UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

x

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

For the quarterly period ended June 30, 2016

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 001-36150

 

SORRENTO THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

 

Delaware

 

33-0344842

(State or Other Jurisdiction of

Incorporation or Organization)

 

(I.R.S. Employer

Identification Number)

9380 Judicial Drive,

San Diego, California 92121

(Address of Principal Executive Offices)

(858) 210-3700

(Registrant’s Telephone Number, Including Area Code)

 

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   x     No   ¨ .

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).    Yes   x     No   ¨

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

 

Large accelerated filer

 

¨

  

Accelerated filer

 

x

 

 

 

 

Non-accelerated filer

 

¨   (Do not check if a smaller reporting company)

  

Smaller reporting company

 

¨

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

The number of shares of the issuer’s common stock, par value $0.0001 per share, outstanding as of August 2, 2016 was 57,570,468.

 

 

 

 

 


 

Sorrento Therapeutics, Inc.

Index to Consolidated Financial Statements

 

Part I

 

Financial Information

 

1

Item 1.

 

Consolidated Financial Statements

  

1

 

 

Consolidated Balance Sheets as of June 30, 2016 (Unaudited) and December 31, 2015 (Audited)

  

1

 

 

Unaudited Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2016 and 2015

  

2

 

 

Unaudited Consolidated Statements of Comprehensive Income (Loss) for the Three and Six Months Ended June 30, 2016 and 2015

 

3

 

 

Unaudited Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2016 and 2015

  

4

 

 

Notes to Unaudited Consolidated Financial Statements

  

5

Item 2.

 

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

  

28

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

  

35

Item 4.

 

Controls and Procedures

  

36

 

 

 

Part II

 

Other Information

 

37

Item 1.

 

Legal Proceedings

  

37

Item 1A.

 

Risk Factors

  

37

Item 6.

 

Exhibits

  

37

Signatures

  

38

 

 

 

 


 

P ART I. FINANCIAL INFORMATION

 

I tem 1.

Consolidated Financial Statements.

SORRENTO THERAPEUTICS, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except for share amounts)

 

 

 

June 30,

 

 

December 31,

 

 

 

2016

 

 

2015

 

 

 

(Unaudited)

 

 

(Audited)

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

98,179

 

 

$

39,038

 

Marketable securities

 

 

34,946

 

 

 

97,366

 

Grants and accounts receivables, net

 

 

867

 

 

 

903

 

Income tax receivable

 

 

1,715

 

 

 

1,715

 

Notes receivable

 

 

10,000

 

 

 

 

Prepaid expenses and other, net

 

 

556

 

 

 

1,996

 

Total current assets

 

 

146,263

 

 

 

141,018

 

Property and equipment, net

 

 

9,203

 

 

 

7,246

 

Intangibles, net

 

 

3,690

 

 

 

3,912

 

Goodwill

 

 

20,626

 

 

 

20,626

 

Investments in common stock

 

 

112,008

 

 

 

112,008

 

Equity method investments

 

 

59,090

 

 

 

58,119

 

Other, net

 

 

524

 

 

 

590

 

Total assets

 

$

351,404

 

 

$

343,519

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

4,423

 

 

$

1,339

 

Accrued payroll and related

 

 

1,491

 

 

 

2,361

 

Current portion of deferred compensation

 

 

944

 

 

 

891

 

Accrued expenses

 

 

37,102

 

 

 

3,927

 

Acquisition consideration payable

 

 

12,000

 

 

 

12,000

 

Derivative liability

 

 

 

 

 

5,520

 

Current portion of debt

 

 

5,067

 

 

 

4,835

 

Total current liabilities

 

 

61,027

 

 

 

30,873

 

Long-term debt

 

 

1,801

 

 

 

4,394

 

Deferred compensation

 

 

12

 

 

 

12

 

Deferred tax liabilities

 

 

35,047

 

 

 

49,341

 

Deferred revenue

 

 

110,875

 

 

 

110,900

 

Deferred rent and other

 

 

7,414

 

 

 

7,061

 

Total liabilities

 

 

216,176

 

 

 

202,581

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Equity:

 

 

 

 

 

 

 

 

Sorrento Therapeutics, Inc. equity

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 100,000,000 shares authorized and no shares

   issued or outstanding

 

 

 

 

 

 

Common stock, $0.0001 par value; 750,000,000 shares authorized and

   65,448,566 and 37,771,459 shares issued and outstanding at

   June 30, 2016 and December 31, 2015, respectively

 

 

7

 

 

 

4

 

Additional paid-in capital

 

 

336,952

 

 

 

184,898

 

Accumulated other comprehensive income

 

 

25,454

 

 

 

73,579

 

Stock subscription receivable

 

 

(43,502

)

 

 

 

Accumulated deficit

 

 

(176,668

)

 

 

(113,329

)

Total Sorrento Therapeutics, Inc. stockholders' equity

 

 

142,243

 

 

 

145,152

 

Noncontrolling interests

 

 

(7,015

)

 

 

(4,214

)

Total equity

 

 

135,228

 

 

 

140,938

 

Total liabilities and equity

 

$

351,404

 

 

$

343,519

 

 

See accompanying unaudited notes

1


 

SORRENTO THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except per share amounts)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant

 

$

328

 

 

$

459

 

 

$

757

 

 

$

697

 

Sales and services

 

 

574

 

 

 

714

 

 

 

1,133

 

 

 

1,453

 

Total revenues

 

 

902

 

 

 

1,173

 

 

 

1,890

 

 

 

2,150

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs of revenues

 

 

295

 

 

 

314

 

 

 

654

 

 

 

823

 

Research and development

 

 

10,631

 

 

 

7,971

 

 

 

18,408

 

 

 

15,811

 

Acquired in-process research and development

 

 

32,000

 

 

 

 

 

 

45,000

 

 

 

 

General and administrative

 

 

4,220

 

 

 

3,072

 

 

 

8,715

 

 

 

5,291

 

Intangible amortization

 

 

111

 

 

 

349

 

 

 

222

 

 

 

935

 

Total costs and operating expenses

 

 

47,257

 

 

 

11,706

 

 

 

72,999

 

 

 

22,860

 

Loss from operations

 

 

(46,355

)

 

 

(10,533

)

 

 

(71,109

)

 

 

(20,710

)

Gain on expiration of derivative liability

 

 

 

 

 

 

 

 

5,520

 

 

 

 

Income (loss) on equity investments

 

 

470

 

 

 

 

 

 

(29

)

 

 

 

Interest expense

 

 

(273

)

 

 

(442

)

 

 

(580

)

 

 

(881

)

Interest income

 

 

45

 

 

 

 

 

 

58

 

 

 

 

Income (loss) before income tax

 

 

(46,113

)

 

 

(10,975

)

 

 

(66,140

)

 

 

(21,591

)

Income tax benefit

 

 

 

 

 

(17

)

 

 

 

 

 

(195

)

Net loss

 

 

(46,113

)

 

 

(10,958

)

 

 

(66,140

)

 

 

(21,396

)

Net loss attributable to noncontrolling interests

 

 

(1,164

)

 

 

 

 

 

(2,801

)

 

 

 

Net loss attributable to Sorrento

 

$

(44,949

)

 

$

(10,958

)

 

$

(63,339

)

 

$

(21,396

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share - basic and diluted per share attributable

   to Sorrento

 

$

(0.97

)

 

$

(0.30

)

 

$

(1.50

)

 

$

(0.59

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares used during period - basic

  and diluted per share attributable to Sorrento

 

 

46,498

 

 

 

36,315

 

 

 

42,228

 

 

 

36,261

 

 

See accompanying unaudited notes

2


 

SORRENTO THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(Unaudited)

(In thousands)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss attributable to Sorrento

 

$

(44,949

)

 

$

(10,958

)

 

$

(63,339

)

 

$

(21,396

)

Other comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Unrealized loss on marketable securities, net of tax

 

 

(11,236

)

 

 

 

 

 

(48,125

)

 

 

 

Total other comprehensive income

 

 

(11,236

)

 

 

 

 

 

(48,125

)

 

 

 

Comprehensive income (loss) attributable to Sorrento

 

 

(56,185

)

 

 

(10,958

)

 

 

(111,464

)

 

 

(21,396

)

Comprehensive income (loss) attributable to

   noncontrolling interests

 

 

 

 

 

 

 

 

 

 

 

 

Comprehensive income (loss)

 

$

(56,185

)

 

$

(10,958

)

 

$

(111,464

)

 

$

(21,396

)

 

See accompanying unaudited notes

3


 

SORRENTO THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In thousands)

 

 

 

 

 

 

 

Six Months Ended June 30,

 

 

 

2016

 

 

2015

 

Operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(66,140

)

 

$

(21,396

)

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

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

1,101

 

 

 

1,427

 

Non-cash interest expense

 

 

123

 

 

 

202

 

Stock-based compensation

 

 

2,391

 

 

 

2,830

 

Acquired in-process research and development

 

 

30,000

 

 

 

 

Provision for doubtful accounts

 

 

29

 

 

 

4

 

Gain on expiration of derivative liability

 

 

(5,520

)

 

 

 

Loss on equity investments

 

 

29

 

 

 

 

Deferred tax provision

 

 

 

 

 

(199

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Grants and other receivables

 

 

7

 

 

 

(170

)

Prepaid expenses and other

 

 

478

 

 

 

(242

)

Accounts payable

 

 

3,084

 

 

 

321

 

Deferred revenue

 

 

(25

)

 

 

 

Accrued expenses and other liabilities

 

 

2,081

 

 

 

9,671

 

Net cash used for operating activities

 

 

(32,362

)

 

 

(7,552

)

Investing activities

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(2,230

)

 

 

(500

)

Investments in common stock

 

 

 

 

 

(11,500

)

Net cash used in investing activities

 

 

(2,230

)

 

 

(12,000

)

Financing activities

 

 

 

 

 

 

 

 

Net principal payments under loan and security agreement

 

 

(2,431

)

 

 

(758

)

Net payments of deferred compensation

 

 

 

 

 

(1,000

)

Proceeds from issuance of common stock, net of issuance costs

 

 

95,751

 

 

 

 

Proceeds from exercise of stock options

 

 

413

 

 

 

1,107

 

Net cash provided by (used in) financing activities

 

 

93,733

 

 

 

(651

)

Net change in cash and cash equivalents

 

 

59,141

 

 

 

(20,203

)

Cash and cash equivalents at beginning of period

 

 

39,038

 

 

 

71,902

 

Cash and cash equivalents at end of period

 

$

98,179

 

 

$

51,699

 

Supplemental disclosures:

 

 

 

 

 

 

 

 

Cash paid during the period for:

 

 

 

 

 

 

 

 

Income taxes

 

$

1

 

 

$

 

Interest paid

 

$

580

 

 

$

 

Supplemental disclosures of non-cash investing and financing activities:

 

 

 

 

 

 

 

 

Change in unrealized gains or (losses) on marketable securities

 

$

(62,420

)

 

$

 

Stock subscription receivable and note receivable issued

 

$

53,502

 

 

$

 

Property and equipment costs incurred but not paid

 

$

578

 

 

$

497

 

 

See accompanying unaudited notes

 

 

4


 

SORRENTO THERAPEUTICS, INC.

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2016

 

 

1. Nature of Operations and Business Activities

Nature of Operations and Basis of Presentation

Sorrento Therapeutics, Inc. (NASDAQ: SRNE), together with its subsidiaries (collectively, the “Company”) is a biopharmaceutical company focused on the discovery, acquisition, development and commercialization of proprietary drug therapeutics for addressing significant unmet medical needs worldwide. The Company’s primary therapeutic focus is oncology, including the treatment of chronic cancer pain, but is also developing therapeutic products for other indications, including immunology and infectious diseases. The Company currently has multiple clinical development programs underway: (i) Chimeric Antigen Receptor-T Cell (“CAR-T”) programs for solid tumors, (ii) resiniferatoxin, or RTX, a non-opiate, ultra-potent and selective agonist of the TRPV-1 receptor for intractable pain in end-stage disease, and (iii) its clinical development programs for its biosimilar/biobetter antibodies.

The Company’s pipeline also includes preclinical fully human therapeutic monoclonal antibodies (mAbs), including its biosimilars/biobetters, its fully human anti-PD-L1 and anti-PD-1 checkpoint inhibitors derived from its proprietary G-MAB ® library platform, antibody drug conjugates (ADCs), bispecific antibodies (BsAbs), as well as Chimeric Antigen Receptor-T Cell (CAR-T) and Chimeric Antigen Receptor Natural Killer (NK) cells (CAR.NK™) for adoptive cellular immunotherapy. The Company’s objective is to develop its antibody drug products and adoptive cellular immunotherapies as: (i) First in Class (FIC), and/or (ii) Best in Class (BIC), which may offer greater efficacy and/or fewer adverse events or side effects as compared to existing drugs, as well as fully human therapeutic antibodies derived from its proprietary G-MAB ® antibody platform and ADCs.  

Through June 30, 2016, the Company had devoted substantially all of its efforts to research and product development, raising capital and building infrastructure, and had not realized revenues from its planned principal operations.

The accompanying interim consolidated financial statements have been prepared by the Company, without audit, in accordance with the instructions to Form 10-Q and, therefore, do not necessarily include all information and footnotes necessary for a fair statement of its financial position, results of operations and cash flows in accordance with United States generally accepted accounting principles (GAAP). The accompanying consolidated financial statements include the accounts of the Company’s wholly-owned subsidiaries and those of a variable interest entity where the Company is the primary beneficiary. For consolidated entities where the Company owns or are exposed to less than 100% of the economics, the Company records net income (loss) attributable to noncontrolling interests in its consolidated statements of operations equal to the percentage of the economic or ownership interest retained in such entities by the respective noncontrolling parties.  Sorrento Therapeutics, Inc. Hong Kong Limited had no operating activity through June 2016.  All intercompany balances and transactions have been eliminated in consolidation.

