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 September 30, 2018

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

 

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 November 2, 2018: 119,982,965 shares

 

 

 

 


Agenus Inc.

Nine Months Ended September 30, 2018

Table of Contents

 

 

 

 

 

Page

PART I

 

 

ITEM 1.

 

Financial Statements:

 

2

 

 

Condensed Consolidated Balance Sheets as of September 30, 2018 (Unaudited) and December 31, 2017

 

2

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2018 and 2017 (Unaudited)

 

3

 

 

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2018 and 2017 (Unaudited)

 

4

 

 

Notes to Unaudited Condensed Consolidated Financial Statements

 

5

ITEM 2.

 

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

 

23

ITEM 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

28

ITEM 4.

 

Controls and Procedures

 

29

 

 

 

PART II

 

 

ITEM 1A.

 

Risk Factors

 

30

ITEM 6.

 

Exhibits

 

53

 

 

Signatures

 

54

 

 

 

 


PART I - FINANCIAL INFORMATION

Item 1.

Financial Statements

AGENUS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

 

 

September 30, 2018

 

 

December 31, 2017

 

ASSETS

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

46,169,404

 

 

$

60,186,617

 

Inventories

 

 

55,491

 

 

 

79,491

 

Accounts receivable

 

 

6,068,854

 

 

 

1,134,493

 

Prepaid expenses

 

 

14,530,053

 

 

 

11,070,960

 

Other current assets

 

 

811,925

 

 

 

1,081,993

 

Total current assets

 

 

67,635,727

 

 

 

73,553,554

 

Property, plant and equipment, net of accumulated amortization and depreciation of

   $37,108,300 and $34,029,085 at September 30, 2018 and December 31, 2017, respectively

 

 

25,838,782

 

 

 

26,178,622

 

Goodwill

 

 

22,959,112

 

 

 

23,048,804

 

Acquired intangible assets, net of accumulated amortization of $6,998,903 and

   $5,461,834 at September 30, 2018 and December 31, 2017, respectively

 

 

12,827,224

 

 

 

14,406,650

 

Other long-term assets

 

 

1,214,394

 

 

 

1,214,394

 

Total assets

 

$

130,475,239

 

 

$

138,402,024

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

 

 

Current portion, long-term debt

 

$

146,061

 

 

$

20,639,735

 

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

 

 

23,920,667

 

 

 

 

Current portion, deferred revenue

 

 

843,150

 

 

 

4,484,882

 

Accounts payable

 

 

11,146,451

 

 

 

8,086,992

 

Accrued liabilities

 

 

21,665,078

 

 

 

21,569,449

 

Other current liabilities

 

 

468,978

 

 

 

1,657,063

 

Total current liabilities

 

 

58,190,385

 

 

 

56,438,121

 

Long-term debt, net of current portion

 

 

13,053,895

 

 

 

142,385,024

 

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

 

 

183,322,966

 

 

 

 

Deferred revenue, net of current portion

 

 

1,469,131

 

 

 

7,748,284

 

Contingent purchase price considerations

 

 

2,917,000

 

 

 

4,373,000

 

Other long-term liabilities

 

 

2,914,480

 

 

 

3,273,387

 

Commitments and contingencies

 

 

 

 

 

 

 

 

STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

 

 

Preferred stock, par value $0.01 per share; 5,000,000 shares authorized:

 

 

 

 

 

 

 

 

Series A-1 convertible preferred stock; 31,620 shares designated, issued, and

   outstanding at September 30, 2018 and December 31, 2017; liquidation value

   of $32,780,230 at September 30, 2018

 

 

316

 

 

 

316

 

Common stock, par value $0.01 per share; 240,000,000 shares authorized; 118,352,706

   and 101,706,117 shares issued at September 30, 2018 and December 31, 2017,

   respectively

 

 

1,183,527

 

 

 

1,017,061

 

Additional paid-in capital

 

 

999,580,589

 

 

 

951,811,958

 

Accumulated other comprehensive loss

 

 

(1,615,893

)

 

 

(2,169,354

)

Accumulated deficit

 

 

(1,129,556,515

)

 

 

(1,026,475,773

)

Total stockholders’ deficit attributable to Agenus Inc.

 

 

(130,407,976

)

 

 

(75,815,792

)

Non-controlling interest

 

 

(984,642

)

 

 

 

Total stockholders’ deficit

 

 

(131,392,618

)

 

 

(75,815,792

)

Total liabilities and stockholders’ deficit

 

$

130,475,239

 

 

$

138,402,024

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

2


AGENUS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

 

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

6,276,136

 

 

$

3,359,399

 

 

$

18,385,111

 

 

$

34,522,815

 

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

 

 

6,526,291

 

 

 

 

 

 

11,947,982

 

 

 

 

Total revenues

 

 

12,802,427

 

 

 

3,359,399

 

 

 

30,333,093

 

 

 

34,522,815

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

(29,854,310

)

 

 

(25,788,707

)

 

 

(88,569,123

)

 

 

(84,253,129

)

General and administrative

 

 

(9,203,406

)

 

 

(8,050,783

)

 

 

(27,616,079

)

 

 

(23,956,543

)

Contingent purchase price consideration fair value adjustment

 

 

180,000

 

 

 

(1,184,000

)

 

 

1,456,000

 

 

 

(123,000

)

Operating loss

 

 

(26,075,289

)

 

 

(31,664,091

)

 

 

(84,396,109

)

 

 

(73,809,857

)

Other expense:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss on early extinguishment of debt

 

 

 

 

 

 

 

 

(10,766,625

)

 

 

 

Non-operating (expense) income

 

 

(117,172

)

 

 

(472,745

)

 

 

(1,489,835

)

 

 

1,917,200

 

Interest expense, net

 

 

(7,538,096

)

 

 

(4,704,871

)

 

 

(16,542,911

)

 

 

(13,765,271

)

Net loss

 

 

(33,730,557

)

 

 

(36,841,707

)

 

 

(113,195,480

)

 

 

(85,657,928

)

Dividends on Series A-1 convertible preferred stock

 

 

(51,752

)

 

 

(51,426

)

 

 

(155,011

)

 

 

(154,034

)

Less: net loss attributable to non-controlling interest

 

 

(604,887

)

 

 

 

 

 

(1,258,242

)

 

 

 

Net loss attributable to Agenus Inc. common stockholders

 

$

(33,177,422

)

 

$

(36,893,133

)

 

$

(112,092,249

)

 

$

(85,811,962

)

Per common share data:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

$

(0.29

)

 

$

(0.37

)

 

$

(1.04

)

 

$

(0.88

)

Weighted average number of Agenus Inc. common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

114,977,416

 

 

 

99,891,980

 

 

 

107,601,000

 

 

 

97,557,409

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation (loss) gain

 

$

(38,276

)

 

$

231,177

 

 

$

553,461

 

 

$

(529,118

)

Other comprehensive (loss) income

 

 

(38,276

)

 

 

231,177

 

 

 

553,461

 

 

 

(529,118

)

Comprehensive loss

 

$

(33,215,698

)

 

$

(36,661,956

)

 

$

(111,538,788

)

 

$

(86,341,080

)

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

 

3


AGENUS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

 

Nine Months Ended September 30,

 

 

 

2018

 

 

2017

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(113,195,480

)

 

$

(85,657,928

)

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

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

4,744,672

 

 

 

4,561,815

 

Share-based compensation

 

 

5,694,829

 

 

 

7,083,948

 

Non-cash royalty revenue

 

 

(11,947,982

)

 

 

 

Non-cash interest expense

 

 

16,063,404

 

 

 

13,360,630

 

Loss (gain) on disposal of assets

 

 

117,817

 

 

 

(19,822

)

Gain on issuance of stock for settlement of milestone obligation

 

 

 

 

 

(14,063

)

Change in fair value of contingent obligations

 

 

(1,456,000

)

 

 

123,000

 

Loss on extinguishment of debt

 

 

10,766,625

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(4,934,361

)

 

 

9,160,979

 

Inventories

 

 

24,000

 

 

 

7,959

 

Prepaid expenses

 

 

(3,469,828

)

 

 

(8,178,360

)

Accounts payable

 

 

2,882,184

 

 

 

1,006,808

 

Deferred revenue

 

 

(1,064,391

)

 

 

(2,006,858

)

Accrued liabilities and other current liabilities

 

 

222,462

 

 

 

(5,962,198

)

Other operating assets and liabilities

 

 

269,216

 

 

 

(1,823,880

)

Net cash used in operating activities

 

 

(95,282,833

)

 

 

(68,357,970

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Proceeds from sale of plant and equipment

 

 

6,187

 

 

 

120,000

 

Purchases of plant and equipment

 

 

(2,995,572

)

 

 

(2,366,429

)

Purchases of held-to-maturity securities

 

 

 

 

 

(14,936,047

)

Proceeds from securities held-to-maturity

 

 

 

 

 

15,000,000

 

Net cash used in investing activities

 

 

(2,989,385

)

 

 

(2,182,476

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Net proceeds from sale of equity

 

 

41,279,969

 

 

 

63,677,302

 

Proceeds from employee stock purchases and option exercises

 

 

1,233,900

 

 

 

833,982

 

Purchase of treasury shares to satisfy tax withholdings

 

 

 

 

 

(527,223

)

Proceeds from sale of future royalties

 

 

204,878,400

 

 

 

 

Transaction costs from sale of future royalties and milestones

 

 

(494,394

)

 

 

 

Repayments of debt

 

 

(161,847,220

)

 

 

 

Payment of capital lease obligation

 

 

(193,164

)

 

 

(216,982

)

Net cash provided by financing activities

 

 

84,857,491

 

 

 

63,767,079

 

Effect of exchange rate changes on cash

 

 

(602,486

)

 

 

400,708

 

Net (decrease) increase in cash and cash equivalents

 

 

(14,017,213

)

 

 

(6,372,659

)

Cash and cash equivalents, beginning of period

 

 

60,186,617

 

 

 

71,448,016

 

Cash and cash equivalents, end of period

 

$

46,169,404

 

 

$

65,075,357

 

Supplemental cash flow information:

 

 

 

 

 

 

 

 

Cash paid for interest

 

$

837,699

 

 

$

837,699

 

Supplemental disclosures - non-cash activities:

 

 

 

 

 

 

 

 

Purchases of plant and equipment in accounts payable and

   accrued liabilities

 

 

122,038

 

 

 

222,203

 

Issuance of common stock, $0.01 par value, issued in connection with the

   settlement of milestone obligation

 

 

 

 

 

1,485,937

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

4


AGENUS INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2018

 

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 immuno-oncology (“I-O”) company dedicated to becoming a leader in the discovery and development of innovative combination therapies and committed to bringing effective medicines to patients with cancer. Our business is designed to drive success in I-O through speed, innovation, and effective combination therapies. We have assembled fully integrated capabilities from novel target discovery, antibody generation, cell line development, and good manufacturing practice (“GMP”) manufacturing together with a comprehensive portfolio consisting of antibody-based therapeutics, adjuvants, cancer vaccine platforms, and cell therapy (through our subsidiary, AgenTus Therapeutics, Inc. (“AgenTus Therapeutics”)). We leverage our immune biology platforms to identify effective combination therapies for development and have developed productive partnerships to advance our innovation.  

We are developing a comprehensive I-O portfolio driven by the following platforms and programs, which we intend to utilize individually and in combination:

 

our antibody discovery platforms, including our Retrocyte Display™, SECANT ® yeast display, and phage display technologies designed to drive the discovery of future CPM antibody candidates;

 

our antibody candidate programs, including our CPM programs;

 

our vaccine programs, including Prophage™, AutoSynVax™ and PhosPhoSynVax ™;  

 

our saponin-based vaccine adjuvants, principally our QS-21 Stimulon ® adjuvant, or QS-21 Stimulon; and

 

our cell therapy subsidiary, AgenTus Therapeutics, which is designed to drive the discovery of future adoptive cell therapy, or “living drugs” (CAR-T and TCR) programs.

Our business activities include product research and development, intellectual property prosecution, manufacturing, regulatory and clinical affairs, corporate finance and development activities, and support of our collaborations. Our product candidates require 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 by continuing our existing arrangements with academic and corporate collaborators and licensees and by entering into new collaborations.

Our cash and cash equivalents at September 30, 2018 were $46.2 million, a decrease of $14.0 million from December 31, 2017.

The following table outlines our quarter end cash and cash equivalents balances and the changes therein (in millions).

 

 

 

Quarter Ended

 

 

 

March 31, 2018

 

 

June 30, 2018

 

 

September 30, 2018

 

Cash and cash equivalents

 

$

52.3

 

 

$

43.2

 

 

$

46.2

 

(Decrease) increase in cash and cash equivalents

 

$

(7.8

)

 

$

(9.2

)

 

$

3.0

 

Cash used in operating activities

 

$

(40.2

)

 

$

(30.5

)

 

$

(24.6

)

Reported net loss

 

$

(54.3

)

 

$

(25.2

)

 

$

(33.7

)

  We have incurred significant losses since our inception. As of September 30, 2018, we had an accumulated deficit of $1.1 billion. Since our inception, we have successfully financed our operations through the sale of equity, notes, corporate partnerships, and interest income. Based on our current plans, including the additional funding we received during October 2018 (see Note O), and funding we anticipate from other sources, including out-licensing and/or partnering opportunities, we believe that our cash resources of $46.2 million as of September 30, 2018 will be sufficient to satisfy our liquidity requirements into the second quarter of 2019. We also continue to monitor the likelihood of success of our key initiatives and can discontinue funding of such activities if they do not prove to be successful, restrict capital expenditures and/or reduce the scale of our operations if necessary. In spite of these anticipated sources of funding and our ability to control our cash burn, in accordance with the requirements of ASU 2014-15, we are required to disclose the existence of a substantial doubt regarding our ability to continue as a going concern for twelve months from when these financial statements were issued.

Our future liquidity needs will be determined primarily by the success of our operations with respect to the progression of our product candidates and key development and regulatory events in the future. Potential sources of additional funding include: (1) pursuing collaboration, out-licensing and/or partnering opportunities for our portfolio programs and product candidates with one or more third parties, (2) renegotiating third party agreements, (3) selling assets, (4) securing additional debt financing and/or (5) selling

5


equity securities. We believe the execution of one or more of these transactions will enable us to fund our planned operations for at least one year from when these financial statements were issued. Our ability to address our liquidity needs will largely be determined by the success of ou r product candidates and key development and regulatory events and our decisions in the future as well as the execution of one or more of the aforementioned contemplated transactions.

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 nine months ended September 30, 2018, are not necessarily indicative of the results that may be expected for the year ending December 31, 2018. 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, 2017 filed with the Securities and Exchange Commission (the “SEC”) on March 16, 2018.

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 loss in total stockholders’ deficit.

 

Note B - Summary of Significant Accounting Policies

Except as detailed below, there have been no material changes to our significant accounting policies during the nine months ended September 30, 2018, as compared to the significant accounting policies disclosed in Note 2 of the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017.

     Revenue

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes existing revenue recognition guidance. We adopted ASU 2014-09 and its related amendments (collectively known as “ASC 606”) on January 1, 2018 using the modified retrospective method- i.e., by recognizing the cumulative effect of initially applying ASC 606 as an adjustment to the opening balance of equity at January 1, 2018. The reported results for 2018 reflect the application of ASC 606 guidance while the reported results for 2017 were prepared under the guidance of ASC 605, Revenue Recognition (“ASC 605”). The adoption of ASC 606 represents a change in accounting principle that will more closely align revenue recognition with the delivery of our goods and services and will provide financial statement readers with enhanced disclosures. The details of the significant changes and quantitative impact of the changes are disclosed in Note J.

In accordance with ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods and services. To achieve this core principle, we apply the following five steps:

1) Identify the contract with the customer

A contract with a customer exists when (i) the Company enters into an enforceable contract with a customer that defines each party’s rights regarding the goods or services to be transferred and identifies the related payment terms, (ii) the contract has commercial substance, and (iii) the Company determines that collection of substantially all consideration for goods and services that are transferred is probable based on the customer’s intent and ability to pay the promised consideration. The Company applies judgment in determining the customer’s intent and ability to pay, which is based on a variety of factors including the customer’s historical payment experience, or in the case of a new customer, published credit and financial information pertaining to the customer.

2) Identify the performance obligations in the contract

6


Performance obligations promised in a contract are identified based on the goods and services that will be transferred to the customer that are both capable of being distinct, whereby the customer can benefit from the good or servi ce either on its own or together with other available resources, and are distinct in the context of the contract, whereby the transfer of the good or service is separately identifiable from other promises in the contract. To the extent a contract includes multiple promised goods and services, the Company must apply judgment to determine whether promised goods and services are capable of being distinct and are distinct in the context of the contract. If these criteria are not met, the promised goods and serv ices are accounted for as a combined performance obligation.

3) Determine the transaction price

The transaction price is determined based on the consideration to which the Company will be entitled in exchange for transferring goods and services to the customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing either the expected value method or the most likely amount method depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Any estimates, including the effect of the constraint on variable consideration, are evaluated at each reporting period for any changes. Determining the transaction price requires significant judgment, which is discussed in further detail for each of the Company’s contracts with customers in Note J.

4) Allocate the transaction price to performance obligations in the contract

If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price to each performance obligation on a relative stand-alone selling price basis unless the transaction price is variable and meets the criteria to be allocated entirely to a performance obligation or to a distinct service that forms part of a single performance obligation. The consideration to be received is allocated among the separate performance obligations based on relative stand-alone selling prices. Determining the amount of the transaction price to allocate to each separate performance obligation requires significant judgement, which is discussed in further detail for each of the Company’s contracts with customers in Note J.

5) Recognize revenue when or as the Company satisfies a performance obligation

The Company satisfies performance obligations either over time or at a point in time. Revenue is recognized over time if either 1) the customer simultaneously receives and consumes the benefits provided by the entity’s performance, 2) the entity’s performance creates or enhances an asset that the customer controls as the asset is created or enhanced, or 3) the entity’s performance does not create an asset with an alternative use to the entity and the entity has an enforceable right to payment for performance completed to date. If the entity does not satisfy a performance obligation over time, the related performance obligation is satisfied at a point in time by transferring the control of a promised good or service to a customer. Examples of control are using the asset to produce goods or services, enhance the value of other assets, settle liabilities, and holding or selling the asset. ASC 606 requires the Company to select a single revenue recognition method for the performance obligation that faithfully depicts the Company’s performance in transferring control of the goods and services. The guidance allows entities to choose between two methods to measure progress toward complete satisfaction of a performance obligation:

 

1.

Output methods - recognize revenue on the basis of direct measurements of the value to the customer of the goods or services transferred to date relative to the remaining goods or services promised under the contract (e.g. surveys of performance completed to date, appraisals of results achieved, milestones reached, time elapsed, and units of produced or units delivered); and

 

 

2.

Input methods - recognize revenue on the basis of the entity’s efforts or inputs to the satisfaction of a performance obligation (e.g., resources consumed, labor hours expended, costs incurred, or time elapsed) relative to the total expected inputs to the satisfaction of that performance obligation.

Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

7


Milestone payments: At the inception of each arrangement that includes development, regulatory or commercial milestone payments, the Company evaluates whether t he milestones are considered probable of being reached and estimates the amount to be included in the transaction price. ASC 606 suggests two alternatives to use when estimating the amount of variable consideration: the expected value method and the most l ikely amount method. Under the expected value method, an entity considers the sum of probability-weighted amounts in a range of possible consideration amounts. Under the most likely amount method, an entity considers the single most likely amount in a rang e of possible consideration amounts. Whichever method is used, it should be consistently applied throughout the life of the contract; however, it is not necessary for the Company to use the same approach for all contracts. The Company use s the most likely amount method for development and regulatory milestone payments. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. The transaction price is then allocated to each per formance obligation on a relative stand-alone selling price basis. The Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probabil ity or achievement of each such milestone and any related constraint, and if necessary, adjusts its estimates of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in th e period of adjustment.

Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

Up-front Fees: Depending on the nature of the agreement, up-front payments and fees may be recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts payable to the Company are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.

Impact of Adopting ASC 606 on Financial Statements

We adopted ASC 606 using the modified retrospective method. The cumulative effect of applying the new guidance to all contracts with customers that were not completed as of January 1, 2018 was recorded as an adjustment to accumulated deficit as of the adoption date. We elected to apply a practical expedient to reflect the aggregate effect of all modifications that occurred before January 1, 2018 when identifying the satisfied and unsatisfied performance obligations, determining the transaction price, and allocating the transaction price to the satisfied and unsatisfied performance obligations. The estimated effect of applying this practical expedient results in a slower recognition of the transaction price, as more consideration is allocated to performance obligations originally identified as a material right at contract inception. As a result of applying the modified retrospective method to adopt the new revenue guidance, the following adjustments were made to the consolidated balance sheet as of January 1, 2018 (in thousands):

 

 

 

As Reported December 31, 2017

 

 

ASC 606 Adjustment

 

 

Adjusted January 1, 2018

 

Consolidated Balance Sheet Data:

 

 

 

 

 

 

 

 

 

 

 

 

Current portion, deferred revenue

 

$

4,485

 

 

$

(2,986

)

 

$

1,499

 

Deferred revenue, net of current portion

 

 

7,748

 

 

 

(5,870

)

 

 

1,878

 

Accumulated deficit

 

$

(1,026,476

)

 

$

8,856

 

 

$

(1,017,620

)

 

Impact of ASC 606 on Financial Statements

In accordance with Topic 606, the disclosure of the impact of adoption to our condensed consolidated statements of income and balance sheets was as follows (in thousands):

 

8


 

 

Nine months ended September 30, 2018

 

 

 

As Reported Under ASC 606

 

 

Adjustments

 

 

Notes

 

 

Balances without Adoption of ASC 606

 

Consolidated Balance Sheet Data:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts receivable

 

$

6,069

 

 

$

(5,000

)

 

 

(1

)

 

$

1,069

 

Current portion, deferred revenue

 

 

843

 

 

 

1,045

 

 

 

(2

)

 

 

1,888

 

Deferred revenue, net of current portion

 

 

1,469

 

 

 

4,863

 

 

 

(2

)

 

 

6,332

 

Accumulated deficit

 

 

(1,129,557

)

 

 

(10,908

)

 

 

(3

)

 

 

(1,140,465

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Consolidated Statement of Operations Data:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development revenue

 

$

18,385

 

 

$

(2,051

)

 

 

(4

)

 

$

16,334

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended September 30, 2018

 

Consolidated Statement of Operations Data:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development revenue

 

$

6,276

 

 

$

(790

)

 

 

(4

)

 

$

5,486

 

 

(1)

Adjustment to accounts receivable to reflect a milestone recognized under ASC 606 and included in accounts receivable on September 30, 2018.

 

(2)

Adjustment to deferred revenue to reflect recognition of revenue under ASC 605 primarily attributable to the change in the timing of revenue recognition for amounts received under the Incyte Collaboration Agreement, see Note J.

 

(3)

Adjustment to accumulated deficit to reflect the reversal of the cumulative transition adjustment and the difference in revenue from ASC 606 to ASC 605, see Note J.

 

(4)

Adjustment to reflect the difference in revenue recognition from ASC 606 to ASC 605 primarily attributable to the timing of milestone recognition and the change in recognition of an upfront fee related to the GSK License and Amended Supply Agreements, see Note J.

 

Note C - 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 Directors’ Deferred Compensation Plan, or “DDCP”). Diluted income per common share is calculated by dividing net income 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, convertible preferred stock, and convertible notes. 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. Therefore, the following potentially dilutive securities have been excluded from the computation of diluted weighted average shares outstanding as of September 30, 2018 and 2017, as they would be anti-dilutive:

 

 

 

Three and Nine Months Ended September 30,

 

 

 

2018

 

 

2017

 

Warrants

 

 

2,900,000

 

 

 

4,351,450

 

Stock options

 

 

16,917,576

 

 

 

14,749,924

 

Non-vested shares

 

 

2,221,795

 

 

 

1,915,991

 

Convertible preferred stock

 

 

333,333

 

 

 

333,333

 

 

Note D - Investments

Cash equivalents consisted of the following as of September 30, 2018 and December 31, 2017 (in thousands):

 

 

 

September 30, 2018

 

 

December 31, 2017

 

 

 

Cost

 

 

Estimated

Fair Value

 

 

Cost

 

 

Estimated

Fair Value

 

Institutional money market funds

 

$

25,372

 

 

$

25,372

 

 

$

57,036

 

 

$

57,036

 

 

As a result of the short-term nature of our investments, there were minimal unrealized holding gains or losses for the three and nine months ended September 30, 2018 and 2017.

 

 

9


Note E - Goodwill and Acquired Intangible Assets

The following table sets forth the changes in the carrying amount of goodwill for the nine months ended September 30, 2018 (in thousands):

 

Balance, December 31, 2017

 

$

23,049

 

Foreign currency translation adjustment

 

 

(90

)

Balance, September 30, 2018

 

$

22,959

 

 

Acquired intangible assets consisted of the following as of September 30, 2018 and December 31, 2017 (in thousands):

 

 

 

As of September 30, 2018

 

 

 

Amortization

period

(years)

 

Gross carrying

amount

 

 

Accumulated

amortization

 

 

Net carrying

amount

 

Intellectual property

 

7-15 years

 

$

16,520

 

 

$

(5,684

)

 

$

10,836

 

Trademarks

 

4.5 years

 

 

821

 

 

 

(821

)

 

 

-

 

Other

 

2-6 years

 

 

569

 

 

 

(494

)

 

 

75

 

In-process research and development

 

Indefinite

 

 

1,916

 

 

 

 

 

 

1,916

 

Total

 

 

 

$

19,826

 

 

$

(6,999

)

 

$

12,827

 

 

 

 

As of December 31, 2017

 

 

 

Amortization

period

(years)

 

Gross carrying

amount

 

 

Accumulated

amortization

 

 

Net carrying

amount

 

Intellectual property

 

7-15 years

 

$

16,545

 

 

$

(4,290

)

 

$

12,255

 

Trademarks

 

4.5 years

 

 

826

 

 

 

(711

)

 

 

115

 

Other

 

2-6 years

 

 

570

 

 

 

(461

)

 

 

109

 

In-process research and development

 

Indefinite

 

 

1,928

 

 

 

 

 

 

1,928

 

Total

 

 

 

$

19,869

 

 

$

(5,462

)

 

$

14,407

 

 

The weighted average amortization period of our finite-lived intangible assets is 9 years. Amortization expense related to acquired intangibles is estimated at $0.5 million for the remainder of 2018 and $1.9 million for each of the years ending December 31, 2019, 2020, 2021 and 2022.

 

 

10


Note F - Debt

Debt obligations consisted of the following as of September 30, 2018 and December 31, 2017 (in thousands):  

 

Debt instrument

 

Principal at

September 30,

2018

 

 

Non-cash

Interest

 

 

Unamortized

Debt Issuance

Costs

 

 

Unamortized

Debt Discount

 

 

Balance at

September 30,

2018

 

Current Portion:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Debentures

 

$

146

 

 

$

 

 

$

 

 

$

 

 

$

146

 

Long-term Portion:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2015 Subordinated Notes

 

 

14,000

 

 

 

 

 

 

 

 

 

(946

)

 

 

13,054

 

Total

 

$

14,146

 

 

$

 

 

$

 

 

$

(946

)

 

$

13,200

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Debt instrument

 

Principal at

December 31,

2017

 

 

Non-cash

Interest

 

 

Unamortized

Debt Issuance

Costs

 

 

Unamortized

Debt Discount

 

 

Balance at

December 31,

2017

 

Current Portion:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Debentures

 

$

146

 

 

$

 

 

$

 

 

$

 

 

$

146

 

Note Purchase Agreement

 

 

15,000

 

 

 

5,494

 

 

 

 

 

 

 

 

 

20,494

 

Total current

 

 

15,146

 

 

 

5,494

 

 

 

 

 

 

 

 

 

20,640

 

Long-term Portion:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2015 Subordinated Notes

 

 

14,000

 

 

 

 

 

 

 

 

 

(1,375

)

 

 

12,625

 

Note Purchase Agreement

 

 

100,000

 

 

 

31,323

 

 

 

(1,362

)

 

 

(201

)

 

 

129,760

 

Total long-term

 

 

114,000

 

 

 

31,323

 

 

 

(1,362

)

 

 

(1,576

)

 

 

142,385

 

Total

 

$

129,146

 

 

$

36,817

 

 

$

(1,362

)

 

$

(1,576

)

 

$

163,025

 

 

We have capital lease agreements that expire in 2020 for equipment with a carrying value of approximately $950,000, which is included in property, plant and equipment, net on our condensed consolidated balance sheet. Under the terms of the capital lease agreements, we will remit payments to the lessors of $94,000 for the remainder of 2018, $375,000 for the year ending December 31, 2019 and $165,000 for the year ending December 31, 2020.  As of September 30, 2018, our remaining obligation under the capital lease agreements is approximately $550,000, of which $360,000 and $180,000 are classified as other current and other long-term liabilities, respectively, on our condensed consolidated balance sheet.

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”), whereby we received gross proceeds of $190.0 million (refer to Note G). Concurrently with the closing of the HCR Royalty Purchase Agreement, we used $161.9 million of these proceeds to redeem Antigenics’ $115.0 million principal amount of notes issued pursuant to the Note Purchase Agreement dated September 4, 2015 with Oberland Capital SA Zermatt LLC and the purchasers named therein (the “Note Purchase Agreement”), as well as the associated accrued and unpaid interest, and the Note Purchase Agreement and the notes issued thereunder were redeemed in full and terminated. In connection with this redemption, we recorded a $10.8 million loss on early extinguishment of debt which primarily reflects the payment of premiums to fully redeem the notes and the write-off of unamortized debt issuance costs and discounts.

 

 

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

 

The following table shows the activity within the liability account in the nine months ended September 30, 2018 (in thousands):

 

11


 

 

Nine months ended September 30, 2018

 

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

 

$

 

Proceeds from sale of future royalties and milestones

 

 

205,000

 

Non-cash royalty revenue

 

 

(11,948

)

Non-cash interest expense recognized

 

 

14,741

 

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

 

 

207,793

 

Less: unamortized transaction costs

 

 

(549

)

Liability related to sale of future royalties and milestones, net

 

$

207,244

 

 

Healthcare Royalty Partners

On January 6, 2018, we, through Antigenics, entered into the HCR Royalty Purchase Agreement with HCR, which closed on January 19, 2018. 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 QS-21 Stimulon adjuvant. At closing, we received gross proceeds of $190.0 million from HCR. As part of the transaction, we reimbursed HCR for transaction costs of $100,000 and incurred approximately $500,000 in transaction costs of our own, which are presented net of the liability in the consolidated balance sheet and will be amortized to interest expense over the estimated life of the HCR Royalty Purchase Agreement. 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 these royalties as revenue when earned, and we recorded the $190.0 million in proceeds from this transaction as a liability on our condensed consolidated balance sheet that will be amortized using the interest method 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 consolidated balance sheets based on the estimated recognition of the royalty payments to be received by HCR in the next 12 months from the financial statement reporting date.

During the nine months ended September 30, 2018, we recognized $11.9 million of non-cash royalty revenue, and we recorded $14.7 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. During the three months ended September 30, 2018, our estimate of the effective annual interest rate over the life of the agreement increased to 14.6%, which results in a prospective interest rate of 14.0%.

There are a number of factors that could materially affect the amount and timing of royalty payments from GSK, all of which are not within our control. Such factors include, but are not limited to, changing standards of care, the introduction of competing products, manufacturing or other delays, biosimilar competition, patent protection, adverse events that result in governmental health authority imposed restrictions on the use of the drug products, significant changes in foreign exchange rates, and other events or circumstances that could result in reduced royalty payments from GSK, all of which would result in a reduction of non-cash royalty revenues and the non-cash interest expense over the life of the HCR Royalty Purchase Agreement. Conversely, if sales of GSK’s vaccines containing QS-21 are more than expected, the non-cash royalty revenues and the non-cash interest expense recorded by us would be greater over the life of the HCR Royalty Purchase Agreement.

Pursuant to the HCR Royalty Purchase Agreement, we will also be entitled to receive up to $40.4 million in milestone payments 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 and (ii) $25.3 million upon reaching $2.75 billion last-twelve-months net sales any time prior to 2026.

Additionally, pursuant to the HCR Royalty Purchase Agreement, we would owe approximately $25.9 million to HCR in 2021 (the “Rebate Payment”) if neither of the following sales milestones are achieved: (i) 2019 sales exceed $1.0 billion or (ii) 2020 sales exceed $1.75 billion. As part of the transaction, we provided a guaranty for the potential Rebate Payment and secured the obligation with substantially all of our assets pursuant to a security agreement, subject to certain customary exceptions and excluding all assets necessary for AgenTus Therapeutics.

XOMA

12


On September 20, 2018, we, through our whol ly-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 paid us $15.0 million at c losin g in exchange for the right to receive 33% of the future royalties and 10% of the future milestones that we are entitled to receive from Incyte Corporation (“Incyte”) and Merck Sharpe & Dohme (“Merck”) under our a greements with each party (see Note J) , net of certain of our obligations to a third party and excluding the $5.0 million milestone from Incyte that we recognized in the quarter ended September 30, 2018 . We retain ed 90% of the future milestones and 67% of the future royalties under our agreements with Incyte and Merck. Although we sold our rights to receive 33% of future royalties an d 10% of future milestones, as a result of our significant continued involvement in the generation of the potential royalties and milestones, we are require d to account for the full amount of these royalties and milestones as revenue when earned, and we recorded the $15.0 million in proceeds from this transaction as a liability on our condensed consolidated balance sheet. Under the terms of the XOMA Royalty P urchase Agreement, s hould the percentage of milestones and royalties ultimately received by XOMA fail to repay the amount received by us at closing we would have no further obligation to XOMA.

 

Note H - Accrued Liabilities

Accrued liabilities consisted of the following as of September 30, 2018 and December 31, 2017 (in thousands):

 

 

 

September 30, 2018

 

 

December 31, 2017

 

Payroll

 

$

5,364

 

 

$

7,790

 

Professional fees

 

 

2,790

 

 

 

2,021

 

Contract manufacturing costs

 

 

5,883

 

 

 

5,528

 

Research services

 

 

6,260

 

 

 

4,663

 

Other

 

 

1,368

 

 

 

1,567

 

Total

 

$

21,665

 

 

$

21,569

 

 

 

Note I - Fair Value Measurements

We measure our contingent purchase price considerations at fair value.

The fair values of our contingent purchase price considerations, $2.9 million, 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 based on estimates from a Monte Carlo simulation of our market capitalization and share price, and other factors impacting the probability of triggering the milestone payments. Market capitalization and share price were evolved using a geometric Brownian motion, calculated daily for the life of the contingent purchase price considerations.

Liabilities measured at fair value are summarized below (in thousands):

 

Description

 

September 30, 2018

 

 

Quoted Prices in

Active

Markets for

Identical Assets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contingent purchase price considerations

 

$

2,917

 

 

$

 

 

$

 

 

$

2,917

 

Total

 

$

2,917

 

 

$

 

 

$

 

 

$

2,917

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Description

 

December 31, 2017

 

 

Quoted Prices in

Active

Markets for

Identical Assets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contingent purchase price consideration

 

$

4,373

 

 

$

 

 

$

 

 

$

4,373

 

Total

 

$

4,373

 

 

$

 

 

$

 

 

$

4,373

 

 

13


The following table presents our liabilities measured at fair value using significant unobservable inputs (Level 3), as of September 30, 2018 (in thousands):

 

Balance, December 31, 2017

 

$

4,373

 

Change in fair value of contingent purchase price considerations

   during the period

 

 

(1,456

)

Balance, September 30, 2018

 

$

2,917

 

The estimated fair values of all of our financial instruments, excluding our outstanding debt as of December 31, 2017, approximate their carrying amounts in our condensed consolidated balance sheets.

The fair value of our outstanding debt balance at September 30, 2018 and December 31, 2017 was $14.2 million and $205.9 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 September 30, 2018 and December 31, 2017 was $14.1 million and $129.1 million, respectively.

 

 

Note J - Revenue from Contracts with Customers

GSK License and Amended GSK Supply Agreements

In July 2006, we entered into a license agreement and a supply agreement with GSK for the use of QS-21 Stimulon (the “GSK License Agreement” and the “GSK Supply Agreement”, respectively). In January 2009, we entered into an Amended and Restated Manufacturing Technology Transfer and Supply Agreement (the “Amended GSK Supply Agreement”) under which GSK has the right to manufacture all of its requirements of commercial grade QS-21 Stimulon. GSK is obligated to supply us (or our affiliates, licensees, or customers) certain quantities of commercial grade QS-21 Stimulon for a stated period of time. Under these agreements, GSK paid an upfront license fee of $3.0 million and agreed to pay aggregate milestones of $5.0 million. In July 2007, the Amended GSK Supply Agreement was further amended, and we were paid an additional fixed fee of $7.3 million. In March 2012 we entered into a First Right to Negotiate and Amendment Agreement amending the GSK License Agreement and the Amended GSK Supply Agreement to clarify and include additional rights for the use of our QS-21 Stimulon (the “GSK First Right to Negotiate Agreement”). In addition, we granted GSK the first right to negotiate for the purchase of the Company or certain of our assets, which such rights expired in March 2017. As consideration for entering into the GSK First Right to Negotiate Agreement, GSK paid us an upfront, non-refundable payment of $9.0 million, $2.5 million of which is creditable toward future royalty payments. As of December 31, 2017, we had received all of the potential $24.3 million in upfront and milestone payments related to the GSK Agreements. We were also generally entitled to receive 2% royalties on net sales of prophylactic vaccines for a period of 10 years after the first commercial sale of a resulting GSK product, but we sold these royalty rights to HCR in January 2018 pursuant to the HCR Royalty Purchase Agreement (See Note G). The GSK License and Amended GSK Supply Agreements may be terminated by either party upon a material breach if the breach is not cured within the time specified in the respective agreement. The termination or expiration of the GSK License Agreement does not relieve either party from any obligation which accrued prior to the termination or expiration. Among other provisions, the license rights granted to GSK survive expiration of the GSK License Agreement. The license rights and payment obligations of GSK under the Amended GSK Supply Agreement survive termination or expiration, except that GSK's license rights and future royalty obligations do not survive if we terminate due to GSK's material breach unless we elect otherwise.

We assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, GSK, is a customer. We identified the following performance obligations under the contract: (1) an exclusive license to QS-21 in the specified field and related technology transfer; and (2) and exclusive license to QS-21 in an additional field.

