the Parties. If Sellers timely deliver the Seller Objections and the Parties do not resolve all such Seller Objections on a mutually agreeable basis within thirty (30) Business Days after Buyer’s receipt of the Seller Objections, any Seller Objections as to which Buyer and Sellers cannot agree upon may be submitted by either Buyer or Sellers to KPMG International Limited (or if such firm is unable or unwilling to act in such capacity, or if Buyer and Sellers desire to use a different firm, such other firm selected by agreement of Buyer and Sellers, the “Designated Accounting Firm”) for resolution as provided herein. Subject to Section 2.6(e), the Designated Accounting Firm shall have the power, authority and duty to resolve any outstanding Seller Objections and the decision of the Designated Accounting Firm shall be final and binding upon the Parties. Upon the agreement of the Parties or the decision of the Designated Accounting Firm, the Closing Date Certificate, as adjusted in accordance with this Section 2.6, if necessary, shall be final, conclusive, and binding with respect to the calculation of the Closing Debt and the Closing Seller Transaction Expenses.

 

14


 

 

 

 

(d)
In resolving any disputed item, the Designated Accounting Firm (i) shall be bound by the provisions of this Section 2.6, (ii) choose, in its entirety, the resolution of the items in dispute as proposed by either Buyer or Sellers in their written presentations to the Designated Accounting Firm and will make no other determination (including by combining elements of the proposed resolutions submitted by Buyer and Sellers), (iii) shall restrict its decision to such items included in the Seller Objections which are then in dispute, (iv) may review only the written presentations of Buyer and Sellers and the terms of this Agreement in resolving any matter which is in dispute, (v) not modify any element of the Closing Date Certificate that is not disputed by the Parties, and (vi) shall render its decision in writing within thirty (30) calendar days after the disputed items have been submitted to it. The fees, costs and expenses of the Designated Accounting Firm shall be paid (i) by the Sellers, if the objections are resolved in favor of the Buyer, or (ii) by the Buyer if the objections are resolved in favor of Sellers.
(e)
If the Final Cash Consideration as finally determined in accordance with this Section 2.6 exceeds the Initial Cash Consideration, then Buyer shall pay the amount of the difference in cash to Sellers and Buyer in accordance with written instructions provided by Sellers within ten (10) Business Days after such final determination. If the Initial Cash Consideration exceeds the Final Cash Consideration as finally determined in accordance with this Section 2.6, then Sellers shall pay to Buyer the amount of the difference in cash to Buyer in accordance with written instructions provided by Buyer within ten (10) Business Days after such final determination.
2.7
Contingent Payments.
(a)
Following the Closing, Buyer shall pay or cause to be paid to the Sellers the Contingent Payment payments based on the PO Revenues attributable to (i) the period from Closing through the last day of the [***] (the “First Measurement Period”), (ii) [***] (the “Second Measurement Period”) and (iii) [***] (the “Third Measurement Period” and together with the First Measurement Period and the Second Measurement Period, the “Contingent Payment Period”)), as follows:
(i)
First Measurement Period: Within [***] following the date on which Buyer has received Work Orders during the First Measurement Period that represent in the aggregate at least [***] in PO Revenues (such Work Orders, the “FMP Work Orders”), Buyer shall pay (i) to Sellers

[***] and (ii) to the Escrow Agent [***] to be held in the CP Escrow Fund.

 

15


 

 

 

 

In the event that the PO Revenues ultimately realized by Buyer under the FMP Work Orders is less than [***], Buyer shall notify Sellers of any such deficiency (such amount, the “FMP Deficiency”) and: (A) if the FMP Deficiency is less than [***], Buyer and Sellers shall jointly instruct the Escrow Agent to pay from the CP Escrow Fund within 10 days of Sellers’ receipt of such notice (subject to extension for resolution of any disputes as contemplated in Section 2.7(b)) to (i) Buyer an amount equal to the FMP Deficiency and (ii) to Sellers an amount equal to the difference between [***] and the FMP Deficiency, or (B) if the FMP Deficiency is more than [***], (i) Buyer and Sellers shall jointly instruct the Escrow Agent to pay from the CP Escrow Fund within 10 days of Buyer’s delivery of such notice (subject to extension for resolution of any disputes as contemplated in Section 2.7(b)) an amount equal to [***] to Buyer and (ii) Sellers shall pay to Buyer within 30 days of Sellers’ receipt of such notice (subject to extension for resolution of any disputes as contemplated in Section 2.7(b)) a cash payment in an amount equal to the difference between [***] and the FMP Deficiency. In the event that the PO Revenues ultimately realized by Buyer under the FMP Work Orders is greater than [***], Buyer and Sellers shall jointly instruct the Escrow Agent to pay from the CP Escrow Fund within 10 days of Sellers’ receipt of such notice an amount equal to [***], and the amount of such excess PO Revenues (the “FMP PO Excess Revenues”) shall carry- forward and be applied to the Second Measurement Period;

(ii)
Second Measurement Period: Within [***] following the date on which Buyer has received Work Orders during the Second Measurement Period that represent in the aggregate (together with the amount of the FMP PO Excess Revenues) at least [***] in PO Revenues (such Work Orders, the “SMP Work Orders”), Buyer shall pay (i) to Sellers [***] and (ii) to the Escrow Agent [***] to be held in the CP Escrow Fund. In the event that the PO Revenues ultimately realized by Buyer under the SMP Work Orders plus the FMP PO Excess Revenues is less than [***], Buyer shall notify Sellers of any such deficiency (such amount, the ”SMP Deficiency”) and: (A) if the SMP Deficiency is less than [***], Buyer and Sellers shall jointly instruct the Escrow Agent to pay from the CP Escrow Fund within 10 days of Sellers’ receipt of such notice (subject to extension for resolution of any disputes as contemplated in Section 2.7(b)) to (i) Buyer an amount equal to the SMP Deficiency and (ii) to Sellers an amount equal to the difference between [***] and the SMP Deficiency, or (B) if the SMP Deficiency is more than [***], (i) Buyer and Sellers shall jointly instruct the Escrow Agent to pay from the CP Escrow Fund within 10 days of Sellers’ receipt of such notice (subject to extension for resolution of any disputes as contemplated in Section 2.7(b)) an amount equal to [***] to Buyer and (ii) Sellers shall pay to Buyer within 30 days of Sellers’ receipt of such notice (subject to extension for resolution of any disputes as contemplated in Section 2.7(b)) a cash payment in an amount equal to the difference between [***] and the SMP Deficiency. In the event that the PO Revenues ultimately realized by Buyer under the SMP Work Orders plus the FMP PO Excess Revenues is greater than [***], Buyer and Sellers shall jointly instruct the Escrow Agent to pay from the CP Escrow Fund within 10 days of Sellers’ receipt of such notice an amount equal to [***], and the amount of such excess PO Revenues (the “SMP PO Excess Revenues”) shall carry-forward and be applied to the Third Measurement Period; and Third Measurement Period: Within [***] following the date on which Buyer has received Work Orders during the Third Measurement Period that represent in the aggregate (together with the amount of the SMP PO Excess Revenues) at least [***] in PO Revenues (such Work Orders, the “TMP Work Orders”), Buyer shall pay (i) to Sellers [***] and (ii) to the Escrow Agent [***] to be held in the CP Escrow Fund.

 

 

 

16


 

(iii)
In the event that the PO Revenues ultimately realized by Buyer under the TMP Work Orders plus the SMP PO Excess Revenues is less than [***], Buyer shall notify Sellers of any such deficiency (such amount, the “TMP Deficiency”) and: (A) if the TMP Deficiency is less than [***], Buyer and Sellers shall jointly instruct the Escrow Agent to pay from the CP Escrow Fund within 10 days of Sellers’ receipt of such notice (subject to extension for resolution of any disputes as contemplated in Section 2.7(b)) to (i) Buyer an amount equal to the TMP Deficiency and (ii) to Sellers an amount equal to the difference between [***] and the TMP Deficiency, or (B) if the TMP Deficiency is more than [***], (i) Buyer and Sellers shall jointly instruct the Escrow Agent to pay from the CP Escrow Fund within 10 days of Sellers’ receipt of such notice (subject to extension for resolution of any disputes as contemplated in Section 2.7(b)) an amount equal to [***] to Buyer and (ii) Sellers shall pay to Buyer within 30 days of Sellers’ receipt of such notice (subject to extension for resolution of any disputes as contemplated in Section 2.7(b)) a cash payment in an amount equal to the difference between [***] and the TMP Deficiency. In the event that the PO Revenues ultimately realized by Buyer under the TMP Work Orders plus the SMP PO Excess Revenues is greater than [***], Buyer and Sellers shall jointly instruct the Escrow Agent to pay from the CP Escrow Fund within 10 days of Sellers’ receipt of such notice an amount equal to [***].
(b)
Statements and Disputes.
(i)
Within ten (10) days of the end of each calendar month of the Contingent Payment Period, Buyer shall deliver to Sellers a statement setting forth (i) each FMP Work Order, SMP Work Order and TMP Work Order received through the end of the prior month, (ii) the PO Revenues realized by Buyer under each FMP Work Order, SMP Work Order and TMP Work Order through the end of the prior month, (iii) the PO Revenues that have not yet been received under each FMP Work Order, SMP Work Order and TMP Work Order through the end of the prior month and (iv) with respect to the statements delivered as of the end of the First Measurement Period, the Second Measurement Period and the Third Measurement Period, Buyer’s calculation of PO Revenue deficiency or excess for the First Measurement Period, the Second Measurement Period or the Third Measurement Period, as applicable.

 

17


 

 

 

 

Each monthly statement is an “Interim PO Revenue Statement” statement, and each statement that is delivered immediately following the last month of the First Measurement Period, the Second Measurement Period and the Third Measurement Period, as applicable, is a “Measurement Date Payment Statement”);

(ii)
With respect to Interim PO Revenue Statements, Buyer shall be reasonably available to review each such statement with Sellers and Sellers’ accountants and discuss any comments and questions, and to make any changes as are agreed to between Buyer and Sellers;
(iii)
With respect to each Measurement Date Payment Statement, Sellers shall have an opportunity to review the Measurement Date Payment Statement for a period of 45 days from Sellers’ receipt thereof during which period the Sellers and Sellers’ accountants shall have reasonable access, during normal business hours and upon reasonable notice, to the relevant financial books and records of the Buyer. All information obtained by the Sellers or Sellers’ accountants shall be deemed to be confidential information and shall not be disclosed or made use of by the Sellers other than for the limited purpose of reviewing the applicable Measurement Date Payment Statement and enforcing its rights under this Agreement;
(iv)
If Sellers disagree with the calculations of PO Revenues as set forth in the applicable Measurement Date Payment Statement, Sellers shall deliver written notice to the Buyer prior to the expiration of the 45-day review period (as same may be extended by the amount of time, if any, that Buyer failed to provide the access contemplated in Section 2.7(b)(iii)), indicating in reasonable detail the basis for such disagreement (an “Earnout Dispute Notice”). Any items included in the Measurement Date Payment Statement which are not disputed by Sellers in the Earnout Dispute Notice shall be deemed agreed to by Sellers. Unless an Earnout Dispute Notice is delivered prior to the end of the 45-day review period (as same may be extended as contemplated above), the PO Revenues and the classifications thereof as “actually received” or as “to be received” as set forth in the applicable Measurement Date Payment Statement shall be final and binding on the Sellers and the Buyer, and any required payment shall be made in accordance with Section 2.7(a)(i) – (iii); and
(v)
If Sellers deliver an Earnout Dispute Notice to Buyer within the 45-day review period (as same may be extended), the Sellers shall confer with Buyer and attempt in good faith to resolve the disagreements set forth in the Earnout Dispute Notice for a period of at least 30 days after the Buyer’s receipt of the Earnout Dispute Notice.

 

18


 

 

 

 

If Sellers and Buyer are able to resolve the disagreements set forth in the Earnout Dispute Notice, they shall reduce such resolution to writing and such agreed upon PO Revenues and the classifications thereof as “actually received” or “to be received” as set forth in the applicable Measurement Date Payment Statement as modified pursuant hereto shall be final and binding on Sellers and Buyer, and any required payment shall be made in accordance with Section 2.7(a)(i) – (iii). If Sellers and Buyer are not able to resolve the disagreements set forth in the Earnout Dispute Notice within 30 days (or such longer period as they may mutually agree), the Buyer and Sellers shall engage the process set forth in Section 2.6(c) and (d), applied mutatis mutandis, to the matters in dispute pursuant to the Earnout Dispute Notice.

(c)
Certain Definitions. As used in this Section 2.7:
(i)
“PO Revenue” means aggregate gross revenues for Conversion Charges (as defined in the Contract Manufacturing Agreement) related to Work Orders, and
(ii)
“Work Order” means a non-cancellable work order or purchase order submitted by a Seller or one of its affiliates to Buyer or its affiliates pursuant to the terms of the Contract Manufacturing Agreement, with agreed-upon terms including quantity, pricing, and delivery, and with margins as guaranteed and as set forth in the Contract Manufacturing Agreement (if any). Each Work Order shall provide for (unless otherwise agreed to by Buyer) payments under such Work Order by a Seller or one of its affiliates to Buyer or its affiliate as follows: (i) [***] of the contemplated PO Revenue for such Work Order upon initiation of the Work Order, (ii) [***] of the contemplated PO Revenue upon receipt by a Seller of written notice from Buyer that Buyer has completed the work under the Work Order and (iii) [***] no later than the 10th day following the date on which the finished work product has been delivered to the end recipient (as specified in the Work Order) in a manner that conforms to the requirements under the applicable Work Order.
2.8
Allocation of the Purchase Price and the Assumed Liabilities. Buyer and Sellers will allocate the Purchase Price and the Assumed Liabilities in accordance with the allocation schedule mutually agreed to by the Parties (the “Allocation Schedule”). After the Closing, the Parties will make consistent use of the allocation, fair market values and useful lives specified in the Allocation Schedule for all Tax purposes and in all filings, declarations and reports with the IRS in respect thereof, including the reports required to be filed under Section 1060 of the Code. No filings made by either Party with any taxing or other authority shall reflect an allocation other than in the manner set forth in the Allocation Schedule and each Party shall timely make all filings required by any taxing authority, including the filing of Internal Revenue Service Form 8594. In any Proceeding related to the determination of any Tax, none of Buyer or any Seller will contend or represent that such allocation is not a correct allocation.

 

19


 

 

 

 

2.9
Withholding Tax. Buyer shall be entitled to deduct and withhold from the Purchase Price all Taxes that Buyer may be required to deduct and withhold under any provision of Tax Law. All such withheld amounts shall be treated as delivered to Sellers hereunder. Prior to withholding any amounts pursuant to this Section 2.9, Buyer shall notify Sellers and shall provide reasonable cooperation to Sellers in good faith to remove or eliminate any such withholding.

SECTION 3.

REPRESENTATIONS AND WARRANTIES OF SELLERS

Sellers hereby represent and warrant to Buyer as follows:

3.1
Organization and Authority; Ownership.
(a)
Agenus Parent is a corporation duly incorporated, validly existing and in good standing under the laws of the State of Delaware and qualified to do business in any other jurisdiction in which the nature of the BioCDMO Business or the ownership of the Purchased Assets requires such qualification by Agenus Parent. Agenus Parent has all requisite corporate power and authority (i) to execute, deliver and perform this Agreement and the Ancillary Agreements to which it is a party and to consummate the applicable transactions contemplated hereby and thereby, and (ii) to own, lease and operate the Purchased Assets (to the extent owned, leased, and operated by Agenus Parent) and to carry on the use of such Purchased Assets as now being conducted and proposed to be conducted. Agenus West is a limited liability company duly formed, validly existing and in good standing under the laws of the State of Delaware and qualified to do business in any other jurisdiction in which the nature of the BioCDMO Business or the ownership of the Purchased Assets requires such qualification, as applicable. Agenus West has all requisite limited liability company power and authority (i) to execute, deliver and perform this Agreement and the Ancillary Agreements to which it is a party and to consummate the transactions contemplated hereby and thereby, and (ii) to own, lease and operate the Purchased Assets (to the extent owned, leased, and operated by Agenus West) and to carry on the use of the Purchased Assets as now being used.
(b)
Agenus Parent owns beneficially and of record, and has good and valid title to, all of the issued and outstanding equity interests of Agenus West, free and clear of all Liens other than transfer restrictions generally imposed by applicable securities Laws. Other than the equity interests owned by Agenus Parent, there are no authorized, issued, outstanding or reserved for issuance (i) units or other voting securities of or equity interests in Agenus West, (ii) securities of Agenus West convertible into or exercisable or exchangeable for units or other voting securities of or equity interests in Agenus West, (iii) options, warrants, rights, agreements or commitments of any kind to acquire from Agenus West, or other obligation of Agenus West or Agenus Parent to issue, sell, transfer, repurchase or redeem, any units or other voting securities of or equity interests in Agenus West or securities convertible into or exercisable or exchangeable for units or other voting securities of or equity interests in Agenus West or (iv) equity appreciation rights, performance units, “phantom” units, profit participation rights or other similar rights or securities that are derivative of or provide economic benefits based directly or indirectly on the value or price of any units or other voting securities of or equity interests in Agenus West.

 

20


 

 

 

 

3.2
Authorization and Binding Obligations. The execution, delivery and performance of this Agreement by Sellers and each Ancillary Agreement to which a Seller is or will be a party have been duly and validly authorized by all necessary corporate or limited liability company action of Sellers, as applicable. This Agreement and each Ancillary Agreement has been duly executed and delivered by Sellers, as applicable, and constitutes a valid and binding agreement of Sellers, as applicable, enforceable against the applicable Seller in accordance with its terms, except as its enforceability may be limited by Enforceability Exceptions.
3.3
No Contravention; Consents. Subject to obtaining the Consents set forth on Schedule

1.1B (the “Required Consents”), the execution, delivery and performance of this Agreement and each Ancillary Agreement and the consummation of the transactions contemplated hereby and thereby will not, after the giving of notice, or the lapse of time, or otherwise (a) violate the organizational documents of either Seller, (b) result in the breach of, constitute a default under, conflict with, result in the termination or cancellation of, or the acceleration of any right or obligation of a Seller under, or result in loss of any benefit of a Seller under, or result in the creation of any Lien upon any of the Purchased Assets, under any Contract to which a Seller is a party or by which any of the Purchased Assets is bound, or (c) violate any Laws or any Federal, state, local or foreign judgment, order or decree applicable to a Seller, the BioCDMO Business or any of the Purchased Assets. Except for such filings as may be required under the HSR Act and CFIUS and the Consents set forth on Schedule 1.1B, no material consent, approval, or authorization of any Governmental Authorities or other third party is required by Sellers in connection with the execution, delivery and performance of this Agreement and the Ancillary Agreements. except for such consents, approvals, Permits, Governmental Orders, declarations, filings or notices which, in the aggregate, would not have a Material Adverse Effect.

3.4
Title to Purchased Assets. Except as set forth on Schedule 3.4, one or both Sellers have good and marketable title to or a valid leasehold in, or otherwise have the right to use, all of the Purchased Assets, free and clear in the case of Purchased Assets owned by Sellers of any Liens except for Permitted Liens. The Purchased Assets include all assets necessary to provide the manufacturing services contemplated under the Contract Manufacturing Agreement. Other than as set forth on Schedule 3.4, the Purchased Assets constitute all assets currently used for the day-to-day operation of the BioCDMO Business as presently conducted by the Sellers. Except as set forth on Schedule 3.4, all tangible personal property included in the Purchased Assets has been reasonably maintained in accordance with good business practice, is in good operating condition and repair, ordinary wear and tear excepted, and is substantially suitable for its present uses.
3.5
Assumed Contracts. Schedule 1.1A is a list of all Assumed Contracts as of the date of this Agreement.

 

21


 

 

 

 

Each Assumed Contract is in full force and effect, and is valid, binding and enforceable against the applicable Seller and, to such Seller’s knowledge, each other party thereto in accordance with its terms. Except as set forth on Schedule 1.1A, no Assumed Contract requires the consent of any other contracting party to the transactions contemplated by this Agreement. No Seller is, and, to Sellers’ knowledge, no other party is in breach or default under any Assumed Contract, and no event has occurred, and no condition exists which, with the passage of time or the giving of notice or both, would constitute such a breach or default by a Seller or, to Sellers’ knowledge, any other party thereto. True and complete copies of each Assumed Contract (including but not limited to the Real Estate Lease) have been delivered to Buyer. Except as set forth on Schedule 1.1A, no Seller is a party to or otherwise bound by any of the following contracts, agreements, or arrangements, whether written or oral, that are related to the Purchased Assets or the day-to-day operation of the BioCDMO Business:

(a)
any lease or sublease of real property;
(b)
any lease or sublease of personal property providing for either (A) annual payments by a Seller in excess of $10,000 or (B) aggregate payments by a Seller in excess of $30,000;
(c)
any contract for capital expenditures or the purchase of goods, services, materials, supplies or equipment providing for either (A) annual payments by a Seller in excess of $10,000 or (B) aggregate payments by a Seller in excess of $30,000;
(d)
any contract with any other brokers, sub-brokers, other intermediaries, referral sources, clients or otherwise relating to the sharing of commissions or fees, rebating or any other similar arrangement;
(e)
any contract granting any Person “most favored nation” status or “exclusivity” or

other preferential terms;

(f)
any contract granting any Person a right of first refusal, right of first offer or other preferential right to purchase or acquire any of the equity interests, assets, properties or business of a Seller;
(g)
any contract for any partnership, joint venture, strategic alliance or other similar arrangement;
(h)
any contract requiring a Seller to make any advance, loan, extension of credit or capital contribution to, or other investment in, any Person;
(i)
any contract with any Governmental Authority (other than standard utility agreements);
(j)
any contract relating to the acquisition or divestiture of any business or all or substantially all of the assets of any Person (whether by merger, sale of equity interests, sale of assets or otherwise), including any contract pursuant to which the a Seller is, or may become, obligated to pay any amount in respect of an “earn- out” or other form of deferred or contingent consideration;

 

22


 

 

 

 

(k)
any contract (A) relating to the incurrence, assumption or guarantee of any outstanding Debt (including all loan agreements, notes, bonds, debentures, indentures or guarantees) or (B) creating or granting a Lien (other than Permitted Liens) on any of the Purchased Assets or any equity securities of a Seller;
(l)
any contract (A) relating to the employment, engagement or termination of any employees of a Seller or (B) providing for any bonus, deferred compensation or other payment to be made to any employee of a Seller as a result of the execution of this Agreement or the consummation of the transactions contemplated hereby;
(m)
any contract that limits or purports to limit the ability of a Seller to (A) engage in any line of business, (B) compete with any Person, (C) operate in any geographic area, (D) solicit or accept business from the clients or prospective clients of any Person or (E) solicit for employment or hire any Person;
(n)
any contract providing for or relating to the settlement or compromise of any claim by or against a Seller in excess of $10,000; or
(o)
any other Contract of a type that is not covered by the other clauses of this Section

3.5 that (A) is material to the conduct of the BioCDMO Business or the absence of which would have a Material Adverse Effect and (B) is not terminable by the a Seller on sixty (60) days’ or less notice and without the payment of any penalty by, or any other material consequence to, a Seller.

3.6
Inventory; Equipment.
(a)
Schedule 3.6(a) sets for a complete list of Inventory as of the date hereof. All Inventory is of a quality and quantity usable in the Ordinary Course of Business. None of such Inventory is slow-moving, obsolete, damaged, defective or of below-standard quality. The values at which such Inventory is carried reflect an inventory valuation policy in accordance with the past custom and practice of Sellers. The quantities of each item of Inventory are not excessive but are reasonable in the present circumstances of the BioCDMO Business. All Inventory is maintained at the facilities of Sellers, and no Inventory is held on a consignment basis.
(b)
Schedule 3.6(b) sets forth a complete and accurate list of all of the Equipment other than items having a book or fair market value individually of less than

$10,000. The Equipment Leases listed on Schedule 1.1A include all leases by a Seller of any item of personal property used in the BioCDMO Business. The Equipment, and all personal property held by a Seller under Equipment Leases, are utilized by Sellers in the Ordinary Course of Business and are in good condition and repair for their present use in the BioCDMO Business.

 

23


 

 

 

 

3.7
Real Property.
(a)
Schedule 3.7(a) sets forth a complete and correct list and description of all real property owned by a Seller (collectively, the “Owned Real Property”). Except as set forth on Schedule 3.7(a), with respect to each parcel of Owned Real Property:

(i) such Seller has good and marketable fee simple title to each parcel of Owned Real Property free and clear of all Liens other than Permitted Liens; (ii) there are no pending or, to Sellers’ Knowledge, threatened condemnation Proceedings, lawsuits, or administrative actions relating to any parcel of Owned Real Property or to Sellers’ Knowledge, any other material matters affecting adversely the current use, occupancy, or value of any parcel of Owned Real Property; (iii) no parcel of Owned Real Property serves any adjoining property for any purpose inconsistent with the use of such parcel of Owned Real Property, and no Owned Real Property is located with any flood hazard area (as defined by the Federal Emergency Management Agency); (iv) there are no leases, subleases, licenses, concessions or other Contracts, written or oral, granting to any Person the right of use or occupancy of any portion of the Owned Real Property; (v) there are no outstanding Contracts, options or rights of first refusal to purchase any of the Owned Real Property, or any portion thereof or interest therein; (vi) no Person (other than Sellers and their affiliates) is in possession of any Owned Real Property; (vii) to Sellers’ Knowledge all buildings, structures and other improvements located on the Owned Real Property, including all material components thereof, are in good condition (subject to normal wear and tear); and

(viii) all material certificates of occupancy, permits, licenses, approvals and other authorizations required in connection with the operation of the BioCDMO Business on the Owned Real Property have been issued to enable the Owned Real Property to be lawfully occupied and used for all of the purposes for which it is currently occupied and used primarily in connection with the operation of the BioCDMO Business have been lawfully issued and are, as of the Closing Date, in full force and effect.

(b)
The Leased Real Property is the only real property that is leased by a Seller. Except as set forth on Schedule 3.7(b), one or both Sellers holds valid leasehold interests in the Leased Real Property, free and clear of any Liens, except any deed of trust or mortgage to which the Real Estate Lease is subordinate. Sellers have delivered to the Buyer accurate and complete copies of the Real Estate Lease. The Real Estate Lease is valid and subsisting and, to Sellers’ Knowledge, no event or condition exists which constitutes, or after notice or lapse of time or both would constitute, a default thereunder. The leasehold interests of a Seller is not subject to any Lien, except any deed of trust or mortgage to which the Real Estate Lease is subordinate. With respect to the Real Estate Lease, Seller has not exercised or given any notice of exercise of, nor has any lessor or landlord exercised or given any notice of exercise by such party of, any option, right of first offer or right of first refusal contained in the Real Estate Lease. The rent set forth in the Real Estate Lease is the actual rent being paid, and there are no separate agreements or understandings with respect to the same. The Real Estate Lease grants Seller the exclusive right to use and occupy the demised premises thereunder.

 

24


 

 

 

 

(c)
Sellers are in peaceful and undisturbed possession of the Leased Real Property and there are no contractual or legal restrictions that preclude or restrict the ability of Sellers to use such Leased Real Property for the purposes for which it is currently being used. Sellers have not subleased, licensed or otherwise granted to any Person the right to use or occupy any portion of the Leased Real Property, and no Seller has received notice or has any Knowledge of any claim of any Person to the contrary.
3.8
Environment, Health and Safety Matters.
(a)
Sellers are in compliance with all Environmental Laws and Occupational Safety and Health Laws related to the Owned Real Property and the Leased Real Property. Without limiting the generality of the foregoing, Sellers and their affiliates have obtained and complied in all respects with all Governmental Authorizations that are required pursuant to Environmental Laws and Occupational Safety and Health Laws for the occupation of the Owned Real Property and the Leased Real Property. An accurate and complete list of all such Governmental Authorizations is set forth on Schedule 3.8(a).
(b)
Sellers have not received any notice, report or other written communication or information regarding (i) any actual, alleged or potential violation of, or failure to comply with, any Environmental Law or Occupational Safety and Health Law, or

(ii) any Liability or potential Liability, including any investigatory, remedial or corrective obligation, relating to a Seller, or any Leased Real Property or other property or facility currently owned, leased, operated or controlled by a Seller in the operation of its BioCDMO Business and arising under any Environmental Law or Occupational Safety and Health Law.

(c)
Sellers have not treated, stored, disposed of, arranged for or permitted the disposal of, transported, handled, generated, manufactured, distributed, exposed any Person to or released any substance, including any Hazardous Material, nor owned or operated the Owned Real Property or the Leased Real Property, in a manner that has given rise to, or could reasonably be expected to give rise to, any Liability, including any Liability for fines, penalties, response costs, corrective costs, personal injury, property damage, natural resources damage or attorneys’ fees, pursuant to the Comprehensive Environmental Response, Compensation and Liability Act of 1980, the Solid Waste Disposal Act, the Resource Conservation and Recovery Act, the Superfund Amendments and Reauthorization Act of 1986, the Federal Water Pollution Control Act, the Federal Clean Water Act, the Federal Clean Air Act, the Toxic Substances Control Act or any other Environmental Law or Occupational Safety and Health Law.
(d)
To Sellers’ Knowledge, no Seller has, expressly or by operation of Law, assumed, undertaken, provided an indemnity with respect to or otherwise become subject to any Liability, including any obligation for corrective or remedial action, of any other Person relating to any Environmental Law.

 

25


 

 

 

 

3.9
Employees; Labor Matters.
(a)
Schedule 1.1C contains an accurate list of all Employees, and showing each such Employee’s (i) name, (ii) the State in which such individual primarily works, (iii) present position, (iv) date of hire, (v) total length of employment or service, including any prior service credit that would affect the calculation of years of service for any purpose; (vi) classification as exempt or non-exempt; (vii) status as full- or part-time; (viii) current annual compensation (including base salary, commissions and deferred compensation); (ix) accrued bonuses, if any, as of the date hereof; (x) accrued but unused or eligibility for vacation or other paid-time- off entitlements as of the date hereof, and (xi) the Seller by whom such Employee is employed. Schedule 1.1C also contains a list of any consultants or independent contractors providing services to Sellers related to the BioCDMO Business and a description of any agreements of Sellers therewith. Except as set forth on Schedule 1.1C, no Persons employed by Agenus Parent work with any Purchased Asset or otherwise devote time on a day-to-day basis to the operations of the BioCDMO Business other than those supporting IT, HR and finance functions.
(b)
Sellers acknowledges that Sellers shall be responsible for satisfying in full all amounts owed to Employees, including, if applicable, wages, salaries, severance pay, sick pay, accrued but unused vacation, any employment, incentive, compensation or bonus agreements and any other benefits or payments pursuant to the terms of any Compensation Arrangement and Employee Plan relating to the period of employment by Sellers (and ending on the Closing Date). Neither Agenus Parent nor Agenus West has (i) enacted an employment policy or (ii) entered into an arrangement or contract with any employee of Agenus Parent or Agenus West, which obligates Sellers or Buyer to make retention payments to such employees.
(c)
Sellers are, and for the past three (3) years have been, in compliance in all material respects with all applicable Laws relating to employment and employment practices, including the terms and conditions of employment, termination of employment, hiring practices and procedures, immigration and employment verification matters, workplace health and safety, workers’ compensation, wages and hours (including minimum wage and overtime payments) and worker classification.
(d)
Neither Seller is, nor has ever been, a party to or otherwise bound by any collective bargaining agreement or other agreement with a labor union or equivalent organization. To the knowledge of the Sellers, there is no organizational campaign or other effort to cause a labor union or equivalent organization to be recognized or certified as a representative on behalf of the Employees. There is no pending or, to the knowledge of the Sellers, threatened labor strike, labor dispute or work stoppage involving the Employees.
(e)
Except as set forth in Schedule 3.9(e), each Employee is an “at-will” employee

and each independent contractor of the Sellers, whose employment or engagement, respectively, may be terminated at any time without advance notice by or Liability to the Sellers.

 

26


 

 

 

 

Except as set forth in Schedule 3.9(e), none of the current Employees or independent contractors (i) is on a paid or unpaid medical, disability, family or other leave of absence, or (ii) has given written notice of termination of his or her employment or engagement. Each Employee or current independent contractor is correctly classified as an employee or non-employee and as “exempt” or “non-exempt” for all purposes (including with respect to eligibility for minimum wage and overtime under the Fair Labor Standards Act and for purposes of taxation and Tax reporting and under the Employee Plans).

(f)
Neither Seller has, within the past twelve (12) months, effectuated (i) a “plant closing” or a “mass layoff” (as such terms are defined in the WARN Act) or (ii) such other transaction, layoff, reduction in force or employment terminations sufficient in number to trigger application of the WARN Act.
(g)
Neither Seller has, within the past three (3) years, received any “cease and desist” letter or similar written communication alleging that any Employee or independent contractor is, and to the knowledge of the Sellers no Employee or independent contractor is, performing any job duties or engaging in other activities on behalf of a Seller in connection with the BioCDMO Business or the Purchased Assets that would violate any employment, non-competition, non- solicitation, non-disclosure or other similar agreement between such individual and any former employer or any applicable Law.
3.10
Absence of Changes. Since December 31, 2024, except as disclosed on Schedule 3.10, there has not been any:
(a)
amendment, cancellation, or termination of any contract, license, or other instrument material to Agenus West and/or the BioCDMO Business;
(b)
sale, assignment, or transfer of any material assets of a Seller related to the BioCDMO Business;
(c)
addition to or modification of the Employee Plans of a Seller or arrangements or practices affecting Employees;
(d)
material damage, destruction or other casualty loss (whether or not covered by insurance) affecting the Purchased Assets;
(e)
loans, advances or capital contributions by a Seller to, or investments in, any Person, other than (i) advances to the Employees in respect of travel and other business-related expenses incurred in the ordinary course of business, and (ii) loans, advances, capital contributions or investments by Agenus Parent that are unrelated to the Purchased Assets, Assumed Liabilities, or the BioCDMO Business; material change in the compensation payable, or benefits provided to, or other material change in the employment terms (including termination or separation of service) for, any of the Employees;

 

27


 

 

 

 

(f)
(g)
incurrence, assumption or guarantee of any Debt other than Debt paid off prior to Closing;
(h)
waiver, release or assignment of any material rights, claims or benefits under any material contract or settlement or compromise any material claims by or against a Seller related to the Purchased Assets, the Assumed Liabilities, or the BioCDMO Business;
(i)
capital expenditures by Agenus West in excess of $25,000 or by Agenus Parent in excess of such amount if such expenditure is related to the Purchased Assets, Assumed Liabilities, or the BioCDMO Business;
(j)
agreement or commitment to do any of the foregoing;
(k)
change in accounting methods or practices by a Seller; or
(l)
change, condition, effect, event or occurrence that, individually or in the aggregate, has had a Material Adverse Effect on the Purchased Assets.
3.11
Taxes. Except as set forth on Schedule 3.11:
(a)
Each Seller has filed, or caused to be filed, with the appropriate Governmental Authority, all required Tax returns, and each Seller has paid, caused to be paid or accrued all Taxes shown to be due and payable or claimed to be due and payable thereon, in each case related to the BioCDMO Business. No Seller is currently the beneficiary of any extension of time within which to file any Tax Return relating to the Purchased Assets or the BioCDMO Business. No Seller has any liability material in amount for any Taxes due and owing, and there are no proceedings pending pursuant to which a Seller is or could be made liable for any Taxes, penalties, interest, or other charges, the liability for which would extend to Buyer as transferee of the Purchased Assets or as owner of the Business following the Closing.
(b)
Each Seller has timely collected or withheld, and timely remitted to the appropriate taxing authorities, all Taxes required to have been collected or withheld from amounts owing to the employees of the Sellers and other third parties for all periods under applicable Law and has complied with all information reporting (including Internal Revenue Service Form 1099) and backup withholding requirements, including maintenance of required records with respect thereto.
(c)
There are no Liens for Taxes on any of the Purchased Assets, nor is any taxing authority in the process of imposing any Liens for Taxes on any of the Purchased Assets other than statutory Liens for current Taxes that are not yet due and payable.

 

28


 

 

 

 

(d)
No Seller has waived or extended or been requested to waive or extend any statute of limitations for the assessment or collection of any Taxes associated with the BioCDMO Business or the Purchased Assets, which waiver or extension is currently in effect.
(e)
During the past three (3) years, no Seller has received any written notice or written inquiry from any Governmental Authority in any jurisdiction where such Seller does not currently file Tax Returns to the effect that the Seller is or may be subject to taxation by that jurisdiction.
(f)
No Seller is, nor has any Seller been, a party to, or a promoter of, a “listed transaction” within the meaning of Section 6707A(c)(2) of the Code and U.S. Treasury Regulation Section 1.6011-4(b)(2).
(g)
Neither Seller has (nor has either Seller previously had) any permanent establishment in any foreign country, and neither Seller engages (nor has either Seller ever previously engaged) in a trade or business in any foreign country.
(h)
Neither Seller is a “foreign person” within the meaning of Section 1445 of the Code. Neither the Code nor any other applicable Law requires the Buyer to withhold any portion of the Purchase Price.
3.12
Claims and Litigation. Except as set forth on Schedule 3.12, there are no Actions pending or, to Sellers’s knowledge, threatened by or against the Purchased Assets or Sellers relating to the BioCDMO Business or the transactions contemplated by this Agreement or the Ancillary Agreements.
3.13
Insurance. Schedule 3.13 sets forth a true and correct list of all insurance policies maintained by or for the benefit of Sellers related to the BioCDMO Business and/or the Purchased Assets, all of which are in full force and effect as of the date hereof. There are no claims pending under any insurance policies related to BioCDMO Business and/or the Purchased Assets as to which coverage has been denied or disputed or in respect of which there is outstanding reservation of rights. All premiums due on the insurance policies have been paid. Neither Seller is in default under, nor has either Seller otherwise failed to comply with, any provision contained in any such insurance policy.
3.14
Compliance with Laws.
(a)
Except as set forth in Schedule 3.14(a), both Sellers are in compliance with applicable Laws and Permits in connection with the BioCDMO Business, except where the failure to be in compliance would not have a Material Adverse Effect.
(b)
Without limiting the generality of Section 3.14(a), the Sellers currently conduct, and for the past five (5) years have conducted, their operations in connection with the BioCDMO Business in compliance in all material respects with all applicable anti-corruption or anti-bribery laws, including the United States Foreign Corrupt Practices Act of 1977, as amended.

 

29


 

 

 

 

The Sellers maintain and are in compliance in all material respects with policies, procedures and internal controls reasonably designed to detect and prevent corruption and to ensure compliance in all material respects with all applicable anti-corruption or anti-bribery laws. The Sellers have not, nor to the knowledge of the Sellers, has any representative acting for or on behalf of the Sellers, made any payments of either cash or other consideration that were or are unlawful under applicable Law, including directly or indirectly (i) using the Sellers’ funds for any illegal or unlawful contribution, gift, entertainment or other payment, (ii) making any bribe, rebate, payoff, influence payment, kickback or other illegal or unlawful payment to any foreign or domestic government official or employee, (iii) making any payment to any customer, supplier or other Person for an unlawful reciprocal practice or (iv) making any illegal or unlawful payment to induce an individual to use such individual’s influence to assist the Sellers in obtaining or retaining business with any Person to secure an improper advantage for the Sellers.

(c)
Without limiting the generality of Section 3.14(a), the Sellers currently conduct the BioCDMO Business and have conducted the BioCDMO Business in material compliance with all applicable Privacy and Security Laws and contractual obligations with respect to the receipt, collection, compilation, use, storage, processing, sharing, safeguarding, security (technical, physical and administrative), disposal, destruction, disclosure, or transfer of Personally Identifiable Information. The Sellers have taken commercially reasonable measures designed to protect and maintain the confidentiality of all Personally Identifiable Information collected by or on behalf of the Sellers in accordance with all Privacy and Security Laws and consistent with commercially reasonable industry practices applicable to such types of data gathered and maintained in the industry in which the Sellers conduct the BioCDMO Business. The Sellers have taken commercially reasonable steps to ensure that all third party service providers, outsourcers, contractors, or other persons who process, store or otherwise handle Personally Identifiable Information for or on behalf of the Sellers have agreed to materially comply with applicable Privacy and Security Laws and taken reasonable steps to protect and secure Personally Identifiable Information from loss, theft, misuse or unauthorized access, use, modification or disclosure. To the knowledge of the Sellers, there has been no unauthorized access, use, or disclosure of Personally Identifiable Information in the possession or control of the Sellers or any of its respective providers or other contractors, or otherwise in connection with the BioCDMO Business.
3.15
Brokers. Except as set forth on Schedule 3.15, neither Seller has engaged any agent, broker or other Person acting pursuant to the express or implied authority of Seller which is or may be entitled to a commission or broker or finder’s fee in connection with the transactions contemplated by this Agreement or otherwise with respect to the sale of the Purchased Assets or the BioCDMO Business.