In determining whether the Company is the primary beneficiary of an entity, the Company applies a qualitative approach that determines whether it has both (i) the power to direct the economically significant activities of the entity and (ii) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. These considerations impact the way the Company accounts for its existing collaborative relationships and other arrangements. The Company continuously assesses whether it is the primary beneficiary of a variable interest entity as changes to existing relationships or future transactions may result in the Company consolidating or deconsolidating one or more of its collaborators or partners.

The balance sheet at December 31, 2015 is derived from the audited consolidated financial statements at that date which are not presented herein.

In the opinion of management, the unaudited financial information for the interim periods presented reflects all adjustments, which are only normal and recurring, necessary for a fair statement of financial position, results of operations and cash flows. These consolidated financial statements should be read in conjunction with the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015. Operating results for interim periods are not expected to be indicative of operating results for the Company’s 2016 fiscal year.    

Liquidity

The Company anticipates that it will continue to incur net losses in the foreseeable future as it (i) advances clinical stage product candidates such as biosimilar/biobetter antibodies, CAR-T programs and RTX in the clinic and potentially pursues other development, (ii) continues to identify a number of potential mAb and ADC drug candidates and further advances various preclinical and

5


 

development activities, (iii) advances its product candidates into the clinic, (iv) invests in additional joint ventures or third party collaboration or acquisition agreements, and (v) expands corporate infrastructure, including the costs associated with being a NASDAQ listed public company. Based on currently available resources, the Company believes it has the ability to meet all obligations due over the course of the next twelve months.

On April 3, 2016, the Company entered into a Securities Purchase Agreement (the “ABG Purchase Agreement”) with ABG SRNE Limited and Ally Bridge LB Healthcare Master Fund Limited (collectively, “Ally Bridge”), pursuant to which, among other things, the Company agreed to issue and sell to Ally Bridge and other purchasers that may be designated by Ally Bridge (collectively, the “ABG Purchasers”), in a private placement transaction (the “ABG Private Placement”), up to $50.0 million in shares of common stock of the Company (“Common Stock”) and warrants to purchase shares of Common Stock. Upon the closing of the ABG Private Placement, the Company will issue to each ABG Purchaser (1) such number of shares (the “ABG Shares”) of Common Stock as is equal to the amount of such ABG Purchaser’s investment divided by $5.55, and (2) a warrant to purchase such number of shares of Common Stock as is equal to 30% of the ABG Shares sold and issued to such ABG Purchaser (each, an “ABG Warrant”); provided that , following the consummation of the ABG Private Placement, Ally Bridge and its affiliates will not beneficially own more than 9.99% of the outstanding shares of Common Stock. Each ABG Warrant will have an exercise price of $8.50 per share, will be immediately exercisable upon issuance, will have a term of three years and will be exercisable on a cash or cashless exercise basis.

Under the terms of the ABG Purchase Agreement, the Company is obligated to prepare and file with the Securities and Exchange Commission (the “SEC”), within 30 days of the closing date of the ABG Private Placement, a registration statement to register for resale the ABG Shares and the shares of Common Stock issuable upon exercise of each ABG Warrant (the “ABG Warrant Shares”), and may be required to effect certain registrations to register for resale the ABG Shares and the ABG Warrant Shares in connection with certain “piggy-back” registration rights granted to the ABG Purchasers.

On April 3, 2016, the Company also entered into a Securities Purchase Agreement (collectively, the “Additional Purchase Agreements”) with each of Beijing Shijilongxin Investment Co., Ltd. ( “Beijing Shijilongxin”), FREJOY Investment Management Co., Ltd. (“Frejoy”) and Yuhan Corporation (“Yuhan”), pursuant to which, among other things, the Company agreed to issue and sell, in separate private placement transactions: (1) to Beijing Shijilongxin, 8,108,108 shares of Common Stock, and a warrant to purchase 1,176,471 shares of Common Stock, for an aggregate purchase price of $45.0 million; (2) to Frejoy, 8,108,108 shares of Common Stock, and a warrant to purchase 1,176,471 shares of Common Stock, for an aggregate purchase price of $45.0 million; and (3) to Yuhan, 1,801,802 shares of Common Stock, and a warrant to purchase 235,294 shares of Common Stock, for an aggregate purchase price of $10.0 million. The warrants to be issued pursuant to each of the Additional Purchase Agreements (collectively, the “Additional Warrants” and, together with each ABG Warrant, the “Warrants”) will have an exercise price of $8.50 per share, will be immediately exercisable upon issuance, will have a term of three years and will be exercisable on a cash or cashless exercise basis.

Under the terms of the Additional Purchase Agreements, each of Beijing Shijilongxin, Frejoy and Yuhan has the right to demand, at any time beginning six months after the closing of the transactions contemplated by the applicable Additional Purchase Agreement, that the Company prepare and file with the SEC a registration statement to register for resale such investor’s shares of Common Stock purchased pursuant to the applicable Additional Purchase Agreement and the shares of Common Stock issuable upon exercise of such investor’s Additional Warrant. In addition, the Company may be required to effect certain registrations to register for resale such shares in connection with certain “piggy-back” registration rights granted to Beijing Shijilongxin, Frejoy and Yuhan.

On May 2, 2016 the Company announced that it closed its previously announced private placement financing of common stock and warrants with Yuhan Corporation for gross proceeds of $10.0 million.  Yuhan purchased 1,801,802 shares of common stock at $5.55 per share and a warrant to purchase 235,294 shares of common stock.  The warrant is exercisable for three years at an exercise price of $8.50 per share.

On June 8, 2016 the Company announced that is closed on the remainder of the $150.0 million financing. Ally Bridge Group ("ABG"), a global healthcare-focused investment group based in Hong Kong, led the financing and, together with Beijing Shijilongxin Investment Co., Ltd. ("Beijing Shijilongxin"), and FREJOY Investment Management Co., Ltd. ("Frejoy") collectively purchased 25,225,221 shares of common stock at $5.55 per share, and warrants to purchase 5,055,642 shares of common stock for total consideration of $140.0 million.

The Company plans to continue to fund its operating losses and capital funding needs through public or private equity or debt financings, strategic collaborations, licensing arrangements, asset sales, government grants or other arrangements.

6


 

On July 11, 2016 the Company announced a license and co llaboration agreement with Les Laboratoires Servier, SAS, a corporation incorporated under the laws of France, and Institut de Recherches Internationales Servier, a company duly organized and existing under the laws of France (individually and collectively , “Servier”) for the development, manufacture and commercialization of products using Sorrento's fully human immuno-oncology anti-PD-1 monoclonal antibody (mAb) STI-A1110. Pursuant to the financial terms of that agreement the Company received a non-refunda ble up-front payment of $27.4 million in July of 2016.

The Company filed a universal shelf registration statement on Form S-3 with the Securities and Exchange Commission (“SEC”), which was declared effective by the SEC in July 2013 (the “2013 Shelf Registration Statement”). The 2013 Shelf Registration Statement provides the Company the ability to offer up to $100.0 million of securities, including equity and other securities as described in the registration statement. After the May 2014 underwritten offering the Company has the ability to offer up to $36.6 million of additional securities under the 2013 Shelf Registration Statement. In November 2014, the Company filed a universal shelf registration statement on Form S-3 with the SEC, which was declared effective by the SEC in December 2014 (the “2014 Shelf Registration Statement”). The 2014 Shelf Registration Statement provides the Company with the ability to offer up to $250.0 million of securities, including equity and other securities as described in the registration statement. Included in the 2014 Shelf Registration Statement is a sales agreement prospectus covering the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $50.0 million of the Company’s common stock that may be issued and sold under a sales agreement with MLV & Co. LLC (the “ATM Facility”).   During the six months ended June 30, 2016 the Company sold approximately $3.6 million under the ATM Facility.  After the first quarter 2016 sales activities the Company has the ability to offer up to $46.4 million of additional securities under the ATM Facility.  The Company cannot be sure that such additional funds will be available on reasonable terms, or at all. If the Company is unable to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, and future prospects.

Subsequent to June 30, 2016, the Company completed a letter agreement with the Chan Soon-Shiong Family Foundation (“Foundation”) and Cambridge Equities, LP (“Cambridge”) (the “Letter Agreement”). Pursuant to the terms of the Letter Agreement, among other things, (a) the Company agreed to sell to Foundation, and Foundation agreed to purchase from the Company, an aggregate of 5,618,326 shares of common stock of NantKwest, Inc. held by the Company, (b) Foundation agreed to sell to the Company, and the Company agreed to purchase all reported shares held by Foundation and Cambridge, an aggregate of 7,878,098 shares of common stock of the Company (“Common Stock”) held by Foundation and Cambridge, (c) Cambridge agreed to forfeit its right to purchase 500,000 shares of Common Stock issuable pursuant a warrant to purchase 1,724,138 shares of Common Stock held by Cambridge, and (d) the Company agreed to pay to Foundation an aggregate of approximately $15.6 million. The transactions contemplated under the Letter Agreement closed on July 7, 2016. Effective with the close of the transaction in July 2016, the Company will retire the 7,878,098 shares and has the ability to sell these shares for additional funds.

If the Company raises additional funds by issuing equity securities, substantial dilution to existing stockholders would result. If the Company raises additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial covenants that may restrict the Company’s ability to operate its business.

 

2. Significant Accounting Policies

Use of Estimates

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.  On an ongoing basis, the Company evaluates its estimates, including those related to the valuation of warrants, stock-based compensation and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that it believes to be reasonable under the circumstances. Management believes that these estimates are reasonable; however, actual results may differ from these estimates.

Cash and Cash Equivalents

The Company considers all highly liquid investments purchased with original maturities of three months or less to be cash equivalents. The Company minimizes its credit risk associated with cash and cash equivalents by periodically evaluating the credit quality of its primary financial institution. The balance at times may exceed federally insured limits. The Company has not experienced any losses on such accounts.

7


 

Fair Value of Financial Instruments

The Company follows accounting guidance on fair value measurements for financial instruments measured on a recurring basis, as well as for certain assets and liabilities that are initially recorded at their estimated fair values. Fair value is defined as the exit price, or the amount that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company uses the following three-level hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs to value its financial instruments:

 

·

Level 1: Observable inputs such as unadjusted quoted prices in active markets for identical instruments.

 

·

Level 2: Quoted prices for similar instruments that are directly or indirectly observable in the marketplace.

 

·

Level 3: Significant unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.

Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires it to make judgments and consider factors specific to the asset or liability. The use of different assumptions and/or estimation methodologies may have a material effect on estimated fair values. Accordingly, the fair value estimates disclosed or initial amounts recorded may not be indicative of the amount that the Company or holders of the instruments could realize in a current market exchange.

The carrying amounts of cash equivalents and marketable securities approximate their fair value based upon quoted market prices. Certain of our financial instruments are not measured at fair value on a recurring basis, but are recorded at amounts that approximate their fair value due to their liquid or short-term nature, such as cash, accounts receivable and payable, and other financial instruments in current assets or current liabilities.

Marketable Securities

Marketable securities are designated as available-for-sale securities and are accounted for at fair value. Marketable securities are classified as short-term or long-term based on the nature of the securities and their availability to meet current operating requirements. Marketable securities that are readily available for use in current operations are classified as short-term available-for-sale securities and are reported as a component of current assets in the accompanying consolidated balance sheets. Marketable securities that are not considered available for use in current operations are classified as long-term available-for-sale securities and are reported as a component of long-term assets in the accompanying consolidated balance sheets.

Securities that are classified as available-for-sale are carried at fair value, with temporary unrealized gains and losses reported as a component of stockholders' equity until their disposition. The cost of securities sold is based on the specific identification method.

All of the Company’s marketable securities are subject to a periodic impairment review. The Company recognizes an impairment charge when a decline in the fair value of its investments below the cost basis is judged to be other-than-temporary.  For the three and six months ended June 30, 2016, no other-than-temporary impairment charges were recorded.

Grants and Accounts Receivable

Grants receivable at June 30, 2016 and December 31, 2015 represent amounts due under several federal contracts with the National Institute of Allergy and Infectious Diseases, or NIAID, a division of the National Institutes of Health, or NIH, collectively, the NIH Grants. The Company considers the grants receivable to be fully collectible; accordingly, no allowance for doubtful amounts has been established. If amounts become uncollectible, they are charged to operations.

Accounts receivable at June 30, 2016 and December 31, 2015 consists of trade receivables from sales and services provided to certain customers, which are generally unsecured and due within 30 days. Estimated credit losses related to trade accounts receivable are recorded as general and administrative expenses and as an allowance for doubtful accounts within grants and accounts receivable, net. The Company reviews reserves and makes adjustments based on historical experience and known collectability issues and disputes. When internal collection efforts on accounts have been exhausted, the accounts are written off by reducing the allowance for doubtful accounts. As of June 30, 2016 and December 31, 2015, the allowance for doubtful accounts was $29,000 and $4,000, respectively.

8


 

Property and Equipment

Property and equipment are carried at cost less accumulated depreciation. Depreciation of property and equipment is computed using the straight-line method over the estimated useful lives of the assets, which are generally three to five years. Leasehold improvements are amortized over the lesser of the life of the lease or the life of the asset. Repairs and maintenance are charged to expense as incurred.

Acquisitions and Intangibles

The Company has engaged in business combination activity. The accounting for business combinations requires management to make judgments and estimates of the fair value of assets acquired, including the identification and valuation of intangible assets, as well as liabilities assumed. Such judgments and estimates directly impact the amount of goodwill recognized in connection with each acquisition, as goodwill presents the excess of the purchase price of an acquired business over the fair value of its net tangible and identifiable intangible assets.