We determined that the fixed payments of $19.3 million constituted all of the consideration to be included in the transaction price and to be allocated to the performance obligations based on their relative stand-alone selling prices. The fixed upfront consideration is recognized under ASC 606 based on when control of the combined performance obligation is transferred to the customer, which corresponds with the service period (through December 2014). At contract inception, the milestones of $5.0 million had been excluded from the transaction price, as we could not conclude that it was probable a significant reversal would not occur. Event driven milestones are a form of variable consideration as the payments are variable based on the occurrence of future events. As part of its estimation of the amount, we considered numerous factors, including that receipt of the milestones is outside of our control and contingent upon success in future clinical trials and the licensee’s efforts. Recognition of event driven milestones should be recognized when the variable consideration is able to be estimated. As of December 31, 2017, all milestones had been received, and therefore recognized.

14


Any consideration related to royalties will be recognized when the related sales occur as they were determined to relate predominantly to the license granted to GSK and therefore have also been excluded from the transaction price. We will re-evaluate the t ransaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

For the three and nine months ended September 30, 2018, we recognized $6.5 million and $11.9 million, respectively, in non-cash royalty revenue from GSK. For both the three and nine months ended September 30, 2017 we did not recognize any revenue from GSK.

The cumulative impact of changing the timing of revenue recognition for the GSK License and Amended GSK Supply Agreements as of January 1, 2018 was a decrease to stockholders' deficit of approximately $2.5 million and a corresponding decrease in deferred revenue of $2.5 million for the portion of the upfront fee creditable toward future royalties, as described above. This amount was included in the transition adjustment, as under ASC 606 it would have been recognized as revenue in March 2012, at the time of the amendment.

Merck Collaboration and License Agreement

During the quarter ended June 30, 2014, we entered into a collaboration and license agreement with Merck to discover and optimize fully-human antibodies against two undisclosed cancer targets using the Retrocyte Display ® . Under this agreement, Merck is responsible for the clinical development and commercialization of antibodies generated under the collaboration. There are no unsatisfied performance obligations relating to this contract. Pursuant to the XOMA Royalty Purchase Agreement, we sold to XOMA 33% of the future royalties and 10% of the future milestones that we are entitled to receive from Merck, and we remain eligible to receive from Merck approximately $85.5 million in potential payments associated with the completion of certain clinical, regulatory and commercial milestones, as well as 67% of all future royalties on worldwide product sales.

For the three months ended September 30, 2018, we did not recognize any revenue from this agreement. For the nine months ended September 30, 2018, we recognized $4.0 million in research and development revenue related to the achievement of a milestone. For both the three and nine months ended September 30, 2017, we did not recognize any revenue from this agreement.

The adoption of ASC 606 did not have an impact on the Merck collaboration and license agreement.

Incyte Collaboration Agreement

On January 9, 2015 and effective February 19, 2015, we entered into a global license, development and commercialization agreement (the “Collaboration Agreement”) with Incyte pursuant to which the parties plan to develop and commercialize novel immuno-therapeutics using our antibody discovery platforms. The Collaboration Agreement was initially focused on four checkpoint modulator programs directed at GITR, OX40, LAG-3 and TIM-3. In addition to the four identified antibody programs, the parties have an option to jointly nominate and pursue the development and commercialization of antibodies against additional targets during a five-year discovery period which, upon mutual agreement of the parties for no additional consideration, can be extended for an additional three years. In November 2015, we and Incyte jointly nominated and agreed to pursue the development and commercialization of three additional CPM targets. In February 2017, we amended the Collaboration Agreement by entering into a First Amendment to License, Development and Commercialization Agreement (the “Amendment”).  See “Amendment” section below.

On January 9, 2015, we also entered into the Stock Purchase Agreement with Incyte Corporation whereby, for an aggregate purchase price of $35.0 million, Incyte purchased approximately 7.76 million shares of our common stock.

Agreement Structure

Under the terms of the Collaboration Agreement, we received non-creditable, nonrefundable upfront payments totaling $25.0 million. In addition, until the Amendment, the parties shared all costs and profits for the GITR, OX40 and two of the additional antibody programs on a 50:50 basis (profit-share products), and we were eligible to receive up to $20.0 million in future contingent development milestones under these programs. Incyte is obligated to reimburse us for all development costs that we incur in connection with the TIM-3, LAG-3 and one of the additional antibody programs (royalty-bearing products) and we are eligible to receive (i) up to $155.0 million in future contingent development, regulatory, and commercialization milestone payments and (ii) tiered royalties on global net sales at rates generally ranging from 6% to 12%. For each royalty-bearing product, we will also have the right to elect to co-fund 30% of development costs incurred following initiation of pivotal clinical trials in return for an increase in royalty rates. Additionally, we had the option to retain co-promotion participation rights in the United States on any profit-share product. Through the direction of a joint steering committee, until the Amendment, the parties anticipated that, for each program, we would serve as the lead for pre-clinical development activities through investigational new drug (“IND”) application filing, and Incyte would serve as the lead for clinical development activities. The parties initiated the first clinical trials of antibodies arising from these

15


programs in 2016. For each additional program beyond GITR, OX40, TIM-3 and LAG-3 that the parties elect to bring into the collaboration, we will have the option to designate it as a profit-share product or a royalty-bearing product.

The Collaboration Agreement will continue as long as (i) any product is being developed or commercialized or (ii) the discovery period remains in effect. Incyte may terminate the Collaboration Agreement or any individual program for convenience upon 12 months’ notice. The Collaboration Agreement may also be terminated by either party upon the occurrence of an uncured material breach of the other party or by us if Incyte challenges patent rights controlled by us. In addition, either party may terminate the Collaboration Agreement as to any program if the other party is acquired and the acquiring party controls a competing program.

Amendment

Pursuant to the terms of the Amendment, the GITR and OX40 programs immediately converted from profit-share programs to royalty-bearing programs and we became eligible to receive a flat 15% royalty on global net sales should any candidates from either of these two programs be approved. Incyte is now responsible for global development and commercialization and all associated costs for these programs. In addition, the profit-share programs relating to TIGIT and one undisclosed target were removed from the collaboration, with the undisclosed target reverting to Incyte and TIGIT to Agenus. Should any of those programs be successfully developed by a party, the other party will be eligible to receive the same milestone payments as the royalty-bearing programs and royalties at a 15% rate on global net sales. The terms for the remaining three royalty-bearing programs targeting TIM-3, LAG-3 and one undisclosed target remain unchanged, with Incyte being responsible for global development and commercialization and all associated costs. The Amendment gives Incyte exclusive rights and all decision-making authority for manufacturing, development, and commercialization with respect to all royalty-bearing programs.

In connection with the Amendment, Incyte paid us $20.0 million in accelerated milestones related to the clinical development of the antibody candidates targeting GITR and OX40.

In February 2017, we also entered into a Stock Purchase Agreement with Incyte, pursuant to which Incyte purchased 10 million shares of our common stock at a purchase price of $6.00 per share.

Pursuant to the XOMA Royalty Purchase Agreement, we sold to XOMA 33% of the future royalties and 10% of the future milestones that we were entitled to receive from Incyte, excluding the $5.0 million milestone that we recognized in the three months ended September 30, 2018. As of September 30, 2018, we remain eligible to receive up to $450.0 million in future potential development, regulatory and commercial milestones across all programs in the collaboration, as well as 67% of all future royalties on worldwide product sales.

Collaboration Revenue

We identified the following performance obligations under the Incyte Collaboration Agreement, as amended: (1) combined license and related research and development (“R&D”) services to a GITR antibody, (2) combined license and related R&D services to an OX40 antibody, (3) combined license and related R&D services to a TIM-3 antibody, (4) combined license and related R&D services to a LAG-3 antibody, (5) combined license and related R&D services to a TIGIT antibody, (6) combined license and related R&D services to a first undisclosed target, (7) combined license and related R&D services to a second undisclosed target, and (8) the option to license certain other mutually agreed-upon antibodies combined with related R&D Services (“Assumed Project Options Development”).  Each of these performance obligations consists of a license or option to a license and related R&D services through the filing of an IND for each antibody candidate.

We concluded that the licenses could be used with other readily available resources if the know-how was also transferred with the license; however, our knowledge and experience is necessary for further development of the licensed antibodies. Therefore, we determined that each of the licensed antibodies and the related developmental R&D services should be treated as a combined performance obligation. We also evaluated whether the Assumed Project Options Development was a material right. At contract inception Incyte paid us a nonrefundable access fee for the ability to exercise the option and bring additional targets into the program. Both we and Incyte have the ability to explore targets and, if mutually agreed upon, convert those targets into assumed projects for no additional license fee. We concluded that Assumed Project Options Development represents a material right and is therefore a performance obligation.

We determined that there were no significant financing components, noncash consideration, or amounts that may be refunded to the customer, and as such the total upfront fixed consideration of the $10.0 million license fee and $15.0 million project access fee would be included in the total transaction price of $25.0 million. This amount was then allocated to the performance obligations on a relative stand-alone selling price basis.

16


The estimated variable consideration to be recognized for developmental R&D services and related reimbursable expenses (“Development Costs”) was determined based on the forecasted amounts in the research plan t hat ha d been approved by the both parties via the joint steering committee (“JSC”). Under the Agreement, Development Costs related to Profit-Sharing products are split equally between us and Incyte. Therefore, our expected revenue is 50% of the costs of th ese programs. Based on review of the budget s presented at the JSC meetings, as well as costs of previous R&D projects, we expect ed the total development costs over the term of the contract would be $43.4 million. This amount was allocated entirely to the d istinct R&D services that forms part of each performance obligation .

We determined that the transaction price of the Collaboration Agreement was $78.7 million as of September 30, 2018, an increase of $10.3 million from the transaction price of $68.4 million as of December 31, 2017. In order to determine the transaction price, we evaluated all the payments to be received during the duration of the contract. We determined that the fixed upfront license fee and project access fee of $10.0 million and $15.0 million, respectively, and the $53.7 million of actual and estimated variable consideration for development costs (including R&D services) and milestones constituted consideration to be included in the transaction price, which is allocated among the performance obligations.

For payments made to Incyte related to their work performed on profit-sharing programs, we considered that we will receive a benefit through the performance of a series of distinct R&D services by Incyte. Additionally, the R&D services are being provided by Incyte at fair value. Therefore, the amount paid to Incyte represents the fair value of the services performed, and no excess will be allocated as a reduction of the transaction price. We will record the consideration paid to Incyte in the same manner that we would purchases for other vendors, classified as R&D expense.

In summary, each of the performance obligations includes a license or option to a license, and respective R&D services that will be performed over time from program initiation through the filing of an IND with respect to each antibody candidate. We have determined that the combined performance obligation is satisfied over time, and that the input method should be applied for all performance obligations that have consideration allocated to them. The cost-cost measure will be applied based on the percentage of completion of R&D services provided during the period compared to the respective budget. We believe this is the best measure of progress because other measures do not reflect how we transfer our performance obligation to Incyte. We will recognize the fixed consideration allocated to each performance obligation over time as the related R&D services are being performed using the input of R&D costs incurred over total R&D costs expected to be incurred through IND filing, beginning on the date a license is granted. A cost-based input method of revenue recognition requires management to make estimates of costs to complete our performance obligations. In making such estimates, significant judgment is required to evaluate assumptions related to cost estimates. The cumulative effect of revisions to estimated costs to complete our performance obligations will be recorded in the period in which changes are identified and amounts can be reasonably estimated. A significant change in these assumptions and estimates could have a material impact on the timing and amount of revenue recognized in future periods.

We considered the nature of the arrangement between Incyte and us in evaluating the classification of the payments to be received under the cost-sharing arrangement. We do not currently have any commercial products available for sale. Our primary operations to date have included research and development activities, licensing intellectual property and performing R&D services for external parties. Accordingly, arrangements such as this Collaboration Agreement represent our ongoing business operations. Therefore, we have concluded that payments received from Incyte under the cost-sharing arrangement represent payments made to us as part of our on-going operations and should be classified as revenue as such amounts are earned.

For the three months ended September 30, 2018, we recognized approximately $6.3 million of research and development revenue. This amount included $0.3 million of the transaction price for the Collaboration Agreement recognized based on proportional performance, $5.0 million for the achievement of a milestone and $1.0 million for research and development services. For the three months ended September 30, 2017, we recognized approximately $3.2 million of research and development revenue.

For the nine months ended September 30, 2018, we recognized approximately $14.4 million of license and collaboration revenue. This amount included $1.1 million of the transaction price for the Collaboration Agreement recognized based on proportional performance, $10.0 million for the achievement of milestones and $3.3 million for research and development services. For the nine months ended September 30, 2017, we recognized approximately $34.0 million of research and development revenue.

We expect to recognize deferred research and development revenue of $0.3 million, $0.8 million, and $1.2 million for the remainder of 2018, 2019, and 2020, respectively, related to performance obligations that are unsatisfied or partially unsatisfied as of September 30, 2018. These amounts exclude amounts (milestones, R&D services and royalties) where we have a right to invoice the customer in the amount that corresponds directly with the value of the performance completed to date.

The cumulative impact of the adoption of ASC 606 for the Incyte Collaboration Agreement as of January 1, 2018 was a decrease to stockholders' deficit of approximately $6.4 million and a corresponding decrease in deferred revenue of $6.4 million.

17


Disaggregation of Revenue

The following table presents revenue (in thousands) for the three and nine months ended September 30, 2018 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 September 30, 2018

 

 

 

United States

 

 

Europe

 

 

Total

 

Revenue Type

 

 

 

 

 

 

 

 

 

 

 

 

Research and development services

 

$

1,014

 

 

$

 

 

$

1,014

 

License and collaboration milestones

 

 

5,000

 

 

 

 

 

 

5,000

 

Recognition of deferred revenue

 

 

262

 

 

 

 

 

 

262

 

Non-cash royalty revenue

 

 

6,526

 

 

 

 

 

 

6,526

 

 

 

$

12,802

 

 

$

 

 

$

12,802

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine months ended September 30, 2018

 

Revenue Type

 

 

 

 

 

 

 

 

 

 

 

 

Research and development services

 

$

3,321

 

 

$

 

 

$

3,321

 

License and collaboration milestones

 

 

10,000

 

 

 

4,000

 

 

 

14,000

 

Recognition of deferred revenue

 

 

1,064

 

 

 

 

 

 

1,064

 

Non-cash royalty revenue

 

 

11,948

 

 

 

 

 

 

11,948

 

 

 

$

26,333

 

 

$

4,000

 

 

$

30,333

 

Contract Balances

Contract assets primarily relate to our rights to consideration for work completed in relation to our R&D services performed but not billed at the reporting date. The contract assets are transferred to the 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. The 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 R&D 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 assets and contract liabilities from contracts with customers (in thousands):

 

Nine months ended September 30, 2018

 

Balance at beginning of period

 

 

Additions

 

 

Deductions

 

 

Balance at end of period

 

Contract assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unbilled receivables from collaboration partners

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

Contract liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Deferred revenue

 

$

3,376

 

 

$

-

 

 

$

(1,064

)

 

$

2,312

 

The change in contract liabilities is primarily related to the recognition of $1.1 million of revenue during the nine months ended September 30, 2018. Deferred revenue related to our Collaboration Agreement with Incyte of $2.3 million as of September 30, 2018, which was comprised of the $25.0 million upfront payment, less $22.7 million of license and collaboration revenue recognized from the effective date of the contract, will be recognized as the combined performance obligation is satisfied.

We also recorded a $6.1 million receivable as of September 30, 2018 that consisted of $1.1 million for R&D services provided and $5.0 million for the achievement of a milestone.

During the three and nine months ended September 30, 2018, 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.

 

 

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Note K - Share-based Compensation Plans

 

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. All stock options have 10-year terms and generally vest ratably over a 3 or 4-year period. A non-cash charge to operations for the stock options granted to non-employees that have vesting or other performance criteria is affected each reporting period, until the non-employee options vest, by changes in the fair value of our common stock.

A summary of option activity for the nine months ended September 30, 2018 is presented below:

 

 

 

Options

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Remaining

Contractual

Term

(in years)

 

 

Aggregate

Intrinsic

Value

 

Outstanding at December 31, 2017

 

 

14,366,787

 

 

$

4.22

 

 

 

 

 

 

 

 

 

Granted

 

 

4,101,113

 

 

 

5.21

 

 

 

 

 

 

 

 

 

Exercised

 

 

(272,493

)

 

 

3.41

 

 

 

 

 

 

 

 

 

Forfeited

 

 

(770,115

)

 

 

4.18

 

 

 

 

 

 

 

 

 

Expired

 

 

(507,716

)

 

 

5.65

 

 

 

 

 

 

 

 

 

Outstanding at September 30, 2018

 

 

16,917,576

 

 

$

4.43

 

 

 

7.26

 

 

$

25,088

 

Vested or expected to vest at September 30, 2018

 

 

16,917,576

 

 

$

4.43

 

 

 

7.26

 

 

$

25,088

 

Exercisable at September 30, 2018

 

 

9,928,173

 

 

$

4.26

 

 

 

6.08

 

 

$

801

 

 

The weighted average grant-date fair values of stock options granted during the nine months ended September 30, 2018 and 2017 were $1.28 and $1.96, respectively.

As of September 30, 2018, $8.7 million of total unrecognized compensation cost related to stock options granted to employees and directors is expected to be recognized over a weighted average period of 2.3 years.  

As of September 30, 2018, unrecognized expense for options granted to outside advisors for which performance (vesting) has not yet been completed but the exercise price of the option is known is $0.9 million. Such amount is subject to change each reporting period based upon changes in the fair value of our common stock, expected volatility, and the risk-free interest rate, until the outside advisor completes his or her performance under the option agreement.

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.

A summary of non-vested stock activity for the nine months ended September 30, 2018 is presented below:

 

 

 

Non-vested

Shares

 

 

Weighted

Average

Grant Date

Fair Value

 

Outstanding at December 31, 2017

 

 

1,313,550

 

 

$

2.91

 

Granted

 

 

1,014,109

 

 

 

3.74

 

Vested

 

 

(53,050

)

 

 

3.77

 

Forfeited

 

 

(52,814

)

 

 

4.26

 

Outstanding at September 30, 2018

 

 

2,221,795

 

 

$

3.23

 

 

As of September 30, 2018, there was approximately $3.5 million of unrecognized share-based compensation expense related to these non-vested shares for which, if all milestones are achieved, will be recognized over a period of 2.5 years. The total intrinsic value of shares vested during the nine months ended September 30, 2018, was $0.2 million.

During the nine months ended September 30, 2018, 140,313 shares were issued under the 2009 Employee Stock Purchase Plan, 53,050 shares were issued as a result of the vesting of non-vested stock and 272,493 shares were issued as a result of stock option exercises.

19


The impact on our results of operations from share-based compensation for the three and nine months ended September 30, 2018 and 2017 , was as follows (in thousands):

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Research and development

 

$

895

 

 

$

969

 

 

$

2,535

 

 

$

3,368

 

General and administrative

 

 

1,010

 

 

 

986

 

 

 

3,160

 

 

 

3,716

 

Total share-based compensation expense

 

$

1,905

 

 

$

1,955

 

 

$

5,695

 

 

$

7,084

 

 

 

Note L - Benefit Plans

Previously, we maintained a multiple employer benefit plan that covered certain international employees. During the year ended December 31, 2017, in connection with the closure of our facility in Basel, Switzerland, we ended our participation in the plan.

We made no contributions to the plan during the three and nine months ended September 30, 2018, and no future contributions are expected. For the three and nine months ended September 30, 2017, we contributed approximately $39,000 and $124,000 to our international multiple employer benefit plan.

 

 

Note M – Equity

 

At the Market Offerings

During the nine months ended September 30, 2018, we received net proceeds of approximately $8.5 million from the sale of approximately 1.9 million shares of our common stock at an average price per share of approximately $4.56 in at-the-market offerings under our Controlled Equity Offering SM sales agreement with Cantor Fitzgerald & Co. We terminated our Controlled Equity Offering SM sales agreement with Cantor Fitzgerald & Co. in May 2018.

In May 2018 we entered into an At Market Issuance Sales Agreement with B. Riley FBR, Inc. with respect to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, up to 20,000,000 shares of our common stock through B. Riley FBR, Inc. as our sales agent. During the nine months ended September 30, 2018, we received net proceeds of approximately $32.8 million from the sale of approximately 14.3 million shares of our common stock at an average price per share of approximately $2.37 in at-the-market offerings under our At Market Issuance Sales Agreement with B. Riley FBR, Inc.

 

 

Note N - Recent Accounting Pronouncements

 

Recently Issued and Adopted

In May 2014, the FASB issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers, (Topic 606) ("ASU 2014-09"). ASU 2014-09 amends the guidance for the recognition of revenue from contracts with customers to transfer goods and services. The FASB subsequently issued additional, clarifying standards to address issues arising from the implementation of the new revenue recognition standard. The new revenue recognition standard and clarifying standards require an entity to recognize revenue when control of promised goods or services is transferred to the customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. We adopted this new standard on January 1, 2018, by using the modified-retrospective method. See Note B and Note J.

 

In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business (“ASU 2017-01”), which provides guidance regarding the definition of a business, with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. We adopted ASU 2017-01 on January 1, 2018 and will apply it prospectively. The impact on our consolidated financial statements in future periods will depend on the specific facts and circumstances of future transactions.

 

In May 2017, the FASB issued ASU No. 2017-09, Compensation – Stock Compensation (Topic 718) Scope of Modification Accounting (“ASU 2017-09”). The amendments in ASU 2017-09 provide guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. We adopted ASU 2017-09 on January 1, 2018. The guidance will be applied prospectively to awards modified on or after the adoption date. The adoption of ASU 2017-09 did not have any impact on our consolidated financial statements.

 

Recently Issued, Not Yet Adopted

20


In February 2016, the FASB issued ASU 2016-02, Leases ( Topic 842) (“ASU 2016- 0 2”) which supersedes Topic 840, Leases. ASU 2016-02 requires lessees to recognize a right-of-use asset and a lease liability on their balance sheets for all leases with terms greater than twelve months. Based on certain criteria, lea ses will be classified as either financing or operating, with classification affecting the pattern of expense recognition in the income statement. For leases with a term of 12 months or less, a lessee is permitted to make an accounting policy election by c lass of underlying asset not to recognize lease assets and lease liabilities. If a lessee makes this election, it should recognize lease expense for such leases generally on a straight-line basis over the lease term. ASU 2016-2 is effective for fiscal year s beginning after December 15, 2018, and interim periods within those years, with early adoption permitted. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified r etrospective approach. The modified retrospective approach includes a number of optional practical expedients primarily focused on leases that commenced before the effective date of Topic 842, including continuing to account for leases that commence before the effective date in accordance with previous guidance, unless the lease is modified. In July 2018, the FASB issued ASU 2018-11, which provides companies an additional, optional, transition method. This optional method allows companies to initially apply the standard at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. Note 15 in our Annual Report on Form 10-K for the year ended December 31, 2017 provides details on our cu rrent lease arrangements. While we continue to evaluate the provisions of ASC 842 to determine how it will be affected, the primary effect of adopting the new standard will be to record assets and obligations for current operating leases. Upon adoption, ba sed on leases in pla ce as of December 31, 2017 , we expect to recognize assets and liabilities of approximately $ 8.2 million related to our operating leases. The adoption of ASC 842 is not expected to have a material impact on our results of operations or c ash flows.

 

In January 2017, the FASB issued ASU 2017-04, Intangibles – Goodwill and Other (Topic 350) (“ASU 2017-04”) that will eliminate the requirement to calculate the implied fair value of goodwill to measure a goodwill impairment charge. Instead, an impairment charge will be based on the excess of a reporting unit’s carrying amount over its fair value. The guidance is effective for the Company in the first quarter of fiscal 2020. Early adoption is permitted. We do not anticipate the adoption of this guidance to have a material impact on our consolidated financial statements, absent any goodwill impairment.

 

In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation (Topic 718) Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”). The amendments in ASU 2018-07 simplify the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The standard will be effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years, with early adoption permitted. We are currently evaluating the impact of adoption of ASU 2018-07 on our consolidated financial statements.

 

In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement ("ASU 2018-13"). The amendments in ASU 2018-13 modify the disclosure requirements of fair value measurements. The standard will be effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years, with early adoption permitted. Certain disclosures are required to be applied on a retrospective basis and others on a prospective basis. We are currently evaluating the impact of adoption of ASU 2018-13 on our financial statement disclosures.

 

In August 2018, the FASB issued ASU No. 2018-15, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that is a Service Contract ("ASU 2018-15"). The amendments in ASU 2018-15 align the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The standard will be effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years, with early adoption permitted. ASU 2018-15 is required to be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. We are currently evaluating the impact of adoption of ASU 2018-07 on our consolidated financial statements.

No other new accounting pronouncement issued or effective during the nine months ended September 30, 2018 had or is expected to have a material impact on our consolidated financial statements or disclosures.

 

 

 

Note O - Subsequent Events

At the Market Offerings

On October 3 & 4, 2018, we received aggregate net proceeds of approximately $3.6 million from the sale of approximately 1.6 million shares of our common stock at an average price per share of approximately $2.32 in at-the-market offerings under our At Market Issuance Sales Agreement with B. Riley FBR, Inc. As of November 07, 2018, approximately 4.1 million shares remain available for sale under this agreement.

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Stock Purchase Agreement

On October 10, 2018, we entered into a Stock Purchase Agreement with certain institutional investors (the “Purchasers”), pursuant to which we issued and sold an aggregate of 18,459 shares of Series C-1 Convertible Preferred Stock (the “Preferred Shares”), at a purchase price of $2,167 per share. Each Preferred Share is convertible into 1,000 shares of our common stock (the “Common Stock”) at a conversion price of $2.167 per share of Common Stock, subject to adjustment. The aggregate purchase price paid by the Purchasers for the Preferred Shares was approximately $40.0 million and we received net proceeds of approximately $39.9 million, after offering expenses. The transaction closed on October 11, 2018.

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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.

We have included 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 in Part II-Item 1A “Risk Factors” of this Quarterly Report on Form 10-Q. 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.

AIM ™, ASV ™, AgenTus ™, Agenus ™, AutoSynVax ™, Oncophage ® , PSV ™, PhosphoSynVax ™, Prophage™, Retrocyte Display™, SECANT ® and Stimulon ® are trademarks of Agenus Inc. and its subsidiaries. All rights reserved.

Overview

We are a clinical-stage immuno-oncology (“I-O”) company dedicated to becoming a leader in the discovery and development of innovative combination therapies and committed to bringing effective medicines to patients with cancer.  Our business is designed to drive success in I-O through speed, innovation, and effective combination therapies. We have assembled fully integrated capabilities from novel target discovery, antibody generation, cell line development, and good manufacturing practice (“GMP”) manufacturing together with a comprehensive portfolio consisting of antibody-based therapeutics, adjuvants, cancer vaccine platforms, and cell therapy (through our subsidiary, AgenTus Therapeutics, Inc. (“AgenTus Therapeutics”)). We leverage our immune biology platforms to identify effective combination therapies for development and have developed productive partnerships to advance our innovation.

We are developing a comprehensive I-O portfolio driven by the following platforms and programs, which we intend to utilize individually and in combination:

 

our antibody discovery platforms, including our Retrocyte Display™, SECANT ® yeast display, and phage display technologies designed to drive the discovery of future CPM antibody candidates;

 

our antibody candidate programs, including our CPM programs;

 

our vaccine programs, including Prophage™, AutoSynVax™ and PhosPhoSynVax ™;

 

our saponin-based vaccine adjuvants, principally our QS-21 Stimulon ® adjuvant, or QS-21 Stimulon; and

 

our cell therapy subsidiary, AgenTus Therapeutics, which is designed to drive the discovery of future adoptive cell therapy, or “living drugs” (CAR-T and TCR) programs.

We assess development, commercialization and partnering strategies for each of our product candidates periodically based on several factors, including pre-clinical and clinical trial results, competitive positioning and funding requirements and resources. As such, we have recently shifted our strategy for first approval from lung cancer to cervical cancer based on increasing competition and recent data that would have hindered our ability to pursue accelerated pathways for approval. We are currently advancing our own combination of CTLA-4 and PD-1 antibodies in second line cervical cancer.

We have formed collaborations with companies such as Incyte Corporation (“Incyte”), Merck Sharpe & Dohme (“Merck”) and Recepta Biopharma SA (“Recepta”). Through these alliances, as well as our own internal programs, we currently have more than a dozen antibody programs in pre-clinical or early phase development, including our anti-CTLA-4 and anti-PD-1 antibody programs

23


(both partnered with Recepta for certain South America territories) and anti-GITR and anti-OX40 antibody programs (both partnered with Incyte). In February 2017, we amended our collaboration agreement with Incyte to, among other things, convert the GITR and OX40 programs from profit-share to royalty-bearing programs, and there are no longer any profit-share programs remaining under the collaboration. Pursuant to the amended agreement, we received accelerated milestone payments of $20.0 million from Incyte related to the clinical developmen t of INCAGN1876 (anti-GITR agonist) and INCAGN1949 (anti-OX40 agonist). Concurrent with the execution of the amendment, we and Incyte also entered into the Stock Purchase Agreement whereby Incyte purchased an additional 10 million shares of our common stoc k at $6.00 per share, resulting in additional proceeds of $60.0 million to us. On September 20, 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 paid us $15.0 million at closing in exchange for the right to receive 33% of the future royalties and 10% of the future milestones that we are entitled to receive fr om Incyte and Merck , net of certain of our obligations to a third party and excluding the next milestone that we expect to receive from Incyte. After taking into account our obligations under the XOMA Royalty Purchase Agreement, as of September 30, 2018, we remain eligible to receive up to $450.0 million and $85.5 million in potential development, regulatory and commercial milestones from Incyte and MDS, respectively.

In addition to our antibody platforms and CPM programs, we are also advancing a series of vaccine programs to treat cancer. In January 2017, we announced a clinical trial collaboration with the National Cancer Institute (“NCI”), which is a double-blind, randomized controlled Phase 2 trial that is evaluating the effect of our autologous vaccine candidate, Prophage, in combination with pembrolizumab (Keytruda ® , Merck & Co., Inc. (“Merck”)) in patients with newly diagnosed glioblastoma. Under this collaboration, we are supplying Prophage, Merck is supplying pembrolizumab and the NCI and Brain Tumor Trials Collaborative member sites are recruiting patients and conducting the trial.

Our QS-21 Stimulon adjuvant is also partnered with GlaxoSmithKline (“GSK”) and is a key component in multiple GSK vaccine programs. These programs are in various stages, with the most advanced being GSK’s shingles program. In 2015, we monetized a portion of the future royalties we were contractually entitled to receive from GSK from sales of its shingles and malaria vaccines through a Note Purchase Agreement (“NPA”) and received net proceeds of approximately $78 million. In October 2017, GSK’s shingles vaccine was approved in the United States by the FDA and granted marketing authorization in Canada by Health Canada, and in November 2017, we exercised our option to issue the $15.0 million in additional notes in accordance with the terms of the NPA. 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 Stimulon adjuvant. We used the majority of the upfront proceeds from HCR to redeem all of the notes issued pursuant to the NPA, resulting in net proceeds to us of approximately $28.0 million at closing. We do not incur clinical development costs for products partnered with GSK.

Our business activities include product research and development, intellectual property prosecution, manufacturing, regulatory and clinical affairs, corporate finance and development activities, and support of our collaborations. Our product candidates require 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 by continuing our existing arrangements with academic and corporate collaborators and licensees and by entering into new collaborations.

In October 2017, we announced the launch of a subsidiary that is advancing our cell therapy business, AgenTus Therapeutics. The subsidiary is focused on the discovery, development, and commercialization of breakthrough “living drugs” to advance cures for cancer patients. AgenTus Therapeutics licenses intellectual property assets from Agenus and has its own management and governance.

Historical Results of Operations

Three months ended September 30, 2018 compared to the three months ended September 30, 2017

Research and development revenue

 We recognized Research and Development (“R&D”) revenue of approximately $6.3 million and $3.4 million during the three months ended September 30, 2018 and 2017, respectively. R&D revenues in the third quarter of 2018 primarily consisted of fees earned under our Collaboration Agreement with Incyte, including $5.0 million related to the recognition of a milestone and $1.0 million related to the reimbursement of development costs, which have decreased due to the stage of the programs under the collaboration. R&D revenues in the third quarter of 2017 primarily consisted of fees earned under our Collaboration Agreement with Incyte, including $2.5 million related to the reimbursement of development costs. During the three months ended September 30, 2018 and 2017, we recorded revenue of $0.3 million and $0.9 million, respectively, from the amortization of deferred revenue. See Notes B and J to our Condensed Consolidated Financial Statements for additional discussion of our revenues, including the adoption of ASC 606 during the first quarter of 2018.

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

24


In January 201 8 , we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our QS-21 Stimulon adjuvant to HCR . As described in Note G 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. During the three months ended September 30, 2018, we recognized approximately $6.5 million in non-cash royalt y revenue related to our agreement with GSK .

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 increased 16% to $29.9 million for the three months ended September 30, 2018 from $25.8 million for the three months ended September 30, 2017. Increased expenses in the three months ended September 30, 2018 primarily relate to a $2.6 million increase in third-party services and other related expenses largely relating to the advancement of our antibody programs, a $2.3 million increase in expenses attributable to the activities of our subsidiary, AgenTus Therapeutics, which began operations in the quarter ended September 30, 2017, and a $0.5 million license payment in the quarter ended September 30, 2018 for which there was no corresponding payment in the quarter ended September 30, 2017. These increases were partially offset by a $1.3 million decrease in expenses for our foreign subsidiaries mainly attributable to the closure of our facility in Basel, Switzerland in 2017.

General and administrative expense  

General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses increased 14% to $9.2 million for the three months ended September 30, 2018 from $8.1 million for the three months ended September 30, 2017. Increased expenses in the three months ended September 30, 2018 primarily relate to a $0.6 million increase in professional fees, a $0.3 million increase in personnel related expenses, primarily due to increased headcount and a $0.3 million increase in expenses attributable to the activities of our subsidiary, AgenTus Therapeutics, which began operations in the quarter ended September 30, 2017.

Contingent purchase price consideration fair value adjustment  

Contingent purchase price consideration fair value adjustment represents the change in the fair value of our purchase price considerations, which resulted from changes in our market capitalization and share price and changes in the credit spread since each year end. The fair value of our contingent purchase price considerations is based on estimates from a Monte Carlo simulation of our market capitalization and share price.

Non-operating income (expense)  

Non-operating income (expense) includes our foreign currency translation adjustment and other income or expense. Non-operating expense decreased $0.4 million for the three months ended September 30, 2018, from expense of $0.5 million for the three months ended September 30, 2017 to an expense of $0.1 million for the three months ended September 30, 2018, primarily due to our decreased foreign currency exchange losses in the third quarter of 2018 compared to the third quarter of 2017.

Interest expense, net 

Interest expense, net increased to approximately $7.5 million for the three months ended September 30, 2018 from $4.7 million for the three months ended September 30, 2017 due to the January 2018 closing of the Royalty Purchase Agreement with HCR and the resulting increase in non-cash interest expense compared to the amount recorded for our Note Purchase Agreement, which was outstanding in the three months ended September 30, 2017, and fully redeemed and terminated simultaneously with the closing of the Royalty Purchase Agreement.

 

Nine months ended September 30, 2018 compared to the nine months ended September 30, 2017

Research and development revenue

We recognized research and development revenue of approximately $18.4 million and $34.5 million during the nine months ended September 30, 2018 and 2017, respectively. R&D revenues in the nine months ended September 30, 2018 primarily consisted of $4.0 million related to the recognition of a milestone under our license agreement with Merck and fees earned under our Collaboration Agreement with Incyte, including $10.0 million related to the recognition of milestones and $3.3 million related to the reimbursement of development costs, which have decreased due to the stage of the programs under the collaboration. R&D revenues in the nine months ended September 30, 2017 primarily consisted of fees earned under our Collaboration Agreement with Incyte, including $20.0 million related to the acceleration of milestone payments and $12.0 million related to the reimbursement of development costs. During the nine months ended September 30, 2018 and 2017, we recorded revenue of $1.1 million and $2.4 million, respectively, from the amortization of deferred revenue. See Notes B and J to our Condensed Consolidated Financial Statements for additional discussion of our revenues, including the adoption of ASC 606 during the first quarter of 2018.

25


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 QS-21 Stimulon adjuvant to HCR. As described in Note G 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. During the nine months ended September 30, 2018, we recognized approximately $11.9 million in non-cash royalty revenue related to our agreement with GSK.

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 increased 5% to $88.6 million for the nine months ended September 30, 2018 from $84.3 million for the nine months ended September 30, 2017. Increased expenses in the nine months ended September 30, 2018 primarily relate to a $5.8 million increase in third-party services and other related expenses largely relating to the advancement of our antibody programs and a $4.4 million increase in expenses attributable to the activities of our subsidiary, AgenTus Therapeutics, which began operations in the quarter ended September 30, 2017. These increases were partially offset by a $0.5 million decrease in personnel related expenses and a $5.4 million decrease in expenses for our foreign subsidiaries due to the closure of our facility in Basel, Switzerland in 2017, which decrease was partially offset by increased expenses attributable to our wholly-owned subsidiary in the United Kingdom, Agenus UK Limited.

General and administrative expense  

General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses increased 15% to $27.6 million for the nine months ended September 30, 2018 from $24.0 million for the nine months ended September 30, 2017. Increased expenses in the nine months ended September 30, 2018 primarily relate to a $1.2 million increase in personnel related expenses, primarily due to increased headcount, a $1.3 million increase in professional fees, a $0.2 million increase in repair and maintenance expense and a $0.9 million increase in expenses attributable to the activities of our subsidiary, AgenTus Therapeutics, which began operations in the quarter ended September 30, 2017.

Contingent purchase price consideration fair value adjustment  

Contingent purchase price consideration fair value adjustment represents the change in the fair value of our purchase price considerations, which resulted from changes in our market capitalization and share price and changes in the credit spread since each year end. The fair value of our contingent purchase price considerations is based on estimates from a Monte Carlo simulation of our market capitalization and share price.

Loss on early extinguishment of debt

Loss on early extinguishment of debt of $10.8 million for the nine months ended September 30, 2018 represents the payment of premiums and the write-off of unamortized debt issuance costs and discounts incurred in connection with the full redemption and termination of Antigenics’ $115.0 million principal amount of notes issued pursuant to the Note Purchase Agreement dated September 4, 2015 with Oberland Capital SA Zermatt LLC and the purchasers named therein.