 

30


 

 

 

 

3.16
Intellectual Property. Other than the Licensed Intellectual Property, there is no material intellectual property (whether owned or licensed by the Sellers) used by or on behalf of the Sellers in connection with the Purchased Assets. To the knowledge of the Sellers, (i) no activity of any Person conflicts with, infringes upon or otherwise misappropriates the Licensed Intellectual Property, and (ii) to Sellers’ Knowledge neither the development nor the manufacturing of biotech products in the manner conducted by the Sellers prior to or as of the Closing conflicts with, infringes upon or otherwise misappropriates any intellectual property rights of any Person.
3.17
Regulatory Matters. Neither Seller has received any written notice, letter, or similar correspondence from the U.S. Food & Drug Administration with respect to the operation of the BioCDMO Business.
3.18
Subsidiaries. Except as set forth on Schedule 3.18, Agenus West does not, directly or indirectly, own any equity interest in, have any investment in, or participate in any joint venture, partnership or similar association or arrangement with, any other Person.
3.19
No Undisclosed Liabilities; Debt and Liens.
(a)
Except as set forth on Schedule 3.19(a), the Sellers do not have any Liabilities other than (i) the Excluded Liabilities and (ii) the Assumed Liabilities, which have been incurred in the ordinary course of business.
(b)
Without limiting the generality of Section 3.19(a), except as set forth in Schedule 3.19(b), (i) the Sellers do not have any Debt, (ii) the Sellers do not guarantee any Debt of any other Person, (iii) there are no Liens (other than Permitted Liens) on the Purchased Assets, and (iv) all Debt may be prepaid at or prior to the Closing without penalty under the terms of the contracts, arrangements, or other instruments governing such Debt. Schedule 3.19(b) sets forth a true, complete and correct list of (A) the holders of all Debt of the Sellers and (B) the amount of Debt owed to each such holder as of the date hereof.
3.20
Permits. The Sellers hold or possess, and are in compliance with and have timely sought the renewal of, all material Permits required for the lawful conduct of its operations related to the BioCDMO Business as currently conducted (collectively, the “Material Permits”), except for any failure to hold or possess any Permit or any non-compliance or non-renewal that is not and would not reasonably be expected to be, individually or in the aggregate, material to the BioCDMO Business. Schedule 3.20 sets forth a true, complete and correct list of each Material Permit, including the holder of such Permit, the type of Permit, the Permit number, the jurisdiction issuing such Permit and the expiration date of such Permit. Except as set forth in Schedule 3.20, (a) each Material Permit is valid and in full force and effect; (b) none of the Sellers or any of its employees has received any written notice or, to the knowledge of the Sellers, other communication alleging, or is in, any material breach of or default under any Material Permit; (c) to the knowledge of the Sellers, no Material Permit will be terminated or impaired solely as a result of the transactions contemplated hereby; and (d) no Actions are pending or, to the knowledge of the Sellers, threatened that if determined or resolved adversely would result in the revocation, cancellation, suspension or adverse modification of any Material Permit.

 

31


 

 

 

 

3.21
Employee Plan Matters.
(a)
Schedule 3.21(a) sets forth a true, complete and correct list of each material Employee Plan. With respect to each such material Employee Plan, the Sellers have made available to the Buyer true, complete and correct copies of the following documents, to the extent applicable: (i) the current plan document, including all amendments thereto, and in the case of unwritten Employee Plans written descriptions of the material terms thereof; (ii) each insurance contract, trust agreement or other funding arrangement; (iii) the most recent summary plan description and summary of material modifications thereto; (iv) the most recent determination or opinion letter (if any) received from the IRS with respect to each Employee Plan intended to be “qualified” within the meaning of Section 401(a) of the Code; (v) the two (2) most recent annual reports on Form 5500 (including any applicable schedules and attachments thereto) filed with the IRS; (vi) the coverage and nondiscrimination testing results for the two (2) most recent plan years; (vii) the most recent financial statements and/or actuarial valuation report; and (viii) all material correspondence within the past two (2) years with the IRS, the Department of Labor or any other Governmental Authority regarding the operation or administration of any Employee Plan.
(b)
Each Employee Plan has been established, operated, administered and funded in compliance with, and complies with, its terms and all applicable Laws (including ERISA and the Code) in all material respects, and there has not been any written notice issued by any Governmental Authority questioning or challenging such compliance. The Sellers have timely paid or made all contributions, distributions, reimbursements and premium payments required under or with respect to each Employee Plan, including accruing in accordance with GAAP and past custom and practice of the Sellers, for any incurred but not reported Liabilities for all periods ending on or before the Closing Date.
(c)
No act or omission has occurred, and no condition exists with respect to any Employee Plan that would subject the Sellers, the Buyer or any of their respective affiliates to any material fine, penalty, Tax or other Liability imposed under ERISA, the Code or other applicable Law, including Section 4980H of the Code. There have been no “prohibited transactions” (within the meaning of Section 406 of ERISA or Section 4975 of the Code) with respect to any Employee Plan.
(d)
Each Employee Plan that is intended to be “qualified” within the meaning of Section 401(a) of the Code has received a favorable and current determination letter from the IRS, or is a prototype plan that is entitled, under applicable IRS guidance, to rely on a favorable opinion letter from the IRS to the prototype plan sponsor (which it has timely received from the IRS), as to the Tax qualification of such Employee Plan under Section 401(a) of the Code and the exemption of the related trust from federal income taxation under Section 501(a) of the Code. No fact or event has occurred since the date of such letter that would reasonably be expected to adversely affect such Tax qualified status or Tax exempt status.

 

32


 

 

 

 

(e)
Each Employee Plan that is subject to Section 409A of the Code is in operational and documentary compliance with Section 409A and all applicable IRS regulations, rulings and notices promulgated thereunder. The Sellers do not have any obligation to gross up, indemnify or otherwise reimburse any Person for any Taxes (or potential Taxes) imposed (or potentially imposed) pursuant to Section 409A or Section 4999 of the Code.
(f)
Neither a Seller nor any of its ERISA Affiliates sponsors, maintains or contributes to, or has ever sponsored, maintained or contributed to, or has had or could have any Liability with respect to, (i) any Employee Plan subject to Title IV of ERISA, Section 302 of ERISA or Section 412 of the Code, (ii) any “multiemployer plan” (as defined in Section 3(37) of ERISA), (iii) any “multiple employer plan” (as defined in Section 413(c) of the Code), (iv) any “multiple employer welfare arrangement” (as defined in Section 3(40) of ERISA), (v) any tax qualified “defined benefit plan” (as defined in Section 3(35) of ERISA) or (vi) any self- insured plan (including any plan pursuant to which a stop loss policy or contract applies).
(g)
Except for health continuation coverage as required by COBRA or any similar applicable state law, no Employee Plan provides or promises any benefits or coverage following the retirement or other termination of service of any employees or independent contractors of the Sellers. Schedule 3.21(g) sets forth a true, complete and correct list of all Liabilities of the Sellers to provide “health continuation coverage” to former employees of the Sellers and their covered dependents with respect to all qualifying events under COBRA and similar state law that occurred prior to the Closing. With respect to all periods prior to the Closing, the Sellers have complied in all material respects with all requirements of COBRA and any similar state law. The Sellers will not have any current obligations to make any severance payments to any former employees or independent contractors as of the Closing.
(h)
Except as set forth in Schedule 3.21(h), neither the execution and delivery of this Agreement nor the consummation of the transactions contemplated hereby will (either alone or in combination with any other event) (i) result in, (ii) accelerate the time of payment, vesting or funding of or (iii) increase the amount or value of, any payment or benefit to any current or former employee, officer, manager or director of or consultant to a Seller. There is no Contract covering any current or former employee or independent contractor of either Seller that, individually or collectively, could give rise to (or already has resulted in) the payment of any amount or provision of any benefit (including accelerated vesting) by the Buyer that could constitute “an excess parachute payment” within the meaning of Section 280G of the Code or would not be deductible under Section 280G of the Code or could be subject to an excise tax under Section 4999 of the Code.

 

33


 

 

 

 

(i)
Each Employee Plan may be amended, terminated or otherwise discontinued as of the Effective Time in accordance with its terms without any Liability to the Buyer or its ERISA Affiliates. None of the Employee Plans is operated, or subject to the laws of any jurisdiction, outside the United States.
(j)
None of the Employee Plans provides benefits to any individual who is not (i) an eligible employee of the Sellers, (ii) an eligible former employee of the Sellers (to the extent coverage of such former employee is required by applicable Law) or

(iii) an eligible spouse or dependent of any person covered by clause (i) or (ii). For purposes of each Employee Plan, the Sellers have correctly classified those individuals performing services for the Sellers as common law employees, leased employees or independent contractors.

(k)
There are no Actions (including any audit or investigation by the IRS, United States Department of Labor or Pension Benefit Guaranty Corporation) pending or, to the knowledge of the Sellers, threatened involving any Employee Plan or the assets thereof, other than routine claims for benefits payable in the ordinary course of business that if determined adverse to Sellers would not have a Material Adverse Effect.

SECTION 4.

REPRESENTATIONS AND WARRANTIES OF BUYER

Buyer hereby represents and warrants to Sellers as follows:

4.1
Organization and Authority. Zydus Pharmaceuticals (USA) Inc. is a corporation duly organized, validly existing and in good standing under the laws of the State of New Jersey. If this Agreement is assigned by Zydus Pharmaceuticals (USA) Inc. to an affiliate prior to Closing, such Buyer shall be duly organized, validly existing and in good standing under the laws of such Buyer’s state of organization. Buyer has all requisite corporate power and authority to execute, deliver and perform this Agreement and the Ancillary Agreements and to consummate the transactions contemplated hereby and thereby.
4.2
Authorization and Binding Obligations. The execution, delivery and performance of this Agreement by Buyer and each Ancillary Agreement to which Buyer is or will be a party have been duly and validly authorized by all necessary corporate action. This Agreement and each Ancillary Agreement to which Buyer is or will be a party has been (or when delivered will be) duly executed and delivered by Buyer and constitutes (or will constitute) a valid and binding agreement of Buyer enforceable against Buyer in accordance with its terms, except as its enforceability may be limited by Enforceability Exceptions.
4.3
No Contravention; Consents. The execution, delivery and performance of this Agreement and each Ancillary Agreement, the consummation of the transactions contemplated hereby and thereby and the compliance with the provisions hereof and thereof by Buyer will not (a) violate the organizational documents of Buyer, (b) violate any Laws applicable to Buyer, (c) require the consent of any third party, or (d) violate, be in conflict with, or constitute a default under any contract or agreement to which Buyer is a party, such that Buyer cannot perform its obligations hereunder.

 

34


 

 

 

 

4.4
Financial Resources. Buyer has the financial resources to pay the Purchase Price as required hereunder and fulfill its other obligations hereunder.
4.5
Brokers. Buyer has not engaged any agent, broker or other Person acting pursuant to the express or implied authority of Buyer which is or may be entitled to a commission or broker or finder’s fee in connection with the transactions contemplated by this Agreement or otherwise with respect to the sale of the Purchased Assets or the BioCDMO Business.
4.6
Independent Investigation. Buyer has conducted its own independent investigation, review and analysis of the BioCDMO Business, the Purchased Assets, and the operations, prospects, condition (financial or otherwise) of the BioCDMO Business, and acknowledges that it has been provided adequate access to the personnel, properties, assets, premises, books and records, and other documents and data of Sellers and the BioCDMO Business for such purposes. Buyer acknowledges and agrees that: (a) in making its decision to enter into this Agreement and to consummate the transactions contemplated hereby, Buyer has relied solely upon its own investigation and the express representations and warranties of Sellers set forth in Section 3 of this Agreement (including the related portions of the Disclosure Schedules); and (b) none of Sellers, or any Person on Sellers’ behalf has made any representation or warranty as to Sellers, the BioCDMO Business, the Purchased Assets or this Agreement, except as expressly set forth in Section 3 of this Agreement (including the related portions of the Disclosure Schedules).

SECTION 5.

PRE-CLOSING COVENANTS OF THE PARTIES

5.1
The Parties each covenant and agree, from and after the execution and delivery of this Agreement, to and including the Closing Date as follows:
(a)
Commercially Reasonable Efforts.
(i)
Sellers covenant and agree that from and after the execution and delivery of this Agreement to and including the Closing Date Sellers shall use their commercially reasonable efforts to cause the transactions contemplated by this Agreement to be consummated in accordance with the terms hereof, and, without limiting the generality of the foregoing, to obtain all Required Consents required to be obtained by Sellers in connection with this Agreement and the transactions contemplated hereby. Sellers shall make all filings with and give all notices to third parties that may be reasonably necessary of Sellers in order to consummate the transactions contemplated hereby.
(ii)
Buyer covenants and agrees that from and after the execution and delivery of this Agreement to and including the Closing Date Buyer shall use its commercially reasonable efforts to cause the transactions contemplated by this Agreement to be consummated in accordance with the terms hereof, including providing commercially reasonable assistance to Sellers with respect to Consents required to be obtained by Sellers in connection with this Agreement and the transactions contemplated hereby.

 

35


 

 

 

 

Buyer shall make all filings with and give all notices to third parties that may be necessary or reasonably required in order to consummate the transactions contemplated hereby.

(b)
Access. Sellers shall give to Buyer and its agents reasonable access during normal business hours to all of Sellers’ personnel, premises, properties, assets, financial statements and records, books, contracts, documents and commitments of or relating to the BioCDMO Business and/or the Purchased Assets, and shall furnish Buyer with all such information concerning the BioCDMO Business as Buyer reasonably may request. All requests by Buyer for access pursuant to this Section 5.1(b) shall be submitted or directed exclusively to such individual(s) as the Sellers may designate in writing from time to time, who initially shall be Zachary Armen. Notwithstanding anything to the contrary in this Agreement, Sellers shall not be required to disclose any information to Buyer if such disclosure would, in the Sellers’ reasonable discretion: (w) cause significant competitive harm to Sellers, any of their affiliates or their respective businesses if the transactions contemplated by this Agreement are not consummated; (x) jeopardize any attorney-client or other privilege; or (y) contravene any applicable Law, fiduciary duty or binding agreement entered into prior to the Effective Date; or (z) reveal bids received from third parties in connection with transactions similar to those contemplated by this Agreement and any information and analysis (including financial analysis) relating to such bids. Prior to the Closing, without the prior written consent of the Sellers, not to be unreasonably withheld, conditioned or delayed, Buyer shall not contact any employees of, suppliers to, or customers of, Sellers or any of their affiliates, and shall have no right to perform invasive or subsurface investigations of the Real Property. Without limiting the foregoing, Sellers shall permit Buyer and its representatives upon reasonable advance notice to conduct environmental due diligence of the Real Property, including the collecting and analysis of samples of indoor or outdoor air, potentially hazardous building materials, surface water, groundwater or surface or subsurface land on, at, in, under or from the Real Property. Any investigation pursuant to this Section 5.1(b) shall be conducted in such manner as not to interfere unreasonably with the conduct of the BioCDMO Business or any other businesses of Sellers. Buyer must promptly repair any damage or loss caused by Buyer or its representatives, and the Buyer shall indemnify and hold Sellers harmless from all claims, losses, liability, costs and expenses, including attorneys’ fees, in connection with such access and due diligence related thereto. Each Party shall, to the extent applicable, and shall cause its representatives to (to the extent applicable), abide by the terms of that certain mutual confidentiality agreement, dated October 25, 2024, by and between Agenus Parent and Zydus Lifesciences Limited, a company incorporated under the laws of India, with respect to any access or information provided pursuant to this Section 5.1(b).

 

36


 

 

 

 

(c)
Ordinary Course. Unless approved by Buyer in writing, Sellers shall conduct the BioCDMO Business and use their commercially reasonable efforts to preserve and maintain the Purchased Assets in good working order and condition, subject to normal wear and tear, in the ordinary course of business consistent with past practice, including maintaining existing insurance policies on the Purchased Assets as in effect on the date hereof. Sellers shall use commercially reasonable efforts to keep their respective organizations intact to preserve the BioCDMO Business and to preserve the goodwill of suppliers, customers, landlords, Governmental Authorities and others dealing with Sellers. Sellers’ Books and Records shall be maintained in a manner consistent with past practice. Without limiting the foregoing, from the date hereof until the Closing Date, Sellers shall:
(i)
preserve and maintain all existing Permits required for the conduct of the BioCDMO Business as currently conducted or the ownership and use of the Purchased Assets; provided that any failure of Sellers to preserve or maintain any Permits as required pursuant to this Section 5.1(c)(i) shall not be considered a breach hereof if such failure would not have a materially adverse impact on the operation by Buyer of the BioCDMO Business or the Purchased Assets post-Closing;
(ii)
pay the debts, Taxes and other obligations of the BioCDMO Business when due;
(iii)
defend and protect the properties and assets included in the Purchased Assets from infringement or usurpation, and refrain from granting new title or property interests or leaseholds in the Purchased Assets;
(iv)
perform all of its material obligations under all Assumed Contracts;
(v)
comply in all material respects with all Laws applicable to the conduct of the BioCDMO Business or the ownership and use of the Purchased Assets; and
(vi)
not take or consent to any action that would cause any of the changes, events or conditions described in Section 3.10 to occur.
(d)
Contracts and Liens. Sellers shall not (i) create, assume, consent to or suffer to exist any Lien on any of the Purchased Assets (other than Permitted Liens); or

(ii) cause or approve the termination of any Assumed Contract without Buyer’s written consent. Unless Buyer shall have given its prior written consent or otherwise in the ordinary course of business, neither Seller shall enter into any new contract, agreement or lease or incur any obligation (including obligations arising from the amendment of any existing contract, agreement or lease) related to the BioCDMO Business that will be binding on Buyer or the Purchased Assets after the Closing.

 

37


 

 

 

 

(e)
Closing Conditions. From the date hereof until the Closing, each Party hereto shall use reasonable best efforts to take such actions as are necessary to satisfy the closing conditions set forth in Section 7 hereof.
(f)
No Solicitation of Other Bids.
(i)
Sellers shall not, and shall not authorize or permit any of their affiliates or any of their respective representatives to, directly or indirectly, (i) encourage, solicit, initiate, facilitate or continue inquiries regarding an Acquisition Proposal; (ii) enter into discussions or negotiations with, or provide any information to, any Person concerning a possible Acquisition Proposal; or (iii) enter into any agreements or other instruments (whether or not binding) regarding an Acquisition Proposal. Sellers shall immediately cease and cause to be terminated, and shall cause their affiliates and all of their respective representatives to immediately cease and cause to be terminated, all existing discussions or negotiations with any Persons conducted heretofore with respect to, or that could lead to, an Acquisition Proposal. For purposes hereof, “Acquisition Proposal” means any inquiry, proposal or offer from any Person (other than Buyer or any of its affiliates) relating to the direct or indirect disposition, whether by sale, merger or otherwise, of all or any portion of the BioCDMO Business or the Purchased Assets.
(ii)
In addition to the other obligations under this Section 5.1, Sellers shall promptly (and in any event within three Business Days after receipt thereof by Sellers or their representatives) advise Buyer orally and in writing of any Acquisition Proposal, any written request for information with respect to any Acquisition Proposal, or any written inquiry with respect to or which could reasonably be expected to result in an Acquisition Proposal and the material terms and conditions of such written request, Acquisition Proposal or inquiry.
(iii)
Sellers agree that the rights and remedies for noncompliance with this Section 5.1(f) shall include having such provision specifically enforced by any court having equity jurisdiction, it being acknowledged and agreed that any such breach shall cause irreparable injury to Buyer and that money damages would not provide an adequate remedy to Buyer.

SECTION 6.

OTHER COVENANTS

6.1
Notice of Breach. Buyer and Sellers shall give prompt notice to one another of (a) the occurrence or nonoccurrence of any event that has caused or would be likely to cause, individually or in the aggregate, (i) a Material Adverse Effect, (ii) any representation or warranty contained in this Agreement to be untrue or inaccurate at or prior to the Closing Date, and (iii) any material failure of Buyer or Sellers, as the case may be, to comply with or satisfy any covenant, condition or agreement to be complied with or satisfied by it hereunder; (b) any written notice or other written communication from any Governmental Authority in connection with the transactions contemplated by this Agreement; and (c) any Actions commenced or, to Sellers’ Knowledge, threatened against, relating to or involving or otherwise affecting the BioCDMO Business, the Purchased Assets or the Assumed Liabilities that, if pending on the date of this Agreement, would have been required to have been disclosed pursuant to Section 3.12 or that relates to the consummation of the transactions contemplated by this Agreement.

 

38


 

 

 

 

The delivery of any notice pursuant to this Section 6.1 shall not cure such breach or non-compliance or limit or otherwise affect the remedies available to the Party receiving such notice (including Section 9.3, Section 9.4, and Section 10.1) and shall not be deemed to amend or supplement the Disclosure Schedules; provided, that if a Party has a right to terminate this Agreement pursuant to Section 10.1 as a result of such matter’s disclosure by another Party under this Section 6.1, but does not elect to terminate within fifteen (15) days of its receipt of such notice, then such recipient shall be deemed to have irrevocably waived any right to terminate this Agreement solely with respect to such matter; provided further, however, that no matter disclosed under this Section 6.1 shall be deemed to have been waived (whether or not such matter, standing alone, triggers a right of termination for the recipient under Section 10.1) if, when combined with other matters disclosed under this Section 6.1, such matters on a combined basis provide the recipient with a separate right of termination.

6.2
Confidentiality.
(a)
Confidential Transaction Information. Except as necessary for the consummation of the transaction contemplated hereby, and except as and to the extent required by Law, each Party will keep confidential all information obtained from the other Party in connection with the transactions contemplated by this Agreement (unless such information thereafter becomes generally available to the public or is otherwise available to it on a non-confidential basis from another source). If this Agreement is terminated, each Party will, upon request, return all information obtained from the other Party in connection with the transactions contemplated by this Agreement.
(b)
Confidential Business Information. From and after the Closing, Sellers shall, and shall cause their affiliates to, hold, and shall use its reasonable best efforts to cause their respective representatives to hold, in confidence any and all information, whether written or oral, concerning its operations related to the BioCDMO Business, except to the extent that Sellers can show that such information (a) is generally available to and known by the public through no fault of a Seller, any of a Seller’s affiliates or their respective representatives; or (b) is lawfully acquired by a Seller, any of its affiliates or their respective representatives from and after the Closing from sources which are not prohibited from disclosing such information by a legal, contractual or fiduciary obligation. If a Seller or any of its affiliates or their respective representatives are compelled to disclose any information by judicial or administrative process or by other requirements of Law, such Seller shall promptly notify Buyer in writing and shall disclose only that portion of such information which such Seller is advised by its counsel in writing is legally required to be disclosed, provided that such Seller shall seek an appropriate protective order or other reasonable assurance that confidential treatment will be accorded such information.

 

39


 

 

 

 

6.3
Bulk Sales. The Parties do not believe that any bulk sales Laws are applicable to the transactions contemplated by this Agreement. To the extent bulk sales Laws do apply, Sellers and Buyer hereby waive compliance by the other with bulk sales Laws applicable to the transactions contemplated hereby; it being understood that any Liabilities arising out of the failure of Sellers to comply with the requirements and provisions of any bulk sales, bulk transfer or similar Laws of any jurisdiction which would not otherwise constitute Assumed Liabilities shall be treated as Excluded Liabilities.
6.4
Further Assurances. The Parties will take all appropriate actions and execute all documents, instruments or conveyances of any kind that may be reasonably necessary or advisable to carry out any of the provisions hereof.
6.5
Governmental Approvals and Consents.
(a)
Each Party shall, as promptly as possible, use its reasonable best efforts to obtain, or cause to be obtained, all consents, authorizations, orders and approvals from all third parties that are described in Schedule 1.1B and all Governmental Authorities that may be or become necessary for its execution and delivery of this Agreement and the performance of its obligations pursuant to this Agreement. Each Party shall cooperate fully with each other Party and such Party’s affiliates in promptly seeking to obtain all such consents, authorizations, orders and approvals. The Parties shall not willfully take any action that will have the effect of delaying, impairing or impeding the receipt of any required consents, authorizations, orders and approvals. If required by the HSR Act and if the appropriate filing pursuant to the HSR Act has not been filed prior to the date hereof, each Party agrees to make an appropriate filing pursuant to the HSR Act with respect to the transactions contemplated by this Agreement as soon as reasonably practicable after the date hereof and to supply as promptly as practicable to the appropriate Governmental Authority any additional information and documentary material that may be requested pursuant to the HSR Act. The Parties acknowledge that the rules and regulations promulgated by the Committee on Foreign Investment in the United States (“CFIUS”) require the Parties to jointly prepare and submit a CFIUS declaration pursuant to 21 C.F.R. Part 800 et al (“CFIUS Filing”) before CFIUS and obtain CFIUS Regulatory Approval. If the CFIUS Filing has not been filed prior to the Effective Date, the Parties shall, using best efforts, jointly prepare and submit the CFIUS Filing before CFIUS. The Parties agree that Sellers and/or its representatives shall take the lead in filing the CFIUS Filing. A “CFIUS Regulatory Approval” shall occur only when one of the following conditions has been met: (i) in response to the CFIUS Filing submitted jointly by the Parties, the Parties have received written notice from CFIUS stating that: (A) CFIUS has concluded that the transaction subject to this Agreement (the “Proposed Transaction”) is not a “covered transaction” and not subject to review under the Defense Production Act; or (B) CFIUS has concluded its consideration of the Proposed Transaction under the Defense Production Act and determined there are no unresolved national security concerns regarding the Proposed Transaction; or

 

40


 

 

 

 

(ii) CFIUS has sent a report to the President of the United States requesting the President’s decision on the Proposed Transaction and either the period under the Defense Production Act during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Proposed Transaction has expired without any such action being announced or taken. The Parties shall respond to all CFIUS inquiries in a timely manner. Each Party shall bear its own fees and costs (including all filing fees) in connection with such Party’s CFIUS Filing. The filing fees for all Parties for all filings under the HSR Act shall be borne equally by Buyer and Sellers, when due.

(b)
All analyses, appearances, meetings, discussions, presentations, memoranda, briefs, filings, arguments, and proposals made by or on behalf of a Party before any Governmental Authority or the staff or regulators of any Governmental Authority, in connection with the transactions contemplated hereunder (but, for the avoidance of doubt, not including any interactions between a Seller with Governmental Authorities in the ordinary course of business, any disclosure which is not permitted by Law or any disclosure containing confidential information) shall be disclosed to the other Parties hereunder in advance of any filing, submission or attendance, it being the intent that the Parties will consult and cooperate with one another, and consider in good faith the views of one another, in connection with any such analyses, appearances, meetings, discussions, presentations, memoranda, briefs, filings, arguments and proposals. Each Party shall give notice to the other Parties with respect to any meeting, discussion, appearance or contact with any Governmental Authority or the staff or regulators of any Governmental Authority, with such notice being sufficient to provide the other Parties with the opportunity to attend and participate in such meeting, discussion, appearance or contact.
(c)
Without limiting the generality of Buyer’s undertaking pursuant to this Section 6.5, Buyer agrees to use its reasonable best efforts to avoid or eliminate each and every impediment under any antitrust, competition or trade regulation Law that may be asserted by any Governmental Authority or any other party so as to enable the Parties to close the transactions contemplated by this Agreement as promptly as possible.
(d)
Notwithstanding the foregoing, nothing in this Section 6.5 shall require, or be construed to require, Buyer or any of its affiliates to agree to (i) sell, hold, divest, discontinue or limit, before or after the Closing Date, any assets, businesses or interests of Buyer or any of its affiliates; (ii) any conditions relating to, or changes or restrictions in, the operations of any such assets, businesses or interests which, in either case, could reasonably be expected to result in a Material Adverse Effect or materially and adversely impact the economic or business benefits to Buyer of the transactions contemplated by this Agreement and the Ancillary Agreements; or (iii) any material modification or waiver of the terms and conditions of this Agreement.

 

41


 

 

 

 

6.6
Supplement to Disclosure Schedules. From time to time prior to the Closing, Sellers shall have the right (but not the obligation) to supplement or amend the Disclosure Schedules hereto with respect to any matter hereafter arising or of which it becomes aware after the date hereof (each a “Schedule Supplement”). Any disclosure in any such Schedule Supplement shall not be deemed to have cured any inaccuracy in or breach of any representation or warranty contained in this Agreement, including for purposes of the indemnification or termination rights contained in this Agreement or of determining whether or not the conditions set forth in Article 7 have been satisfied; provided, however, that if Buyer has the right to, but does not elect to, terminate this Agreement within three Business Days of its receipt of such Schedule Supplement, then Buyer shall be deemed to have irrevocably waived any right to terminate this Agreement with respect to such matter. Notwithstanding anything to the contrary in the foregoing, Sellers shall update (a) Schedule 1.1C to reflect the change in employers for Ronald Tetrault and Emma Wilson as contemplated in Section 6.12(a), and (b) Schedule 3.19(b) to reflect updated Debt information, and deliver each such Schedule three (3) days prior to Closing.
6.7
Public Announcements. No Party shall make any public announcements in respect of this Agreement, the Ancillary Agreements or the transactions contemplated hereby or thereby or otherwise communicate with any news media without the prior written consent of the other Parties (which consent shall not be unreasonably withheld, conditioned or delayed), and the Parties shall cooperate as to the timing and contents of any such announcement, provided that one Party shall not prevent another Party from timely complying with applicable Law, including public company reporting obligations under the Securities Act of 1934, as amended.
6.8
Books and Records.
(a)
After the Closing, for the period(s) required by applicable Law, Buyer shall:
(i)
retain the books and records related to the Purchased Assets purchased hereunder, the Assumed Liabilities and the employees who transitioned to Buyer; and
(ii)
upon reasonable notice, afford Sellers and their representatives with reasonable access (including the right to make photocopies), during normal business hours, to such books and records.
(b)
After the Closing, for the period(s) required by applicable Law, Sellers shall:
(i)
retain the books and records (including personnel files) of Sellers which relate to the BioCDMO Business and its operations for periods prior to the Closing; and
(ii)
upon reasonable notice, afford the Buyer's representatives reasonable access (including the right to make, at Buyer's expense, photocopies), during normal business hours, to such books and records.

 

42


 

 

 

 

Neither Buyer nor Sellers shall be obligated to provide the other Parties with access to any books or records (including personnel files) pursuant to this Section 6.8 where such access would violate any Law.

6.9
Leases. Sellers will not cause or permit the Real Estate Lease to be amended, modified, extended, renewed or terminated, nor shall Sellers enter into any new lease, sublease, license or other agreement for the use or occupancy of any Owned Real Property requiring rental without the prior written consent of Buyer, which consent shall not be unreasonably withheld, conditioned or delayed.
6.10
Transfer Taxes. Except with respect to Excluded Tax Liabilities, all transfer, documentary, sales, use, stamp, registration, value added and other such Taxes and fees (including any penalties and interest) incurred in connection with this Agreement (shall be borne and paid by Buyer when due. Buyer shall, at its own expense, timely file any Tax Return or other document with respect to such Taxes or fees (and Sellers shall cooperate with respect thereto as necessary).
6.11
Tax Clearance Certificates. Prior to Closing, each Seller shall obtain from the California Department of Tax and Fee Administration a Certificate of Tax and Fee Clearance. Agenus West shall also notify all of the other taxing authorities in the jurisdictions that impose Taxes on Agenus West or where Agenus West has a duty to file Tax Returns of the transactions contemplated by this Agreement in the form and manner required by such taxing authorities, if the failure to make such notifications or receive any available tax clearance certificate could subject the Buyer to any Taxes of Agenus West. If any taxing authority asserts that Agenus West is liable for any Tax, Sellers shall promptly pay any and all such amounts and shall provide evidence to the Buyer that such liabilities have been paid in full or otherwise satisfied.
6.12
Employees and Employee Benefits.
(a)
As soon as practicable after the Effective Date but in any event prior to Closing, Sellers shall cause Ronald Tetrault and Emma Wilson, each of whom as of the Effective Date are employed by Agenus Parent, to transition from employment with Agenus Parent to employment with Agenus West. Sellers shall notify Buyer in writing upon fulfillment by Sellers of the foregoing obligation and shall provide supporting documentation evidencing such fulfillment.
(b)
Prior to the Closing Date but after the fulfillment of Sellers’ obligations in Section 6.12(a) above, Buyer shall make offers to all Employees employed as of the time the offers are made, offering employment by Buyer or an affiliate of Buyer on substantially the same terms and conditions as such Employees have as of the Effective Date (an “Offer”). The Offer shall be contingent on the Closing and the requirement that Employees resign from employment with Agenus West as of the Closing Date. Commencing on the Closing Date, Buyer shall employ all Employees who have accepted an Offer and resigned from employment with Agenus West (the “Transferring Employees”). Sellers shall bear any and all obligations and liability under the WARN Act resulting from employment losses pursuant to this Section 6.12.

 

43


 

 

 

 

(c)
Sellers shall be solely responsible, and Buyer shall have no obligations whatsoever for, any compensation or other amounts payable to any current or former employee, officer, director, independent contractor or consultant of the BioCDMO Business, including, without limitation, hourly pay, commission, bonus, salary, accrued vacation, fringe, pension or profit sharing benefits or severance pay for any period relating to the service with Agenus West or Agenus Parent, as applicable, at any time on or prior to the Closing Date and Agenus West or Agenus Parent, as applicable, shall pay all such amounts to all entitled persons on or prior to the Closing Date, provided that post-Closing Buyer shall credit all Transferring Employees for all purposes other than severance for the Transferring Employee’s service with Agenus West or Agenus Parent, as applicable, pre-Closing.
(d)
Sellers shall remain solely responsible for the satisfaction of all claims for medical, dental, life insurance, health accident or disability benefits brought by or in respect of current or former employees, officers, directors, independent contractors or consultants of the BioCDMO Business or the spouses, dependents or beneficiaries thereof, which claims relate to events occurring on or prior to the Closing Date. Sellers also shall remain solely responsible for all workers’ compensation claims of any current or former employees, officers, directors, independent contractors or consultants of the BioCDMO Business which relate to events occurring on or prior to the Closing Date. Sellers shall pay, or cause to be paid, all such amounts to the appropriate persons as and when due.
(e)
Effective as soon as practicable following the Closing Date, Buyer shall provide Transferring Employees with the ability to contribute to a defined contribution retirement plan on terms substantially similar to, or more favorable than, that provided by Sellers.
(f)
Each Transferring Employee shall be eligible to receive the salary and benefits maintained for employees of Agenus West (excluding any employee stock options or other incentive or equity compensation granted to such employees by Agenus Parent) on substantially similar terms and conditions in the aggregate as are provided to similarly situated employees of Agenus West.
(g)
Each Transferring Employee shall be given service credit for the purpose of eligibility under the group health plan and eligibility and vesting only under the defined contribution retirement plan for his or her period of service with Agenus West prior to the Closing Date; provided, however, that (i) such credit shall be given pursuant to payroll or plan records, at the election of Buyer, in its sole and absolute discretion; and

(ii) such service crediting shall be permitted and consistent with Buyer's defined contribution retirement plan or Buyer shall make good faith efforts to amend Buyer’s defined contribution retirement plan to recognize the prior service of Transferring Employees.

6.13
Non-Competition; Non-Solicitation.

 

44


 

 

 

 

(a)
For a period of four (4) years commencing on the Closing Date (the “Restricted Period”), Sellers shall not, and shall not permit any of their respective controlled affiliates to, directly or indirectly, (i) engage in or assist others in engaging in the Restricted Business anywhere in the world; (ii) have an ownership or other interest in any Person that engages directly or indirectly in the Restricted Business anywhere in the world in any capacity, including as a partner, shareholder, member, employee, principal, agent, trustee or consultant; or (iii) cause, induce or encourage any known material actual client, customer, supplier or licensor of the BioCDMO Business (including any existing or former client or customer of Sellers and any Person that becomes a client or customer of the BioCDMO Business after the Closing), or any other Person who is known to have a material business relationship with the BioCDMO Business, to terminate or modify any such actual relationship. Notwithstanding the foregoing, each Seller may own, directly or indirectly, solely as an investment, securities of any Person traded on any national securities exchange if such Seller is not a controlling Person of, or a member of a group which controls, such Person and does not, directly or indirectly, own two percent (2%) or more of any class of securities of such Person. For the avoidance of doubt, this Section 6.13(a) is a covenant not to own or operate its own manufacturing business, and nothing in this Section 6.13 shall prohibit Sellers or any of their respective affiliates from using for their product development and manufacturing requirements such developer(s) or manufacturer(s) as they may choose in its sole discretion; provided that notwithstanding anything to the contrary herein, Sellers shall continue to be bound by any exclusivity provisions or other obligations set forth in the Contract Manufacturing Agreement and nothing in this Section 6.13 shall be interpreted as superseding any provision in the Contract Manufacturing Agreement.
(b)
During the Restricted Period, neither Seller shall, nor shall either Seller permit any of its affiliates to, directly or indirectly: (i) hire or solicit any Person who (A) is provided an Offer by Buyer or an affiliate of Buyer or (B) was employed by Buyer (or an affiliate of Buyer) at any time during the two (2) year period immediately prior to the solicitation or hiring, or (ii) encourage any employee or former employee of Buyer (or an affiliate of Buyer) to leave employment with Buyer. Notwithstanding the above, neither Section 6.13(a) nor (b) shall prevent Sellers from engaging Transferring Employees in limited consulting engagements with Sellers or any of their affiliates in support of the Sellers’ non-BioCDMO businesses so long as such engagements do not interfere with the Transferring Employees’ employment with Buyer. If, at any time during the Restricted Period, Sellers request a waiver of the prohibitions contained in this Section as to a particular employee or former employee of Buyer (or an affiliate of Buyer), Buyer agrees to consider such request in good faith.
(c)
Sellers each acknowledge that a breach or threatened breach of this Section 6.13 could give rise to irreparable harm to Buyer, for which monetary damages would not be an adequate remedy, and hereby agrees that in the event of a breach or a threatened breach by Sellers of any such obligations, Buyer shall, in addition to any and all other rights and remedies that may be available to it in respect of such breach, be entitled to seek equitable relief, including a temporary restraining order, an injunction, specific performance and any other relief that may be available from a court of competent jurisdiction (without any requirement to post bond).

 

45


 

 

 

 

(d)
Sellers each acknowledge that the restrictions contained in this Section

6.13 are reasonable and necessary to protect the legitimate interests of Buyer and constitute a material inducement to Buyer to enter into this Agreement and consummate the transactions contemplated by this Agreement. In the event that any covenant contained in this Section 6.13 should ever be adjudicated to exceed the time, geographic, product or service or other limitations permitted by applicable Law in any jurisdiction, then any court is expressly empowered to reform such covenant, and such covenant shall be deemed reformed, in such jurisdiction to the maximum time, geographic, product or service or other limitations permitted by applicable Law. The covenants contained in this Section 6.13 and each provision hereof are severable and distinct covenants and provisions. The invalidity or unenforceability of any such covenant or provision as written shall not invalidate or render unenforceable the remaining covenants or provisions hereof, and any such invalidity or unenforceability in any jurisdiction shall not invalidate or render unenforceable such covenant or provision in any other jurisdiction.

6.14
Real Estate.
(a)
Within twenty (20) days following the Effective Date (or, if not practicable despite Buyer’s best efforts, as soon as reasonably practicable), Buyer, at its sole cost and expense, shall obtain an owner’s title insurance commitment (the “Title Commitment”) for each parcel of Owned Real Property from a title company mutually agreed to by the Parties. Buyer shall provide Sellers with a copy of each Title Commitment within five (5) days after Buyer’s receipt thereof. Buyer shall cause each Title Commitment to be updated within five (5) days of the date on which Closing is scheduled to occur pursuant hereto. Each Title Commitment shall show that title will be vested in Buyer as good marketable title in fee simple, free and clear of all liens and encumbrances except (i) real property taxes and assessments which are a lien but not yet due and payable, (ii) applicable zoning and building laws, rights of the public in legal highways and other Permitted Liens, and (iii) any other matter of record which Buyer has expressly agreed to assume in writing or for which Buyer has not delivered an Objection in accordance with Section 6.14(c) (collectively, the “Permitted Encumbrances”).
(b)
Buyer shall have the right, but not the obligation, to obtain current surveys of the Owned Real Property (each, a “Survey”). If required in order to convey title to the Owned Real Property from a Seller to Buyer, Buyer shall obtain a new boundary legal description of the applicable Owned Real Property (the “Legal Description”) from a surveying and engineering firm mutually agreeable to Buyer and Sellers. If Buyer obtains any Survey and/or the Legal Description, then Buyer shall be responsible for the cost thereof.
(c)
If a Title Commitment or a Survey contain matters that are not acceptable to Buyer in its sole discretion (collectively, the “Objections”), then Buyer shall provide Sellers with written notice of all such Objections within sixty (60) days following the Effective Date. Sellers shall have ten (10) days after Buyer’s delivery of such notice to advise Buyer in writing whether Sellers are able and willing (in their discretion) to cure any or all Objections and/or revise the applicable Survey to eliminate the objectionable matters, in each case, at Sellers’ sole cost and expense (the “Objection Response”). If Sellers are unable or unwilling to cure all Objections to Buyer’s satisfaction, then Buyer

 

46


 

 

 

 

shall, within fifteen (15) days following Buyer’s receipt of the Objection Response, either

(i) terminate this Agreement by providing written notice of this intent to Sellers, in which event Buyer and Sellers shall have no further obligations to each other, or (ii) waive the Objections and proceed to Closing, subject to all other terms and conditions of this Agreement. Notwithstanding the foregoing: (a) Buyer shall not be required to object to any mortgage, lien or other monetary encumbrance affecting all or any portion of the Owned Real Property and all such mortgages, liens and monetary encumbrances, shall be satisfied or released in full by Sellers at or prior to Closing at Sellers’ sole cost and expense; (b) Buyer shall have the continuing right until Closing to object to any new title matters that arise or are created after the effective date of any Title Commitment; and (c) Sellers agree to reasonably cooperate with Buyer in connection with Buyer’s efforts to forfeit any oil and gas leases applicable to the Owned Real Property, including, without limitation, execution by Sellers of any applicable notices, affidavits, or other similar documents required to forfeit the oil and gas leases. If the basis for the Objections makes the title unmarketable, then the closing date and Outside Date shall be adjourned for a reasonable time to allow Sellers to eliminate the Objections, not to exceed forty-five (45) days.