Goodwill and Other Long-Lived Assets

Goodwill, which has an indefinite useful life, represents the excess of cost over fair value of net assets acquired. Goodwill is reviewed for impairment at least annually during the fourth quarter, or more frequently if events occur indicating the potential for impairment. During its goodwill impairment review, the Company may assess qualitative factors to determine whether it is more likely than not that the fair value of its reporting unit is less than its carrying amount, including goodwill. The qualitative factors include, but are not limited to, macroeconomic conditions, industry and market considerations, and the overall financial performance of the Company. If, after assessing the totality of these qualitative factors, the Company determines that it is not more likely than not that the fair value of its reporting unit is less than its carrying amount, then no additional assessment is deemed necessary. Otherwise, the Company proceeds to perform the two-step test for goodwill impairment. The first step involves comparing the estimated fair value of the reporting unit with its carrying value, including goodwill. If the carrying amount of the reporting unit exceeds its fair value, the Company performs the second step of the goodwill impairment test to determine the amount of loss, which involves comparing the implied fair value of the goodwill to the carrying value of the goodwill. The Company may also elect to bypass the qualitative assessment in a period and elect to proceed to perform the first step of the goodwill impairment test. The Company performed its annual assessment for goodwill impairment in the fourth quarter of 2015, noting no impairment.  There have not been any triggering events through June 30, 2016.

The Company evaluates its long-lived assets with definite lives, such as property and equipment, acquired technology, customer relationships, patent and license rights, for impairment by considering competition by products prescribed for the same indication, the likelihood and estimated future entry of non-generic and generic competition with the same or similar indication and other related factors. The factors that drive the estimate of the life are often uncertain and are reviewed on a periodic basis or when events occur that warrant review. Recoverability is measured by comparison of the assets’ book value to future net undiscounted cash flows that the assets are expected to generate. There have not been any impairment losses of long-lived assets through June 30, 2016.

Derivative Liability

Derivative liabilities are recorded on the consolidated balance sheets at fair value on the date of issuance and are revalued on each balance sheet date until such instruments are exercised or expire, with changes in the fair value between reporting periods recorded as other income or expense.  The Company estimates the fair value of derivative liabilities using the Black-Scholes option pricing model.

Investments in Other Entities

The Company holds a portfolio of investments in equity securities that are accounted for under either the equity method or cost method. Investments in entities over which the Company has significant influence but not a controlling interest are accounted for using the equity method, with the Company’s share of earnings or losses reported in other income (expense), net.

The Company’s cost method investments are included in investments in common stock on the consolidated balance sheets.  The Company’s equity method investments are included in equity method investments on the consolidated balance sheets.

All investments are reviewed on a regular basis for possible impairment. If an investment's fair value is determined to be less than its net carrying value and the decline is determined to be other-than-temporary, the investment is written down to its fair value. Such an evaluation is judgmental and dependent on specific facts and circumstances. Factors considered in determining whether an other-than-temporary decline in value has occurred include: market value or exit price of the investment based on either market-

9


 

quoted prices or future rounds of financing by the investee; length of time that the market value was below its cost basis; financial condition and business prospects of the investee; the Company’s intent and ability to retain the investment for a sufficient period of time to allow for recovery in market value of the investment; issues that raise concerns about the investee's ability to continue as a going concern; any other information that we may be aware of related to the inv estment. The Company does not report the fair value of its equity investments in non-publicly traded companies because it is not practical to do so.

Research and Development Costs and Collaborations

All research and development costs are charged to expense as incurred. Such costs primarily consist of lab supplies, contract services, stock-based compensation expense, salaries and related benefits.

Acquired In-Process Research and Development Expense

The Company has acquired and may continue to acquire the rights to develop and commercialize new drug candidates. The up-front payments to acquire a new drug compound, as well as future milestone license payments, are immediately expensed as acquired in-process research and development provided that the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, have no alternative future use.

Income Taxes

The provisions of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 740-10, Uncertainty in Income Taxes, address the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under ASC 740-10, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by taxing authorities, based on the technical merits of the position. The Company has determined that it has uncertain tax positions.

The Company accounts for income taxes using the asset and liability method to compute the differences between the tax basis of assets and liabilities and the related financial amounts, using currently enacted tax rates.

The Company has deferred tax assets, which are subject to periodic recoverability assessments. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount that more likely than not will be realized. As of June 30, 2016 and December 31, 2015, the Company maintained a full valuation allowance against its deferred tax assets, with the exception of an amount equal to its deferred tax liabilities, which can be expected to reverse over a definite life.

Revenue Recognition

The Company’s revenues are generated primarily from various NIH grant awards, and from the sale of customized reagents and the provision of contract development services. The revenue from the NIH grant awards is based upon subcontractor and internal costs incurred that are specifically covered by the grant, and where applicable, a facilities and administrative rate that provides funding for overhead expenses. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs internal expenses that are related to the grant.

Revenues from sales are generated from the sale of customized reagents which include industrial standard cytotoxins, linkers, and linker-toxins used for preparing ADCs.  Contract development services include providing synthetic expertise to customer’s synthesis by delivering proprietary cytotoxins, linkers and linker-toxins and ADC service using industry standard toxin and antibodies provided by customers. Revenue is recognized when, (i) persuasive evidence of an arrangement exists, (ii) the product has been shipped or the services have been rendered, (iii) the price is fixed or determinable, and (iv) collectability is reasonably assured.

License fees for the licensing of product rights are recorded as deferred revenue upon receipt of cash and recognized as revenue on a straight-line basis over the license period.

The Company is obligated to accept from customers the return of products sold that are damaged or do not meet certain specifications. The Company may authorize the return of products sold in accordance with the terms of its sales contracts, and estimates allowances for such amounts at the time of sale. The Company has not experienced any sales returns.

10


 

Stock-based Compensation

The Company accounts for stock-based compensation in accordance with FASB ASC Topic 718, which establishes accounting for equity instruments exchanged for employee services. Under such provisions, stock-based compensation cost is generally measured at the grant date, based on the calculated fair value of the award and an estimate of forfeitures, and is recognized as an expense, under the straight-line method, over the employee’s requisite service period (generally the vesting period of the equity grant).

The Company accounts for equity instruments, including restricted stock or stock options, issued to non-employees in accordance with authoritative guidance for equity based payments to non-employees. Stock options issued to non-employees are accounted for at their estimated fair value determined using the Black-Scholes option-pricing model. The fair value of options and restricted stock granted to non-employees is re-measured over the vesting period, and the resulting changes in fair value are recognized as expense in the period of the change in proportion to the services rendered to date.

Net Earnings (Loss) per Share

Basic net earnings (loss) per share is computed by dividing net income (loss) for the period by the weighted average number of common shares outstanding during the period. Diluted net earnings (loss) per share reflects the additional dilution from potential issuances of common stock, such as stock issuable pursuant to the exercise of stock options or the exercise of outstanding warrants. The treasury stock method and if-converted method are used to calculate the potential dilutive effect of these common stock equivalents. Potentially dilutive shares are excluded from the computation of diluted net earnings (loss) per share when their effect is anti-dilutive. In periods where a net loss is presented, all potentially dilutive securities are anti-dilutive and are excluded from the computation of diluted net loss per share.

Comprehensive Income (Loss )

Comprehensive income (loss) is comprised of net income (loss) and adjustments for the change in unrealized gains and losses on our investments in available-for-sale marketable securities, net of taxes. The Company displays comprehensive income (loss) and its components in its consolidated statements of comprehensive income (loss).

Segment Information

The Company is engaged primarily in the discovery and development of innovative therapies focused on oncology and the treatment of chronic cancer pain as well as immunology and infectious diseases based on its platform technologies. Accordingly, the Company has determined that it operates in one operating segment.

Recent Accounting Pronouncements

In March 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net). This update amends the principal-versus-agent implementation guidance and illustrations in the Board’s new revenue standard (ASC 606). The FASB issued the ASU in response to concerns identified by stakeholders, including those related to (1) determining the appropriate unit of account under the revenue standard’s principal-versus-agent guidance and (2) applying the indicators of whether an entity is a principal or an agent in accordance with the revenue standard’s control principle. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017, with early adoption permitted. The Company is currently evaluating the effect that the updated standard will have on its consolidated results of operations, financial position or cash flows.  

In April 2016, the FASB issued Accounting Standards Update No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing. This update clarifies how an entity identifies performance obligations related to customer contracts as well as help to improve the operability and understanding of the licensing implementation guidance. The amendments in this update affect the guidance in Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (Topic 606), which is not yet effective but will become effective for annual and interim periods beginning after December 15, 2017. The Company has not yet selected a transition method nor has it determined the effect of the standard on its consolidated results of operations, financial position or cash flows.  

In May 2016, the FASB issued Accounting Standards Update No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients. This update clarifies the objectives of collectability, sales and other taxes, noncash consideration, contract modifications at transition, completed contracts at transition and technical correction. The amendments in this update affect the guidance in Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers

11


 

(Topic 606), which is not yet effective but will be come effective for annual and interim periods beginning after December 15, 2017. The Company has not yet selected a transition method nor has it determined the effect of the standard on its consolidated results of operations, financial position or cash flo ws.   

In June 2016, the FASB issued Accounting Standards Update No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . This update provides financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. To achieve this objective, the amendments in this update replace the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company is currently evaluating the effect that the updated standard will have on its consolidated results of operations, financial position or cash flows.

 

 

3. Fair Value Measurements

 

The Company measures the fair value of financial assets and liabilities based on authoritative guidance that defines fair value, establishes a framework consisting of three levels for measuring fair value, and requires disclosures about fair value measurements.  Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date.

 

The Company’s marketable securities are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets.  The Company’s derivative liability was classified within Level 3 of the fair value hierarchy because the value was calculated using significant judgment based on the Company’s own assumptions in the valuation of this liability.

 

The following table presents the Company’s financial assets and liabilities that are measured at fair value on a recurring basis.  (in thousands):

 

 

 

Fair Value Measurements at June 30, 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance

 

 

Quoted Prices in Active Markets (Level 1)

 

 

Significant Other Observable Inputs (Level 2)

 

 

Significant Unobservable Inputs (Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Marketable securities

 

$

34,946

 

 

$

34,946

 

 

$

 

 

$

 

Total assets

 

$

34,946

 

 

$

34,946

 

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair Value Measurements at December 31, 2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance

 

 

Quoted Prices in Active Markets (Level 1)

 

 

Significant Other Observable Inputs (Level 2)

 

 

Significant Unobservable Inputs (Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Marketable securities

 

$

97,366

 

 

$

97,366

 

 

$

 

 

$

 

Total assets

 

$

97,366

 

 

$

97,366

 

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Derivative liability

 

$

5,520

 

 

$

 

 

$

 

 

$

5,520

 

Total liabilities

 

$

5,520

 

 

$

 

 

$

 

 

$

5,520

 

 

12


 

The following table includes a summary of the derivative liability measured at fair value using significant unobservable inputs (Level 3) during the six months en ded June 30, 2016 (in thousands): 

 

 

 

 

 

 

 

 

Derivative Liability

 

 

 

 

 

 

Beginning balance at December 31, 2015

 

$

5,520

 

  Gain on expiration of derivative liability

 

 

(5,520

)

Ending balance at June 30, 2016

 

$

 

 

 

4 . Marketable Securities

Marketable securities consisted of the following as of June 30, 2016 (in thousands):

 

 

 

June 30, 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost

 

 

Gross Unrealized Gains

 

 

Gross Unrealized Losses

 

 

Fair Value

 

Available-for-sale securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NantKwest common shares

 

$

10,000

 

 

$

87,366

 

 

$

(62,420

)

 

$

34,946

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

On July 27, 2015, NantKwest, Inc., or NantKwest, completed its initial public offering (“IPO”).  Prior to the IPO the Company’s investment in NantKwest was accounted for using the cost method and the total investment of $10.0 million was classified as part of investments in common stock on the Company’s consolidated balance sheets.  The common shares were subject to restrictions in a lock-up agreement through December 27, 2015 as well as limitations under Rule 144 of the Securities Act of 1933. As these were short term restrictions, the Company did not apply a marketability discount.  For the three and six months ended June 30, 2016, the Company recorded an unrealized loss of $11.2 million and $48.1 million, respectively, representing the difference between the $10.0 million cost basis and the estimated fair value net of tax of $0 as of June 30, 2016, as accumulated other comprehensive income in the stockholder's equity section of the Company’s consolidated balance sheet and as a change in unrealized gains and losses on marketable securities in the Company’s consolidated statements of comprehensive income (loss).   The tax effect of $14.3 million on the unrealized gain on marketable securities as of December 31, 2015 was reversed during the three months ended March 31, 2016 due to the decrease in the value of the marketable securities as of March 31, 2016.   The Company’s investment in NantKwest, Inc. will be revalued on each balance sheet date.  The fair value of the Company’s holdings in NantKwest at June 30, 2016 is a Level 1 measurement. Subsequent to June 30, 2016, the Company closed a transaction with the Chan Soon-Shiong Family Foundation and Cambridge Equities, LP to sell all of its investment in NantKwest, Inc.

 

5. Notes Receivable

 

In June 2016, the Company closed its previously announced securities purchase agreements with certain investors. In addition to the cash received the Company received consideration in the form of secured promissory notes for 9,640,060 shares totaling $53.5 million (the Secured Notes).  The Secured Notes accrue interest at 5% per annum, and all principal and interest is due and payable in December, 2016.  The Secured Notes are collateralized by the assets of the investors.  

 

In July 2016, the Company received a partial payment with accrued interest from one investor totaling $10.0 million and the Company expects to receive the remaining $43.5 million prior to December 31, 2016. The $43.5 million in notes are reflected as a stock subscription receivable in the Company’s consolidated balance sheets.