Non-operating income (expense)  

Non-operating income (expense) includes our foreign currency translation adjustment and other income or expense. Non-operating expense increased $3.4 million for the nine months ended September 30, 2018, from income of $1.9 million for the nine months ended September 30, 2017 to an expense of $1.5 million for the nine months ended September 30, 2018, primarily due to our increased foreign currency exchange losses in the nine months ended September 30, 2018 compared to gains in the nine months ended September 30, 2017.

Interest expense, net:

Interest expense, net increased to approximately $16.5 million for the nine months ended September 30, 2018 from $13.8 million for the nine months ended September 30, 2017 due to the January 2018 closing of the Royalty Purchase Agreement with HCR and the resulting increase in non-cash interest expense compared to the amount recorded for our Note Purchase Agreement, which was outstanding in the nine months ended September 30, 2017, and fully redeemed and terminated simultaneously with the closing of the Royalty Purchase Agreement.

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Research and Development Programs

 

For the nine months ended September 30, 2018, our research and development programs consisted largely of our antibody programs as indicated in the following table (in thousands). 

 

 

 

 

 

Nine Months Ended September 30,

 

 

Year Ended December 31,

 

 

 

 

 

 

 

 

 

Research and

Development Program

 

Product

 

2018

 

 

2017

 

 

2016

 

 

2015

 

 

Prior to

2015

 

 

Total

 

Heat shock proteins for cancer

 

Prophage and ASV

 

$

8,713

 

 

$

12,499

 

 

$

8,202

 

 

$

5,508

 

 

$

309,681

 

 

$

344,603

 

Antibody programs*

 

Various

 

 

69,282

 

 

 

95,656

 

 

 

83,919

 

 

 

63,290

 

 

 

13,422

 

 

 

325,569

 

Vaccine adjuvant

 

QS-21 Stimulon

 

 

157

 

 

 

222

 

 

 

77

 

 

 

142

 

 

 

13,657

 

 

 

14,255

 

Other research and development programs

 

 

 

 

10,417

 

 

 

7,748

 

 

 

2,772

 

 

 

1,504

 

 

 

66,318

 

 

 

88,759

 

Total research and development expenses

 

 

 

$

88,569

 

 

$

116,125

 

 

$

94,970

 

 

$

70,444

 

 

$

403,078

 

 

$

773,186

 

 

*

Prior to 2014, costs were incurred by 4-AB, which we acquired in February 2014.

 

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 our CPM antibody programs are early stage, and because further development of HSP-based vaccines is dependent on clinical trial results, 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. Active programs involving QS-21 Stimulon depend on our licensee successfully completing clinical trials, successfully manufacturing QS-21 Stimulon to meet demand, obtaining regulatory approvals and successfully commercializing product candidates containing QS-21 Stimulon.

 

Liquidity and Capital Resources

We have incurred annual operating losses since inception, and we had an accumulated deficit of $1.1 billion as of September 30, 2018. We expect to incur significant losses over the next several years as we continue to develop 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 the sale of equity and debt securities, and interest income earned on cash, cash equivalents, and short-term investment balances. From our inception through September 30, 2018, we have raised aggregate net proceeds of approximately $1.17 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 the offering of up to $250 million of common stock, preferred stock, warrants, debt securities and units. The Registration Statement includes a prospectus covering the offer, issuance and sale of up to 20 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 FBR, Inc. as our sales agent. We sold approximately 14.3 million and 1.6 million shares of our common stock pursuant to the Sales Agreement during the nine months ended September 30, 2018 and the month of October 2018, respectively, and received aggregate net proceeds totaling $36.4 million. Accordingly, as of November 7, 2018, approximately 4.1 million shares remain available for sale under the Sales Agreement.

As of September 30, 2018, we had debt outstanding of $14.1 million in principal. In February 2015, we issued subordinated notes in the aggregate principal amount of $14.0 million with annual interest at 8% (the “2015 Subordinated Notes”). The 2015 Subordinated Notes are due in February 2020. We and Antigenics entered into the Note Purchase Agreement with certain purchasers pursuant to which Antigenics issued, and we guaranteed, limited recourse notes in the aggregate principal amount of $100.0 million, with an option to issue an additional $15.0 million principal amount of limited recourse notes, which we exercised in November

27


2017 . The limited recourse notes were due on the earlier of (i) the 10 th anniversary of the first commercial sale of GSK’s shingles or malaria vaccines and (ii) September 8, 2030. In January 2018, we entered into a Royalty Purch ase Agreement with HCR whereby we received proceeds of $190.0 million. We used $161.9 million of these proceeds to redeem all of the notes issued pursuant to the NPA .

Our cash, cash equivalents, and short-term investments at September 30, 2018 were $46.2 million, a decrease of $14.0 million from December 31, 2017. Based on our current plans, including the additional funding we received during October 2018 (see Note O), and funding we anticipate from other sources, including out-licensing and/or partnering opportunities, we believe that our cash resources of $46.2 million as of September 30, 2018 will be sufficient to satisfy our liquidity requirements into the second quarter of 2019. We also continue to monitor the likelihood of success of our key initiatives and can discontinue funding of such activities if they do not prove to be successful, restrict capital expenditures and/or reduce the scale of our operations if necessary. In spite of these anticipated sources of funding and our ability to control our cash burn, in accordance with the requirements of ASU 2014-15, we are required to disclose the existence of a substantial doubt regarding our ability to continue as a going concern for twelve months from when these financial statements were issued.

Our future liquidity needs will be determined primarily by the success of our operations with respect to the progression of our product candidates and key development and regulatory events in the future. Potential sources of additional funding include: (1) pursuing collaboration, out-licensing and/or partnering opportunities for our portfolio programs and product candidates with one or more third parties, (2) renegotiating third party agreements, (3) selling assets, (4) securing additional debt financing and/or (5) selling equity securities. Satisfying long-term liquidity needs may require the successful commercialization and/or substantial out-licensing or partnering arrangements for our antibody discovery platforms, CPM antibody programs, and HSP-based vaccines. Our long-term success will also be dependent on the successful identification, development and commercialization of potential other product candidates, each of which will require additional capital with no certainty of timing or probability of success. If we incur operating losses for longer than we expect, and/or we are unable to raise additional capital, we may become insolvent and be unable to continue our operations.

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 $228.7 million over the term of the related activities. Through September 30, 2018, we have expensed $161.4 million as research and development expenses and $160.5 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 have also entered into sponsored research agreements related to our product candidates that required payments of $9.6 million, of which $8.5 million have been paid as of September 30, 2018. We plan to enter into additional agreements with third party providers as well as sponsored research agreements, 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. For example, our collaboration with Incyte for the development, manufacture and commercialization of CPM antibodies against certain targets is managed by a joint steering committee, which is controlled by Incyte. 

Net cash used in operating activities for the nine months ended September 30, 2018 and 2017 was $95.3 million and $68.4 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, and the risks highlighted under Part II, Item 1A. “Risk Factors”, of this Quarterly Report on Form 10-Q.

 

Off-Balance Sheet Arrangements

 

We did not have any off-balance sheet arrangements as of September 30, 2018.

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 1% and 18% of our cash used in operations for the nine months ended September 30, 2018 and the year ended December 31, 2017, respectively, was from our foreign

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subsidiar ies . We are also 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 ex posures. Our currency exposures vary but are primarily concentrated in the Swiss Franc and British Pound , in large part du e to our wholly-owned subsidiaries , 4-Antibody AG , a company formally with operations in Switzerland , and Agenus UK Limited, with oper ations in England . 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, 2017 .

We had cash and cash equivalents at September 30, 2018 of $46.2 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 September 30, 2018.

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 annually 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 September 30, 2018 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

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PART II - OTHER INFORMATION

Item 1A.

Risk Factors

Our future operating results could differ materially from the results described in this Quarterly Report on Form 10-Q due to the risks and uncertainties described below. You should consider carefully the following information about risks below in evaluating our business. If any of the following risks actually occur, our business, financial conditions, results of operations and future growth prospects would likely be materially and adversely affected. In these circumstances, the market price of our common stock would likely decline. These risk factors restate and supersede the risk factors set forth under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2018 filed with the SEC on August 9, 2018.

We cannot assure investors that our assumptions and expectations will prove to be correct. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements. 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. Factors that could cause or contribute to such differences include those factors discussed below.

Risks Related to our Business

If we incur operating losses for longer than we expect, or we are not able to raise additional capital, we may be unable to continue our operations, or we may become insolvent.

Our net losses for the years ended December 31, 2017, 2016, and 2015, were $120.7 million, $127.0 million, and $87.9 million, respectively. During the nine months ended September 30, 2018, we generated a net loss of $113.2 million. We expect to incur additional losses over the next several years as we continue to research and develop our technologies and pursue partnering opportunities, regulatory strategies, commercialization, and related activities. Furthermore, our ability to generate cash from operations is dependent on the success of our licensees and collaboration partners, as well as the likelihood and timing of new strategic licensing and partnering relationships and/or successful development and commercialization of product candidates, including through our antibody programs and platforms, our vaccine programs, and our saponin-based vaccine adjuvants.

On September 30, 2018, we had $46.2 million in cash and cash equivalents and short-term investments. We believe that, based on our current plans, including the additional funding we received during October 2018 (see Note O), and funding we anticipate from other sources, including out-licensing and/or partnering opportunities, our cash resources at September 30, 2018, will be sufficient to satisfy our liquidity requirements into the second quarter of 2019. We also continue to monitor the likelihood of success of our key initiatives and can discontinue funding of such activities if they do not prove to be successful, restrict capital expenditures and/or reduce the scale of our operations if necessary.

To date, we have financed our operations primarily through the sale of equity and debt securities. In order to finance future operations, we will be required to raise additional funds in the capital markets, through arrangements with collaboration partners or from other sources. Additional financing may not be available on favorable terms, or at all. If we are unable to raise additional funds when we need them or if we incur operating losses for longer than we expect, we may not be able to continue some or all of our operations, or we may become insolvent. We also may be forced to license or sell technologies to others under agreements that are on unfavorable terms or allocate to third parties substantial portions of the potential value of these technologies.

There are a number of factors that will influence our future capital requirements, including, without limitation, the following:

 

the number and characteristics of the product candidates we and our partners pursue;

 

our and our partners’ ability to successfully develop, manufacture, and commercialize product candidates;

 

the scope, progress, results and costs of researching and developing our future product candidates and conducting pre-clinical and clinical trials;

 

the timing of, and the costs involved in, obtaining regulatory approvals for our and our licensees’ product candidates;

 

the cost of manufacturing;

 

our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such arrangements;

 

the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing our intellectual property rights;

 

the costs associated with any successful commercial operations; and

 

the timing, receipt and amount of sales of, or royalties on, our future products and those of our partners, if any.

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General economic conditions in the United States economy and abroad may have a material adverse effect on our liquidity and financial condition, particularly if our a bility to raise additional funds is impaired. The ability of potential patients and/or health care payers to pay for our future products, if any, could also be adversely impacted, thereby limiting our potential revenue. In addition, any negative impacts fr om any deterioration in the credit markets on our collaboration partners could limit potential revenue from our product candidates.

Our obligations to HCR and the holders of our 2015 Subordinated Notes could materially and adversely affect our liquidity.

In January 2018, we and our wholly-owned subsidiary, Antigenics LLC (“Antigenics”), entered into a Royalty Purchase Agreement with HCR, pursuant to which HCR purchased 100% of Antigenics’ worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our QS-21 Stimulon adjuvant. As consideration for the purchase of the royalty rights, HCR paid $190.0 million at closing, less certain transaction expenses. Of the closing proceeds, approximately $161.9 million was used to redeem Antigenics’ $115.0 million principal amount of notes issued pursuant to the Note Purchase Agreement with Oberland Capital SA Zermatt LLC, and we retained approximately $28.0 million of net proceeds. Antigenics is also entitled to receive up to $40.35 million in milestone payments 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 and (ii) $25.25 million upon reaching $2.75 billion last-twelve-months net sales any time prior to 2026. Antigenics will owe approximately $25.9 million to HCR in 2021 if neither of the following sales milestones are achieved: (i) 2019 sales of GSK’s vaccines exceed $1.0 billion or (ii) 2020 sales GSK’s vaccines exceed $1.75 billion (the “Rebate Payment”). As part of the transaction, we provided a guaranty for the potential Rebate Payment and secured the obligation with substantially all of our assets pursuant to a security agreement. If GSK’s sales do not achieve either of the relevant milestones and we are obligated to make the Rebate Payment, our liquidity could be materially and adversely affected.

In February 2015, we exchanged senior subordinated promissory notes that we issued in 2013 for new senior subordinated promissory notes in the aggregate principal amount of $5.0 million with annual interest at 8%, and we issued an additional $9.0 million principal amount of such notes (the “2015 Subordinated Notes”). The 2015 Subordinated Notes were originally due February 2018, and in March 2017, we amended the 2015 Subordinate Notes to extend the maturity date to February 2020. The 2015 Subordinated Notes include default provisions that allow for the acceleration of the principal payment of the 2015 Subordinated Notes in the event we become involved in certain bankruptcy proceedings, become insolvent, fail to make a payment of principal or (after a grace period) interest on the 2015 Subordinated Notes, default on other indebtedness with an aggregate principal balance of $13.5 million or more if such default has the effect of accelerating the maturity of such indebtedness, or become subject to a legal judgment or similar order for the payment of money in an amount greater than $13.5 million if such amount will not be covered by third-party insurance. If we default on the 2015 Subordinated Notes and the repayment of such indebtedness is accelerated, our liquidity could be materially and adversely affected.

If we do not have sufficient cash on hand to pay the Rebate Payment when due, or to otherwise service our 2015 Subordinated Notes, we may be required, among other things, to:

 

seek additional financing in the debt or equity markets;

 

refinance or restructure all or a portion of our indebtedness;

 

sell, out-license, or otherwise dispose of assets; and/or

 

reduce or delay planned expenditures on research and development and/or commercialization activities.

Such measures might not be sufficient to enable us to make principal and interest payments. In addition, any such financing, refinancing, or sale of assets might not be available on favorable terms, if at all.

We are dependent upon our collaboration with Incyte to further develop, manufacture and commercialize antibodies against certain targets. If we or Incyte fail to perform as expected, the potential for us to generate future revenues under the collaboration could be significantly reduced, the development and/or commercialization of these antibodies may be terminated or substantially delayed, and our business could be adversely affected.

In February 2017, we amended the terms of our collaboration agreement with Incyte to, among other things, convert the GITR and OX40 programs from profit-share programs, where we and Incyte shared all costs and profits on a 50:50 basis, to royalty-bearing programs, where Incyte funds 100% of the costs and we are eligible for potential milestones and royalties. In addition, the profit-share programs relating to TIGIT and one undisclosed target were removed from the collaboration, with TIGIT reverting to Agenus and the undisclosed target reverting to Incyte, each with a potential 15% royalty to the other party on any global net sales. The remaining three royalty-bearing programs in the collaboration targeting TIM-3, LAG-3 and one undisclosed target remain unchanged, and there are no more profit-share programs under the collaboration. For each program in the collaboration, we serve as the lead for pre-clinical

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development activities through the filing of an IND, and Incyte has exclusive rights and all decision-making authority for manufacturing, clinical development and commercialization . Accordingly, the timely and successful completion by Incyte of clinical development and commercialization activities will significantly affect the timing and amount of any royalties or milesto nes we may receive under the collaboration agreement. In addition, in March 2017 we transferred manufacturing responsibilities to Incyte for antibodies under that collaboration. Any delays or weaknesses in the ability of Incyte to successfully manufacture could have an adverse impact on those programs. Incyte’s activities will be influenced by, among other things, the efforts and allocation of resources by Incyte, which we cannot control. If Incyte does not perform in the manner we expect or fulfill its res ponsibilities in a timely manner, or at all, the clinical development, manufacturing, regulatory approval, and commercialization efforts related to antibodies under the collaboration could be delayed or terminated. There can be no assurance that any of the development, regulatory or sales milestones will be achieved, or that we will receive any future milestone or royalty payments under the collaboration agreement. In September 2018, we sold to XOMA (US) LLC a portion of the royalties and milestones we are entitled to receive from Incyte.

In addition, our collaboration with Incyte may be unsuccessful due to other factors, including, without limitation, the following:

 

Incyte may terminate the agreement or any individual program for convenience upon 12 months’ notice;

 

Incyte has control over the development of assets in the collaboration;

 

Incyte may change the focus of its development and commercialization efforts or prioritize other programs more highly and, accordingly, reduce the efforts and resources allocated to our collaboration;

 

Incyte may choose not to develop and commercialize antibody products, if any, in all relevant markets or for one or more indications, if at all; and

 

If Incyte is acquired during the term of our collaboration, the acquirer may have competing programs or different strategic priorities that could cause it to reduce its commitment to our collaboration.

If Incyte terminates our collaboration agreement, we may need to raise additional capital and may need to identify and come to agreement with another collaboration partner to advance certain of our antibody programs. Even if we are able to find another partner, this effort could cause delays in our timelines and/or additional expenses, which could adversely affect our business prospects and the future of our antibody product candidates under the collaboration.

Our antibody programs are in early stage development, and there is no guarantee that we or our partners will be successful in advancing antibody product candidates into and through clinical development.

Our antibody programs are currently in early stage development, and many of our antibody programs are pre-clinical. Even if our pre-clinical studies or our and/or our partners’ clinical trials produce positive results, they may not necessarily be predictive of the results of future clinical trials. Many companies in the pharmaceutical, biopharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving positive results in pre-clinical development or earlier clinical trials, and we cannot be certain that we will not face similar setbacks. These setbacks have been caused by, among other things, pre-clinical findings made while clinical trials were underway or safety or efficacy observations made in clinical trials, including adverse events. Moreover, pre-clinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily in pre-clinical studies and clinical trials nonetheless failed to obtain regulatory approval. If we and our partners fail to produce positive results in clinical trials of antibodies, our business and financial prospects would be materially adversely affected.

Although we are pursuing indications and combinations that enable rapid paths to a Biologic License Application filing as early as 2020, there is no guarantee that we will be able to do so on that timeline or at all. Earlier this year we shifted our strategy for first approval from lung cancer to cervical cancer, and we have not yet fully evaluated the impact this could have on our previously stated timelines, or our costs. In addition, our timelines are aggressive and subject to various factors outside of our control, including patient accrual rates for our clinical trials. If our trials are unable to accrue patients at the rate we expect, we are unlikely to hit our anticipated timelines and our business and financial prospects could be materially adversely affected.

Similarly, although we are striving to file a number of INDs to advance novel antibodies, cell therapy candidates, and neoantigen vaccine combinations into the clinic in the next nine to twelve months, there is no guarantee that we will be able to do so on that timeline, if at all. Our stated timelines are aggressive and subject to various risks, including resource constraints. If we are unable to advance novel candidates into the clinic as planned due to resource constraints or otherwise, our business and partnering prospects could be materially adversely affected.

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We have und ergone significant growth across multiple locations over the past few years, and are focusing on further enhancing core areas and capabilities as we move toward commercialization.  In addition, we have consolidated certain sites while expanding others to f ocus on our core priorities and future needs.  We may encounter difficulties in managing these growth and/or consolidation efforts, either of which could disrupt our operations.

Since our acquisition of Agenus Switzerland Inc., formerly known as 4-Antibody AG (“4-AB”) in February 2014, we have more than tripled our headcount, in part through various acquisitions and the expansion of our research and development activities both nationally and internationally. While we have restructured our organization over the past two years, we expect to continue increasing our headcount in certain core areas as we continue to build our development, manufacturing and commercialization capabilities and integrate our acquired technology platforms. To manage these organizational changes, we must continue to implement and improve our managerial, operational and financial systems and continue to recruit, train and retain qualified personnel. If our management is unable to effectively manage our growth, our expenses may increase more than expected, our ability to generate revenue could be reduced, and we may not be able to implement our business strategy.

As part of our efforts to optimize efficiency across our organization, we closed our Jena, Germany office in 2016 and consolidated these operations in the United Kingdom and Switzerland. In 2017, we completed a reduction in force in our Lexington, MA facility, which included certain members of our management, in line with our prioritization efforts, and we closed our office in Basel, Switzerland and transferred our research and development assets and capabilities there to the United Kingdom. If these transition efforts prove to be unsuccessful, or if we identify management or operational gaps in connection with our changes, it could cause delays in discovery timelines and increased costs for certain of our internal and partnered programs, which also could have an adverse effect on our business, financial condition and results of operations.

Our synthetic Heat Shock Protein (“HSP”) peptide-based platform is in early stage development, and there is no guarantee that a product candidate will progress from this platform.

In June 2014, we reported positive results from a Phase 2 trial with HerpV TM , a vaccine candidate for genital herpes from our synthetic HSP peptide-based platform. While the HerpV Phase 2 trial met its formal endpoints, subjects were not followed long enough to determine whether the magnitude of the effect on viral load would be sufficient to significantly reduce the incidence, severity, or duration of herpetic lesions or reduce the risk of viral transmission. Although we have not advanced this program into a Phase 3 trial, we initiated our ASV synthetic cancer vaccine program based on our prior findings with this platform. We initiated our first clinical trial for our first AutoSynVax product candidate in 2017; however, there is no guarantee that results of this trial or any potential future clinical trials will be positive. Although we are planning to initiate a combination trial with ASV and one or more of our antibodies, the timeline is uncertain and there is no guarantee that we will be able to do so at all. Furthermore, it is possible that research and discoveries by others will render any product candidate from this platform as obsolete or noncompetitive.

We may not be able to advance clinical development or commercialize our cancer vaccine candidates or realize any benefits from these programs.

The probability of future clinical development efforts leading to marketing approval and commercialization of Prophage vaccines is highly uncertain. Prophage vaccines have been in clinical development for over 16 years, including multiple Phase 1 and 2 trials in eight different tumor types as well as randomized Phase 3 trials in metastatic melanoma and adjuvant renal cell carcinoma. To date, the only marketing approval for Prophage is in Russia where commercialization of the approved product was unsuccessful. All of our currently planned trials involving Prophage are intended to be sponsored by third parties, and there is no guarantee that they will occur at all. In addition, while we believe Prophage vaccines may provide clinical benefit to some patients as a monotherapy and in combination with other therapies, there is no guarantee that, if completed, subsequent Prophage trials would yield useful translational and/or efficacy data.

Our current clinical trial plans with Prophage vaccines entail one government sponsored IND in which we provide support and product supply. For third-party sponsored trials, we lack the ability to control trial design, timelines, tumor tissue procurement and data availability. For example, in January 2017, we announced a clinical trial collaboration with the National Cancer Institute (“NCI”), whereby the NCI is conducting a double-blind, randomized controlled Phase 2 trial to evaluate the effect of Prophage vaccine in conjunction with Merck’s pembrolizumab on the overall survival rate of patients with newly diagnosed glioblastoma (“ndGBM”). In addition, the Phase 2 trial of Prophage vaccine in combination with bevacizumab in patients with surgically resectable recurrent glioma that was being conducted under the sponsorship of the Alliance for Clinical Trials in Oncology, a cooperative group of the NCI, has been closed. Our other cancer vaccine programs (ASV and PSV) are in Phase 1 and pre-clinical development, respectively, and there is no guarantee that they will successfully advance in and through the clinic. ASV also utilizes QS-21 Stimulon, and any inability or delay in securing adequate supplies of the adjuvant could have an adverse impact on the program or otherwise delay timelines. Current and future studies may eventually be terminated due to, among other things, slow enrollment, lack of probability

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that they will yield useful translational and/or efficacy data, lengthy timelines, or the unlikelihood that results will support timely or successful regulatory filings.

Changes in our manufacturing strategies, manufacturing problems, or increased demand may cause delays, unanticipated costs, or loss of revenue streams within or across our programs.

Our antibody programs will require substantial manufacturing development and investment to progress. We are currently progressing a portfolio of antibody programs that are at different stages of development. If these efforts are delayed or do not produce the desired outcomes, this will cause delays in development timelines and increased costs, which may cause us to limit the size and scope of our efforts and studies. In 2015, we secured our own antibody manufacturing capabilities with the purchase of a manufacturing pilot plant from XOMA Corporation (“XOMA”), and we expect this facility to supply us with antibody drug substance requirements through clinical proof-of-concept studies. We will also need to develop or secure later phase and/or commercial manufacturing capabilities for larger, registrational studies or any commercial supply requirements. For the programs for which we will produce our own drug substance, we will continue to rely on third parties for fill-finish services and other parts of the manufacturing process. These services include the storage and maintenance of our drug substance during all stages of the manufacturing process. While we maintain insurance to cover certain potential losses, there is no guarantee that our insurance coverage will be adequate. Furthermore, we currently rely on contract manufacturing organizations (“CMOs”) and contract research organizations (“CROs”) to support some of our existing antibody programs. Our dependence on external CMOs for the manufacture of certain antibodies results in intrinsic risks to our performance, timelines, and costs of our accelerated development plans, and which could divert resources away from our antibody programs and/or lead to delays in the development of our product candidates. In the event that our antibody programs require progressively larger production capabilities, our options for qualified CMOs may become more limited.

To date, we have manufactured our Prophage vaccines in our Lexington, MA facility. Manufacturing of the Prophage vaccines is complex, and various factors could cause delays or an inability to supply the vaccine. Deviations in the processes controlling manufacture or deficiencies in size or quality of source material could result in production failures. Specific vulnerabilities in the process may exist in tumor types in which quality or quantity of tissue is limited. In addition, regulatory bodies may require us to make our manufacturing facility a single product facility. In such an instance, we would no longer have the ability to manufacture Prophage vaccines in addition to other product candidates in our current facility.

We have given our corporate QS-21 Stimulon licensee, GSK, manufacturing rights for QS-21 Stimulon for use in their product programs. We have retained the right to manufacture QS-21 for ourselves and third parties, although no other such programs are anticipated to bring us substantial revenues in the near future, if ever. Although we have the right to secure certain quantities of QS-21 from GSK and we have some internal supply in-house, we currently do not have an alternative long term supply partner for this adjuvant.

Our ability to efficiently manufacture our product candidates is contingent, in part, upon our own, and our CMOs’, ability to ramp up production in a timely manner without the benefit of years of experience and familiarity with the processes, which we may not be able to adequately transfer. We currently rely upon and expect to continue to rely upon third parties, potentially including our collaborators or licensees, to produce materials required to support our product candidates, pre-clinical studies, clinical trials, and any future commercial efforts. A number of factors could cause production interruptions at either our manufacturing facility or the facilities of our CMOs or suppliers, including equipment malfunctions, labor or employment retention problems, natural disasters, power outages, terrorist activities, or disruptions in the operations of our suppliers. Alternatively, there is the possibility we may have excess manufacturing capacity if product candidates do not progress as planned.

As mentioned above, reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured all of our product candidates ourselves, including reliance on the third party for regulatory compliance, the possibility of breach of the manufacturing agreement by the third party because of factors beyond our control, and the possibility of termination or non-renewal of the agreement by the third party, based on its own business priorities, at a time that is costly or inconvenient for us.

Biopharmaceutical manufacturing is also subject to extensive government regulation. Components of a finished therapeutic product approved for commercial sale or used in late-stage clinical trials must be manufactured in accordance with current good manufacturing practices. These regulations govern manufacturing processes and procedures (including record-keeping) and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale. Our facilities and quality systems and the facilities and quality systems of some or all of our third-party contractors must pass a pre-approval inspection for compliance with the applicable regulations as a condition of regulatory approval of a product candidate. In addition, facilities are subject to on-going inspections and routine audits, and minor changes in manufacturing processes may require additional regulatory approvals and audits, either of which could cause us to incur significant additional costs, set-backs or delays and eventual loss of revenue.

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Risks associated with doing business internationally could negatively affect our business.

We currently have research and development operations in the United Kingdom, and we expect to pursue pathways to develop and commercialize our product candidates in both U.S. and non-U.S. jurisdictions. Various risks associated with foreign operations may impact our success. Possible risks of foreign operations include fluctuations in the value of foreign and domestic currencies, requirements to comply with various jurisdictional requirements such as data privacy regulations, disruptions in the import, export, and transportation of patient tumors and our products or product candidates, the product and service needs of foreign customers, difficulties in building and managing foreign relationships, the performance of our licensees or collaborators, geopolitical instability, unexpected regulatory, economic, or political changes in foreign and domestic markets, including without limitation any resulting from the United Kingdom’s withdrawal from the European Union or our current political regime, and limitations on the flexibility of our operations and costs imposed by local labor laws.  

Our competitors may have superior products, manufacturing capability, selling and marketing expertise and/or financial and other resources.

Our product candidates and the product candidates in development by our collaboration partners may fail because of competition from major pharmaceutical companies and specialized biotechnology companies that market products, or that are engaged in the development of product candidates and for the treatment cancer. Many of our competitors, including large pharmaceutical companies, have greater financial and human resources and more experience than we do. Our competitors may:

 

develop safer or more effective therapeutic drugs or therapeutic vaccines and other products;

 

establish superior intellectual property positions;

 

discover technologies that may result in medical insights or breakthroughs, which render our drugs or vaccines obsolete, possibly before they generate any revenue, if ever;

 

adversely affect our ability to recruit patients for our clinical trials;

 

solidify partnerships or strategic acquisitions that may increase the competitive landscape;

 

develop or commercialize their product candidates sooner than we commercialize our own, if ever; or

 

implement more effective approaches to sales and marketing and capture some of our potential market share.

There is no guarantee that our product candidates will be able to compete with potential future products being developed by our competitors.

The CPM landscape is crowded with several competitors developing assets against a number of targets. Development plans are spread out across various indications and lines of therapy, either alone or in combination with other assets. Competitors range from small cap to large cap companies, with assets in pre-clinical or clinical stages of development. Therefore, the landscape is dynamic and constantly evolving. We and our partners have CPM antibody programs, currently in clinical stage development targeting PD-1, CTLA-4, GITR, OX40, TIM-3 and LAG-3. We are aware of many companies that have antibody-based products on the market or in clinical development that are directed to the same biological targets as these programs, including, without limitation, the following: (1)  BMS markets ipilimumab, an anti-CTLA-4 antibody, and nivolumab, an anti-PD-1 antibody, and is developing additional antagonists to LAG-3, TIM-3 as well as agonists to GITR and OX-40. BMS also has next generation anti-CTLA-4 antibodies in the clinic, which may be competitive to our next generation anti-CTLA-4 program, (2) Merck has an approved anti-PD-1 antibody, as well as anti-CTLA-4 and LAG-3 antagonists and an anti-GITR agonist in clinical development, (3) Regeneron has an approved anti-PD-1 antibody as well as antibodies targeting CTLA-4, LAG-3 and GITR in clinical development, (4) AstraZeneca has an approved anti PD-L1 antibody, as well as anti-CTLA-4, PD-1, GITR and OX40 targeting antibodies in the clinic, (5) Pfizer has an approved anti-PD-L1 (with Merck KgaA) as well as anti-PD-1, and anti-OX40 antibodies in clinical development, and (6) Roche/Genentech has an approved anti-PD-L1 antibody. We are also aware of other competitors with PD-1/PD-L1 antibodies in clinical development, including but not restricted to AbbVie, Arcus Biosciences, Boehringer Ingelheim, Tesaro, Beigene, Eli Lilly, Jiangsu HengRui Medicine, Shanghai Junshi, Macrogenics/Incyte, CytomX/BMS, Symphogen, Janssen, CBT Pharmaceuticals, Checkpoint Therapeutics, CStone Pharmaceuticals, Livzon MabPharm Inc, Suzhou Alphamab, Mabspace Biosciences, Henlix Biotech Inc. and Akeso Biopharma. We are also aware of competitors with pre-clinical antibodies against PD-1 or PD-L1. In addition, we are aware of competitors with clinical stage antibodies against GITR, OX40, LAG-3, TIM-3 as well as our earlier stage programs such as TIGIT and CD137. As outlined above, some of these include, but are not limited to, BMS, Pfizer, Novartis, Merck, Tesaro, Eli Lilly, OncoMed, Boehringer Ingelheim, Potenza and Symphogen. Additionally, we are aware of competitors developing preclinical assets and bispecifics against these targets. There is no guarantee that our antibody product candidates will be able to compete with our competitors’ antibody products and product candidates.

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We are conducting both single ar m and combination trials in second line cervical cancer. We are aware that Merck’s PD-1 antagonist, Keytruda, has been approved in advanced cervical cancer. We are also aware of industry sponsored clinical trials, including exploratory studies, that are underway in cervical cancer. Clinical stage competitors include, but are not limited to, Regeneron (anti-PD-1), Ono Pharmaceuticals and BMS (anti-PD-1 alone or in combination with agents against other checkpoint targets), Seattle Genetics and Genmab (a ntibody drug conjugate targeting Tissue Factor) and Iovance Biotherapeutics (autologous TILs). Additionally, we are aware of other early stage clinical trials testing alternate checkpoint targets in cervical cancer patients. These include, but are not limi ted to, OX40 +/- CD137 agonists (Pfizer) and anti-PD-1 + anti-ICOS (GSK/Merck) , anti-CTLA-4 (treme) and anti-ICOS (GSK/AZ) .

We have autologous vaccine programs in development including our Prophage vaccine in clinical development for GBM. We are aware of other therapeutic options in GBM that could compete with our vaccine, including but not restricted to the following: Schering Corporation, a subsidiary of Merck, markets temozolomide for treatment of patients with ndGBM and refractory astrocytoma. Other companies are developing vaccines for the treatment of patients with ndGBM, including, but not limited to, Northwest Biotherapeutics (DC-Vax), Mimivax Inc. (SurVaxM) and Annias Immunotherapeutics (CMV Vaccine). Other companies may begin development programs as well. We are advancing our neoantigen vaccine, AutoSynVax, in solid tumors.  There are companies advancing individualized or synthetic vaccine technologies and/or patient-specific medicine techniques that compete with our HSP based vaccines such as: Aduro Biotech, Neon Therapeutics, Gritstone Oncology, Advaxis/Amgen, BioNTech, Moderna/Merck, Genocea Biosciences, Argos Therapeutics, ISA Pharmaceuticals, Nouscom, ImmuneDesign, EpiVax Inc., Achilles Therapeutics, Vaccibody and BrightPath Biotherapeutics.

In addition, and prior to regulatory approval, if ever, our vaccines and our other product candidates may compete for access to patients with other products in clinical development, with products approved for use in the indications we are studying, or with off-label use of products in the indications we are studying. We anticipate that we will face increased competition in the future as new companies enter markets we seek to address and scientific developments surrounding immunotherapy and other traditional cancer therapies continue to accelerate.

We are aware of compounds that claim to be comparable to QS-21 Stimulon that are being used in clinical trials. Several other vaccine adjuvants are in development and could compete with QS-21 Stimulon for inclusion in vaccines in development. These adjuvants may include, but are not limited to, (1) oligonucleotides, under development by Pfizer, Idera, and Dynavax, (2) MF59, under development by Novartis, (3) IC31, under development by Intercell (now part of Valneva), and (4) MPL, under development by GSK. In the past, we have provided QS-21 Stimulon to other entities under materials transfer arrangements. In at least one instance, it is possible that this material was used unlawfully to develop synthetic formulations and/or derivatives of QS-21. In addition, companies such as Adjuvance Technologies, Inc., CSL Limited, and Novavax, Inc., as well as academic institutions and manufacturers of saponin extracts, are developing saponin adjuvants, including derivatives and synthetic formulations. These sources may be competitive to our ability to execute future partnering and licensing arrangements involving QS-21 Stimulon. The existence of products developed by these and other competitors, or other products of which we are not aware, or which other companies may develop in the future, may adversely affect the marketability of products developed or sold using QS-21 Stimulon.

We are also aware of a third party that manufactures pre-clinical material purporting to be comparable to QS-21 Stimulon. The claims being made by this third party may create marketplace confusion and have an adverse effect on the goodwill generated by us and our partners with respect to QS-21 Stimulon. We are also aware of at least two manufacturers of QS-21. Any diminution of this goodwill may have an adverse effect on our ability to commercialize future products, if any, incorporating this technology, either alone or with a third party.

Failure to realize the anticipated benefits of our strategic acquisitions and licensing transactions could adversely affect our business, operations and financial condition.

An important part of our business strategy has been to identify and advance a pipeline of product candidates by acquiring and in-licensing product candidates, technologies and businesses that we believe are a strategic fit with our existing business. Since we acquired 4-AB in 2014, we have completed numerous additional strategic acquisitions and licensing transactions. The ultimate success of these strategic transactions entails numerous operational and financial risks, including:

 

higher than expected development and integration costs;

 

difficulty in combining the technologies, operations and personnel of acquired businesses with our technologies, operations and personnel;

 

exposure to unknown liabilities;

 

difficulty or inability to form a unified corporate culture across multiple office sites both nationally and internationally;

 

inability to retain key employees of acquired businesses;

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disruption of our business and diversion of our management’s time and attention; and

 

difficulty or inability to secure financing to fund development activities for such acquired or in-licensed product candidates, technologies or businesses.

We have limited resources to integrate acquired and in-licensed product candidates, technologies and businesses into our current infrastructure, and we may fail to realize the anticipated benefits of our strategic transactions. Any such failure could have an adverse effect on our business, operations and financial condition.

Failure to enter into and/or maintain significant licensing, distribution and/or collaboration agreements in a timely manner and on favorable terms to us may hinder or cause us to cease our efforts to develop and commercialize our product candidates, increase our development timelines, and/or increase our need to rely on partnering or financing mechanisms, such as sales of debt or equity securities, to fund our operations and continue our current and anticipated programs.

As previously noted, our ability to advance our antibody programs depends in part on collaboration agreements such as our collaboration with Incyte. See “Risk Factors—Risks Related to Our Business—We are dependent upon our collaboration with Incyte to further develop, manufacture and commercialize antibodies against certain targets. If we or Incyte fail to perform as expected, the potential for us to generate future revenues under the collaboration could be significantly reduced, the development and/or commercialization of these antibodies may be terminated or substantially delayed, and our business could be adversely affected.” In addition, from time to time we engage in efforts to enter into licensing, distribution and/or collaboration agreements with one or more pharmaceutical or biotechnology companies to assist us with development and/or commercialization of our other product candidates. If we are successful in entering into such agreements, we may not be able to negotiate agreements with economic terms similar to those negotiated by other companies. We may not, for example, obtain significant upfront payments, substantial royalty rates or milestones. If we fail to enter into any such agreements in a timely manner or at all, our efforts to develop and/or commercialize our product candidates may be undermined. In addition, if we do not raise funds through any such agreements, we will need to rely on other financing mechanisms, such as sales of debt or equity securities, to fund our operations. Such financing mechanisms, if available, may not be sufficient or timely enough to advance our programs forward in a meaningful way in the short-term.