(d)
Within ten (10) Business Days following the Effective Date, Sellers shall deliver to Buyer the following written or electronic information relating to the Owned Real Property to the extent that such information is within Sellers’ possession or control:

(a) existing surveys (including legal descriptions); (b) existing farm leases and residential leases; (c) a completed Phase I Environmental Site Assessment owner’s questionnaire (a form to be provided by Buyer); (d) a completed residential property disclosure form for each residential dwelling on the Owned Real Property; and (e) a completed lead based paint disclosure form for each residential dwelling on the Owned Real Property. Sellers shall have a continuing obligation to Buyer during the term of this Agreement to deliver to Buyer, immediately after Sellers’ receipt thereof, all communications with all governmental authorities concerning the Owned Real Property (e.g., violation notices, notices pertaining to assessments, condemnation notices, etc.), as well as all non- privileged communications or other documents relating to any threatened or pending claim concerning the Owned Real Property or that otherwise could adversely affect the Owned Real Property or its value. Within thirty (30) days following the Effective Date, Sellers shall deliver to Buyer an updated Phase I Environmental Site Assessment, dated as of the Effective Date or later (the “Updated Phase I”). If the Updated Phase I includes any material findings, then Buyer shall, within fifteen (15) days following Buyer’s receipt of the Updated Phase I, either (i) terminate this Agreement by providing written notice of this intent to Sellers, in which event Buyer and Sellers shall have no further obligations to each other, or (ii) waive the findings and proceed to Closing, subject to all other terms and conditions of this Agreement.

(e)
Risk of loss to the Owned Real Property from fire or other casualty shall be borne by Sellers until delivery of the Deeds, provided that if the Owned Real Property or any portion thereof is damaged or destroyed in any material respect by fire or other casualty prior to the Closing, then in such event Buyer shall have the option to (i) proceed with the transaction and be entitled to insurance, not exceeding the Purchase Price, if any, paid to Sellers under any and all policies of insurance covering the Owned Real Property so damaged or destroyed, or (ii) terminate this Agreement, in which case the Parties shall have no further obligations to the other (other than the provisions specifically identified as surviving after the termination of this Agreement).

 

47


 

 

 

 

(f)
If prior to Closing, all or any portion of the Owned Real Property has been taken or if Sellers shall receive a notice from any Governmental Authority (or quasi- governmental authority) having eminent domain power over the Owned Real Property of its intention to take, by eminent domain proceeding, any part of the Owned Real Property (a “Taking”), Buyer shall have the option, exercisable within ten (10) days after receipt of notice, to elect in writing to terminate this Agreement by delivering notice of such termination to Sellers, whereupon this Agreement shall be deemed canceled and of no further force or effect, and no Party shall have any further rights or liabilities against or to the other except pursuant to the provisions of this Agreement which are expressly provided to survive the termination hereof. If Buyer shall not timely elect to terminate this Agreement, then Buyer and Sellers shall consummate this transaction in accordance with this Agreement; provided, however, that Sellers shall, on the Closing Date, (i) assign and remit to Buyer the proceeds of any award or other proceeds of such Taking which have been collected by Sellers as a result of such Taking, or (ii) if no award or other proceeds shall have been collected, deliver to Buyer an assignment of Sellers’ rights to any such award or other proceeds which may be payable to Sellers as a result of such Taking. Sellers shall promptly notify Buyer in writing of the commencement or occurrence of any condemnation proceedings.
6.15
Assets and Permits Not Assigned. Notwithstanding anything to the contrary in this Agreement, no contracts, Permits, properties, rights or other assets of Sellers shall be deemed sold, transferred or assigned to Buyer pursuant to this Agreement if (a) the attempted sale, transfer or assignment thereof to Buyer without the consent or approval of any other Person would be ineffective or would constitute a breach of contract or a violation of any Law or would in any other way adversely affect the rights of a Seller (or Buyer as transferee or assignee), and (b) such consent or approval is not obtained at or prior to the Closing. In such case, to the extent possible, (x) the beneficial interest in or to such contracts, Permits, properties, rights and assets (collectively, the “Beneficial Rights”) shall in any event pass at the Closing to Buyer under this Agreement; and (y) pending such consent or approval, Buyer shall discharge the obligations of the applicable Seller under such Beneficial Rights (to the extent such obligations are Assumed Liabilities) as agent for such Seller, and for no additional consideration, such Seller shall act as Buyer’s agent in the receipt of any benefits, rights or interest received from the Beneficial Rights. Sellers will use their reasonable best efforts, at Sellers’ sole cost, to obtain and secure all consents and approvals that may be necessary to effect the legal and valid sale, transfer or assignment of the contracts, Permits, properties, rights or assets underlying the Beneficial Rights to Buyer without any change in any of the material terms or conditions of such contracts, Permits, properties, rights or assets, including their formal assignment or novation, if advisable. Once such consent or approval is obtained, the applicable Seller will sell, assign, transfer, convey and deliver to Buyer the relevant Purchased Asset to which such consent or approval relates for no additional consideration.

 

48


 

 

 

 

Sellers will make or complete any such transfers as soon as reasonably practicable and cooperate with Buyer in any other reasonable arrangement designed to provide Buyer with the benefits of such contracts, Permits, properties, rights and assets, including enforcement at the cost and for the account of Buyer of any and all rights of Sellers against the other Party thereto arising out of the breach or cancellation thereof by such other Person or otherwise.

6.16
Data Room Delivery. Within thirty (30) days following the Closing Date, Sellers shall deliver to Buyer, in a format reasonably acceptable to Buyer, a copy of the Data Room. Sellers shall not upload any documentation or otherwise make changes to the Data Room on or after the Closing Date.
6.17
Storage of Excluded Assets. If any Excluded Assets remain on the premises of any portion of the Real Property following Closing, Sellers shall pay monthly storage fees to Buyer at prevailing market rates, to be charged by Buyer each month by written notice or invoice.

SECTION 7.

CONDITIONS PRECEDENT TO OBLIGATIONS TO CLOSE

7.1
Conditions to Obligations of All Parties to Close. The obligations of each Party to consummate the transactions contemplated by this Agreement shall be subject to the fulfillment, at or prior to the Closing, of each of the following conditions:
(a)
The filings of Buyer and Sellers pursuant to the HSR Act and CFIUS, shall have been made and the applicable waiting period and any extensions thereof shall have expired or been terminated or, with respect to CFIUS, a CFIUS Regulatory Approval shall have been received.
(b)
No Governmental Authority shall have enacted, issued, promulgated, enforced or entered any Governmental Order which is in effect and has the effect of making the transactions contemplated by this Agreement illegal, otherwise restraining or prohibiting consummation of such transactions or causing any of the transactions contemplated hereunder to be rescinded following completion thereof.
(c)
Sellers shall have received all consents, authorizations, orders and approvals from the Governmental Authorities, and Buyer shall have received all consents, authorizations, orders and approvals from the Governmental Authorities, in each case, in form and substance reasonably satisfactory to Buyer and Sellers, and no such consent, authorization, order and approval shall have been revoked.
(d)
The Allocation Schedule shall have been agreed to by the Parties in each Party’s

reasonable discretion.

7.2
Conditions to Obligations of Sellers to Close. The obligations of Sellers to sell the Purchased Assets and to otherwise consummate the transactions contemplated by this Agreement are subject to the satisfaction or waiver, on or prior to the Closing Date, of each of the following conditions Representations, Warranties and Covenants.

 

49


 

 

 

 

(a)
All representations and warranties of Buyer contained in this Agreement shall be true and complete at and as of the Closing Date as if such representations and warranties were made at and as of the Closing Date, except for (a) any inaccuracy that could not reasonably be expected to have a Material Adverse Effect on Buyer, (b) any representation or warranty that is expressly stated only as of a specified earlier date, in which case such representation or warranty shall be true as of such earlier date, or (c) changes in any representation or warranty that are permitted by this Agreement; and Buyer shall have performed, in all material respects, all agreements and covenants required hereby to be performed by Buyer prior to or on the Closing Date.
(b)
Closing Deliveries. Buyer shall have tendered the documents and other items to be delivered to Sellers by Buyer pursuant to Section 8.3 of this Agreement.
7.3
Conditions to Obligations of Buyer to Close. The obligations of Buyer to purchase the Purchased Assets and to otherwise consummate the transactions contemplated by this Agreement are subject to the satisfaction or waiver, on or prior to the Closing Date, of each of the following conditions:
(a)
Representations, Warranties and Covenants. Other than the representations and warranties of Sellers contained in Section 3.1, Section 3.2, Section 3.3, Section 3.15, and Section 3.19(b), all representations and warranties of Sellers contained in this Agreement shall be true and complete (without giving effect to any limitation indicated by the words “Material Adverse Effect,” “in all material respects,” “in any material respect,” “material,” or “materially”) at and as of the Closing Date as if such representations and warranties were made at and as of the Closing Date (taking into account for purposes of Section 3.9(a) the delivery of the supplement of Schedule 1.1C as set forth in Section 6.6 hereof), except for (i) any inaccuracies that could not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Sellers, (ii) any representation or warranty that is expressly stated only as of a specified earlier date, in which case such representation or warranty shall be true as of such earlier date, or (iii) changes in any representation or warranty that are permitted by this Agreement, or, (iv) solely with respect to Section 3.9(a). The representations and warranties of Sellers contained in Section 3.1, Section 3.2, Section 3.3, and Section 3.15 shall be true and correct in all respects on and as of the date hereof and on and as of the Closing Date with the same effect as though made at and as of such date (except those representations and warranties that address matters only as of a specified date, the accuracy of which shall be determined as of that specified date in all respects). The representations and warranties of Sellers in Section 3.19(b) (as qualified and/or supplemented by Section 3.19(b) of the Disclosure Schedules), shall be true and correct in all material respects: (i) on and as of the date hereof, and (ii) after delivery of the supplement of Schedule 3.19(b) deliverable pursuant to Section 6.6 hereof, on and as of the Closing Date with the same effect as though made at and as of such date. Sellers shall have performed, in all material respects, all agreements and covenants required hereby to be performed by Sellers prior to or on the Closing Date, provided that, with respect to agreements and covenants that are qualified by materiality, Sellers shall have performed such agreements and covenants, as so qualified, in all respects.

 

50


 

 

 

 

(b)
From the date of this Agreement, there shall not have occurred any Material Adverse Effect, nor shall any event or events have occurred that, individually or in the aggregate, with or without the lapse of time, would reasonably be expected to result in a Material Adverse Effect.
(c)
Buyer shall have received all Permits that are necessary for it to operate the Purchased Assets as operated by Sellers as of the Closing Date; provided that Buyer shall have used its best efforts to obtain all such Permits. Sellers shall cooperate with Buyer in good faith to assist Buyer in obtaining any such Permits.
(d)
Buyer shall have received (at Buyer’s expense) an owner's title insurance policy with respect to each Owned Real Property, issued by a nationally recognized title insurance company reasonably acceptable to Buyer, written as of the Closing Date, insuring Buyer in such amounts and together with such endorsements, and otherwise in such form, as Buyer shall reasonably require. Such title insurance policy shall insure fee simple title to each Owned Real Property, free and clear of all Liens other than Permitted Liens.
(e)
Closing Deliveries. Sellers shall have tendered the documents and other items to be delivered by one or both Sellers pursuant to Section 8.2 of this Agreement.
(f)
Material Consents. Each Required Consent shall have been obtained without any material adverse change in the terms or conditions of each Assumed Contract to which such Required Consent relates from those in effect on the date hereof.
(g)
Payoffs. Sellers shall have provided Buyer with all applicable Payoff Letters at least two (2) days prior to Closing; understanding that at the Closing, Buyer will pay by wire transfer of immediately available funds out of the Purchase Price, to the Persons specified in each Payoff Letter, the applicable Payoff Letter Amount pursuant to instructions contained in such Payoff Letter.
(h)
Employees. Buyer shall have received acceptances of the Offers extended by it pursuant to Section 6.12(a) from: (i) Renuka Siverdian and Al Dadson; and (ii) other Employees representing at least seventy percent (70%) of the number of Offers extended. For the avoidance of doubt, the acceptances contemplated in the foregoing subsection (i) shall be excluded for purposes of calculating the percentage of acceptances required by subsection (ii).
(i)
Sellers and Buyer (or their respective affiliates) shall have executed and delivered that certain Securities Purchase Agreement, pursuant to which Buyer (or its affiliate) shall purchase from Agenus Parent a portion of the authorized capital stock of Agenus Parent at a purchase price of $7.50 per share, subject to the terms and conditions therein, and the transactions contemplated by such Securities Purchase Agreement shall be consummated and closed simultaneously with the Closing contemplated herein.

 

51


 

 

 

 

(j)
Agenus Parent and Buyer’s affiliate, Zydus LifeSciences Ltd., shall have executed and delivered that certain BOT/BAL License Agreement, pursuant to which Agenus Parent will grant an exclusive license to Zydus LifeSciences Ltd. to use or otherwise access the Agenus IP (as defined therein) on the terms and subject to the conditions set forth therein.

SECTION 8. THE CLOSING

8.1
The Closing. At the Closing, which shall take place at such location agreed to by the Parties, Sellers shall make such deliveries as are set forth in Section 8.2, and Buyer shall make such deliveries as are set forth in Section 8.3. All transactions at Closing are deemed to have taken place simultaneously and no transaction shall be deemed to have been completed, nor shall any document be deemed to have been delivered, until all transactions shall have been completed and all documents delivered.
8.2
Deliveries by Sellers to Buyer. Sellers shall deliver to Buyer:
(a)
A bill of sale duly executed by Agenus West, in customary form, as shall be mutually agreed to by the Parties;
(b)
An assignment and assumption agreement (the “Assignment and Assumption Agreement”) duly executed by each Seller relating to the Assumed Contracts and other Purchased Assets, in customary form, as shall be mutually agreed to by the Parties;
(c)
A manufacturing know-how license agreement covering the Licensed Intellectual Property, duly executed by each Seller (the “License Agreement”), in customary form, as shall be mutually agreed to by the Parties (under which the applicable Seller will retain ownership of the Licensed Intellectual Property, including the right to enforce it, with Sellers granting Buyer a right to use it);
(d)
A duly executed assignment and assumption of the lease for the Leased Real Property (the “Assignment and Assumption of Lease”);
(e)
A duly executed estoppel certificate and subordination, non-disturbance, and attornment agreement, signed by landlord and tenant, with respect to the Leased Real Property, in a form mutually agreed to by the Parties;
(f)
A duly executed general warranty deed in recordable form for each Owned Real Property, including transferable and approved legal descriptions for each Owned Real Property;
(g)
The Certificate of Tax and Fee Clearance from the California Department of Tax and Fee Administration required by Section 6.11;
(h)
A copy of the Escrow Agreement duly executed by each Seller; FIRPTA certifications duly executed by each Seller;

 

52


 

 

 

 

(i)
(j)
Any applicable state or local transfer or gains tax return or other documents or affidavits required to transfer title to the Owned Real Property in accordance with this Agreement;
(k)
Such other good and sufficient instruments of conveyance and transfer as are reasonably necessary to vest in Buyer good and valid title to the Purchased Assets, free and clear of all Liens other the Permitted Liens;
(l)
A copy of each document evidencing each Required Consent;
(m)
A transition services agreement, in a form as shall be mutually agreed to by the Parties (the “Transition Services Agreement”), duly executed by each Seller;
(n)
A certificate of Sellers attesting to their fulfillment of the conditions set forth in Section 7.1 and 7.3;
(o)
A copy of the resolutions of each Seller, approving the transactions contemplated by this Agreement;
(p)
A contract manufacturing agreement, in the form attached hereto as Exhibit A

(the “Contract Manufacturing Agreement”), duly executed by each Seller;

(q)
All keys and access codes for the Owned Real Property and Leased Real Property in a Seller’s possession or control, together with possession of such properties; and
(r)
Such other documents reasonably requested by Buyer to give effect to the transactions contemplated by this Agreement.
8.3
Deliveries by Buyer to Sellers. Buyer shall deliver:
(a)
To Sellers,
(i)
the Closing Cash Consideration, less the [***] for deposit into the Indemnification Escrow Fund, paid by Buyer on the Closing Date by wire transfer of immediately available funds to the account or accounts of Sellers pursuant to wire instructions provided to Buyer at least 48 hours prior to Closing;
(ii)
The Assignment and Assumption Agreement, duly executed by Buyer;
(iii)
The Transition Services Agreement, duly executed by Buyer;
(iv)
A certificate of Buyer attesting to its fulfillment of the conditions set forth in Section 7.1 and 7.2;
(v)
A copy of the Escrow Agreement, duly executed by Buyer; The Contract Manufacturing Agreement, duly executed by Buyer;

 

53


 

 

 

 

(vi)
(vii)
The Assignment and Assumption of Lease, duly executed by Buyer;
(viii)
The License Agreement, duly executed by Buyer;
(ix)
A copy of the resolutions of Buyer approving the transactions contemplated by this Agreement;
(x)
A letter of credit (currently in the amount of $2,634,030) for the benefit of the landlord under the Real Estate Lease, in a form acceptable to the landlord, to replace Agenus Parent’s existing letter of credit, which is to be returned to Agenus Parent and canceled; and
(xi)
Such other documents reasonably requested by Sellers to give effect to the transactions contemplated by this Agreement; and
(b)
To Escrow Agent: (i) [***] for deposit into the Indemnification Escrow Fund by wire transfer of immediately available funds to accounts designated by the Escrow Agent, to be held for the purpose of securing the indemnification obligations of Sellers set forth in the Agreement; and (ii) the Escrow Agreement, duly executed by Buyer and Sellers; and
(c)
On behalf of the Sellers, the Closing Debt and the Closing Seller Transaction Expenses to the Persons, in the amounts and in accordance with the instructions set forth in the Payoff Letters or as otherwise provided to the Buyer by the Sellers in a form reasonably acceptable to the Buyer. All such amounts so paid shall nevertheless be deemed paid to the Sellers for all purposes of this Agreement, and no interest shall be paid or accrued in respect of such amounts.

SECTION 9.

INDEMNIFICATION

9.1
Survival. The Parties, intending to modify any applicable statute of limitations, agree that: (a) the representations and warranties of Sellers in this Agreement shall survive the Closing for a period of twenty-four (24) months, provided that the Fundamental Representations (except for Section 3.11 (Taxes)), Section 3.8 (Environment, Health and Safety Matters) and Section 4 (Representations and Warranties of Buyer) shall survive the Closing for five (5) years, and the representations and warranties set forth in Section

3.11 (Taxes) shall survive for the longer of (i) five (5) years and (ii) the full period of all applicable statutes of limitations (giving effect to any waiver, mitigation or extension thereof) plus 60 days; (b) the covenants and agreements of the Parties herein shall survive the Closing in accordance with their respective terms until the date that the Party required to perform under such covenant or agreement (or such portion thereof) has fully completed the performance required thereby (the “Survival Expiration Date”); and (c) this Section 9 and any right to seek specific performance or other equitable remedies to the extent otherwise available hereunder shall survive the Closing indefinitely. Notwithstanding the foregoing, any claims for indemnification properly set forth in a

 

54


 

 

 

 

Claim Notice delivered prior to the expiration of the Survival Expiration Date with respect to the applicable covenant or agreement will not thereafter be barred by such expiration and such claims will survive until finally resolved.

9.2
No Other Representations; Acknowledgements. Buyer acknowledges and agrees, on behalf of itself and each of its affiliates, that: (a) each such Person has relied solely on the representations and warranties of Sellers specifically contained in this Agreement, the covenants and agreements set forth herein, and on the results of such Persons’ independent investigation and verification; (b) the representations and warranties of Sellers expressly set forth in this Agreement constitute the sole and exclusive representations and warranties of any kind of Sellers or any of their affiliates in connection with the transactions contemplated by this Agreement, and none of Sellers or any of their affiliates has made or make (and each specifically negates and disclaims) any other representations or warranties of any kind or character whatsoever, whether express or implied, oral or written, past, present, or future, of, as to, concerning, with respect to, or in connection with the transactions contemplated by this Agreement; (c) each such Person has made his or her own inquiry and investigation into, and, based thereon, has formed an independent judgment concerning Sellers and the BioCDMO Business, and the financial condition, results of operations, assets, liabilities, properties and projected operations of the BioCDMO Business, and (d) each such Person has been furnished with or given access to such information about the Sellers and the BioCDMO Business as requested. In connection with the investigation of the Sellers and the BioCDMO Business, the Buyer, its affiliates and representatives may have received (directly or indirectly) from Sellers certain projections, estimates and other forecasts and certain business plan information related to the BioCDMO Business (collectively, the “Sellers’ Projections”). The Buyer hereby acknowledges that (i) there are uncertainties inherent in attempting to make such Sellers’ Projections, (ii) that Sellers are not making and have not made, and the Buyer has not relied upon, any representation or warranty with respect to the Sellers’ Projections, including the reasonableness of any underlying assumptions, (iii) that the Buyer is making its own evaluation of the adequacy and accuracy of all Sellers’ Projections (including the reasonableness of the disclosed assumptions underlying such Sellers’ Projections), and (iv) the Buyer shall not have any claim against Sellers with respect to such Sellers’ Projections.
9.3
Indemnification by Sellers. Subject to the limitations expressly set forth in Section 9.1 and Section 9.5, from and after the Closing, Sellers shall, jointly and severally, defend, indemnify and hold harmless Buyer and its affiliates (collectively, the “Buyer Indemnified Parties”) from and against, and will pay and reimburse them for, any and all Losses incurred or suffered by any Buyer Indemnified Party directly or indirectly arising out of, relating to, in connection with, based upon or resulting from any of the following:
(a)
any inaccuracy in or breach of any of the representations or warranties of Sellers contained in this Agreement, the Ancillary Agreements or in any certificate or instrument delivered by or on behalf of Seller pursuant to this Agreement, as of the date such representation or warranty was made or as if such representation or warranty was made on and as of the Closing Date (except for representations and warranties that expressly relate to a specified date, the inaccuracy in or breach of which will be determined with reference to such specified date);

 

55


 

 

 

 

(b)
any breach of any covenant or agreement of Sellers contained in this Agreement;
(c)
the specific indemnity items listed on Schedule 9.3(c); and
(d)
Excluded Assets and/or Excluded Liabilities (including, for the avoidance of doubt, the Excluded Tax Liabilities).
9.4
Indemnification by Buyer. Subject to the limitations expressly set forth in Section 9.1 and Section 9.5, from and after the Closing, Buyer shall defend, indemnify and hold harmless Sellers and their affiliates (collectively, the “Seller Indemnified Parties”), from and against, and will pay and reimburse them for, any and all Losses incurred or suffered by any Seller Indemnified Party directly or indirectly arising out of, in connection with, based upon or resulting from any of the following:
(a)
any breach of, inaccuracy in, or failure to be true of, any representation of Buyer contained in this Agreement, the Ancillary Agreements or in any certificate or instrument delivered by or on behalf of Buyer pursuant to this Agreement as of the date such representation or warranty was made or as if such representation or warranty was made on and as of the Closing Date (except for representations and warranties that expressly relate to a specified date, the inaccuracy in or breach of which will be determined with reference to such specified date);
(b)
any breach of any covenant or agreement of Buyer contained in this Agreement; and
(c)
the Assumed Liabilities.
9.5
Limitations on Liability. Notwithstanding anything to the contrary contained in this Agreement and excluding for purposes of this Section 9.5 all claims for fraud and gross negligence:
(a)
Any Losses payable to a Buyer Indemnified Party pursuant to this Section 9 shall be satisfied: (i) from the Indemnification Escrow Fund; and (ii) to the extent the amount of Losses exceeds the amounts then available to the Buyer Indemnified Parties from the Indemnification Escrow Fund, then from Sellers (including at Buyer’s election by way of setoff against any amount otherwise payable by Buyer or its affiliates to a Seller, including but not limited to a contingent payment due and payable pursuant to Section 2.7 hereof). The exercise of such setoff right in good faith, whether or not ultimately determined to be justified, will not constitute a breach under this Agreement. Neither the exercise of, nor the failure to exercise, such right of set-off or to give notice of a claim under this Agreement will constitute an election of remedies or limit Buyer or any of its affiliates in any manner in the enforcement of any other remedies that may be available to it. If Buyer or Sellers become entitled to any distribution of all or any portion of the Indemnification Escrow Fund pursuant to this Section 9, Buyer and Sellers shall take all actions necessary under the Escrow Agreement (including the execution and delivery of joint written instructions to the Escrow Agent) to cause the Escrow Agent to release to Buyer and Sellers, as applicable, the amounts to be paid from the Indemnification Escrow Fund in accordance with this Agreement.

 

56


 

 

 

 

(b)
The maximum aggregate liability of Sellers, on the one hand, and Buyer, on the other hand, in satisfaction of claims for indemnification pursuant to Section 9.3(a) or Section 9.4(a), as applicable, shall not exceed [***] (the “Cap”), provided that the Cap shall not apply to Losses due to any breach of any Fundamental Representation, fraud, or gross negligence. The maximum aggregate liability of the Seller and Agenus Parent in satisfaction of claims for any indemnifiable Losses related to any breach of any Fundamental Representation shall not exceed the Purchase Price.
(c)
The obligation of Sellers to indemnify the Buyer Indemnified Parties pursuant to Section 9.3(a) and the obligation of Buyer to indemnify the Seller Indemnified Parties pursuant to Section 9.4(a), shall each only apply after the aggregate amount of the applicable Indemnifying Party’s obligations exceeds [***] (the “Basket”), at which time the first [***] shall be treated as a deductible (the “Deductible) and such indemnification obligations shall apply only as to amounts above the Deductible Amount, provided that neither Basket nor the Deductible shall apply to Losses due to any breach of any Fundamental Representation, fraud, or gross negligence.
(d)
For purposes of (A) determining whether there has been an inaccuracy or breach of any representation or warranty made by the Sellers or the Buyer hereunder, and

(B) calculating the amount of any Losses arising from such inaccuracy or breach, such representations and warranties shall be read without regard to any materiality, Material Adverse Effect, or similar qualifications that may be contained therein as if such qualification were deleted from such representation or warranty.

(e)
Notwithstanding the fact that any Indemnified Party may have the right to assert claims for indemnification under or in respect of more than one provision of this Agreement or another agreement entered into in connection herewith in respect of any fact, event, condition or circumstance, no Indemnified Party shall be entitled to recover the amount of any damages or Losses suffered by such Indemnified Party more than once under all such agreements in respect of such fact, event, condition or circumstance.
(f)
The amount of any Losses under this Section 9 shall be net of the amount, if any, received by an Indemnified Party from any third party, including any insurance company or other insurance provider (“Third-Party Reimbursement”), but less all costs of collection or recovery with respect to such Third-Party Reimbursement.
9.6
Direct Claim Procedure.

 

57


 

 

 

 

(a)
Any Buyer Indemnified Party or Seller Indemnified Party that seeks indemnity under this Section 9 (an “Indemnified Party”) on account of a Loss which does not result from a Third Party Claim will give written notice (any notice in respect of an indemnification claim given under this Section 9.6(a) or Section 9.6(b), a “Claim Notice”) to the Party from whom indemnification is sought (an “Indemnifying Party”) as soon as is reasonably practicable after the Indemnified Party becomes aware of the Claim. A Claim Notice under this Section 9.6(a) shall contain (i) a description and, if known, the estimated amount of any Losses incurred or reasonably expected to be incurred by the Indemnified Party, and (ii) a reasonable explanation of the basis for the Claim Notice to the extent of the facts then known by the Indemnified Party; provided, that no delay or deficiency on the part of the Indemnified Party in so notifying the Indemnifying Party will relieve the Indemnifying Party of any Liability under this Agreement, except to the extent such delay or deficiency actually prejudices the Indemnifying Party.
(b)
Within thirty (30) days after delivery of a Claim Notice, the Indemnifying Party will deliver to the Indemnified Party a written response to such Claim Notice. If the Indemnifying Party fails to respond within thirty (30) days after delivery of the Claim Notice, then the Indemnifying Party will be deemed to have irrevocably accepted the Claim Notice and agreed to pay the Losses at issue in the Claim Notice.
(c)
If, within thirty (30) days after delivery of the Claim Notice, the Indemnifying Party delivers a written notice disputing the Indemnified Party’s entitlement to indemnification for the Losses described in the Claim Notice and specifying in reasonable detail the Indemnifying Party’s basis therefor, then the dispute may be resolved by any legally available means consistent with the provisions of Section

10.4 and Section 11.3.

9.7
Third Party Claims Procedure.
(a)
If the Indemnified Party seeks indemnity under this Section 9 in response to a claim or Proceeding by another Person that is not a Party (a “Third Party Claim”), then the Indemnified Party will give a Claim Notice to the Indemnifying Party within thirty (30) days after the Indemnified Party has received notice of the assertion of such Third Party Claim (and becomes aware that such Indemnified Party may be entitled to indemnification therefor hereunder) and will include in the Claim Notice (i) the facts constituting the basis for such Third Party Claim and the amount of the damages claimed by the other Person, in each case to the extent known to the Indemnified Party, accompanied by reasonable supporting documentation submitted by such third party (to the extent then in the possession of the Indemnified Party), and (ii) the assertion of the claim or the notice of the commencement of any Proceeding relating to such Third Party Claim; provided, that no delay or deficiency on the part of the Indemnified Party in so notifying the Indemnifying Party will relieve the Indemnifying Party of any Liability under this Agreement except to the extent such delay or deficiency actually prejudices the Indemnifying Party.

 

58


 

 

 

 

(b)
In the event of a Third Party Claim, the Indemnifying Party will be entitled to participate in the defense thereof, and may assume control of such defense if: (i) such Third Party Claim involves only monetary damages and does not seek an injunction or other equitable relief against the Indemnified Party; (ii) the maximum amount of monetary damages and related costs and expenses which could be payable with respect to such Third Party Claim shall not exceed the Losses for which the Indemnifying Party would be obligated to indemnify with respect to such Third Party Claim hereunder; (iii) the Third Party Claim is not asserted directly by or on behalf of a Person that is a then-current supplier of the BioCDMO Business, (iv) in the reasonable opinion of counsel to the Indemnified Party there is no actual or potential nonwaivable conflict that exists between the Indemnified Party and the Indemnifying Party in connection with the defense of such Third Party Claim; and (v) the Indemnifying Party elects in writing to assume control of such defense within thirty (30) days after the delivery of the Claim Notice. Notwithstanding any such assumption of the defense of a Third Party Claim by the Indemnifying Party, the Indemnified Party shall be entitled to participate in such defense at its own cost and expense. The Indemnifying Party will not agree to any settlement of, or consent to the entry of any Order (other than an Order of dismissal on the merits without costs) arising from, any Third Party Claim without the prior written consent of the Indemnified Party; provided, that the consent of the Indemnified Party will not be required if (1) the Indemnifying Party agrees in writing to pay any amounts payable pursuant to such settlement or Order, (2) such settlement or Order includes a full, complete and unconditional release of the Indemnified Party from any further Liability related to such Third Party Claim, (3) such settlement or Order does not require the admission of any liability on the part of the Indemnified Party or include any finding or admission of any violation of Law or wrongdoing by the Indemnified Party and (4) such settlement or Order does not impose any injunctive relief or other restrictions of any kind or nature on any Indemnified Party.
(c)
If the Indemnifying Party (i) does not, within thirty (30) days after its receipt of a Claim Notice with respect to a Third Party Claim, elect in writing to the Indemnified Party to assume control of the defense of such Third Party Claim or

(ii) fails to diligently prosecute the defense of such Third-Party Claim, then the Indemnified Party may conduct the defense of such Third Party Claim; provided, that the Indemnified Party will not agree to any settlement of, or the entry of any Order (other than an Order of dismissal on the merits without costs) arising from, any such Third Party Claim without the prior written consent of the Indemnifying Party (such consent not to be unreasonably withheld, conditioned or delayed).

(d)
The Indemnified Party and the Indemnifying Party shall reasonably cooperate in order to ensure the proper and adequate defense of a Third Party Claim, including by providing reasonable access to each other’s relevant books and records and employees, in each case, upon reasonable advance notice on a mutually convenient basis during normal business hours. The Indemnified Party and the Indemnifying Party shall use reasonable efforts to avoid production of confidential information (consistent with applicable Law), and to cause all communications among employees, counsel and others representing any party to a Third Party Claim to be made so as to preserve any applicable attorney-client or work-product privileges.

 

59


 

 

 

 

9.8
Order and Manner of Payment. Subject in all respects to the terms of Section 9.5 above, any indemnification payment pursuant to this Section 9 will be effected by wire transfer of immediately available funds from the Indemnifying Party pursuant to this Section 9.8, to an account designated by the Indemnified Party, and will be made within five (5) Business Days after the date on which (i) the amount of such payments are determined by mutual agreement of the Indemnifying Party and the Indemnified Party, (ii) the amount of such payments are determined pursuant to Section 9.7 if a written response has not been timely delivered in accordance with Section 9.6(b), or (iii) both such amount and the Indemnifying Party’s obligation to pay such amount have been finally determined by a final Order of a court having jurisdiction over such matter.
9.9
Tax Treatment of Indemnification Payments. All indemnification payments made under this Agreement shall be treated by the Parties as an adjustment to the Purchase Price for Tax purposes, unless otherwise required by Law.
9.10
Exclusive Remedy; No Rescission. From and after the Closing, subject to and except for Section 2.6, Section 2.7, Section 6.13 and Section 10.4, the sole and exclusive remedy of the Parties for any breach of any representation, warranty, agreement or covenant under this Agreement (other than claims or causes of action arising from fraud) will be pursuant to the indemnification obligations set forth in this Section 9. Notwithstanding the foregoing, nothing herein will limit the right of any Party to seek specific performance, injunctive or equitable relief for any breach or threatened breach of any covenant or agreement in this Agreement in accordance with Section 10.4. Notwithstanding anything to the contrary contained in this Agreement or otherwise, no breach of any representation, warranty, covenant or agreement contained in this Agreement shall give rise to any right on the part of any Party, after the Closing, to rescind this Agreement or any of the transactions contemplated hereby.

SECTION 10. TERMINATION

10.1
Termination. This Agreement may be terminated at any time prior to the Closing:
(a)
by the mutual written consent of the Sellers and Buyer;
(b)
by Buyer by written notice to Sellers:
(i)
pursuant to Buyer’s termination rights set forth in Section 6.14(c) or Section 6.14(d);
(ii)

 

60


 

 

 

 

if Buyer is not then in material breach of any provision of this Agreement and there has been a material breach, inaccuracy in or failure to perform any representation, warranty, covenant or agreement made by Sellers pursuant to this Agreement that would give rise to the failure of any of the conditions specified in Section 7 and such breach, inaccuracy or failure cannot be cured by Sellers by July 31, 2025 (the “Outside Date”); provided that, (1) if such breach is curable by Sellers through the exercise of commercially reasonable efforts within 45 days (or 15 days for any breach that has caused or would cause a Material Adverse Effect on the Purchased Assets), then Sellers shall have the right in their discretion to extend the Outside Date by 45 (or 15, as applicable) days and (2) the Outside Date is subject to extension by Sellers for up to 45 days to eliminate any Objections that have been raised in accordance with Section 6.14(c); provided further that the Outside Date shall automatically extend for so long as the parties remain in active discussions with an applicable Governmental Authority with respect to obtaining clearance under the HSR Act or CFIUS; or

(iii)
if any of the conditions set forth in Section 7.1 and Section 7.3 shall not have been fulfilled by the Outside Date, unless such failure shall be due to the failure of Buyer to perform or comply with any of the covenants, agreements or conditions hereof to be performed or complied with by it prior to the Closing.
(c)
by Sellers by written notice to Buyer if:
(i)
Sellers are not then in material breach of any provision of this Agreement and there has been a material breach, inaccuracy in or failure to perform any representation, warranty, covenant or agreement made by Buyer pursuant to this Agreement that would give rise to the failure of any of the conditions specified in Section 7 and such breach, inaccuracy or failure cannot be cured by Buyer by the Outside Date; provided that, if such breach is curable by Buyer through the exercise of commercially reasonable efforts within 45 days (or 15 days for any breach that has caused or would cause a Material Adverse Effect on the Sellers), then Buyer shall have the right in its discretion to extend the Outside Date by 45 (or 15, as applicable) days; provided further that the Outside Date shall automatically extend for so long as the parties remain in active discussions with an applicable Governmental Authority with respect to obtaining clearance under the HSR Act or CFIUS; or
(ii)
any of the conditions set forth in Section 7.1 and Section 7.2 shall not have been fulfilled by the Outside Date, unless such failure shall be due to the failure of Sellers to perform or comply with any of the covenants, agreements or conditions hereof to be performed or complied with by it prior to the Closing.
(d)
by Buyer or the Sellers in the event that:
(i)
there shall be any Law that makes consummation of the transactions contemplated by this Agreement illegal or otherwise prohibited; or any Governmental Authority shall have issued a Governmental Order restraining or enjoining the transactions contemplated by this Agreement, and such Governmental Order shall have become final and non- appealable.

 

61


 

 

 

 

(ii)
10.2
Effect of Termination. Upon termination of this Agreement pursuant to Section 10.1, this Agreement will forthwith become null and void and there will be no liability or obligation on the part of any Party (or any of their respective officers, directors, employees, representatives or affiliates), except:
(a)
that the obligations set forth in this Section 10 and Section 11 hereof shall survive termination; and
(b)
that nothing herein shall relieve any Party from liability for any willful breach of any provision hereof.
10.3
Specific Performance. The Parties recognize that if either Party refuses to perform under the provisions of this Agreement or otherwise breaches its obligation to consummate this Agreement, monetary damages alone would not be adequate to compensate the non- breaching Party for its injury. The non-breaching Party shall therefore be entitled, in addition to any other remedies that may be available, to obtain specific performance of the terms of this Agreement. If any action is brought by the non-breaching Party to enforce this Agreement, the breaching Party shall waive the defense that there is an adequate remedy at law, and the non-breaching Party shall not be required to pay or post any bond in connection with any such equitable relief.
10.4
Surviving Obligations. The rights and obligations of the Parties described in Section 6.2(a), this Section 10, and Section 11 shall survive any termination of this Agreement.

SECTION 11.

MISCELLANEOUS

11.1
Notices. All notices, demands, and requests required or permitted to be given under the provisions of this Agreement shall be (i) in writing, may be sent by telecopy (with automatic machine confirmation), delivered by personal delivery, or sent by commercial delivery service or certified mail, return receipt requested, (ii) deemed to have been given on the date of actual receipt, which may be conclusively evidenced by the date set forth in the records of any commercial delivery service or on the return receipt, and

(iii) addressed to the recipient at the address specified below, or with respect to any Party, to any other address that such Party may from time to time designate in a writing delivered in accordance with this Section 11.1:

 

62


 

If to Buyer:

Zydus Pharmaceuticals USA Inc. 73 Route 31 North

Pennington, New Jersey 08534 United States

Attention: Ravi Yadavar and Crystal Fisher Telephone: 1.609.730.1900

Email: [***]

[***]

 

with a copy (which shall not constitute notice) to:

Attention: Vinita Mehra & Jen Vessells 65 East State Street c/o Agenus Inc. 3 Forbes Road

Suite 1800

Columbus, OH 43215

Telephone: 1.614.255.5508

 

 

63


 

If to Sellers:

Lexington, MA 02421 United States

Attention: Legal Department Telephone: 1.781.674.4400 Email: [***]

with a copy (which shall not constitute notice) to:

Attention: Mark Seelig & Denis Dufresne Meister Seelig & Fein PLLC

125 Park Ave, 7th Floor New York, NY 10017 Telephone: 1.212.655-3548

 

 

64


 

 

11.2
Expenses. Except as otherwise provided in this Agreement, Sellers and Buyer shall each be liable for its own fees and expenses incurred in connection with the negotiation, preparation, execution or performance of this Agreement and the consummation of the transactions contemplated herein. All recording costs for instruments of transfer, and all stamp, sales, use and transfer taxes shall be paid by Buyer.
11.3
Choice of Law and Forum.
(a)
THIS AGREEMENT SHALL BE CONSTRUED AND INTERPRETED AND THE RIGHTS OF THE PARTIES DETERMINED IN ACCORDANCE WITH THE LAWS OF THE STATE OF DELAWARE, WITHOUT GIVING EFFECT TO THE PRINCIPLES OF CONFLICTS OF LAW OF SUCH STATE.
(b)
ANY LEGAL SUIT, ACTION OR PROCEEDING ARISING OUT OF OR BASED UPON THIS AGREEMENT, THE ANCILLARY DOCUMENTS OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY MAY BE INSTITUTED IN THE FEDERAL COURTS OF THE UNITED STATES OF AMERICA OR THE COURT OF CHANCERY OF THE STATE OF DELAWARE IN EACH CASE LOCATED IN THE CITY OF WILMINGTON AND COUNTY OF NEW CASTLE COUNTY, AND EACH PARTY IRREVOCABLY SUBMITS TO THE EXCLUSIVE JURISDICTION OF SUCH COURTS IN ANY SUCH SUIT, ACTION OR PROCEEDING. SERVICE OF PROCESS, SUMMONS, NOTICE OR OTHER DOCUMENT BY MAIL TO SUCH PARTY'S ADDRESS SET FORTH HEREIN SHALL BE EFFECTIVE SERVICE OF PROCESS FOR ANY SUIT, ACTION OR OTHER PROCEEDING BROUGHT IN ANY SUCH COURT. THE PARTIES IRREVOCABLY AND UNCONDITIONALLY WAIVE ANY OBJECTION TO THE LAYING OF VENUE OF ANY SUIT, ACTION OR ANY PROCEEDING IN SUCH COURTS AND IRREVOCABLY WAIVE AND AGREE NOT TO PLEAD OR CLAIM IN ANY SUCH COURT THAT ANY SUCH SUIT, ACTION OR PROCEEDING BROUGHT IN ANY SUCH COURT HAS BEEN BROUGHT IN AN INCONVENIENT FORUM.