 

 

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6 . Investments  

As of June 30, 2016 and December 31, 2015, the aggregate carrying amount of the Company’s cost-method investments in non-publicly traded companies was $112.0 million and included an ownership interest in NantCell, Inc., NantBioScience, Inc., Brink Biologics, Inc., Coneksis, Inc., and Globavir Biosciences, Inc. The Company’s cost-method investments are assessed for impairment quarterly. The Company has determined that it is not practicable to estimate the fair value of its cost-method investments on a regular basis and does not reassess the fair value of cost-method investments if there are no identified events or changes in circumstances that may have a significant adverse effect on the fair value of the investments.  No impairment losses were recorded during the three and six months ended June 30, 2016 and 2015.

 

CARgenix

I n August 2015,  the Company and TNK Therapeutics, Inc. (“TNK”), its subsidiary entered into a Membership Interest Purchase Agreement (the “Membership Interest Purchase Agreement”) with CARgenix Holdings LLC (“CARgenix”) and the members of CARgenix (the “Members”) pursuant to which the Members sold all of their membership interests in CARgenix to TNK for: (1) a cash payment of $100.00, and (2) $6.0 million in shares of TNK Class A common stock, subject to adjustment in certain circumstances, to be issued to the Members upon a financing resulting in gross proceeds (individually or in the aggregate) to TNK of at least $50.0 million (a “Qualified Financing”). In accordance with the March 2016, Amendment No. 1, in the event a Qualified Financing does not occur by September 15, 2016 or TNK does not complete an initial public offering of shares of its capital stock by October 15, 2016, in lieu of receiving shares of TNK pursuant to the acquisition, the Members shall receive an aggregate of 309,917 shares of Company common stock, subject to adjustment in certain circumstances. The Membership Interest Purchase Agreement further provides that 20% of the shares of TNK or the Company’s, as applicable, issuable to the Members shall be held in escrow to secure certain post-closing adjustment and indemnification rights of TNK for a period of 12 months following the closing of the transaction.  The aggregate purchase price of $6.0 million was recognized as acquired in-process research and development expense in the consolidated statement of operations during the three months ended September 30, 2015.  The corresponding acquisition liability will remain until settlement.  

 

BDL

In August 2015, the Company and TNK entered into a Stock Purchase Agreement (the “Stock Purchase Agreement”) with BDL Products, Inc. (“BDL”) and the stockholders of BDL (“Stockholders”) pursuant to which the Stockholders sold all of their shares of capital stock in BDL to TNK for: (1) a cash payment of $100.00, and (2) $6.0 million in shares of TNK Class A common stock, subject to adjustment in certain circumstances, to be issued to the Stockholders upon a Qualified Financing.  In accordance with the March 2016, Amendment No. 1, in the event a Qualified Financing does not occur by September 15, 2016 or TNK does not complete an initial public offering of shares of its capital stock by September 30, 2016, in lieu of receiving shares of TNK pursuant to the acquisition, the Stockholders shall receive an aggregate of 309,917 shares of Company common stock, subject to adjustment in certain circumstances. The Stock Purchase Agreement further provides that 20% of the shares of TNK or the Company’s, as applicable, issuable to the Stockholders shall be held in escrow to secure certain post-closing adjustment and indemnification rights of TNK for a period of 12 months following the closing of the transaction.  The aggregate purchase price of $6.0 million was recognized as acquired in-process research and development expense in the consolidated statement of operations during the three months ended September 30, 2015.  The corresponding acquisition liability will remain until settlement.  

 

7 . Equity Method Investments

NANTibody

In April 2015, the Company and NantCell, Inc., or NantCell, a wholly-owned subsidiary of NantWorks, Inc., a private company owned by Dr. Patrick Soon-Shiong, an affiliate of the Company, established a new joint venture called Immunotherapy NANTibody, LLC, or NANTibody, as a stand-alone biotechnology company with $100.0 million initial joint funding.  NantCell owns 60% of the equity interest of NANTibody and agreed to contribute $60.0 million to NANTibody.  The Company owns 40% of NANTibody and in July 2015, the Company had NantPharma, LLC, or NantPharma, contribute its portion of the initial joint funding of $40.0 million to NANTibody from the proceeds of the sale of IgDraSol.  NANTibody will focus on accelerating the development of multiple immuno-oncology monoclonal antibodies (mAbs) for the treatment of cancer, including but not limited to anti-PD-1, anti-PD-L1, anti-CTLA4 mAbs, and other immune-check point antibodies as well as antibody drug conjugates (ADCs) and bispecific antibodies.

The Company is accounting for its interest in NANTibody as an equity method investment, due to the significant influence the Company has over the operations of NANTibody through its board representation and 40% voting interest.  The Company’s investment in NANTibody is reported in equity method investments on the consolidated balance sheets and its share of NANTibody’s income or loss is recorded in income (loss) on equity investments on the consolidated statement of operations.  The financial

14


 

statements of NANTibody are not received sufficiently timely for the Company to record its portion of earnings or loss in the current financial statements and therefore the Company reports its portion of earnings or loss o n a quarter lag.  As of June 30, 2016, the carrying value of the Company’s investment in NANTibody was approximately $39.9 million.

NANTibody recorded a total net income of $806,000 for the three months ended March 31, 2016 and a net loss of $964,000 for the three months ended December 31, 2015.  The Company recorded a total net income of $322,000 for the three months ended June 30, 2016 and a loss of $63,000 for the six months ended June 30, 2016 from NANTibody in income (loss) on equity investments on the consolidated statement of operations. As of March 31, 2016, NANTibody had $100.4 million in current assets and $628,000 in current liabilities.

NantStem

In July 2015, the Company and NantBioScience, Inc., or NantBioScience, a wholly-owned subsidiary of NantWorks, established a new joint venture called NantCancerStemCell, LLC, or NantStem, as a stand-alone biotechnology company with $100.0 million initial joint funding.  As initially organized, NantBioScience was obligated to make a $60.0 million cash contribution to NantStem for a 60% equity interest in NantStem, and the Company was obligated to make a $40.0 million cash contribution to NantStem for a 40% equity interest in NantStem.  Fifty percent of these contributions were funded in July 2015 and the remaining amounts were to be made by no later than September 30, 2015. The Company had NantPharma contribute its portion of the initial joint funding of $20.0 million to NantStem from the proceeds of the sale of IgDraSol.   Pursuant to a Side Letter dated October 13, 2015, the NantStem joint venture agreement was amended to relieve the Company of the obligation to contribute the second $20.0 million payment, and its ownership interest in NantStem was reduced to 20%.  NantBioScience’s funding obligations were unchanged.  The Side Letter was negotiated at the same time the Company issued a call option on shares of NantKwest that it owned to Cambridge Equities, LP, a related party to the Company and to NantBioScience.  The call option was a derivative as defined in ASC 815 and was recognized at fair value every reporting period the call option agreement was in effect, with changes in fair value recognized in current operations.  The call option expired unexercised on March 31, 2016 and the Company recorded a gain of $5.5 million upon the cancellation of the derivative liability.

The Company is accounting for its interest in NantStem as an equity method investment, due to the significant influence the Company has over the operations of NantStem through its board representation and 20% voting interest.  The Company’s investment in NantStem is reported in equity method investments on the consolidated balance sheets and its share of NantStem’s income or loss is recorded in income (loss) on equity investments on the consolidated statement of operations.  The financial statements of NantStem are not received sufficiently timely for the Company to record its portion of earnings or loss in the current financial statements and therefore the Company reports its portion of earnings or loss on a quarter lag.  As of June 30, 2016, the carrying value of the Company’s investment in NantStem was approximately $18.2 million.

NantStem recorded a total net income of $739,000 for the three months ended March 31, 2016 and a loss of $566,000 for the three months ended December 31, 2015.  For the three and six months ended June 30, 2016, the Company recorded $148,000 and $34,000, respectively, in income from NantStem in income (loss) on equity investments on the consolidated statement of operations.  As of March 31, 2016, NantStem had $80.3 million in current assets and $142,000 in current liabilities.

Shanghai Three

The Company is accounting for its interest in Shanghai Three-Alliance Biotech Co. LTD (“Shanghai Three”), a China based company, as an equity method investment, due to the significant influence the Company has over the operations of Shanghai Three through its 25% voting interest.  The Company’s investment in Shanghai Three is reported in equity method investments on the consolidated balance sheets and its share of Shanghai Three’s income or loss is recorded in income (loss) on equity investments on the consolidated statement of operations.  The financial statements of Shanghai Three are not received sufficiently timely for the Company to record its portion of earnings or loss in the current financial statements and therefore the Company reports its portion of earnings or loss on a quarter lag.  As of June 30, 2016, the carrying value of the Company’s investment in Shanghai Three was approximately $1.0 million. 

Shanghai Three incurred no operating expenses for the three months ended March 31, 2016.  As of March 31, 2016, Shanghai Three had $540,000 in current assets and $3.0 million in current liabilities.

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3SBio

In June 2016, the Company and TNK entered into a joint venture agreement with Shenyang Sunshine Pharmaceutical Company Ltd (“3SBio”), a China based company, to develop and commercialize proprietary immunotherapies, including those developed from, including or using TNK’s chimeric antigen receptor T cell (“CAR-T”) technology targeting carcinoembryonic antigen (“CEA”) positive cancers.  In June 2016, 3SBio purchased $10.0 million of Company common stock and warrants as part of the Company’s private placement offering.

Under the terms of the agreement 3SBio will contribute an initial investment of $10.0 million to the joint venture and TNK will grant the joint venture an exclusive license to the CEA CAR-T technology and two additional CARs for cellular therapy for the Greater China market, including Mainland China, Hong Kong and Macau. 3SBio will own 51% of the joint venture while TNK will own 49%.  As of June 30, 2016, funding and operations of the joint venture had not yet begun, as a result no investment has been recorded as of June 30, 2016.  

Yuhan

In March 2016, the Company and Yuhan Corporation, or Yuhan, a South Korea company, entered into an agreement to form a joint venture company called ImmuneOncia Therapeutics, LLC, to develop and commercialize a number of immune checkpoint antibodies against undisclosed targets for both hematological malignancies and solid tumors.  During the three months ended June 30, 2016, Yuhan purchased $10.0 million of Company common stock and warrants as part of the Company’s private placement offering.

Under the terms of the joint venture agreement, Yuhan will contribute an initial investment of $10.0 million to ImmuneOncia, and the Company will grant ImmuneOncia an exclusive license for one of its immune checkpoint antibodies for specified countries while retaining the rights for US, European, and Japanese markets, as well as global rights for ImmuneOncia to two additional antibodies that will be selected by ImmuneOncia from a group of pre-specified antibodies from the Company’s immuno-oncology antibody portfolio. Yuhan will own 51% of ImmuneOncia, while the Company will own 49%. Yuhan’s Chief Scientific Officer Dr. Su Youn Nam will be appointed CEO of ImmuneOncia.   As of June 30, 2016, funding and operations of the joint venture had not yet begun, as a result no investment has been recorded as of June 30, 2016.  

8. Goodwill and Intangible Assets

As of both June 30, 2016 and December 31, 2015, the Company had goodwill of $20.6 million, respectively.  The Company performed a qualitative test for goodwill impairment as of December 31, 2015. Based upon the results of the qualitative testing the Company concluded that it is more-likely-than-not that the fair values of the Company’s goodwill was in excess of its carrying value and therefore performing the first step of the two-step impairment test was unnecessary. No goodwill impairment was recognized for the three or six months ended June 30, 2016 and 2015.

 

The Company’s intangible assets, excluding goodwill, include patent rights, core technologies and customer relationships. Amortization for the intangible assets that have finite useful lives is generally recorded on a straight-line basis over their useful lives.  A summary of the Company’s identifiable intangible assets is as follows (in thousands):

 

 

 

June 30, 2016

 

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Intangibles, net

 

Customer relationships

 

$

1,320

 

 

$

668

 

 

$

652

 

Acquired technology

 

 

3,410

 

 

 

446

 

 

 

2,964

 

Patent rights

 

 

90

 

 

 

16

 

 

 

74

 

Total intangible assets

 

$

4,820

 

 

$

1,130

 

 

$

3,690

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2015

 

 

 

Gross Carrying Amount

 

 

Accumulated Amortization

 

 

Intangibles, net

 

Customer relationships

 

$

1,320

 

 

$

536

 

 

$

784

 

Acquired technology

 

 

3,410

 

 

 

358

 

 

 

3,052

 

Patent rights

 

 

90

 

 

 

14

 

 

 

76

 

Total intangible assets

 

$

4,820

 

 

$

908

 

 

$

3,912

 

 

As of June 30, 2016, the remaining weighted average life for identifiable intangible assets is 15 years.

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Patent rights are stated at cost and depreciated on a straight-line basis over the estimated useful lives of the as sets, determined to be approximately 19 years from the date of transfer of the rights to the Company in April 2013. Amortization expense for both the three months ended June 30, 2016 and 2015 was $1,250, respectively.  Amortization expense for both the six months ended June 30, 2016 and 2015 was $2,500, respectively, which has been included in intangibles amortization.

Acquired technology is stated at cost and depreciated on a straight-line basis over the estimated useful lives of the assets, determined to be approximately 19 years from the date of acquisition of the technology in December 2013. Amortization expense for both the three months ended June 30, 2016 and 2015 was $44,000, respectively.  Amortization expense for both the six months ended June 30, 2016 and 2015 was $88,000, respectively, which has been included in intangibles amortization.

Customer relationships are stated at cost and depreciated on a straight-line basis over the estimated useful lives of the assets, determined to be approximately five years from the date of acquisition in December 2013. Amortization expense for both the three months ended June 30, 2016 and 2015 was $66,000, respectively.  Amortization expense for both the six months ended June 30, 2016 and 2015 was $132,000, respectively, which has been included in intangibles amortization.