Because we rely on collaborators and licensees for the development and commercialization of certain of our product candidate programs, these programs may not prove successful, and/or we may not receive significant payments from such parties.

Part of our strategy is to develop and commercialize many of our product candidates by continuing or entering into arrangements with academic, government, or corporate collaborators and licensees. Our success depends on our ability to negotiate such agreements on favorable terms and on the success of the other parties in performing research, pre-clinical and clinical testing, completing regulatory applications, and commercializing product candidates. Our research, development, and commercialization efforts with respect to antibody candidates from our technology platforms are, in part, contingent upon the participation of institutional and corporate collaborators. For example, in February 2015, we began a broad collaboration with Incyte to pursue the discovery and development of antibodies. See “Risk Factors-Risks Related to our Business—We are dependent upon our collaboration with Incyte to further develop, manufacture and commercialize antibodies against certain targets. If we or Incyte fail to perform as expected, the potential for us to generate future revenues under the collaboration could be significantly reduced, the development and/or commercialization of these antibodies may be terminated or substantially delayed, and our business could be adversely affected.” Furthermore, we have a collaboration arrangement with Recepta for CTLA-4 and PD-1, giving Recepta rights to certain South American countries and requiring us to agree upon development plans for these product candidates. Disagreements or the failure of either party to perform satisfactorily could have an adverse impact on these programs.

The Brain Tumor Trials Collaborative, through the NCI, is sponsoring a Phase 2 clinical trial of our Prophage vaccine candidate in combination with Merck’s pembrolizumab in patients with glioma. When our licensees or third-party collaborators sponsor clinical trials using our product candidates, we cannot control the timing of enrollment, data readout, or quality of such trials or related activities.  

Development activities for our collaboration programs may fail to produce marketable products due to unsuccessful results or abandonment of these programs, failure to enter into future collaborations or license agreements, or the inability to manufacture product supply requirements for our collaborators and licensees. Several of our agreements also require us to transfer important rights and regulatory compliance responsibilities to our collaborators and licensees. As a result of these collaboration agreements, we will not control the nature, timing, or cost of bringing these product candidates to market. Our collaborators and licensees could choose not to, or be unable to, devote resources to these arrangements or adhere to required timelines, or, under certain circumstances, may terminate these arrangements early. They may cease pursuing product candidates or elect to collaborate with different companies. In addition, these collaborators and licensees, outside of their arrangements with us, may develop technologies or products that are competitive with those that we are developing. From time to time, we may also become involved in disputes with our collaborators or licensees. Such disputes could result in the incurrence of significant expense, or the termination of collaborations. We may be unable

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to fulfill all of our obligations to our collaborators, which may result in the termination of collaborations. As a result of these factors, our strategic collaborations may not yield revenue. Furthermore, we may not be able to enter into new coll aborations on favorable terms or at all. Failure to generate significant revenue from collaborations could increase our need to fund our operations through sales of debt or equity securities and would negatively affect our business prospects.

Our internal computer systems, or those of our third-party CROs, CMOs, licensees, collaborators or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption in our business and operations or could subject us to sanctions and penalties that could have a material adverse effect on our reputation or financial condition.

Despite the implementation of security measures, our internal computer systems and those of our current and future CROs, CMOs, licensees, collaborators and other contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Potential vulnerabilities can also be exploited from inadvertent or intentional actions of our employees, third-party vendors, business partners, or by malicious third parties. Attacks of this nature are increasing in their frequency, levels of persistence, sophistication and intensity, and are being conducted by sophisticated and organized groups and individuals with a wide range of motives (including, but not limited to, industrial espionage) and expertise, including organized criminal groups, “hacktivists,” nation states and others. In addition to the extraction of sensitive information, such attacks could include the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other means to affect service reliability and threaten the confidentiality, integrity and availability of information. In addition, the prevalent use of mobile devices increases the risk of data security incidents. While we are not aware of any such material system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations. For example, the loss of clinical trial data from completed, on-going or future clinical trials could result in delays in our regulatory approval efforts and significant costs to recover or reproduce the data. Likewise, we rely on third parties to manufacture certain of our drug candidates and conduct clinical trials, and similar events relating to their computer systems could also have a material adverse effect on our business. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liabilities and the further development and commercialization of our product candidates could be delayed. We do not maintain cyber liability insurance, and would therefore have no coverage for any losses resulting from any data security incident.

We use and store customer, vendor, employee and business partner and, in certain instances patient, personally identifiable information in the ordinary course of our business. We are subject to various domestic and international privacy and security regulations, including but not limited to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which mandates, among other things, the adoption of uniform standards for the electronic exchange of information in common healthcare transactions, as well as standards relating to the privacy and security of individually identifiable health information, which require the adoption of administrative, physical and technical safeguards to protect such information. In addition, many states have enacted comparable laws addressing the privacy and security of health information, some of which are more stringent than HIPAA. Failure to comply with these standards, or a computer security breach or cyber-attack that affects our systems or results in the unauthorized release of proprietary or personally identifiable information, could subject us to criminal penalties and civil sanctions, and our reputation could be materially damaged, and our operations could be impaired. We may also be exposed to a risk of loss or litigation and potential liability, which could have a material adverse effect on our business, results of operations and financial condition.

We are highly reliant on certain members of our management team. In addition, we have limited internal resources and if we fail to recruit and/or retain the services of key employees and external consultants as needed, we may not be able to achieve our strategic and operational objectives.

Garo H. Armen, Ph.D., the Chairman of our Board of Directors and our Chief Executive Officer who co-founded the Company in 1994, is integral to building our company and developing our technology. If Dr. Armen is unable or unwilling to continue his relationship with Agenus, our business may be adversely impacted. We have an employment agreement with Dr. Armen, and he plays an important role in our day-to-day activities. We do not carry a key employee insurance policy for Dr. Armen or any other employee.

Our future growth success depends to a significant extent on the skills, experience and efforts of our executive officers and key members of our clinical and scientific staff. We face intense competition for qualified individuals from other pharmaceutical, biopharmaceutical and biotechnology companies, as well as academic and other research institutions. We may be unable to retain our current personnel or attract or assimilate other highly qualified management and clinical personnel in the future on acceptable terms. The loss of any or all of these individuals could harm our business and could impair our ability to support our collaboration partners or our growth generally. If our management is unable to effectively manage our growth, our expenses may increase more than expected, our ability to generate revenue could be reduced and we may not be able to implement our business strategy. Moreover, in connection with our 2017 restructuring activities, certain positions on our management team were eliminated and Dr. Robert Stein retired from his role as President of R&D to become a senior R&D advisor to the Company. Any key capability gaps identified following this restructuring could have a material adverse effect on our business, financial condition and results of operations.

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We intend to advance our cell therapy business through our subsidiary, Agen Tus Therapeutics, eventually with separate funding. Moving intellectual property assets into AgenTus Therapeutics in foreign jurisdictions could have adverse tax consequences, and there is no guarantee that we will be able to attract external funding. More over, even if the business is funded, there is no guarantee that it will be successful.

We are currently in the process of pursuing external funding and partnership opportunities to advance AgenTus Therapeutics, but Agenus is currently funding such operations. There is no guarantee that external funding will be available. If funding is available, there is no guarantee that it will be on attractive or acceptable terms, or that it will be adequate to advance the business to an inflection point for additional funding. Similarly, there is no guarantee that partnership opportunities will be available on attractive terms, if at all. If external funding is not available, we may be forced to either retire these programs or continue to use internal resources to advance them. In addition, our cell therapy assets are pre-clinical. Even if adequate funding and partnership opportunities are available, there is no guarantee that we will be successful in advancing one or more product candidates into and through clinical development. In addition, most of the efforts being made on behalf of AgenTus Therapeutics are being led by a separate AgenTus chief executive officer, utilizing Agenus’ management team and internal G&A resources. The current structure could distract management and divert Agenus resources from Agenus’ own core pipeline and programs.

The cell therapy assets necessary to enable AgenTus Therapeutics are currently owned or controlled by Agenus in the United States and Switzerland. In connection with capitalizing AgenTus Therapeutics, these assets will be transferred or licensed to new legal entities within the United States and Europe and potentially others. Transferring these assets or licensing them on an exclusive basis would require that taxes be paid based on the fair market value of the assets. While we expect to have adequate net operating losses to offset any tax liabilities, there is no guarantee that this will be the case in all relevant jurisdictions. Moreover, we have previously disclosed our interest in potentially issuing a tax-free dividend to Agenus’ stockholders in the form of stock of AgenTus Therapeutics. There is no guarantee that any such dividend will be tax-free or that it will be issued at all, or the timing thereof. If we issue a dividend in the form of stock, there could be adverse tax consequences for certain of our stockholders.

Calamities, power shortages or power interruptions could disrupt our business and materially adversely affect our operations.

If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our facilities, that damaged critical infrastructure (such as our manufacturing facility) or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue certain activities, such as for example our manufacturing capabilities, for a substantial period of time. We own an antibody pilot plant manufacturing facility and lease additional office space in Berkeley, CA. This location is in an area of seismic activity near active earthquake faults. Any earthquake, terrorist attack, fire, power shortage or other calamity affecting our facilities or those of third parties upon whom we depend may disrupt our business and could have a material adverse effect on our business, results of operations, financial condition and prospects. The disaster recovery and business continuity plans we have in place currently are limited and are unlikely to prove adequate in the event of a serious disaster or similar event. We may incur substantial expenses and delays as a result of the limited nature of our disaster recovery and business continuity plans, which could have a material adverse effect on our business.  

Comprehensive tax reform legislation could adversely affect our business and financial condition.

On December 22, 2017, President Trump signed into law the “Tax Cuts and Jobs Act” (the “TJCA”) that significantly reforms the Internal Revenue Code of 1986, as amended. The TCJA, among other things, includes changes to U.S. federal tax rates, imposes significant additional limitations on the deductibility of interest and net operating loss carryforwards, allows for the expensing of capital expenditures, and puts into effect the migration from a “worldwide” system of taxation to a territorial system. Our net deferred tax assets and liabilities were revalued at the newly enacted U.S. corporate rate. We did not recognize any tax expense in the year of enactment as our net deferred tax assets have a full valuation allowance recorded. We continue to examine the impact this tax reform legislation may have on our business. The impact of this tax reform is uncertain and could be adverse.

Risks Related to Regulation of the Biopharmaceutical Industry

The drug development and approval process is uncertain, time-consuming, and expensive.

Drug development, including non-clinical testing and clinical development, and the process of obtaining regulatory approvals for new therapeutic products, is lengthy, expensive, and uncertain. For example, as of September 30, 2018, we had spent more than 20 years and $773.2 million on our research and development programs. The development and regulatory approval processes also can vary substantially based on the therapeutic area, type, complexity, and novelty of the product. We must provide regulatory authorities with manufacturing, product characterization, and pre-clinical and clinical data demonstrating that our product candidates are safe and effective before they can be approved for commercial sale. It may take us many years to complete our testing, and failure can occur at any stage. Results of pre-clinical studies do not necessarily predict clinical results, and promising results in early clinical studies might

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not be confirmed in later studies. Any pre-clinical or clinical test may fail to produce results satisfactory to regulatory authorities for many reasons, including but not limited to emerging manufacturing or control issues, limitations of pre-clinical assessments, difficult ies to enroll a sufficient number of patients, changing therapeutic landscape or failure to prospectively identify the benefit/risk profile of the new product. Pre-clinical and clinical data can be interpreted in different ways, which could delay, limit, o r prevent regulatory approval. Negative or inconclusive results from a pre-clinical study or clinical trial, adverse medical events during a clinical trial, or safety issues emerging with products of the same class of drug could require additional studies or cause a program to be terminated, even if other studies or trials relating to the program are successful. We or the FDA, other regulatory agencies, or an institutional review board may suspend or terminate human clinical trials at any time on various gr ounds.

The timing and success of a clinical trial is dependent on obtaining and maintaining sufficient cash resources, successful production of clinical trial material, enrolling sufficient patients in a timely manner, avoiding or mitigating serious or significant adverse patient reactions, and demonstrating efficacy of the product candidate in order to support a favorable risk versus benefit profile, among other considerations. The timing and success of our clinical trials, in particular, are also dependent on clinical sites and regulatory authorities accepting each trial’s protocol, statistical analysis plan, product characterization tests, and final clinical results. In addition, regulatory authorities may request additional information or data that is not readily available. Delays in our ability to respond to such requests would delay, and failure to adequately address concerns would prevent, our commercialization efforts. We have encountered in the past, and may encounter in the future, delays in initiating trial sites and enrolling patients into our clinical trials. Future enrollment delays will postpone the dates by which we expect to complete the impacted trials and the potential receipt of regulatory approval. There is no guarantee we will successfully initiate and/or complete our clinical trials.

Delays or difficulties in obtaining regulatory approvals or clearances for our product candidates may:

 

adversely affect the marketing of any products we or our licensees or collaborators develop;

 

impose significant additional costs on us or our licensees or collaborators;

 

diminish any competitive advantages that we or our licensees or collaborators may attain;

 

limit our ability to receive royalties and generate revenue and profits; and

 

adversely affect our business prospects and ability to obtain financing.

Delays or failures in our receiving regulatory approval for our product candidates in a timely manner may result in us having to incur additional development expense and subject us to having to secure additional financing. As a result, we may not be able to commercialize them in the time frame anticipated, and our business will suffer.

Even if we or our partners receive marketing approval for our product candidates, such product approvals could be subject to restrictions or withdrawals. Regulatory requirements are subject to change. Further, even if we or our partners receive marketing approval, we may not receive sufficient coverage and adequate reimbursement for our products.

Regulatory authorities generally approve products for particular indications. If an approval is for a limited indication, this limitation reduces the size of the potential market for that product. Product approvals, once granted, are subject to continual review and periodic inspections by regulatory authorities. Our operations and practices are subject to regulation and scrutiny by the United States government, as well as governments of any other countries in which we do business or conduct activities. Later discovery of previously unknown problems or safety issues, and/or failure to comply with domestic or foreign laws, knowingly or unknowingly, can result in various adverse consequences, including, among other things, possible delay in approval or refusal to approve a product, warning letters, fines, injunctions, civil penalties, recalls or seizures of products, total or partial suspension of production, refusal of the government to renew marketing applications, complete withdrawal of a marketing application, corrective action requirements, and/or criminal prosecution, withdrawal of an approved product from the market, and/or exclusion from government health care programs. Such regulatory enforcement could have a direct and negative impact on the product for which approval is granted and could have a negative impact on the approval of any pending applications for marketing approval of new drugs or supplements to approved applications.

Because we operate in a highly regulated industry, regulatory authorities could take enforcement action against us in connection with our licensees’ or collaborators’, and/or our business and marketing activities for various reasons. For example, the Foreign Corrupt Practices Act prohibits U.S. companies and their representatives from offering, promising, authorizing, or making payments to foreign governmental officials for the purpose of obtaining or retaining business abroad.

From time to time, new legislation is passed into law that could significantly change the statutory provisions governing the approval, manufacturing, and marketing of products regulated by the FDA and other foreign health authorities. Additionally, regulations and guidance are often revised or reinterpreted by health agencies in ways that may significantly affect our business and our products. It is impossible to predict whether further legislative changes will be enacted, or whether regulations, guidance, or interpretations will change, and what the impact of such changes, if any, may be. For example, the Patient Protection and Affordable Care Act and the Health Care and Education Affordability Reconciliation Act of 2010 (collectively the “ACA”), enacted in March

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2010, substantially changed the way healthcare is financed by both governmental and private insurers, and sig nificantly impacted the pharmaceutical industry. With regard to pharmaceutical products, among other things, ACA is expected to expand, increase, and change the methodology regarding industry rebates for drugs covered under Medicaid programs; impose an ann ual, nondeductible fee on any entity that manufactures or imports specific branded prescription drugs and biologic agents, apportioned among those entities according to market share in certain government healthcare programs; expand eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level; expand the entities eligible for discounts under the Public Health Service pharmaceutica l pricing program; create a new Patient Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and make changes to the coverage requirements un der the Medicare D program. Significant legislative changes to the ACA also appear possible in the 115 th U.S. Congress under the Trump Administration.

We expect both government and private health plans to continue to require healthcare providers, including healthcare providers that may one day purchase our products, to contain costs and demonstrate the value of the therapies they provide. Even if our product candidates are approved, the commercial success of our products will depend substantially on the extent to which they are covered by third-party payors, including government health authorities and private health insurers. In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors, and coverage and reimbursement for products can differ significantly from payor to payor. If coverage and reimbursement are not available, or reimbursement is available only to limited levels, we or our collaborators may not be able to successfully commercialize our product candidates.

New data from our research and development activities, and/or resource considerations could modify our strategy and result in the need to adjust our projections of timelines and costs of programs.

Because we are focused on novel technologies, our research and development activities, including our nonclinical studies and clinical trials, involve the ongoing discovery of new facts and the generation of new data, based on which we determine next steps for a relevant program. These developments can occur with varying frequency and constitute the basis on which our business is conducted. We make determinations on an ongoing basis as to which of these facts or data will influence timelines and costs of programs. We may not always be able to make such judgments accurately, which may increase the costs we incur attempting to commercialize our product candidates. We monitor the likelihood of success of our initiatives and we may need to discontinue funding of such activities if they do not prove to be commercially feasible, due to our limited resources.

We may need to successfully address a number of technological challenges in order to complete development of our product candidates. Moreover, these product candidates may not be effective in treating any disease or may prove to have undesirable or unintended side effects, toxicities, or other characteristics that may preclude our obtaining regulatory approvals or prevent or limit commercial use.

Risks Related to Intellectual Property Rights

If we are unable to obtain and enforce patent protection for our product candidates and related technology, our business could be materially harmed.

We rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to our product candidates and technology. Any disclosure to or misappropriation by third parties of our confidential proprietary information could enable competitors to duplicate or surpass our technological achievements, eroding our competitive position in the market. Our patent applications may not result in issued patents, and, even if issued, the patents may be challenged and invalidated. Moreover, our patents and patent applications may not be sufficiently broad to prevent others from practicing our technologies or developing competing products. We also face the risk that others may independently develop similar or alternative technologies or may design around our proprietary property.

Issued patents may be challenged, narrowed, invalidated or circumvented. In addition, court decisions may introduce uncertainty in the enforceability or scope of patents owned by biotechnology companies. The legal systems of certain countries do not favor the aggressive enforcement of patents, and the laws of foreign countries may not allow us to protect our inventions with patents to the same extent as the laws of the United States. Because patent applications in the United States and many foreign jurisdictions are typically not published until 18 months after filing, or in some cases not at all, and because publications of discoveries in scientific literature lag behind actual discoveries, we cannot be certain that we were the first to make the inventions claimed in our issued patents or pending patent applications, or that we were the first to file for protection of the inventions set forth in our patents or patent applications. As a result, we may not be able to obtain or maintain protection for certain inventions. Therefore, the enforceability and scope of our patents in the United States and in foreign countries cannot be predicted with certainty and, as a result, any patents that we own, or license may not provide sufficient protection against competitors. We may not be able to obtain or maintain patent protection from our pending patent applications, from those we may file in the future, or from those we may license from third parties. Moreover, even if we are able to obtain patent protection, such patent protection may be of insufficient scope to achieve our business objectives.

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Patent terms may be inadequate to protect our competitive position on our product candidates for an adeq uate amount of time. Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after its effective filing date. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Without patent protection for our product candidates, we may be open to competition from biosimilar or generic versions of our product candidates. Furthermore, the product development timeline for biotechnology products is lengthy and it is possible that our issued patents covering our product candidates in the United States and other jurisdictions may expire prior to commercial launch. For example, if we encounter delays in our development efforts, including our clinical trials, the pe riod of time during which we could market our product candidates under patent protection could be reduced.

Our strategy depends on our ability to identify and seek patent protection for our discoveries. This process is expensive and time consuming, and we and our current or future licensors or licensees may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner or in all jurisdictions where protection may be commercially advantageous. It is also possible that we or our current licensors or licensees, or any future licensors or licensees, may not identify patentable aspects of inventions made in the course of development and commercialization activities in time to obtain patent protection on them. Therefore, these and any of our patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. Defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, for example with respect to proper priority claims, inventorship, etc. If we or our current licensors or licensees, or any future licensors or licensees, fail to establish, maintain or protect such patents and other intellectual property rights, such rights may be reduced or eliminated. If our current licensors or licensees, or any future licensors or licensees, are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised. If there are material defects in the form or preparation of our patents or patent applications, such patents or applications may be invalid and unenforceable. Despite our efforts to protect our proprietary rights, unauthorized parties may be able to obtain and use information that we regard as proprietary. The issuance of a patent does not ensure that it is valid or enforceable, so even if we obtain patents, they may not be valid or enforceable against third parties. In addition, the issuance of a patent does not give us the right to practice the patented invention. Third parties may have blocking patents that could prevent us from marketing our own patented product and practicing our own patented technology. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.

The patent landscape in the field of therapeutic antibody development, manufacture and commercialization is crowded. For example, we are aware of third party patents directed to methods for identifying and producing therapeutic antibodies. We are also aware of third party patents directed to antibodies to numerous targets for which we also seek to identify, develop, and commercialize antibodies. For example, some patents claim antibodies based on competitive binding with existing antibodies, some claim antibodies based on specifying sequence or other structural information, and some claim various methods of discovery, production, or use of such antibodies.

These or other third-party patents could impact our freedom to operate in relation to our technology platforms, as well as in relation to development and commercialization of antibodies identified by us as therapeutic candidates. As we discover and develop our candidate antibodies, we will continue to conduct analyses of these third-party patents to determine whether we believe we might infringe them, and if so, whether they would be likely to be deemed valid and enforceable if challenged. If we determine that a license for a given patent or family of patents is necessary or desirable, there can be no guarantee that a license would be available on favorable terms, or at all. Inability to obtain a license on favorable terms, should such a license be determined to be necessary or desirable, could, without limitation, result in increased costs to design around the third-party patents, delay product launch, or result in cancellation of the affected program or cessation of use of the affected technology.

Third parties may also seek to market biosimilar versions of any approved products. Alternatively, third parties may seek approval to market their own products similar to or otherwise competitive with our products. In these circumstances, we may need to defend and/or assert our patents, including by filing lawsuits alleging patent infringement. In any of these types of proceedings, a court or agency with jurisdiction may find our patents invalid and/or unenforceable. Even if we have valid and enforceable patents, these patents still may not provide protection against competing products or processes sufficient to achieve our business objectives.

We own, co-own or have exclusive rights to approximately 25 issued United States patents and approximately 95 issued foreign patents. We also own, co-own or have exclusive rights to approximately 35 pending United States patent applications and approximately 155 pending foreign patent applications. However, our patents may not protect us against our competitors. Our patent positions, and those of other biopharmaceutical, pharmaceutical and biotechnology companies, are generally uncertain and involve complex legal, scientific, and factual questions. The standards which the United States Patent and Trademark Office (“USPTO”) uses to grant patents, and the standards which courts use to interpret patents, are not always applied predictably or uniformly and can change, particularly as new technologies develop. Consequently, the level of protection, if any, that will be provided by our patents if we attempt to enforce them and they are challenged, is uncertain. In addition, the type and extent of patent claims that will be issued to us in the future is uncertain. Any patents that are issued may not contain claims that permit us to stop competitors from using similar technology.

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Through our acquisitions of 4-AB, PhosImmune and certain assets of Celexion, we own, co-own, or have exclusive rights to a number of patents and patent applications directed to v arious methods and compositions, including methods for identifying therapeutic antibodies and product candidates arising out of such entities’ technology platforms. In particular, we own patents and patent applications relating to our Retrocyte Display TM t echnology platform, a high throughput antibody expression platform for the identification of fully-human and humanized monoclonal antibodies. This patent family is projected to expire between 2029 and 2031. Through our acquisition of PhosImmune, we own, co -own, or have exclusive rights to patents and patent applications directed to various methods and compositions, including a patent directed to methods for identifying phosphorylated proteins using mass spectrometry. This patent is projected to expire in 20 23. We also own patents and patent applications relating to the SECANT ® platform, a platform used for the generation of novel monoclonal antibodies. This patent family is projected to expire between 2028 and 2029. In addition, as we advance our research an d development efforts with our institutional and corporate collaborators, we are seeking patent protection for newly identified therapeutic antibodies and product candidates. We can provide no assurance that any of our patents, including the patents that w e acquired or in-licensed in connection with our acquisitions of 4-AB, PhosImmune and certain assets of Celexion, will have commercial value, or that any of our existing or future patent applications, including the patent applications that we acquired or i n-licensed in connection with our acquisitions of 4-AB, PhosImmune and certain assets of Celexion, will result in the issuance of valid and enforceable patents.

Our issued patents covering Prophage vaccine and methods of use thereof, alone or in combination with other agents, expired or will expire at various dates between 2015 and 2024. In particular, our issued U.S. patents covering Prophage composition of matter expired in 2015. In addition, our issued patents covering QS-21 Stimulon composition of matter expired in 2008. We continue to explore means of extending the life cycle of our patent portfolio.

The patent position of biopharmaceutical, pharmaceutical or biotechnology companies, including ours, is generally uncertain and involves complex legal and factual considerations. The standards which the USPTO and its foreign counterparts use to grant patents are not always applied predictably or uniformly and can change. There is also no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in biopharmaceutical, pharmaceutical or biotechnology patents. The laws of some foreign countries do not protect proprietary information to the same extent as the laws of the United States, and many companies have encountered significant problems and costs in protecting their proprietary information in these foreign countries. Outside the United States, patent protection must be sought in individual jurisdictions, further adding to the cost and uncertainty of obtaining adequate patent protection outside of the United States. Accordingly, we cannot predict whether additional patents protecting our technology will issue in the United States or in foreign jurisdictions, or whether any patents that do issue will have claims of adequate scope to provide competitive advantage. Moreover, we cannot predict whether third parties will be able to successfully obtain claims or the breadth of such claims. The allowance of broader claims may increase the incidence and cost of patent interference proceedings, opposition proceedings, post-grant review, inter partes review, and/or reexamination proceedings, the risk of infringement litigation, and the vulnerability of the claims to challenge. On the other hand, the allowance of narrower claims does not eliminate the potential for adversarial proceedings and may fail to provide a competitive advantage. Our issued patents may not contain claims sufficiently broad to protect us against third parties with similar technologies or products or provide us with any competitive advantage.

We may become involved in lawsuits to protect or enforce our patents, which could be expensive, time consuming and unsuccessful.

Third parties may infringe or misappropriate our intellectual property, including our existing patents, patents that may issue to us in the future, or the patents of our licensors or licensees to which we have a license. As a result, we may be required to file infringement claims to stop third-party infringement or unauthorized use. Further, we may not be able to prevent, alone or with our licensors or licensees, misappropriation of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States.

If we or one of our licensors or licensees were to initiate legal proceedings against a third party to enforce a patent covering our product candidates, the defendant could counterclaim that the patent covering our product candidates is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent.

In addition, within and outside of the United States, there has been a substantial amount of litigation and administrative proceedings, including interference and reexamination proceedings before the USPTO or oppositions and other comparable proceedings in various foreign jurisdictions, regarding patent and other intellectual property rights in the biopharmaceutical industry. Recently, the Leahy-Smith America Invents Act, or the American Invents Act (“AIA”), introduced new procedures, including inter partes review and post grant review. These procedures may be used by competitors to challenge the scope and/or validity of our patents, including those patents perceived by our competitors as blocking entry into the market for their products, and the outcome of such challenges.

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Even after they have been issued, our patents and any patents which we license may be challenged, narrowed, invalidated or circumvented. If our patents are invalidated or otherwise limited or will expire prior to the commercialization of our product candidates, other companie s may be better able to develop products that compete with ours, which could adversely affect our competitive business position, business prospects and financial condition.

The following are non-exclusive examples of litigation and other adversarial proceedings or disputes that we could become a party to involving our patents or patents licensed to us:

 

we or our collaborators may initiate litigation or other proceedings against third parties to enforce our patent rights;

 

third parties may initiate litigation or other proceedings seeking to invalidate patents owned by or licensed to us or to obtain a declaratory judgment that their product or technology does not infringe our patents or patents licensed to us;

 

third parties may initiate opposition proceedings, post-grant review, inter partes review, or reexamination proceedings challenging the validity or scope of our patent rights, requiring us or our collaborators and/or licensors or licensees to participate in such proceedings to defend the validity and scope of our patents;

 

there may be a challenge or dispute regarding inventorship or ownership of patents currently identified as being owned by or licensed to us;

 

the USPTO may initiate an interference or derivation proceeding between patents or patent applications owned by or licensed to us and those of our competitors, requiring us or our collaborators and/or licensors or licensees to participate in an interference or derivation proceeding to determine the priority of invention, which could jeopardize our patent rights; or

 

third parties may seek approval to market biosimilar versions of our future approved products prior to expiration of relevant patents owned by or licensed to us, requiring us to defend our patents, including by filing lawsuits alleging patent infringement.

These lawsuits and proceedings would be costly and could affect our results of operations and divert the attention of our managerial and scientific personnel. There is a risk that a court or administrative body could decide that our patents are invalid or not infringed by a third party’s activities, or that the scope of certain issued claims must be further limited. An adverse outcome in a litigation or proceeding involving our own patents could limit our ability to assert our patents against these or other competitors, affect our ability to receive royalties or other licensing consideration from our licensees, and may curtail or preclude our ability to exclude third parties from making, using and selling similar or competitive products. An adverse outcome may also put our pending patent applications at risk of not issuing, or issuing with limited and potentially inadequate scope to cover our product candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. Additionally, it is also possible that prior art of which we are aware, but which we do not believe affects the validity or enforceability of a claim, may, nonetheless, ultimately be found by a court of law or an administrative panel to affect the validity or enforceability of a claim, for example, if a priority claim is found to be improper. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we could lose at least part, and perhaps all, of the patent protection on our relevant product candidates. Such a loss of patent protection could have a material adverse impact on our business.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or administrative proceedings, there is a risk that some of our confidential information could be compromised by disclosure. In addition, during the course of litigation or administrative proceedings, there could be public announcements of the results of hearings, motions or other interim proceedings or developments or public access to related documents. If investors perceive these results to be negative, the market price for our common stock could be significantly harmed. Any of these occurrences could adversely affect our competitive business position, business prospects, and financial condition.

Intellectual property rights do not necessarily address all potential threats to our competitive advantage. The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage. For example:

 

others may be able to develop a platform that is similar to, or better than, ours in a way that is not covered by the claims of our patents;

 

others may be able to make compounds that are similar to our product candidates but that are not covered by the claims of our patents;

 

we might not have been the first to make the inventions covered by patents or pending patent applications;

 

we might not have been the first to file patent applications for these inventions;

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any patents that we obtain may not provide us with any competiti ve advantages or may ultimately be found invalid or unenforceable; or

 

we may not develop additional proprietary technologies that are patentable.

Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties.

Our success will depend in part on our ability to operate without infringing the proprietary rights of third parties. Other entities may have or obtain patents or proprietary rights that could limit our ability to make, use, sell, offer for sale or import our future approved products or impair our competitive position. In particular, the patent landscape around the discovery, development, manufacture and commercial use of our pre-clinical CPM antibody programs and therapeutic antibodies is crowded.

Third parties may have or obtain valid and enforceable patents or proprietary rights that could block us from developing product candidates using our technology. Our failure to obtain a license to any technology that we require may materially harm our business, financial condition and results of operations. Moreover, our failure to maintain a license to any technology that we require may also materially harm our business, financial condition, and results of operations. Furthermore, we would be exposed to a threat of litigation.

In the biopharmaceutical industry, significant litigation and other proceedings regarding patents, patent applications, trademarks and other intellectual property rights have become commonplace. The types of situations in which we may become a party to such litigation or proceedings include:

 

we or our collaborators may initiate litigation or other proceedings against third parties seeking to invalidate the patents held by those third parties or to obtain a judgment that our products or processes do not infringe those third parties’ patents;

 

if our competitors file patent applications that claim technology also claimed by us or our licensors or licensees, we or our licensors or licensees may be required to participate in interference, derivation or other proceedings to determine the priority of invention, which could jeopardize our patent rights and potentially provide a third party with a dominant patent position;

 

if third parties initiate litigation claiming that our processes or products infringe their patent or other intellectual property rights, we and our collaborators will need to defend against such proceedings; and

 

if a license to necessary technology is terminated, the licensor may initiate litigation claiming that our processes or products infringe or misappropriate their patent or other intellectual property rights and/or that we breached our obligations under the license agreement, and we and our collaborators would need to defend against such proceedings.

These lawsuits would be costly and could affect our results of operations and divert the attention of our management and scientific personnel. There is a risk that a court would decide that we or our collaborators are infringing the third party’s patents and would order us or our collaborators to stop the activities covered by the patents. In that event, we or our collaborators may not have a viable alternative to the technology protected by the patent and may need to halt work on the affected product candidate or cease commercialization of an approved product. In addition, there is a risk that a court will order us or our collaborators to pay the other party damages. An adverse outcome in any litigation or other proceeding could subject us to significant liabilities to third parties and require us to cease using the technology that is at issue or to license the technology from third parties. We may not be able to obtain any required licenses on commercially acceptable terms or at all. Any of these outcomes could have a material adverse effect on our business.

The biopharmaceutical industry has produced a significant number of patents, and it may not always be clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform or predictable. If we are sued for patent infringement, we would need to demonstrate that our products or methods either do not infringe the patent claims of the relevant patent or that the patent claims are invalid, and we may not be able to do this. Proving invalidity is difficult. For example, in the United States, proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if we are successful in these proceedings, we may incur substantial costs and divert management’s time and attention in pursuing these proceedings, which could have a material adverse effect on us. If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, defend an infringement action or challenge the validity of the patents in court. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful conclusion. In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action successfully or have infringed patents declared invalid, we may incur substantial monetary damages, encounter significant delays in bringing our product candidates to market and be precluded from manufacturing or selling our product candidates.

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The cost of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the cost of such litigation and proceedings more effectively than we can because of their substantially greater resources. Uncertainties resulting from the initiation and co ntinuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. Patent litigation and other proceedings may also absorb significant management time.  

If we fail to comply with our obligations under our intellectual property licenses with third parties, we could lose license rights that are important to our business.

We are currently party to various intellectual property license agreements. These license agreements impose, and we expect that future license agreements may impose, various diligence, milestone payment, royalty, insurance and other obligations on us. These licenses typically include an obligation to pay an upfront payment, yearly maintenance payments and royalties on sales. If we fail to comply with our obligations under the licenses, the licensors may have the right to terminate their respective license agreements, in which event we might not be able to market any product that is covered by the agreements. Termination of the license agreements or reduction or elimination of our licensed rights may result in our having to negotiate new or reinstated licenses with less favorable terms, which could adversely affect our competitive business position and harm our business.

If we are unable to protect the confidentiality of our proprietary information, the value of our technology and products could be adversely affected.

In addition to patent protection, we also rely on other proprietary rights, including protection of trade secrets, and other proprietary information. To maintain the confidentiality of trade secrets and proprietary information, we enter into confidentiality agreements with our employees, consultants, collaborators and others upon the commencement of their relationships with us. These agreements require that all confidential information developed by the individual or made known to the individual by us during the course of the individual’s relationship with us be kept confidential and not disclosed to third parties. Our agreements with employees and our personnel policies also provide that any inventions conceived by the individual in the course of rendering services to us shall be our exclusive property. However, we may not obtain these agreements in all circumstances, and individuals with whom we have these agreements may not comply with their terms. Thus, despite such agreement, such inventions may become assigned to third parties. In the event of unauthorized use or disclosure of our trade secrets or proprietary information, these agreements, even if obtained, may not provide meaningful protection, particularly for our trade secrets or other confidential information. To the extent that our employees, consultants or contractors use technology or know-how owned by third parties in their work for us, disputes may arise between us and those third parties as to the rights in related inventions. To the extent that an individual who is not obligated to assign rights in intellectual property to us is rightfully an inventor of intellectual property, we may need to obtain an assignment or a license to that intellectual property from that individual, or a third party or from that individual’s assignee. Such assignment or license may not be available on commercially reasonable terms or at all.

Adequate remedies may not exist in the event of unauthorized use or disclosure of our proprietary information. The disclosure of our trade secrets would impair our competitive position and may materially harm our business, financial condition and results of operations. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to maintain trade secret protection could adversely affect our competitive business position. In addition, others may independently discover or develop our trade secrets and proprietary information, and the existence of our own trade secrets affords no protection against such independent discovery.

As is common in the biopharmaceutical industry, we employ individuals who were previously or concurrently employed at research institutions and/or other biopharmaceutical, biotechnology or pharmaceutical companies, including our competitors or potential competitors. We may be subject to claims that these employees, or we, have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers, or that patents and applications we have filed to protect inventions of these employees, even those related to one or more of our product candidates, are rightfully owned by their former or concurrent employer. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to the USPTO and various foreign patent offices at various points over the lifetime of our patents and/or applications. We have systems in place to remind us to pay these fees, and we rely on our outside counsel or service providers to pay these fees when due. Additionally, the USPTO and various foreign patent offices require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. We employ reputable law firms and other professionals to

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help us comply, and in many cases, an inadv ertent lapse can be cured by payment of a late fee or by other means in accordance with rules applicable to the particular jurisdiction. However, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent applica tion, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If such an event were to occur, it could have a material adverse effect on our business. In addition, we are responsible for the payment of patent fees for patent ri ghts that we have licensed from other parties.

If any licensor of these patents does not itself elect to make these payments, and we fail to do so, we may be liable to the licensor for any costs and consequences of any resulting loss of patent rights.

Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.

Obtaining and enforcing patents in the biopharmaceutical industry involves both technological and legal complexity, and therefore, is costly, time-consuming and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation. Further, recent U.S. Supreme Court rulings have either narrowed the scope of patent protection available in certain circumstances or weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained.

For our U.S. patent applications containing a claim not entitled to priority before March 16, 2013, there is a greater level of uncertainty in the patent law. In September 2011, AIA was signed into law. The AIA includes a number of significant changes to U.S. patent law, including provisions that affect the way patent applications will be prosecuted and may also affect patent litigation. The USPTO is currently developing regulations and procedures to govern administration of the AIA, and many of the substantive changes to patent law associated with the AIA. It is not clear what other, if any, impact the AIA will have on the operation of our business. Moreover, the AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.