 

65


 

 

 

 

(c)
EACH PARTY ACKNOWLEDGES AND AGREES THAT ANY CONTROVERSY WHICH MAY ARISE UNDER THIS AGREEMENT OR THE ANCILLARY DOCUMENTS IS LIKELY TO INVOLVE COMPLICATED AND DIFFICULT ISSUES AND, THEREFORE, EACH SUCH PARTY IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LEGAL ACTION ARISING OUT OF OR RELATING TO THIS AGREEMENT, THE ANCILLARY DOCUMENTS OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY. EACH PARTY TO THIS AGREEMENT CERTIFIES AND ACKNOWLEDGES THAT (A) NO REPRESENTATIVE OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT SEEK TO ENFORCE THE FOREGOING WAIVER IN THE EVENT OF A LEGAL ACTION, (B) SUCH PARTY HAS CONSIDERED THE IMPLICATIONS OF THIS WAIVER, (C) SUCH PARTY MAKES THIS WAIVER VOLUNTARILY, AND (D) SUCH PARTY HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 11.3.
11.4
Assignment. Neither this Agreement nor any of the rights or obligations hereunder may be assigned by a Party without the prior written consent of the other Parties; provided that Buyer may assign this Agreement and any of the rights or obligations hereunder to an affiliate of Buyer upon written notice to Sellers; provided further that no assignment by Buyer without Sellers consents shall relieve Buyer of its obligations under this Agreement and Buyer shall remain liable for all obligations hereunder (including any breaches of this Agreement by its assignee) as if Buyer remained an original party hereto. Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and assigns, and no other person shall have any right, benefit or obligation hereunder.
11.5
Entire Agreement; Amendments. This Agreement, all Schedules and Exhibits, and all documents and certificates to be delivered by the Parties pursuant hereto, collectively represent the entire understanding and agreement between the Parties with respect to the subject matter of this Agreement. All Schedules and Exhibits attached to this Agreement shall be deemed part of this Agreement and are incorporated herein, where applicable, as if fully set forth herein. This Agreement supersedes all prior negotiations, letters of intent or other writings between the Parties and their respective representatives with respect to the subject matter hereof and cannot be amended, supplemented, or modified except by an agreement in writing that makes specific reference to this Agreement or an agreement delivered pursuant hereto, as the case may be, and which is signed by the Party against which enforcement of any such amendment, supplement, or modification is sought.
11.6
Waivers of Compliance; Consents.

 

66


 

 

 

 

Except as otherwise provided in this Agreement, any failure of any of the Parties to comply with any obligation, representation, warranty, covenant, agreement, or condition herein may be waived by the Party entitled to the benefits thereof only by a written instrument signed by the Party granting such waiver, but such waiver or failure to insist upon strict compliance with such obligation, representation, warranty, covenant, agreement, or condition shall not operate as a waiver of, or estoppel with respect to, any subsequent or other failure. Whenever this Agreement requires or permits consent by or on behalf of any Party, such consent shall be given in writing in a manner consistent with the requirements for a waiver of compliance as set forth in this Section 11.6.

11.7
Severability. In the event that any one or more of the provisions contained in this Agreement or in any other instrument referred to herein, shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision of this Agreement or any other such instrument and this Agreement shall be construed in a manner that, as nearly as possible, reflects the original intent of the Parties.
11.8
Non-recourse. Absent fraud or gross negligence, (a) this Agreement may only be enforced against, and any claim, action, suit or other proceeding based upon, arising out of, or related to this Agreement, or the negotiation, execution or performance of this Agreement, may only be brought against the entities that are expressly named as parties hereto and then only with respect to the specific obligations set forth herein with respect to such Party, and (b) no past, present or future director, officer, employee, incorporator, manager, member, partner, stockholder, affiliate, agent, attorney or other representative of any Party or of any affiliate of any Party, or any of their successors or permitted assigns, shall have any liability for any obligations or liabilities of any Party under this Agreement or for any claim or proceeding based on, in respect of or by reason of the transactions contemplated hereby.
11.9
Counterparts; Delivery; Form of Signature. This Agreement may be executed in any number of counterparts, each of which is an original, and all of which counterparts together shall constitute one and the same fully executed instrument. Delivery of an executed counterpart’s signature page of this Agreement, by facsimile, electronic mail in portable document format (.pdf) or by any other electronic means intended to preserve the original graphic and pictorial appearance of a document, has the same effect as delivery of an executed original of this Agreement. Any such counterpart may be executed by the manual or electronic signature of a Party. Each Party agrees that the electronic signatures of the Parties included in this Agreement are intended to authenticate this writing and to have the same force and effect as manual signatures, to the extent and as provided for under applicable Law.

[End of Page. Signatures Follow.]

 

67


 

 

 

 

IN WITNESS WHEREOF, this Agreement has been executed by the Parties as of the date first above written.

 

 

 

 


 

BUYER:

Zydus Pharmaceuticals (USA) Inc.

 

By: /s/ Punit Patel

Name: Punit Patel Title: Director By: /s/ Garo H. Armen

 

 

 


 

AGENUS WEST:

AGENUS WEST LLC

 

Name: Garo H. Armen Title: President AGENUS INC.

 

 

 


 

 

AGENUS PARENT:

 

By:/s/ Garo H. Armen

Name: Garo H. Armen Title: Chairman and CEO

 

 


 

 

 

 

 

EXHIBIT A

 

 

FORM OF CONTRACT MANUFACTURING AGREEMENT

 

 

[***]

 


 

 

 

 

 

Annexure 1 Statement of Work

 

73


 

 

 

 

 

 

 

Annexure 2 Technology Transfer Agreement

 

74


 

 

 

 

 

Annexure 3 EBITDA Definition

[***]

 

75


 

 

 

 

 

DISCLOSURE SCHEDULES

 

These Disclosure Schedules are delivered pursuant to the Asset Purchase Agreement (the “Agreement”), dated as of June 3, 2025 by and between Agenus West LLC, a limited liability company organized under the laws of the State of Delaware (the “Seller”), and Agenus Inc., a Delaware corporation (“Agenus Parent” and together with Agenus West, each a “Seller” and collectively, “Sellers”), on the one hand, and Zydus Pharmaceuticals (USA) Inc., a corporation organized under the laws of the State of New Jersey (“Buyer”), on the other hand. Sellers and Buyer are sometimes referred to herein as the “Parties” and each as a “Party.”

The information set forth these Disclosure Schedules is disclosed under separate section and subsection references that correspond to the sections and subsections of Article 3 of the Agreement to which such information relates; provided, however that the information set forth in each section and subsection of these Disclosure Schedules shall qualify the representations and warranties set forth in the corresponding section or subsections of Article 3 and any other representations and warranties set forth in Article 3 where such information is relevant, whether or not cross references are expressly set forth in these Disclosure Schedule in one or more instances, so long as the applicability of such qualification is reasonably apparent from such disclosure. Unless the context otherwise requires, all capitalized terms used in these Disclosure Schedules shall have the respective meanings assigned to such terms in this Agreement. Certain information set forth in these Disclosure Schedules is included solely for informational purposes, and may not be required to be disclosed pursuant to this Agreement. No reference to or disclosure of any item or other matter in these Disclosure Schedules shall be construed as an admission or indication that such item or other matter is required to be referred to or disclosed in these Disclosure Schedules. No disclosure in these Disclosure Schedules relating to any possible breach or violation of any agreement or Law shall be construed as an admission or indication that any such breach or violation exists or has actually occurred. The inclusion of any information in these Disclosure Schedules shall not be deemed to be an admission or acknowledgment by the Sellers that in and of itself, such information is material to or outside the ordinary course of the business or is required to be disclosed on these Disclosure Schedules. No disclosure in these Disclosure Schedules shall be deemed to create any rights in any third party.

 

76


 

 

 

 

 

Schedule 1.1A Assumed Contracts

 

[***]

 

 

77


 

 

 

 

 

 

Schedule 1.1B Required Consents

 

[***]

 

 

78


 

 

 

 

 

 

Schedule 1.1C Employees

 

[***]

 

 


 

 

 

 

 

 

 

Schedule 1.1D Equipment

 

[***]

 


 

 

 

 

 

 

Schedule 1.1E Excluded Assets

[***]

 

 


 

 

 

 

 

 

 

Schedule 1.1G Permits

 

[***]

 

 

 


 

 

 

 

 

 

 

Schedule 1.1H Permitted Liens

 

[***]

 


 

 

 

 

 

 

 

Schedule 1.1I Purchased Assets

 

[***]

 

 


 

 

 

 

 

 

 

Schedule 2.1 Certain Assets

 

[***]

 


 

 

Assumed Liabilities

 

[***]

 


 

 

Title to Assets

 

[***]

 


 

 

 

 

 

 

 

Schedule 3.6(a) Inventory

 

[***]

 


 

 

 

 

 

 

 

Schedule 3.6(b) Equipment

 

[***]

 


 

 

 

 

 

 

 

Schedule 3.7(a) Owned Real Property Schedule 3.7(b) Leased Real Property

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

 

 

 

[***]

 


 

 

 

 

 

 

 

Schedule 3.8(a) Governmental Authorizations

 

[***]

 


 

 

 

 

 

 

 

Schedule 3.9(e) Employee Matters

 

[***]

 


 

10

Absence of Changes

 

[***]

 


 

11

Tax Matters

 

[***]

 


 

12

Litigation

 

[***]

 


 

13

Insurance

 

[***]

 

 


 

 

Compliance with Laws

 

[***]

 


 

 

 

 

 

 

 

Schedule 3.15 Brokers

 

[***]

 


 

 

 

 

 

 

 

Schedule 3.18 Subsidiaries

 

[***]

 


 

 

 

 

 

 

 

Schedule 3.19(a) Undisclosed Liabilities

 

[***]

 


 

 

 

 

 

 

 

Schedule 3.19(b) Debt

 

[***]

 

 

 

 


 

 

 

 

 

 

 

Schedule 3.20 Licenses

 

[***]

 


 

 

 

 

 

 

 

Schedule 3.21(a) Employee Plans

 

[***]

 


 

 

 

 

 

 

 

Schedule 3.21(g) COBRA

 

[***]

 


 

 

 

 

 

 

 

Schedule 3.21(h) Parachute Payments

 

[***]

 


 

 

 

 

 

Schedule 9.3(c) Specific Indemnity Items AGENUS ZYDUS BOT/BAL LICENSE AGREEMENT

 

[***]

 


EX-10.2 3 agen-ex10_2.htm EX-10.2 EX-10.2

 

 

Exhibit 10.2

Certain portions of this exhibit (indicated by “[***]”) have been omitted in compliance with Regulation S-K Item 601(b)(10)(iv) as the Company determined the omitted information (i) is not material and (ii) is the type that the Company customarily and actually treats as private or confidential.

 

This License Agreement (this Agreement ) dated as of June 3 , 2025 (the Effective

Date ) is by and between Agenus Inc., a Delaware corporation with offices at 3 Forbes Road, Lexington, Massachusetts 02421 USA (“Agenus or “Licensor ) and Zydus LifeSciences Ltd. company organized and existing under the laws of India having an address at Zydus Corporate Park, Scheme No. 63, Khoraj (Gandhinagar), 536, Sarkhej Gandhinagar Hwy, Near Vaishnodevi Circle, Ahmedabad, Gujarat 382481 ( Licensee ) and Agenus and Licensee may each be referred to herein individually as a Party or, collectively, as the Parties

WHEREAS, Agenus and Licensee are each in the business of discovering, developing, manufacturing, and commercializing biopharmaceutical products;

WHEREAS, Agenus owns or controls the Agenus IP, which relat to its proprietary Agenus Antibody known as BOT/BAL targeting CTLA 4 and PD

WHEREAS, Licensee desires to access the proprietary Agenus Antibody known as BOT/BAL targeting CTLA 4 and PD and to obtain an exclusive license under the Agenus IP to Develop, Manufacture and Commercialize a Licensed Product(s) for use in the Field in the Territory, all terms as defined herein and

WHEREAS, Agenus is willing to grant the requested exclusive license under the Agenus IP on the terms and conditions set out in this Agreement.

NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound hereby, agree as follows:

img64963062_0.jpg DEFINITIONS

1.1
Defined Terms Capitalized terms used throughout this Agreement shall have the following definitions:
(a)
Accounting Standards” with respect to a Party means that such Party shall maintain records and books of accounts in accordance with generally accepted accounting principles in the Territory, and consistently maintained
(b)
Additional Active” means any active pharmaceutical or biological

ingredients that are not the Agenus Antibody.

(c)
Affiliate means, as to a Person, any Person which, directly or indirectly, controls, is controlled by, or is under common control with such Person. For the purposes of this definition, control refers to any of the following: (a) direct or indirect ownership of more than fifty percent (50%) of the voting securities entitled to vote for the election of directors in the case of a corporation, or of more than fifty percent (50%) of the equity interest with the power to direct management in the case of any other type of legal entity; (b) status as a general partner in any partnership; or (c) any other arrangement where an entity possesses, directly or indirectly, the power to direct the management or policies of another entity, whether through ownership of voting securities, by contract or otherwise.

 

 

 

 

(d)
“Agenus Antibody” means one or more molecules, or the one or more genes encoding such molecule(s), which comprise or consist of BOT and BAL, used either individually as monotherapies or in cominbation with each other or other products.
(e)
“Agenus IP” means the Licensed Patent Rights and the Licensed Know-

How.

(f)
“Applicable Law” means federal, state, local, national and supra-national laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law, including any rules, regulations, guidelines, or other requirements of a Regulatory Authority, that may be in effect from time to time during the Term and applicable to a particular activity.
(g)
“BAL” or “Balstilimab” means the antibody targeting PD-1 identified by Chemical Abstract Service Registry Number 2148321-77-9 and internally referenced by Agenus as “AGEN2034.”
(h)
“BOT” or “Botensilimab” means means the antibody targeting CTLA-4 identified by Chemical Abstract Service Registry Number 2408310-37-0 and internally referenced by Agenus as “AGEN1181.”
(i)
“Business Day” means a day other than a Saturday or Sunday or federal or state holiday in Boston, Massachusetts or in Ahmedabad, India.
(j)
“cGCP” means the standards of current good clinical practice as are required by governmental agencies in countries in which the Licensed Products are intended to be sold under this Agreement, including as set forth in the United States Federal Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder and applicable regulations or guidelines from ICH, as amended from time to time.
(k)
“cGMP” means the current Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356/EEC, ICH Guidelines Q7A and United States Good Manufacturing Practices for Finished Pharmaceuticals pursuant to 21

C.F.R. 210 et seq., as amended from time to time.

(l)
“Change in Control” means, with respect to a Party: (a) any transaction or series of related transactions pursuant to which a Third Party that does not, itself or together with its Affiliates, prior thereto beneficially own at least fifty percent (50%) of the voting power of the outstanding securities of such Party acquires or otherwise becomes the beneficial owner of securities of such Party representing at least fifty percent (50%) of the voting power of the then outstanding securities of such Party with respect to the election of directors; or (b) a merger (including a reverse triangular merger), reorganization, consolidation, share exchange, or similar transaction including the sale of all or substantially all of the assets of the company, in each case involving such Party in which the holders of voting securities representing at least fifty percent (50%) of the voting power of the then outstanding securities of such Party immediately prior thereto and their Affiliates cease to hold voting securities that represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization, consolidation, share exchange, or similar transaction.

 

2


 

 

 

 

(m)
“Clinical Trial” means a study in humans of a Licensed Product to be carried out by Licensee in accordance with the terms of this Agreement.
(n)
“CMA” means that Contract Manufacturing Agreement anticipated to be entered into by and between Agenus and an Affiliate of Licensee for the manufacturing of drug substance and drug product thereunder, including the Agenus Antibody.
(o)
“Combination Product” means any product or treatment regimen that

comprises, or is a combination of, (a) any Agenus Antibody and (b) any Other Component.

(p)
“Commercialization” means any and all activities directed to the pre- marketing, branding, marketing, promotion, distribution, pricing, labeling, reimbursement, offering for sale, distribution, storage, handling, selling, importing and exporting for sale and sale of a pharmaceutical or biologic product, including name-patient sales, and interacting with Regulatory Authorities following receipt of Regulatory Approval in the applicable country or region for such pharmaceutical or biologic product regarding the foregoing, including seeking any required reimbursement approval, but excluding activities primarily directed to Manufacturing or Development. “Commercialize,” “Commercializing,” and “Commercialized” will be construed accordingly.
(q)
“Commercially Reasonable Efforts” of a Party means, with respect to an obligation or objective, the reasonable, diligent, good faith efforts of such Party (including the efforts of its Affiliates and sublicensees), of the type to accomplish such objective as a similarly situated (with respect to size, stage of development and assets) biopharmaceutical company would normally use to accomplish a similar objective for a compound or product at a similar stage in its development or product life and of similar market potential taking into consideration safety and efficacy, cost to Develop, the competitiveness of alternative products, the proprietary position, the likelihood of Regulatory Approval, profitability, and all other relevant factors. Subject to and consistent with the foregoing, Commercially Reasonable Efforts shall include that the applicable Party (i) regularly assigns responsibility for obligations to employee(s) who monitor progress of such obligations; (ii) sets goals with respect to such obligations and objectives; and (iii) makes decisions and allocates resources designed to advance progress with respect to and achieve such obligations and objectives.
(r)
“Confidential Information” means, subject to Section 10.1(b), any technical, scientific or business information of one Party or its Affiliates disclosed or made available to the other Party or its Affiliates in connection with this Agreement or generated pursuant to the activities contemplated hereunder, regardless of whether such information is specifically designated as confidential and regardless of whether such information is in oral, written, electronic or other form, or otherwise obtained through observation of a Party.
(s)

 

3


 

 

 

 

“Control” or “Controlled” means, with respect to any Know-How or Patent Rights or intellectual property rights therein, the possession by a Party or any of its Affiliates, whether by ownership or license (other than by a license granted under this Agreement), of the ability to grant to the other Party access, a license and/or a sublicense in, to or under such Know- How, Patent Right or intellectual property right as provided herein without requiring the consent of a Third Party or violating the terms of any agreement or other arrangement with any Third Party or creating a payment obligation upon such Party under any agreement entered into after the Effective Date, in each case, (a) as of the Effective Date, or (b) if any of the same are acquired or created after the Effective Date, at the date it is acquired or created by the relevant Party.

Notwithstanding anything in this Agreement to the contrary, a Party shall be deemed to not Control any Patent Rights, Know-How or intellectual property rights that are owned or controlled by a Third Party described in the definition of “Change in Control”, or such Third Party’s Affiliates, (i) prior to the closing of such Change in Control, or (ii) after such Change in Control to the extent that such Patent Rights, Know-How or intellectual property rights are conceived, discovered, developed, made or reduced to practice by such Third Party or its Affiliates (other than such Party) after such Change in Control without using such Party’s technology.

(t)
“CTLA-4” means cytotoxic T-lymphocyte-associated protein 4.
(u)
“Development” or “Develop” means all internal and external research, development, and regulatory activities related to Licensed Products, including (i) pre-clinical studies and Clinical Trials and (ii) 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 or to obtain, support, or maintain Regulatory Approval of a pharmaceutical or biologic product, but excluding activities primarily directed to Manufacturing. “Develop,” “Developing,” and “Developed” will be construed accordingly.
(v)
“FDA” means the United States Food and Drug Administration or any

successor agency thereto.

(w)
“Field” means all uses (including all oncology and non-oncology indications) of an Agenus Antibody and/or Licensed Product as a monotherapy or combination therapy with each other or with other components.
(x)
“First Commercial Sale” means, on a country-by-country basis, the first sale of a Licensed Product in such country for use or consumption by the general public (following receipt of all Regulatory Approvals that are required in order to sell such Licensed Product in such country) and for which any of Licensee or its Affiliates or sublicensees has invoiced sales of such Licensed Product in such country; provided, however, that the following shall not constitute a First Commercial Sale: (a) any sale to an Affiliate or sublicensee, unless such Affiliate or sublicensee is the last Person in the distribution chain of the Licensed Product;
(b)
any use of such Licensed Product in clinical trials or non-clinical development activities; or
(c)
any disposal or transfer of such Licensed Product for a bona fide charitable purpose, compassionate use, or samples.
(y)
“Generic Product” means in respect of any Licensed Product any pharmaceutical product that (a) is sold by a Third Party that is not an Affiliate or Sublicensee of Licensee under a marketing authorization granted by a Regulatory Authority to a Third Party, (b) created to be the same as the Licensed Product in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use, and (c) is approved in reliance on a prior Regulatory Approval of the Licensed Product granted to Licensee, an Affiliate of Licensee or Sublicensee by the applicable Regulatory Authority and is bioequivalent to, therapeutically and clinically equivalent to, and interchangeable with, or is biosimilar to, the Licensed Product.

 

4


 

 

 

 

(z)
“ICH” means International Conference on Harmonization of Technical

Requirements for Registration of Pharmaceuticals for Human Use.

(aa) “IND” means an investigational new drug application filed with the US Food and Drug Administration pursuant to 21 C.F.R. §312 (as amended from time to time) for authorization to commence Clinical Trials of a Licensed Product, and the equivalent regulatory filing in countries outside of the United States.

(bb) “Inventions” means all inventions, discoveries, improvements, Results and other technology (whether or not patentable), and any intellectual property rights therein, including Patent Rights, that are discovered, made, conceived or reduced to practice in performance of this Agreement.

(cc) “Know-How” means any and all proprietary and technical information that is not, as of the date of disclosure, in the public domain or otherwise excluded pursuant to Section 10.1(b), including information comprising or relating to data, materials, results, inventions, improvements, protocols, formulas, processes, methods, technology, compositions, articles of manufacture, formulations, discoveries, findings, know-how and trade secrets of any kind, including scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, financial and commercial information or data, sequence information, vectors and host cells that include DNA, in each case (whether or not patented or patentable) in written, electronic or any other form now known or hereafter developed.

(dd) “LICR Agreement” means that certain License Agreement, entered into January 25, 2016, by and between Agenus, its wholly owned subsidiary, Agenus Switzerland Inc. (f/k/a 4-Antibody AG), the Ludwig Institute for Cancer Research Ltd. (“LICR”), on behalf of itself and the Memorial Sloan-Kettering Cancer Center (“MSKCC”).

(ee) “Licensed Know-How” means all Know-How Controlled by Agenus as of the Effective Date pertaining to the Licensed Patent Rights and necessary or reasonably useful in the Development, Manufacture or Commercialization of the Licensed Product.

(ff) “Licensed Patent Rights” means all rights in the Territory under (i) the Patent Rights listed on Exhibit A, (ii) all Licensed Improvement Patent Rights, (iii) all Patent Rights that issue from the foregoing, and (iv) all continuations, continuations-in-part, divisionals, extensions, substitutions, reissues, re-examinations and renewals of any of the Patent Rights listed in (i)-(iii).

(gg) “Licensed Product” means (i) any product containing the Agenus Antibody in the Field and (ii) any process that incorporates or uses the foregoing. Licensed Product excludes Additional Actives owned or Controlled by Agenus. Subject to the immediately preceding sentence, Licensed Product may include Additional Actives if employed with an Agenus Antibody.

 

5


 

 

 

 

(hh) “MAA” means a Marketing Authorization Application, Biologics License Application, or similar application, as applicable, and all amendments and supplements thereto, submitted to the FDA, European Medicines Agency (“EMA”), Japan's Ministry of Health, Labor and Welfare, or any equivalent filing in a country or regulatory jurisdiction other than the US or EU with the applicable Regulatory Authority, to obtain marketing approval for a Licensed Product(s), in a country or in a group of countries.

(ii)
“Manufacture” or “Manufacturing” means, as applicable, all activities and operations associated with the production, manufacture, supply, receipt, import, processing, filling, finishing, inspections, testing, packaging, labeling, shipping, warehousing, storage and handling of a Licensed Product or Agenus Antibody as applicable, including: cell line development; process and formulation development; process validation; stability and release testing; manufacturing scale-up; pre-clinical, clinical and commercial manufacture and supply; qualification and validation of Third Party contract manufacturers, scale up, process and equipment validation, and initial manufacturing licenses, approvals and inspections; analytical development and product characterization; quality assurance and quality control development; testing and release; packaging development and final packaging and labeling; shipping configurations and shipping studies; and overseeing the conduct of any of the foregoing. When used as a verb, “Manufacture” means to engage in Manufacturing.

(jj) “Net Sales” means, with respect to a Licensed Product and a period of time, the gross amount invoiced by Licensee or a Related Party thereof to non-Related Party Third Parties for any Licensed Product in the Territory during such period, less the following items consistent with applicable Generally Accepted Accounting Principles (“GAAP”) consistently applied:

(i)
trade, quantity, and cash discounts allowed;
(ii)
discounts, refunds, rebates, chargebacks, retroactive price adjustments, customer cash and non-cash coupons, credits, group purchasing organization or pharmaceutical benefit manager administrative fees and any other allowances that effectively reduce the net selling price;
(iii)
Licensed Product returns and allowances, including by reason of expiry, breakages, defects, rejection, recalls, or field destroys;
(iv)
GST, excise taxes, and sales, use, value-added and other consumption taxes (excluding for the avoidance of doubt, taxes imposed on, or measured by, income);
(v)
import or export duties and tariffs;
(vi)
uncollectible amounts on previously sold Licensed Products;
(vii)
a deduction of a fixed percentage of 1% of cumulative annual gross sales for distribution and warehouse expenses and inventory management fees; freight insurance, customs charges, freight, shipping and other transportation costs incurred in shipping Licensed Product to third parties;

 

6


 

 

 

 

(viii)
(ix)
any fees, commission or charges of similar nature paid to a Third Party not being the buyer of the Licensed Product, where such fees or charges are directly related to identifiable sales of the Licensed Product; and
(x)
any other specifically identifiable amounts included in gross amounts invoiced for Licensed Product to the extent such amounts are customary exclusions from net sales calculations in the biopharmaceutical industry for reasons substantially equivalent to those listed above and are reasonable in amount relative to similar deductions taken by Licensee in calculating net sales of its other products.

Net Sales shall be calculated in accordance with GAAP. In the case of any sale or other disposal for value, such as barter or counter-trade, of a product, or part thereof, other than in an arm’s length transaction exclusively for cash, Net Sales shall be calculated as above on the value of the non-cash consideration received or the fair market price (if higher) of such product in the country of sale or disposal, as determined in accordance with Accounting Standards. In no event will any particular amount of deduction identified above be deducted more than once in calculating Net Sales (i.e., no “double counting” of deductions).

In the case where a Licensed Product is sold as part of a Combination Product in a country in the Territory, Net Sales for the Licensed Product included in such Combination Product in such country shall be calculated as follows:

(xi)
if the Licensed Product is sold separately in such country and the Other Component in the Combination Product is sold separately in such country, Net Sales for the Licensed Product shall be calculated by multiplying actual Net Sales of such Combination Product in such country by the fraction A/(A+B), where A is the invoice price of the Licensed Product when sold separately in such country and B is the total invoice price of the Other Component in the Combination Product when sold separately in such country;
(xii)
if the Licensed Product is sold separately in such country but the Other Component in the Combination Product is not sold separately in such country, Net Sales for the Licensed Product shall be calculated by multiplying actual Net Sales of such Combination Product in such country by the fraction A/D, where A is the invoice price of the Licensed Product when sold separately in such country and D is the invoice price of the Combination Product in such country;
(xiii)
if the Licensed Product is not sold separately in such country but the Other Component in the Combination Product is sold separately in such country, Net Sales for the Licensed Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction 1 – (B/D), where B is the invoice price of the Other Component in the Combination Product when sold separately in such country and D is the invoice price of the Combination Product in such country; or
(xiv)

 

7


 

 

 

 

if neither the Agenus Antibody nor the Other Component are sold separately in a given country as the Combination Product, then the Net Sales allocable to such Combination Product in each such country shall be determined by mutual agreement reached in good faith by the Parties prior to the end of the accounting period in question based on an equitable method that takes into account, on a country-by-country basis, all relevant factors (including variations in potency, the relative contribution of each active ingredient in the combination, and relative value to the end user of each active ingredient).

To the extent that Licensee of an Affiliate provides to a purchasing Person discounts or allowances that are applicable to purchases of Combination Products, such discounts and allowances shall be allocated between the Licensed Product and the Other Component(s) in a commercially reasonable manner that does not unfairly or inappropriately bias the level of discounting against the Licensed Product as compared to the Other Component(s).

In the event that the Parties cannot align on the Net Sales allocable to a Combination Product in any country, the Parties agree to submit this specific dispute first to the Managers for resolution and in the event that the Managers are unable to resolve the dispute, such dispute will be resolved pursuant to Section 14.1.

(kk) “Other Component” means any (a) pharmaceutically active compound, substance, or therapeutic agent that are not an Agenus Antibody, or (b) products that do not contain an Agenus Antibody, but excluding drug delivery vehicles and devices, cytotoxic compounds or other therapeutically active ingredients conjugated, engineered or otherwise linked to a Licensed Product, adjuvant, excipient or diagnostic compound.

(ll) “Patent Rights” means all the rights and interests in and to all patents and patent applications, underlying inventions, and patent term extensions or restorations, in any jurisdiction in the applicable Territory, including certificates of invention, applications for certificates of invention and priority rights, provisional patent applications, divisionals, continuations, substitutions, continuations-in-part, and all patents granted thereon; and all re- examinations, re-issues, additions, renewals, extensions, confirmations or registrations based on any such patent or patent application; and any extensions or restorations by existing or future extension or restoration mechanisms, including patent term extensions and supplementary protection certificates.

(mm) “PD-1” means programmed cell death protein 1.

(nn) “Person” means any individual, partnership, limited liability company, firm, corporation, association, trust, unincorporated organization or other entity.

(oo) “Prosecution” or “Prosecute” means, with respect to a particular Patent Right, all activities associated with the preparation, filing, prosecution and maintenance of such Patent Right, as well as re-examinations, reissues, applications for patent term adjustments and extensions, supplementary protection certificates and the like with respect to that Patent Right, together with the conduct of interference, opposition, invalidation, reexamination, reissue proceeding, post-grant review, inter partes review, derivation proceeding or other similar administrative proceeding or administrative appeal thereof, with respect to that Patent Right.

 

8


 

presentation

 

9


 

 

 

 

(pp) “Publication” means any publication in a scientific journal, any abstract to be presented to any scientific audience not subject to confidentiality obligations, any at any scientific conference, including slides, posters and texts of oral or other public presentations presented to an audience not subject to confidentiality obligations, any other scientific presentation, disclosure of a clinical trial on clinicaltrials.gov or similar clinical trial registries, and any other oral, written or electronic disclosure directed to a scientific audience not subject to confidentiality obligations, in each case which pertains to the Licensed Product.

(qq) “Regulatory Approval” means, with respect to a product, any and all approvals by a Regulatory Authority (including supplements, amendments), permits, licenses, registrations and authorizations necessary for the manufacture, distribution, use, promotion, marketing, transport, offer for sale, sale or other commercialization of such product or components thereof in a regulatory jurisdiction, leading up to and including marketing authorization, including MAA approval.

(rr) “Regulatory Authority” or “Regulatory Authorities” means, with respect to a country, the regulatory authority or regulatory authorities of such country with authority over the testing, manufacture, use, storage, importation, promotion, marketing, pricing or sale of a product in such country, including the FDA and the EMA.

(ss) “Subcontractor” means a Third Party contractor engaged by a Party to perform certain obligations or exercise certain rights of such Party under this Agreement on a fee-for-service basis, excluding all Sublicensees.

(tt) “Sublicensee” means any Third Party to which a license to Develop, Manufacture or Commercialize a Licensed Product has been granted by Licensee (directly or through multiple tiers), or who otherwise receives a sublicense of rights granted to Licensee hereunder.

(uu) “Sublicense Income” means the fair market cash value of any and all consideration received by Licensee from a Sublicensee under or otherwise in connection with any transaction or related transactions involving a sublicense of rights hereunder, including without limitation license issue fees, option fees and other licensing fees, royalties, equity securities or other payments of any kind whatsoever, or any other consideration, irrespective of the form of payment. Notwithstanding the immediately preceding sentence, specifically excluded from Sublicense Income is (i) any value contributed to reimburse or cover a development or commercial expense incurred pursuant to a bona fide co-development or co- commercialization agreement with such Sublicensee; or (ii) a purchase of equity in Licensee by said Sublicensee at market value (provided that any premium above fair market value shall constitute Sublicense Income) or (iii) amounts extended under a bona fide commercial loan to Licensee by a sublicensee provided that any loan amount forgiven or not otherwise subject to repayment shall not be excluded from Sublicense Income.

(vv) “Territory” means the Asia Pacific (APAC) countries Listed in Exhibit B, which may be amended pursuant to Section 4.1(b).

(ww) “Third Party” means any Person other than a Party or an Affiliate.

(xx) “Valid Claim” means (a) a claim of an issued patent that has not expired

 

10


 

 

 

 

or been abandoned, or been revoked, held invalid or unenforceable by a patent office, court or other governmental agency of competent jurisdiction in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period) and that is not admitted to be invalid or unenforceable through reissue, disclaimer or otherwise (i.e., only to the extent the subject matter is disclaimed or is sought to be deleted or amended through reissue); or

(b) a claim of a pending patent application that was filed in good faith and has not been (i) cancelled, withdrawn, abandoned, finally rejected or expired without the possibility of appeal or refiling, or (ii) pending for more than seven (7) years since such claim was first presented in unamended form.

1.2
Additional Definitions. Each of the following definitions is set forth in the section of this Agreement indicated below:

 

Term

Section

Additional Third Party License

8.1(c)

Agenus Improvements

9.1

Agenus Improvement Patent Rights

9.1

Agenus Indemnified Parties

13.1

Agenus Results

5.4

Claims

13.1

Clinical Supply Agreement

3.1

Clinical Trial Plan

5.1

Commercial Supply Agreement

3.1

Competing Product

4.6

Delivery

3.2

Disclosing Party

10.1(a)

Dispute

14.1(b)

Disputing Party

14.1(b)

Exchange Rate

8.3(c)

Force Majeure event

14.5

Forecast

5.1

Indemnified Party

13.3

Joint Improvements

9.1

Joint Improvement Patent Rights

9.1

Licensee Improvements

9.1

Licensed Improvement Patent Rights

9.1

Licensee Indemnified Parties

13.2

Licensed Patent Right Challenge

9.5

Limited Approval

5.1

 

 

11


 

 

 

 

 

LICR

1.1(dd)

Losses

13.1

MAE

2.2(a)

Manager

2.1

MSKCC

1.1(dd)

Payment Statement

8.3(a)

Product Trademarks

7.1

Promotional Materials

7.2

Quality Agreement

3.4

Recipient

10.1(a)

Results

5.4

Royalty or Royalties

8.1

Rules

14.1(d)

SDEA

6.5

SEBI Regulations

12.2(j)

SEC

10.2(b)

Sell Off Period

11.3(e)

Senior Executive

2.2(c)

Supply Agreement

3.1

Term

11.1

Zydus’ UPSI

12.2(j)

 

 

 

 

img64963062_1.jpg COORDINATION AND DECISION MAKING

2.1
Coordination Each Party shall appoint one (1) representative to act as a collaboration manager (each, a Manager ) to coordinate activities of the Parties under this Agreement. The Parties shall meet at least once every six (6) months to engage in dialogue on mutually agreed subjects, pursuant to an agenda to be circulated by the Managers at least ten (10) days prior to each such meeting. Coordination meetings shall be at such times and places as the Parties mutually agree, and may be conducted in person or telephonically. Agenda topics may include Licensee progress under the Comercialization Plan, communications with Regulatory Authorities regarding the Licensed Products, discussion of Results, adverse events and other material matters relating to Clinical Trials and Publication opportunities In advance of each such meeting, Licensee shall deliver an updated Clinical Trial Plan to the Agenus Manager together with a written report regarding Development, Manufacturing and Commercialization activities in respect of Licensed Products since the last such meeting

 


 

 

 

 

2.2
Decision Making To the extent that the Parties disagree on matters relating to the Development, Manufacture, or Commercialization of Licensed Products in the Territory in the Field pursuant to this Agreement:
(a)
Agenus shall have final decision making authority with respect to all matters that could reasonably be expected to have a material adverse effect on the safety profile of the Agenus Antibody (an “MAE ) outside of the Territory By way of example and not limitation, an MAE would include a matter that could reasonably be expected to impact the safety profile of the Agenus Antibody, but would not include a matter relating to the Development, Manufacture or Commercialization of Licensed Products if the outcome of the decision would not reasonably be expected to have a material adverse effect on global Development, Manufacture, and Commercialization of the Agenus Antibody
(b)
Subject to Section 2.2(a) Licensee shall have final decision making authority with respect to all matters directly relating to the Licensed Products or any Additional Active Controlled by Licensee
(c)
For all other matters, the matter shall be referred to the Chief Executive Officers of each Party, or such other officer designated by the Chief Executive Officer (each a Senior Executive”) for their consideration. The Senior Executives will discuss in good faith and use reasonable efforts to resolve the matter referred to them. If the Senior Executives cannot reach a mutually acceptable decision within thirty (30) days after the issue was referred to them, then such matter may be brought in any court of competent jurisdiction subject to Section 14.1

img64963062_2.jpg SUPPLY OF AGENUS ANTIBODY

3.1
Supply Agreement Within a reasonable time following approval of a clinical trial in the Territory, the Parties shall use reasonable efforts to enter into a supply agreement (the “Clinical Supply Agreement”) pursuant to which Agenus will agree to supply Licensee with all of Licensee’s and its Affiliates’ and Sublicensees’ requirements of Agenus Antibody for use in Clinical Trials for the Licensed Products, itself or through use of an Affiliate or Agenus Subcontractor Within six (6) months from the first filing submitted for MAA, the Parties shall use reasonable efforts to enter into a supply agreement (the “Commercial Supply Agreement”) pursuant to which Agenus will agree to supply Licensee with all of Licensee’s and its Affiliates’ and Sublicensees’ requirements of Agenus Antibody for use in Commercialization of the Licensed Products in the Territory, itself or through use of an Affiliate or Agenus Subcontractor. Clincial Supply Agreement and Commericial Supply Agreement hereinafter collectively referred to as the “Supply Agreement”) Without limiting the foregoing, unless otherwise agrees or required by Applicable Law, the Supply Agreement shall provide for (i) pricing at Agenus’ fully burdened costs plus all logistics, shipping, and any VAT or other applicable transfer taxes

(ii) other customary supply terms, including forecasting, forecast, inventory, safety stock and the Parties’ obligation to enter into a Quality Agreement In the event that the Parties cannot come to agreement on the terms for said Supply Agreement Agenus will assist Licensee in engaging a mutually agreed Third Party contractor to provide supply of the Agenus Antibody at Licensee expense In such a case, Agenus’ agreement shall not be unreasonably withheld or delayed.

 

2


 

 

 

 

3.2
Delivery Unless otherwise agreed in an applicable purchase order, each preclinical or clinical order of Agenus Antibody shall be shipped CIP (Incoterms 2010) Licensee’s designated facility, using a common carrier selected by Agenus and reasonably acceptable to Licensee, and title and risk of loss for any order shall pass to Licensee upon Licensee taking possession of the shipment (“Delivery”). Licensee shall be responsible for customs and other import clearance of any Agenus Antibody (with reasonable cooperation from Agenus), payment of all tariffs, duties, customs, fees, expenses and charges payable in connection with the import or export of the Agenus Antibody, and record keeping in connection with such import into the Territory
3.3
Permits and Approvals. During the Term, Agenus and its Third Party Manufacturing contractors, if any, will be responsible for maintaining any licenses, permits and approvals necessary for the Manufacture of the Agenus Antibody in accordance with the provisions of this Agreement and Licensee will be responsible for maintaining any other licenses, permits and approvals necessary for the Manufacture and Commercialization of the Licensed Product(s) in the Territory in accordance with the provisions of this Agreement. Each Party will promptly notify the other Party if such Party receives notice that any such license, permit, or approval is or may be revoked or suspended.
3.4
Quality Agreements Within ninety (90) days after the Parties enter into the Clinical Supply Agreement and within ninety (90) days after the Parties enter into the Commercial Supply Agreement, Licensor and Licensee will, in each case, enter into a separate standard quality agreement (to be agreed upon and executed by the Parties) setting forth the Parties’ respective obligations in detail regarding the Manufacture, packaging, testing, storage, and release of Licensed Products to assure such Licensed Products is Manufactured in the Field in the Territory according to agreed specifications and complies with Applicable Laws (in each case, the Quality Agreement )

img64963062_3.jpg LICENSES

4.1
License Grant
(a)
License to Licensee Subject to the terms and conditions of this Agreement, Agenus hereby grants to Licensee during the Term a royalty bearing, nontransferable (except as permitted in Section 14.2), sublicensable (subject to Section 4.4), exclusive (even as to Agenus, except as otherwise set forth herein) right and license under the Agenus IP to Develop, Manufacture and Commercialize Licensed Products in the Field in the Territory.