Estimated future amortization expense related to intangible assets at June 30, 2016 is as follows (in thousands):

 

Years Ending December 31,

 

Amount

 

2016 (remaining 6 months)

 

$

223

 

2017

 

 

445

 

2018

 

 

436

 

2019

 

 

181

 

2020

 

 

181

 

Thereafter

 

 

2,224

 

Total

 

$

3,690

 

 

 

9. Significant Agreements and Contracts

License Agreement with The Scripps Research Institute

In January 2010, the Company entered into a license agreement, or the TSRI License, with The Scripps Research Institute, or TSRI. Under the TSRI License, TSRI granted the Company an exclusive, worldwide license to certain TSRI patent rights and materials based on quorum sensing for the prevention and treatment of Staphylococcus aureus (“Staph”) infections, including Methicillin-resistant Staph. In consideration for the license, the Company: (i) issued TSRI a warrant for the purchase of common stock, (ii) agreed to pay TSRI a certain annual royalty commencing in the first year after certain patent filing milestones are achieved, (iii) agreed to pay a royalty on any sales of licensed products by the Company or its affiliates and a royalty for any revenues generated by the Company through its sublicense of patent rights and materials licensed from TSRI under the TSRI License. The TSRI License requires the Company to indemnify TSRI for certain breaches of the agreement and other matters customary for license agreements. The parties may terminate the TSRI License at any time by mutual agreement. In addition, the Company may terminate the TSRI License by giving 60 days’ notice to TSRI and TSRI may terminate the TSRI License immediately in the event of certain breaches of the agreement by the Company or upon the Company’s failure to undertake certain activities in furtherance of commercial development goals. Unless terminated earlier by either or both parties, the term of the TSRI License will continue until the final expiration of all claims covered by the patent rights licensed under the agreement. The warrant was exercised in February 2015.  For the three months ended June 30, 2016 and 2015, the Company recorded $2,000   and $21,000 in patent prosecution and maintenance costs associated with the TSRI License, respectively.  For the six months ended June 30, 2016 and 2015, the Company recorded $22,000   and $46,000 in patent prosecution and maintenance costs associated with the TSRI License, respectively.  All such costs have been included in general and administrative expenses.

17


 

License Agreement with Mabtech Limited

I n August 2015, the Company entered into an exclusive licensing agreement to develop and commercialize multiple prespecified biosimilar and biobetter antibodies from Mabtech Limited.  Under the terms of the agreement, the Company will develop and market these four monoclonal antibodies (mAbs) for the North American, European and Japanese market. The Company made an initial license payment of $10.0 million and in February 2016, paid an additional $10.0 million license payment, both of which were recognized as acquired in-process research and development expense in the consolidated statements of operations as the Company determined there was no alternative future use for the license.  In June 2016, the Company agreed to accelerate and pay a $30.0 million milestone license payment by July 31, 2016, which has been accrued and recognized as acquired in-process research and development expense as of June 30, 3016, in exchange for the purchase by Mabtech Limited and one or more of its affiliates in June 2016, of $20.0 million of Company common stock and warrants.  The amended agreement includes additional milestone payments totaling $150.0 million payable over the next three years.      

License Agreement with NantCell

In April 2015, the Company and NantCell entered into a license agreement. Under the terms of the agreement the Company granted an exclusive license to NantCell covering patent rights, know-how, and materials related to certain antibodies, anti-body drug conjugates (ADC) and two CAR-TNK products.  NantCell agreed to pay a royalty not to exceed five percent (5%) to the Company on any net sales of products (as defined) from the assets licensed by the Company to NantCell.  In addition to the future royalties payable under this agreement, NantCell paid an upfront payment of $10.0 million to the Company and issued 10 million shares of NantCell common stock to the Company valued at $100.0 million based on recent NantCell equity activity with a third party.  As of June 30, 2016, the Company had not yet provided all of the items noted in the agreement and therefore has recorded the entire upfront payment and value of the equity interest received as deferred revenue.  The Company will recognize the upfront payment and the value of the equity interest received over the expected license period of approximately ten years on a straight line basis.  The Company’s ownership interest in NantCell does not provide the Company with control or the ability to exercise significant influence, therefore the $100.0 million investment will be carried at cost in the consolidated balance sheets and evaluated for other-than-temporary impairment on a quarterly basis.

NIH Grants

In June 2014, the NIAID awarded the Company a Phase II STTR grant to support the advanced preclinical development of human bispecific antibody therapeutics to prevent and treat Staphylococcus aureus ( S. aureus or Staph) infections, including methicillin-resistant S. aureus (MRSA), or the Staph Grant III award. The project period for this Phase II grant covers a two-year period which commenced in June 2014, with total funds available of approximately $1.0 million per year for up to 2 years. During the three months ended June 30, 2016 and 2015, the Company recorded $218,000 and $331,000 of revenue, respectively, associated with the Staph Grant III award.  During the six months ended June 30, 2016 and 2015, the Company recorded $457,000 and $417,000 of revenue, respectively, associated with the Staph Grant III award.       

In June 2014, the NIAID awarded the Company a Phase I STTR grant entitled “Anti-Pseudomonas Immunotherapy and Targeted Drug Delivery”. This grant will support the preclinical development of novel anti- Pseudomonas aeruginosa mAb immunotherapy or an antibody-mediated targeted antibiotic delivery vehicle. Each modality may be an effective and safe stand-alone therapy and/or a component of a “cocktail” therapeutic option for prevention and treatment of P. aeruginosa infections. The project period for this Phase I grant covers a two-year period which commenced in July 2014, with total funds available of approximately $300,000 per year for up to 2 years. During the three months ended June 30, 2016 and 2015, the Company recorded $98,000 and $38,000 of revenue, respectively, associated with the Phase I STTR grant award.  During the six months ended June 30, 2016 and 2015, the Company recorded $224,000 and $93,000 of revenue, respectively, associated with the Phase I STTR grant award.   

In July 2014, the National Cancer Institute (NCI), a division of the NIH, awarded the Company a Phase I STTR grant, entitled “Targeting of Myc-Max Dimerization for the Treatment of Cancer”. This grant will support the preclinical development of the Myc inhibitor, which interferes with the protein-protein interaction (PPI) between Myc and its obligatory dimerization partner, Max, preventing sequence-specific binding to DNA and subsequent initiation of oncogenic transformation. The project period for this Phase I grant covers a one-year period which commenced in August 2014, with total funds available of approximately $225,000. During the three months ended June 30, 2016 and 2015, the Company recorded $0 and $56,000 of revenue, respectively, associated with the Phase I Myc grant award.  During the six months ended June 30, 2016 and 2015, the Company recorded $0 and $130,000 of revenue, respectively, associated with the Phase I Myc grant award.     

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In August 2014, the National Heart, Lung, and Blood Institute (NHBLI), a division of the NIH awarded the Company a Phase I Small Business Technology Transfer (SBIR) grant entitled “Human Anti-WISP-1 Antibodies for Treatment of Idiopathic Pulmonary Fibrosis”. This grant will advance th e Company’s immunotherapy targeting WNT-1 Inducible Signaling Protein-1(WISP1) for the treatment of Idiopathic Pulmonary Fibrosis (IPF). WISP1 is a protein that has been shown to be upregulated in IPF, linked to key growth factors, cellular proliferation, hyperplasia and is correlated with late stage cancers. IPF is a fatal disease, which results in progressive loss of lung function due to fibrosis of the lungs. The project period for this Phase I grant covers a one-year period which commenced in August 201 4, with total funds available of approximately $225,000.  During the three months ended June 30, 2016 and 2015, the Company recorded $0 and $21,000 of revenue, respectively, associated with the Phase I WISP1 grant award. During the six months ended June 30 , 2016 and 2015, the Company recorded $52,000 and $31,000 of revenue, respectively, associated with the Phase I WISP1 grant award.     

 

 

10. Loan and Security Agreement

In September 2013, the Company entered into a $5.0 million loan and security agreement with two banks pursuant to which: (i) the lenders provided the Company a term loan which was funded at closing, (ii) the Company repaid its then outstanding equipment loan balance of $762,000, and (iii) the lenders received a warrant to purchase an aggregate 31,250 shares of the Company’s common stock at an exercise price of $8.00 per share exercisable for seven years from the date of issuance. The value of the warrants, totaling $215,000, was recorded as debt discount and additional paid-in capital.

In March 2014, the Company entered into an amended and restated loan and security agreement, increasing the September 2013 facility to $12.5 million from $5.0 million, with the same two banks. Such loan was funded at closing and is secured by a lien covering substantially all of the Company’s assets, excluding intellectual property, which is subject to a negative pledge. In October 2014, the Company entered into a second amendment to its amended and restated loan and security agreement to extend the interest only payments on the outstanding amount of the loan from October 1, 2014 to May 1, 2015, after which equal monthly payments of principal and interest are due until the loan maturity date of September 30, 2017. The amended and restated loan: (i) interest rate is 7.95% per annum, and (ii) provided the Lenders additional warrants to purchase an aggregate of 34,642 shares of the Company’s common stock at an exercise price of $12.99 per share, exercisable for seven years from the date of issuance. The value of the warrants, totaling $322,000, was recorded as debt discount and additional paid-in capital.

At the Company’s option, it may prepay all of the outstanding principal balance, subject to certain pre-payment fees ranging from 1% to 3% of the prepayment amount. In the event of a final payment of the loans under the loan agreement, either in the event of repayment of the loan at maturity or upon any prepayment, the Company is obligated to pay the amortized portion of the final fee of $781,000.

The Company is also subject to certain affirmative and negative covenants under the loan agreement, including limitations on its ability to: undergo certain change of control events; convey, sell, lease, license, transfer or otherwise dispose of any equipment financed by loans under the loan agreement; create, incur, assume, guarantee or be liable with respect to indebtedness, subject to certain exceptions; grant liens on any equipment financed under the loan agreement; and make or permit any payment on specified subordinated debt. In addition, under the loan agreement, subject to certain exceptions, the Company is required to maintain with the lender its primary operating, other deposit and securities accounts.

Long-term debt and unamortized discount balances are as follows (in thousands):

 

Face value of amended and restated loan

 

$

6,974

 

Fair value of all warrants

 

 

(536

)

Accretion of debt discount

 

 

430

 

Balance at June 30, 2016

 

$

6,868

 

 

19


 

Future minimum payments under the amended and restated loan and security agreement are as follows (in thousands):

 

Year Ending December 31,

 

 

 

 

2016

 

$

2,748

 

2017

 

 

4,579

 

Total future minimum payments

 

 

7,327

 

Unamortized interest

 

 

(353

)

Debt discount

 

 

(106

)

Total minimum payment

 

 

6,868

 

Current portion

 

 

(5,067

)

Long-term debt

 

$

1,801

 

 

11. Stockholders’ Equity

 

Common Stock

 

The Company has a Sales Agreement with MLV & Co. LLC, ("MLV") to permit the sale by MLV, acting as its sales agent, of up to $50.0 million in additional shares of the Company's common stock from time to time in an at-the-market offering under the Sales Agreement. All sales of shares have been and will continue to be made pursuant to an effective shelf registration statement on Form S-3 filed with the SEC. The Company pays MLV a commission of approximately 2% of the aggregate gross proceeds the Company receives from all sales of the Company's common stock under the Sales Agreement. There were net proceeds on sales of approximately $3.5 million at a weighted average price of $6.37 under the Sales Agreement during the three months ended March 31, 2016.  There was no sales activity under the Sales Agreement during the three months ended June 30, 2016 or during the six months ended June 30, 2015.

During the three months ended June 30, 2016 the Company closed its private placement offering of common stock and warrants with Yuhan Corporation, Ally Bridge Group ("ABG"), together with Beijing Shijilongxin Investment Co., Ltd. ("Beijing Shijilongxin"), and FREJOY Investment Management Co., Ltd. ("Frejoy").  The Company collectively sold 27,027,027 shares of common stock at $5.55 per share, and warrants to purchase 5,290,936 shares of common stock for total consideration of $150.0 million.  The Company incurred $4.2 million in offering commissions and expenses which have been netted against the gross proceeds.  The warrants are exercisable for three years at an exercise price of $8.50 per share.  The Company received consideration in the form of secured promissory notes for 9,640,060 shares totaling $53.5 million.  In July 2016, the Company received a partial payment with accrued interest from one investor totaling $10.0 million and as of June 30, 2016, has recorded this as notes receivable on the consolidated balance sheets.  The remaining $43.5 million in notes are reflected as a stock subscription receivable in the Company’s consolidated balance sheets.

 

12. Stock Incentive Plans

2009 Non-Employee Director Grants

In September 2009, prior to the adoption of the 2009 Stock Incentive Plan, the Company’s Board of Directors approved the reservation and issuance of 8,000 nonstatutory stock options to the Company’s non-employee directors. The options vested on the one year anniversary of the vesting commencement date in October 2010, and were exercisable for up to 10 years from the grant date. No further shares may be granted under this plan and, as of June 30, 2016, all options had been cancelled and no   options were outstanding.

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2009 Stock Incentive Plan

In October 2009, the Company’s stockholders approved the 2009 Stock Incentive Plan. In June 2016, the Company’s stockholders approved, among other items, the amendment and restatement of the 2009 Stock Incentive Plan, or the Stock Plan, to increase the number of common shares authorized to be issued pursuant to the Stock Plan to 6,260,000. Such shares of the Company’s common stock are reserved for issuance to employees, non-employee directors and consultants of the Company. The Stock Plan provides for the grant of incentive stock options, non-incentive stock options, stock appreciation rights, restricted stock awards, unrestricted stock awards, restricted stock unit awards and performance awards to eligible recipients. Recipients of stock options shall be eligible to purchase shares of the Company’s common stock at an exercise price equal to no less than the estimated fair market value of such stock on the date of grant. The maximum term of options granted under the Stock Plan is ten years. Employee option grants will generally vest 25% on the first anniversary of the original vesting commencement date, with the balance vesting monthly over the remaining three years. The vesting schedules for grants to non-employee directors and consultants will be determined by the Company’s Compensation Committee.  