An important change introduced by the AIA is that, as of March 16, 2013, the United States transitioned to a “first-inventor-to- file” system for deciding which party should be granted a patent when two or more patent applications are filed by different parties claiming the same invention. A third party that files a patent application in the USPTO after that date but before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by the third party. This will require us to be cognizant going forward of the time from invention to filing of a patent application. Furthermore, our ability to obtain and maintain valid and enforceable patents depends on whether the differences between our technology and the prior art allow our technology to be patentable over the prior art. Since patent applications in the United States and most other countries are confidential for a period of time after filing, we cannot be certain that we were the first to either (i) file any patent application related to our product candidates or (ii) invent any of the inventions claimed in our patents or patent applications.

Among some of the other changes introduced by the AIA are changes that limit where a patentee may file a patent infringement suit and providing opportunities for third parties to challenge any issued patent in the USPTO. This applies to all of our U.S. patents, even those issued before March 16, 2013. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal court necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action.

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.

We may have received confidential and proprietary information from third parties. In addition, we employ individuals who were previously employed at other biopharmaceutical, biotechnology or pharmaceutical companies. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise improperly used or disclosed confidential information of these third parties or our employees’ former employers. Further, we may be subject to ownership disputes in the future arising, for example, from conflicting obligations of consultants or others who are involved in developing our product candidates. We may also be subject to claims that former employees, consultants, independent contractors, collaborators or other third parties have an ownership interest in our patents or other intellectual property. Litigation may be necessary to defend against these and other claims challenging our right to and use of confidential and proprietary information. If we fail in defending any such claims, in addition to paying monetary damages, we may lose our rights therein. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against these claims, litigation could result in substantial cost and be a distraction to our management and employees.

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We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting and defending patents on our product candidates in all countries throughout the world would be prohibitively expensive. The requirements for patentability may differ in certain countries, particularly developing countries. For example, China has a heightened requirement for patentability, and specifically requires a detailed description of medical uses of a claimed drug. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement on infringing activities is inadequate. These products may compete with our product candidates, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biopharmaceuticals, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. In addition, certain countries in Europe and certain developing countries, including India and China, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those countries, we may have limited remedies if our patents are infringed or if we are compelled to grant a license to our patents to a third party, which could materially diminish the value of those patents. This could limit our potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we own or license. Finally, our ability to protect and enforce our intellectual property rights may be adversely affected by unforeseen changes in foreign intellectual property laws.

Risks Related to Litigation

We may face litigation or regulatory investigations that could result in substantial damages and may divert management’s time and attention from our business.

From time to time we may become a party to legal proceedings, claims and investigations that arise in the ordinary course of business such as, but not limited to, patent, employment, securities, commercial and environmental matters. While we currently believe that the ultimate outcome of any of these proceedings will not have a material adverse effect on our financial position, results of operations, or liquidity, litigation is subject to inherent uncertainty. Furthermore, litigation and regulatory investigations consume both cash and management attention.

We maintain property and general commercial insurance coverage as well as errors and omissions and directors and officers insurance policies. This insurance coverage may not be sufficient to cover us for future claims.

If we or our employees fail to comply with laws or regulations, it could adversely impact our reputation, business and stock price .

We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional and/or negligent failures to comply with FDA regulations, to provide accurate information to the FDA, to comply with manufacturing standards we have established, to comply with federal and state health care fraud and abuse, transparency, and/or data privacy and security laws and regulations, to report financial information or data accurately or to disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices; to promote transparency; and to protect the privacy and security of patient data. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.

While we have adopted a corporate compliance program, we may not be able to protect against all potential issues of noncompliance. Efforts to ensure that our business complies with all applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations, or case law involving applicable laws and regulations.

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Employee misconduct could also involve the improper use or disclosure of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. In addition, during the course of our operations, our directors, executives and employees may have access to material, nonpublic information regarding our business, our results of operations or potential transactions we are considering. We may not be able to prevent a director, executive or employee from trading in our common stock on the basis of, or while having access to, material, nonpublic information. If a director, executive or employee was to be investigated, or an action was to be brought against a director, executive or employee for insider trad ing, it could have a negative impact on our reputation and our stock price. Such a claim, with or without merit, could also result in substantial expenditures of time and money, and divert the attention of our management team.

Product liability and other claims against us may reduce demand for our products and/or result in substantial damages.

We face an inherent risk of product liability exposure related to testing our product candidates in human clinical trials and manufacturing antibodies in our Berkeley, CA facility and may face even greater risks if we ever sell products commercially. An individual may bring a product liability claim against us if one of our product candidates causes, or merely appears to have caused, an injury. Product liability claims may result in:

 

regulatory investigations;

 

injury to our reputation;

 

withdrawal of clinical trial volunteers;

 

costs of related litigation;

 

substantial monetary awards to plaintiffs; and

 

decreased demand for any future products.

We manufacture the Prophage vaccines from a patient’s cancer cells, and medical professionals must inject the vaccines into the same patient from which they were manufactured. A patient may sue us if a hospital, a shipping company, or we fail to receive the removed cancer tissue or deliver that patient’s vaccine. We do not have any other insurance that covers loss of or damage to the Prophage vaccines or tumor material, and we do not know whether such insurance will be available to us at a reasonable price or at all. We have limited product liability coverage for use of our product candidates. Our product liability policy provides $10.0 million aggregate coverage and $10.0 million per occurrence coverage. This limited insurance coverage may be insufficient to fully cover us for future claims.

We are also subject to laws generally applicable to businesses, including but not limited to, federal, state and local wage and hour, employee classification, mandatory healthcare benefits, unlawful workplace discrimination and whistle-blowing. Any actual or alleged failure to comply with any regulation applicable to our business or any whistle-blowing claim, even if without merit, could result in costly litigation, regulatory action or otherwise harm our business, results of operations, financial condition, cash flow and future prospects.

If we do not comply with environmental laws and regulations, we may incur significant costs and potential disruption to our business.

We use or may use hazardous, infectious, and radioactive materials, and recombinant DNA in our operations, which have the potential of being harmful to human health and safety or the environment. We store these hazardous (flammable, corrosive, toxic), infectious, and radioactive materials, and various wastes resulting from their use, at our facilities pending use and ultimate disposal. We are subject to a variety of federal, state, and local laws and regulations governing use, generation, storage, handling, and disposal of these materials. We may incur significant costs complying with both current and future environmental health and safety laws and regulations. In particular, we are subject to regulation by the Occupational Safety and Health Administration, the Environmental Protection Agency, the Drug Enforcement Agency, the Department of Transportation, the Centers for Disease Control and Prevention, the National Institutes of Health, the International Air Transportation Association, and various state and local agencies. At any time, one or more of the aforementioned agencies could adopt regulations that may affect our operations. We are also subject to regulation under the Toxic Substances Control Act and the Resource Conservation Development programs.

Although we believe that our current procedures and programs for handling, storage, and disposal of these materials comply with federal, state, and local laws and regulations, we cannot eliminate the risk of accidents involving contamination from these materials. Although we have a workers’ compensation liability policy, we could be held liable for resulting damages in the event of an accident or accidental release, and such damages could be substantially in excess of any available insurance coverage and could substantially disrupt our business.

49


Risks Related to our Common Stock

Provisions in our organizational documents could prevent or frustrate attempts by stockholders to replace our current management.

Our certificate of incorporation and bylaws contain provisions that could make it more difficult for a third party to acquire us without the consent of our Board of Directors. Our certificate of incorporation provides for a staggered board and removal of directors only for cause. Accordingly, stockholders may elect only a minority of our Board at any annual meeting, which may have the effect of delaying or preventing changes in management. In addition, under our certificate of incorporation, our Board of Directors may issue additional shares of preferred stock and determine the terms of those shares of stock without any further action by our stockholders. Our issuance of additional preferred stock could make it more difficult for a third party to acquire a majority of our outstanding voting stock and thereby effect a change in the composition of our Board of Directors. Our certificate of incorporation also provides that our stockholders may not take action by written consent. Our bylaws require advance notice of stockholder proposals and director nominations and permit only our president or a majority of the Board of Directors to call a special stockholder meeting. These provisions may have the effect of preventing or hindering attempts by our stockholders to replace our current management. In addition, Delaware law prohibits a corporation from engaging in a business combination with any holder of 15% or more of its capital stock until the holder has held the stock for three years unless, among other possibilities, the board of directors approves the transaction. Our Board of Directors may use this provision to prevent changes in our management. Also, under applicable Delaware law, our Board of Directors may adopt additional anti-takeover measures in the future.

Our stock has historically had low trading volume, and its public trading price has been volatile.

During the period from our initial public offering on February 4, 2000 to September 30, 2018, and the nine months ended September 30, 2018, the closing price of our common stock has fluctuated between $1.59 (or $0.27 pre-reverse stock split) and $315.78 (or $52.63 pre-reverse stock split) per share and $1.59 and $6.04 per share, respectively. The average daily trading volume for the nine months ended September 30, 2018 was approximately 1,501,240 shares, while the average daily trading volume for the year ended December 31, 2017 was approximately 1,174,002 . The market may experience significant price and volume fluctuations that are often unrelated to the operating performance of individual companies. In addition to general market volatility, many factors may have a significant adverse effect on the market price of our stock, including:

 

continuing operating losses, which we expect over the next several years as we continue our development activities;

 

announcements of decisions made by public officials or delays in any such announcements;

 

results of our pre-clinical studies and clinical trials or delays in anticipated timing;

 

delays in our regulatory filings or those of our partners;

 

announcements of new collaboration agreements with strategic partners or developments by our existing collaboration partners;

 

announcements of acquisitions;

 

announcements of technological innovations, new commercial products, failures of products, or progress toward commercialization by our competitors or peers;

 

failure to realize the anticipated benefits of acquisitions;

 

developments concerning proprietary rights, including patent and litigation matters;

 

publicity regarding actual or potential results with respect to product candidates under development;

 

quarterly fluctuations in our financial results, including our average monthly cash used in operating activities;

 

variations in the level of expenses related to any of our product candidates or clinical development programs;

 

additions or departures of key management or scientific personnel;

 

conditions or trends in the biopharmaceutical, biotechnology and pharmaceutical industries generally;

 

other events or factors, including those resulting from war, incidents of terrorism, natural disasters or responses to these events;

 

changes in accounting principles;

50


 

general economic and market conditions and other factors that may be unrelated to our operating performance or the operating performance of our competitors, including chang es in market valuations of similar companies; and

 

sales of common stock by us or our stockholders in the future, as well as the overall trading volume of our common stock.

In the past, securities class action litigation has often been brought against a company following a significant decline in the market price of its securities. This risk is especially relevant for us because many biopharmaceutical, biotechnology and pharmaceutical companies experience significant stock price volatility.

The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. If one or more of the analysts who covers us downgrades our stock, or publishes inaccurate or unfavorable research about our business, our stock price would likely decline. If one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, demand for our stock could decrease, which could cause our stock price and trading volume to decline.

The sale of a significant number of shares could cause the market price of our stock to decline.

The sale by us or the resale by stockholders of a significant number of shares of our common stock could cause the market price of our common stock to decline. As of November 2, 2018, we had 119,982,965 shares of common stock outstanding. All of these shares are eligible for sale on Nasdaq, although certain of the shares are subject to sales volume and other limitations. We have filed registration statements to permit the sale of approximately 22,200,000 shares of common stock under our equity incentive plans, and to permit the sale of 1,500,000 shares of common stock under our 2015 Inducement Equity Plan. In addition, at our annual shareholder meeting in June 2018, our shareholders approved a resolution to add an additional 9,000,000 shares of common stock to the pool available under our equity incentive plan, which shares have not been registered with the Securities and Exchange Commission (“SEC”) yet. We have also filed registration statements to permit the sale of approximately 167,000 shares of common stock under our Employee Stock Purchase Plan, to permit the sale of 325,000 shares of common stock under our Directors’ Deferred Compensation Plan, to permit the sale of approximately 31,100,319 shares of common stock pursuant to various private placement agreements and to permit the sale of up to 20,000,000 shares of our common stock pursuant to our At Market Issuance Sales Agreement. As of the date of filing, an aggregate of approximately 32,100,000 of these shares remained available for sale. In October 2018, we completed a private placement of 18,459 shares of preferred stock that are convertible into 18,459,000 shares of common stock, the resale of which has not been registered with the SEC yet. In connection with our acquisition of 4-AB in February 2014, we are obligated to make contingent milestone payments to the former shareholders of 4-AB, payable in cash or shares of our common stock at our option, as follows (i) $10.0 million upon our market capitalization exceeding $750.0 million for 30 consecutive trading days prior to the earliest of (a) February 12, 2024, (b) the sale of 4-AB or (c) the sale of Agenus and (ii) $10.0 million upon our market capitalization exceeding $1.0 billion for 30 consecutive trading days prior to the earliest of (a) February 12, 2024, (b) the sale of 4-AB or (c) the sale of Agenus. In connection with our acquisition of PhosImmune in December 2015, we issued 1,631,521 shares of our common stock to the shareholders of PhosImmune and other third parties having a fair market value of approximately $7.4 million at closing. In addition, we may be obligated in the future to pay certain contingent milestones payments, payable at our election in cash or shares of our common stock of up to $35.0 million in the aggregate. We are also obligated to file registration statements covering any additional shares that may be issued to XOMA or the former shareholders of PhosImmune in the future pursuant to the terms of our agreements with XOMA and PhosImmune, respectively. The market price of our common stock may decrease based on the expectation of such sales.

As of September 30, 2018, warrants to purchase approximately 2,900,000 shares of our common stock with a weighted average exercise price per share of $4.52 were outstanding.

As of September 30, 2018, options to purchase 16,917,576 shares of our common stock with a weighted average exercise price per share of $4.43 were outstanding. These options are subject to vesting that occurs over a period of up to four years following the date of grant. As of September 30, 2018, we had 9,928,173 vested options and 2,221,795 non-vested shares outstanding.

As of September 30, 2018, our outstanding shares of Series A-1 Convertible Preferred Stock were convertible into 333,333 shares of our common stock.

We may issue additional common stock, preferred stock, restricted stock units, or securities convertible into or exchangeable for our common stock. Furthermore, substantially all shares of common stock for which our outstanding stock options or warrants are exercisable are, once they have been purchased, eligible for immediate sale in the public market. The issuance of additional common stock, preferred stock, restricted stock units, or securities convertible into or exchangeable for our common stock or the exercise of stock options or warrants would dilute existing investors and could adversely affect the price of our securities. In addition, such securities may have rights senior to the rights of securities held by existing investors.

51


We do not intend to pay cash dividends on our commo n stock and, consequently your ability to obtain a return on your investment will depend on appreciation in the price of our common stock.

We have never declared or paid any cash dividend on our common stock and do not intend to do so in the foreseeable future. We currently anticipate that we will retain future earnings for the development, operation and expansion of our business. Therefore, the success of an investment in shares of our common stock will depend upon any future appreciation in their value. There is no guarantee that shares of our common stock will appreciate in value or maintain their current value.

Our independent auditor’s report for the fiscal year ended December 31, 2017 includes an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.

In its report accompanying our audited consolidated financial statements for the year ended December 31, 2017 , our independent registered public accounting firm included an explanatory paragraph regarding concerns about our ability to continue as a going concern . The inclusion of a going concern explanatory paragraph may negatively impact the trading price of our common stock and make it more difficult, time consuming or expensive to obtain necessary financing. In the event we are unable to continue our operations, we may have to liquidate our assets and it is likely that investors will lose all or a part of their investment.

Failure to maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 and to comply with changing regulation of corporate governance and public disclosure could have a material adverse effect on our operating results and the price of our common stock.

The Sarbanes-Oxley Act of 2002 and rules adopted by the SEC and Nasdaq have resulted in significant costs to us. In particular, our efforts to comply with Section 404 of the Sarbanes-Oxley Act of 2002 and related regulations regarding the required assessment of our internal control over financial reporting, and our independent registered public accounting firm’s audit of internal control over financial reporting, have required commitments of significant management time. We expect these commitments to continue.

Our internal control over financial reporting (as defined in Rules 13a-15 of the Exchange Act) is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of our consolidated financial statements for external purposes in accordance with U.S. GAAP. Because of its inherent limitations, internal control over financial reporting may not prevent or detect all deficiencies or weaknesses in our financial reporting. While our management has concluded that there were no material weaknesses in our internal control over financial reporting as of December 31, 2017, our procedures are subject to the risk that our controls may become inadequate because of changes in conditions or as a result of a deterioration in compliance with such procedures. No assurance is given that our procedures and processes for detecting weaknesses in our internal control over financial reporting will be effective.

Changing laws, regulations and standards relating to corporate governance and public disclosure, are creating uncertainty for companies. Laws, regulations and standards are subject to varying interpretations in some cases due to their lack of specificity, and as a result, their application in practice may evolve over time as new guidance is provided, which could result in continuing uncertainty regarding compliance matters and higher costs caused by ongoing revisions to disclosure and governance practices. If we fail to comply with these laws, regulations and standards, our reputation may be harmed, and we might be subject to sanctions or investigation by regulatory authorities, such as the SEC. Any such action could adversely affect our operating resul ts and the market price of our common stock.

52


Item 6.

Exhibits

 

Exhibit No.

 

Description

 

 

 

3.1

 

Form of Certificate of Designation of Preferences, Rights and Limitations of Series C-1 Convertible Preferred Stock. Incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on October 11, 2018.

 

 

 

4.1 (1)

 

Royalty Purchase Agreement dated September 20, 2018, by and among Agenus Inc., Agenus Royalty Fund, LLC and XOMA (US) LLC. Filed herewith.

 

 

 

10.1

 

Amendment No.1 to Consulting Agreement, effective July 1, 2018, by and between Agenus Inc. and Dr. Robert Stein. Filed herewith.

 

 

 

10.2

 

Consulting Agreement, effective July 1, 2018, as amended, by and between AgenTus Therapeutics, Inc. and Dr. Robert Stein. Filed herewith.

 

 

 

10.3

 

Consulting Agreement dated July 12, 2018, by and between Agenus Inc. and Karen Valentine. Filed herewith.

 

 

 

10.4

 

Stock Purchase Agreement dated October 10, 2018, between the Company and the purchasers listed on Exhibit A thereto. Incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on October 11, 2018.

 

 

 

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

 

 

 

101.SCH

 

XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL

 

XBRL Calculation Linkbase Document

 

 

 

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

101.LAB

 

XBRL Label Linkbase Document

 

 

 

101.PRE

 

XBRL Taxonomy Presentation Linkbase Document

 

 

 

(1)

Certain confidential material contained in the document has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934.

 

53


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:

 

November 7, 2018

 

AGENUS INC.

 

 

 

 

 

 

 

 

 

/s/ CHRISTIAN CORTIS, PH.D.

 

 

 

 

Christian Cortis, Ph.D.

Chief Strategy Officer and Head of Finance, Principal Financial Officer

 

 

 

54

 

[ ******** ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Exhibit 4.1

 

 

 

ROYALTY PURCHASE AGREEMENT

dated as of September 20, 2018

among Agenus Royalty Fund , LLC
as Seller,

AGENUS Inc.
as Seller Parent

and

XOMA (US) LLC
Purchaser                

 

 

 


 

TABLE OF CONTENTS

Page

ARTICLE I DEFINITIONS

1

 

Section 1.01

Definitions.1

 

ARTICLE II PURCHASE AND SALE OF THE PURCHASED ROYALTY INTERESTs

1

 

Section 2.01

Purchase and Sale.1

 

 

Section 2.02

Transfers and Payments in Respect of the Purchased Royalty Interests.1

 

 

Section 2.03

Purchase Price.1

 

 

Section 2.04

No Assumed Obligations.1

 

 

Section 2.05

Excluded Assets.1

 

ARTICLE III REPRESENTATIONS AND WARRANTIES OF SELLER Parent

1

 

Section 3.01

Organization; Operations of Seller Parent and Seller.1

 

 

Section 3.02

Corporate Authorization.1

 

 

Section 3.03

Governmental Authorization.1

 

 

Section 3.04

Ownership.1

 

 

Section 3.05

Solvency.1

 

 

Section 3.06

Litigation.1

 

 

Section 3.07

Compliance with Laws.1

 

 

Section 3.08

Conflicts.1

 

 

Section 3.09

No Withholding1

 

 

Section 3.10

License Agreements1

 

 

Section 3.11

Products; Royalties.1

 

 

Section 3.12

Intellectual Property Matters.1

 

 

Section 3.13

No Other Representations or Warranties.1

 

ARTICLE IV REPRESENTATIONS AND WARRANTIES OF THE PURCHASER

1

 

Section 4.01

Organization.1

 

 

Section 4.02

Authorization.1

 

 

Section 4.03

Broker’s Fees.1

 

 

Section 4.04

Conflicts.1

 

 

Section 4.05

Access to Information.1

 

ARTICLE V COVENANTS

1

 

Section 5.01

Books and Records.1

 

 

Section 5.02

Confidentiality; Public Announcement.1

 

 

Section 5.03

Commercially Reasonable Efforts; Further Assurance.1

 

 

Section 5.04

Remittance to Joint Escrow Account.1

 

[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

 

Section 5.05

Incyte Agreement, Merck Agreement. 1

 

 

Section 5.06

Audits.1

 

 

Section 5.07

Notice.1

 

 

Section 5.08

Seller Operations.1

 

 

Section 5.09

Special Purpose Vehicle Covenants1

 

 

Section 5.10

Patent Maintenance1

 

 

Section 5.11

[ ******** ] 1

 

ARTICLE VI THE CLOSING; CONDITIONS TO CLOSING

1

 

Section 6.01

Closing.1

 

 

Section 6.02

Conditions Applicable to Purchaser in Closing.1

 

 

Section 6.03

Conditions Applicable to Seller in Closing.1

 

ARTICLE VII EXPIRATION

1

 

Section 7.01

Expiration Date.1

 

 

Section 7.02

Effect of Expiration.1

 

ARTICLE VIII MISCELLANEOUS

1

 

Section 8.01

Survival.1

 

 

Section 8.02

Specific Performance.1

 

 

Section 8.03

Notices.1

 

 

Section 8.04

Successors and Assigns.1

 

 

Section 8.05

Indemnification.1

 

 

Section 8.06

Independent Nature of Relationship.1

 

 

Section 8.07

Tax.1

 

 

Section 8.08

Entire Agreement.1

 

 

Section 8.09

Governing Law.1

 

 

Section 8.10

Severability.1

 

 

Section 8.11

Counterparts; Effectiveness.1

 

 

Section 8.12

Amendments; No Waivers.1

 

 

 

 


[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

 

EXHIBITS

Exhibit A —Form of Bill of Sale

Exhibit B —Incyte Agreement

Exhibit C

—Merck Agreement

Exhibit D

—LICR Agreement

Exhibit E —Intellectual Property Matters

Exhibit F —Form of Incyte Direction Letter

Exhibit G —Form of Merck Direction Letter

Exhibit H —Form of L egal Opinion of Goodwin Procter LLP

 

 

 

[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

ROYALTY PURCHASE AGREEMENT

This ROYALTY PURCHASE AGREEMENT (as amended, supplemented or otherwise modified from time to time, this “ Agreement ”) is made and entered into as of September 20, 2018, by and among AGENUS ROYALTY FUND, LLC, a Delaware limited liability company (“ Seller ”), Agenus Inc ., a Delaware corporation (“ Seller Parent ”), and XOMA (US) LLC (“ Purchaser ”).

WHEREAS , Seller wishes to sell, assign, convey and transfer to Purchaser, and Purchaser wishes to purchase from Seller, the Purchased Royalty Interests, upon and subject to the terms and conditions hereinafter set forth.

NOW, THEREFORE , in consideration of the mutual covenants, agreements representations and warranties set forth herein, the parties hereto agree as follows:

ARTICLE I
DEFINITIONS

Section 1.01 Definitions .

The following terms, as used herein, shall have the following meanings:

Affiliate ” shall mean any Person that controls, is controlled by, or is under common control with another Person.  For purposes of this definition, “ control ” shall mean (i) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors, and (ii) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interests with the power, or the power by contract or otherwise, to direct the management and policies of such non-corporate entities.

Agenus Switzerland ” shall mean Agenus Switzerland Inc., a joint stock company organized under the laws of Switzerland formerly known as 4-Antibody AG, and a wholly-owned subsidiary of Seller Parent.

Agreement ” shall have the meaning set forth in the first paragraph hereof.

Bankruptcy Event ” shall mean the occurrence of any of the following:

(i) Seller shall commence any case, proceeding or other action (a) under any existing or future law of any jurisdiction, domestic or foreign, relating to bankruptcy, insolvency, reorganization, relief of debtors or the like, seeking to have an order for relief entered with respect to such party, or seeking to adjudicate it bankrupt or insolvent, or seeking reorganization, arrangement, adjustment, winding-up, liquidation, dissolution, composition or other relief with respect to it or its respective debts, or (b) seeking appointment of a receiver, trustee, custodian or other similar official for it or for all or any portion of its assets, or Seller shall make a general assignment for the benefit of its creditors; or

[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

(ii) there shall be commenced against Seller any case, proceeding or other action of a nature referred to in clause (i) above which remains undismissed, undischarged or unbonded for a period of ninety (90) calendar days; or

(iii) there shall be commenced against Seller any case, proceeding or other action seeking issuance of a warrant of attachment, execution, distraint or similar process against (a) all or any substantial portion of its assets and/or (b) the Royalties, which results in the entry of an order for any such relief which shall not have been vacated, discharged, stayed, satisfied or bonded pending appeal within forty-five (45) calendar days from the entry thereof; or

(iv) Seller shall take any action in furtherance of, or indicating its consent to, approval of, or acquiescence in, any of the acts set forth in clause (i), (ii) or (iii) above; or

(v) Seller shall become unable, admit in writing its inability, or fail generally, to pay its debts as they become due; or

(vi) Seller shall be in a financial condition such that the sum of its debts, as they become due and mature, is greater than the fair value of its property on a going concern basis.

Bill of Sale ” shall mean the Bill of Sale pursuant to which Seller shall assign to Purchaser all of its right, title and interest in and to the Purchased Royalty Interests purchased hereunder, which Bill of Sale shall be substantially in the form of Exhibit A .

Business Day ” shall mean any day other than a Saturday, a Sunday, any day which is a legal holiday under the laws of New York, or any day on which banking institutions located in New York or in the state in which the Depository Bank is located are authorized or required by law or other governmental action to close.

Closing ” shall have the meaning set forth in Section 6.01.

Closing Date ” shall have the meaning set forth in Section 6.01.

Confidential Information ” shall mean, as it relates to Seller Parent, Seller and their respective Affiliates, the Incyte Agreement, the Merck Agreement,  the Licensed Products, the Patent Rights, know-how, trade secrets, confidential business information, financial data and other like information (including but not limited to ideas, research and development, know-how, formulas, schematics, compositions, technical data and results, techniques, inventions (whether patentable or not), practices, methods, specifications, customer and supplier lists, pricing and cost information, and business and marketing plans and proposals), inventory, ideas, algorithms, processes, computer software programs or applications (in both source code and object code form), client lists, tangible or intangible proprietary information or material, and any other technical or scientific information, as well as any such information that would be deemed “Confidential Information” of Merck under the Merck Agreement or of Incyte under the Incyte Agreement, in each case, regardless of whether such information is specifically designated as confidential and

- 2 –

[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

regardless of whether such information is in written, oral, electronic, or other form.  For the avoidance of doubt, any notices or reports delivered by a Seller Party pursuant to this Agreement shall be deemed to be Confidential Information.

Confidentiality Breach ” means, with respect to the disclosure of any Confidential Information that a Seller Party received pursuant or related to the Merck Agreement, Incyte Agreement or LICR Agreement, as applicable, to Purchaser, that such disclosure would be expected, in Seller Parent’s reasonable, good faith judgment, to constitute a breach by Seller Parent of its confidentiality obligations under such agreement.

Depository Bank ” shall mean Bank of New York Mellon or such other bank or financial institution as may be agreed between the parties from time to time.

Direction Letters ” shall have the meaning set forth in Section 2.02(a)i.

Discrepancy ” shall have the meaning set forth in Section 2.02(a)iii.

Dispute ” shall mean any opposition, interference proceeding, reexamination proceeding, cancellation proceeding, re-issue proceeding, invalidation proceeding, inter parties review proceeding, injunction, claim, lawsuit, proceeding, hearing, investigation, complaint, arbitration, mediation, demand, investigation, or decree.

EMA ” shall mean the European Medicines Agency.

Excluded Incyte Milestone ” shall mean one Milestone Payment of $5,000,000 to be received by Seller from Incyte for the advancement of the TIM-3 program into clinical development pursuant to Section 7.5(b) of the Incyte Agreement.

Excluded Liabilities and Obligations ” shall have the meaning set forth in Section 2.04.

Exploitation ” shall mean, with respect to a Licensed Product, the manufacture, use, sale, offer for sale (including marketing and promotion), importation, distribution or other commercialization.

FDA ” shall mean the United States Food and Drug Administration and any successor agency thereto.

Governmental Authority ” shall mean any government, court, regulatory or administrative agency or commission, or other governmental authority, agency or instrumentality, whether foreign, federal, state or local (domestic or foreign), including each Patent Office, the FDA, the EMA, or any other government authority in any country.

Incyte ” shall mean Incyte Europe Sarl, a Swiss limited liability company, its Affiliates and any successors-in-interest and assigns under the Incyte Agreement.

Incyte Agreement ” shall mean that certain License, Development and Commercialization Agreement, dated as of January 9, 2015, by and between Seller Parent and Incyte, as amended on February 14, 2017, and as may be further amended from time to time, together with the following

- 3 –

[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

letter agreements, letter dated November 6, 2015, Side Letter No. 1 dated February 2, 2016, Side Letter No. 2 dated April 20, 2016 and Side Letter No. 3 dated December 21, 2017 .

Incyte Confidential Information ” shall have the meaning set forth in Section 5.02(f).

Incyte Direction Letter ” shall have the meaning set forth in Section 5.04(c).

Joint Escrow Account ” shall mean the deposit account established and maintained at the Depository Bank into which payments of the Royalties and Milestones are to be remitted in accordance with Section 2.02(a) (and the terms of an escrow agreement to be agreed upon by the parties) and the account from which the Depository Bank transfers funds into the Purchaser Account and the Seller Account.

Knowledge ” shall mean, with respect to the Seller Parties and their Affiliates, the actual knowledge of (i) Garo Armen, Chief Executive Officer of the Seller Parent, (ii) Christine Klaskin, VP of Finance of the Seller Parent, (iii) Evan Kearns, Vice President and General Counsel of the Seller Parent, (iv) Michael Plater, Chief Business Officer of the Seller Parent, and (v) Christian Cortis, Chief Strategy Officer & Head of Finance of the Seller Parent and their respective successors in such positions, provided that with respect to Sections 3.11(g) and 3.12, “Knowledge” shall mean the actual knowledge of Michael Robinson, Vice President, Head of Intellectual Property, and his successor in such position.

Law ” shall mean any law, rule, ordinance or regulation, or any judgment, order, writ, decree, permit or license of any Governmental Authority.

License Party Audit ” shall have the meaning set forth in Section 5.06(b).

Licensed Patents ” means pending or granted: (i) patent applications as set forth in Exhibit E , and the patents resulting therefrom, if any, (ii) divisionals, continuations, continuations-in-part (solely to the extent such continuations-in-part disclose the same invention disclosed in any of the foregoing), reissues, renewals, substitutions, registrations, re-examinations, revalidations, and the like of any such patents and patent applications the subject of (i) above, and (iii) any and all foreign equivalents of the patents and patent applications the subject of (i) and (ii) above.

Licensed Product ” as to the Incyte Agreement or the Merck Agreement, as applicable, shall mean each Product covered therein as of the date hereof.

LICR ” shall mean the Ludwig Institute for Cancer Research Ltd., a non-profit corporation organized under the laws of Switzerland, its Affiliates and any successors-in-interest and assigns under the LICR Agreement.

LICR Agreement ” shall mean that certain License Agreement dated as of December 5, 2014, by and between LICR and Seller Parent, and as may be further amended from time to time in the future.

Lien ” shall mean lien, hypothecation, charge, instrument, preference, priority, security agreement, security interest, interest, mortgage, option, privilege, pledge, liability, covenant, order, tax, right of recovery, trust or deemed trust (whether contractual, statutory or otherwise arising) or

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[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

any encumbrance, right or claim of any other person of any kind whatsoever whether choate or inchoate, filed or unfiled, noticed or unnoticed, recorded or unrecorded, contingent or non-contingent, material or non-material, known or unknown.

Losses ” shall mean collectively, any and all damages, losses, assessments, awards, cause of actions, claims, charges, costs and expense (including reasonable expenses of investigation and reasonable attorneys’ fees and expenses), fines, judgments, liabilities, obligations or penalties; provided , however that Losses shall not include any lost profits  or consequential, punitive, special or incidental damages except any lost profits or consequential, punitive, special or incidental damages awarded or payable by a Purchaser Indemnified Party to a Third Party in connection with a claim or action for which the Seller Parent is required to indemnify the Purchaser pursuant to Section 8.05.

Material Adverse Effect ” shall mean a material adverse effect on (i) the validity or enforceability of any of the Transaction Documents, the Incyte Agreement or the Merck Agreement, (ii) the ability of a Seller Party or any of its Affiliates to perform any of its material obligations under any of the Transaction Documents, the Incyte Agreement or the Merck Agreement, (iii) the rights or remedies of Purchaser under any of the Transaction Documents, the Incyte Agreement or the Merck Agreement,  (iv)  the timing, amount or duration of the Royalties, taken as a whole, and recognizing the early stage nature of the Licensed Products and the risks associated with the development and potential commercialization of early stage biopharmaceutical products, or (v) the right of  Purchaser to receive payments in respect of the Purchased Royalty Interests in accordance with the Transaction Documents, the Incyte Agreement or the Merck Agreement.

Merck ” shall mean Merck Sharp & Dohme Corp., a corporation organized and existing under the laws of New Jersey, its Affiliates and any successors-in-interest and assigns under the Merck Agreement.

Merck Agreement ” shall mean that certain License and Research Collaboration Agreement dated as of April 25, 2014, by and between Merck and Seller Parent, as amended effective April 25, 2015, and February 6, 2017, and as may be further amended from time to time.

Milestones ” shall mean one hundred percent (100%) of all future milestone payments that become owed, accrued or otherwise payable to Seller after the Closing pursuant to Section 5.4 of the Merck Agreement and Section 7.5 of the Incyte Agreement including, without limitation, all clinical, regulatory, commercial and sales milestones pursuant to such sections (collectively, the “ Milestone Payments ”), and any future sums accrued, paid or due, other than Milestone Payments, that are (i) in lieu of the Milestone Payments (which shall not consist of securities without Purchaser’s prior written consent); (ii) in satisfaction of the obligation to pay the Milestone Payments; or (iii) indemnity payments, recoveries, damages, settlement or other amounts to which Seller is or may become entitled to pursuant to or in connection with the Incyte Agreement or the Merck Agreement, as applicable, or any Licensed Patent thereunder, whether based on actual or alleged infringement, breach, or other circumstance, in each case described in this clause (iii) to the extent such infringement, breach, default or other circumstance has resulted or would result in a reduction in, or such payment is made in lieu of, Milestone Payments; and (iv) all proceeds (including any damages, monetary awards or other amounts recovered, whether by judgment or

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[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

settlement) paid, owed, accrued or otherwise payable with respect to any of the foregoing of any suit, proceeding or other legal action taken to enforce the right to receive any of the foregoing (other than amounts awarded or recovered in connection with any judgment or settlement for reimbursement of the costs and expenses (including attorneys’ fees) of the party bringing such suit or proceeding or taking such other legal action).

Net Sales ” shall mean “Net Sales” as such term is defined in the Incyte Agreement or the Merck Agreement, as applicable.

Patent Rights ” shall mean “Patent Rights” as such term is defined in the Incyte Agreement or the Merck Agreement, as applicable, but only to the extent such Patent Rights are owned or controlled by Seller Parent or its Affiliates.

Permitted Liens ” shall mean any: (a) Liens in favor of Purchaser or its Affiliates; (b) Liens created, permitted or required by the Transaction Documents in favor of Purchaser; (c) Liens incurred by Purchaser after the Closing Date; and (d) Liens that will be released at the Closing.

Person ” shall mean an individual, corporation, partnership, limited liability company, association, trust or other entity or organization, but not including a government or political subdivision or any agency or instrumentality of such government or political subdivision.

Product ” shall mean “Royalty Bearing Product” as such term is defined in the Incyte Agreement or “Product” as such term is defined in the Merck Agreement, as applicable.

Purchase Price ” shall be the amount set forth in Section 2.03 which shall be payable in United States Dollars.

Purchased Royalty Interests ” shall mean (a) thirty three percent (33%) of all of the Royalties (net of all outbound royalties paid, owed, accrued or otherwise payable by Seller Parent or its Affiliates to LICR under the LICR Agreement); (b) ten percent (10%) of all future Milestones (other than the Excluded Incyte Milestone); and (c) in the case of each of (a) and (b) above, all “accounts” (as such term is defined in the UCC) of Seller with respect to the Royalties and Milestones.  For clarity, the Purchased Royalty Interests do not include any portion of the Excluded Incyte Milestone.

Purchaser ” shall have the meaning set forth in the first paragraph hereof.

Purchaser Account ” shall mean Purchaser’s deposit account with Silicon Valley Bank which account Purchaser may change from time to time by furnishing written notice to Seller.  

Purchaser Indemnified Party ” shall have the meaning set forth in Section 8.05(a).

Purchaser-Requested Audit ” shall have the meaning set forth in Section 5.06(a).

Representatives ” shall have the meaning set forth in Section 5.02(b).

“[ ******** ]” shall have the meaning set forth in Section [ ******** ].

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[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

Royalty ” or “ Royalties ” shall mean without duplication, (a) one hundred percent (100%) of all royalties paid, owed, accrued or otherwise payable after the Closing by Incyte pursuant to Section 7.6 of the Incyte Agreement with respect to Net Sales of any applicable Licensed Product thereunder, (b) all royalties paid, owed, accrued or otherwise payable after the Closing by Merck pursuant to Section 5.5 of the Merck Agreement with respect to Net Sales of any applicable Licensed Product thereunder (collectively (a) and (b) are hereinafter referred to as “ Royalty Payments ”), (c) any sums accrued, paid or due, other than Royalty Payments, that are (i) in lieu of the Royalty Payments (which shall not consist of securities without Purchaser’s prior written consent); (ii) in satisfaction of the obligation to pay the Royalty Payments; or (iii) indemnity payments, recoveries, damages, settlement or other amounts to which Seller is or may become entitled to pursuant to or in connection with the Incyte Agreement or the Merck Agreement, as applicable, or any Licensed Patent thereunder, whether based on actual or alleged infringement, breach, default or other circumstance, in each case described in this clause (iii) to the extent such infringement, breach, or other circumstance has resulted or would result in a reduction in, or such payment is made in lieu of, Royalty Payments; and (d) all proceeds (including any damages, monetary awards or other amounts recovered, whether by judgment or settlement) paid, owed, accrued or otherwise payable with respect to any of the foregoing of any suit, proceeding or other legal action taken to enforce the right to receive any of the foregoing (other than amounts awarded or recovered in connection with any judgment or settlement for reimbursement of the costs and expenses (including attorneys’ fees) of the party bringing such suit or proceeding or taking such other legal action).