 

3


 

 

 

 

(b)
[***]
(c)
Licensee and its sublicensees shall be solely responsible for all costs and expenses in connection with such Development, Manufacture and Commercialization The foregoing license does not include, and expressly prohibits, Development, Manufacture or Commercialization of any Additional Active owned or Controlled by Agenus unless mutually agreed upon in writing any method or thereof owned or Controlled by Agenus In the event Licensee requests modification of the formulation of the Agenus Antibody to further the Development, Manufacture or Commercialization of a Licensed Product, Agenus will (i) first, subject to any confidentiality obligations to Third Parties, use reasonable efforts to provide Licensee all information that is reasonably requested by Licensee with regard to the formulation of the Agenus Antibody and that is necessary for the Licensed Product, as well as provide reasonable assistance to the Licensee team with any questions it may have in order for Licensee to make such modification to the formulation of the Agenus Antibody in its own lab or Third Party lab, or (ii) second, subject to its own manufacturing capacity constraints that may exist at the time of such request, use Commercially Reasonable Efforts to conduct such modification on a fee for service basis and on terms and pricing to be agreed upon between the Parties. For clarity, Licensee’s exclusive Development rights granted hereunder will not be voided in any way should Licensee determine that a Licensed Product shall also include Additional Actives not owned or Controlled by Agenus.
(d)
License to Agenus. Subject to the terms and conditions of this Agreement, Agenus hereby reserves, and Licensee hereby grants to Agenus, an irrevocable, nontransferable (except as permitted in Section 14.2), sublicensable, non-exclusive right and license under the Agenus IP for research and development of the Agenus Antibody, and an an irrevocable, nontransferable (except as permitted in Section 14.2), sublicensable (solely in connection with Agenus product licenses), royalty-bearing (on terms to be negotiated in good faith), non- exclusive right and license under the Licensee Improvement Patent Rights that involve either (i) a modification of the Agenus Antibody formulation or (ii) the Agenus Antibody to Develop, Manufacture, and Commercialize Agenus products outside the Field. The foregoing license expressly excludes Development, Manufacture and Commercialization of any Additional Active owned or Controlled by Licensee, or any method or use thereof owned or Controlled by Licensee.
4.2
No Implied Licenses or Rights. Except as expressly licensed in Section 4.1, all rights in and to the Patent Rights or Know-How of each Party and its Affiliates are hereby retained by such Party and its Affiliates. For the purposes of clarity, and notwithstanding any other provision of this Agreement, the licenses granted in Section 4.1(a) give Licensee no rights to Develop, Manufacture or Commercialize the Agenus IP or any Licensed Product outside of the Field or the Territory, and the license granted in Section 4.1(d) gives Agenus no rights to Develop, Manufacture or Commercialize Licensee Improvement Patent Rights in the Field, nor any rights to Develop, Manufacture or Commercialize Licensee Patent Rights or Know-How other than the Licensee Improvement Patent Rights. Notwithstanding the exclusive licenses granted to Licensee pursuant to Section 4.1(a), Agenus retains the right to practice under the Agenus IP: (i) to exercise its rights and to perform (and to sublicense Third Parties to perform) its obligations under this Agreement and (ii) for all purposes other than the Development, Manufacture or Commercialization of Licensed Products in the Field in the Territory.

 

14


 

 

 

 

4.3
LICR Agreement. Without limiting the representations and warranties made herein by Agenus with regard to its rights to Develop, Manufacture and Commercialize the Agenus Antibody, Licensee acknowledges and agrees that certain of the Agenus IP has been exclusively licensed to Agenus pursuant to the LICR Agreement and is subject to the terms and conditions thereof including but not limited to: (a) the reporting and record-keeping obligations with respect to sales of “Products” (as that term is defined in the LICR Agreement) as provided in Sections 2.6 and 3.8 of the LICR Agreement, (b) indemnification under Section 5.4(a)(ii) of the LICR Agreement, and (iii) obligations of non-use of name as provided in Section 6.5 of the LICR Agreement. In the event of any conflict or inconsistency between any applicable provision of this Agreement and such provisions of the LICR Agreement, such provisions of the LICR Agreement shall prevail with respect to the relevant Agenus IP licensed to Agenus by LICR pursuant to the LICR

Agreement. Nothing in the immediately preceding sentence shall serve to waive, nor shall it conflict with, any representation made by Agenus to Licensee herein with regard to Licensee’s rights to Develop, Manufacture and Commercialize the Agenus Antibody, nor Licensee’s right to enforce such representations and seek applicable remedies for material breaches thereof. For purposes of clarity, all obligations of Agenus, financial or otherwise, that do not attach to sublicensees of Agenus under the LICR Agreement shall be the sole responsibility of Agenus.

4.4
Sublicensing.
(a)
Sublicense Grant. Subject to the terms and conditions of this Agreement, Agenus hereby grants to Licensee the right to sublicense all or any of Licensee’s licensed rights to and under the Agenus IP to one or more Third Parties.
(b)
Scope of Sublicense. No sublicense may exceed the scope of rights granted to Licensee hereunder. Licensee shall require all sublicenses to be in writing and to: (a) include an agreement by the Sublicensee to be bound by the terms and conditions of this Agreement including an audit right by Agenus of the same scope as provided in Section 8.4, (b) acknowledge Agenus’ right to enforce its rights in the Agenus IP as set forth herein; (c) provide that the term of the sublicense thereunder may not extend beyond the Term; and (d) indicate that Agenus is a third party beneficiary and entitled to enforce the terms and conditions of the sublicense in the event Licensee fails to do so. Licensee shall enforce all sublicenses at its cost and shall be responsible for the acts and omissions of its Sublicensees.
(c)
Licensee Liability. Notwithstanding any sublicense agreement, Licensee shall remain primarily liable to Agenus for all of Licensee’s duties and obligations contained in this Agreement, including the payment of all Royalties due pursuant to Section 8.1. Any act or omission of a Sublicensee that would be a breach of this Agreement and not timely cured (to the extent curable) if committed or omitted by Licensee will be a breach by Licensee if not timely cured (to the extent curable). Each sublicense agreement must contain a right of termination by Licensee for the Sublicensee’s: (a) breach of any payment or reporting obligations affecting Agenus; (b) participation in a Licensed Patent Right Challenge; (c) violation of any US export control Laws in connection with the sale or distribution of any Licensed Product; or (d) breach of any other terms or conditions of the sublicense agreement which breach would constitute a breach of this Agreement if Licensee failed to comply therewith.

 

15


 

 

 

 

In the event of a Sublicensee breach of these obligations, and if after a reasonable cure period provided in the sublicense agreement, not to exceed thirty (30) Business Days without Agenus’ written consent, the Sublicensee fails to cure the Sublicensee breach, Licensee fails to cure such breach, or the breach is otherwise not capable of being cured, then Licensee shall terminate the sublicense agreement by written notice to the Sublicensee within five (5) Business Days thereafter and concurrently provide a copy of such notice to Agenus. In the event the Sublicensee breach does not cause Agenus to be in breach of its upstream obligations, then such termination of the sublicense by Licensee will cure the breach by Licensee. In the event the Sublicensee breach causes Agenus to be in breach of its upstream obligations, such termination will only cure the breach by Licensee if (i) the breach is capable of being cured and (ii) the termination also cures any corresponding breach by Agenus of its upstream obligations.

 

 

4.5
Technology Transfer. Agenus shall disclose and provide to Licensee all tangible embodiments of data and information concerning the Licensed Know-How and Regulatory Documentation (including without limitation all safety data for the Agenus Antibody) in its Control as of the Effective Date critical to, necessary or useful for Developing, Manufacturing, or Commercializing Licensed Products in the Territory, consistent with the Technology Transfer Plan attached as Exhibit C.
4.6
Competing Product. Agenus shall not, and shall ensure that its Affiliates do not, directly or indirectly, Develop, Manufacture, or Commercialize, or collaborate with, enable, or otherwise authorize, license, grant, or transfer any right to any Third Party to Develop, Manufacture, or Commercialize, any Additional Active or product directed to the Field in the Territory including an antibody targeting CTLA-4 or PD-1 and having the same indication as any Licensed Product, other than the Agenus Antibody and the Licensed Products in accordance with this Agreement (such other active ingredient or product, a “Competing Product”).
4.7
Licensor’s Covenant. Except as expressly permitted under this Agreement, during the Term, Licensor covenants and agrees on behalf of itself and its Affiliates not to practice the Agenus IP to Develop or Commercialize the Licensed Product in the Field in the Territory. In the event Licensor’s or its Affiliates’ or other sublicensees’ Development activities (including regulatory activities) of the Licensed Products outside the Territory or outside the Field initiated for the first time after the Effective Date would reasonably be expected to materially adversely impact Licensee’s Development or Commercialization of the Licensed Products in the Field in the Territory, to the extent Licensor has knowledge of such activities, Licensor will give Licensee reasonable advance notice of any such activities prior to undertaking such activities except to the extent it is prohibited from doing so under confidentiality obligations to Affiliates, sublicensees or other third parties. The Parties will discuss in good faith such activities and Licensor will consider in good faith the views of Licensee and suggestions to minimize the impact of such activities on Licensee’s Development or Commercialization of the Licensed Products in the Field in the Territory, provided, however, that Licensee will not have any obligation to take any measures to minimize the impact of such activities to the extent this would be contrary to its obligations under agreements or other business relationships with third parties

 

16


 

 

 

 

4.8
Licensee’s Covenant During the Royalty Term, Licensee will not Manufacture a Generic Product of any Licensed Product for sale outside the Field and/or Territory, and will not Commercialize a Generic Product outside the Field and/or Territory.

img64963062_4.jpg CLINICAL TRIALS

5.1
Plan As soon as is reasonably practicable, Licensee shall deliver a copy of its proposed written plan describing in reasonable detail the proposed program of its Clinical Trials of the Licensed Product(s) ( Clinical Trial Plan”) for Agenus’ review. The Clinical Trial Plan shall include a rolling forecast of the quantity of Agenus Antibody that Licensee expects to need (the “Forecast”) for Clinical Trials of the Licensed Product. The Forecast shall be divided into calendar quarters and shall include a delivery schedule for the first four (4) calendar quarters. Such Forecast shall become effective, along with the associated delivery schedule, following written approval by Agenus of the Forecast or update thereto. Agenus shall have a limited right to approve (or withhold approval for) each Clinical Trial Plan only in connection with (a) matters that present a reasonable risk of MAE to the Agenus Antibody or (b) matters that have a negative impact on Agenus’ ability to supply the Agenus Antibody set forth in the Forecast (collectively, Agenus’ “Limited Approval”). The initial Clinical Trial Plan shall be updated at least annually by Licensee and submitted to Agenus for review and Limited Approval not later than October 1 of each calendar year during the Term. Notwithstanding any of the above with regard to MAE and Forecast implications, Agenus’ Limited Approval rights shall not be unreasonably withheld or delay d
5.2
Responsibility Licensee shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approvals for t least one Licensed Product in the Field and in the Territory in accordance with the Clinical Trial Plan
5.3
Compliance In performing any Development activities for the Licensed Product each Party hereto shall comply, and shall ensure any Persons performing work on behalf of Licensee comply, with all Applicable Law, including GCP, the Health Insurance Portability and Accountability Act of 1996, Federal Food, Drug and Cosmetic Act, the

P blic Health Service Act, the Health Information Technology for Economic and Clinical Health Act, P.L. No. 111 005, Part I, Title XIII, Subpart D, 13401 through 13409 the Sunshine Act and federal anti kickback statute (42 U.S.C. 1320a 7(h)) and the related safe harbor regulations and the Limitation on Certain Physician Referrals, also referred to as the Stark Law (42 U.S.C. 1395 (nn)) and all applicable anti bribery laws, and in each case,

y US equivalent

5.4
Data Sharing The Parties will exchange information reasonably relevant for regulatory filings for the Licensed Product or otherwise relating to the safety or efficacy of Licensed Products through the coordination meetings described in Section 2.1 In addition, the Parties will provide each other regular written updates regarding Development and Commercialization activities of the License Products, together with copies of all relevant preclinical (but excluding the qualitative and quantitative details of formulations created under this Agreement) and clinical data (the “Results”) including as reasonably requested for Agenus to meet all applicable regulatory reporting requirements Licensee will maintain all Results in validated computer systems that are compliant with 21 C.F.R.

 

7


 

 

 

 

§11. All Results delivered to Agenus shall first be de identified for patient protected information (unless otherwise agreed by the Parties in writing) whether the Clinical Trial is conducted by Licensee, its Affiliate or a Third Party. In the event of a safety concern Licensee shall provide access to all other data related to the Clinical Trial in accordance with procedures set forth in Section 6.2, including case report forms, investigator reports, raw data and any analyses thereof relevant to any safety issues. Licensee shall ensure that any agreement it or its Affiliates enters into with any Third Party regarding the Licensed Product or its components shall include data sharing obligations for such Third Party necessary to permit Licensee to comply with the obligations set forth in this Section 5.4but subject to any confidential requirements of existing confidentiality agreements or, if required, the execution of new confidentiality agreements in order to share relevant data. In addition, Agenus will provide Licensee regular updates regarding monotherapy Development activities p formed solely by or on behalf of Agenus related to monotherapy development of the Agenus Antibody, together with copies of all relevant pre linical and clinical monotherapy data (the “Agenus Results ) The Parties may agree to share other such information based on mutual agreement. Agenus will maintain all Agenus Results in validated computer systems that are compliant with 21 C.F.R. §11. All Agenus Results delivered to Licensee shall first be de identified for patient protected information (unless otherwise agreed by the Parties in writing) whether the clinical trial is conducted by Agenus, its Affiliate or a Third Party. In the event of a safety concern, Agenus shall provide access to all other data related to the clinical trial in accordance with procedures set forth in Section 6.2, including case report forms, investigator reports, raw data and any analyses thereof relevant to any safety issues. The Parties agree that, from time to time, they will

reasonable effo ts to work with each other upon request to facilitate communications with those Third Parties, Sublicensees, or other entities that have the right to Develop, Manufacture or Commercialize the Agenus Antibody in their respective licensed products or in their respective fields and territories for the purpose of exchanging information that may be useful to all parties concerned

img64963062_5.jpg REGULATORY MATTERS

6.1
Responsibility Licensee shall be solely responsible for, at Licensee’s cost and expense, preparing, filing and maintaining, and shall own, the Regulatory Approvals and other regulatory filings for the Licensed Product in the Field and in the Territory Licensee shall keep the Agenus Manager inform d of scheduled meetings, teleconferences and other interactions with regulators relevant to the Licensed Product
6.2
Data Retention and Documentation Each Party, at its own costs, shall be responsible for archiving all relevant and required original documentation in its possession or ontrol related to the Clinical Trials and Manufacturing under this Agreement, including batch ecords raw data and results in relation to the use in Clinical Trials Manufacturing and control of each Agenus Antibody or Licensed Product. The Parties shall keep all original lab notebooks for the longer of ten (10) years or as required by Applicable Law and shall keep all such notebooks up to date in accordance with each Party’s standard practices.

 

8


 

 

 

 

6.3
Audits.
(a)
By Licensee. No more than once per twelve (12) month period or more frequently as reasonably required to address any quality issues, and upon not less than thirty (30) days’ prior written notice, Agenus will, and will use Commercially Reasonable Efforts to ensure that its Third Party manufacturers will, accommodate Licensee’s reasonable request to inspect the parts of the facilities where the Manufacture of the Agenus Antibody is carried out in order to assess compliance with cGMP, and audit the Agenus books and records directly related to the Manufacture of such Agenus Antibody. Such audits and inspections shall take place during normal business hours and not exceed two (2) Business Days. Such audits and inspections shall be conducted in a manner that minimizes interruption of Manufacturing activities. Persons inspecting or auditing the facilities, books or records shall be required to enter into separate confidentiality agreements, if not expressly covered by this Agreement and shall abide by the safety protocols and standard operating procedures of the audited facility while on site.
(b)
By Agenus. No more than once per twelve (12) month period or more frequently as reasonably required to address any quality issues, and upon not less than thirty (30) days’ prior written notice, Licensee will: (a) accommodate Agenus’ reasonable request to inspect the parts of the facilities where the Licensed Product is Manufactured and audit the Licensee books and records directly related to the Manufacture of the Licensed Product. Licensee will also permit Agenus, and shall require its Affiliates and Persons performing work on any Clinical Trials to permit Agenus, to inspect any study sites and to audit the books and records of such Persons to determine compliance with Section 5.3. Such audits and inspections shall take place during normal business hours and not exceed two (2) Business Days and shall be at Agenus’ sole cost and expense. Such audits and inspections shall be conducted in a manner that minimizes interruption of Licensee’s or the study site’s operations. Persons inspecting or auditing the facilities, books or records shall be required to enter into separate confidentiality agreements, if not expressly covered by this Agreement, and shall abide by the safety protocols and standard operating procedures of the audited facility while on site.
6.4
Inspections of Manufacturing Facilities by Regulatory Authorities.
(a)
Agenus Antibody Manufacturing. In connection with any audit by a Regulatory Authority relating to any Clinical Trial, Agneus will reasonably accommodate requests to, and will use Commercially Reasonable Efforts to ensure that it and any Third Party manufacturers will allow representatives of any Regulatory Authority to inspect the relevant parts of facilities where the Manufacture of the Agenus Antibody is carried out and to inspect batch records and related documentation to verify compliance with cGMP and Applicable Law, and will promptly notify Licensee of the scheduling of any such inspection directly relating to the Manufacture of Agenus Antibody being supplied under this Agreement for Clinical Trial purposes, as well as any deficiencies identified and remediation plans with respect thereto. Persons inspecting or auditing such facilities, books or records shall be required to enter into separate confidentiality agreements and to abide by the safety protocols and standard operating procedures of the audited facility while on site.

 

19


 

 

 

 

(b)
Licensed Product Manufacturing. In connection with any audit by a Regulatory Authority relating to the Clinical Trial or the Licensed Product, Licensee (or its Third Party manufacturer) will reasonably accommodate requests to allow representatives of any Regulatory Authority to inspect the relevant parts of facilities where the Manufacture of the Licensed Product is carried out and to inspect batch records and related documentation to verify compliance with cGMP and Applicable Law, and will promptly notify Agenus of any deficiencies identified and remediation plans with respect thereto. To the extent allowable under Applicable Law, Persons inspecting or auditing such facilities, books or records shall be required to enter into separate confidentiality agreements and to abide by the safety protocols and standard operating procedures of the audited facility while on site.
6.5
Adverse Events Reporting. Licensee shall be responsible for reporting all safety related events for the Licensed Product to appropriate Regulatory Authorities according to the Applicable Law and provide all necessary safety reporting information to ensure Agenus meets all applicable regulatory reporting obligations. Agenus shall be responsible for reporting all safety related events, including annual reporting obligations, for the Agenus Antibody to the appropriate Regulatory Authorities according to Applicable Law. Licensee and Agenus shall keep each other reasonably informed of any adverse reactions, or other material safety findings related to the Licensed Product or Agenus Antibody. The Parties shall coordinate adverse event reporting in accordance with a Safety Data Exchange Agreement to be entered into by the Parties after the Effective Date, as it may be amended by the Parties from time to time (“SDEA”).
6.6
Rights of Reference.
(a)
For Licensee. Agenus hereby grants, and will cause its Affiliates and Third Party licensees and sublicensees to grant, to Licensee and its Affiliates a “Right of Reference,” as that term is defined in 21 C.F.R. §314.3(b) (or any successor rule or analogous law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data included in the IND and Regulatory Approval for the Agenus Antibody controlled by Agenus solely as required for filing and approval of an IND for the Licensed Product, and Agenus will provide, and will cause its Affiliates and Third Party contractors, as applicable, to provide, a signed statement or letter of authorization to this effect, if requested by Licensee, in accordance with 21 C.F.R. §314.50(g)(3) (or any successor or analogous law outside of the United States). For purposes of clarity, Licensee may use and permit reference to such data as Licensee reasonably determines to be required by the applicable Regulatory Authority in respect of the Licensee Improvements.
(b)
For Agenus. Licensee hereby grants, and will cause its Affiliates and Third Party licensees and sublicensees to grant, to Agenus and its Affiliates a “Right of Reference,” as that term is defined in 21 C.F.R. §314.3(b) (or any successor rule or analogous law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data included in the IND, Regulatory Approval or other regulatory documentation for the Licensed Product, but excluding Licensee proprietary information which is formulation specific as developed in the Licensed Products, and Licensee will provide, and will cause its Affiliates and Third Party licensees and sublicensees to provide, a signed statement or letter of authorization to this effect, if requested by Agenus, in accordance with 21 C.F.R.

 

20


 

 

 

 

§314.50(g)(3) (or any successor or analogous law outside of the United States). For purposes of clarity, Agenus may use and permit reference to such data as Agenus reasonably determines to be required by the applicable Regulatory Authority in respect of the Agenus Antibody Agenus further agrees to discuss strategies and procedures regarding its own independent Commercialization activities with respect to the Agenus Antibody (but for clarity not the Development, Manufacture or Commercialization activities of Agenus partners sublicensees other Third Parties regardless of whether such Development, Manufacture or Commercialization activities are done in coordination with Agenus)

img64963062_6.jpg PROMOTION

7.1
Branding Licensee shall be responsible for filing new trademark application(s) in its own name for Commercialization of the Licensed Product in the Territory. Licensee shall provide all proposed product names and related trademarks for Licensed Product (“Product Trademarks”) to Agenus for review and discussion All uses of the Product Trademarks to identify and/or in connection with the Commercialization of Licensed Products shall be in accordance with applicable Regulatory Approvals and all Applicable Laws. Licensee shall ensure that Commercialization activities pursuant to this Agreement do not result in the infringement, dilution or other violation of any Third Party trademark or other proprietary rights, permissible under Applicable Law in the applicable jurisdiction and would not be deemed as immoral, scandalous, misleading and/or confusing to a reasonable consumer in such jurisdiction
7.2
Promotional Materials Licensee shall be responsible for the creation, preparation, production, reproduction and filing with the applicable Regulatory Authorities, of relevant written sales, promotion and advertising materials relating to Licensed Products ( Promotional Materials”) for use in the Field and in the Territory. All such Promotional Materials shall be compliant with Applicable Law. Upon reasonable request, Licensee shall periodically share representative Promotional Materials with Agenus
7.3
Sales and Distribution Licensee shall be solely responsible for handling all returns of Licensed Products as well as all aspects of Licensed Product order processing, invoicing and collection, distribution, inventory and receivables of Licensed Products sold.
7.4
Recalls, Market Withdrawals or Corrective Actions In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with a Licensed Product sold during the Term, or in the event Licensee or any of its Affiliates or Sublicensees determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal, Licensee shall advise Agenus thereof by telephone, facsimile or e mail as promptly as practicable, but in any event within twenty four (24) hours and prior to public disclosure of such recall, market withdrawal or corrective action conducted. Licensee, in consultation with Agenus, shall decide whether to conduct a recall, market withdrawal or similar action and the manner in which any such recall shall be conducted. Agenus shall make available all of its pertinent records that may be reasonably requested by Licensee in order to effect a recall. Licensee shall bear all costs and expenses that may be incurred in connection with any Licensed Product recall or withdrawal except to the extent the recall arises from the Agenus Antibody supplied pursuant to Section 3.1in accordance with the Supply Agreement, or any other breach by Agenus of its obligations under this Agreement

 

 


 

 

 

 

img64963062_7.jpg FINANCIAL TERMS

8.1
Running Royalties
(a)
General. As consideration for the licenses granted in Section 4 Licensee will pay to Agenus royalty equal to [***] on Net Sales of all Licensed Products in the Territory, subject to adjustment as set forth herein
(b)
Generic Entry. Notwithstanding the foregoing, (i) for Net Sales based on sales of a Licensed Product in a country in the Territory, any payments owed with respect to such Licensed Product pursuant to this Section 8.1 will be reduced by [***] for the remainder of the applicable Royalty Term, such reduction to be prorated appropriately for the then current calendar quarter, if at any time a Generic Product is available in such country in the Territory
(c)
Third Party Patents If the intellectual property rights from any Third Party cover the composition of matter of Agenus Antibody in a country in the Territory, then Licensee may, subject to the obligations set forth in this section, negotiate and obtain a license under, or otherwise pay amounts with respect to any litigation regarding, such Third Party’s intellectual property right(s) (each such Third Party license or payment referred to herein as an Additional Third Party License”). Licensee shall provide written notice to Agenus promptly

after receiving notice of the allegation from the Third Party of its claim that its intellectual property rights cover the composition of matter of an Agenus Antibody, and will keep Agenus updated on all correspondence and discussions between Licensee and the Third Party with respect to this subject. Licensee will also take advice from Agneus on how to respond to such Third Party claims before entering into a license with or otherwise paying any amounts to, such Third Party. If Licensee has complied with these notification and consultation obligations srt forth in this section with respect to such license or payment, any royalty otherwise payable to Agenus under this Agreement with respect to Net Sales of any Licensed Product by Licensee, its Affiliates or Sublicensees in such country will be reduced by the amounts payable to Third Parties pursuant to any Additional Third Party Licenses, such reduction to continue (and be carried forward for use) until all such amounts have been expended

 

8.2
Income Subject to Royalties The Royalties set forth in Section 8.1 shall be payable on Net Sales received by Licensee or its Affiliates on the Licensed Products, including Sublicense Income. The Royalties on Net Sales shall be payable on sales of Licensed Products within a given country until the later of (a) the expiration of the last Valid Claim of a Licensed Patent covering the sale of any Licensed Product in the country or (b) [***] following First Commercial Sale in the given country (“Royalty Term”) In the event only clause (b), but not clause (a), applies for given country, the royalty rates as set forth in Section 8.3shall be reduced for sales of Licensed Products in such country by [***].

 

22


 

 

 

 

 

8.3
Payment Terms and Royalty Statements.
(a)
Payment Statements. Starting on the date of First Commercial Sale of a Licensed Product or earlier receipt of Sublicense Income by Licensee, its Affiliates or Sublicensees, during the Royalty Term, Licensee shall furnish to Agenus a quarterly written report for each calendar quarter no later than thirty (30) days following completion of each calendar quarter showing all payments due to Agenus pursuant to Section 8.18.2 (“Payment Statement”) for the relevant Quarterly Period including:
(i)
the gross amount invoiced by Licensee or any of its Affiliates to any Third Party for the sale to such Third Party of Licensed Products;
(ii)
the calculation of Net Sales, including the applicable Royalty rate and the type and amount of all deductions and offsets allocated with respect to such Net Sales;
(iii)
the calculation of Sublicense Income payments;
(iv)
if applicable, the exchange rate, used for calculating any Royalties and the Sublicense Income; and
(v)
such other particulars as are reasonably necessary for an accurate accounting of the payments due pursuant to this Agreement.
(b)
Invoicing.
(i)
Agenus shall invoice Licensee for all Royalties and any other sums payable under this Agreement within thirty (30) days following the delivery of each Payment Statement for the applicable calendar quarter.
(ii)
Licensee shall pay each undisputed invoice within thirty (30) days after receipt. Any overdue payments to Agenus by Licensee on undisputed invoices under this Agreement will accrue interest on a daily basis at a rate of one percent (1%) per month, compounded monthly (or the maximum legal interest rate allowed by Applicable Law, if less) from and after such date and Licensee shall be responsible for reasonable legal fees and expenses incurred by Agenus in connection with the collection thereof.
(c)
Currency. Licensee or its Affiliates shall make all payments in US dollars by wire transfer of immediately available funds to a bank account to be designated in writing by Agenus. For the purpose of converting the local currency in which any Royalties arise into US dollars, the rate of exchange to be applied (“Exchange Rate”) shall be the simple average of daily Bloomberg FX Fixing rate for each calendar quarter as published on Bloomberg page BFIX.
8.4
Audit Rights. For a period of three (3) years following each calendar year, Licensee will keep, and will cause its Affiliates and sublicensees to keep, full, true and accurate books and records limited to all particulars relevant to the calculation of Net of Licensed Products and Sublicense Income payments (including the relevant statements obtained from its Affiliates and Sublicensees) in sufficient detail to enable Agenus to verify the amounts payable to it or by it under this Agreement.

 

23


 

Sales

 

24


 

 

 

 

 

Agenus will have the right, not more than once during any calendar year and at its own expense, to have the books and records of Licensee and its Affiliates audited by an independent certified public accounting firm reasonably acceptable to both Parties. Audits under this Section 8.4 will be conducted at the principal place of business of the financial personnel with responsibility for preparing and maintaining such records, during normal business hours, upon at least thirty (30) calendar days prior written notice, and for the sole purpose of verifying amounts payable by or to Agenus under this Agreement. Agenus will cause its accounting firm to enter into a reasonably acceptable confidentiality agreement with the audited Person(s) If the audit demonstrates that the Licensee has not paid all royalties owing to Agenus hereunder, Licensee will pay any such underpayment to Agenus promptly and in any event within ten

(10) Business Days of receiving a valid invoice from Agenus. Further, if the amount at issue is greater than ten percent ( 0%) of the amount owed to Agenus with respect to the audited period, then Licensee will reimburse Agenus for the reasonable out f pocket cost of the audit.

8.5
Taxes All payments due to Agenus from Licensee pursuant to this Agreement will be paid without any deduction for any VAT, that Licensee or its Affiliates or sublicensees may be required to pay to any tax authorities. In case of withholding taxes on income, mandated by applicable law, Agenus will use reasonable efforts to assist Licensee to minimize and obtain all available exemptions from such VAT, withholding other taxes. Subject to such documentation being provided by Agenus, Licensee shall pay the amounts due under this Agreement without such VAT, withholding or other taxes In all other cases, Licensee shall deduct such withholding taxes and will promptly provide to Agenus applicable receipts evidencing payment of such VAT, withholding or other taxes and other documentation reasonably requested by Agenus.

img64963062_8.jpg INTELLECTUAL PROPERTY

9.1
Ownership of Program Technology Agenus shall own any and all Inventions made solely, as between the Parties, by employees, officers, contractors, consultants or agents (“Representatives”) of Agenus ( Agenus Improvements”), and any Patent Rights therein (“Agenus Improvement Patent Rights ) The Parties shall jointly own the Intellectual Property Rights in the Territory for any Inventions made by Representatives of Agenus in conjunction with Representatives of Licensee ( Joint Improvements ), and any Patent Rights therein (“Joint Improvement Patent Rights ), and Agenus shall own the Intellectual Property Rights to such invention outside the Territory Licensee shall own any and all Inventions made solely, as between the parties, by Representatives of Licensee

( Licensee Improvements”), and any Patent Rights therein (“Licensee Improvement Patent Rights”). All Agenus Improvement Patent Rights and Joint Improvement Patent Rights that are necessary or reasonably useful for the Development, Manufacture or Commercialization of the Licensed Product (the “Licensed Improvement Patent Rights”) shall be included in

 

25


 

 

 

 

the Licensed Patent Rights licensed to Licensee hereunder.

9.2
Ownership Disputes. The Parties will attempt in good faith to resolve any disputes regarding ownership of Inventions, and all Patent Rights and any other intellectual property rights therein. In the event the Parties are unable to resolve such dispute through escalation to Senior Executives of the Party, such dispute will be resolved pursuant to Section 14.1.
9.3
Prosecution, Enforcement and Defense of Patent Rights.
(a)
Agenus shall have the first right, at its discretion, to Prosecute, enforce and defend throughout the world any Agenus Improvement Patent Rights. In any Territory where Agenus chooses not to Prosecute, enforce or defend Agenus Improvement Patent Rights, Licensee shall have the right, subject to the terms and conditions of this Agreement and any retained rights of Agenus’ upstream licensors, LICR and MSKCC, under the LICR Agreement, to cause Agenus to Prosecute, enforce or defend such Agenus Improvement Patent Rights, provided that (i) such Prosecution, enforcement or defense would not in Agenus’ reasonable determination adversely affect Agenus’ Patent Rights strategy and (ii) Licensee shall reimburse Agenus for all reasonable out of pocket expenses incurred in connection with such Prosecution, enforcement or defense, provided that Licensee may then offset such reimbursed expenses against payments otherwise owed to Agenus under this Agreement. Licensee in its sole discretion may provide notice that it no longer wishes to reimburse such Prosecution, enforcement or defense expenses and Agenus may either cease to incur additional expenses in connection with such Prosecution, enforcement or defense or shall continue at Agenus’ own expense.
(b)
Licensee shall have the first right, at its discretion, to Prosecute throughout the world any Joint Improvement Patent Rights, provided that if Agenus reasonably determines in good faith that Prosecution of any Joint Improvement Patent Rights as proposed by Licensee would reasonably be expected to materially and adversely impact the Agenus IP, then Agenus shall have the right to cause Licensee to Prosecute or abandon such Joint Improvement Patent Rights in accordance with Agenus’ Patent Rights strategy. In any jurisdiction where Licensee chooses not to Prosecute Agenus Improvement Patent Rights, Agenus shall have the right, subject to the terms and conditions of this Agreement, to cause Licensee to Prosecute such Joint Improvement Patent Rights, provided that Agenus shall reimburse Licensee for all reasonable out of pocket expenses incurred in connection with such Prosecution. Agenus in its sole discretion may provide notice that it no longer wishes to reimburse such Prosecution expenses and Licensee shall either cease to incur additional expenses in connection with such Prosecution or shall continue at Licensee’s own expense. The Parties shall work together to agree upon the strategy to enforce and/or defend any Joint Improvement Patent Rights. Approval of both Parties in writing shall be required prior to the enforcement and/or defense of any Joint Improvement Patent Rights.
(c)
Licensee shall have the sole right, at its discretion, to Prosecute, enforce and defend throughout the world any Licensee Improvement Patent Rights.

 

26


 

 

 

 

(d)
With respect to Licensed Improvement Patent Rights, the Party responsible for Prosecution shall consult with and keep the other Party fully informed of material issues relating to the Prosecution of such Patent Rights, and shall furnish to the other Party copies of documents relevant to such Prosecution in sufficient time prior to the filing of such document to allow for review and comment by the other Party and, to the extent possible in the reasonable exercise of its discretion, the Party responsible for Prosecution shall incorporate all of such comments.
(e)
Notwithstanding anything in this Agreement to the contrary, Agenus shall use Commercially Reasonable Efforts to pursue and maintain Licensed Patent Rights in the Territory. In the event that Agenus elects not to or is unable to enforce (e.g., due to insolvency, bankruptcy, liquidation, or similar proceeding or circumstance) Licensed Patent Rights in the Territory, Licensee shall have the right, at its discretion, to Prosecute, enforce and defend any Licensed Patent Rights in the Territory.
9.4
Cooperation. Each Party hereby agrees to provide to the other Party all reasonable assistance and cooperation reasonably necessary to enable such other Party to undertake Prosecution, enforcement and defense of Patent Rights as contemplated by this Agreement, including: (a) to cause its employees, and to use reasonable efforts to cause its licensees, sublicensees, independent contractors, agents and consultants, to be reasonably available to the other Party (or to the other Party’s authorized attorneys, agents or representatives); (b) to endeavor in good faith to coordinate its efforts with the other Party to minimize or avoid interference with the Prosecution, enforcement and defense of the other Party’s Patent Rights that are subject to this Agreement; (c) to provide any necessary powers of attorney and executing any other required documents or instruments required to give effect to the terms of this Agreement; and (d) to cause its employees, and to use reasonable efforts to cause its licensees, sublicensees, independent contractors, agents and consultants, to provide any and all information required for the other Party to comply with its relevant duties of disclosure as required by Applicable Law in the United States or any other jurisdiction.
9.5
Challenges to Licensed Patent Rights. Neither Licensee nor any of its Affiliates or Sublicensees shall institute or actively participate as an adverse party in, or otherwise provide material support to, any legal action or administrative proceeding in the Territory to invalidate or limit the scope of any Licensed Patent Right claim or obtain a ruling that any Licensed Patent Right claim is unenforceable or not patentable or that any Licensed Product does not infringe one or more claims of any Licensed Patent Right (“Licensed Patent Right Challenge”) until the expiration of eighty (80) Business Days after Licensee serves on Agenus written notice of Licensee’s or any Licensee Affiliate’s or Sublicensee’s intention to bring or participate in a Licensed Patent Right Challenge. Licensee shall also provide to Agenus a complete written disclosure of each and every basis then known to Licensee or any Licensee Affiliate or Sublicensee for the Licensed Patent Right Challenge and shall provide Agenus with a copy of any document or publication that Licensee or any Licensee Affiliate or Sublicensee may use in connection with the Licensed Patent Rdight Challenge. Licensee’s failure to comply with this provision will constitute a material breach of this Agreement. If a claim of a Licensed Patent Right is adjudged to be not invalid by a governmental authority of competent jurisdiction, the Royalty rates and Sublicense Income payments due Agenus under this Agreement will be doubled with respect to Net Sales of Licensed Products occurring and sublicenses executed on or after the initiation of the Licensed Patent Right Challenge.

 

27


 

 

 

 

 

img64963062_9.jpg CONFIDENTIALITY

10.1
Confidential Information
(a)
Obligations In connection with the performance of their respective obligations under this Agreement, each Party (the Disclosing Party ) may, itself or through its Affiliates or designees, disclose certain Confidential Information to the other Party (the Recipient ) or its Affiliates or designees. During the Term and for a period of ten (10) years thereafter, except as provided herein, the Recipient shall maintain all Confidential Information of the Disclosing Party in strict confidence and shall not use such Confidential Information for any purpose, except that the Recipient may disclose or permit the disclosure of any such Confidential Information to its Affiliates and sublicensees, or its or their respective directors, officers, employees, consultants, advisors and agents, on a need t know basis, who in each case are obligated to maintain the confidential nature of such Confidential Information on terms no less stringent than those of this Article 10. In addition, the Recipient may use or disclose Confidential Information of the Disclosing Party in exercising the Recipient s rights hereunder to fulfill its obligations and/or duties hereunder; provided that such disclosure is made to a Person who is obligated to confidentiality and non use obligations no less rigorous than those of this Article 10
(b)
Exceptions The obligations of confidentiality and non use set forth above shall not apply to the extent that the Recipient can demonstrate that the relevant Confidential Information of the Disclosing Party: (i) was publicly known prior to the time of its disclosure nder this Agreement; (ii) became publicly known after the time of its disclosure under this Agreement other than through acts or omissions of the Recipient, its Affiliates or sublicensees in violation of this Agreement; (iii) is or was disclosed to the Recipient or any of its Affiliates by a Third Party having no obligation of confidentiality with respect to such Confidential Information; (iv) is independently developed by the Recipient or any of its Affiliates without access to such Confidential Information as evidenced by written records; or (v) was known by Recipient or any of its Affiliates at the time of receipt from Disclosing Party or any of its Affiliates as documented by Recipient s or any of its Affiliate s records.
(c)
Mandatory Disclosures In addition, the Recipient or any of its Affiliates may disclose Confidential Information of the Disclosing Party to the extent necessary to comply with Applicable Law or a court or administrative order; provided that the Recipient provides to the Disclosing Party prior written notice of such disclosure, to the extent reasonably possible, and that the Recipient takes all reasonable and lawful actions to obtain confidential treatment for such disclosure and, to the extent possible, to minimize the extent of such disclosure.
(d)
Permitted Disclosures In addition, a Party may disclose (and, in connection therewith, use) Confidential Information of the other Party, if such disclosure:

 

28


 

 

 

 

(i)
subject to the provisions of Section 10.2(a), is made to Regulatory Authorities solely to the extent necessary to gain or maintain approval (A) to conduct Clinical Trials of the Licensed Product in accordance with the terms and conditions of this Agreement,

(B) by Agenus (with such disclosure right only applicable to Agenus) to Manufacture or Commercialize the Agenus Antibody or (C) by Licensee (with such disclosure right only applicable to Licensee), to Develop, Manufacture or Commercialize the Licensed Product as provided hereunder;

(ii)
is made to its Affiliates, sublicensees, agents, consultants, or other Third Parties (including service providers) in connection with a bona fide transaction for an assignment of this Agreement, a licensing transaction related to the Agenus Antibody or Licensed Product under this Agreement, a loan, financing or investment, or an acquisition, merger, consolidation or similar transaction (or for such Persons to determine their interest in performing such activities or entering into such transactions), in each case on the condition that any Third Parties to whom such disclosures are made agree to be bound by confidentiality and non-use obligations no less rigorous than those contained in this Agreement; or
(iii)
consists entirely of Confidential Information previously approved by the Disclosing Party for disclosure by the Recipient.
(e)
Responsibility. Each Recipient shall be responsible for any breach of the obligations of this Section 10.1 by any Person to whom such Recipient or its Affiliate disclosed the Disclosing Party’s Confidential Information.
10.2
Publicity; Terms of this Agreement.
(a)
Publicity. Except as required by judicial order or Applicable Law, or as set forth below, neither Party may make any public announcement or other public disclosure or issue any press release referring to this Agreement, the transactions contemplated hereby or a Licensed Product, or relating to any Inventions or Patent Rights therein that are owned or co- owned by the other Party and that constitute Confidential Information, without the prior approval of the other Party. The Party preparing any such public announcement shall provide the other Party with a draft thereof at least three (3) Business Days prior to the date on which such Party would like to make the public announcement. The contents of any previously approved disclosure shall not require subsequent approval provided that the duplicated language is substantially unmodified and is presented in its original context. Notwithstanding the foregoing, either Party may use the other Party’s name to make factual public statements as to the existence of this Agreement and the relationship between the Parties. Except as expressly set forth herein, neither Party may use the name or trademark of the other Party or its employees in any press release, advertising or promotional materials without the prior express written permission of the other Party.
(b)
Regulatory Reporting. Notwithstanding the terms of this Article 10, either Party will be permitted to disclose the existence and terms of this Agreement to the extent required or advisable, based on the advice of such Party’s legal counsel, to comply with Applicable Law, including the rules and regulations promulgated by the US Securities and Exchange Commission (“SEC”) or any other governmental authority or similar Regulatory Authority in a country other than the United States or of any stock exchange or listing entity).

 

29


 

 

 

 

Notwithstanding the foregoing, before disclosing this Agreement or any of the terms hereof pursuant to this Section 10.2(a), to the extent practicable given the circumstances of the disclosure, the Parties will consult with each other on the terms of this Agreement for which confidential treatment will be sought in making any such disclosure.