The following table summarizes stock option activity as of June 30, 2016 and the changes for the period then ended (dollar values in thousands):

 

 

 

Options Outstanding

 

 

Weighted-

Average

Exercise Price

 

 

Aggregate Intrinsic Value

 

Outstanding at December 31, 2015

 

 

2,957,616

 

 

$

8.95

 

 

$

4,506

 

Options Granted

 

 

462,950

 

 

$

5.86

 

 

 

 

 

Options Canceled

 

 

(443,481

)

 

$

8.73

 

 

 

 

 

Options Exercised

 

 

(89,976

)

 

$

4.76

 

 

 

 

 

Outstanding at June 30, 2016

 

 

2,887,109

 

 

$

8.62

 

 

$

934

 

  

The Company uses the Black-Scholes valuation model to calculate the fair value of stock options. The fair value of employee stock options was estimated at the grant date using the following assumptions:

 

 

 

Six Months Ended June 30,

 

 

 

2016

 

 

2015

 

Weighted-average grant date fair value

 

$

5.86

 

 

$

11.56

 

Dividend yield

 

 

 

 

 

 

Volatility

 

 

75

%

 

 

75

%

Risk-free interest rate

 

 

1.45

%

 

 

1.65

%

Expected life of options

 

6.1 years

 

 

6.1 years

 

  

The assumed dividend yield was based on the Company’s expectation of not paying dividends in the foreseeable future. Due to the Company’s limited historical data, the estimated volatility incorporates the historical and implied volatility of comparable companies whose share prices are publicly available. The risk-free interest rate assumption was based on the U.S. Treasury’s rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the award being valued. The weighted average expected life of options was estimated using the average of the contractual term and the weighted average vesting term of the options.

The total employee and director stock-based compensation recorded as operating expenses was $1,082,000 and $801,000 for the three months ended June 31, 2016 and 2015, and $2,120,000 and $1,783,000 for the six months ended June 30, 2016 and 2015, respectively.

The total unrecognized compensation cost related to unvested stock option grants as of June 30, 2016 was $6,206,000 and the weighted average period over which these grants are expected to vest is 2.8 years.

The Company records equity instruments issued to non-employees as expense at their fair value over the related service period as determined in accordance with the authoritative guidance and periodically revalues the equity instruments as they vest.  Stock-based compensation expense related to non-employee consultants recorded as operating expenses was $44,000 and $571,000 for the three months ended June 30, 2016 and 2015, and $96,000 and $992,000 for the six months ended June 30, 2016 and 2015, respectively.

21


 

Common Stock Reserved for Future Issuance

Common stock reserved for future issuance consists of the following at June 30, 2016:

 

Common stock warrants outstanding under the underwriters agreement

 

 

182,600

 

Common stock warrants outstanding under the loan and security agreement

 

 

65,892

 

Common stock warrants outstanding under the Cambridge securities agreement

 

 

1,724,138

 

Common stock warrants outstanding under the private placement security agreements

 

 

5,290,936

 

Authorized for future grant or issuance under the amended and restated 2009 Stock Incentive Plan

 

 

2,919,703

 

Issuable under BDL and CARgenix acquisition agreements

 

 

619,834

 

Issuable under assignment agreement based upon achievement of certain milestones

 

 

80,000

 

 

 

 

10,883,103

 

 

Subsidiary Equity Grants

In May 2015, the Company’s subsidiary TNK Therapeutics, Inc., or TNK, adopted the TNK 2015 Stock Option Plan and reserved 10.0 million shares of TNK class A common stock.   During the three and six months ended June 30, 2016, TNK awarded zero and 402,000 options, respectively, with a weighted average grant date fair value of $0.84 per share to certain Company personnel, directors and consultants under such plan.  During the three months ended June 30, 2016, TNK cancelled 100,000 options.  Stock options granted under this plan typically vest a portion immediately upon grant and the remaining options over two to four years or monthly over four years from the grant date and have a contractual term of ten years. As of June 30, 2016, approximately 2.9 million options were outstanding.

In May 2015, TNK granted a warrant to the Company’s CEO to purchase 9.5 million shares of TNK class B common stock which have 10 to 1 voting rights.  Warrant shares totaling 4.0 million are exercisable evenly over forty months and the remaining warrant shares are exercisable if certain defined events occur within four years from date of issuance at an initial exercise price of $0.01 per share.  The exercise price of the warrant is subject to customary adjustment provisions for stock splits, stock dividends, recapitalizations and the like.  As of June 30, 2016, 9.5 million warrants were outstanding.

In May 2015, the Company’s subsidiary LA Cell, Inc., or LA Cell, adopted the LA Cell 2015 Stock Option Plan and reserved 10.0 million shares of LA Cell class A common stock.  During the three and six months ended June 30, 2016, LA Cell awarded zero and 401,500 options, respectively, with a weighted average grant date fair value of $0.20 per share to certain Company personnel, directors and consultants under such plan.  During the three months ended June 30, 2016, LA Cell cancelled 201,500 options.  Stock options granted under this plan typically vest a portion immediately upon grant and the remaining options over two to four years or monthly over four years from the grant date and have a contractual term of ten years. As of June 30, 2016, approximately 1.9 million options were outstanding.

In May 2015, LA Cell granted a warrant to the Company’s CEO to purchase 9.5 million shares of LA Cell class B common stock which have 10 to 1 voting rights.  Warrant shares totaling 4.0 million are exercisable evenly over forty months and the remaining warrant shares are exercisable if certain defined events occur within four years from date of issuance at an initial exercise price of $0.01 per share.  The exercise price of the warrant is subject to customary adjustment provisions for stock splits, stock dividends, recapitalizations and the like.  As of June 30, 2016, 9.5 million warrants were outstanding.

In October 2015, the Company’s subsidiary Concortis Biosystems, Corp., or CBC, adopted the CBC 2015 Stock Option Plan and reserved 10.0 million shares of CBC class A common stock.  During the three and six months ended June 30, 2016, CBC awarded zero and 9,750 options, respectively, with a weighted average grant date fair value of $0.17 per share to certain Company personnel under such plan.  During the three and six months ended June 30, 2016, zero and 420,000 options were cancelled by CBC, respectively.  Stock options granted under this plan typically vest a portion immediately upon grant and the remaining options over two to four years or monthly over four years from the grant date and have a contractual term of ten years. As of June 30, 2016, approximately 1.8 million options were outstanding.

In October 2015, CBC granted a warrant to the Company’s CEO to purchase 9.5 million shares of CBC class B common stock which have 10 to 1 voting rights.  Warrant shares totaling 4.0 million are exercisable evenly over forty months and the remaining warrant shares are exercisable if certain defined events occur within four years from date of issuance at an initial exercise price of $0.25 per share.  The exercise price of the warrant is subject to customary adjustment provisions for stock splits, stock dividends, recapitalizations and the like.  As of June 30, 2016, 9.5 million warrants were outstanding.

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In October 2015, the Company’s subsidiary Scintilla Pharmaceuticals, Inc., or Scintilla, adopted the Scintilla 2015 Stock Option Plan and reserved 10.0 million shares of Scintilla class A common stock.  During the three and six months ended June 30, 2016, Scintilla awarded zero and 2,000 options, respectively, with a weighted average grant date fair value of $0.01 per s hare to certain Company personnel under such plan.  During the three and six months ended June 30, 2016, zero and 200,000 options were cancelled by Scintilla, respectively.  Stock options granted under this plan typically vest a portion immediately upon gr ant and the remaining options over two to four years or monthly over four years from the grant date and have a contractual term of ten years. As of June 30, 2016, approximately 1.0 million options were outstanding.

In October 2015, Scintilla granted a warrant to the Company’s CEO to purchase 9.5 million shares of Scintilla class B common stock which have 10 to 1 voting rights.  Warrant shares totaling 4.0 million are exercisable evenly over forty months and the remaining warrant shares are exercisable if certain defined events occur within four years from date of issuance at an initial exercise price of $0.01 per share.  The exercise price of the warrant is subject to customary adjustment provisions for stock splits, stock dividends, recapitalizations and the like.   As of June 30, 2016, 9.5 million warrants were outstanding.

In October 2015, the Company’s subsidiary Sorrento Biologics, Inc., or Biologics, adopted the Biologics 2015 Stock Option Plan and reserved 10.0 million shares of Biologics class A common stock.  No options were awarded or cancelled during the three and six months ended June 30, 2016 under such plan. Stock options granted under this plan typically vest a portion immediately upon grant and the remaining options over two to four years or monthly over four years from the grant date and have a contractual term of ten years. As of June 30, 2016, approximately 1.4 million options were outstanding.

In October 2015, Biologics granted a warrant to the Company’s CEO to purchase 9.5 million shares of Biologics class B common stock which have 10 to 1 voting rights.  Warrant shares totaling 4.0 million are exercisable evenly over forty months and the remaining warrant shares are exercisable if certain defined events occur within four years from date of issuance at an initial exercise price of $0.01 per share.  The exercise price of the warrant is subject to customary adjustment provisions for stock splits, stock dividends, recapitalizations and the like.   As of June 30, 2016, 9.5 million warrants were outstanding.

The total director stock-based compensation recorded as operating expenses by the Company for TNK, LA Cell, CBC, Scintilla and Biologics was $41,000 and $0 for the three months ended June 30, 2016 and 2015 and was $83,000 and $0 for the six months ended June 30, 2016 and 2015, respectively.  Total unrecognized stock-based compensation expense related to unvested director stock option and warrant grants for these entities as of June 30, 2016 was $451,000, and the weighted-average period over which these grants are expected to vest is approximately 3.2 years.  The Company records equity instruments issued to non-employees as expense at their fair value over the related service period as determined in accordance with the authoritative guidance and periodically revalues the equity instruments as they vest.  Stock based compensation expense related to non-employee consultants recorded as operating expenses by the Company for TNK, LA Cell, CBC, Scintilla and Biologics was $44,000 and $0 for the three months ended June 30, 2016 and 2015 and was $92,000 and $0 for the six months ended June 30, 2016 and 2015, respectively.

The weighted-average assumptions used in the Black-Scholes option and warrant pricing model used by TNK, LA Cell, CBC, Scintilla and Biologics to determine the fair value of stock option grants for directors and non-employee consultants for the six months ended June 30, 2016 were as follows: expected dividend yield – 0%, risk-free interest rate – 1.39% to 1.74%, expected volatility – 75% to 77%, and expected term of 4.0 to 6.1 years.

 

In May 2014, the Company’s subsidiary Ark Animal Health, Inc., or Ark, adopted the Ark 2014 Stock Option Plan and reserved and awarded 600,000 options to certain directors and consultants under such plan. Stock options granted under such plan typically vest a portion immediately upon grant and the remaining options over one year from the grant date and will have a contractual term of ten years. As of June 30, 2016, 351,000 options were outstanding.

The total director and consultant stock-based compensation recorded as operating expenses by the Company for Ark for the three months ended June 30, 2016 and 2015 was $0 and $22,000 and was $0 and $55,000 for the six months ended June 30, 2016 and 2015, respectively.  No unrecognized stock-based compensation expense related to unvested stock option grants existed as of June 30, 2016.

13. Investment in Variable Interest Entity

The Company’s consolidated financial statements include the financial results of LA Cell, Inc. (LA Cell), a consolidated subsidiary of the Company and a variable interest entity in which the Company is the primary beneficiary.

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In September 2015, LA Cell exclusively licensed certain technology from City of Hope.  The technology includes cell-pen etrating antibody therapies that enables modified monoclonal antibodies (mAbs) to penetrate into cells and target disease-causing molecules.  Utilizing mAbs derived from the Company's antibody portfolio, LA Cell is focused on developing therapies against i mportant oncology targets, including but not limited to c-MYC, mutated KRAS, STAT3, and FoxP3.  Pursuant to the license agreement, LA Cell made a $2.0 million upfront payment to City of Hope and has paid additional license payments of $5.0 million to City of Hope as of June 30, 2016.  The license agreement also provides for development and sales milestone payments and royalties based on net sales, as defined in the license agreement.

Upon the formation of LA Cell, the Company held all of the outstanding stock of LA Cell. As of June 30, 2016, the Company held an aggregate of approximately a 48% ownership of outstanding shares but which include a majority of the voting rights.  

For the three and six months ended June 30, 2016, LA Cell recognized $3.0 million and $5.0 million, respectively, in acquired in-process research and development expense in the Company’s consolidated statements of operations and incurred minimal general and administrative expenses.

 

14. Derivative Liability

On October 13, 2015, the Company wrote a call option to Cambridge Equities, LP (Cambridge), a related party, on up to 2.0 million shares of NantKwest, Inc., (NantKwest) common stock held by the Company (the Option Agreement).  As of June 30, 2016, the Company holds approximately 5.6 million shares of common stock of NantKwest, par value $.0001 per share, which is classified as available-for-sale and reported in its consolidated financial statements as marketable securities.  The Option Agreement gave Cambridge the right to purchase up to 2.0 million shares at a price of $15.295 per share from time to time during the first quarter of 2016.  There is no contractual option premium associated with this Option Agreement.  The Option Agreement is a derivative as defined in ASC 815 and is recognized at fair value every reporting period the Option Agreement is in effect, with changes in fair value recognized in current operations.  The call option expired unexercised on March 31, 2016 and for the three and six months ended June 30, 2016 the Company recorded a gain of $0 and $5.5 million, respectively, upon the cancelation of the derivative liability.  As of June 30, 2016 no derivative liability was recorded on the Company’s consolidated balance sheets .

15. Income Taxes

The Company maintains deferred tax assets that reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. These deferred tax assets include net operating loss carryforwards, research credits and temporary differences. In assessing the Company's ability to realize deferred tax assets, management considers, on a periodic basis, whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. As such, management has determined that it is appropriate to maintain a full valuation allowance against the Company's U.S. federal and state deferred tax assets, with the exception of an amount equal to its deferred tax liabilities, which can be expected to reverse over a definite life.