Secured Party ” has the meaning set forth in Section 6.02(j).

Seller ” has the meaning set forth in the preamble.

Seller Account ” shall mean a segregated account established for the benefit of Seller.

Seller Indemnified Party ” has the meaning set forth in Section 8.05(b).

Seller Organizational Documents ” means the certificate of formation of Seller dated as of September 14, 2018 and the limited liability company agreement of Seller dated as of September 14, 2018.

Seller Parent ” has the meaning set forth in the preamble.

Seller Party ” shall mean Seller and Seller Parent, individually, and “ Seller Parties ” shall mean Seller and Seller Parent, collectively.

“[ ******** ]” shall have the meaning set forth in Section [ ******** ].

Specified Persons ” shall mean (i) Garo Armen, Chief Executive Officer of the Seller Parent, (ii) Christine Klaskin, VP of Finance of the Seller Parent, (iii) Evan Kearns, Vice President and General Counsel of the Seller Parent, (iv) Michael Plater, Chief Business Officer of the Seller Parent and (v) Christian Cortis, Chief Strategy Officer & Head of Finance, and their respective successors in such positions provided that with respect to Section 3.11(g) and 3.12, “Specified

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[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

Person” shall mean Michael Robinson, Vice President, Head of Intellectual Property, and his successor in such position .

“[ ******** ]” shall have the meaning set forth in Section [ ******** ].

Subsidiary ” or “ Subsidiaries ” shall mean with respect to any Person (i) any corporation of which the outstanding capital stock having at least a majority of votes entitled to be cast in the election of directors under the ordinary circumstances shall at the time be owned, directly or indirectly, by such Person or (ii) any other Person of which at least a majority voting interest under ordinary circumstances is at the time owned, directly or indirectly, by such Person.

Third Party ” shall mean any Person other than Seller, Seller Parent or Purchaser or their respective Affiliates.

Third Party Patents ” shall mean, with respect to any Third Party, any and all issued patents and pending patent applications as of the date of this Agreement, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, and renewals, all letters patent granted thereon, and all patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms (including regulatory extensions), and all supplementary protection certificates, together with any foreign counterparts thereof anywhere in the world, of such Third Party.

Transaction Documents ” shall mean, collectively, this Agreement and the Bill of Sale.

UCC ” shall mean the Uniform Commercial Code (or any similar or equivalent legislation) as in effect in any applicable jurisdiction.

ARTICLE II
PURCHASE AND SALE OF THE PURCHASED ROYALTY INTERESTs

Section 2.01 Purchase and Sale .

(a) Subject to the terms and conditions of this Agreement, on the Closing Date, Seller hereby sells, assigns, transfers, conveys and grants to Purchaser, and Purchaser hereby purchases, acquires and accepts from Seller, all of Seller’s rights, title and interest in and to the Purchased Royalty Interests, free and clear of any and all Liens, other than Permitted Liens.  

(b) Each of Seller and Purchaser intends and agrees that the sale, assignment and transfer of the Purchased Royalty Interests under this Agreement shall be, and is, a true sale by Seller to Purchaser that is absolute and irrevocable and that provides Purchaser with the full benefits of ownership of the Purchased Royalty Interests, and each of Seller and Purchaser do not intend the transactions contemplated hereunder to be, or for any purpose characterized as, a loan from Purchaser to Seller, or a pledge or security agreement.  Seller waives any right to contest or otherwise assert that this Agreement is other than a true sale by Seller to Purchaser under applicable law, which waiver shall be enforceable against Seller in any bankruptcy or insolvency proceeding relating to Seller.

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(c) Seller hereby consents to Purchaser recording and filing, at Purchaser’s sole cost and expense, financing statements (and continuation statements with respect to such financing statements when applicable) meeting the requirements of applicable law in such manner and in such jurisdictions as are necessary or appropriate to (i) evidence or perfect the sale, assignment, transfer, conveyance and grant by Seller to Purchaser, and the purchase, acquisition and acceptance by Purchaser from Seller, of the Purchased Royalty Interests and (ii) perfect the security interest in the Purchased Royalty Interests granted by Seller to Purchaser pursuant to Section 2.01(d) .

(d) Notwithstanding that Seller and Purchaser expressly intend for the sale, contribution, assignment, transfer, conveyance and granting of the Purchased Royalty Interests to be a true, complete, absolute and irrevocable sale and assignment, in the event that any transfer contemplated by this Agreement is held not to be a sale, Seller hereby assigns, conveys, grants and pledges to Purchaser, as security for its obligations created hereunder, a first priority security interest in and to all of Seller’s right, title and interest in, to and under the Purchased Royalty Interests, whether now owned or hereafter acquired, and any “proceeds” (as such term is defined in the UCC) thereof and, solely in such event, this Agreement shall constitute a security agreement.

Section 2.02 Transfers and Payments in Respect of the Purchased Royalty Interests .

(a) Payments of the Royalties .  Purchaser shall be entitled to receive the following transfers and payments in respect of the Purchased Royalty Interests:

i. Effective upon the Closing, Purchaser shall be entitled to receive any and all payments of the Purchased Royalty Interests.  Any and all payments of the Purchased Royalty Interests shall be paid by Incyte, Merck or other payor, as applicable, into the Joint Escrow Account by wire transfer of immediately available funds in accordance with the Incyte Direction Letter or Merck Direction Letter (collectively, the “ Direction Letters ”), as the case may be, or other instruction letter provided to such other payor in compliance with Section 5.04(c), and distributed from the Joint Escrow Account to the Purchaser Account.  If Seller or its Affiliates receives any payment on account of any Purchased Royalty Interests directly from the payor of such Purchased Royalty Interests, Seller or any of its Affiliates, as the case may be, shall hold such amounts in trust for the benefit of Purchaser and, within five (5) Business Days after receipt thereof, transfer all such funds into the Joint Escrow Account by wire transfer of immediately available funds.  

ii. Notwithstanding any claim or set-off which Seller may have against Purchaser or which Incyte or Merck, as applicable, may have against Seller, Seller shall use its reasonable best efforts to ensure that Incyte and Merck remit all payments that each is required to pay under the Incyte Agreement or the Merck Agreement, respectively, with respect to the Purchased Royalty Interests directly to the Joint Escrow Account, pursuant to the Direction Letters.

iii. For the avoidance of doubt, the parties understand and agree that if Incyte or Merck, as applicable, fails to make any payment in respect of the Purchased Royalty Interests when Seller or Purchaser reasonably believes they are due under the Incyte Agreement or the Merck Agreement, as applicable (each such unpaid amount, a

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[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

Discrepancy ”), because of a disagreement with Incyte or Merck, as applicable, as to when, whether or the amount of any payment of the Purchased Royalty Interests that are owed, then Seller shall not be obligated to pay to Purchaser or otherwise compensate or make Purchaser whole with respect to any such Discrepancy, but instead the parties shall attempt to recover such Discrepancy from Incyte or Merck, as applicable; provided , however , that nothing in this Section 2.02(a) shall limit or affect in any respect the rights of any Purchaser Indemnified Party under Section 8.05 .

iv. For the avoidance of doubt, the parties understand and agree that if Incyte or Merck, as applicable, fails to pay any payment in respect of the Purchased Royalty Interests when Seller or Purchaser reasonably believes they are due under the Incyte Agreement or the Merck Agreement, as applicable, because of any set-off under any of the agreements effectuated by Incyte or Merck, as the case may be, then Seller shall pay to Purchaser the amount required to make Purchaser whole with respect to any such deficiency, by depositing the amount thereof in the Purchaser Account.

Section 2.03 Purchase Price .

In consideration for the sale of the Purchased Royalty Interests, and subject to the terms and conditions set forth herein, Purchaser shall pay to Seller, or its designee, on the Closing Date, the sum of $15,000,000 (the “ Purchase Price ”) by wire transfer to an account designated in writing by Seller prior to the Closing.

Section 2.04 No Assumed Obligations .

Notwithstanding any provision in this Agreement or any other writing to the contrary, Purchaser is acquiring only the Purchased Royalty Interests and is not assuming any liability or obligation of either Seller Party or any of their Affiliates of whatever nature, whether presently in existence or arising or asserted hereafter, whether under the Incyte Agreement, the Merck Agreement or any Transaction Document or otherwise.  All such liabilities and obligations shall be retained by and remain obligations and liabilities of such Seller Party (the “ Excluded Liabilities and Obligations ”).

Section 2.05 Excluded Assets .

Purchaser does not, by purchase of the rights granted hereunder or otherwise pursuant to any of the Transaction Documents, acquire any assets or contract rights of Seller or any of its Affiliates under the Incyte Agreement, the Merck Agreement, the Patent Rights or any other assets of either Seller Party (including the Excluded Incyte Milestone), other than the Purchased Royalty Interests.

ARTICLE III
REPRESENTATIONS AND WARRANTIES OF SELLER Parent

Seller and Seller Parent, as applicable, hereby represents and warrants to Purchaser as of the date first written above the following:

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[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

Section 3.01 Organization; Operations of Seller Parent and Seller .

(a) Seller Parent is a corporation duly organized, validly existing and in good standing under the laws of Delaware, and has all powers and all licenses, authorizations, consents and approvals required to conduct its business as now conducted and as proposed to be conducted in connection with the transactions contemplated by the Transaction Documents to which Seller Parent is a party and the Incyte Agreement and the Merck Agreement.  Seller Parent is duly qualified to do business as a foreign corporation and is in good standing in every jurisdiction in which the failure to do so could reasonably be expected to result, individually or in the aggregate, in a Material Adverse Effect.

(b) Seller is a limited liability company duly organized, validly existing and in good standing under the laws of Delaware, and has all powers and all licenses, authorizations, consents and approvals required to conduct its business as now conducted and as proposed to be conducted in connection with the transactions contemplated by the Transaction Documents to which Seller is a party.  Seller is duly qualified to do business as a foreign limited liability company and is in good standing in every jurisdiction in which the failure to do so could reasonably be expected to result, individually or in the aggregate, in a Material Adverse Effect.

(c) Since September 14, 2018, Seller (i) has had no business activities other than acquiring the right to receive payments under the Merck Agreement and the Incyte Agreement, selling the Purchased Royalty Interests to Purchaser as contemplated hereby and otherwise performing its obligations under the Transaction Documents and (ii) has not been, is not, and will not be engaged, in any business unrelated to effecting the transactions contemplated by the Transaction Documents.  Since September 14, 2018, the sole assets of Seller that it has owned consist exclusively of the right to receive payments under the Merck Agreement and the Incyte Agreement and any rights arising under the Incyte Agreement or the Merck Agreement, as applicable.  Since September 14, 2018, Seller has not incurred any obligations or liabilities or engaged in any business activities of any type or kind whatsoever or entered into any agreements or arrangements with any Person, except as required to execute and deliver the Transaction Documents and to consummate the transactions contemplated thereby.  Immediately prior to Closing, Seller shall have no obligations or liabilities, except those incurred in connection with, and pursuant to the Transaction Documents and the transactions contemplated thereby.

Section 3.02 Corporate Authorization .

Each Seller Party has all necessary corporate or limited liability company, as applicable, power and authority to enter into, execute and deliver the Transaction Documents to which it is a party and to perform all of the obligations to be performed by it hereunder and thereunder and to consummate the transactions contemplated hereunder and thereunder.  The Transaction Documents to which such Seller Party is a party have been duly authorized, executed and delivered by such Seller Party and each Transaction Document to which it is a party constitutes the valid and binding obligation of such Seller Party, enforceable against such Seller Party in accordance with its terms, subject, as to enforcement of remedies, to bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally or general equitable principles.

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[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

Section 3.03 Governmental Authorization .

Except for filings with the Securities and Exchange Commission, its successor or foreign equivalent, the execution and delivery by a Seller Party of the Transaction Documents to which it is a party, and the performance by such Seller Party of its obligations hereunder and thereunder and under the Incyte Agreement and the Merck Agreement, as applicable, do not require any notice to, action or consent by, or in respect of, or filing with, any Governmental Authority.

Section 3.04 Ownership .

Seller is the exclusive owner of the entire right, title (legal and equitable) and interest in, to and under the Purchased Royalty Interests and has good and valid title thereto, free and clear of all Liens (other than Permitted Liens).  The Purchased Royalty Interests sold, assigned, transferred, conveyed and granted to Purchaser at the Closing are not pledged, sold, contributed, assigned, transferred, conveyed or granted by Seller to any Person, nor has Seller consented to any such action.  Seller has full right to sell, contribute, assign, transfer, convey and grant the Purchased Royalty Interests to Purchaser.  Upon the sale, assignment, transfer, conveyance and granting by Seller of the Purchased Royalty Interests to Purchaser, Purchaser shall acquire good and valid title to the Purchased Royalty Interests free and clear of all Liens, other than Permitted Liens, and shall be the exclusive owner of the Purchased Royalty Interests.

Section 3.05 Solvency .

Assuming consummation of the transactions contemplated by the Transaction Documents to which Seller is a party (i) the present fair saleable value of Seller’s assets is greater than the amount required to pay its debts as they become due, (ii)  Seller does not have unreasonably small capital with which to engage in its business, (iii) Seller will be able to realize upon its assets and pay its debts and other obligations as they mature, and (iv) Seller has not incurred, will not incur, nor does it have present plans or intentions to incur, debts or liabilities beyond its ability to pay such debts or liabilities as they become absolute and matured.

Section 3.06 Litigation .

(a) There is no (i) action, suit, arbitration proceeding, claim, investigation or other proceeding pending or, to the Knowledge of Seller and its Affiliates, threatened against Seller Parent or any of its Affiliates or (ii) any inquiry of any Governmental Authority pending or, to the Knowledge of Seller and its Affiliates, threatened against Seller Parent or any of its Affiliates, in each case with respect to clauses (i) and (ii) above, which, if adversely determined, could reasonably be expected to result, individually or in the aggregate, in a Material Adverse Effect.

(b) To the actual knowledge of any Specified Person there is no (i) action, suit, arbitration proceeding, claim, investigation or other legal proceeding pending or threatened against Incyte or any of its Affiliates or Merck or any of its Affiliates (x) involving the Licensed Products or (y) involving Seller Parent or any of its Affiliates or (ii) any inquiry of any Governmental Authority pending or threatened against Incyte or any of its Affiliates or Merck or any of its Affiliates involving the Licensed Products, in each case with respect to clauses (i) and (ii) above,

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which, if adversely determined, could reasonably be expected to result, individually or in the aggregate, in a Material Adverse Effect.

Section 3.07 Compliance with Laws .

None of Seller, Seller Parent or any of its Subsidiaries (A) are in violation of, or have violated, or to the Knowledge of Seller and its Affiliates, are under investigation with respect to, or been given notice of any violation of, in any material respect, any law, rule, ordinance or regulation of, or any judgment, order, writ decree, permit or license granted, issued or entered by, any Governmental Authority or (B) are subject to any judgment, order, writ decree, permit or license granted, issued or entered by, any Governmental Authority, which in the case of (A) or (B), could reasonably be expected to result in a Material Adverse Effect.

Section 3.08 Conflicts .

(a) Neither the execution and delivery of any of the Transaction Documents to which Seller or Seller Parent is a party nor the performance or consummation of the transactions contemplated hereby and thereby will:  (i) contravene, conflict with, result in a breach or violation of, constitute a default under, or accelerate the performance provided by, any provisions of the certificate of incorporation or by-laws (or other organizational or constitutional documents) of Seller Parent or any of its Affiliates; (ii) contravene, conflict with, result in a breach or violation of, constitute a default under, or accelerate the performance provided by or give rise to any right of termination, cancellation or acceleration of any right or obligation of any provision of the Incyte Agreement or Merck Agreement; (iii) require any consent of any Person or Governmental Authority; (iv) result in the creation or imposition of any Lien on the Purchased Royalty Interests, other than Permitted Liens; or (v) except as would not reasonably be expected to result in a Material Adverse Effect, contravene, conflict with, result in a breach or violation of, constitute a default under, or accelerate the performance provided by, in any material respects any provisions of any Law, contract or agreement (other than the Incyte Agreement or Merck Agreement) to which Seller Parent or any of its Affiliates or any of their respective assets or properties are subject or bound.

(b) Neither Seller Party has granted, nor does there exist, any Lien (other than a Permitted Lien) on the Purchased Royalty Interests.  Neither Seller Party has granted, nor does there exist, any Lien (other than a Permitted Lien and Liens in favor of the Secured Party) on the Incyte Agreement or Merck Agreement.

Section 3.09 No Withholding

No deduction or withholding for or on account of any tax has been made or, to the Knowledge of Seller and its Affiliates, was required to be made under applicable Law from any payment to Seller under the Incyte Agreement or the Merck Agreement, as applicable.  As of the Closing Date, to the Knowledge of Seller and its Affiliates, no deduction or withholding for or on account of any tax is required to be made under applicable Law from any payment by Seller to Purchaser under this Agreement.

Section 3.10 License Agreements .

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The Incyte Agreement attached hereto as Exhibit B , the Merck Agreement attached hereto as Exhibit C , and the LICR Agreement attached hereto as Exhibit D are true, correct and complete copies of each such agreement, as in effect on the date hereof, and there have been no amendments or modifications to such agreements which are not reflected in such exhibits.

Section 3.11 Products; Royalties .

(a) Since February 14, 2017, Incyte has been responsible for the clinical development of each of the Licensed Products being clinically developed under the Incyte Agreement, and is responsible for seeking all applicable regulatory approvals from applicable Governmental Authorities for each of such Licensed Products, and Seller Parent or its Affiliates have no responsibility for the clinical development of any of such Licensed Products nor for seeking any regulatory approvals from any Governmental Authorities for any of such Licensed Products.

(b) To the Knowledge of Seller and its Affiliates, Incyte is in compliance with its obligations to develop each of the Licensed Products currently being developed under the Incyte Agreement and to seek and obtain regulatory approvals from applicable Governmental Authorities for such Licensed Products.  

(c) Merck has been responsible for the clinical development of the Licensed Product being clinically developed under the Merck Agreement and is responsible for seeking all applicable regulatory approvals from applicable Governmental Authorities for such Licensed Product, and Seller Parent or its Affiliates have no responsibility for the development of such Licensed Product nor for seeking any regulatory approvals from any Governmental Authorities for such Licensed Product.

(d) To the Knowledge of Seller and its Affiliates, Merck is in compliance with its obligations to develop the Licensed Product currently being developed under the Merck Agreement and seek and obtain regulatory approvals from applicable Governmental Authorities for such Licensed Product.  

(e) Other than (i) the Incyte Agreement, (ii) the Merck Agreement, (iii) the LICR Agreement, (iv) the Transaction Documents, (v) any third party contractor agreements entered into on Incyte’s behalf in performance of pre-clinical services, (vi) agreements with the Secured Party, and (vii) the statutory right of remuneration arising under German law, as of the Closing, neither Seller Parent nor any of its Affiliates shall have entered into, are a party to, or are otherwise subject to any agreement, contract, instrument or other binding obligation that in any way relates to or involves the Royalties, Milestones or the Products (which, for purposes of clarity, the parties acknowledge and agree shall not include any agreement, contract, instrument or other binding obligation that relates to the Patent Rights but does not otherwise relate to or involve the Royalties, Milestones or the Products and shall not include any expired material transfer, research or similar agreement or contract manufacturing or similar agreement relating to or involving the Royalties, Milestones or the Products).

(f) To the Knowledge of Seller and its Affiliates, neither Seller Parent nor Seller nor any of their Affiliates has received any information from Incyte or Merck, as applicable, or any Third Party or Governmental Authority, whether through any form of written, oral or digital

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communication and whether or not under any of the express provisions of the Incyte Agreement or the Merck Agreement, as applicable (including pursuant to any joint steering committee meeting or the meeting of any other organized body provided for under any such agreement) relating to any of the Licensed Products (including any of the clinical trials for any of the Licensed Products or any of the studies related to those clinical trials) that would reasonably be expected to result in a Material Adverse Effect.

(g) To the actual knowledge of the Specified Persons, no Third Party Patent that Incyte or Merck, as applicable, does not have the right to use, has been, or is infringed by Incyte’s or Merck’s, as applicable, Exploitation of an applicable Licensed Product.

(h) Neither Seller Parent nor Agenus Switzerland has (i) received any notice of any dispute from LICR, including pursuant to Article 8 of the LICR Agreement, or (ii) given any notice of any dispute to LICR, including pursuant to Article 8 of the LICR Agreement.

Section 3.12 Intellectual Property Matters .

  

(a) Exhibit E sets forth an accurate and complete list of all pending Licensed Patents licensed to Incyte pursuant to the Incyte Agreement, and, to the Knowledge of Seller and its Affiliates, Exhibit E sets forth an accurate and complete list of all pending Licensed Patents licensed to Merck pursuant to the Merck Agreement, including for each such Licensed Patent: (i) the jurisdictions in which such Licensed Patent application is pending, (ii) the pending patent application serial number, and (iii) the owner of such Licensed Patent application.

(b) To the Knowledge of Seller and its Affiliates, the Licensed Patents have been diligently prosecuted in accordance with applicable Law.  To the Knowledge of Seller and its Affiliates, each individual involved in the filing and prosecution of the Licensed Patents has complied in all material respects with all applicable duties of candor and good faith in dealing with the United States Patent Office in connection with the filing and prosecution of the Licensed Patents.

(c) To the Knowledge of Seller and its Affiliates, (i) there are no unpaid maintenance or renewal fees payable by Seller to any Governmental Authority or Third Party that currently are overdue for any of the Licensed Patents and (ii) no Licensed Patents have lapsed or been abandoned, cancelled or expired.

(d) To the Knowledge of Seller and its Affiliates, the Licensed Patents have not been the subject of any litigation, interference, reissue, inter partes review, post-grant review, or re-examination proceedings.

(e) To the Knowledge of Seller and its Affiliates, Seller Parent has not received any written notice of any pending or threatened Dispute, litigation, interferences, inter partes reviews, post-grant reviews, reexaminations, or like patent office proceedings involving any Licensed Patents.

(f) To the Knowledge of Seller and its Affiliates, neither Seller Parent or any of its Affiliates has received written notice of any threatened or actual action, suit or proceeding

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that claims that the manufacture, use, marketing, sale, offer for sale, importation or distribution of a Product infringes any patent or other intellectual property rights of any other Person or constitutes misappropriation of any other Person’s trade secrets or other intellectual property rights.

(g) To the Knowledge of Seller and its Affiliates, there is no Third Party infringing any Licensed Patents.  Neither Seller nor any of its Affiliates has received any notice of infringement of any Licensed Patents.

Section 3.13 No Other Representations or Warranties .

  

Except for the representations and warranties contained in this Article III, neither Seller Party nor any other Person has made or makes any other express or implied representation or warranty, either written or oral, on behalf of a Seller Party, including any representation or warranty as to the accuracy or completeness of any information regarding the Purchased Royalty Interests, the Licensed Products or the Royalties furnished or made available to Purchaser or its Representatives (including any information, documents, management presentations or material delivered to Purchaser, or in any other form in expectation of the transactions contemplated hereby) or as to the future revenue, profitability or success of the Licensed Products, or any representation or warranty arising from statute or otherwise in Law.

ARTICLE IV
REPRESENTATIONS AND WARRANTIES OF THE PURCHASER

Purchaser represents and warrants to the Seller Parties as of the date first written above, the following:

Section 4.01 Organization .

Purchaser is a limited liability company duly formed, validly existing and in good standing under the laws of Delaware and has all powers and all licenses, authorizations, consents and approvals required to carry on its business as now conducted.

Section 4.02 Authorization .

Purchaser has all necessary power and authority to enter into, execute and deliver the Transaction Documents and to perform all of the obligations to be performed by it hereunder and thereunder and to consummate the transactions contemplated hereunder and thereunder.  The Transaction Documents have been duly authorized, executed and delivered by Purchaser and each Transaction Document constitutes the valid and binding obligation of Purchaser, enforceable against Purchaser in accordance with its terms, subject, as to enforcement of remedies, to bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally and general equitable principles.

Section 4.03 Broker’s Fees .

Purchaser has not taken any action that would entitle any Person to any commission or broker’s fee that would be payable by Seller or its Affiliates in connection with the transactions contemplated by the Transaction Documents.

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Section 4.04 Conflicts .

Neither the execution and delivery of this Agreement or any other Transaction Document nor the performance or consummation of the transactions contemplated hereby or thereby will:  (i) contravene, conflict with, result in a breach or violation of, constitute a default under, or accelerate the performance provided by, in any material respects, any provisions of (A) any law, rule or regulation of any Governmental Authority, or any judgment, order, writ, decree, permit or license of any Governmental Authority, to which Purchaser or any of its assets or properties may be subject or bound; or (B) any contract, agreement, commitment or instrument to which Purchaser is a party or by which Purchaser or any of its assets or properties is bound or committed; (ii) contravene, conflict with, result in a breach or violation of, constitute a default under, or accelerate the performance provided by, any provisions of any organizational or constitutional documents of Purchaser; or (iii) require any notification to, filing with, or consent of, any Person or Governmental Authority.

Section 4.05 Access to Information .

Purchaser acknowledges that it has (i) reviewed the Incyte Agreement and the Merck Agreement and such other documents and information relating to the Licensed Products and (ii) has had the opportunity to ask such questions of, and to receive answers from, representatives of Seller concerning the Incyte Agreement, the Merck Agreement and the Licensed Products, in each case as it deemed necessary to make an informed decision to purchase the Purchased Royalty Interests in accordance with the terms of this Agreement. Purchaser acknowledges the early stage nature of the Licensed Products and accepts the risks associated with the development and potential commercialization of early stage biopharmaceutical products.  Purchaser has such knowledge, sophistication and experience in financial and business matters that it is capable of evaluating the risks and merits of purchasing the Purchased Royalty Interests in accordance with the terms of this Agreement.

Section 4.06

Financing .

Purchaser has sufficient funds available to consummate all of the transactions contemplated by any of the Transaction Documents and to pay the Purchase Price and all other cash amounts required to be paid in connection with the transactions contemplated by the Transaction Documents, and, when so required to pay or otherwise perform, as applicable, Purchaser will be able to pay or otherwise perform the obligations of Purchaser or any of its Affiliates under the Transaction Documents (including the Purchase Price payment at Closing and all other cash amounts required to be paid at or in connection with the Closing).  Purchaser acknowledges and agrees that its obligations under this Agreement are not contingent on obtaining financing.

ARTICLE V
COVENANTS

The parties covenant and agree as follows:

Section 5.01 Books and Records .

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(a) Subject to Section 5.02(g) , as promptly as practicable (but in no event more than two (2) Business Days) after receipt by Seller Parent or any of its Affiliates of notice of any action, claim, investigation or proceeding (commenced or threatened) relating to the transactions contemplated by any Transaction Document or the Purchased Royalty Interests that, if determined adversely, would reasonably be expected to result in a Material Adverse Effect, Seller Parent shall inform Purchaser of the receipt of such notice and the substance of such action, claim, investigation or proceeding and, if in writing, shall furnish Purchaser with a copy of such notice and any related materials with respect to such action, claim, investigation or proceeding.

(b) Seller shall keep and maintain, or cause to be kept and maintained, full and accurate books of accounts and records adequate to reflect accurately all Royalties and Milestones paid and/or payable with respect to the Incyte Agreement and the Merck Agreement and all deposits made into, and disbursements made from, the Joint Escrow Account.  Seller shall provide information as the amount and calculation of the amount of all Royalties and Milestones paid into the Joint Escrow Account hereunder in sufficient detail for Purchaser to review the same for accuracy and shall certify that such calculations are correct.

(c) Subject to Section 5.02(g), Purchaser shall have the right, from time to time, not more than twice per calendar year to request a meeting or teleconference with the appropriate representatives of Seller Parent to discuss the progress of the development of the Products, and/or during normal business hours and upon at least ten (10) Business Days’ prior written notice to Seller, to visit the offices and properties of Seller where books and records relating or pertaining to the Purchased Royalty Interests are kept and maintained, to inspect and make extracts from and copies of such books and records, to discuss, with officers of Seller, the Purchased Royalty Interests and to verify compliance with the provisions of the Transaction Documents, including, without limitation, provisions relating to the receipt and application of the Royalties and Milestones.  

(d) Subject to Section 5.02(g), as promptly as practicable (but in no event more than five (5) Business Days) after receipt by Seller Parent or any of its Affiliates of any material written notice, certificate, offer, proposal, correspondence, report or other material written communication from Incyte, Merck, or any other payor of any Royalties or Milestones, or any Governmental Authority directly relating to or referencing the Purchased Royalty Interests, Seller Parent shall inform Purchaser of such receipt and the substance contained therein and, if requested by Purchaser, shall furnish Purchaser with a copy of such material written notice, certificate, offer, proposal, correspondence, report or other material written communication.

Section 5.02 Confidentiality; Public Announcement .

(a) Except as expressly authorized in this Agreement or the other Transaction Documents or except with the prior written consent of Seller Parent, Purchaser hereby agrees that (i) it will use the Confidential Information of the Seller Parties solely for the purpose of the transactions contemplated by this Agreement and the other Transaction Documents and exercising its rights and remedies and performing its obligations hereunder and thereunder; (ii) it will keep confidential the Confidential Information of the Seller Parties; and (iii) it will not furnish or disclose to any Person any Confidential Information of the Seller Parties.

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(b) Subject to Section 5.02(f) , but otherwise n otwithstanding anything to the contrary set forth in this Agreement or any other Transaction Document, Purchaser may, without the consent of Seller Parent, furnish or disclose Confidential Information of the Seller Parties to Purchaser’s Affiliates and its and their actual and potential partners, directors, officers, employees, managers, officers, investors, co-investors, partners, financing parties, bankers, agents, consultants, advisors, insurers, rating agencies, self-regulatory organizations, trustees and representatives (“ Representatives ”) on a need-to-know basis provided that such Persons shall be informed of the confidential nature of such information and shall be obligated to keep such information confidential pursuant to the terms of this Section 5.02 .  Each party hereby acknowledges that the United States federal and state securities laws prohibit any Person that has material, non-public information about a company from purchasing or selling securities of such a company or from communicating such information to any other Person under circumstances in which it is reasonably foreseeable that such Person is likely to purchase or sell such securities.

(c) If Purchaser, its Affiliates or their respective Representatives are required by applicable law or legal or judicial process (including by deposition, interrogatory, request for documents, subpoena, civil investigative demand or similar process) to furnish or disclose any portion of the Confidential Information of the Seller Parties, Purchaser shall, to the extent practicable and legally permitted, provide such Seller Party, as promptly as practicable, with written notice of the existence of, and terms and circumstances relating to, such requirement, so that such Seller Party may seek a protective order or other appropriate remedy, at such Seller Party’s expense (and, if such Seller Party seeks such an order, Purchaser, such Affiliates or such Representatives, as the case may be, shall provide, at such Seller Party’s expense, such cooperation as such Seller Party shall reasonably require).  Subject to the foregoing, Purchaser, such Affiliates or such Representatives, as the case may be, may disclose that portion (and only that portion) of the Confidential Information of such Seller Party that is legally required to be disclosed; provided , however , that Purchaser, such Affiliates or such Representatives, as the case may be, shall exercise reasonable efforts (at the Seller Parties’ expense) to preserve the confidentiality of the Confidential Information of the Seller Parties, including by obtaining reliable assurance that confidential treatment will be accorded any such Confidential Information disclosed.  

(d) Subject to Section 5.02(f), but otherwise notwithstanding anything to the contrary contained in this Agreement or any of the other Transaction Documents, Purchaser may disclose the Confidential Information of the Seller Parties, as the case may be, including this Agreement, the other Transaction Documents and the terms and conditions hereof and thereof, to the extent necessary in connection with the enforcement of its rights and remedies hereunder or thereunder or as required to perfect Purchaser’s rights hereunder or thereunder; provided that, Purchaser shall only disclose that portion of the Confidential Information that its counsel advises that it is legally required to disclose and will exercise commercially reasonable efforts to ensure that confidential treatment will be accorded to that portion of the Confidential Information that is being disclosed, including requesting confidential treatment of information in the Transaction Documents and Purchaser shall, to the extent practicable and legally permitted, provide such Seller Party, as promptly as practicable, with written notice of such request for confidential treatment of information in the Transaction Documents, so that such Seller Party may also seek a protective order or other appropriate remedy.  In any event, Purchaser will not oppose action by a Seller Party to obtain an appropriate protective order or other reliable assurance that confidential treatment will

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be accorded the Confidential Information in the event that confidential treatment cannot be obtained by Purchaser .

(e) Subject to Section 5.02(d), each of Seller Parent, Seller and Purchaser shall not, and shall cause their respective Affiliates not to, without the prior written consent of the other party, issue any press release or make any other public disclosure with respect to the transactions contemplated by this Agreement or any other Transaction Document, except if and to the extent that any such release or disclosure is required by applicable law or by any Governmental Authority of competent jurisdiction, including in connection with such party’s filings with the Securities and Exchange Commission, its successor or foreign equivalent, in which case, Seller Parent, Seller, Purchaser or their respective Affiliates, as the case may be, shall use commercially reasonable efforts to consult in good faith with the other party regarding the form and content thereof before issuing such press release or making such public announcement; provided however, that once a party consults with the other parties regarding a release or disclosure, such party may continue to make substantially similar releases or discloses in the future without the need to consult the other parties.

(f) If a Seller Party discloses or furnishes to Purchaser any Confidential Information, that a Seller Party received as a Recipient (as defined in the Incyte Agreement) pursuant to the Incyte Agreement (such Confidential Information, “ Incyte Confidential Information ”), pursuant to this Agreement, then with respect to all Incyte Confidential Information so disclosed or furnished, Purchaser hereby agrees to be bound by Article 11 of the Incyte Agreement with respect to the confidentiality and non-use of such Incyte Confidential Information, in addition to the confidentiality and non-use obligations under this Agreement.

(g) If a Seller Party reasonably believes that the provision of any notice, books, records, discussion, certificate, offer, proposal, correspondence, report or other written communication to Purchaser pursuant to this Agreement would constitute a Confidentiality Breach, then such Seller Party shall instead provide Purchaser (i) a written summary of all information contained in such notice, books, records, discussion, certificate, offer, proposal, correspondence, report or other written communication; provided that to the extent that such Seller Party reasonably believes that providing Purchaser with any portion of the summary set forth in clause (i) would constitute a Confidentiality Breach, then such Seller Party shall instead (ii) paraphrase or otherwise describe the substance of such portion of such notice, books, records, discussion, certificate, offer, proposal, correspondence, report or other written communication to the maximum extent possible without causing a Confidentiality Breach in the reasonable belief of such Seller Party.

Section 5.03 Commercially Reasonable Efforts; Further Assurance .

Subject to the terms and conditions of this Agreement, each party hereto will use its commercially reasonable efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary under applicable laws and regulations to consummate the transactions contemplated by any Transaction Document.  Purchaser and the Seller Parties agree to execute and deliver such other documents, certificates, agreements and other writings and to take such other actions as may be necessary in order to consummate or implement expeditiously the transactions contemplated by any Transaction Document and to vest in Purchaser good, valid and marketable

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rights and interests in and to the Purchased Royalty Interests free and clear of all Liens, other than Permitted Liens.   

Section 5.04 Remittance to Joint Escrow Account .

(a) Not later than thirty (30) Business Days following the Closing Date, Seller and Purchaser shall establish the Joint Escrow Account and Seller and Purchaser, each acting reasonably, shall execute and deliver all documents, certificates and agreements as are reasonably required to establish the Joint Escrow Account.

(b) The Joint Escrow Account shall be maintained by Seller and Purchaser throughout the term of this Agreement.

(c) Seller Parent and/or its Affiliates shall instruct and use commercially reasonable efforts to cause the payor of any Royalties and Milestones (including Incyte and Merck) to pay such Royalties and Milestones directly into the Joint Escrow Account, and in furtherance thereof, promptly following the establishment of the Joint Escrow Account, Seller Parent shall send an irrevocable letter executed by a duly authorized officer of Seller Parent to each of Incyte and Merck in the form attached hereto as Exhibit F to Incyte (the “ Incyte Direction Letter ”) and in the form attached hereto as Exhibit G to Merck (the “ Merck Direction Letter ”), with instructions to pay all such Royalties and Milestones payable under the Incyte Agreement or the Merck Agreement, as applicable, to the Joint Escrow Account.  Without in any way limiting the foregoing, commencing on the Closing Date and at any time thereafter, any and all Purchased Royalty Interests received by Seller Parent or any of its Affiliates shall be held in trust for the benefit of Purchaser and transferred to the Joint Escrow Account within five (5) Business Days of Seller Parent’s or its Affiliate’s knowledge of its receipt thereof.   

Section 5.05 Incyte Agreement, Merck Agreement .

(a) Neither Seller Parent nor its Affiliates shall, without the written consent of Purchaser, (i) forgive, release or compromise, or agree to any delay or postponement of the payment of, any Purchased Royalty Interests owed under the Incyte Agreement or the Merck Agreement, as applicable, (ii) waive, amend, cancel or terminate, exercise or fail to exercise any of their rights constituting or involving the right to receive the Purchased Royalty Interests, (iii) amend, modify, restate, cancel, supplement, terminate or waive any provision of the Incyte Agreement, the LICR Agreement or the Merck Agreement, as applicable, or grant any consent thereunder, or agree to do any of the foregoing, including entering into any agreement with Incyte, LICR or Merck, as applicable, under the provisions of the Incyte Agreement or the Merck Agreement, respectively, in all such cases, referring to or directly involving, the Purchased Royalty Interests, if the effect thereof would reasonably be expected to result in an adverse effect on the Purchased Royalty Interests, (iv) create, incur, assume or suffer to exist any Lien, upon or with respect to the Purchased Royalty Interests, or agree to do or suffer to exist any of the foregoing, except for any Permitted Liens, (v) amend Sections 7.5 or 7.6 of the Incyte Agreement or (vi) amend Sections 5.4 or 5.5 of the Merck Agreement .  