10.3
Publications. Licensee shall have the right to make disclosures pertaining to the Licensed Product in Publications in accordance with the following procedure: Licensee shall provide Agenus with an advance copy of the proposed Publication, and Agenus shall then have thirty (30) business days prior to submission of any Publication in which to recommend any changes it reasonably believes are necessary to preserve any Patent Rights or Know-How belonging in whole or in part to Agenus. If Agenus informs Licensee that such Publication, in the non-publishing Party’s reasonable judgment, could be expected to have a material adverse effect on any patentable invention owned by or licensed, in whole or in part, to Agenus, or on any Know-How which is Confidential Information of Agenus, Licensee shall delay or prevent such Publication as follows: (i) with respect to an Invention, such Publication shall be delayed sufficiently long (not to exceed an additional sixty (60) days) to permit the timely preparation and filing of a patent application; and (ii) with respect to Know-How which is Confidential Information of Agenus, such Know-How shall be deleted from the Publication.
10.4
Return of Confidential Information.
(a)
Return. Upon the expiration or termination of this Agreement, upon request, the Recipient will return to the Disclosing Party or destroy all Confidential Information, materials (including the Agenus Antibody) and embodiments of Know-How received by the Recipient or any of its Affiliates from the Disclosing Party or any of its Affiliates (and all copies and reproductions thereof). In addition, the Recipient and its Affiliates will destroy: (a) any notes, reports or other documents prepared by the Recipient which contain Confidential Information of the Disclosing Party; and (b) any Confidential Information of the Disclosing Party (and all copies and reproductions thereof) which is in electronic form or cannot otherwise be returned to the Disclosing Party.
(b)
Destruction. Nothing in this Section 10.4 will require the alteration, modification, deletion or destruction of archival tapes or other electronic back-up media made in the ordinary course of business; provided that the Recipient and its Affiliates will continue to be bound by its obligations of confidentiality and other obligations under this Article 10 with respect to any of the Disclosing Party’s Confidential Information contained in such archival tapes or other electronic back-up media. Any requested destruction of the Disclosing Party’s Confidential Information will be certified in writing to the Disclosing Party by an authorized officer of the Recipient supervising such destruction.
(c)
Retained Copy. Notwithstanding the foregoing, (i) the Recipient and its Affiliates may retain one copy of the Disclosing Party’s Confidential Information solely for the purpose of determining the Recipient’s continuing obligations under this Article 10 and (ii) the Recipient and its Affiliates may retain the Disclosing Party’s Confidential Information and its own notes, reports and other documents to the extent reasonably required (x) to exercise the rights of the Recipient expressly surviving expiration or termination of this Agreement; (y) to perform the obligations of the Recipient expressly surviving expiration or termination of this Agreement; or (z) for regulatory or archival purposes.

 

30


 

 

 

Notwithstanding the return or destruction of the Disclosing Party s Confidential Information, the Recipient shall continue to be bound by its obligations of confidentiality and other obligations under this Article 10

img64963062_10.jpg TERM AND TERMINATION

11.1
Term The term of this Agreement (the Term ) shall commence on the Effective Date and unless terminated in accordance with Section 11.2 shall continue in full force and effect for each Licensed Product and country in the Territory on a Licensed Product by Licensed Product and country by country basis.
11.2
Termination
(a)
For Material Breach Either Party may, without prejudice to any other remedies available to it in law or equity, terminate this Agreement in the event that the other Party has materially breached a provision under this Agreement. The breaching Party will have sixty (60) days after written notice thereof was provided to the breaching Party by the non breaching Party to remedy such default. Any such termination will become effective at the end of such sixty (60) day period unless the breaching Party has cured any such breach or default prior to the expiration of such sixty (60) day period or the parties have agreed otherwise
(b)
For Insolvency of Licensee Agenus shall have the right to terminate this Agreement upon the insolvency bankruptcy, liquidation of Licensee
(c)
For Insolvency of Agenus. Licensee shall have the right to terminate this Agreement upon the insolvency bankruptcy, liquidation of Agenus.

 

11.3
Consequences of Termination In the event that this Agreement is terminated pursuant to Section 11.2 the following provisions shall apply
(a)
Supply Agenus shall have no further obligation to supply to Licensee, its Affiliates or their respective Sublicensee and Subcontractors with Agenus Antibody
(b)
Rights of Reference The right of reference under Section 6.6(a) shall terminate automatically and the right of reference under Section 6.6(b) shall survive indefinitely.
(c)
License Termination Within thirty (30) days after termination or expiration of this Agreement, Licensee shall:
(i)
Submit a Payment Statement to Agenus, and any payments due Agenus will become immediately payable with submission of the final Payment Statement;
(ii)
Immediately cease all activities concerning, including all practice and use of, the Licensed Patent Rights and Licensed Know How, except as expressly permitted under Section 11.3(e) and Return to Agenus all documents and tangible materials (and any copies) containing, reflecting, incorporating, or based on Agenus’ Confidential Information; permanently erase such Confidential Information from its computer systems; and certify in writing to Agenus that it has complied with the requirements of this Section 11.3(c)

 

31


 

 

 

 

(iii)
(d)
Sublicenses. Upon any termination of this Agreement, any sublicense that was in effect immediately prior to such termination, and such Sublicensees’ rights under such sublicenses, will survive termination, with Agenus as the Sublicensee’s direct licensor; provided that such Sublicensee: (i) is not the cause of a breach that resulted in the termination of this Agreement and is not itself in breach of obligations under its sublicense or this Agreement other than such obligations as neither affect nor relate to Agenus, the Licensed Patent Rights, or the Licensed Know How; and (ii) within sixty (60) days after termination of this Agreement provides written notice to Agenus of its election to continue its sublicense as a direct license from Agenus and of its agreement to assume all obligations (including obligations for payment) contained in its sublicense agreement as direct obligations of the Sublicensee to Agenus. Any sublicense granted by Licensee must contain provisions corresponding to those of this sectio regarding termination and the conditions of the continuation of any sublicense.
(e)
Inventory If termination occurs at any time after Regulatory Approval of the Licensed Product, then for a period of three hundred sixty (360) days after the effective date of the expiration or earlier termination of this Agreement (other than termination by Agenus pursuant to Section 11.2(a)) (the “Sell Off Period”), Licensee will have the right to sell or otherwise dispose of all existing Licensed Products in its possession and to complete the manufacture of and sell all Licensed Products in the course of manufacture as of the effective date of such expiration or termination. Licensee shall ensure that all sales of Licensed Products during the Sell Off Period are in accordance with the applicable terms and conditions of this Agreement, except that Royalty would be payable on such sales under Article 8
11.4
Survival in All Cases Termination of this Agreement will be without prejudice to or limitation on any other remedies available to nor any accrued obligations of either Party. In addition, Sections 6.6(b), Sections 8.3(b) 8.5 Article 9 Article 10, Sections

11.3 11.4, Sections 12.4 12.5 Article 13 and Sections 14.1 14.4 14.7 and 14.10, together with related definitions, will survive any expiration or termination of this Agreement.

img64963062_11.jpg REPRESENTATIONS AND WARRANTIES

12.1
Mutual Representations and Warranties In addition to the representations and warranties set forth elsewhere in this Agreement, each Party represents, warrants, and covenants to the other Party that:
(a)
it is duly incorporated or organized, validly existing and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver and perform this Agreement;
(b)
the execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action and shall not violate (i) such Party s organizational documents, (ii) any agreement, instrument or contractual obligation to which such Party is a party or by which it is bound, (iii) any requirement of any Applicable Law, or (iv) any order, writ, judgment, injunction, decree, determination or award of any court or governmental agency presently in effect applicable to such Party;

 

 


 

 

(c)
this Agreement is a legal, valid and binding obligation of such Party enforceable against it in accordance with its terms and conditions, except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium or other laws relating to or affecting creditors’ rights generally and by general equitable principles; and
(d)
neither Party, nor any of such Party’s employees, officers, independent contractors, consultants or agents who will render services relating to a Licensed Product: (i) has ever been debarred or is subject to debarment or received notice from FDA of an intent to debar or has been convicted of a crime for which an entity or person could be debarred under 21 U.S.C. Section 335a; or (ii) has ever been under indictment for a crime for which a person or entity could be debarred under said Section 335a. If during the Term a Party has reason to believe that it or any of its employees, officers, independent contractors, consultants or agents rendering services relating to a Licensed Product: (x) is or will be debarred or convicted of a crime for which a person or entity could be debarred under 21 U.S.C. Section 335a; or (y) is or will be under indictment for a crime for which a person or entity could be debarred under Section 335a, then such Party shall immediately notify the other Party of same in writing; and
(e)
as of the Effective Date, it is not currently bound by any agreement with any Third Party, or by any outstanding order, judgment, or decree of any court or administrative agency that restricts it from granting to such other Party the rights set forth in this Agreement.
12.2
Additional Representations of Agenus. Agenus represents and warrants and covenants to Licensee that, as of the Effective Date:
(a)
Agenus has not granted to any Third Party, and to Agenus’ knowledge MSKCC and LICR have not granted to any Third Party, any licenses or other rights under the Licensed Patent Rights and Licensed Know-How that are in conflict with the terms and conditions of this Agreement.
(b)
The use of the Agenus Antibody in Agenus’ business as currently

conducted does not infringe the intellectual property rights of any Third Party.

(c)
Ownership; Sufficiency. Agenus holds the right to grant Licensee the exclusive license granted pursuant to Section 4.1(a) under the Licensed Patent Rights and has good title to all Licensed Patent Rights, jointly with LICR and MSKCC, free and clear of any mortgage, pledge, security interest, lien or any other similar encumbrance in the Field in the Territory. Assignments of all Licensed Patent Rights have been properly executed and recorded. The Licensed Patent Rights includes all Patent Rights owned, licensed or controlled by Agenus and its Affiliates that relate to or are useful for the Development, Manufacturing or Commercialization of the Licensed Product. The Patent Rights listed on Exhibit A are subject to the inter-institutional agreement between MSKCC and LICR having an effective date of January 1, 2013.

 

32


 

 

All issued Licensed Patent Rights are valid and enforceable. Agenus has no knowledge of any circumstances that may negate the validity or enforceability of any issued Licensed Patent Rights. All issuance, renewal, maintenance and other payments that are or have become due with respect thereto have been timely paid by or on behalf of Agenus. Provided that Licensee is in compliance with this Agreement, no third party will have any rights to frustrate, suspend or terminate the license granted pursuant to Section 4.1(a) of this Agreement.

(d)
Protection Measures. Agenus has taken reasonable measures to protect the proprietary nature of the Licensed Know-How, and to maintain in confidence all trade secrets and information comprising a part thereof. To the knowledge of Agenus, there has been no: (i) unauthorized disclosure of any third party proprietary information in the possession, custody or control of Agenus, or (ii) breach of Agenus’ security procedures wherein information relating to the Agenus Antibody has been disclosed without authorization to a third person.
(e)
Non-infringement of Third Party Rights. There has been no complaint, claim or notice, or, to the knowledge of Agenus, threat of any of the foregoing (including any notification that a license under any patent is or may be required) in connection with the Agenus Antibody, received by Agenus alleging any infringement, violation or misappropriation of any Patents or Know-How rights of any Third Party, and there has been no request or demand for indemnification or defense received by Agenus from any reseller, distributor, customer, user or any other third party in connection with the Agenus Antibody.
(f)
Infringement of Agenus’ Rights. To the knowledge of Agenus, no third party (including, without limitation, any current or former employee, founder, inventor of any of the Licensed Patent Rights, or consultant to Agenus) is infringing, violating or misappropriating any of the Licensed Patent Rights or Licensed Know-How and no third party has any right to Commercialize the Licensed Patent Rights and Licensed Know-How in the Field in the Territory or to conduct human clinical trials of any Licensed Product without the prior written consent of Agenus, its Affiliates or sublicensees, as applicable.
(g)
Employee and Inventor Assignments. Each employee of Agenus and its Affiliates, and any Agenus inventor of the Licensed Patent Rights has executed a valid and binding written agreement expressly assigning to Agenus, or an Affiliate thereof, as appropriate, all right, title and interest in any inventions and works of authorship, whether or not patentable, invented, created, developed, conceived and/or reduced to practice during the term of such employee’s employment and all Patents and Know-How rights therein. An inventorship determination was performed with regard to the existing Licensed Patent Rights and to Agenus’ knowledge, the inventorship is correct.
(h)
Support and Funding. Agenus has neither sought, applied for nor received any support, funding, resources or assistance from any federal, state, local or foreign governmental or quasi-governmental agency or funding source in connection with the Development, Manufacture or Commercialization of the Agenus Antibody. To the knowledge of Agenus, MSKCC and LICR have neither sought, applied for nor received any support, funding, resources or assistance from any federal, state, local or foreign governmental or quasi- governmental agency or funding source in connection with the Development, Manufacture or Commercialization of the Agenus Antibody.

 

33


 

 

 

 

(i)
Agenus acknowledges that (i) the representations it is making in this Article 12 to Licensee are material to Licensee’s decision to execute this Agreement; and (ii) Licensee is relying upon these representations to its detriment. In the event that a court of competent jurisdiction determines in a final and non-appealable decision that Agenus breached or otherwise violated these representations, Agenus shall be obligated to indemnify and hold harmless Licensee pursuant to Section 13.2 to the extent of any Losses arising from such breach or violation, along with any other damage amounts arising out of or relating to such breach or violation.
(j)
Insider Trading. Agenus acknowledges that the Licensee is a publicly traded listed entity in India and in terms of Securities and Exchange Board of India (Prohibition of Insider Trading) Regulations, 2015, as detailed at https://www.sebi.gov.in (the “SEBI Regulations”) any trading in securities of a publicly traded listed entity is subject to the approval of Securities and Exchange Board of India. Any trading by Agenus, its Affiliates, while in possession of any unpublished price sensitive information of the Licensee or any of its Affiliates (being a publicly listed entity) (“Zydus’ UPSI”), in the securities thereof or disclosure of Zydus’ UPSI to any third person, is prohibited under SEBI Regulations. Agenus shall communicate to all its Affiliates having knowledge of Zydus’ UPSI that they are required to refrain from trading in securities of the Licensee while in possession of Zydus’ UPSI and are required to refrain from disclosing the same to any third party. Agenus further undertakes to inform the Licensee as soon as Agenus becomes aware of any contravention or probable contravention of SEBI Regulations by any of its Affiliate and to extend full cooperation to the Licensee in connection with any inquiry or proceedings in respect of the same.

 

12.3
Additional Representations of Licensee. Licensee represents, warrants and covenants to Agenus that:
(a)
It shall not, and shall ensure that its Affiliates and Sublicensees shall not, engage in any Development, Manufacturing, or Commercialization activities relating to the Licensed Products or the Agenus Antibody outside of the Territory or outside of the Field, except as may be conducted under the CMA.
(b)
It has not received any notice or threat of any claim, suit, action, or proceeding, and has no knowledge or reason to know of any information, that could: (a) invalidate or render unenforceable any claim of any Licensed Patent Right; (b) prove that the Licensed Products are not covered by any claim of any Licensed Patent Right; or (c) cause any claim of any Licensed Patent Right to fail to issue or be materially limited or restricted as compared with its currently pending scope.
(c)
Neither Licensee nor its Affiliates, nor any Person working on any Clinical Trial on behalf of Licensee or its Affiliates, has been disqualified or has received notice of disqualification from receiving investigational drugs or test articles pursuant to 21 C.F.R. §§

312.70 or 812.119, 21 C.F.R. §§ 56.120, 56.121 or 21 C.F.R. Part 58, or sanctioned by a Federal Health Care Program (as defined in 42 U.S.C. Sec. 1320 a-7b(f)), including, but not limited to the federal Medicare or a state Medicaid program, or suspended, excluded, sanctioned or otherwise declared ineligible from any federal agency or program, or has any reason to believe such disqualification, suspension, exclusion, sanction or ineligibility procedures could be instituted.

 

34


 

 

 

 

 

Licensee shall ensure all Persons working on any Clinical Trial will disclose such information pertaining to such disqualification, suspension, exclusion, sanction or ineligibility to Licensee. In the event that during the Term, any such Person (i) becomes so disqualified, suspended, excluded, sanctioned or ineligible, or (ii) receives notice of an action or threat of an action with respect to such disqualification suspension, exclusion, sanction or ineligibility, Licensee shall notify Agenus immediately of the same.

12.4
DISCLAIMER OF WARRANTIES EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT EACH PARTY DISCLAIMS ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR THAT ANY AGENUS ANTIBODY OR LICENSED PRODUCT ARE FREE FROM THE RIGHTFUL CLAIM OF ANY THIRD PARTY, BY WAY OF INFRINGEMENT OR OTHERWISE AGENUS CANNOT, AND DOES NOT, GUARANTEE THAT ANY AGENUS ANTIBODY WILL BE SUCCESSFULLY DEVELOPED OR COMMERCIALIZED, AND NEITHER PARTY CAN, NOR DOES EITHER PARTY, GUARANTEE THAT ANY LICENSED PRODUCT WILL BE SUCCESSFULLY DEVELOPED, MANUFACTURED, OR COMMERCIALIZED
12.5
EXCLUSION OF CONSEQUENTIAL AND INDIRECT DAMAGES EXCLUDING ANY INDEMNITY OBLIGATIONS SET FORTH IN Article 13 AND EXCEPT FOR LOSSES DUE TO A PARTY’S GROSS NEGLIGENCE, WILLFUL MISCONDUCT, OR FRAUD TO THE FULLEST EXTENT PERMITTED BY LAW, NEITHER PARTY WILL BE LIABLE TO THE OTHER OR ANY OTHER PERSON FOR ANY INJURY TO OR LOSS OF GOODWILL, REPUTATION, BUSINESS PRODUCTION, REVENUES, PROFITS, ANTICIPATED PROFITS, CONTRACTS OR OPPORTUNITIES (REGARDLESS OF HOW THESE ARE CLASSIFIED AS DAMAGES), OR FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, EXEMPLARY, SPECIAL, OR ENHANCED DAMAGES WHETHER ARISING OUT OF BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, PRODUCT LIABILITY OR OTHERWISE (INCLUDING THE ENTRY INTO, PERFORMANCE OR BREACH OF THIS AGREEMENT), REGARDLESS OF WHETHER SUCH LOSS OR DAMAGE WAS FORESEEABLE OR THE PARTY AGAINST WHOM SUCH LIABILITY IS CLAIMED HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGE, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.

img64963062_12.jpg INDEMNIFICATION

13.1
By Licensee Licensee agrees, at Licensee’s cost and expense, to defend, indemnify and hold harmless Agenus and its Affiliates, sublicensees, and their respective directors, officers, employees, licensors and agents, and its and their respective successors, heirs and assigns (the Agenus Indemnified Parties ) from and against any and all losses, liabilities, costs, damages, fees or expenses (including reasonable legal fees, expert fees and expenses of litigation) ( Losses ) arising out of any claims, demands, suits, actions, or judgments by any Third Party ( Claims ) to the extent resulting from (a) any acts or omissions of Licensee or a Licensee Indemnified Party in connection with Licensee’s performance of its obligations or exercise of its rights under this Agreement, including without limitation any use, sale, transfer, or other disposition by Licensee or any of its Affiliates or Sublicensees or any of the foregoing Persons’ respective transferees of Licensed Products or any other products made by use of Licensed Patent Rights or Licensed Know-How; (b) any material breach by Licensee of any representation, warranty, covenant or obligation set forth in this Agreement; or (c) failure to comply with Applicable Laws; in each case, except to the extent such Claims result from a cause for which Agenus is obligated to indemnify Licensee under Section 13.2.

 

35


 

 

 

 

 

13.2
By Agenus. Agenus agrees, at Agenus’ cost and expense, to defend, indemnify and hold harmless Licensee and its Affiliates, and their respective directors, officers, employees and agents, and its and their respective successors, heirs and assigns (the “Licensee Indemnified Parties”) from and against any and all Losses arising out of any Claims to the extent resulting from (a) any acts or omissions of Agenus or a Agenus Indemnified Party in connection with Agenus’ Development, Manufacture or Commercialization of the Licensee Improvement Patent Rights; (b) any material breach by Agenus of any representation, warranty, covenant or obligation set forth in this Agreement; or (c) failure to comply with Applicable Laws; in each case, except to the extent such Claims result from a cause for which Licensee is obligated to indemnify Agenus under Section 13.1.
13.3
Process. In the event of any such Claim against any of the Agenus Indemnified Parties or Licensee Indemnified Parties (each, an “Indemnified Party”) by any Third Party, the Indemnified Party will promptly notify the indemnifying Party in writing of the Claim; provided, however, that the failure of an Indemnified Party to give such notice shall not diminish the indemnification obligation of the indemnifying Party under this Article 13 except to the extent that the indemnifying Party’s ability to defend against the same is materially prejudiced thereby. The indemnifying Party shall assume direction and control of the defense, litigation, settlement, appeal or other disposition of such Claim with counsel selected by the indemnifying Party and reasonably acceptable to the Indemnified Party. The Indemnified Party will cooperate with the indemnifying Party and may, at its option and expense, be separately represented in any such action or proceeding; provided, however, that the Indemnified Party’s legal fees and expenses shall be indemnifiable Losses if the interest of the Indemnified Party and those of the indemnifying Party with respect to such Claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under Applicable Law or ethical rules. The indemnifying Party shall not be responsible for indemnification of any Claims compromised or settled without its prior written consent. Notwithstanding the foregoing, the indemnifying Party will not settle a Third Party Claim without the prior written consent of the Indemnified Party, if such settlement would impose any monetary obligation on the Indemnified party or require the Indemnified Party to submit to an injunction or other equitable relief or if such settlement admits the fault of the Indemnified Party. Notwithstanding anything to the contrary above, in the event of any such Claim against an Indemnified Party by a governmental authority asserting criminal liability or seeking an injunction or similar against the Indemnified Party, the Indemnified Party will have the right to control the defense, litigation, settlement, appeal or other disposition of the Claim at the indemnifying Party s expense.

 

36


 

 

 

 

 

13.4
Insurance Clinical trial insurance shall be maintained by each Party for the duration of any Clinical Trial and for at least five (5) years thereafter. No later than the First Commercial Sale of a Licensed Product, each Party shall, at its sole cost and expense, obtain, pay for, and maintain in full force and effect commercial general liability insurance in commercially reasonable and appropriate amounts that (a) provides product liability coverage concerning the Licensed Products and contractual liability coverage for the other Party’s defense and indemnification obligations under this Agreement, and (b) in any event, provide commercial general liability limits at levels that the Parties mutually agree upon as appropriate upon commercialization of the Licensed Product. To the extent any insurance coverage required under this Section 13.4 is purchased on a “claims made” basis, such insurance must cover all prior acts of Licensee during the Term, and be continuously maintained for a period of time that the Parties mutually agree upon as appropriate upon commercialization of the Licensed Product Each Party shall have the other Party named in each policy as an additional insured. Upon request by a Party the other Party shall provide such Party with certificates of insurance or other reasonable written evidence of all coverages described in this Section 13.4. Additionally, each Party shall provide the other Party with written notice at least thirty (30) days prior to such Party cancelling, not renewing, or materially changing the insurance. Where permitted by Applicable Law, the insurance policies described in this Section 13.4 above shall contain waiver of the insurer’s subrogation rights against the non insured Party.

img64963062_13.jpg MISCELLANEOUS

14.1
Governing Law; Arbitration
(a)
This Agreement including the dispute resolution and arbitration clause contained herein including this clause shall be governed by and construed in accordance with the the laws of England and Wales
(b)
Any and all disputes or differences between Licensor and Licensee arising out of or in connection with this Agreement (including any document or agreement executed between Licensor and Licensee pursuant to or in connection with this Agreement) or their

pective performance, including the validity, breach or termination thereof (“Dispute”), shall first be raised by Licensor and Licensee ( Disputing Party”) by notice in writing and as far as it is possible, be settled amicably through good faith negotiations between Licensor and Licensee.

(c)
If, after thirty (30) days of a Dispute being raised by Disputing Party by notice in writing, Licensor and Licensee have not reached an amicable settlement, such Dispute may be submitted to arbitration by Disputing Party that initiated the Dispute upon written notice to that effect.
(d)
Arbitration: If a Dispute is referred to arbitration in accordance with subsection (c) then the Dispute shall be submitted to the rules of London Court of International Arbitration for the time being in force ( Rules ), which rules are deemed to be incorporated by reference in this clause and by way of a final and binding arbitral award issued by one arbitrator appointed in accordance with the said Rules.

 

37


 

 

 

 

The seat of the arbitration shall be London and the language of the arbitration shall be English. The decision of such arbitrator shall be written, reasoned, final, binding and conclusive on the Parties, and judgment thereon may be entered in any court having jurisdiction over the Parties and the subject matter hereof.

(e)
All legal and arbitration fees, costs and expenses shall be paid by the losing party. If it becomes necessary for a party to enforce an arbitral award by legal action of any kind, the defaulting party shall pay all legal costs and expenses and attorney’s fees, including any costs of additional litigation or arbitration that shall be incurred by the party seeking to enforce the award.
14.2
Assignment. Neither Party may assign its rights and obligations under this Agreement without the prior written consent of the other Party, except that either Party may make such assignment without the prior written consent of the other Party (i) to an Affiliate (so long as such Party will remain jointly and severally liable with such Affiliate with respect to all obligations so assigned) or (ii) in connection with a Change in Control or in connection with the sale of all or substantially all of the assets to which this Agreement relates. No assignment will release either Party from responsibility for the performance of any accrued obligation of such Party hereunder. This Agreement will be binding upon and enforceable against the successor to or any permitted assignee from either of the Parties.
14.3
Entire Agreement; Amendments. This Agreement and the Exhibits referred to in this Agreement, together with the Supply Agreement and the SDEA, constitute the entire agreement between the Parties with respect to the subject matter hereof, and supersede all previous arrangements with respect to the subject matter hereof, whether written or oral.
14.4
Notices. All communications, notices, instructions and consents provided for herein or in connection herewith will be made in writing and be sent to the address below and will be (a) given in person, (b) sent by registered or certified mail, return receipt requested, postage prepaid, or (c) sent by a reputable overnight courier service or (d) if such notice(s) is sent through e-mail then, when sent, subject to the production by the sender’s successful transmission e-mail sent report. Any such communication, notice, instruction or consent will be deemed to have been delivered: (i) on receipt if given in person; (ii) three (3) Business Days after it is sent by registered or certified airmail, return receipt requested, postage prepaid within the same country as the recipient’s address or five (5) Business Days after it is sent by registered or certified airmail, return receipt requested, postage prepaid from another country; or (iii) one (1) Business Day after it is sent via a reputable overnight courier service.

Notices to Licensee will be addressed to: Address: Zydus Lifesciences

Ltd.

Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr.

 

38


 

 

 

 

Vaishnodevi Circle, Sarkhej-Gandhinagar Highway, Ahmedabad-382481,

Gujarat, India Attention: Mr. Alok Garg Email:[***]

Copy to: Mr. Mukund Thakkar

Email: [***]

Notices to Agenus will be addressed to:

Agenus Inc.

3 Forbes Road

Lexington, Massachusetts 02421-7305 Attention: Vice President Business Development Copy to: General Counsel

provided, however, that if either Party will have designated a different address by notice to the other Party in accordance with this Section 14.4, then to the last address so designated.

14.5
Force Majeure. No failure or omission by either Party in the performance of any obligation of this Agreement will be deemed a breach of this Agreement or create any liability to the extent the same arises from an event, act, occurrence, condition or state of facts, in each case outside the reasonable control of such Party (which may include acts of God, acts of any government, any rules, regulations or orders issued by any governmental authority or by any officer, department, agency or instrumentality thereof, fire, storm, flood, earthquake, accident, war, rebellion, insurrection, riot, terrorism and invasion, strike, labor disturbance, inability to obtain raw materials, acts or omissions of a Third Party); provided that (a) the Party affected by such cause (each a “Force Majeure event”) promptly notifies the other Party and uses diligent efforts to cure such failure or omission as soon as is practicable after the occurrence of such Force Majeure event and (b) any timeline associated with performance of obligations hereunder shall automatically be extended by a duration equal to the delay directly caused by the applicable Force Majeure event.
14.6
Independent Contractors. It is understood and agreed that the relationship between the Parties is that of independent contractors and that nothing in this Agreement will be construed to create a joint venture or any relationship of employment, agency or partnership between the Parties to this Agreement. Neither Party is authorized to make any representations, commitments or statements of any kind on behalf of the other Party or to take any action that would bind the other Party. Furthermore, none of the transactions contemplated by this Agreement will be construed as a partnership for any tax purposes.
14.7
No Implied Waivers; Rights Cumulative.

 

39


 

 

 

 

No failure on the part of a Party to exercise, and no delay by either Party in exercising, any right, power, remedy or privilege under this Agreement, or provided by statute or at law or in equity or otherwise, will impair, prejudice or constitute a waiver of any such right, power, remedy or privilege by such Party or be construed as a waiver of any breach of this Agreement or as an acquiescence therein by such Party, nor will any single or partial exercise of any such right, power, remedy or privilege by a Party preclude any other or further exercise thereof or the exercise of any other right, power, remedy or privilege.

14.8
Severability. If, under Applicable Law, any provision of this Agreement is invalid or unenforceable, or otherwise directly or indirectly affects the validity of any other material provision(s) of this Agreement, this Agreement will endure except for such invalid or unenforceable provision. The Parties will consult one another and use good faith efforts to agree upon a valid and enforceable provision that is a reasonable substitute in view of the intent of this Agreement.
14.9
Execution in Counterparts. This Agreement may be executed in any number of counterparts, each of which will be deemed an original, and all of which together will constitute one and the same instrument. Signatures provided by facsimile transmission or in Adobe™ Portable Document Format (.pdf) sent by electronic mail will be deemed to be original signatures.
14.10
No Third Party Beneficiaries. No Person other than Licensee and Agenus (and their respective successors and permitted assignees) and LICR, to the extent expressly set forth herein, will be deemed an intended beneficiary hereunder or have any right to enforce any obligation of this Agreement.
14.11
Performance by Affiliates. Agenus may exercise its rights and perform its obligations through one or more of its Affiliates in accordance with the intercompany agreements between them and otherwise in Agenus’ reasonable discretion provided the Affiliates have the appropriate skill and experience to perform said obligation, provided that Agenus will remain liable hereunder for the prompt performance of all such obligations hereunder.
14.12
Conflicting Provisions. In the event of inconsistencies between this Agreement and any exhibit hereto, the terms of this Agreement will control. In the event of inconsistencies between this Agreement, the Supply Agreement and the SDEA, the following principles shall determine which conflicting provisions among the agreements shall control:
(a)
The Supply Agreement shall control with respect to the supply of the Agenux Antibody;
(b)
the SDEA shall control with respect to the management of activities for adverse events, serious adverse events, complaints, recalls and market withdrawals; and
(c)
this Agreement shall control with respect to all other matters.
14.13
Construction.

 

40


 

 

 

 

In construing this Agreement, unless expressly specified otherwise: (a) references to Articles, Sections, Schedule and Exhibits are to articles and sections of, and exhibits to, this Agreement; (b) except where the context otherwise requires, use of either gender includes any other gender, and use of the singular includes the plural and vice versa; (c) headings and titles are for convenience only and do not affect the interpretation of this Agreement; (d) any list or examples following the word “including” will be interpreted without limitation to the generality of the preceding words; (e) references to a law include any amendment or modification to such law and any rules or regulations issued thereunder, and (f) all references to “Dollars” or “$” herein will mean US Dollars.

14.14
Representation by Legal Counsel. Each Party represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption will apply against the Party which drafted such terms and provisions.

 

 

[signature page follows]

 

41


 

 

 

IN WITNESS WHEREOF, the Parties have signed this License Agreement as of the date last signed below.

 

 

AGENUS INC:

ZYDUS LIFESCIENCES LTD:

 

 

Name: /s/ Garo Armen

Name: /s/ Mukund A. Thakkar

Title: CEO of Agenus, Inc.

Title: Sr. Vice President - Legal

Date: 6/2/2025

Date: 6/2/2025

 

 

 

Name: /s/ Dhaval Soni

 

Title: Company Secretary

 

Date: 6/2/2025

 

 

 

 


 

 

 

 

 

Exhibit A

LICENSED PATENT RIGHTS

 

 

[***]

 


 

 

Exhibit B

ASIA PACIFIC (APAC) COUNTRIES INCLUDED IN TERRITORY

India Sri Lanka

 


 

Exhibit C

Technology Transfer Plan

 

 

[To be agreed]

 


EX-10.3 4 agen-ex10_3.htm EX-10.3 EX-10.3

Exhibit 10.3

Certain portions of this exhibit (indicated by “[***]”) have been omitted in compliance with Regulation S-K Item 601(b)(10)(iv) as the Company determined the omitted information (i) is not material and (ii) is the type that the Company customarily and actually treats as private or confidential.

 

AGENUS INC.

SECURITIES PURCHASE AGREEMENT

This Securities Purchase Agreement (this “Agreement”) is made and entered into as of June 3, 2025, by and among Agenus Inc., a Delaware corporation (the “Company”), and Zynext Ventures USA LLC (“Purchaser”).

RECITALS

WHEREAS, the Company desires to issue and sell to Purchaser, and Purchaser desires to purchase from the Company, 2,133,333 shares of the common stock, par value $0.01 per share, of the Company (the “Common Stock”), on the terms and conditions set forth in this Agreement;

WHEREAS, the Company and Purchaser are executing and delivering this Agreement in reliance upon the exemption from securities registration under the Securities Act of 1933, as amended (the “Securities Act”).

NOW, THEREFORE, in consideration of the foregoing, the mutual promises hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

1.
AGREEMENT TO PURCHASE AND SELL STOCK.
(a)
Authorization. The Company’s Board of Directors (the “Board”) has authorized the issuance and sale, pursuant to the terms and conditions of this Agreement, of the Purchased Shares.
(b)
Agreement to Purchase and Sell Securities. Subject to the terms and conditions of this Agreement, Purchaser agrees to purchase, and the Company agrees to sell and issue to Purchaser, at the Closing (as defined below), the Purchased Shares for the aggregate purchase price of $15,999,997.50, which represents a price per Purchased Share of $7.50.
(c)
Use of Proceeds. The Company intends to apply the net proceeds from the sale of the Purchased Shares for working capital and general corporate purposes, including to advance the development, registration and commercialization of its product candidates.
2.
CLOSING. The purchase and sale of the Purchased Shares shall take place via remote exchange of documents simultaneously with the closing of the Asset Purchase (as defined below) or at such other time and place as the Company and Purchaser mutually agree upon (which time and place are referred to in this Agreement as the “Closing”).

 


 

At the Closing, the Company shall, against delivery of payment for the Purchased Shares by wire transfer of immediately available funds in accordance with the Company’s instructions set forth in Exhibit A attached hereto, authorize its transfer agent to issue to Purchaser (or its nominee in accordance with Purchaser’s delivery instructions) in global form through a book-entry account maintained by the Company’s transfer agent, a number of shares of Common Stock representing the number of Purchased Shares, and bearing the legend set forth in Section 4(l) herein. The date of the Closing is referred to herein as the Closing Date.
3.
REPRESENTATIONS AND WARRANTIES OF THE COMPANY. Except as set forth in the SEC Documents (as defined below) (other than as to the Fundamental Representations, which are not so qualified), the Company hereby makes the following representations and warranties to Purchaser, as of the date hereof (except for the representations and warranties that speak as of a specific date, which shall be made as of such date). “Fundamental Representations” means the representations and warranties made by the Company in Sections 3(a) (Organization Good Standing and Qualification), 3(b) (Capitalization), 3(c) (Due Authorization), 3(d) (Valid Issuance of Shares), 3(e) (Governmental Consents), 3(f) (Non-Contravention), 3(l) (SEC Documents), 3(y) (Price Stabilization of Common Stock), 3(aa) (General Solicitation); 3(bb) (No Integrated Offering), 3(dd) (Nasdaq Listing Matters), 3(ee) (Brokers and Finders), 3(ff) (No Disqualification Events), 3(kk) (Investment Company), and 3(ll) (Reliance by the Purchaser).
(a)
Organization Good Standing and Qualification. The Company is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware and has all corporate power and authority required to (i) carry on its business as presently conducted and (ii) enter into this Agreement and the other agreements, instruments and documents contemplated hereby, and to consummate the transactions contemplated hereby and thereby. The Company is qualified to do business and is in good standing in each jurisdiction in which the failure to so qualify would have a Material Adverse Effect. Each of the Company’s subsidiaries has been duly incorporated or organized and is validly existing, has full corporate or other power and authority necessary to conduct its business as presently conducted, and is qualified to do business and is in good standing in all jurisdictions in which the failure to be in good standing or be so authorized or qualified would have a Material Adverse Effect. As used in this Agreement, “Material Adverse Effect” means a material adverse effect on, or a material adverse change in, or a group of such effects on or changes in, the business, operations, financial condition, results of operations, assets or liabilities of the Company and its subsidiaries, taken as a whole.
(b)
Capitalization. The capitalization of the Company, prior to the issuance of the Purchased Shares, is as follows:
(i)
The authorized capital stock of the Company consists of 800,000,000 shares of Common Stock, par value $0.01 per share, and 5,000,000 shares of preferred stock, par value $0.01 per share (the “Preferred Stock”).
(ii)
As of May 14, 2025, the issued and outstanding capital stock of the Company consisted of (A) 27,851,868 shares of Common Stock (other than as described to the Purchaser) and (B) 31,620 shares of Preferred Stock. The shares of issued and outstanding capital stock of the Company have been duly authorized and validly issued, are fully paid and nonassessable and have not been issued in violation of or are not otherwise subject to any preemptive or other similar rights.

-2-

 


 

(iii)
As of May 14, 2025, the Company had (1) 5,211,870 shares of Common Stock issuable upon exercise of outstanding options and (2) 1,032,052 shares of Common Stock issuable upon exercise of outstanding warrants.
(iv)
As of May 14, 2025, the Company’s outstanding 31,620 shares of Preferred Stock were convertible into 16,666 shares of Common Stock.
(v)
As of May 14, 2025, the Company had 12,984 shares of Common Stock reserved for issuance under its equity incentive plans.

With the exception of the foregoing in this Section 3(b), as of May 14, 2025, there were no outstanding subscriptions, options, warrants, convertible or exchangeable securities or other rights granted to or by the Company to purchase shares of Common Stock or other securities of the Company, and there were no commitments, plans or arrangements to issue any shares of Common Stock (other than as described to the Purchaser) or any security convertible into or exchangeable for Common Stock.

(c)
Due Authorization. All corporate actions on the part of the Company necessary for the authorization, execution, delivery of, and the performance of all obligations of the Company under this Agreement and the authorization, issuance, reservation for issuance and delivery of all of the Purchased Shares being sold under this Agreement have been taken, no further consent or authorization of the Company or the Board or its stockholders is required, and this Agreement constitutes a valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except (i) as may be limited by (1) applicable bankruptcy, insolvency, reorganization or others laws of general application relating to or affecting the enforcement of creditors’ rights generally and (2) the effect of rules of law governing the availability of equitable remedies and (ii) as rights to indemnity or contribution may be limited under federal or state securities laws or by principles of public policy thereunder.
(d)
Valid Issuance of Purchased Shares.
(i)
Purchased Shares. The Purchased Shares will be, upon payment therefor by Purchaser in accordance with this Agreement, duly authorized, validly issued, fully paid and non-assessable, and free from all taxes, liens and charges with respect to the issue thereof.
(ii)
Compliance with Securities Laws. Subject to the accuracy of the representations made by Purchaser in Section 4 hereof, the Purchased Shares (assuming no change in applicable law and no unlawful distribution of the Purchased Shares by Purchaser or other parties) will be issued to Purchaser in compliance with applicable exemptions from (A) the registration and prospectus delivery requirements of the Securities Act and (B) the registration and qualification requirements of all applicable securities laws of the states of the United States.
(e)
Governmental Consents.

-3-

 


 

No consent, approval, order or authorization of, or registration, qualification, designation, declaration or filing with, or notice to, any federal, state or local governmental authority or self regulatory agency on the part of the Company is required in connection with the issuance of the Purchased Shares to Purchaser, or the consummation of the other transactions contemplated by this Agreement, except (i) such filings as have been made prior to the date hereof, (ii) such filings as may be required by the Nasdaq Capital Market (“Nasdaq”) and (iii) such additional post-Closing filings as may be required to comply with applicable state and federal securities laws and the listing requirements of Nasdaq.
(f)
Non-Contravention. Assuming the accuracy of the representations and warranties made by Purchaser in Section 4 hereof, the execution, delivery and performance of this Agreement by the Company, and the consummation by the Company of the transactions contemplated hereby (including issuance of the Purchased Shares), do not (i) contravene or conflict with the Certificate of Incorporation (the “Certificate of Incorporation”) or Bylaws (the “Bylaws”) of the Company; (ii) constitute a violation of any provision of any federal, state, local or foreign law, rule, regulation, order or decree applicable to the Company; or (iii) constitute a default (with or without notice or lapse of time or both) or require any consent under, give rise to any right of termination, cancellation or acceleration of, or to a loss of any material benefit to which the Company is entitled under, or result in the creation or imposition of any lien, claim or encumbrance on any assets of the Company under, any material contract to which the Company is a party or any material permit, license or similar right relating to the Company or by which the Company may be bound or affected, except in the case of clauses (ii) and (iii), for such violations, breaches or defaults as would not be reasonably likely to have a Material Adverse Effect.
(g)
Litigation. There is no action, suit, proceeding, claim, arbitration or investigation (“Action”) pending or, to the Company’s knowledge, threatened in writing: (i) against the Company, its activities, properties or assets, or any officer, director or employee of the Company in connection with such officer’s, director’s or employee’s relationship with, or actions taken on behalf of, the Company, that is reasonably likely to have a Material Adverse Effect on the Company (except as set forth on Schedule 3(g)), or (ii) that seeks to prevent, enjoin, alter, challenge or delay the transactions contemplated by this Agreement (including the issuance of the Purchased Shares). The Company is not a party to or subject to the provisions of, any order, writ, injunction, judgment or decree of any court or government agency or instrumentality that is reasonably likely to have a Material Adverse Effect. Neither the Company nor any subsidiary, nor to the knowledge of the Company, any director or officer of the Company or any subsidiary, is, or within the last ten years has been, the subject of any action involving a claim of violation of or liability under federal or state securities laws relating to the Company or such subsidiary or a claim of breach of fiduciary duty relating to the Company or such subsidiary.
(h)
Compliance with Law; Permits. The Company has complied and is currently in compliance with all applicable statutes, laws, rules, regulations and orders of the United States of America and all states thereof, foreign countries and other governmental bodies and agencies having jurisdiction over the Company’s business or properties, except for any instance of non-compliance that has not had, and would not reasonably be expected to have, a Material Adverse Effect. The Company has all required licenses, permits, certificates and other authorizations (collectively, “Governmental Authorizations”) from such federal, state or local government or governmental agency, department or body that are currently necessary for the operation of the business of the Company as currently conducted, except where the failure to possess currently such Governmental Authorizations has not had and is not reasonably expected to have a Material Adverse Effect.