The Company is subject to taxation in the U.S. and various state jurisdictions. The Company's tax years for 2007 and later are subject to examination by the U.S. and state tax authorities due to the existence of the NOL carryforwards.

As of the June 30, 2016, the Company had approximately $1.8 million of unrecognized tax benefits that, if recognized, would impact the effective income tax rate for continuing operations, subject to possible offset by an increase in the deferred tax asset valuation allowance. As of June 30, 2015, there were no unrecognized tax benefits.

 

The Company recognizes interest and penalties related to unrecognized tax benefits in its provision for income taxes. For the three and six months ended June 30, 2016 and 2015, no expense was recorded related to interest and penalties. The Company believes that no significant amount of the liabilities for uncertain tax positions will expire within twelve months of June 30, 2016.

 

16. Commitments and Contingencies

Litigation

In the normal course of business, the Company may be named as a defendant in one or more lawsuits. The Company is not a party to any outstanding material litigation and management is currently not aware of any legal proceedings that, individually or in the aggregate, are deemed to be material to its financial condition or results of operations.  On April 25, 2016, Wildcat Liquid Alpha, LLC (“WLA”) filed a complaint in the Court of Chancery of the State of Delaware seeking an order compelling the Company to provide WLA with certain documents, books and records for inspection and copying pursuant to an April 11, 2016 demand made by

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WLA.  The Company believes that WLA’s April 11, 2016 demand for documents and the corresponding litigation are deficient and without merit, and will vigorously defend itself against both. The Company is unable to determine whether any loss will occur with respect to this matter or to estimate the range of such potential loss; therefore, no amount of loss has been accrued by the Company as of the date of filing of this Quarterly Report on Form 10-Q. Furthermore, there is no guarantee that the Company will prevail in this action or receive any relief if it does prevail.

On May 13, 2016, WLA filed a derivative action in the Court of Chancery of the State of Delaware against each of the members of the Board and against the Company as nominal defendant alleging, among other things: (1) breach of fiduciary duty with respect to the Company’s prior announcement of four transactions through which investors agreed to purchase up to $150 million of shares of our common stock and warrants; (2) breach of fiduciary duty with respect to the formation of, and certain options and warrants issued by, certain of the Company’s subsidiaries to Dr. Ji and members of the Board; (3) waste of corporate assets; (4) unjust enrichment; and (5) mismanagement, including questioning the Company’s decisions to make passive investments in other corporations (the “Derivative Action”). The Company believes that the Derivative Action is without merit, and will vigorously defend itself against the action. The Company is unable to determine whether any loss will occur with respect to the Derivative Action or to estimate the range of such potential loss; therefore, no amount of loss has been accrued by the Company as of the date of filing of this Quarterly Report on Form 10-Q. Furthermore, there is no guarantee that the Company will prevail in this suit or receive any damages or other relief if it does prevail .

Operating Leases

The Company currently leases in San Diego, California approximately 43,000 square feet of corporate office and laboratory space, approximately 10,875 square feet of laboratory and office space at a second location and approximately 6,350 square feet of laboratory and office space at a third location.  The Company’s lease agreements in San Diego, as amended, for its corporate office and laboratory space and its second laboratory and office space, expire in December 2025, April 2017 and June 2018, respectively.  

For all leased properties the Company has provided a total security deposit of $346,000 to secure its obligations under the various leases, which has been included in prepaid and other assets.

 

17. Related Party Agreements

During the three and six months June 30, 2016 and 2015, the Company purchased products totaling $0 and $117,000 and $350,000 and $415,000, respectively, from Levena Biopharma Co., LTD (Levena), a Chinese Corporation.  The Company’s former Senior Vice President and Head of Antibody Drug Conjugates was one of the owners of Levena.  Levena ceased to be a related party during the first quarter of 2016.

In December 2014, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with Cambridge Equities, LP (Cambridge), an affiliated entity of Dr. Patrick Soon-Shiong (the “Investor”) pursuant to which the Company agreed to issue and sell to the Investor an aggregate of approximately 7.2 million shares of the Company’s common stock at a price of $5.80 per share for an aggregate purchase price of $41.7 million. In connection with the Purchase Agreement, the Investor received a warrant to purchase approximately 1.7 million shares of the Company’s Common Stock. The warrant is exercisable for a period of three years from the date of issuance at an initial exercise price of $5.80 per share.

In December 2014, the Company entered into a joint development and license agreement with Conkwest Inc., which has changed its name to NantKwest, and of which Dr. Patrick Soon-Shiong is a majority owner.  In addition, the Company purchased approximately 5.6 million shares of NantKwest common stock for $10.0 million.  Subsequent to June 30, 2016, the Company closed a transaction with the Chan Soon-Shiong Family Foundation and Cambridge Equities, LP to sell all of its investment in NantKwest, Inc. held by the Company.  See Note 19.

As described more fully in Notes 7 and 9, during 2015, the Company entered into a joint venture called Immunotherapy NANTibody, LLC, with NantCell, a wholly-owned subsidiary of NantWorks, a private company owned by Dr. Patrick Soon-Shiong.  In July 2015, the Company contributed its portion of the initial joint funding of $40.0 million to the Immunotherapy NANTibody joint venture.  The Company and NantCell have also entered into a license agreement pursuant to which the Company received a $10.0 million upfront license payment and $100.0 million of vested NantCell common stock.  As of June 30, 2016, the Company had not yet provided all of the items noted in the agreement and therefore has recorded the entire upfront payment and value of the equity interest received as deferred revenue.  

As described more fully in Notes 7 and 14, t he Company entered into a joint venture called NantCancerStemCell, LLC, or NantStem, with NantBioScience, a wholly-owned subsidiary of NantWorks.   In connection with negotiated changes to the structure of NantStem the Company issued a call option on shares of NantKwest that it owned to Cambridge, a related party to the Company and

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to NantBioScience.  The call option to Cambridge was on up to 2.0 million shares of NantKwest common s tock held by the Company (the Option Agreement).   The Option Agreement gave Cambridge the right to purchase up to 2.0 million shares at a price of $15.295 from time to time in the first quarter of 2016.  There was no option premium associated with this Op tion Agreement.  The Option Agreement was a derivative as defined in ASC 815 and was marked to fair value every reporting period the Option Agreement was in effect, with changes in fair value recognized in earnings.   The call option expired unexercised on March 31, 2016 and for the three and six months ended June 30, 2016 the Company recorded a gain of $0 and $5.5 million, respectively, upon the cancelation of the derivative liability.  As of June 30, 2016 no derivative liability was recorded on the Company ’s consolidated balance sheets.   In April 2015, the Company purchased 1.0 million shares of NantBioScience common stock for $10.0 million.  

In May 2015, the Company entered into a stock sale and purchase agreement with NantPharma, a private company owned by NantWorks pursuant to which the Company sold its equity interests in IgDraSol, its wholly-owned subsidiary and holder of the rights to Cynviloq for an upfront payment of $90.05 million and potential regulatory and sales milestones of up to $1.2 billion.  

As described more fully in Note 9, in June 2016, the Company agreed to accelerate and pay a $30.0 million milestone license payment by July 31, 2016, which has been accrued and recognized as acquired in-process research and development expense as of June 30, 2016, in exchange for the purchase by Mabtech Limited and one or more of its affiliates in June 2016, of $20.0 million of Company common stock and warrants.

As described more fully in Note 7, in March 2016, the Company and Yuhan entered into an agreement to form a joint venture company called ImmuneOncia Therapeutics, LLC, to develop and commercialize a number of immune checkpoint antibodies against undisclosed targets for both hematological malignancies and solid tumors.  During the three months ended June 30, 2016, Yuhan purchased $10.0 million of Company common stock and warrants.

As described more fully in Note 7, in June 2016, the Company and TNK entered into a joint venture agreement with 3SBio to develop and commercialize proprietary immunotherapies, including those developed from, including or using TNK’s chimeric antigen receptor T cell (“CAR-T”) technology targeting carcinoembryonic antigen (“CEA”) positive cancers.  In June 2016, 3SBio purchased $10.0 million of Company common stock and warrants.

18. Subsequent Events

Subsequent to June 30, 2016, the Company completed a letter agreement with the Chan Soon-Shiong Family Foundation (“Foundation”) and Cambridge Equities, LP (“Cambridge”) (the “Letter Agreement”). Pursuant to the terms of the Letter Agreement, among other things, (a) the Company agreed to sell to Foundation, and Foundation agreed to purchase from the Company, an aggregate of 5,618,326 shares of common stock of NantKwest, Inc. held by the Company, (b) Foundation agreed to sell to the Company, and the Company agreed to purchase all reported shares held by Foundation and Cambridge, an aggregate of 7,878,098 shares of common stock of the Company (“Common Stock”) held by Foundation and Cambridge, (c) Cambridge agreed to forfeit its right to purchase 500,000 shares of Common Stock issuable pursuant a warrant to purchase 1,724,138 shares of Common Stock held by Cambridge, and (d) the Company agreed to pay to Foundation an aggregate of approximately $15.64 million. The transactions contemplated under the Letter Agreement closed on July 7, 2016. Effective with the close of the transaction in July 2016, the Company will retire the 7,878,098 shares and has the ability to sell these shares for additional funds.

On July 11, 2016 the Company announced a license and collaboration agreement with Les Laboratoires Servier, SAS, a corporation incorporated under the laws of France, and Institut de Recherches Internationales Servier, a company duly organized and existing under the laws of France (individually and collectively, “Servier”) for the development, manufacture and commercialization of products using Sorrento's fully human immuno-oncology anti-PD-1 monoclonal antibody (mAb) STI-A1110.  Pursuant to the financial terms of that agreement the Company received a non-refundable up-front payment of $27.4 million in July of 2016.  

On August 2, 2016, the Company, its subsidiary Scintilla Pharmaceuticals, Inc., (“Scintilla”), and Scilex Pharmaceuticals, Inc. (“Scilex”) entered into a binding term sheet (the “Binding Term Sheet”) setting forth the terms and conditions by which Scintilla will, through a subsidiary, purchase all of the issued and outstanding equity of Scilex (the “Acquisition”). Subject to certain conditions, and in exchange for all of the issued and outstanding equity of Scilex, Scintilla will: (1) at the closing of the Acquisition (the “Closing”), pay to the equityholders of Scilex an aggregate of $100.00 (the “Cash Consideration”), and (2) following the earlier to occur of (a) the closing of the next third party equity financing of Scintilla or the initial public offering of shares of common stock of Scintilla (“Scintilla Common Stock”) in the United States (a “Financing”), or (b) the two-year anniversary of the Closing, issue to the equityholders of Scilex an aggregate of $70,000,000 of shares of Scintilla Common Stock, subject to adjustment in certain circumstances, based upon the valuation of Scintilla immediately after such Financing or otherwise as of the two-year anniversary of the Closing (the “Stock Consideration”); however, 20% of the Stock Consideration will be placed into escrow, a portion of which will be held for a period of up to six or 12 months to secure certain obligations of Scilex and its equityholders in connection with the

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Acquisition. The Cash Consideration and the Stock Consideration will be paid to the Scilex equityholders on a pro rata basis based on each such equityholder’s equity interest in Scilex as of the Closing.

The final terms of the Acquisition are subject to the negotiation and finalization of the definitive agreements relating to the Acquisition and the material terms of the Acquisition may differ from those set forth in the Binding Term Sheet. In addition, the Closing will be subject to various customary and other closing conditions.

 

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I tem 2.

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

This Quarterly Report on Form 10-Q contains “forward-looking statements” about our expectations, beliefs or intentions regarding our potential product offerings, business, financial condition, results of operations, strategies or prospects. You can identify forward-looking statements by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made and are often identified by the use of words such as “assumes,” “plans,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” or “will,” and similar expressions or variations. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described under the caption “Risk Factors” included elsewhere in this Quarterly Report on Form 10-Q and in our other filings with the Securities and Exchange Commission, or the SEC. Furthermore, such forward-looking statements speak only as of the date of this report. We undertake no obligation to update any forward-looking statements to reflect events or circumstances occurring after the date of such statements.

Overview

We are a biopharmaceutical company engaged in the discovery, acquisition, development and commercialization of proprietary drug therapeutics for addressing significant unmet medical needs worldwide. Our primary therapeutic focus is oncology, including the treatment of chronic cancer pain, but we are also developing therapeutic products for other indications, including immunology and infectious diseases. We currently have multiple clinical development programs underway: (i) CAR-T programs for solid tumors, (ii) resiniferatoxin, or RTX, a non-opiate, ultra-potent and selective agonist of the TRPV-1 receptor for intractable pain in end-stage disease, and (iii) biosimilar/biobetter antibodies clinical development programs .   

Our pipeline also includes preclinical fully human therapeutic monoclonal antibodies (mAbs), including biosimilars/biobetters, fully human anti-PD-L1 and anti-PD-1 checkpoint inhibitors derived from our proprietary G-MAB ® library platform, antibody drug conjugates (ADCs), bispecific antibodies (BsAbs), as well as Chimeric Antigen Receptor-T cell (CAR-T) and Chimeric Antigen Receptor Natural Killer (NK) cells (CAR.NK™) for adoptive cellular immunotherapy. Our objective is to develop our antibody drug products and adoptive cellular immunotherapies as: (i) First in Class (FIC), and/or (ii) Best in Class (BIC), which may offer greater efficacy and/or fewer adverse events or side effects as compared to existing drugs, as well as fully human therapeutic antibodies derived from our proprietary G-MAB ® antibody library platform and ADCs.    