(b) Subject to Section 5.02(g) , Seller Parent shall, as promptly as practicable, provide to Purchaser copies of any formal notice or report directly relating to the Purchased Royalty

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Interests and prepared by Incyte or Merck, as applicable, it has received pursuant to the Incyte Agreement or the Merck Agreement, as applicable.

(c) Subject to Section 5.02(g) , as promptly as practicable after (A) receiving written or oral notice from Incyte or Merck, as applicable (i) terminating the Incyte Agreement or the Merck Agreement, respectively, (ii) alleging any breach of or default or dispute under the Incyte Agreement or the Merck Agreement, as applicable, by Seller Parent which, if not cured or adversely determined, as applicable, could reasonably be expected to result, individually or in the aggregate, in a Material Adverse Effect, or (iii) asserting the existence of any facts, circumstances or events which alone or together with other facts, circumstances or events could reasonably be expected (with or without the giving of notice or passage of time or both) to give rise to a breach of or default under the Incyte Agreement or the Merck Agreement, as applicable, by Seller Parent which, if not cured, could reasonably be expected to result in a Material Adverse Effect, or give rise to the right to terminate the Incyte Agreement, or the Merck Agreement, as applicable, by Incyte or Merck, respectively, or (B) Seller or any of its Affiliates obtains Knowledge of any fact, circumstance or event which alone or together with other facts, circumstances or events could reasonably be expected (with or without the giving of notice or passage of time or both) to give rise to a breach of or default under the Incyte Agreement or the Merck Agreement, as applicable, by Seller Parent or its Affiliates which, if not cured, could reasonably be expected to result in a Material Adverse Effect, or give rise to the right to terminate the Incyte Agreement, or the Merck Agreement, as applicable, by Incyte or Merck, respectively, in each case, Seller Parent shall promptly give a written notice to Purchaser describing in reasonable detail the relevant dispute, breach or default, including a copy of any written notice received from Incyte or Merck, as applicable, and, in the case of any breach or default or alleged breach or default by Seller Parent, describing in reasonable detail any action Seller Parent proposes to take to dispute or correct such dispute, alleged breach or default and (i) dispute such breach or default, or (ii) cure as promptly as practicable such breach or default in accordance with applicable Law and in a manner consistent in all material respects with the standard with which Seller Parent or its Affiliates would dispute or cure a breach in the administration of its own business (assuming, for these purposes, that the Incyte Agreement or the Merck Agreement, as applicable, were the only business of Seller Parent).

(d) Seller Parent shall not take any actions under the Merck Agreement, the Incyte Agreement or the LICR Agreement that could reasonably be expected to result in a Material Adverse Effect without the prior written consent of Purchaser.  Notwithstanding anything to the contrary contained in this Agreement, Seller Parent and its Affiliates may directly or indirectly (including by sublicense or otherwise) research, develop, manufacture, use, sell, offer for sale (including marketing and promotion), import, distribute or otherwise commercialize any biopharmaceutical product or products, except as would be a breach of the Incyte Agreement or the Merck Agreement.

(e) Seller Parent shall, except as would not reasonably be expected to result in a Material Adverse Effect, ensure that all licenses, covenants, releases and other rights granted under the Incyte Agreement or the Merck Agreement, as applicable, by or on behalf of Seller Parent and each of its Affiliates are, and shall at all such times remain, valid, enforceable and in full force and effect to the extent required by the Incyte Agreement or the Merck Agreement, as applicable.

Section 5.06 Audits .

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(a) Consultation .  During the term of this Agreement, Seller Parent and Purchaser shall consult with each other regarding the timing, manner and conduct of any audit of Incyte’s or Merck’s records, as applicable, with respect to the Royalties and the Milestones.   If in the course of such consultation, Purchaser requests that Seller Parent conduct an inspection or audit of Incyte’s or Merck’s records, as applicable (each a “ Purchaser-Requested Audit ”), with respect to the Royalties and the Milestones, as applicable, Seller Parent shall consider such request in good faith and act on such request in a manner consistent in all material respects with the standard with which Seller Parent would act in the administration of its own business (assuming, for these purposes, that the Incyte Agreement or the Merck Agreement, as applicable, were the only business of Seller Parent).   During any time that the Purchased Royalty Interests owned by Purchaser constitute a greater percentage of the royalties associated with the Incyte Agreement or the Merck Agreement than is then owned by Seller and its Affiliates, then the above-referenced Purchaser-Requested Audit (and the below referenced License Party Audit) shall become an automatic mandatory rights of Purchaser (with Seller Parent or its assignee retaining its own separate right) not subject to Seller’s prior consent and Purchaser shall have the right to require Seller and its Affiliates to enforce provisions contained in the Incyte Agreement or the Merck Agreement as applicable.

(b) Audits .  To the extent Seller Parent has the right to perform or cause to be performed inspections or audits under the Incyte Agreement or the Merck Agreement, as applicable, regarding payments payable and/or paid thereunder (each, a “ License Party Audit ”), Seller Parent, subject to Section 5.06(a), shall exercise such right in Seller Parent’s sole discretion.  If conducting a Purchaser-Requested Audit, Seller Parent shall, to the extent permitted by the Incyte Agreement or the Merck Agreement, as applicable, select such public accounting firm to conduct the Purchaser-Requested Audit as Purchaser shall reasonably recommend, and reasonably acceptable to Seller Parent, for such purpose.  Subject to Section 5.02(g) , as promptly as practicable after completion of any License Party Audit (whether or not requested by Purchaser), Seller Parent shall deliver to Purchaser an audit report summarizing the results of such License Party Audit.  If an inspection or audit constitutes a Purchaser-Requested Audit, all of the expenses of any such Purchaser-Requested Audit (including, without limitation, the fees and expenses of the independent public accounting firm) that would otherwise be borne by Seller Parent pursuant to the Incyte Agreement or the Merck Agreement, as applicable, shall instead be borne (as such expenses are incurred, upon the provision to Purchaser of written documentation evidencing such expenses) by Purchaser, provided that any reimbursement by Incyte or Merck, as applicable, of the expenses of the Purchaser-Requested Audit shall belong to Purchaser.  Any deficiency in payments of Royalties or Milestones made by Incyte or Merck, as applicable, demonstrated in a License Party Audit shall be paid promptly, in accordance with the Incyte Agreement or the Merck Agreement, as applicable, to Purchaser and Seller by deposit in the Joint Escrow Account for further distribution to Purchaser and Seller pursuant to the terms hereof.

Section 5.07 Notice .

Each Seller Party shall provide Purchaser with written notice as promptly as practicable (and in any event within five (5) Business Days) after becoming aware of any of the following:

i. any Bankruptcy Event;

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ii. any material breach or default by a Seller Party of any covenant, agreement or other provision of this Agreement or any other Transaction Document to which such Seller Party is a party; or

iii. any representation or warranty made by Seller Parent in any of the Transaction Documents or in any certificate delivered to Purchaser pursuant hereto shall prove to be untrue, inaccurate or incomplete in any material respect on the date as of which made;

with, in the case of clause (i) above, a copy to the Depository Bank.  If Purchaser has actual notice of any Bankruptcy Event, it shall be entitled to give written notice thereof to the Depository Bank, provided it concurrently delivers a copy thereof to Seller.

Section 5.08 Seller Operations .  

 

Except as permitted under Section 8.04, all of the equity interests in Seller are, and shall always be, owned, directly or indirectly, by Seller Parent.  Following the Closing, Seller will not acquire or otherwise possess any assets or incur any liabilities, Liens (other than Permitted Liens) or other obligations (contractual or otherwise) except in connection with the performance of its obligations under the Transaction Documents or resulting out of the ownership of assets that are not the Purchased Royalty Interests.  Seller will not undertake any actions other than to enter into and perform its obligations under the Transaction Documents and all documents, instruments, or agreements directly related thereto.  Neither Seller nor Seller Parent or any of their Affiliates or any manager of Seller shall amend or alter the Seller Organizational Documents, agree to dissolve Seller or otherwise windup its affairs or allow or take any action for Seller to become subject to any Bankruptcy Event.  Seller Parent shall use commercially reasonable efforts to complete the dissolution of Agenus Switzerland and the transfer of all of the assets and liabilities of Agenus Switzerland to Seller Parent in a timely fashion.

Section 5.09 Special Purpose Vehicle Covenants

 

(a) Seller will at all times remain in existence as a limited liability company separate and distinct from Seller Parent or any other Person and will not consent to or enter into any agreement or contract with respect to any reorganization, merger, recapitalization or consolidation of Seller with or into any other Person.  Seller shall maintain its accounts, books and records separate from any other Person (including Seller Parent) and will not commingle any funds with any other Person (including Seller Parent).

(b) Seller shall not:

(i) fail to hold itself out to the public and all other Persons as a legal entity separate from the owners of its capital stock and from any other Person;

(ii) commingle its assets with assets of any other Person except in connection with, and for the limited purposes of, operation of the Joint Escrow Account;

(iii) fail to conduct its business only in its own name, nor fail to comply with all organizational formalities necessary to maintain its separate existence;

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[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

(iv) fail to maintain separate financial statements, showing its assets and liabilities separate and apart from those of any other Person nor have its assets listed on any financial statement of any other Person; provided , however, that Seller’s assets may be included in a consolidated financial statement of its Affiliates in conformity with applicable provisions of GAAP (provided that such assets shall also be listed on Seller’s own separate balance sheet);

(v) fail to pay its own liabilities and expenses only out of its own funds, except in respect of short term advances to be repaid;

(vi) enter into any transaction with an Affiliate except transactions that are at prices and on terms and conditions that could be obtained on an arm’s-length basis from unrelated Third Parties;

(vii) fail to correct any known misunderstanding regarding its separate identity and not identify itself as a department or division of any other Person;

(viii) fail to maintain adequate capital in light of its contemplated business purpose, transactions and liabilities; provided, however, that the foregoing shall not require the holders of its capital stock to make additional capital contributions to Seller;

(ix) fail to cause the representatives of Seller to act at all times with respect to Seller consistently and in furtherance of the foregoing and in the best interests of Seller;

(x) make any payment or distribution of assets with respect to any obligation of any other person other than as required under trade or commercial agreements entered into in the ordinary course of business; or

(xi) engage in any business activity other than as contemplated hereunder or under the other Transaction Documents and any activities ancillary or related thereto.

Section 5.10 Patent Maintenance

 

(a) Seller Parent and its Affiliates shall, subject to the provisions of the Incyte Agreement and any rights of Incyte thereunder, and except as would not reasonably be expected to result in a Material Adverse Effect, (i) prosecute and maintain the Licensed Patents licensed to Incyte in accordance with, and, subject to, the Incyte Agreement, and (ii) not disclaim or abandon any of such applicable Licensed Patents, or fail to take any commercially reasonable action necessary to prevent the disclaimer or abandonment of such applicable Licensed Patents, except, in each case, where the disclaimer or abandonment of any such applicable Licensed Patents is commercially reasonable or is pursuant to instruction by Incyte or Merck.  For the avoidance of doubt, Seller Parent shall have no obligation to pursue, request or obtain patent term extension under 35 U.S.C. 156, or any foreign counterpart thereto, in connection with any Licensed Patent.

(b) With respect to patent applications included in the Licensed Patents, Seller Parent and its Affiliates shall exercise commercially reasonable judgment in the continued prosecution and maintenance of each patent application included in the Licensed Patents and of any continuation or divisional patent application thereof.

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[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

Section 5.11 [ ******** ]

If Seller Parent or an Affiliate [ ******** ] or [ ******** ] (as applicable), and/or [ ******** ] by [ ******** ], as applicable, [ ******** ] Seller Parent or its Affiliates (any [ ******** ], a “[ ******** ]”)], and Seller Parent or its Affiliates [ ******** ] or [ ******** ] or [ ******** ] with respect to the [ ******** ] and [ ******** ] of such [ ******** ] (each a [ ******** ]), then this Agreement shall [ ******** ] or [ ******** ], as applicable, [ ******** ] (e.g., the [ ******** ] in respect of [ ******** ] would result in [ ******** ]), and such [ ******** ] shall be deemed to be part of the [ ******** ]. If Seller Parent or an Affiliate [ ******** ] and Seller Parent or such Affiliate [ ******** ] or [ ******** ] (each a “[ ******** ]”) prior to the [ ******** ], then on or before [ ******** ] of such [ ******** ], the parties shall [ ******** ] or [ ******** ], as applicable, [ ******** ] (e.g., the [ ******** ] in respect of [ ******** ] would result in [ ******** ]). For purposes of the foregoing, with respect to [ ******** ] that are [ ******** ], a [ ******** ] will consist of the [ ******** ] under a [ ******** ] or by Seller under a [ ******** ], but only to the extent Seller or its Affiliates [ ******** ] or [ ******** ] under the [ ******** ] or the [ ******** ] (as applicable) prior to [ ******** ].

ARTICLE VI
THE CLOSING; CONDITIONS TO CLOSING

Section 6.01 Closing .

Subject to the closing conditions set forth in Sections 6.02 and 6.03, the closing of the transactions contemplated under this Agreement (the “ Closing ”) shall take place on the date hereof, or such later date as may be agreed upon by Purchaser and Seller (such date, the “ Closing Date ”).  

Section 6.02 Conditions Applicable to Purchaser in Closing .

The obligations of Purchaser to effect the Closing, including the requirement to pay the Purchase Price pursuant to Section 2.03, shall be subject to the satisfaction of each of the following conditions, as of the Closing Date, any of which may be waived by Purchaser in its sole discretion:

(a) Accuracy of Representations and Warranties .  The representations and warranties of the Seller Parent set forth in the Transaction Documents shall be true, correct and complete in all material respects, as of the Closing Date.

(b) No Adverse Circumstances .  There shall not have occurred or be continuing any event or circumstance described in the definition of a Material Adverse Effect.

(c) Litigation .  No action, suit, litigation, proceeding or investigation shall have been instituted, be pending or, to the Knowledge of Seller and its Affiliates, threatened (i) challenging or seeking to make illegal, to delay or otherwise directly or indirectly to restrain or prohibit the consummation of the transactions contemplated by this Agreement, or seeking to obtain damages

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in connection with the transactions contemplated by this Agreement, or (ii) seeking to restrain or prohibit Purchaser’s acquisition or future receipt of the Purchased Royalty Interests.

(d) Officer’s Certificate .  Purchaser shall have received a certificate of the President of Seller pursuant to which such officer certifies that the conditions set forth in Sections 6.02(a), (b) and (c) shall have been satisfied in all material respects.

(e) Bill of Sale .  A Bill of Sale substantially in the form set forth in Exhibit A shall have been executed and delivered by Seller to Purchaser, and Purchaser shall have received the same.

(f) Legal Opinion .  Purchaser shall have received the opinions of Goodwin Procter LLP, counsel to Seller, in the form set forth in Exhibit H .

(g) Corporate Documents of Seller and Seller Parent .  Purchaser shall have received certificates of an executive officer of each of Seller and Seller Parent (the statements made in which shall be true and correct on and as of the Closing Date):  (i) attaching copies, certified by such officer as true and complete, of the certificate of formation or incorporation and the operating agreement or by-laws, as applicable, of Seller or Seller Parent (as applicable); (ii) attaching copies, certified by such officer as true and complete, of resolutions of the board of directors or Sole Manager, as applicable, of Seller or Seller Parent (as applicable) authorizing and approving the execution, delivery and performance by Seller or Seller Parent (as applicable) of the Transaction Documents and the transactions contemplated herein and therein; (iii) setting forth the incumbency of the officer or officers of Seller or Seller Parent (as applicable) who have executed and delivered the Transaction Documents including therein a signature specimen of each officer or officers; and (iv) attaching copies, certified by such officer as true and complete, of a certificate of the appropriate Governmental Authority of Seller’s or Seller Parent’s (as applicable) jurisdiction of incorporation, stating that such party is in good standing under the laws of such jurisdiction.

(h) Covenants .  (i) Seller shall have complied in all material respects with the covenants set forth in the Transaction Documents and (ii) Seller Parent shall have complied in all material respects with the covenants set forth in the Transaction Documents to which it is a party.

(i) Financing Statements .   Purchaser shall have received such other certificates, documents and financing statements as Purchaser may reasonably request, including one or more financing statements satisfactory to Purchaser to create, evidence and perfect the sale of the Purchased Royalty Interests pursuant to Section 2.01(c) and the back-up security interest granted pursuant to Section 2.01(d).

(j) Release of Liens .  Seller Parent shall have received an executed and delivered authorization from HealthCare Royalty Partners III, L.P., as secured party on its own behalf and in a representative capacity for certain of its affiliates (the “ Secured Party ”) to release the Lien of the Secured Party on the Purchased Royalty Interests pursuant to that certain Security Agreement dated January 19, 2018, by and between Seller Parent and Secured Party.

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[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

Section 6.03 Conditions Applicable to Seller in Closing .

The obligations of Seller to effect the Closing shall be subject to the satisfaction of each of the following conditions, any of which may be waived by Seller in its sole discretion:

(a) Accuracy of Representations and Warranties .  The representations and warranties of Purchaser set forth in this Agreement shall be true, correct and complete as of the Closing Date in all material respects.

(b) Litigation .  No action, suit, litigation, proceeding or investigation shall have been instituted, be pending or, to the actual k nowledge of Purchaser, threatened (i) challenging or seeking to make illegal, to delay or otherwise directly or indirectly to restrain or prohibit the consummation of the transactions contemplated by this Agreement, or seeking to obtain damages in connection with the transactions contemplated by this Agreement, or (ii) seeking to restrain or prohibit Purchaser’s acquisition of the Purchased Royalty Interests.

(c) Officer’s Certificate .  Seller shall have received at the Closing a certificate of an authorized representative of Purchaser certifying that the conditions set forth in Sections 6.03(a), ((b)) and ((d)) have been satisfied in all respects as of the Closing Date.

(d) Covenants .  Purchaser shall have complied in all material respects with the covenants set forth in the Transaction Documents.

(e) Purchase Price .  Seller shall have received payment of the Purchase Price in accordance with Section 2.03.

(f) Release of Liens .  Seller Parent shall have received an executed and delivered Lien release from the Secured Party.

ARTICLE VII
EXPIRATION

Section 7.01 Expiration Date .

This Agreement shall terminate six (6) months following receipt by Purchaser of all payments of the Purchased Royalty Interests to which it is entitled hereunder.

 

Section 7.02

Effect of Expiration .

In the event of the expiration of this Agreement pursuant to Section 7.01, this Agreement shall forthwith become void and have no effect without any liability on the part of any party hereto or its Affiliates, directors, officers, stockholders, managers or members other than the provisions of this Section 7.02 and Sections 5.02, 8.01 and 8.05 hereof, which shall survive any termination as set forth in Section 8.01.  Nothing contained in this Section 7.02 shall relieve any party from liability for any breach of this Agreement.

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ARTICLE VIII
MISCELLANEOUS

Section 8.01 Survival .

All representations and warranties made herein and in any other Transaction Document or any closing certificates delivered pursuant to this Agreement shall survive the execution and delivery of this Agreement and the Closing and shall continue to survive until the receipt by Purchaser of the last payment due pursuant to the terms of both the Incyte Agreement and the Merck Agreement.  Notwithstanding anything in this Agreement or implied by law to the contrary, all of the agreements contained in Sections 5.02, 8.01 and 8.05 shall survive indefinitely following the execution and delivery of this Agreement and the Closing and the expiration of this Agreement.

Section 8.02 Specific Performance .

Each of the parties hereto acknowledges that the other parties will have no adequate remedy at law if it fails to perform any of its obligations under any of the Transaction Documents.  In such event, each of the parties agrees that the other parties shall have the right, in addition to any other rights they may have (whether at law or in equity), to specific performance of this Agreement.

Section 8.03 Notices .

All notices, consents, waivers and communications hereunder given by any party to the other shall be in writing and delivered personally, by hand, by a recognized overnight courier, or by dispatching the same by certified or registered mail, return receipt requested, with postage prepaid, or by email ( provided any notice given by email shall also be given by another method of delivery permitted by this Section 8.03), in each case addressed:

If to Purchaser:

XOMA (US) LLC

2200 Powell Street

Suite 310
Emeryville, CA 94608

Attention: Legal Department
Email: bob.maddox@xoma.com

 

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

 

Donahue Fitzgerald LLP

1999 Harrison St. 25th Floor

Oakland, California 94612

Attention:  Steven K. Lee, Esq.
Email: slee@donahue.com

If to Seller Parent:

Agenus Inc.

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[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

3 Forbes Road

Lexington, MA 02421

Attention: Legal Department

Email: evan.kearns@agenusbio.com

If to Seller:

Agenus Royalty Fund, LLC

3 Forbes Road

Lexington, MA 02421

Attention: Legal Department

Email: evan.kearns@agenusbio.com

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

Goodwin Procter LLP

100 Northern Ave

Boston, MA 02210

Attention: Arthur R. McGivern, Esq.

Email: AMcGivern@goodwinlaw.com

or to such other address or addresses as Purchaser, Seller Parent or Seller may from time to time designate by notice as provided herein, except that notices of changes of address shall be effective only upon receipt.  All such notices, consents, waivers and communications shall:  (a) when posted by certified or registered mail, postage prepaid, return receipt requested, be effective three (3) Business Days after dispatch, unless such communication is sent trans-Atlantic, in which case they shall be deemed effective five (5) Business Days after dispatch, (b) when delivered by a recognized overnight courier or in person, be effective upon receipt when hand delivered or (c) on the date sent by e-mail of a PDF document if sent during normal business hours of the recipient, and on the next Business Day if sent after normal business hours of the recipient, and followed by a transmission pursuant to another method of delivery permitted by this Section 8.03.

Section 8.04 Successors and Assigns .

The provisions of this Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and assigns.  Neither Seller Party shall be entitled to assign any of their obligations and rights under the Transaction Documents to which such Seller Party is a party without the prior written consent of Purchaser.  Purchaser may assign any of its obligations and rights under the Transaction Documents, without restriction and without the consent of Seller; provided that, notwithstanding any assignment pursuant to this Section 8.04, Purchaser shall remain obligated with respect to the payment of the Purchase Price in connection with the Closing.

Section 8.05 Indemnification .

(a) Seller Parent hereby agrees to indemnify and hold Purchaser and its Affiliates and any of their respective partners, directors, managers, members, officers, employees and agents

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(each a “ Purchaser Indemnified Party ”) harmless from and against any and all Losses incurred or suffered by any Purchaser Indemnified Party arising out of (i) any breach of any representation, warranty or certification made by a Seller Party in any of the Transaction Documents to which such Seller Party is a party or certificates given by such Seller Party in writing pursuant hereto or thereto, (ii) any breach of or default under any covenant or agreement by a Seller Party pursuant to any Transaction Document to which such Seller Party is a party; (iii) any Excluded Liabilities and Obligations, (iv) any breach of any representation, warranty or certification made by a Seller Party in any of the Transaction Documents to which such Seller Party is party or certificates given by a Seller Party to Purchaser in writing pursuant to any Transaction Document to which such Seller Party is a party, to the extent directly or indirectly related to the Purchased Royalty Interests or the Purchaser’s interest therein or (v) any breach of or default under any covenant or agreement by a Seller Party pursuant to any Transaction Document to which such Seller Party is party, to the extent directly or indirectly related to the Purchased Royalty Interests or Purchaser’s interest therein; provided that the foregoing shall exclude any indemnification to any Purchaser Indemnified Party (i) that results from the gross negligence or willful misconduct of such Purchaser Indemnified Party, or (ii) to the extent resulting from acts or omissions of Seller Parent or any of its Affiliates based upon the written instructions from any Purchaser Indemnified Party.

(b) Purchaser hereby agrees to indemnify and hold Seller Parent, its Affiliates and any of their respective partners, directors, managers, officers, employees and agents (each a “ Seller Indemnified Party ”) harmless from and against any and all Losses incurred or suffered by a Seller Indemnified Party arising out of any breach of any representation, warranty or certification made by Purchaser in any of the Transaction Documents or certificates given by Purchaser in writing pursuant hereto or thereto or any breach of or default under any covenant or agreement by Purchaser pursuant to any Transaction Document, to the extent any such Losses are not subject to indemnification by Seller hereunder; provided , however , that the foregoing shall exclude any indemnification to any Seller Indemnified Party (i) that results from the gross negligence or willful misconduct of such Seller Indemnified Party, or (ii) to the extent resulting from acts or omissions of Purchaser or any of its Affiliates based upon the written instructions from any Seller Indemnified Party.

(c) If any claim, demand, action or proceeding (including any investigation by any Governmental Authority) shall be brought or alleged against an indemnified party in respect of which indemnity is to be sought against an indemnifying party pursuant to the preceding paragraphs, the indemnified party shall, promptly after receipt of notice of the commencement of any such claim, demand, action or proceeding, notify the indemnifying party in writing of the commencement of such claim, demand, action or proceeding, enclosing a copy of all papers served, if any, provided that, the omission to so notify such indemnifying party will not relieve the indemnifying party from any liability that it may have to any indemnified party under the foregoing provisions of this Section 8.05 unless, and only to the extent that, such omission results in the forfeiture of, or have a material adverse effect on the exercise or prosecution of, substantive rights or defenses by the indemnifying party.  In case any such action is brought against an indemnified party and it notifies the indemnifying party of the commencement thereof, the indemnifying party will be entitled to participate therein and, to the extent that it may wish and provided that the indemnifying party acknowledges in writing to the indemnified party that it would have an indemnity obligation pursuant to this Section 8.05 with respect to such action, to assume and control the defense thereof, with counsel reasonably satisfactory to such indemnified party, and

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after notice from the indemnifying party to such indemnified party of its election so to assume the defense thereof, the indemnifying party will not be liable to such indemnified party under this Section 8.05 for any legal or other expenses subsequently incurred by such indemnified party in connection with the defense thereof other than reasonable costs of investigation.  In any such proceeding, an indemnified party shall have the right to retain its own counsel, but the reasonable fees and expenses of such counsel shall be at the expense of such indemnified party; provided that the indemnifying party shall be responsible for the indemnified party’s reasonable fees and expenses of such counsel if (i) the indemnifying party and the indemnified party shall have mutually agreed to the retention of such counsel, (ii) the indemnifying party has assumed the defense of such proceeding and has failed within a reasonable time to retain counsel reasonably satisfactory to such indemnified party or (iii) the named parties to any such proceeding (including any impleaded parties) include both the indemnifying party and the indemnified party and representation of both parties by the same counsel would be inappropriate due to actual or potential conflicts of interests between them based on the advice of counsel to the indemnified party.  It is agreed that the indemnifying party shall not, in connection with any proceeding or related proceedings in the same jurisdiction, be liable for the reasonable fees and expenses of more than one separate law firm (in addition to local counsel where necessary) for all such indemnified parties.  The indemnifying party shall not be liable for any settlement of any proceeding effected without its written consent, but if settled with such consent or if there be a final judgment for the plaintiff, the indemnifying party agrees to indemnify the indemnified party from and against any indemnifiable Loss under this Agreement by reason of such settlement or judgment.  No indemnifying party shall, without the prior written consent of the indemnified party, effect any settlement of any pending or threatened proceeding in respect of which any indemnified party is or could have been a party and indemnity could have been sought hereunder by such indemnified party, unless such settlement (i) includes an unconditional written release of such indemnified party, in form and substance reasonably satisfactory to the indemnified party, from all liability on claims that are the subject matter of such claim or proceeding, (ii) does not include any statement as to an admission of fault, culpability or failure to act by or on behalf of any indemnified party and (iii) does not impose any continuing material obligation or restrictions on any indemnified party.

(d) No claim for indemnification hereunder for breach of any representations or warranties contained in any Transaction Document may be made after the expiration of the survival period applicable to such representation or warranty; provided that any written claim for breach thereof made prior to such expiration date and delivered to the party against whom such indemnification is sought shall survive thereafter with respect to such claim.

(e) Following the date first written above, except in the case of fraud or intentional breach, the indemnification afforded by this Section 8.05 shall be the sole and exclusive remedy for any and all Losses sustained or incurred by a party hereto in connection with the transactions contemplated by the Transaction Documents, including with respect to any breach of any representation, warranty or certification made by a party hereto in any of the Transaction Documents or certificates given by a party in writing pursuant hereto or thereto or any breach of or default under any covenant or agreement by a party pursuant to any Transaction Document.  NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED IN THIS AGREEMENT OR PROVIDED FOR UNDER APPLICABLE LAW, EXCEPT AS PROVIDED FOR IN THIS SECTION 8.05 AND FOR INSTANCES OF ACTUAL FRAUD OR WILLFUL

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MISCONDUCT, NONE OF THE PARTIES HERETO SHALL BE LIABLE TO ANY OTHER PARTY HERETO OR ANY PERSON, WHETHER IN CONTRACT, TORT OR OTHERWISE, FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE OR MULTIPLE DAMAGES OR LOST PROFITS  RELATING TO THE BREACH OR ALLEGED BREACH HEREOF, WHETHER OR NOT THE POSSIBILITY OF SUCH DAMAGES HAVE BEEN DISCLOSED TO ANY PARTY HERETO IN ADVANCE OR COULD HAVE BEEN REASONABLY FORESEEN.  Notwithstanding the foregoing, in the event of any breach or failure in performance of any covenant or agreement contained in any Transaction Document, the non-breaching party shall be entitled to seek specific performance, injunctive or other equitable relief.  For clarity, neither party shall have any right to terminate this Agreement or any other Transaction Document as a result of any breach by the other party hereof or thereof, but instead shall have the right to seek indemnification under this Section 8.05 and such specific performance.

(f) Other than with respect to a breach of Sections 5.04, 5.08 or 5.09, or any fraud or intentional breach, in no event shall the maximum aggregate amount of Losses that may be recovered by the Purchaser Indemnified Parties under this Agreement pursuant to Section 8.05 [ ******** ].

Section 8.06 Independent Nature of Relationship .

(a) The relationship between the Seller Parties, on the one hand, and Purchaser is solely that of sellers and purchaser, and neither Purchaser nor Seller has any fiduciary or other special relationship with the other or any of their respective Affiliates.  Nothing contained herein or in any other Transaction Document shall be deemed to constitute the Seller Parties and Purchaser as a partnership, an association, a joint venture or other kind of entity or legal form.  Any party shall not refer other party as a “partner” or the relationship as a “partnership” or “joint venture”.

(b) No officer or employee of Purchaser will be located at the premises of Seller Parent or any of its Affiliates.  No officer, manager or employee of Purchaser shall engage in any commercial activity with Seller Parent or any of its Affiliates other than as contemplated herein and in the other Transaction Documents.

(c) Seller Parent and/or any of its Affiliates shall not at any time obligate Purchaser, or impose on Purchaser any obligation, in any manner or respect to any Person not a party hereto.

Section 8.07 Tax .

(a) For U. S, federal, state and local income tax purposes, Seller and Purchaser shall treat the transactions contemplated by the Transaction Documents as a sale of the Purchased Royalty Interests.  The parties hereto agree not to take any position that is inconsistent with the provisions of this Section 8.07(a) on any tax return or in any audit or other administrative or judicial proceeding unless otherwise required by law (including a good faith resolute of any tax audit).  If there is an inquiry by any Governmental Authority of Purchaser or Seller related to this Section 8.07(a), Seller and Purchaser shall cooperate in responding to such inquiry in a reasonable manner consistent with this Section 8.07(a) .

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(b) To the extent any amount is withheld at source from a payment made pursuant to the Incyte Agreement or the Merck Agreement, as applicable, such withheld amount shall for all purposes of this Agreement be treated as paid to Seller and Purchaser on a pro rata basis in accordance with each of the party’s underlying ownership interest in each such payment (taking into account any amounts withheld); e.g., with respect to Purchaser, amounts so withheld shall be attributed to Purchaser, and deemed paid to Purchaser, in accordance with the Purchased Royalty Interests.  Any amounts withheld pursuant to this Section 8.07(b) attributable to Purchaser shall be credited for the account of Purchaser.  If there is an inquiry by any Governmental Authority of Purchaser related to this Section 8.07 , Seller shall cooperate with Purchaser in responding to such inquiry in a reasonable manner consistent with this Section 8.07 .  Neither party shall have any obligation to gross-up or otherwise pay the other party any amounts with respect to source withholding.  All amounts withheld at source as described herein shall for all purposes of this Agreement be deemed to have been received by the party to which they are attributed as provided above or to which the payment subject to such withholding was made.

(c) Any and all payments from Seller to Purchaser under this Agreement shall be made without any deduction or withholding of any tax except as required by applicable law, provided that Seller shall not make any deduction or withholding of any U.S. tax as long as Purchaser has delivered to Seller a properly executed IRS Form W-9 or any other applicable or successor forms prior to the payment and that as a result withholding is not required by applicable law.  If any withholding or deduction is required at source from a payment made pursuant to the Incyte Agreement, the Merck Agreement or this Agreement, Seller and Purchaser shall take commercially reasonable measures and cooperate with Incyte or Merck, as applicable, to obtain any available reduction or exemption from such tax.

Section 8.08 Entire Agreement .

This Agreement, together with the Exhibits and Schedule hereto (which are incorporated herein by reference), and the other Transaction Documents, constitute the entire agreement between the parties with respect to the subject matter hereof and supersede all prior agreements, understandings and negotiations, both written and oral, between the parties with respect to the subject matter of this Agreement.  No representation, inducement, promise, understanding, condition or warranty not set forth herein (or in the Exhibits, Schedule or other Transaction Documents) has been made or relied upon by either party hereto.  None of this Agreement, nor any provision hereof, is intended to confer upon any Person other than the parties hereto any rights or remedies hereunder.

Section 8.09 Governing Law .

This Agreement shall be construed in accordance with and governed by the laws of the State of New York without giving effect to the principles of conflicts of law thereof.  

Section 8.10 Severability .

If one or more provisions of this Agreement are held to be unenforceable under applicable law, such provision shall be excluded from this Agreement and the balance of the Agreement shall

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[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

be interpreted as if such provision were so excluded and shall be enforceable in accordance with its terms.

Section 8.11 Counterparts; Effectiveness .

This Agreement may be signed in any number of counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument.  This Agreement shall become effective when each party hereto shall have received a counterpart hereof signed by the other party hereto.  Any counterpart may be executed by electronic signature and such electronic signature shall be deemed an original.

Section 8.12 Amendments; No Waivers .

(a) This Agreement or any term or provision hereof may not be amended, changed or modified except with the written consent of the parties hereto.  No waiver of any right hereunder shall be effective unless such waiver is signed in writing by the party against whom such waiver is sought to be enforced.

(b) No failure or delay by any party in exercising any right, power or privilege hereunder shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege.  The rights and remedies herein provided shall be cumulative and not exclusive of any rights or remedies provided by law.

 

[Signature page follows]

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[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed by their respective authorized officers as of the date first above written.

Agenus Inc.

 

 

By: /s/Garo H. Armen

Name: Garo H. Armen  

Title:   Chairman and CEO

 

  

Agenus Royalty Fund, LLC

 

 

By: /s/Christine M. Klaskin

Name: Christine M. Klaskin  

Title:   Treasurer

  

[Signature Page to Royalty Purchase Agreement]

 

[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


 

xoma (us) llc

 

 

By: /s/Jim Neal

Name: Jim Neal

Title: CEO

 

[Signature Page to Royalty Purchase Agreement]

 

[********] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Exhibit 10.1

 

AMENDMENT NO. 1 TO

CONSULTING AGREEMENT

This AMENDMENT NO. 1 TO CONSULTING AGREEMENT (this “Amendment”), effective as of July 1, 2018 (the “Amendment Effective Date”), is by and between Agenus Inc., a Delaware corporation having an address at 149 Fifth Avenue, Suite 500, New York, NY 10010 (the “Company”), and Dr. Robert Stein, an individual currently residing at 7 Peter Cooper Rd., Apt 10-B, New York, NY 10010 (the “Consultant”) (each a “Party” and together the “Parties”).  Capitalized terms used in this Amendment and not otherwise defined herein shall have those meanings attributed to them in the Agreement (as defined below).

WITNESSETH

 

WHEREAS, the Company and the Consultant are parties to that certain Consulting Agreement effective as of April 1, 2017 (the “Agreement”); and

 

WHEREAS, the Parties now wish to amend the Agreement as set forth herein.

 

NOW, THEREFORE, the Parties agree as follows:

 

1.

Section 1.1 of the Agreement is hereby deleted and replaced with the following:

 

Description of Services . Subject to the terms and conditions of this Agreement, Agenus hereby retains Consultant as a Senior Advisor, Research & Development, to its CEO, Dr. Garo Armen, and/or his designees, to provide scientific guidance and advisory services to Agenus and/or its Affiliates, and such other services as may be requested from time to time (collectively, the “ Services ”).  Consultant shall make himself available to Agenus and/or its Affiliates for up to 20 hours per week, including providing updates to the CEO at least bi-weekly, and participating in Agenus research personnel meetings upon request of the CEO or his designee.  Consultant shall perform the Services promptly and in compliance with the provisions of this Agreement and all applicable laws, rules and regulations, including if applicable, laws and regulations administered by the U.S. Food and Drug Administration (“ FDA ”) regarding the promotion and marketing of pharmaceutical products.  Consultant shall ensure that the Services are performed promptly and diligently. As used in this Agreement “Affiliate” means any corporation, firm, partnership or other entity, which controls, is controlled by or is under common control with a Party.  As used in this Agreement, “control” means direct or indirect ownership of fifty percent (50%) or more of the outstanding stock or other voting rights entitled to elect directors thereof or the ability to otherwise control the management of the corporation, firm, partnership or other entity.”    

 

 

2.

Section 2.1 of the Agreement is hereby deleted and replaced with the following:

 

Compensation.   In exchange for the timely completion of Services during the Term, Agenus shall pay to Consultant a monthly retainer of $25,000 (the “ Compensation ”), and Consultant shall be entitled to continuation of vesting during the Term with

 

 


respect to all equity incentive awards held by Consultant as of the Amendment Effective Date .  In the event of a Change of Control (as defined in the Employment Agreement) during the Term, all vesting of Consultant’s stock options will immediately be accelerated in full.   All payments for Compensation shall be made within 15 days following the end of each month Services are performed .  All monies to be paid under this Agreement shall be paid to Consultant in U.S. Dollars.   Consultant acknowledges and agrees that payments made hereunder are for Services performed by Consultant.  No payments shall be passed through to third parties on behalf of Agenus without a valid invoice or other written documentation between the Parties evidencing such payment arrangement .”