-4-

 


 

The Company has not received any written notice regarding any revocation or material modification of any such Governmental Authorization, which, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, has had or would reasonably be expected to result in a Material Adverse Effect.
(i)
Compliance with Health Care Laws. The Company and its subsidiaries are in compliance in all material respects with all Health Care Laws to the extent applicable to the Company’s current business and research use only products. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)); (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) the European Union (“EU”) Clinical Trials Regulation (Regulation (EU) No. 536/2014); (vi) the EU Regulation regarding community procedures for authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Regulation (EC) No. 726/2004); (vii) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (viii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, and (ix) the regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has received written or, to the Company’s knowledge, oral notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries nor any of their respective employees, officers, directors, or, to the knowledge of the Company, agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, suspension, or exclusion.
(j)
Compliance with Regulatory Requirements.

-5-

 


 

Any preclinical tests and studies or clinical trials conducted by, on behalf of, or sponsored by the Company or any of its subsidiaries in the past three (3) years (“Studies”), were and, if still pending, are being conducted in all material respects in accordance with all applicable laws and regulations and protocols governing the conduct of such Studies, the protocols, procedures and controls submitted to the FDA or any foreign governmental body exercising comparable authority (together with the FDA, the “Regulatory Authorities”), and any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical tests and studies and clinical trials. The descriptions of the Studies contained in the SEC Documents are accurate in all material respects; to the knowledge of the Company, there are no other preclinical studies and clinical trials, the results of which are inconsistent with or would call into question the results described in the SEC Documents in any material respect; and neither the Company nor any of its subsidiaries has received any written notice or correspondence from the FDA or any other Regulatory Authority or institutional review board exercising comparable authority requiring or threatening the termination, suspension, or clinical hold of Studies, where such termination, suspension or clinical hold would reasonably be expected to have a Material Adverse Effect. Neither the Company nor its officers, employees or, to the knowledge of the Company, any agents involved in development of any new data included in the Company’s regulatory filings (for clarity, not including any third-party data or publications relied upon the Company, its officers, employees or agents) has been convicted of (or investigated for) any crime or engaged in conduct reasonably expected to result in exclusion under 42 U.S.C. Section 1302a-7 or any similar state law or regulation. To the knowledge of the Company, none of Company’s contract manufacturers responsible for the manufacture of any product candidate of the Company, or any of their respective officers, employees or agents (in their performance of such services for the Company) has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable law.
(k)
SEC Documents.
(i)
Reports. Since January 1, 2022, the Company has filed in a timely manner all reports, schedules, forms, statements and other documents required to be filed by it with the United States Securities and Exchange Commission (the “SEC”) pursuant to the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the rules and regulations promulgated thereunder. The Company has filed on the SEC’s EDGAR system, prior to the date hereof, its Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “Form 10-K”), its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 (the “Form 10-Q”) its Proxy Statement for its Annual Meeting of Stockholders to be held on June 17, 2025 (the “Proxy Statement”), and any Current Report on Form 8-K (“Form 8-Ks”) required to be filed by the Company with the SEC for events occurring since December 31, 2024 and prior to the date of this Agreement (the Form 10-K, Form 10-Q, Proxy Statement and Form 8-Ks, together with all exhibits, schedules and other attachments that are filed with such documents, are collectively referred to herein as the “SEC Documents”). Each SEC Document, as of its date (or, if amended or superseded by a filing prior to the Closing Date, then on the date of such filing), did not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements made therein, in light of the circumstances under which they were made, not misleading. Each SEC Document, as it may have been subsequently amended by filings made by the Company with the SEC prior to the date hereof, complied in all material respects with the requirements of the Exchange Act and the rules and regulations of the SEC promulgated thereunder applicable to such SEC Document.

-6-

 


 

(ii)
Sarbanes-Oxley. The Chief Executive Officer and the Principal Financial Officer of the Company have signed, and the Company has furnished to the SEC, all certifications required by Sections 302 and 906 of the Sarbanes-Oxley Act of 2002. Such certifications contain no exceptions to the matters certified therein and have not been modified or withdrawn; and neither the Company nor any of its officers has received notice from any governmental entity questioning or challenging the accuracy of such certifications. The Company is otherwise in compliance with all applicable effective provisions of the Sarbanes-Oxley Act of 2002 and the rules and regulations issued thereunder by the SEC, except where such non-compliance would not be reasonably likely to have a Material Adverse Effect.
(iii)
Financial Statements. The financial statements of the Company in the SEC Documents present fairly, in accordance with United States generally accepted accounting principles (“GAAP”), the financial position of the Company as of the dates indicated, and the results of its operations and cash flows for the periods therein specified, subject, in the case of unaudited financial statements for interim periods, to normal year-end audit adjustments and abbreviated footnote disclosure.
(l)
Absence of Certain Changes. Since December 31, 2024, the business and operations of the Company have been conducted in the ordinary course consistent with past practice, and there has not been:
(i)
any declaration, setting aside or payment of any dividend or other distribution of the assets of the Company with respect to any shares of capital stock of the Company or any repurchase, redemption or other acquisition by the Company or any subsidiary of the Company of any outstanding shares of the Company’s capital stock dividends;
(ii)
any damage, destruction or loss, whether or not covered by insurance, except for such occurrences, individually and collectively, that have not had, and would not reasonably be expected to have, a Material Adverse Effect;
(iii)
any waiver by the Company of a valuable right or of a material debt owed to it, except for such waivers, individually and collectively, that have not had, and would not reasonably be expected to have, a Material Adverse Effect;
(iv)
any material change or amendment to, or any waiver of any material right under a material contract or arrangement by which the Company or any of its assets or properties is bound or subject;
(v)
any change by the Company in its accounting principles, methods or practices or in the manner in which it keeps its accounting books and records, except any such change required by a change in GAAP or by the SEC; or
(vi)
any other event or condition of any character, except for such events and conditions that have not resulted, and are not expected to result, either individually or collectively, in a Material Adverse Effect.

-7-

 


 

(m)
Intellectual Property.
(i)
To its knowledge, the Company solely and exclusively owns or has obtained valid and enforceable licenses for, free and clear of all liens or encumbrances, all patents, patent rights, inventions, trade secrets, know-how, trademarks, service marks, trade names, copyrights or other intellectual property (collectively, “Intellectual Property”) necessary for its business as now conducted and currently proposed to be conducted in the future as described in the SEC Documents, and, to the knowledge of the Company, the conduct of its current and proposed business does not infringe or misappropriate, in any material respect, any Intellectual Property of any third party. The Company has not received any written communications (in each case that has not been resolved) of any alleged infringement or misappropriation or breach of any Intellectual Property rights of others.
(ii)
There are no orders, settlement agreements or stipulations to which the Company is a party or by which the Company is bound that restricts the Company’s rights to use any Intellectual Property in the operation of the business as currently conducted.
(iii)
There is no pending or, to the Company’s knowledge, threatened in writing action, suit, proceeding or claim by others: (A) challenging the Company’s rights in or to any Intellectual Property necessary for its business as now conducted and currently proposed to be conducted in the future as described in the SEC Documents, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim; or (B) challenging the validity, enforceability or scope of any Intellectual Property necessary for its business as now conducted and currently proposed to be conducted in the future as described in the SEC Documents, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim.
(iv)
The Company has materially complied with the terms of each agreement pursuant to which Intellectual Property has been licensed to the Company as described in the SEC Documents; all such agreements are in full force and effect, and to the Company’s knowledge, there is no material default by any other party thereto.
(v)
The Company has taken reasonable and customary actions to protect its rights in, and to prevent the unauthorized use and disclosure of, material trade secrets and confidential business information (including confidential ideas, research and development information, know-how, formulas, compositions, technical data, designs, drawings, specifications, research records, records of inventions, test information, financial, marketing and business data, supplier lists and information, and business plans) owned by the Company, and, to the knowledge of the Company, there has been no unauthorized use or disclosure of such material trade secrets and confidential business information.
(n)
Registration Rights. The Company is not subject to any agreement providing any individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein (each, a “Person”) any rights (including piggyback registration rights) to have any securities of the Company included in the Registration Statement (as defined in Section 5(a)(i)).

-8-

 


 

(o)
Title to Property and Assets. The properties and assets of the Company are owned by the Company free and clear of all mortgages, deeds of trust, liens, charges, encumbrances and security interests except for (i) statutory liens for the payment of current taxes that are not yet delinquent and (ii) liens, encumbrances and security interests that arise in the ordinary course of business and do not materially detract from the value of the properties and assets of the Company. With respect to the property and assets it leases, the Company is in compliance with such leases in all material respects.
(p)
Taxes. The Company has filed or has valid extensions of the time to file all necessary federal, state, and foreign income and franchise tax returns due prior to the date hereof and has paid or accrued all taxes shown as due thereon, and the Company has no knowledge of any material tax deficiency which has been asserted against it. No assessment in connection with United States federal tax returns has been made against the Company. The charges, accruals and reserves on the books of the Company in respect of any income and corporation tax liability for any years not finally determined are adequate to meet any assessments or reassessments for additional income tax for any years not finally determined, except to the extent of any inadequacy that would not result in a Material Adverse Effect. No audits, examinations, or other proceedings with respect to any material amounts of taxes of the Company and its subsidiaries are presently in progress or have been asserted or proposed in writing without subsequently being paid, settled or withdrawn. There are no liens on any of the assets of the Company. At all times since inception, the Company has been and continues to be classified as a corporation for U.S. federal income tax purposes. Neither the Company nor any of its subsidiaries has been a United States real property holding corporation within the meaning of Code Section 897(c)-2 during the period specified in Code Section 897(c)(1)(A)(ii).
(q)
Environmental Laws. The Company and its subsidiaries (i) are in compliance with any and all applicable foreign, federal, state and local laws and regulations relating to the protection of human health and safety, the environment or hazardous or toxic substances or wastes, pollutants or contaminants (“Environmental Laws”), (ii) have received all permits and other Governmental Authorizations required under applicable Environmental Laws to conduct their business and (iii) are in compliance with all terms and conditions of any such permit, license or approval, except where such noncompliance with Environmental Laws, failure to receive required permits, licenses or other approvals or failure to comply with the terms and conditions of such permits, licenses or approvals would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. None of the Company nor any of its subsidiaries has received since January 1, 2024, any written notice or other communication (in writing or otherwise), whether from a governmental authority or any other Person, that alleges that the Company or any subsidiary is not in compliance with any Environmental Law and, to the knowledge of the Company, there are no circumstances that may prevent or interfere with the Company’s or any subsidiary’s compliance in any material respects with any Environmental Law in the future, except where such failure to comply would not reasonably be expected to have a Material Adverse Effect. To the knowledge of the Company: (i) no current or (during the time a prior property was leased or controlled by the Company) prior property leased or controlled by the Company or any subsidiary has received since January 1, 2024, any written notice or other communication relating to property owned or leased at any time by the Company, whether from a governmental authority, or other Person, that alleges that such current or prior owner or the Company or any subsidiary is not in compliance with or violated any Environmental Law relating to such property and (ii) the Company has no material liability under any Environmental Law.

-9-

 


 

(r)
Insurance. The Company maintains insurance of the types and in the amounts that the Company reasonably believes is prudent and covering such risks that is customary for comparably situated companies and is adequate for the conduct of its business and the value of its properties and assets, all of which insurance is in full force and effect in all material respects. Other than customary end of policy notifications from insurance carriers, since January 1, 2024, the Company has not received any notice or other communication regarding any actual or possible: (i) cancellation or invalidation of any insurance policy or (ii) refusal or denial of any coverage, reservation of rights or rejection of any material claim under any insurance policy.
(s)
Labor Relations. No material labor dispute exists or, to the knowledge of the Company, is imminent with respect to any of the employees of the Company.
(t)
Employee Benefits. Except as would not be reasonably likely to result in a Material Adverse Effect, each Benefit Plan has been established and administered in accordance with its terms and in compliance with the applicable provisions of ERISA, the Code, the Patient Protection and Affordable Care Act of 2010, as amended, and other applicable laws, rules and regulations. The Company and its subsidiaries are in compliance with all applicable federal, state and local laws, rules and regulations regarding employment, except for any failures to comply that are not reasonably likely, individually or in the aggregate, to have a Material Adverse Effect. There is no labor dispute, strike or work stoppage against the Company or its subsidiaries pending or, to the knowledge of the Company, threatened which may interfere with the business activities of the Company, except where such dispute, strike or work stoppage is not reasonably likely, individually or in the aggregate, to have a Material Adverse Effect. “Benefit Plan” or “Benefit Plans” means employee benefit plans as defined in Section 3(3) of ERISA and all other employee benefit practices or arrangements, including, without limitation, any such practices or arrangements providing severance pay, sick leave, vacation pay, salary continuation for disability, retirement benefits, deferred compensation, bonus pay, incentive pay, stock options or other stock-based compensation, hospitalization insurance, medical insurance, life insurance, scholarships or tuition reimbursements, maintained by the Company or to which the Company or any of its subsidiaries is obligated to contribute for employees or former employees of the Company and its subsidiaries.
(u)
Internal Accounting Controls. The Company and its Subsidiaries maintain a system of internal accounting controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) sufficient to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP, including policies and procedures sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset accountability, (iii) access to assets is permitted only in accordance with management’s general or specific authorization, and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. The Company has not identified any material weaknesses in the design or operation of the Company’s internal control over financial reporting.

-10-

 


 

The Company’s “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) are reasonably designed to ensure that all information (both financial and non-financial) required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that all such information is accumulated and communicated to the Company’s management as appropriate to allow timely decisions regarding required disclosure.
(v)
Transactions With Officers and Directors. None of the officers, directors, stockholders, customers, or suppliers of the Company, other than Purchaser, has entered into any transaction with the Company or any of its subsidiaries that would be required to be disclosed pursuant to Item 404(a), (b) or (c) of Regulation S-K of the SEC, except in connection with the transactions contemplated by this Agreement.
(w)
Price Stabilization of Common Stock. The Company has not taken, nor will it take, directly or indirectly, any action designed to stabilize or manipulate the price of the Common Stock to facilitate the sale or resale of the Purchased Shares.
(x)
General Solicitation. Neither the Company nor any other person or entity authorized by the Company to act on its behalf has engaged in a general solicitation or general advertising (within the meaning of Regulation D as promulgated by the SEC under the Securities Act (“Regulation D”)) of investors with respect to offers or sales of the Purchased Shares.
(y)
Registration Statement Matters. The Company meets the eligibility requirements for use of a registration statement on Form S-3 for the resale of the Purchased Shares by Purchaser. Assuming the completion and timely delivery of the Registration Statement Questionnaire (attached hereto as Appendix II) (the “Registration Statement Questionnaire”) by Purchaser to the Company, the Company is not aware of any facts or circumstances that would prohibit or delay the preparation and filing of a registration statement with respect to the Registrable Shares (as defined below).
(z)
No Integrated Offering. Neither the Company, nor any affiliate of the Company, nor any Person acting on its or their behalf has, directly or indirectly, made any offers or sales of any security or solicited any offers to buy any security, under circumstances that would cause this offering of the Purchased Shares to be integrated with prior offerings by the Company for purposes of the Securities Act, or any applicable stockholder approval provisions, including, without limitation, under the rules and regulations of the Nasdaq, nor will the Company take any action or steps that would cause the offering of the Purchased Shares to be integrated with other offerings.
(aa)
Nasdaq Listing Matters. The Common Stock of the Company is quoted on Nasdaq under the ticker symbol “AGEN.” The Company has not received any notice that it is not in compliance with the listing or maintenance requirements of Nasdaq. The issuance and sale of the Purchased Shares under this Agreement does not contravene the rules and regulations of Nasdaq. As of the date hereof, there is no suit, action, proceeding or investigation pending or, to the knowledge of the Company, threatened in writing against the Company by Nasdaq or the SEC to prohibit or terminate the listing of the Common Stock on the Nasdaq Capital Market or to deregister the Common Stock under the Exchange Act.

-11-

 


 

The Company has taken no action as of the date hereof that is designed to terminate the registration of the Common Stock under the Exchange Act.
(bb)
Brokers and Finders. Neither Purchaser nor any of its affiliates will be responsible for any fees or commissions of any broker or finder retained or utilized by the Company or any other Person authorized by the Company to act on its behalf in connection with the transactions contemplated by this Agreement.
(cc)
No Disqualification Events. No “bad actor” disqualifying event described in Rule 506(d)(1)(i)-(viii) of the Securities Act (a “Disqualification Event”) is applicable to the Company or, to the knowledge of the Company, any Covered Person (as defined below), except for a Disqualification Event as to which Rule 506(d)(2)(ii–iv) or (d)(3), is applicable. “Covered Person” means, with respect to the Company as an “issuer” for purposes of Rule 506 promulgated under the Securities Act, any person listed in the first paragraph of Rule 506(d)(1). No person has been or will be paid (directly or indirectly) remuneration for solicitation of the Purchaser in connection with the sale of the Shares pursuant to this Agreement.
(dd)
Compliance with Sanctions. None of the Company, any of its subsidiaries or, to the knowledge of the Company, any director, officer, agent, employee, affiliate or representative of the Company or any of its subsidiaries is a Person that is, or is more than fifty (50) percent owned in the aggregate by or acting on behalf of one or more Persons that are, currently the subject or target of any sanctions administered or enforced by the United States Government, including, without limitation, the U.S. Department of the Treasury’s Office of Foreign Assets Control, the United Nations Security Council, the European Union, His Majesty’s Treasury, or other relevant sanctions authority (collectively, “Sanctions”), nor is the Company located, organized or resident in a country or territory that is the subject of Sanctions; and the Company will not directly or indirectly use the proceeds of the sale of the Purchased Shares, or lend, contribute or otherwise make available such proceeds to any subsidiaries, joint venture partners or other Person, to fund any activities of or business (i) with any Person that, at the time of such funding, is a designated target of Sanctions or (ii) in any other manner that will result in a violation by any Person (including any Person participating in the transaction, whether as underwriter, advisor, investor or otherwise) of Sanctions. The Company has not knowingly engaged in, are not now knowingly engaged in, and will not engage in, any dealings or transactions with any Person that at the time of the dealing or transaction is or was the subject of Sanctions.
(ee)
Compliance with Anti-Money Laundering Laws. The operations of the Company and its subsidiaries are and have been conducted for the past five (5) years in compliance in all material respects with applicable financial recordkeeping and reporting requirements, including those of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the applicable money laundering statutes of all jurisdictions where the Company or any of its subsidiaries conducts business, the rules and regulations thereunder and any related or similar rules, regulations or guidelines issued, administered or enforced by any governmental or regulatory agency (collectively, the “Anti-Money Laundering Laws”) and no action, suit or proceeding by or before any court or governmental or regulatory agency, authority or body or any arbitrator involving the Company or any of its subsidiaries with respect to the Anti-Money Laundering Laws is pending or, to the knowledge of the Company, threatened.

-12-

 


 

(ff)
Security. Except as would not reasonably be expected to have a Material Adverse Effect, the Company and its subsidiaries’ information technology assets and equipment, computers, systems, networks, hardware, software, websites, applications, and databases (collectively, “IT Systems”) are adequate for, and operate and perform in all material respects as required in connection with the operation of the business of the Company and its subsidiaries as currently conducted, and are free and clear of all material Trojan horses, time bombs, malware and other malicious code. Except as would not reasonably be expected to have a Material Adverse Effect, the Company and its subsidiaries have implemented and maintained commercially reasonable physical, technical and administrative controls designed to maintain and protect the confidentiality, integrity, availability, privacy and security of all sensitive, confidential or regulated data (“Confidential Data”) used or maintained in connection with their businesses and Personal Data, and the integrity, availability continuous operation, redundancy and security of all IT Systems. “Personal Data” means the following data used in connection with the Company’s and its subsidiaries’ businesses and in their possession or control: (i) a natural person’s name, street address, telephone number, e-mail address, photograph, social security number or other tax identification number, driver’s license number, passport number, credit card number, bank information, or customer or account number; (ii) information that identifies, relates to, or may reasonably be used to identify an individual; (iii) any information regarding an individual’s medical history, mental or physical condition, or medical treatment or diagnosis by a health care professional; (iv) an individual’s health insurance policy number or subscriber identification number, any unique identifier used by a health insurer to identify the individual, or any information in an individual’s application and claims history; (v) any information which would qualify as “protected health information” under the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”); (vi) any information which would qualify as “personal data,” “personal information” (or similar term) under the Privacy Laws (as defined in Section 3(jj)); and (vii) any other piece of information that alone, or combined with other information, allows the identification of such natural person, or his or her family, or permits the collection or analysis of any data related to an identified person’s health or sexual orientation. To the knowledge of the Company and except as would not reasonably be expected to have a Material Adverse Effect, during the past three (3) years, there have been no breaches, outages or unauthorized uses of or accesses to the IT Systems, Confidential Data, and Personal Data.
(gg)
Compliance with Data Privacy Laws. The Company and its subsidiaries are, and in the past three (3) years were, in material compliance with all applicable state and federal data privacy and security laws and regulations regarding the collection, use, storage, retention, disclosure, transfer, disposal, or any other processing (collectively “Process” or “Processing”) of Personal Data, including HIPAA, the California Consumer Privacy Act, and the European Union General Data Protection Regulation (EU 2016/679) (collectively, the “Privacy Laws”). To ensure compliance with the Privacy Laws, the Company and its subsidiaries have in place, comply with, and take all appropriate steps necessary to ensure compliance in all material respects with their policies and procedures relating to data privacy and security, and the Processing of Personal Data and Confidential Data (the “Privacy Statements”).

-13-

 


 

The Company and its subsidiaries have, except as would not reasonably be expected to have a Material Adverse Effect, at all times since January 1, 2022 provided accurate notice of its Privacy Statements then in effect to its clients, employees, third party vendors and representatives. None of such disclosures made or contained in any Privacy Statements have been materially inaccurate, misleading, incomplete, or in material violation of any Privacy Laws. The Company further represents that neither it nor any of its subsidiaries: (i) has received notice of any actual or potential claim, complaint, proceeding, regulatory proceeding or liability under or relating to, or actual or potential violation of, any of the Privacy Laws, contracts related to the Processing of Personal Data or Confidential Data, or Privacy Statements, and has no knowledge of any event or condition that would reasonably be expected to result in any such notice; (ii) is currently conducting or paying for, in whole or in part, any investigation, remediation, or other corrective action pursuant to any Privacy Law or contract; or (iii) is a party to any order, decree, or agreement that imposes any obligation or liability under any Privacy Law.
(hh)
Investment Company. The Company is not now, and after the sale of the Purchased Shares under this Agreement and the application of the net proceeds from the sale of the Purchased Shares described in Section 1(c) herein will not be, an “investment company” within the meaning of the Investment Company Act of 1940, as amended.
(ii)
Reliance by the Purchaser. The Company acknowledges that the Purchaser will rely upon the truth and accuracy of, and the Company’s compliance with, the representations, warranties, agreements, acknowledgements and understandings of the Company set forth herein.
4.
REPRESENTATIONS, WARRANTIES AND CERTAIN AGREEMENTS OF PURCHASER. Purchaser hereby represents and warrants to the Company and agrees that:
(a)
Organization Good Standing and Qualification. Purchaser has all corporate, membership or partnership power and authority required to enter into this Agreement and the other agreements, instruments and documents contemplated hereby, and to consummate the transactions contemplated hereby and thereby.
(b)
Authorization. The execution of this Agreement has been duly authorized by all necessary corporate, membership or partnership action on the part of Purchaser. This Agreement constitutes Purchaser’s legal, valid and binding obligation, enforceable in accordance with its terms, except (i) as may be limited by (A) applicable bankruptcy, insolvency, reorganization or other laws of general application relating to or affecting the enforcement of creditors’ rights generally and (B) the effect of rules of law governing the availability of equitable remedies and (ii) as rights to indemnity or contribution may be limited under federal or state securities laws or by principles of public policy thereunder.
(c)
Litigation. There is no Action pending, or to its knowledge threatened, to which Purchaser is a party that is reasonably likely to prevent, enjoin, alter or delay the transactions contemplated by this Agreement.
(d)
Purchase for Own Account. The Purchased Shares are being acquired for investment for Purchaser’s own account, not as a nominee or agent, and not with a view to the public resale or distribution thereof within the meaning of the Securities Act, without prejudice, however, to Purchaser’s right at all times to sell or otherwise dispose of all or any part of such securities in compliance with applicable federal and state securities laws and as otherwise contemplated by this Agreement.

-14-

 


 

Purchaser also represents that it has not been formed for the specific purpose of acquiring the Purchased Shares.
(e)
Investment Experience. Purchaser understands that the purchase of the Purchased Shares involves substantial risk. Purchaser has experience as an investor in securities of companies and acknowledges that it can bear the economic risk of its investment in the Purchased Shares and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of this investment in the Purchased Shares and protecting its own interests in connection with this investment. Purchaser understands that nothing in this Agreement or any other materials presented to
(f)
Purchaser by or on behalf of the Company in connection with the purchase and sale of the Purchased Shares constitutes legal, tax or investment advice.
(g)
Accredited Investor Status. Purchaser is an “accredited investor” within the meaning of Regulation D promulgated under the Securities Act.
(h)
Broker Dealer. Purchaser is not a broker or dealer registered pursuant to Section 15 of the Exchange Act.
(i)
Reliance Upon Purchaser’s Representations. Purchaser understands that the issuance and sale of the Purchased Shares to it will not be registered under the Securities Act on the ground that such issuance and sale will be exempt from registration under the Securities Act, and that the Company’s reliance on such exemption is based on Purchaser’s representations set forth herein.
(j)
Receipt of Information. Purchaser has had an opportunity to ask questions and receive answers from the Company regarding the terms and conditions of the issuance and sale of the Purchased Shares and the business, properties, prospects and financial condition of the Company and to obtain any additional information requested and has received and considered all information it deems relevant to make an informed decision to purchase the Purchased Shares. Neither such inquiries nor any other investigation conducted by or on behalf of Purchaser or its representatives or counsel shall modify, amend or affect Purchaser’s right to rely on the truth, accuracy and completeness of such information and the Company’s representations and warranties contained in this Agreement.
(k)
Restricted Securities. Purchaser understands that the Purchased Shares have not been registered under the Securities Act and Purchaser will not sell, offer to sell, assign, pledge, hypothecate or otherwise transfer any of the Purchased Shares unless (i) pursuant to an effective registration statement under the Securities Act, (ii) such holder provides the Company with an opinion of counsel, in form and substance reasonably acceptable to the Company and its counsel, to the effect that a sale, assignment or transfer of the Purchased Shares may be made without registration under the Securities Act and the transferee agrees to be bound by the terms and conditions of this Agreement, or (iii) such holder provides the Company with reasonable assurances (in the form of seller and broker representation letters) that the Purchased Shares can be sold pursuant to Rule 144 promulgated under the Securities Act (“Rule 144”).

-15-

 


 

(l)
Legends.
(i)
Purchased Shares. Purchaser agrees that any certificates representing the Purchased Shares, whether maintained in a book-entry system or otherwise, shall bear the following legend:

“THESE SECURITIES HAVE NOT BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE "SECURITIES ACT"), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS AS EVIDENCED BY A LEGAL OPINION OF COUNSEL TO THE TRANSFEROR TO SUCH EFFECT, THE SUBSTANCE OF WHICH SHALL BE REASONABLY ACCEPTABLE TO THE COMPANY.”

The Company shall cause its counsel to issue a legal opinion to the Company's transfer agent promptly after the date on which the Registration Statement is declared effective (the “Effective Date”), if required by the Company's transfer agent, to effect the removal of the legend hereunder upon receipt of a letter from the transferee that it has complied with the prospectus delivery requirements under the Securities Act.

Purchaser agrees that the removal of the restrictive legend from certificates representing securities as set forth in this Section 4(l) is predicated upon Purchaser’s warranty that Purchaser will sell any securities pursuant to the registration requirements of the Securities Act, including any applicable prospectus delivery requirements.

In addition, Purchaser agrees that the Company may place stop transfer orders with its transfer agent with respect to such Certificates in order to implement the restrictions on transfer set forth in this Agreement. The appropriate portion of the legend and the stop transfer orders will be removed promptly upon delivery to the Company of such satisfactory evidence as reasonably may be required by the Company that such legend or stop orders are not required to ensure compliance with the Securities Act.

(m)
Questionnaires. Purchaser has completed or caused to be completed the Share Issuance Questionnaire and the Registration Statement Questionnaire for use in preparation of the Registration Statement (as defined in Section 5(a)(i) below), and the answers to such questionnaires are true and correct as of the date of this Agreement; provided, that Purchaser shall be entitled to update such information by providing written notice thereof to the Company at least 48 hours before the effective date of the Registration Statement.

-16-

 


 

(n)
Beneficial Ownership. The purchase by Purchaser of the Purchased Shares issuable to it at the Closing will not result in Purchaser (individually or together with any other Person with whom Purchaser has identified, or will have identified, itself as part of a “group” in a public filing made with the SEC involving the Company’s securities, where such aggregation would be made according to Section 13(d) of the Exchange Act) acquiring, or obtaining the right to acquire, in excess of 19.999% of the outstanding shares of Common Stock or the voting power of the Company on a post-transaction basis that assumes that such Closing shall have occurred. Purchaser does not presently intend to, alone or together with others, make a public filing with the SEC to disclose that it has (or that it together with such other Persons have) acquired, or obtained the right to acquire, as a result of such Closing (when added to any other securities of the Company that it or they then own or have the right to acquire), in excess of 19.999% of the outstanding shares of Common Stock or the voting power of the Company on a post-transaction basis that assumes that each Closing shall have occurred (including assuming the effectiveness of any “blocker” or similar limitations on beneficial ownership contained in the applicable documentation for the Purchased Shares).
(o)
Restrictions on Short Sales. Purchaser represents, warrants and covenants that neither Purchaser nor any affiliate of Purchaser which (x) had knowledge of the transactions contemplated hereby, (y) has or shares discretion relating to Purchaser’s investments or trading or information concerning Purchaser’s investments, including in respect of the Purchased Shares, or (z) is subject to Purchaser’s review or input concerning such affiliate’s investments or trading, has or will, directly or indirectly, during the period beginning on the date on which the Company first contacted Purchaser regarding the transactions contemplated by this Agreement (and involving the Company) and ending on the Closing Date, engage in (i) any “short sales” (as such term is defined in Rule 3b-3 promulgated under the Exchange Act) of the Common Stock, including, without limitation, the maintaining of any short position with respect to, establishing or maintaining a “put equivalent position” (within the meaning of Rule 16a-1(h) under the Exchange Act) with respect to, entering into any swap, derivative transaction or other arrangement (whether any such transaction is to be settled by delivery of Common Stock, other securities, cash or other consideration) that transfers to another, in whole or in part, any economic consequences or ownership, or otherwise disposes of, any of the Purchased Shares by Purchaser or (ii) any hedging transaction which establishes a net short position with respect to the Purchased Shares (clauses (i) and (ii) together, a “Short Sale”); except for (1) Short Sales by Purchaser or an affiliate of Purchaser which was, prior to the date on which Purchaser was first contacted by the Company regarding the transactions contemplated by this Agreement, a market maker for the Common Stock, provided that such Short Sales are in the ordinary course of business of Purchaser or an affiliate of Purchaser and are in compliance with the Securities Act, the rules and regulations of the Securities Act and such other securities laws as may be applicable, (2) Short Sales by Purchaser or an affiliate of Purchaser which by virtue of the procedures of Purchaser are made without knowledge of the transactions contemplated by this Agreement or (3) Short Sales by Purchaser or an affiliate of Purchaser to the extent that Purchaser or such affiliate of Purchaser is acting in the capacity of a broker-dealer executing unsolicited third-party transactions.

-17-

 


 

(p)
Lock-Up. Purchaser agrees that, excluding any transfers of Purchased Shares between Purchaser and any of its affiliates, until the 12 month anniversary of the Closing Date, Purchaser shall not, and shall not cause any other holder of the Purchased Shares to, without the prior written consent of the Company, sell, dispose of, transfer, make any Short Sale of, grant any option for the purchase of, or enter into any hedging or similar transaction with the same economic effect as a sale, any Common Stock or other securities of the Company held by Purchaser, including the Purchased Shares (the “Lock-Up Period”).
(q)
Standstill. Purchaser agrees that, until the first (1st) anniversary of the Closing Date, neither Purchaser nor any affiliate of Purchaser will, without the prior written consent of the Company: (i) acquire, offer to acquire, or agree to acquire, directly or indirectly, by purchase or otherwise, any voting shares or direct or indirect rights to acquire any voting shares of, or economic interest in (through derivative securities or otherwise), the Company or any successor thereto; (ii) make, or in any way participate, directly or indirectly, in any “solicitation” of “proxies” to vote (as such terms are used in the rules of the SEC), seek to advise or influence any person or entity with respect to the voting of any voting shares of the Company or seek or propose to have called, or cause to be called, any meeting of the stockholders of the Company; (iii) make any public announcement with respect to, or submit a proposal for, or offer of (with or without conditions) any extraordinary transaction involving the Company or any of its securities or assets; or (iv) form, join or in any way participate in a “group” as defined in Section 13(d)(3) of the Exchange Act in connection with any of the foregoing, provided however, that the Company will not object to Purchaser’s participation in any at-the-market offering conducted by the Company in order to maintain its percentage interest as a result of any diluting issuance.

The provisions of this Section 4(q) shall be inoperative and of no force or effect if, from and after the date hereof: (i) any person or group shall have acquired or entered into a binding definitive agreement that has been approved by the Board (or any duly constituted committee thereof composed entirely of independent directors) to acquire more than 50% of the outstanding voting securities of the Company, (ii) any person commences a tender or exchange offer which, if consummated, would result in such person’s acquisition of beneficial ownership of more than 50% of the outstanding voting securities of the Company, and in connection therewith, the Company files with the SEC a Schedule 14D-9 with respect to such offer that does not recommend that the Company’s stockholders reject such offer; or (iii) the Board (or any duly constituted committee thereof composed entirely of independent directors) shall have determined in good faith, after consultation with outside legal counsel, that the failure to waive, limit, amend or otherwise modify the standstill provisions, would be reasonably likely to be inconsistent with the fiduciary duties of the Board under applicable law; provided, however, that with respect to clauses (i), (ii) and (iii) of this sentence, Purchaser shall not have solicited, initiated or participated with any such other Person or group in connection with any of the transactions contemplated by clauses (i), (ii) and (iii) of this sentence.

 

5.
CERTAIN AGREEMENTS OF THE COMPANY.
(a)
Registration of the Purchased Shares. The Company hereby agrees that it shall:

-18-

 


 

(i)
prepare and file with the SEC as soon as practicable and in no event later than sixty (60) days following the Closing, a registration statement on Form S-3 (the “Registration Statement”), to enable the resale of the Purchased Shares (together with any shares of Common Stock issued as a dividend or other distribution with respect to, or in exchange for, or in replacement of, the Purchased Shares, the “Registrable Shares”) by Purchaser from time to time on Nasdaq and use commercially reasonable efforts to cause such Registration Statement to be declared effective, within seventy-five (75) days following the Closing Date or, in the event of a review of the Registration Statement by the SEC, within one-hundred twenty (120) days following the Closing Date, and, subject to exceptions provided herein, to remain continuously effective until the earlier of (A) the date on which all Registrable Shares purchased by Purchaser pursuant to this Agreement have been sold thereunder or (B) the date that is two years following the Closing Date (the “Registration Period”). In the event that the Company does not meet the requirements for the use of Form S-3, the Company shall use such other form as is available for such a registration, and shall convert such other form to Form S-3, or file a replacement registration statement on Form S-3, promptly after the first date on which it meets such requirements;
(ii)
prepare and file with the SEC such amendments (including post-effective amendments) and supplements to the Registration Statement and the Prospectus (as defined below) used in connection therewith as may be necessary to keep the Registration Statement effective at all times until the end of the Registration Period;
(iii)
furnish to Purchaser with respect to the Registrable Shares registered under the Registration Statement a copy of each final Prospectus (as defined below) in which Purchaser is listed as a selling securityholder in order to facilitate the public sale or other disposition of all or any of the Registrable Shares by Purchaser;
(iv)
promptly notify Purchaser named as a selling securityholder when the Registration Statement has been declared effective;
(v)
promptly notify Purchaser in writing of the existence of any fact or the happening of any event, during the Registration Period (but not as to the substance of any such fact or event), that makes any statement of a material fact made in the Registration Statement, the Prospectus, any amendment or supplement thereto, or any document incorporated by reference therein untrue, or that requires the making of any additions to or changes in the Registration Statement or the Prospectus in order to make the statements therein not misleading (provided, however, that no notice by the Company shall be required pursuant to this subsection (vi) in the event that the Company either contemporaneously files a prospectus supplement to update the Prospectus or a Form 8-K or other appropriate Exchange Act report that is incorporated by reference into the Registration Statement, which, in either case, contains the requisite information with respect to such material event that results in such Registration Statement no longer containing any such untrue or misleading statements);
(vi)
furnish to Purchaser upon written request, from the date of this Agreement until the end of the Registration Period, one copy of its periodic reports filed with the SEC pursuant to the Exchange Act and the rules and regulations promulgated thereunder, if, during such period, such documents cease to be filed on the SEC’s EDGAR system or a successor thereto; and

-19-

 


 

(vii)
bear all expenses in connection with the procedures described in paragraphs (i) through (vii) of this Section 5(a) and the registration of the Registrable Shares pursuant to the Registration Statement other than fees and expenses, if any, of legal counsel or other advisers to Purchaser or underwriting discounts, brokerage fees and commissions incurred by Purchaser, if any, except that the Company shall bear all expenses related to the removal of restrictive legends under Rule 144, if applicable.

It shall be a condition precedent to the obligations of the Company to take any action pursuant to this Section 5(a) with respect to Registrable Shares held by a Purchaser that Purchaser shall timely furnish to the Company a completed Registration Statement Questionnaire on or before the Closing Date and such other written information regarding itself, the Registrable Shares to be sold by Purchaser, and the intended method of disposition of the Registrable Shares as shall be required to effect the registration of the Registrable Shares. Purchaser shall update such information as and when necessary by written notice to the Company.

(b)
Transfer of Registrable Shares After Registration; Suspension.
(i)
Purchaser agrees that it will not offer to sell or make any sale, assignment, pledge, hypothecation or other transfer with respect to the Purchased Shares that would constitute a sale within the meaning of the Securities Act except pursuant to (1) the Registration Statement, (2) Rule 144 of the Securities Act or (3) another exemption from registration under the Securities Act, and that it will promptly notify the Company of any changes in the information set forth in the Registration Statement after it is prepared regarding Purchaser or its plan of distribution to the extent required by applicable law.
(ii)
In addition to any suspension rights under paragraph (iii) below, upon the happening of any pending corporate development, public filing with the SEC or similar event, that, in the judgment of Company’s Board of Directors, renders it advisable to suspend use of the Prospectus, or upon the request by an underwriter in connection with an underwritten public offering of the Company’s securities, the Company may, on not more than two (2) non-consecutive occasions for not more than ninety (90) days on each such occasion, suspend use of the Prospectus, on written notice to Purchaser (which notice will not disclose the content of any material non-public information and will indicate the date of the beginning and end of the intended period of suspension, if known), in which case Purchaser shall discontinue disposition of Registrable Shares covered by the Registration Statement or Prospectus until copies of a supplemented or amended Prospectus are distributed to Purchaser or until Purchaser is advised in writing by the Company that sales of Registrable Shares under the applicable Prospectus may be resumed and have received copies of any additional or supplemental filings that are incorporated or deemed incorporated by reference in any such Prospectus. The suspension and notice thereof described in this Section 5(b)(ii) shall be held in strictest confidence and shall not be disclosed by Purchaser.
(iii)

-20-

 


 

In the event of: (A) any request by the SEC or any other federal or state governmental authority during the period of effectiveness of the Registration Statement for amendments or supplements to a Registration Statement or related Prospectus or for additional information, (B) the issuance by the SEC or any other federal or state governmental authority of any stop order suspending the effectiveness of a Registration Statement or the initiation of any proceedings for that purpose, (C) the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Registrable Shares for sale in any jurisdiction or the initiation of any proceeding for such purpose, or (D) any event or circumstance which necessitates the making of any changes in the Registration Statement or Prospectus, or any document incorporated or deemed to be incorporated therein by reference, so that, in the case of the Registration Statement, it will not contain any untrue statement of a material fact or any omission to state a material fact required to be stated therein or necessary to make the statements therein not misleading, and that in the case of the Prospectus, it will not contain any untrue statement of a material fact or any omission to state a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading, then the Company shall deliver a certificate in writing to Purchaser (the “Suspension Notice”) to the effect of the foregoing (which notice will not disclose the content of any material non-public information and will indicate the date of the beginning and end of the intended period of suspension, if known), and, upon receipt of such Suspension Notice, Purchaser will discontinue disposition of Registrable Shares covered by the Registration Statement or Prospectus (a “Suspension”) until Purchaser’s receipt of copies of a supplemented or amended Prospectus prepared and filed by the Company, or until Purchaser is advised in writing by the Company that the current Prospectus may be used, and have received copies of any additional or supplemental filings that are incorporated or deemed incorporated by reference in any such prospectus. In the event of any Suspension, the Company will use its commercially reasonable efforts to cause the use of the Prospectus so suspended to be resumed as soon as possible after delivery of a Suspension Notice to Purchaser.

 

(c)
Indemnification. For the purpose of this Section 5(c), the term “Registration Statement” shall include any preliminary or final Prospectus, exhibit, supplement or amendment included in or relating to the Registration Statement referred to in Section 5(a).
(i)
Registration Indemnification by the Company. The Company agrees to indemnify and hold harmless Purchaser and each person, if any, who controls Purchaser within the meaning of the Securities Act, to the fullest extent permitted by law, against any and all losses, claims, damages, liabilities or reasonable expenses (including without limitation reasonable and documented attorney fees and disbursements and other documented out of pocket expenses reasonably incurred in connection with investigating, preparing, or defending any action, claim, or proceeding, pending or threatened, and the costs of enforcement thereof) (collectively, “Losses”), joint or several, to which Purchaser or such controlling person may become subject, under the Securities Act, the Exchange Act or any other federal or state statutory law or regulation, or at common law or otherwise (including in settlement of any litigation, if such settlement is effected with the written consent of the Company, which consent shall not be unreasonably withheld), insofar as such Losses (or actions in respect thereof as contemplated below) arise out of or are based upon any untrue statement or alleged untrue statement of any material fact contained in the Registration Statement, the Prospectus, or any amendment or supplement thereto, or arise out of or are based upon the omission or alleged omission to state in any of them a material fact required to be stated therein or necessary to make the statements in any of them, in light of the circumstances under which they were made, not misleading, and will reimburse Purchaser and each such controlling person for any reasonable legal and other expenses as such reasonable expenses are incurred by Purchaser or such controlling person in connection with investigating, defending, settling, compromising or paying any such loss, claim, damage, liability, expense or action; provided, however, that the Company will not be liable in any such case to the extent that any such loss, claim, damage, liability, expense or action arises out of or is based upon (A) an untrue statement or alleged untrue statement or omission or alleged omission made in the Registration Statement, the Prospectus or any amendment to or supplement of the Registration Statement or Prospectus made in reliance upon and in conformity with written information furnished to the Company by or on behalf of Purchaser expressly for use in the Registration Statement or the Prospectus, (B) the failure of Purchaser to comply with the covenants and agreements contained in this Agreement respecting resale of the Purchased Shares, or (C) any untrue statement or omission of a material fact required to make such statement not misleading in any Prospectus that is corrected in any subsequent Prospectus that was delivered to Purchaser before the pertinent sale or sales by Purchaser.

-21-

 


 

(ii)
Registration Indemnification by Purchaser. Purchaser will indemnify and hold harmless the Company, each of its directors, each of its officers who signed the Registration Statement and each person, if any, who controls the Company within the meaning of the Securities Act, against any Losses to which the Company, its directors, its officers who signed the Registration Statement and any controlling persons may become subject, under the Securities Act, the Exchange Act, or any other federal or state statutory law or regulation, or at common law or otherwise (including in settlement of any litigation, if such settlement is effected with the written consent of Purchaser, which consent shall not be unreasonably withheld) insofar as such Losses (or actions in respect thereof as contemplated below) arise out of or are based upon any untrue statement or alleged untrue statement of any material fact contained in the Registration Statement, the Prospectus, or any amendment or supplement to the Registration Statement or Prospectus, or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, in each case to the extent, but only to the extent, that such untrue statement or alleged untrue statement or omission or alleged omission was made in the Registration Statement, the Prospectus, or any amendment or supplement thereto, in reliance upon and in conformity with written information furnished to the Company by or on behalf of Purchaser expressly for use therein, and Purchaser will reimburse the Company, each of its directors, each of its officers who signed the Registration Statement, and any controlling persons for any reasonable legal and other expense incurred by the Company, its directors, its officers who signed the Registration Statement, and any controlling persons, in connection with investigating, defending, settling, compromising or paying any such loss, claim, damage, liability, expense or action; provided, however, that Purchaser shall not be liable for any such untrue statement or alleged untrue statement or omission or alleged omission with respect to which Purchaser has delivered to the Company in writing a correction before the occurrence of the event from which such loss was incurred. Notwithstanding the provisions of this Section 5(c), Purchaser shall not be liable for any indemnification obligation under this Agreement in excess of the aggregate amount of net proceeds received by Purchaser from the sale of the Registrable Shares pursuant to the Registration Statement.

-22-

 


 

(iii)
General Indemnity. The Company agrees to indemnify and hold harmless the Purchaser and its affiliates, and their respective directors, officers, trustees, members, managers, employees, investment advisers, and agents, from and against any and all Losses to which such Person may become subject as a result of any breach of representation, warranty, covenant, or agreement made by or to be performed on the part of the Company under this Agreement, and will reimburse any such Person for all such amounts as they are incurred by such Person solely to the extent such amounts have been finally judicially determined not to have resulted from such Person’s fraud or willful misconduct.
(iv)
Specific Indemnity. The Company agrees to indemnify and hold harmless Purchaser and each person, if any, who controls Purchaser within the meaning of the Securities Act, to the fullest extent permitted by law, against any and all Losses, joint or several, to which Purchaser or such controlling person may become subject, under the Securities Act, the Exchange Act or any other federal or state statutory law or regulation, or at common law or otherwise (including in settlement of any litigation, if such settlement is effected with the written consent of the Company, which consent shall not be unreasonably withheld), insofar as such Losses (or actions in respect thereof as contemplated below) arise out of or are based upon any securities class action lawsuit pertaining to any period prior to the Closing Date.
(v)
Indemnification Procedure.
(A)
Promptly after receipt by an indemnified party under this Section 5(c) of notice of the threat or commencement of any action, such indemnified party will, if a claim in respect thereof is to be made against an indemnifying party under this Section 5(c), promptly notify the indemnifying party in writing of the claim; but the omission so to notify the indemnifying party will not relieve it from any liability which it may have to any indemnified party for contribution or otherwise under the indemnity agreement contained in this Section 5(c) or otherwise, to the extent it is not prejudiced as a result of such failure.
(B)
In case any such action is brought against any indemnified party and such indemnified party seeks or intends to seek indemnity from an indemnifying party, the indemnifying party will be entitled to participate in, and, to the extent that it may wish, jointly with all other indemnifying parties similarly notified, to assume the defense thereof with counsel reasonably satisfactory to such indemnified party; provided, however, if the defendants in any such action include both the indemnified party and the indemnifying party and the indemnified party shall have reasonably concluded that there may be a conflict between the positions of the indemnifying party and the indemnified party in conducting the defense of any such action or that there are legal defenses available to it or other indemnified parties that are different from or additional to those available to the indemnifying party, the indemnified party or parties shall have the right to select separate counsel to assume such legal defenses and to otherwise participate in the defense of such action on behalf of such indemnified party or parties. Upon receipt of notice from the indemnifying party to such indemnified party of its election so to assume the defense of such action and approval by the indemnified party of counsel, the indemnifying party will not be liable to such indemnified party under this Section 5(c) for any legal or other expenses subsequently incurred by such indemnified party in connection with the defense thereof unless:

-23-

 


 

1)
the indemnified party shall have employed such counsel in connection with the assumption of legal defenses in accordance with the proviso to the preceding sentence (it being understood, however, that the indemnifying party shall not be liable for the expenses of more than one separate counsel, approved by such indemnifying party, representing all of the indemnified parties who are parties to such action); or
2)
the indemnifying party shall not have employed counsel reasonably satisfactory to the indemnified party to represent the indemnified party within a reasonable time after notice of commencement of the action against the indemnified party,

in each of which cases the reasonable fees and expenses of counsel for the indemnified party shall be at the expense of the indemnifying party.

(vi)
Contribution. If the indemnification provided for in this Section 5(c) is required by its terms but is for any reason held to be unavailable to, or is otherwise insufficient to hold harmless, an indemnified party under this Section 5(c) with respect to any losses, claims, damages, liabilities or expenses referred to in this Agreement, then each indemnifying party shall contribute to the amount paid or payable by such indemnified party as a result of any losses, claims, damages, liabilities or expenses referred to in this Agreement:
(A)
in such proportion as is appropriate to reflect the relative faults of the Company and Purchaser in connection with the statements or omissions or inaccuracies in the representations and warranties in this Agreement that resulted in such losses, claims, damages, liabilities or expenses, as well as any other relevant equitable considerations, or
(B)
if the allocation provided by clause (A) above is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative faults referred to in clause (A) above but the relative benefits received by the Company and Purchaser from the sale of the Purchased Shares.

The respective relative benefits received by the Company on the one hand and Purchaser on the other shall be deemed to be in the same proportion as the amount to which the consideration paid by Purchaser to the Company pursuant to this Agreement for the Purchased Shares purchased by Purchaser that were sold pursuant to the Registration Statement bears to the difference (the “Difference”) between the amount Purchaser paid for the Purchased Shares that were sold pursuant to the Registration Statement and the amount received by Purchaser from such sale. The relative fault of the Company and Purchaser shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to state a material fact or the inaccurate or the alleged inaccurate material fact relates to information supplied by the Company or by Purchaser and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission. The amount paid or payable by a party as a result of the losses, claims, damages, liabilities and expenses referred to above shall be deemed to include, subject to the limitations set forth in Section 5(c)(v), any reasonable legal or other fees or expenses incurred by such party in connection with investigating or defending any such action or claim. The provisions set forth in Section 5(c)(v) with respect to the notice of the threat or commencement of any threat or action shall apply if a claim for contribution is to be made under this Section 5(c)(vi); provided, however, that no additional notice shall be required with respect to any threat or action for which notice has been given under Section 5(c)(v) for purposes of indemnification.

-24-

 


 

The Company and Purchaser agree that it would not be just and equitable if contribution pursuant to this Section 5(c)(vi) were determined solely by pro rata allocation or by any other method of allocation which does not take account of the equitable considerations referred to in this paragraph. Notwithstanding the provisions of this Section 5(c)(vi), Purchaser shall not be required to contribute any amount in excess of the amount by which the Difference exceeds the amount of any damages that Purchaser has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who is not guilty of such fraudulent misrepresentation.

(d)
Board Participation; Information Rights; and Right of First Offer.
(i)
Board Observer. The Company agrees that, until [***], Purchaser shall be entitled to designate one individual as a non-voting observer (the “Observer”) to the Board with the right to attend all meetings of the Board and committees and subcommittees thereof, provided that, during such period Purchaser beneficially owns [***] or more of the outstanding Common Stock of the Company. Following [***], the Company agrees that Purchaser shall be entitled to designate the Observer until the date on which Purchaser or its affiliate ceases to beneficially own [***] or more of the outstanding Common Stock of the Company. During such time, the Purchaser may remove and replace the individual serving as the Observer at any time in its sole discretion. The Company will deliver to the Observer copies of all materials that may be distributed from time to time to the members of the Board (in their capacity as such) at such time as such materials are so distributed to them, including copies of any written consents, and the Observer shall otherwise be given copies of all materials, including access to all electronic portals and materials, given or made available to other members of the Board, in order to afford the Observer the same access as all other members of the Board. The Observer shall enter into a customary confidentiality agreement with the Company pursuant to which the Observer will agree to hold in confidence all documents or materials so provided to the Observer on terms satisfactory to the Company before being granted the rights contained in this Section 5(d), and the Observer shall agree to adhere to all applicable Company policies, including, without limitation, the Company’s Insider Trading Policy. The Company shall enter into an indemnification agreement with the Observer commensurate to the Company’s indemnification agreements with its directors. In no event shall the Observer (i) have the right to propose or offer any motions or resolutions to the Board or committees and subcommittees thereof; or (ii) have the right to vote on any matter under consideration by the Board or any committees and subcommittees thereof or otherwise have any power to cause the Company to take, or not to take, any action. Notwithstanding anything herein to the contrary, the Company may withhold information or materials from the Observer or exclude the Observer from any meeting or portion thereof if the Board determines, acting in good faith, that access to such information or materials or attendance at such meeting (or portion thereof) would (i) adversely affect the attorney-client or work product privilege between the Company and its counsel; (ii) such exclusion is necessary to avoid a conflict of interest or disclosure that is restricted by any agreement to which the Company or any of its affiliates is a party or otherwise bound with any other person; (iii) the Observer or Purchaser is in material breach of this Agreement or the Company’s policies applicable to Purchaser or the Observer and such breach remains uncured, or (iv) the exclusion is required by law, regulation or the rule of any stock exchange.

-25-

 


 

(ii)
Board Member. In lieu of appointing an Observer pursuant to Section 5(d)(i), the Company agrees that, for so long as Purchaser is permitted to appoint an Observer in accordance with Section 5(d)(i), it shall, at the option of Purchaser, nominate one (1) director for election to its Board of Directors at its annual meeting of stockholders, as specified by Purchaser, provided that Purchaser provides written notice to the Company of such individual to be nominated no later than March 1 of the year of any such nomination, and further provided that such nominated individual otherwise satisfies all legal, SEC, Nasdaq, or other requirements for nomination to the Board of Directors of the Company as the Company may reasonably specify. If such nominated individual resigns, fails to be elected by the stockholders, or becomes no longer employed by or affiliated with the Purchaser, Purchaser may, at its option, appoint a different individual to serve as an interim director and nominee at the next annual meeting of stockholders or appoint an Observer. For so long as Purchaser is permitted to appoint an Observer in accordance with Section 5(d)(i), if Purchaser is not represented by a current director, then it may appoint an Observer pursuant to Section 5(d)(i). At no time will Purchaser (x) have appointment power over more than one director to the Board or (y) be represented by both an Observer and a director. The Company shall maintain appropriate directors’ and officers’ insurance during all times that Purchaser’s nominee serves as a director.
(iii)
Information Rights. The Company agrees that, until the earlier of (i) the [***] and (ii) the date on which Purchaser or its affiliate ceases to beneficially own [***] or more of the outstanding Common Stock of the Company, the Company shall, provide to Purchaser information reasonably requested by Purchaser, provided that the Company shall not be obligated to provide information (i) that the Company reasonably believes to be competitively sensitive information or (ii) if such provision of information would (A) be in violation of any federal, state or local laws or regulations, (B) violate attorney-client privilege, (C) be in violation of a confidentiality agreement between the Company and a third party other than Purchaser or its affiliates.
(iv)
Right of First Offer. The Company agrees that, for so long as Purchaser is permitted to appoint an Observer in accordance with Section 5(d)(i), each time the Company proposes to offer common stock or any other securities convertible to common stock in either (x) a marketed public offering or (y) a private placement of public equity (“New Equity Securities”), at any time following the date hereof, the Company will provide the Purchaser with at least five (5) business days’ prior written notice of such offering, including the price and terms thereof (the “Proposed Issuance Notice”). Purchaser shall have the option within two (2) days following receipt of the Proposed Issuance Notice by delivering an irrevocable written notice to the Company to agree on behalf of itself or its affiliates to subscribe for, on the same terms and conditions as those specified in the Proposed Issuance Notice, all or part of Purchaser’s Pro Rata Shares (as defined below). “Pro Rata Shares” shall be equal to (i) the total number of such New Equity Securities, multiplied by (ii) a fraction, the numerator of which shall be the aggregate number of shares of Common Stock held by the Investor immediately prior to the issuance of such New Equity Securities and the denominator of which shall be the total number of shares of Common Stock outstanding immediately prior to the issuance of such New Equity Securities. Purchaser will have the right, but not the obligation, to invest an amount up to but not greater than the Pro Rata Shares.

-26-

 


 

Such investments by the Purchaser will be on the same terms and at the same price as the Company offers to the other investors purchasing New Equity Securities in such offerings. For the avoidance of doubt, the right of first offer under this Section 5(d)(iv) shall not apply to: (i) issuances or sales of Common Stock or other securities to any existing or prospective employees, officers, directors, managers or consultants of the Company or any of its subsidiaries pursuant to any stock option, employee stock purchase, employee benefits or similar equity incentive plan or other compensation agreement of the Company or any of its subsidiaries; (ii) issuances or sales in, or in connection with, a merger, business combination or reorganization of the Company or any of its subsidiaries with or into another Person or an acquisition by the Company or any of its subsidiaries of another Person or substantially all the assets of another Person; (iii) issuances by the Company or a wholly-owned subsidiary of the Company to the Company or another wholly-owned subsidiary of the Company; or (iv) issuances as a dividend or upon any stock split, reclassification, recapitalization, exchange or readjustment of Common Stock, or other similar transaction (in each case, on a pro rata basis).
(e)
Governmental Approvals and Consents.
(i)
Each of the Company and Purchaser shall, as promptly as possible, use its reasonable best efforts to obtain, or cause to be obtained, all consents, authorizations, orders and approvals from any court, agency, authority, department, regulatory body or other instrumentality of any government or country or of any national, federal, state, provincial, regional, county, city or other political subdivision of any such government or any supranational organization of which any such country is a member, which has competent and binding authority to decide, mandate, regulate, enforce, or otherwise control the activities of the Company and Purchaser or their affiliates contemplated by this Agreement (collectively, “Governmental Authorities” that may be or become necessary for its execution and delivery of this Agreement and the performance of its obligations pursuant to this Agreement. Each of the Company and Purchaser shall cooperate fully with each other and each other’s affiliates in promptly seeking to obtain all such consents, authorizations, orders and approvals. The Company and Purchaser shall not willfully take any action that will have the effect of delaying, impairing or impeding the receipt of any required consents, authorizations, orders and approvals. If required by the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”) and if the appropriate filing pursuant to the HSR Act has not been filed prior to the date hereof, each of the Company and Purchaser agrees to make an appropriate filing pursuant to the HSR Act with respect to the transactions contemplated by this Agreement as soon as reasonably practicable after the date hereof and to supply as promptly as practicable to the appropriate Governmental Authority any additional information and documentary material that may be requested pursuant to the HSR Act. Each of the Company and Purchaser acknowledge that the rules and regulations promulgated by the Committee on Foreign Investment in the United States (“CFIUS”) require the Company and Purchaser to jointly prepare and submit a CFIUS declaration pursuant to 21 C.F.R. Part 800 et al (“CFIUS Filing”) before CFIUS and obtain CFIUS Regulatory Approval. If the CFIUS Filing has not been filed prior to the date hereof, the Company and Purchaser shall, using best efforts, jointly prepare and submit the CFIUS Filing before CFIUS. The Company and Purchaser agree that the Company and/or its representatives shall take the lead in filing the CFIUS Filing.

-27-

 


 

A “CFIUS Regulatory Approval” shall occur only when one of the following conditions has been met: (i) in response to the CFIUS Filing submitted jointly by the Company and Purchaser, the Company and Purchaser have received written notice from CFIUS stating that: (A) CFIUS has concluded that the transaction subject to this Agreement and the Asset Purchase Agreement (the “Proposed Transaction”) is not a “covered transaction” and not subject to review under the Defense Production Act; or (B) CFIUS has concluded its consideration of the Proposed Transaction under the Defense Production Act and determined there are no unresolved national security concerns regarding the Proposed Transaction; or (ii) CFIUS has sent a report to the President of the United States requesting the President’s decision on the Proposed Transaction and either the period under the Defense Production Act during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Proposed Transaction has expired without any such action being announced or taken. The Company and Purchaser shall respond to all CFIUS inquiries in a timely manner. Each of the Company and Purchaser shall bear its own fees and costs (including all filing fees) in connection with such party’s CFIUS Filing.
(ii)
All analyses, appearances, meetings, discussions, presentations, memoranda, briefs, filings, arguments, and proposals made by or on behalf of the Company and Purchaser before any Governmental Authority or the staff or regulators of any Governmental Authority, in connection with the transactions contemplated hereunder (but, for the avoidance of doubt, not including any interactions between a the Company with Governmental Authorities in the ordinary course of business, any disclosure which is not permitted by Law or any disclosure containing confidential information) shall be disclosed to the other party hereunder in advance of any filing, submission or attendance, it being the intent that the Company and Purchaser will consult and cooperate with one another, and consider in good faith the views of one another, in connection with any such analyses, appearances, meetings, discussions, presentations, memoranda, briefs, filings, arguments and proposals. Each of the Company and Purchaser shall give notice to the other party with respect to any meeting, discussion, appearance or contact with any Governmental Authority or the staff or regulators of any Governmental Authority, with such notice being sufficient to provide the other party with the opportunity to attend and participate in such meeting, discussion, appearance or contact.
(iii)
Without limiting the generality of Purchaser’s undertaking pursuant to this Section 5(e), Purchaser agrees to use its reasonable best efforts to avoid or eliminate each and every impediment under any antitrust, competition or trade regulation law that may be asserted by any Governmental Authority or any other party so as to enable the Company and Purchaser to close the transactions contemplated by this Agreement as promptly as possible.
(iv)
Notwithstanding the foregoing, nothing in this Section 5(e) shall require, or be construed to require, the Company, Purchaser or any of their respective affiliates to agree to (i) sell, hold, divest, discontinue or limit, before or after the Closing Date, any assets, businesses or interests of Purchaser or any of its affiliates; (ii) any conditions relating to, or changes or restrictions in, the operations of any such assets, businesses or interests which, in either case, could reasonably be expected to materially and adversely impact the economic or business benefits to the Company or Purchaser of the transactions contemplated by this Agreement and the Asset Purchase Agreement; or (iii) any material modification or waiver of the terms and conditions of this Agreement.

 

-28-

 


 

(f)
Removal of Legends.
(i)
In connection with any sale, assignment, transfer or other disposition of the Shares by the Purchaser pursuant to Rule 144 or pursuant to any other exemption under the Securities Act such that the purchaser acquires freely tradable shares and upon compliance by the Purchaser with the requirements of this Agreement, if requested by the Purchaser, the Company shall request the Transfer Agent to remove any restrictive legends related to the book entry account holding such shares and make a new, unlegended entry for such book entry shares sold or disposed of without restrictive legends as soon as reasonably practicable following any such request therefor from the Purchaser, provided that the Company has timely received from the Purchaser customary representations and other documentation reasonably acceptable to the Company in connection therewith. The Company shall be responsible for the fees of its Transfer Agent, its legal counsel and all DTC fees associated with such legend removal.
(ii)
Subject to receipt from the Purchaser by the Company and the Transfer Agent of customary representations and other documentation reasonably acceptable to the Company and the Transfer Agent in connection therewith, upon the earliest of such time as the Shares (i) have been registered under the Securities Act pursuant to an effective registration statement, (ii) have been sold pursuant to Rule 144, and (iii) are eligible for resale under Rule 144(b)(1) without the requirement for the Company to be in compliance with the current public information requirements under Rule 144(c)(1) (or any successor thereto), the Company shall, in accordance with the provisions of this Section 5(f) and as soon as reasonably practicable following any request therefor from a Purchaser accompanied by such customary and reasonably acceptable documentation referred to above, (A) deliver to the Transfer Agent instructions that the Transfer Agent shall make a new, unlegended entry for such book entry shares, and (B) cause its counsel to deliver to the Transfer Agent one or more opinions to the effect that the removal of such legends in such circumstances may be effected under the Securities Act if required by the Transfer Agent to effect the removal of the legend in accordance with the provisions of this Agreement. Any shares subject to legend removal under this Section 5(f) may be transmitted by the Transfer Agent to the Purchaser by crediting the account of the Purchaser’s prime broker with the DTC System as directed by such Purchaser. The Company shall be responsible for the fees of its Transfer Agent and all DTC fees associated with such issuance.
(g)
Further Assurances. Each party agrees to cooperate with each other and their respective officers, employees, attorneys, accountants and other agents, and, generally, do such other reasonable acts and things in good faith as may be necessary to effectuate the intents and purposes of this Agreement, subject to the terms and conditions hereof and compliance with applicable law, including taking reasonable action to facilitate the filing of any document or the taking of reasonable action to assist the other parties hereto in complying with the terms hereof. The Purchaser acknowledges that the Company will rely on the acknowledgments, understandings, agreements, representations and warranties contained in this Agreement. Prior to the Closing, the Company agrees to promptly notify Purchaser if any of the acknowledgments, understandings, agreements, representations and warranties set forth in Section 3 of this Agreement are no longer accurate. Prior to the Closing, Purchaser agrees to promptly notify the Company if any of the acknowledgments, understandings, agreements, representations and warranties set forth in Section 4 of this Agreement are no longer accurate.

-29-

 


 

6.
CONDITIONS TO PURCHASER’S OBLIGATIONS AT CLOSING. The obligations of Purchaser under Section 1(b) of this Agreement are subject to the fulfillment or waiver, on or before the Closing, of each of the following conditions:
(a)
Representations and Warranties True. Each of the representations and warranties of the Company contained in Section 3 shall be true and correct in all material respects on and as of the date hereof (provided, however, that such qualification shall only apply to representations or warranties not otherwise qualified by materiality) and on and as of the date of the Closing with the same effect as though such representations and warranties had been made as of the Closing (except for representations and warranties that speak as of a specific date).
(b)
Performance. The Company shall have performed and complied in all material respects with all agreements, obligations and conditions contained in this Agreement that are required to be performed or complied with by it on or before the Closing and shall have obtained all approvals, consents and qualifications necessary to complete the purchase and sale described herein; provided, however, that the Company may furnish to Purchaser an electronic copy of the book-entry statement reflecting the issuance of the Purchased Shares on the next business day.
(c)
Compliance Certificate. The Company will have delivered to Purchaser a certificate signed on its behalf by its Chief Executive Officer or Principal Financial Officer certifying that the conditions specified in Sections 6(a) and 6(b) hereof have been fulfilled.
(d)
Agreement. The Company shall have executed and delivered to Purchaser this Agreement.
(e)
Securities Exemptions. The offer and sale of the Purchased Shares to Purchaser pursuant to this Agreement shall be exempt from the registration requirements of the Securities Act and the registration and/or qualification requirements of all applicable state securities laws.
(f)
No Suspension of Trading or Listing of Common Stock. The Common Stock of the Company (i) shall be designated for quotation or listed on Nasdaq and (ii) shall not have been suspended from trading on Nasdaq.
(g)
Good Standing Certificates. The Company shall have delivered to Purchaser a certificate of the Secretary of State of the State of Delaware, dated as of a date within five days of the date of the Closing, with respect to the good standing of the Company.
(h)
Secretary’s Certificate. The Company shall have delivered to Purchaser a copy of a certificate of the Company executed by the Company’s Secretary attaching and certifying to the truth and correctness of (A) the Certificate of Incorporation, (B) the Bylaws and (C) the resolutions adopted by the Company’s Board of Directors in connection with the transactions contemplated by this Agreement.
(i)
Opinion of Company Counsel. The Company shall have delivered to the Purchaser the opinion and negative assurance representation of Ropes & Gray LLP, dated as of the Closing Date in customary form and substance to be reasonably agreed upon with the Purchaser.

-30-

 


 

(j)
No Statute or Rule Challenging Transaction. No statute, rule, regulation, executive order, decree, ruling, injunction, action, proceeding or interpretation shall have been enacted, entered, promulgated, endorsed or adopted by any court or governmental authority of competent jurisdiction or any self-regulatory organization or the staff of any of the foregoing, having authority over the matters contemplated hereby which questions the validity of, or challenges or prohibits the consummation of, any of the transactions contemplated by this Agreement.
(k)
Governmental Approvals. All required filings have been made and required approvals obtained (or waiting periods expired or terminated) under applicable laws, including but not limited to the HSR Act and CFIUS.
(l)
Closing of Asset Purchase. All conditions precedent to the consummation of the transaction (“Asset Purchase”) set forth in the Asset Purchase Agreement by and between the parties (or their affiliates) shall have been satisfied or waived by the party entitled to the benefit thereof (other than those conditions that (x) may only be satisfied at the consummation of the Asset Purchase, but subject to the satisfaction or waiver of such conditions as of the closing of the Asset Purchase or (y) will be satisfied by the Closing), and the Asset Purchase shall become effective substantially concurrently with the transaction herein.
(m)
Other Actions. The Company shall have executed such certificates, agreements, instruments and other documents, and taken such other actions as shall be customary or reasonably requested by Purchaser in connection with the transactions contemplated hereby.
7.
CONDITIONS TO THE COMPANY’S OBLIGATIONS AT CLOSING. The obligations of the Company to Purchaser under this Agreement are subject to the fulfillment or waiver, on or before the Closing, of each of the following conditions:
(a)
Representations and Warranties True. The representations and warranties of Purchaser contained in Section 4 shall be true and correct in all material respects on and as of the date hereof (provided, however, that such qualification shall only apply to representations and warranties not otherwise qualified by materiality) and on and as of the date of the Closing with the same effect as though such representations and warranties had been made as of the Closing.
(b)
Performance. Purchaser shall have performed and complied in all material respects with all agreements, obligations and conditions contained in this Agreement that are required to be performed or complied with by it on or before the Closing and shall have obtained all approvals, consents and qualifications necessary to complete the purchase and sale described herein.
(c)
Agreement. Purchaser shall have executed and delivered to the Company this Agreement (and Appendix I and II hereto).

-31-

 


 

(d)
Securities Exemptions. The offer and sale of the Purchased Shares to Purchaser pursuant to this Agreement shall be exempt from the registration requirements of the Securities Act and the registration and/or qualification requirements of all applicable state securities laws.
(e)
Payment of Purchase Price. Purchaser shall have delivered to the Company by wire transfer of immediately available funds to the Company’s account pursuant to wire instructions set forth in Exhibit A attached hereto, full payment of the purchase price for the Purchased Shares as specified in Section 1(b).
(f)
Other Actions. Purchaser shall have executed such certificates, agreements, instruments and other documents, and taken such other actions as shall be customary or reasonably requested by the Company in connection with the transactions contemplated hereby.
(g)
No Statute or Rule Challenging Transaction. No statute, rule, regulation, executive order, decree, ruling, injunction, action, proceeding or interpretation shall have been enacted, entered, promulgated, endorsed or adopted by any court or governmental authority of competent jurisdiction or any self-regulatory organization or the staff of any of the foregoing, having authority over the matters contemplated hereby which questions the validity of, or challenges or prohibits the consummation of, any of the transactions contemplated by this Agreement.
8.
TERMINATION.

This Agreement shall terminate and be void and of no further force and effect, and all obligations of the parties hereunder shall terminate without any further liability on the part of any party in respect thereof, upon the earliest to occur of (a) such date and time that the Asset Purchase Agreement, dated as of the date hereof, by and between the parties here to, is terminated in accordance with its terms and (b) if, on the closing date of the transactions contemplated by the Asset Purchase Agreement, any of the conditions of Closing set forth in Section 6 have not been satisfied as of the time required hereunder to be so satisfied or waived by the party entitled to grant such waiver, or are not capable of being satisfied and, as a result thereof, the transactions contemplated by this Agreement will not be and are not consummated, provided however, that nothing herein shall relieve any party to this Agreement of any liability for common law fraud or for any willful breach of any representation, warranty, covenant, obligation, or other provision contained in this Agreement and each party will be entitled to any remedies at law or in equity to recover losses, liabilities, or damages arising from any such willful breach. Upon the termination of this Agreement in accordance with this Section, except as set forth in the proviso to the immediately preceding sentence, this Agreement shall be void and of no further effect and any portion of the Purchase Price paid by the Purchaser to the Company in connection herewith shall promptly be returned to the Purchaser.

 

9.
MISCELLANEOUS.
(a)
Successors and Assigns. The terms and conditions of this Agreement will inure to the benefit of and be binding upon the respective successors and permitted assigns of the parties.

-32-

 


 

The Company shall not assign this Agreement or any rights or obligations hereunder without the prior written consent of Purchaser. Purchaser may assign its rights under this Agreement to any person to whom Purchaser assigns or transfers any Purchased Shares, provided that such transferee agrees in writing to be bound by the terms and provisions of this Agreement, and such transfer is in compliance with the terms and provisions of this Agreement and permitted by federal and state securities laws.
(b)
Governing Law. This Agreement will be governed by and construed and enforced under the internal laws of the State of Delaware, without reference to principles of conflict of laws or choice of laws. Any and all disputes arising out of, concerning, or related to this Agreement, or to the interpretation, performance, breach or termination thereof shall be referred to and resolved by the federal courts located in Wilmington, Delaware or, to the extent no such court does not have subject matter jurisdiction, the state courts of the State of Delaware located in Wilmington, Delaware (the “Specified Courts”). Each of the parties hereto irrevocably and unconditionally submits to the exclusive jurisdiction of the Specified Courts, waives any objection to the laying of venue of any suit, action or proceeding brought in such courts and waives any claim that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum. EACH PARTY HEREBY IRREVOCABLY WAIVES ANY RIGHT IT MAY HAVE, AND AGREES NOT TO REQUEST, A JURY TRIAL FOR THE ADJUDICATION OF ANY DISPUTE HEREUNDER OR IN CONNECTION HEREWITH OR ARISING OUT OF THIS AGREEMENT OR ANY TRANSACTION CONTEMPLATED HEREBY. THIS SECTION HAS BEEN FULLY DISCUSSED BY EACH OF THE PARTIES HERETO AND THESE PROVISIONS WILL NOT BE SUBJECT TO ANY EXCEPTIONS. EACH PARTY HERETO HEREBY FURTHER WARRANTS AND REPRESENTS THAT SUCH PARTY HAS REVIEWED THIS WAIVER WITH ITS LEGAL COUNSEL, AND THAT SUCH PARTY KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS FOLLOWING CONSULTATION WITH LEGAL COUNSEL.
(c)
Counterparts. This Agreement may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. Signatures to this Agreement transmitted by email in “portable document format” (“.pdf”) or by any other electronic means intended to preserve the original graphic and pictorial appearance of this Agreement shall have the same effect as physical delivery of the paper document bearing original signature.
(d)
Headings. The headings and captions used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement. All references in this Agreement to sections, paragraphs, exhibits and schedules will, unless otherwise provided, refer to sections and paragraphs hereof and exhibits and schedules attached hereto, all of which exhibits and schedules are incorporated herein by reference.
(e)
Notices. Any notices and other communications required or permitted under this Agreement shall be in writing and shall be delivered (i) personally by hand or by courier, (ii) mailed by United States first-class mail, postage prepaid or (iii) sent by electronic mail (1) if to Purchaser, at Purchaser’s address or electronic mail address set forth below, or at such address or electronic mail address as Purchaser may designate by giving at least ten (10) days’ advance written notice to the Company or (2) if to the Company, to its address or electronic mail address set forth below, or at such other address or electronic mail address as the Company may designate by giving at least ten (10) days’ advance written notice to Purchaser.

-33-

 


 

All such notices and other communications shall be deemed given upon (i) receipt or refusal of receipt, if delivered personally, (ii) three (3) days after being placed in the mail, if mailed, or (iii) transmission, if by electronic mail.

The address of the Company for the purpose of this Section 8(e) is as follows:

Agenus Inc.
3 Forbes Road
Lexington, Massachusetts 02421
Tel: 781.674.4400

Attention: Garo H. Armen

Email: [***]

 

The address of the Purchaser for the purpose of this Section 8(e) is as follows:

 

Zynext Ventures USA LLC

73 Route 31N

Pennington, NJ 08534

Tel: 609.730.1900

Attention: Ravi Yadavar, Board of Managers

Email: [***]

 

With a copy at the same address to:

Attention: Crystal Fisher, Secretary
Email: [***]

 

(f)
Amendments and Waivers. This Agreement may be amended and the observance of any term of this Agreement may be waived only with the written consent of the Company and Purchaser; provided that any provision for the sole benefit of the Company may be waived by the Company. Any amendment effected in accordance with this Section 8(f) will be binding upon Purchaser, the Company and their respective successors and permitted assigns.
(g)
Severability. If any provision of this Agreement is held to be unenforceable under applicable law, such provision will be excluded from this Agreement and the balance of the Agreement will be interpreted as if such provision were so excluded and will be enforceable in accordance with its terms.
(h)
Entire Agreement. This Agreement, together with all exhibits and schedules hereto and thereto constitutes the entire agreement and understanding of the parties with respect to the subject matter hereof and supersedes any and all prior negotiations, correspondence, agreements, understandings, duties or obligations between the parties with respect to the subject matter hereof.
(i)
Meaning of Include and Including. Whenever in this Agreement the word “include” or “including” is used, it shall be deemed to mean “include, without limitation” or “including, without limitation,” as the case may be, and the language following “include” or “including” shall not be deemed to set forth an exhaustive list.

-34-

 


 

(j)
Fees, Costs and Expenses. Except as otherwise provided for in this Agreement, all fees, costs and expenses (including attorneys’ fees and expenses) incurred by any party hereto in connection with the preparation, negotiation and execution of this Agreement and the exhibits and schedules hereto and the consummation of the transactions contemplated hereby and thereby (including the costs associated with any filings with, or compliance with any of the requirements of any governmental authorities), shall be the sole and exclusive responsibility of such party.
(k)
8-K Filing and Publicity. As soon as practicable following the execution of this Agreement but in no event later than 9:30 a.m. Eastern Time on the day following the execution of this Agreement, with the prior review by Purchaser, the Company shall file a Current Report on Form 8-K with the SEC describing the transaction contemplated by this Agreement as an exhibit to such filing (the “8-K Filing” including all attachments); provided that the Company shall consider any comments from Purchaser to the 8-K Filing in good faith. Neither the Company nor any Purchaser shall issue any press releases or any other public statements with respect to the transaction contemplated by this Agreement without the prior consent of the other party; provided, however, that the Company shall be entitled, (i) without the prior approval of any Purchaser, to issue any press release or make any other public disclosure (including a press release pursuant to Rule 135(c) under the Securities Act) in substantial conformity with the 8-K Filing or (ii) with the prior review of Purchaser, if permitted by law, to issue any press release or other public disclosure as is required by applicable law, regulations, and Nasdaq rules; provided that the Company shall consider any comments to a press release or other public disclosure from Purchaser in good faith.
(l)
Stock Splits, Dividends and other Similar Events. The provisions of this Agreement shall be appropriately adjusted to reflect any stock split, stock dividend, reorganization or other similar event that may occur with respect to the Company after the date hereof and prior to the Closing Date.
(m)
Remedies. In addition to being entitled to exercise all rights provided herein, Purchaser and the Company will be entitled to specific performance under this Agreement. The parties agree that monetary damages may not be adequate compensation for any loss incurred by reason of any breach of obligations described in the foregoing sentence and hereby agrees to waive in any action for specific performance of any such obligation the defense that a remedy at law would be adequate.

[Remainder of page intentionally left blank.]

* * *

-35-

 


 

IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date and year first above written.

AGENUS INC.

 

 

By: /s/ Garo Armen

Name: Garo H. Armen

Title: Chief Executive Officer and President of the Board of Directors

 

 

 

 

ZYNEXT VENTURES USA LLC

 

 

By: /s/ Jay Kothari

Name: Jay Kothari

Title: Manager

 

 

[Securities Purchase Agreement]

 


 

 

EXHIBIT A

COMPANY WIRE INSTRUCTIONS

 

[***]

37

 


 

Schedule 3(g)

[***]

38

 


 

APPENDIX I

AGENUS INC.

SHARE ISSUANCE QUESTIONNAIRE

 

[***]

39

 


 

APPENDIX II

 

AGENUS INC.

REGISTRATION STATEMENT QUESTIONNAIRE

 

[***]

40

 


EX-31.1 5 agen-ex31_1.htm EX-31.1 EX-31.1

 

Exhibit 31.1

Certification Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended

I, Garo H. Armen, certify that:

1.
I have reviewed this Quarterly Report on Form 10-Q of Agenus Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
4.
The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
a.
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles;
c.
evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.
disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and
5.
The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent function):
a.
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
b.
any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

 

 

Date: August 11, 2025

 

/s/ GARO H. ARMEN, PH.D.

 

 

 

Garo H. Armen, Ph.D.

 

 

 

Chief Executive Officer and Principal Executive Officer

 

 


EX-31.2 6 agen-ex31_2.htm EX-31.2 EX-31.2

 

Exhibit 31.2

Certification Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended

I, Christine M. Klaskin, certify that:

1.
I have reviewed this Quarterly Report on Form 10-Q of Agenus Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
4.
The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
a.
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles;
c.
evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.
disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and
5.
The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent function):
a.
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
b.
any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

 

 

Date: August 11, 2025

 

/s/ CHRISTINE M. KLASKIN

 

 

 

Christine M. Klaskin

 

 

 

VP, Finance and Principal Financial Officer

 

 


EX-32.1 7 agen-ex32_1.htm EX-32.1 EX-32.1

 

Exhibit 32.1

Certification

Pursuant to 18 U.S.C. Section 1350,

As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the Quarterly Report on Form 10-Q of Agenus Inc. (the “Company”) for the quarterly period ended June 30, 2025 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned to his/her knowledge hereby certifies, pursuant to 18 U.S.C. Section 1350, that:

(i)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(ii)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

/s/ GARO H. ARMEN, PH.D.

 

Garo H. Armen, Ph.D.

 

Chief Executive Officer and Principal Executive Officer

 

 

 

/s/ CHRISTINE M. KLASKIN

 

Christine M. Klaskin

 

VP, Finance and Principal Financial Officer

Date: August 11, 2025

A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

The foregoing certification is being furnished to the Securities and Exchange Commission as an exhibit to the Report and should not be considered filed as part of the Report.