 

 

3.

Section 3.1 of the Agreement is hereby deleted and replaced with the following:

 

Term .  This Amendment shall commence on the Amendment Effective Date and shall remain in effect for a period of 12 months, unless extended by mutual written agreement of the Parties, or earlier terminated in accordance with the provisions of this Article 3 (such 12-month period as it may be extended or terminated, the “ Term ”).”

 

4.

Section 3.2 of the Agreement is hereby deleted and replaced with the following:

 

Termination .

 

(a)

The Parties may mutually agree to terminate this Agreement at any time.

 

(b)

Agenus may terminate this Agreement immediately upon written notice to Consultant (or his legal representative) in the event (i) of the death or legal incapacity of Consultant; (ii) that Consultant is otherwise no longer able to perform the Services; or (iii) if Consultant breaches any provision of Sections 1.2, 1.3, 1.4, 1.5 or Articles 4, 5 or 6.

 

(c)

Either Party may terminate this Agreement for convenience at any time upon 90 days’ prior written notice.”

 

5.

Except as set forth in this Amendment, the Agreement shall remain in full force and effect.

 

 

6.

This Amendment may be executed in counterparts, which, when taken together, shall constitute one agreement. If any signature is delivered by facsimile transmission or by e-mail delivery of a “.pdf” format data file, such signature shall create a valid and binding obligation of the Party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or “.pdf” signature page were an original thereof.

 

 

7.

This Amendment shall be governed by and construed in accordance with the laws of the State of New York irrespective of any conflicts of law principles thereof.

 

 

 

 


IN WITNESS WHEREOF, the Parties hereto hav e executed this Amendment as of the Amendment Effective Date.

 

AGENUS INC.

 

 

CONSULTANT

By: /s/ Garo H. Armen _________

Name:  Garo H. Armen

Title:    Chairman & CEO

 

/s/ Robert Stein _________

Name:  Dr. Robert Stein

 

 

 

 

 

Exhibit 10.2

 

CONSULTING AGREEMENT

This Consulting Agreement (the “ Agreement ”), effective as of July 1, 2018 (the “ Effective Date ”), is made between AgenTus Therapeutics, Inc., a Delaware corporation, having an address at 3 Forbes Road, Lexington, MA 02421 (“ AgenTus ”), and Dr. Robert Stein, an individual currently residing at 7 Peter Cooper Rd., Apt 10-B, New York, NY 10010 (the “ Consultant ”) (each a “ Party ” and collectively the “ Parties ”).

WHEREAS, AgenTus desires to retain the services of Consultant, and Consultant desires to perform certain services for AgenTus;

NOW, THEREFORE, in consideration of the mutual covenants and promises contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, AgenTus and Consultant hereby agree as follows:

1. Services .

1.1 Description of Services . Subject to the terms and conditions of this Agreement, AgenTus or its designee hereby retains Consultant to perform for AgenTus and/or potentially its Affiliates (as hereinafter defined) the services specified in one or more attachments (the “ Attachment ”) to this Agreement executed by the Parties (the “ Services ”).  Consultant shall perform the Services promptly and in compliance with the provisions of this Agreement and all applicable laws, rules and regulations, including if applicable, laws and regulations administered by the U.S. Food and Drug Administration (“ FDA ”) regarding the promotion and marketing of pharmaceutical products.  Consultant shall ensure that the Services are performed promptly and diligently.  

As used in this Agreement “Affiliate” means any corporation, firm, partnership or other entity, which controls, is controlled by or is under common control with a Party.  As used in this Agreement, “control” means direct or indirect ownership of fifty percent (50%) or more of the outstanding stock or other voting rights entitled to elect directors thereof or the ability to otherwise control the management of the corporation, firm, partnership or other entity.

1.2 Non-Solicitation .  Consultant agrees that during the term of this Agreement and for a period of two (2) years thereafter, Consultant shall not, directly or indirectly, (i) solicit, divert, or take away, or attempt to divert or take away, the business or patronage of any actual or prospective clients, customers, or accounts of AgenTus, or (ii) recruit, solicit, or hire any employee of AgenTus, or induce or attempt to induce any employee of AgenTus, to discontinue his or her relationship with AgenTus.

1.3 Third Party Obligations .  Consultant represents and warrants to AgenTus that none of his or her current obligations conflict with this Agreement or the Services to be provided hereunder.  Consultant covenants not to enter into any such conflicting agreement or incur any such conflicting obligation without the prior written consent of AgenTus.  Consultant further covenants that the performance of the Services will not breach any agreement or obligation with

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any third party, including without limitation any obligation to refrain from engaging in activities that may compete with such party.

1.4 No Disparagement; Moral Hazard Clause .  Consultant agrees that during the Term and thereafter, Consultant shall not disparage AgenTus or any of its Affiliates, or their respective directors, officers, employees, consultants, or agents, or otherwise make any statement or take any actions that would be materially harmful to the business, interests or reputation of AgenTus or any of its Affiliates, or their respective directors, officers, employees, consultants, or agents. Consultant further agrees that that during the Term and thereafter, Consultant shall not engage in any behavior that could adversely impact the reputation of Agenus, including but not limited to committing, or being arrested for or charged with, any crime, or committing any acts of moral turpitude.

2. Compensation .

2.1 Compensation.   In exchange for the timely completion of Services during the Term, AgenTus shall pay to Consultant compensation as set forth in the applicable Attachment. Fees will be paid upon documented completion of Service in accordance with the requirements set forth in the Attachment. All compensation and expense reimbursements to be paid under this Agreement shall be paid to Consultant in the currency set forth in the applicable Attachment.  Consultant acknowledges and agrees that payments made hereunder are for Services performed by Consultant.  No payments shall be passed through to third parties on behalf of AgenTus without a valid invoice or other written documentation between the Parties evidencing such payment arrangement.

2.2 Reimbursement of Expenses .  AgenTus shall reimburse Consultant for reasonable travel and other out-of-pocket expenses pre-approved by AgenTus in writing, and incurred by Consultant in performance of the Services and in accordance with AgenTus’ Travel & Expense Policy and Procedures, as may be amended from time to time by AgenTus, provided that Consultant shall have submitted to AgenTus written expense statements and other supporting documentation in a form that is reasonably satisfactory to AgenTus. AgenTus shall provide Consultant with a check for any amounts due under this Section 2.2 within forty-five (45) days after AgenTus receives satisfactory documentation.

2.3 Independent Contractor .  Consultant is an independent contractor of AgenTus.  Consultant acknowledges and agrees that AgenTus will not provide Consultant with any benefits.  Without in any way limiting the generality of the foregoing, Consultant acknowledges and agrees that he or she has no right to participate in any AgenTus (or its Affiliates) equity plan(s).  Consultant is also responsible for the payment and the withholding of all applicable taxes, levies and/or duties applicable to any compensation or reimbursements paid to Consultant hereunder in accordance with all applicable laws, rules and regulations.

2.4 No Additional Obligation/Fair Market Value.   Consultant acknowledges and agrees that the compensation payable hereunder represents AgenTus’ full and complete obligation for any and all Services to be rendered by Consultant under this Agreement.  Consultant further represents to AgenTus that the compensation paid hereunder represents fair market value for Consultant’s time and the Services hereunder and is consistent with fees paid to

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Consultant for similar time and services provided by Consultant to others.  Both Parties acknowledge that the compensation is not determined in a manner that takes into account the volume or value of any future business that might be generated between the Parties.  In addition, Consultant and AgenTus acknowledge that nothing in this Agreement shall be construed to require Consultant to promote, purchase, prescribe, or otherwise recommend any AgenTus products being marketed or under development.

3. Term and Termination .

3.1 Term .  This Agreement shall commence on the Effective Date and shall automatically renew for successive one month periods until either Party terminates the Agreement in accordance with the provisions of this Article 3.

3.2 General Termination by AgenTus .  AgenTus may terminate this Agreement with or without cause upon seven (7) days prior written notice to Consultant with no further obligation to Consultant, other than payment of compensation in accordance with Article 2 for Services rendered in accordance with this Agreement prior to the date of such termination notice.

3.3 Immediate Termination by AgenTus .  In addition, AgenTus may terminate this Agreement immediately upon written notice to Consultant (or his/her legal representative) in the event (i) of the death or legal incapacity of Consultant or (ii) that Consultant is otherwise no longer able to perform the Services or (iii) if Consultant breaches or threatens to breach any provision of Sections 1.2, 1.3, 1.4, 7.3 or Articles 4, 5 or 6.

3.4 Termination by Consultant .  In the event that AgenTus commits a material breach of its obligations under this Agreement, Consultant may terminate this Agreement upon fifteen (15) days prior written notice to AgenTus, unless the breach is cured within such fifteen (15) day notice period.

3.5 Survival .  The following provisions shall survive the expiration or termination of this Agreement: Articles 4, 5 and 6; Sections 1.2, 1.4, 7.3 through 7.10, and this Section 3.5.

4. Confidential Information .

4.1 Definition of Confidential Information .  Confidential Information shall mean any technical or business information furnished by or on behalf of AgenTus to Consultant in connection with this Agreement or developed by Consultant in the course of performing the Services, regardless of whether such Confidential Information is in oral, electronic or written form.  Such Confidential Information may include, without limitation, trade secrets, know-how, inventions, technical data or specifications, testing methods, business or financial information,

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research and development activities, product and marketing plans, and customer and supplier information.

4.2 Obligations .  Consultant shall

(a) maintain all Confidential Information in strict confidence; and

(b) use all Confidential Information solely for the purpose of providing the Services as requested by AgenTus; and

(c) reproduce the Confidential Information only to the extent necessary for providing the Services as requested by AgenTus, with all such reproductions being considered Confidential Information;

(d) disclose the Confidential Information only as expressly permitted in order to perform the Services; and

(e) not disclose or publish any Confidential Information to any third party without the express prior written consent of AgenTus, in each case in AgenTus’ sole discretion.

4.3 Exceptions .  The obligations of Consultant under Section 4.2 shall not apply to the extent that Consultant can demonstrate that certain information:

(a) was in the public domain prior to the time of its disclosure or development under this Agreement;

(b) entered the public domain after the time of its disclosure or development under this Agreement other than due to an act or omission by Consultant;

(c) was independently developed by Consultant prior to the time of its disclosure or development under this Agreement and without access to Confidential Information; or

(d) is or was disclosed to Consultant at any time prior to its disclosure or development under this Agreement, without restriction, by a third party having no fiduciary relationship with AgenTus and having no obligation of confidentiality with respect to such Confidential Information.

4.4 Required Disclosures .  In addition Consultant may disclose Confidential Information to the extent necessary to comply with applicable laws or regulations, or with a court or administrative order, provided that Consultant (i) gives AgenTus prompt written notice of such requirement, (ii) takes all reasonable and lawful actions to obtain confidential treatment for such disclosure and, if possible, to minimize the extent of such disclosure, and (iii) discloses only the Confidential Information strictly required to comply with such legal obligation.

4.5 Return of Confidential Information; Survival of Obligations .  Upon the termination of this Agreement, or earlier at the request of AgenTus, Consultant shall return to AgenTus all originals, copies, and summaries of documents, materials, and other tangible

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manifestations of Confidential Information in the possession or control of Consultant .  The obligations set forth in this Article 4 shall remain in effect for a period of five (5) years after termination of this Agreement, except that the obligations of Consultant to return Confidential Information shall survive until fulfilled.  Consultant acknowledges and agrees that the Confidential Information is of extreme value to AgenTus , and any use or disclosure thereof other than as expressly allowed under this Agreement would cause irreparable harm to AgenTus for which AgenTus could obtain relie f as contemplated in Section 7.9 of this Agreement, and that such unauthorized disclosure may represent Consultant’s violat ion of U.S. securities laws.

5. Developments; Third Party IP; Avoidance of Claims .

5.1 Developments .  “ Developments ” shall mean any and all inventions, developments, data, discoveries, improvements, ideas, or concepts, and related documentation, and any other works of invention or authorship (whether or not patentable or copyrightable) which Consultant has conceived, discovered, developed, or reduced to practice or tangible medium in the course of providing the Services, or which arise from access to and/or use of Confidential Information, and any and all intellectual property rights in any of the foregoing.  Consultant shall promptly disclose to AgenTus any and all Developments.  Consultant acknowledges and agrees that all Confidential Information and Developments is and shall remain the exclusive property of AgenTus or the third party entrusting any Confidential Information to AgenTus.  Consultant shall and hereby assigns, conveys, and grants to AgenTus, all of his or her right, title, and interest in and to any and all Developments.  

5.4 Third-Party Intellectual Property .  Consultant acknowledges that AgenTus does not desire to acquire any trade secrets, know-how, confidential information, or other intellectual property that Consultant may have acquired from or developed for any third party (“ Third-Party IP ”).  Consultant agrees that in the course of providing the Services, Consultant shall not improperly use or disclose any Third-Party IP.

5.5 Avoidance of Claims by Third-Parties .  Unless covered by an appropriate agreement between any third party and AgenTus, Consultant shall not engage in any activities or use any facilities, funds or equipment, in the course of providing Services, which could result in claims of ownership to any Developments by such third party.

6. U.S. Foreign Corrupt Practices Act Compliance .  

6.1 FCPA .  Consultant understands that AgenTus’ parent entity, Agenus Inc. (“ Agenus ”) is an issuer of securities in the United States and is subject to the provisions of the U. S. Foreign Corrupt Practices Act, 15 U.S.C. §§ 78m, 78dd-1 through 78dd-3 (“ FCPA ”).  This law prohibits making, promising or offering to make corrupt payments to foreign officials, political parties or candidates, or making payments to other persons who will offer or make payments to any of the aforementioned parties in order to obtain business, retain business or gain an improper advantage.  Consultant represents and warrants to AgenTus that Consultant is familiar with and understands the FCPA.  

6.2 Representations .  Consultant represents and warrants to AgenTus that throughout the period in which Consultant provides Services to AgenTus, neither Consultant, nor any person

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performing Services on behalf of Consultant will engage in any activity that could cause a violation of any provision of the FCPA by AgenTus .  Consultant represents and warrants that Consultant has not made, promised to make, or arranged for any third party to make any payments or gifts to foreign officials in connection with Consultant s engagement by AgenTus .  Further, Consultant represents and warrants to AgenTus that Consultant has not violated any anti-corruption law and further that Consultant is not involved in, or the subject of, any investigation involving bribery, corruption or improper payments to foreign government officials, as defined in the FCPA.  Consultant agrees to update these representations and warranties on a periodic basis as required by AgenTus in a format prescribed by AgenTus .

6.3 Notice of Violation .  Consultant agrees to notify AgenTus immediately in writing if Consultant or any person who is performing Services hereunder on behalf of Consultant is suspected of violating any anti-corruption law or becomes involved in, or a subject of, an investigation or law enforcement inquiry into possible improper payments to foreign officials or possible violations of anti-corruption laws.   Consultant further agrees to provide such notification if Consultant or any person performing Services hereunder on behalf of Consultant becomes involved in any action, suit, claim, investigation or proceeding that is pending, or to the knowledge of Consultant threatened, relating to a potential violation of any anti-corruption laws, including the FCPA.

6.4 Audits .  Consultant agrees to grant AgenTus the right to audit Consultant’s books and records regarding the receipt and disposition of any payments made to Consultant by AgenTus, and Consultant further agrees to cooperate with AgenTus in connection with such audits.

6.5 Material Provision .  It is agreed between Consultant and AgenTus that this Article 6 is deemed by the Parties to be a material provision of this Agreement.

6.6 AgenTus Policy .  Consultant has received a copy of AgenTus’ Policy on Improper Payments and Compliance with the FCPA (the “ Policy ”).  Consultant represents and warrants that Consultant has had the opportunity to review the Policy, understands the Policy, and will comply with it.

7. Miscellaneous .

7.1 Counterparts . This Agreement may be executed in counterparts, which, when taken together, shall constitute one agreement. If any signature is delivered by facsimile transmission or by e-mail delivery of a “.pdf” format data file, such signature shall create a valid and binding obligation of the Party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or “.pdf” signature page were an original thereof.

7.2 Assignment .  This Agreement may not be assigned by either Party without the prior written consent of the other Party, except that AgenTus may assign this Agreement to an affiliate or in connection with the merger, consolidation, or sale of all or substantially all of its business or assets relating to this Agreement.  This Agreement shall inure to the benefit of and be

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binding upon the Parties and their respective lawful successors, assigns, heirs, and personal representatives .

7.3 Insider Trading .  Consultant acknowledges that Consultant may receive material, non-public information about AgenTus (and potentially its Affiliates) and its business in the course of providing the Services, that this information must be maintained in strict confidence, and that the U.S. securities laws restrict trading on the basis of such information or providing such information to third parties who may trade on such information.

7.4 Publicity .  Consultant consents to use by AgenTus of Consultant’s name and likeness in written materials or oral presentations to current or prospective customers, investors or others, provided that such materials or presentations accurately describe the nature of Consultant’s relationship with or contribution to AgenTus.

7.5 Notices .   Any notice or other communication required or permitted hereunder shall be in writing and shall be deemed given (a) when delivered personally, (b) upon confirmation of delivery by email if sent during normal business hours, and otherwise on the next business day, (c) on the next business day after timely delivery to an overnight courier (postage prepaid), or (d) on the third business day after deposit in the United States mail (certified or registered mail return receipt requested, postage prepaid), to the addresses of the Parties set forth in the first paragraph of this Agreement, and in the case of correspondence to AgenTus, with a copy to “Legal Department” at the same address.   Either Party may change its designated address by notice to the other Party in the manner provided in this Section 7.5.

7.6 Entire Agreement; Amendment .  This Agreement constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes any and all prior or contemporaneous oral and prior written agreements and understandings.  This Agreement may be modified, amended, or supplemented only by means of a written instrument signed by both Parties.  Any waiver of any rights or failure to act in a specific instance shall relate only to such instance and shall not be construed as an agreement to waive any rights or fail to act in any other instance, whether or not similar.

7.7 Governing Law .  This Agreement has been drafted in the English Language and the English language shall govern its interpretation.  This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware irrespective of any conflict of laws principles.

7.8 Severability .  In the event that any provision of this Agreement shall, for any reason, be held to be invalid or unenforceable in any respect, such invalidity or unenforceability shall not affect any other provision hereof, and this Agreement shall be construed as if such invalid or unenforceable provision had not been included herein.  If any provision hereof shall, for any reason, be held by a court to be excessively broad as to duration, geographical scope, activity, or subject matter, it shall be construed by limiting and reducing it to make it enforceable to the extent compatible with applicable law as then in effect.  To the extent this Agreement may be construed in accordance with the laws of any state that limits the assignability to AgenTus of certain Developments, the provisions of this Agreement shall be modified to conform to such

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state limitation while most closely effectuating the original intention of the Parties (e.g., by providing for fully paid up license rights, or the like) .

7.9 Equitable Relief .  Consultant acknowledges that the restrictions contained in this Agreement are necessary for the protection of the business and goodwill of AgenTus and are reasonable for such purpose.  Consultant agrees that any breach or threatened breach of his or her obligations under this Agreement will cause irreparable harm to AgenTus.  Therefore, in addition to any other remedies that may be available to AgenTus, AgenTus may apply for and obtain immediate injunctive relief in any court of competent jurisdiction to restrain the breach or threatened breach of, or otherwise to specifically enforce, any obligations of Consultant under this Agreement.

7.10 Massachusetts Information Security Regulations Compliance . Massachusetts Information Security Regulations, 201 Code of Mass. Regs. 17.00 et seq. (the “ IS Regulations ”) mandate procedures to safeguard the “Personal Information,” as defined in the IS Regulations, of Massachusetts residents. Because Consultant may have access to the Personal Information of AgenTus’ employees, contractors, business associates, or customers who are Massachusetts residents (“ Protected Information ”), the IS Regulations require Consultant to certify compliance with the IS Regulations. Accordingly, Consultant agrees that, as long as Consultant has access to or maintains copies of Protected Information Consultant will: (a) comply with the IS Regulations with respect to the Protected Information, (b) promptly notify AgenTus of any suspected or actual data breach involving Protected Information, and (c) cooperate with AgenTus to investigate and remediate any suspected or actual data breach involving Protected Information.

7.11 Whistleblower Notice .  Pursuant to 18 USC § 1833(b), an individual may not be held criminally or civilly liable under any federal or state trade secret law for disclosure of a trade secret: (i) made in confidence to a government official, either directly or indirectly, or to an attorney, solely for the purpose of reporting or investigating a suspected violation of law; and/or (ii) in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal.  Accordingly, the Parties to this Agreement have the right to disclose in confidence trade secrets to Federal, State, and local government officials, or to an attorney, for the sole purpose of reporting or investigating a suspected violation of law. The Parties also have the right to disclose trade secrets in a document filed in a lawsuit or other proceeding, but only if the filing is made under seal and protected from public disclosure.

 

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IN WITNESS WHEREOF, the Parties each have caused this Agreement to be executed by their duly respective authorized representative as of the Effective Date.

 

AGENTUS THERAPEUTICS, INC.

CONSULTANT

 

/s/ Bruno Lucidi _________                                         /s/ Robert B. Stein          

Name: Bruno Lucidi

Name: Robert B. Stein

Title:   CEO

 

          

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Attachment 1

Consulting Services

THE UNDERSIGNED HEREBY ACKNOWLEDGE AND AGREE THAT THIS ATTACHMENT IS INCORPORATED BY REFERENCE INTO, AND SUBJECT TO THE PROVISIONS OF, THAT CERTAIN CONSULTING AGREEMENT BETWEEN THE PARTIES DATED AS OF THE DATE HEREOF (THE “AGREEMENT”).

Description of Services

During the Term of the Agreement, Consultant shall provide up to twenty (20) hours of scientific guidance and advisory services to AgenTus Therapeutics, Inc. per week (“ AgenTus ”).

For the avoidance of doubt, general consulting Services specifically excludes any Services provided pursuant to any other Attachment.

Compensation

In exchange for the timely completion of Services during the Term, AgenTus shall pay Consultant $10,416.67 per month.

Payment of Compensation shall be made within 15 days following the end of each month.  In accordance with Section 2.2 (Reimbursement of Expenses) of the Agreement, AgenTus agrees to reimburse Consultant for pre-approved, reasonable and necessary out-of-pocket expenses incurred by Consultant in performance of the Services.

AGENTUS THERAPEUTICS, INC.

CONSULTANT

                                                                    

/s/ Bruno Lucidi _____________ /s/ Robert B. Stein ________

Name: Bruno Lucidi

Name: Robert B. Stein

Title:  CEO

 

 

 

   

Exhibit 10.3

 

CONSULTING AGREEMENT

This Consulting Agreement (the “ Agreement ”), effective as of July 12, 2018 (the “ Effective Date ”), is made by and between Agenus Inc., a Delaware corporation having an address at 3 Forbes Road, Lexington, MA 02421 (“ Agenus ”), and Karen H. Valentine, an individual having an address at 15 Sarah Way, Concord, MA 01742 (the “ Consultant ”) (each a “ Party ” and collectively the “ Parties ”).

WHEREAS, Consultant and Agenus are parties to an Employment Agreement originally dated as of September 16, 2008, as amended (the “Employment Agreement”), and Consultant voluntarily ended her employment with Agenus effective as of the Effective Date; and

WHEREAS, Agenus desires to retain Consultant’s services following the termination of Consultant’s employment with Agenus, and Consultant desires to perform certain services for Agenus.

NOW, THEREFORE, in consideration of the mutual covenants and promises contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Agenus and Consultant hereby agree as follows:

1. Services .

1.1 Description of Services . Subject to the terms and conditions of this Agreement, Agenus hereby retains Consultant to provide up to 8 hours per month of general advice, counsel, and mentoring to facilitate legal department transition activities as may be requested by Agenus’ General Counsel (or his designees) from time to time (the “ Services ”).  Consultant shall perform the Services in compliance with the provisions of this Agreement and all applicable laws, rules and regulations.  As used in this Agreement “Affiliate” means any corporation, firm, partnership or other entity, which controls, is controlled by or is under common control with a Party.  As used in this Agreement, “control” means direct or indirect ownership of fifty percent (50%) or more of the outstanding stock or other voting rights entitled to elect directors thereof or the ability to otherwise control the management of the corporation, firm, partnership or other entity.

1.2 Third Party Obligations .  Consultant represents and warrants to Agenus that none of her current obligations conflict with this Agreement or the Services to be provided hereunder.  Consultant covenants not to enter into any such conflicting agreement or incur any such conflicting obligation without the prior written consent of Agenus.  Consultant further covenants that the performance of the Services will not breach any agreement or obligation with any third party, including without limitation any obligation to refrain from engaging in activities that may compete with such party.  For the avoidance of doubt, Consultant shall be entitled to serve on one or more boards of directors of other companies in the same industry as the Company (including without limitation other immuno-oncology companies) without being in violation of this Section 1.2; provided, however, that Consultant shall not share or otherwise use (directly or indirectly) any Confidential Information (as defined below) in any such role.

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1.3 No Disparagement .   Consultant agrees that during the T erm and thereafter, Consultant shall not disparage Agenus or any of its Affiliates, or their respective directors, officers, employees, consultants, or agents, or otherwise make any statement or take any actions that would be materially harmful to the business, interests or reputation of Agenus or any of its Affiliates, or their respective directors, officers, employees, consultants, or agents.

2. Compensation .

2.1 Compensation.   In exchange for the timely completion of Services during the Term (as defined below), Agenus shall pay Consultant a retainer of $1,500.00 per month, and Consultant shall be entitled to continuation of vesting during the Term with respect to all equity incentive awards held by Consultant.  Unless otherwise agreed between the Parties, no other compensation will be paid for the performance of Services by Consultant under this Agreement. All payments shall be made to Consultant within fifteen (15) days after the last day of each calendar month during the Term without the need for an invoice.

2.2 Reimbursement of Expenses .  Agenus shall reimburse Consultant for all reasonable travel and other out-of-pocket expenses that are incurred by Consultant in performance of the Services and in accordance with Agenus’s reimbursement policies, as they may be amended from time to time by Agenus, provided that Consultant shall have submitted to Agenus written expense statements and other supporting documentation in a form that is reasonably satisfactory to Agenus. Agenus shall provide Consultant with a check for any amounts due under this Section 2.2 within forty-five (45) days after Agenus receives satisfactory documentation.

2.3 Independent Contractor .  Consultant is an independent contractor of Agenus and Consultant acknowledges and agrees that Agenus will not provide Consultant with any employment benefits.  Consultant is also responsible for the payment and the withholding of any applicable taxes, levies and/or duties applicable to any compensation or reimbursements paid to Consultant hereunder in accordance with all applicable laws, rules and regulations.

3. Term and Termination .

3.1 Term .  This Agreement shall commence on the Effective Date and shall remain in effect for a period of one (1) year, unless extended by mutual written agreement of the Parties, or earlier terminated in accordance with the provisions of this Article 3.

3.2 Termination for Material Breach .  In the event that either Party commits a material breach of its obligations under this Agreement, the other Party may terminate this Agreement upon fifteen (15) days prior written notice, unless the breach is cured within such fifteen (15) day notice period.

3.3 Survival .  The following provisions shall survive the expiration or termination of this Agreement: Articles 4, 5 and 6; Sections 1.3, 7.3 through 7.10, and this Section 3.3.

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4. Confidential Information .

4.1 Definition of Confidential Information .  Confidential Information shall mean any technical or business information furnished by or on behalf of Agenus to Consultant in connection with this Agreement or developed by Consultant in the course of performing the Services, regardless of whether such Confidential Information is in oral, electronic or written form.  Such Confidential Information may include, without limitation, trade secrets, know-how, inventions, technical data or specifications, testing methods, business or financial information, research and development activities, product and marketing plans, and customer and supplier information.

4.2 Obligations .  Consultant shall

(a) maintain all Confidential Information in strict confidence; and

(b) use all Confidential Information solely for the purpose of providing the Services as requested by Agenus; and

(c) reproduce the Confidential Information only to the extent necessary for providing the Services as requested by Agenus, with all such reproductions being considered Confidential Information;

(d) disclose the Confidential Information only as expressly permitted in order to perform the Services; and

(e) not disclose or publish any Confidential Information to any third party without the express prior written consent of Agenus, in each case in Agenus’s sole discretion.

4.3 Exceptions .  The obligations of Consultant under Section 4.2 shall not apply to the extent that Consultant can demonstrate that certain information:

(a) was in the public domain prior to the time of its disclosure or development under this Agreement;

(b) entered the public domain after the time of its disclosure or development under this Agreement other than due to an act or omission by Consultant;

(c) was independently developed by Consultant prior to the time of its disclosure or development under this Agreement and without access to Confidential Information; or

(d) is or was disclosed to Consultant at any time prior to its disclosure or development under this Agreement, without restriction, by a third party having no fiduciary relationship with Agenus and having no obligation of confidentiality with respect to such Confidential Information.

4.4 Required Disclosures .  In addition Consultant may disclose Confidential Information to the extent necessary to comply with applicable laws or regulations, or with a court

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or administrative order, provided that Consultant (i) gives Agenus prompt written notice of such requirement, (ii) takes all reasonable and lawful actions to obtain confidential treatment for such disclosure and, if possible, to minimize the extent of such disclosure , and (iii) discloses only the Confidential Information strictly required to comply with such legal obligation .

4.5 Return of Confidential Information; Survival of Obligations .  Upon the termination of this Agreement, or earlier at the request of Agenus, Consultant shall return to Agenus all originals, copies, and summaries of documents, materials, and other tangible manifestations of Confidential Information in the possession or control of Consultant.  The obligations set forth in this Article 4 shall remain in effect for a period of five (5) years after termination of this Agreement, except that the obligations of Consultant to return Confidential Information shall survive until fulfilled.  Consultant acknowledges and agrees that the Confidential Information is of extreme value to Agenus, and any use or disclosure thereof other than as expressly allowed under this Agreement would cause irreparable harm to Agenus for which Agenus could obtain relief as contemplated in Section 7.9 of this Agreement, and that such unauthorized disclosure may represent Consultant’s violation of U.S. securities laws.

5. Developments; Third Party IP; Avoidance of Claims .

5.1 Developments .  “ Developments ” shall mean any and all inventions, developments, data, discoveries, improvements, ideas, or concepts, and related documentation, and any other works of invention or authorship (whether or not patentable or copyrightable) which Consultant has conceived, discovered, developed, or reduced to practice or tangible medium in the direct course of providing the Services, or which arise from access to and/or use of Confidential Information, and any and all intellectual property rights in any of the foregoing.  Consultant shall promptly disclose to Agenus any and all Developments.  Consultant acknowledges and agrees that all Confidential Information and Developments is and shall remain the exclusive property of Agenus or the third party entrusting any Confidential Information to Agenus.  Consultant shall and hereby assigns, conveys, and grants to Agenus, all of her right, title, and interest in and to any and all Developments.  

5.2 Third-Party Intellectual Property .  Consultant acknowledges that Agenus does not desire to acquire any trade secrets, know-how, confidential information, or other intellectual property that Consultant may have acquired from or developed for any third party (“ Third-Party IP ”).  Consultant agrees that in the course of providing the Services, Consultant shall not improperly use or disclose any Third-Party IP.

5.3 Avoidance of Claims by Third-Parties .  Unless covered by an appropriate agreement between any third party and Agenus, Consultant shall not engage in any activities or use any facilities, funds or equipment, in the course of providing Services, which could result in claims of ownership to any Developments by such third party.

6. U.S. Foreign Corrupt Practices Act Compliance .  Consultant understands that Agenus is an issuer of securities in the United States and is subject to the provisions of the U. S. Foreign Corrupt Practices Act, 15 U.S.C. §§ 78m, 78dd-1 through 78dd-3 (“ FCPA ”).  This law prohibits making, promising or offering to make corrupt payments to foreign officials, political parties or candidates, or making payments to other persons who will offer or make payments to any of the

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aforementioned parties in order to obtain business, retain business or gain an improper advantage.  Consultant represents and warrants to Agenus that Consultant is familiar with and understands the FCPA, and Consultant further represents and warrants to Agenus that throughout the period in which Consultant provides Services to Agenus, neither Consultant, nor any person performing Services on behalf of Consultant will engage in any activity that could cause a violation of any provision of the FCPA by Agenus .

7. Miscellaneous .

7.1 Counterparts . This Agreement may be executed in counterparts, which, when taken together, shall constitute one agreement. If any signature is delivered by facsimile transmission or by e-mail delivery of a “.pdf” format data file, such signature shall create a valid and binding obligation of the Party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or “.pdf” signature page were an original thereof.

7.2 Assignment .  This Agreement may not be assigned by either Party without the prior written consent of the other Party, except that Agenus may assign this Agreement to an affiliate or in connection with the merger, consolidation, or sale of all or substantially all of its business or assets relating to this Agreement.  This Agreement shall inure to the benefit of and be binding upon the Parties and their respective lawful successors, assigns, heirs, and personal representatives.

7.3 Insider Trading .  Consultant acknowledges that Consultant may receive material, non-public information about Agenus and its business in the course of providing the Services, that this information must be maintained in strict confidence, and that the U.S. securities laws restrict trading on the basis of such information or providing such information to third parties who may trade on such information.

7.4 Publicity .  Consultant consents to use by Agenus of Consultant’s name and likeness in written materials or oral presentations to current or prospective customers, investors or others, provided that such materials or presentations accurately describe the nature of Consultant’s relationship with or contribution to Agenus.

7.5 Notices .   Any notice or other communication required or permitted hereunder shall be in writing and shall be deemed given (a) when delivered personally, (b) upon confirmation of delivery by email if sent during normal business hours, and otherwise on the next business day, (c) on the next business day after timely delivery to an overnight courier (postage prepaid), or (d) on the third business day after deposit in the United States mail (certified or registered mail return receipt requested, postage prepaid), to the addresses of the Parties set forth in the first paragraph of this Agreement, and in the case of correspondence to Agenus, with a copy to “Legal Department” at the same address.   Either Party may change its designated address by notice to the other Party in the manner provided in this Section 7.5.

7.6 Entire Agreement; Amendment .  This Agreement constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes any and all prior or contemporaneous oral and prior written agreements and understandings, with the exception of

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the Employment Agreement (to the extent the provisions thereof survive its termination ) .    I n the event of a discrepancy between this Agreement and the surviving provisions of the Employment Agreement, the Employment Agreement shall govern.   This Agreement may be modified, amended, or supplemented only by means of a written instrument signed by both Parties.  Any waiver of any rights or failure to act in a specific instance shall relate only to such instance and shall not be construed as an agreement to waive any rights or fail to act in any other instance, whether or not similar.

7.7 Governing Law .  This Agreement has been drafted in the English Language and the English language shall govern its interpretation.  This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts irrespective of any conflict of laws principles.

7.8 Severability .  In the event that any provision of this Agreement shall, for any reason, be held to be invalid or unenforceable in any respect, such invalidity or unenforceability shall not affect any other provision hereof, and this Agreement shall be construed as if such invalid or unenforceable provision had not been included herein.  If any provision hereof shall, for any reason, be held by a court to be excessively broad as to duration, geographical scope, activity, or subject matter, it shall be construed by limiting and reducing it to make it enforceable to the extent compatible with applicable law as then in effect.  To the extent this Agreement may be construed in accordance with the laws of any state that limits the assignability to Agenus of certain Developments, the provisions of this Agreement shall be modified to conform to such state limitation while most closely effectuating the original intention of the Parties (e.g., by providing for fully paid up license rights, or the like).

7.9 Equitable Relief .  Consultant acknowledges that the restrictions contained in this Agreement are necessary for the protection of the business and goodwill of Agenus and are reasonable for such purpose.  Consultant agrees that any breach or threatened breach of her obligations under this Agreement will cause irreparable harm to Agenus.  Therefore, in addition to any other remedies that may be available to Agenus, Agenus may apply for and obtain immediate injunctive relief in any court of competent jurisdiction to restrain the breach or threatened breach of, or otherwise to specifically enforce, any obligations of Consultant under this Agreement.

7.10 Massachusetts Information Security Regulations Compliance . Massachusetts Information Security Regulations, 201 Code of Mass. Regs. 17.00 et seq. (the “ IS Regulations ”) mandate procedures to safeguard the “Personal Information,” as defined in the IS Regulations, of Massachusetts residents. Because Consultant may have access to the Personal Information of Agenus’s employees, contractors, business associates, or customers who are Massachusetts residents (“ Protected Information ”), the IS Regulations require Consultant to certify compliance with the IS Regulations. Accordingly, Consultant agrees that, as long as Consultant has access to or maintains copies of Protected Information Consultant will: (a) comply with the IS Regulations with respect to the Protected Information, (b) promptly notify Agenus of any suspected or actual data breach involving Protected Information, and (c) cooperate with Agenus to investigate and remediate any suspected or actual data breach involving Protected Information.

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7.11 Whistleblower Notice .  Pursuant to 18 USC § 1833(b), an individual may not be held criminally or civilly liable under any federal or state trade secret law for disclosure of a trade secret: (i) made in confidence to a government official, either directly or indirectly, or to an attorney, solely for the purpose of reporting or investigating a suspected violation of law; and/or (ii) in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal.  Accordingly, the Parties to this Agreement have the right to disclose in confidence trade secrets to Federal, State, and local government officials, or to an attorney, for the sole purpose of reporting or investigating a suspected violation of law. The Parties also have the right to disclose trade secrets in a document filed in a lawsuit or other proceeding, but only if the filing is made under seal and protected from public disclosure.

IN WITNESS WHEREOF, the Parties each have caused this Agreement to be executed by their duly respective authorized representative as of the Effective Date.

 

AGENUS INC.

CONSULTANT

 

/s/Garo H. Armen /s/Karen H. Valentine

Name: Garo H. Armen

Karen H. Valentine

Title:   Chairman and CEO

 

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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:   November 7, 2018

 

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

 

 

 

Garo H. Armen, Ph.D.

 

 

 

Chief Executive Officer and Principal Executive Officer

 

 

 

Exhibit 31.2

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

I, Christian Cortis, 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:   November 7, 2018

 

/s/ CHRISTIAN CORTIS, PH.D.   

 

 

 

Christian Cortis, Ph.D.

 

 

 

Chief Strategy Officer and Head of Finance,

 

 

 

Principal Financial Officer

 

 

 

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 September 30, 2018 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/ CHRISTIAN CORTIS, PH.D.

 

Christian Cortis, Ph.D.

 

Chief Strategy Officer and Head of Finance,

 

Principal Financial Officer

Date: November 7, 2018

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.