Through June 30, 2016, we identified and further developed a number of potential drug product candidates across various therapeutic areas, and intend to select several lead product candidates to further advance into preclinical development activities in 2016. It is too early to assess which of these candidates, if any, will merit further evaluation in clinical trials. Our libraries were designed to facilitate the rapid identification and isolation of highly specific, antibody therapeutic product candidates that are fully-human and that bind to disease targets appropriate for antibody therapy. We built our initial antibody expression and production capabilities to enable us to make sufficient product material to conduct preclinical safety and efficacy testing in animal models.

Although we intend to retain ownership and control of product candidates by advancing their development, we regularly also consider, (i) partnerships with pharmaceutical or biopharmaceutical companies and (ii) sale of our products in each case, in order to balance the risks and costs associated with drug discovery, development and commercialization with efforts to maximize our stockholders’ returns. Our partnering objectives include generating revenue through license fees, milestone-related development fees and royalties as well as profit shares or joint ventures to generate potential returns from our product candidates.

Recent Developments

On April 3, 2016, we entered into a Securities Purchase Agreement (the “ABG Purchase Agreement”) with ABG SRNE Limited and Ally Bridge LB Healthcare Master Fund Limited (collectively, “Ally Bridge”), pursuant to which, among other things, we agreed to issue and sell to Ally Bridge and other purchasers that may be designated by Ally Bridge (collectively, the “ABG Purchasers”), in a private placement transaction (the “ABG Private Placement”), up to $50.0 million in shares of our common stock (“Common Stock”) and warrants to purchase shares of Common Stock. Upon the closing of the ABG Private Placement, we will issue to each ABG Purchaser (1) such number of shares (the “ABG Shares”) of Common Stock as is equal to the amount of such ABG Purchaser’s investment divided by $5.55, and (2) a warrant to purchase such number of shares of Common Stock as is equal to 30% of the ABG Shares sold and issued to such ABG Purchaser (each, an “ABG Warrant”); provided that , following the consummation of the ABG Private Placement, Ally Bridge and its affiliates will not beneficially own more than 9.99% of the outstanding shares of Common Stock. Each ABG Warrant will have an exercise price of $8.50 per share, will be immediately exercisable upon issuance, will have a term of three years and will be exercisable on a cash or cashless exercise basis.

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Under the terms of the ABG Pur chase Agreement, we are obligated to prepare and file with the Securities and Exchange Commission (the “SEC”), within 30 days of the closing date of the ABG Private Placement, a registration statement to register for resale the ABG Shares and the shares of Common Stock issuable upon exercise of each ABG Warrant (the “ABG Warrant Shares”), and may be required to effect certain registrations to register for resale the ABG Shares and the ABG Warrant Shares in connection with certain “piggy-back” registration r ights granted to the ABG Purchasers.

On April 3, 2016, we also entered into a Securities Purchase Agreement (collectively, the “Additional Purchase Agreements”) with each of Beijing Shijilongxin Investment Co., Ltd. ( “Beijing Shijilongxin”), FREJOY Investment Management Co., Ltd. (“Frejoy”) and Yuhan Corporation (“Yuhan”), pursuant to which, among other things, we agreed to issue and sell, in separate private placement transactions: (1) to Beijing Shijilongxin, 8,108,108 shares of Common Stock, and a warrant to purchase 1,176,471 shares of Common Stock, for an aggregate purchase price of $45.0 million; (2) to Frejoy, 8,108,108 shares of Common Stock, and a warrant to purchase 1,176,471 shares of Common Stock, for an aggregate purchase price of $45.0 million; and (3) to Yuhan, 1,801,802 shares of Common Stock, and a warrant to purchase 235,294 shares of Common Stock, for an aggregate purchase price of $10.0 million. The warrants to be issued pursuant to each of the Additional Purchase Agreements (collectively, the “Additional Warrants” and, together with each ABG Warrant, the “Warrants”) will have an exercise price of $8.50 per share, will be immediately exercisable upon issuance, will have a term of three years and will be exercisable on a cash or cashless exercise basis.

Under the terms of the Additional Purchase Agreements, each of Beijing Shijilongxin, Frejoy and Yuhan has the right to demand, at any time beginning six months after the closing of the transactions contemplated by the applicable Additional Purchase Agreement, that we prepare and file with the SEC a registration statement to register for resale such investor’s shares of Common Stock purchased pursuant to the applicable Additional Purchase Agreement and the shares of Common Stock issuable upon exercise of such investor’s Additional Warrant. In addition, we may be required to effect certain registrations to register for resale such shares in connection with certain “piggy-back” registration rights granted to Beijing Shijilongxin, Frejoy and Yuhan.

On May 2, 2016 we closed our previously announced private placement of common stock and warrants with Yuhan Corporation for gross proceeds of $10.0 million.  Yuhan purchased 1,801,802 shares of common stock at $5.55 per share and a warrant to purchase 235,294 shares of common stock.  The warrant is exercisable for three years at an exercise price of $8.50 per share.

On June 8, 2016 we closed on the remainder of the $150.0 million financing. Ally Bridge Group ("ABG"), a global healthcare-focused investment group based in Hong Kong, led the financing and, together with Beijing Shijilongxin Investment Co., Ltd. ("Beijing Shijilongxin"), and FREJOY Investment Management Co., Ltd. ("Frejoy") collectively purchased 25,225,221 shares of common stock at $5.55 per share, and warrants to purchase 5,055,642 shares of common stock for total consideration of $140.0 million.

In June 2015, the National Institutes of Health, or NIH announced that the Clinical Center suspended operations of its Pharmaceutical Development Section after FDA inspections that occurred in May 2015.  An FDA inspection report issued on May 29, 2015 noted “deficiencies in the physical facility, including flaws in the air handling system, and operational failures including inadequate quality control, insufficient employee training, and lack of compliance with standard operating procedures”.  As a result, 46 clinical programs, including the resiniferatoxin (RTX) study in patients with severe pain in advanced cancer, were placed on clinical hold by the FDA.  NIH has developed an interim corrective action/preventative action plan which has not yet been approved by the FDA.  The Company plans to continue with its already planned corporate IND for RTX.

Subsequent to June 30, 2016, we completed a letter agreement with the Chan Soon-Shiong Family Foundation (“Foundation”) and Cambridge Equities, LP (“Cambridge”) (the “Letter Agreement”). Pursuant to the terms of the Letter Agreement, among other things, (a) we agreed to sell to Foundation, and Foundation agreed to purchase from us, an aggregate of 5,618,326 shares of common stock of NantKwest, Inc. held by us, (b) Foundation agreed to sell to us, and we agreed to purchase all reported shares held by Foundation and Cambridge, an aggregate of 7,878,098 shares of our common stock (“Common Stock”) held by Foundation and Cambridge, (c) Cambridge agreed to forfeit its right to purchase 500,000 shares of Common Stock issuable pursuant a warrant to purchase 1,724,138 shares of Common Stock held by Cambridge, and (d) we agreed to pay to Foundation an aggregate of approximately $15.6 million. The transactions contemplated under the Letter Agreement closed on July 7, 2016. Effective with the close of the transaction in July 2016, we will retire the 7,878,098 shares and we have the ability to sell these shares for additional funds.

On July 11, 2016 we announced a license and collaboration agreement with Les Laboratoires Servier, SAS, a corporation incorporated under the laws of France, and Institut de Recherches Internationales Servier, a company duly organized and existing under the laws of France (individually and collectively, “Servier”) for the development, manufacture and commercialization of products using our fully human immuno-oncology anti-PD-1 monoclonal antibody (mAb) STI-A1110. Pursuant to the financial terms of that agreement we received a non-refundable up-front payment of $27.4 million in July of 2016.

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Critical Accounting Policies and Estimates

Management’s discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements which are prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities, related disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. We continually evaluate our estimates and judgments, the most critical of which are those related to income taxes and stock-based compensation. We base our estimates and judgments on historical experience and other factors that we believe to be reasonable under the circumstances. Materially different results can occur as circumstances change and additional information becomes known.

During the quarter ended June 30, 2016, there were no significant changes to the items that we disclosed as our critical accounting policies and estimates in Note 2 to our consolidated financial statements for the year ended December 31, 2015 contained in our 2015 Form 10-K, as filed with the SEC.

Results of Operations

The following describes certain line items set forth in our consolidated statements of operations.

Comparison of the Three Months Ended June 30, 2016 and 2015

Revenues . Revenues were $902,000 for the three months ended June 30, 2016, as compared to $1,173,000 for the three months ended June 30, 2015. The net decrease of $271,000 is primarily due to a decrease in activities under our active grants for the three months ended June 30,2016 compared to the corresponding period of 2015 and by lower sales and service revenues generated from the sale of customized reagents and providing contract development services.

In June 2014, the National Institute of Allergy and Infectious Diseases, or NIAID, a division of the National Institutes of Health, or NIH awarded us a Phase II STTR grant to support the advanced preclinical development of human bispecific antibody therapeutics to prevent and treat Staphylococcus aureus ( S. aureus or Staph) infections, including methicillin-resistant S. aureus (MRSA), or the Staph Grant III award. The project period for this Phase II grant covers a two-year period which commenced in June 2014, with total funds available of approximately $1 million per year for up to 2 years. During the three months ended June 30, 2016 and 2015, we recorded $218,000 and $331,000 of revenue, respectively, associated with the Staph Grant III award.

In June 2014, we were awarded a Phase I STTR grant entitled “Anti-Pseudomonas Immunotherapy and Targeted Drug Delivery” from the NIAID. This grant will support the preclinical development of novel anti- Pseudomonas aeruginosa mAb immunotherapy or an antibody-mediated targeted antibiotic delivery vehicle. Each modality may be an effective and safe stand-alone therapy and/or a component of a “cocktail” therapeutic option for prevention and treatment of P. aeruginosa infections. The project period for this Phase I grant covers a two-year period which commenced in July 2014, with total funds available of approximately $300,000 per year for up to 2 years.  During the three months ended June 30, 2016 and 2015, we recorded $98,000 and $38,000 of revenue, respectively, associated with the Phase I STTR grant award.

In July 2014, we were awarded a Phase I STTR grant from the National Cancer Institute (NCI), a division of the NIH, entitled “Targeting of Myc-Max Dimerization for the Treatment of Cancer”. This grant will support the preclinical development of the Myc inhibitor, which interferes with the protein-protein interaction (PPI) between Myc and its obligatory dimerization partner, Max, preventing sequence-specific binding to DNA and subsequent initiation of oncogenic transformation. The project period for this Phase I grant covers a one-year period which commenced in August 2014, with total funds available of approximately $225,000.  During the three months ended June 30, 2016 and 2015, we recorded $0 and $56,000 of revenue, respectively associated with the Phase I Myc grant award.

In August 2014, we were awarded a Phase I Small Business Technology Transfer (SBIR) grant from the National Heart, Lung, and Blood Institute (NHBLI), a division of the NIH, entitled “Human Anti-WISP-1 Antibodies for Treatment of Idiopathic Pulmonary Fibrosis”. This grant will advance the Company’s immunotherapy targeting WNT-1 Inducible Signaling Protein-1(WISP1) for the treatment of Idiopathic Pulmonary Fibrosis (IPF). WISP1 is a protein that has been shown to be upregulated in IPF, linked to key growth factors, cellular proliferation, hyperplasia and is correlated with late stage cancers. IPF is a fatal disease, which results in progressive loss of lung function due to fibrosis of the lungs. The project period for this Phase I grant covers a one-year period which commenced in August 2014, with total funds available of approximately $225,000.  During the three months ended June 30, 2016 and 2015, we recorded $0 and $21,000 of revenue, respectively, associated with the Phase I WISP1 grant award.

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Revenues from a human immune-oncology anti PD-L1 license agreement for the three months ended June 30, 2016 and 2015, were $13,000 and $13,000, respectively.  We had no other revenue during the three months ended June 30, 201 6 and 2015 as we have not yet developed any product candidates for commercialization or earned any licensing or royalty payments.

We expect that any revenue we generate will fluctuate from quarter to quarter as a result of the unpredictability of the demand for products and services offered as well as the timing and amount of grant awards, research and development reimbursements and other payments received under any strategic collaborations, if any.

Cost of revenues . Cost of revenues for the three months ended June 30, 2016 and 2015 were $295,000 and $314,000, respectively, and relate to the sale of customized reagents and providing contract development services. The costs generally include employee-related expenses including salary and benefits, direct materials and overhead costs including rent, depreciation, utilities, facility maintenance and insurance.

Research and Development Expenses . Research and development expenses for the three months ended June 30, 2016 and 2015 were $10,631,000 and $7,971,000, respectively. Research and development expenses include the costs to advance our CAR-T programs for solid tumors, our RTX program towards entering into future clinical trials, our biosimilar/biobetter antibodies development, costs to identify, isolate and advance human antibody drug candidates derived from our libraries as well as advancing our ADC preclinical drug candidates, preclinical testing expenses and the expenses associated with fulfilling our development obligations related to the NIH grant awards, collectively the NIH Grants. Such expenses consist primarily of salaries and personnel related expenses, stock-based compensation expense, clinical development expenses, preclinical testing, lab supplies, consulting costs, depreciation and other expenses. The increase of $2,660,000 is primarily attributable to salaries and personnel related expenses and lab supplies and other preclinical related expenses. We expect research and development expenses to increase in absolute dollars as we: (i) advance our CAR-T programs, (ii) advance RTX into clinical trials and pursue other potential indications, the cost of acquiring, developing and manufacturing clinical trial materials, and other regulatory operating activities, (iii) advance our biosimilar/biobetter antibodies clinical development program, (iv) incur incremental expenses associated with our efforts to further advance a number of potential product candidates into preclinical development activities, (v) continue to identify and advance a number of fully human therapeutic antibody and ADC preclinical product candidates, (vi) incur higher salary, lab supply and infrastructure costs incurred in connection with supporting all of our programs, and (vii) invest in our JV’s or other third party agreements.

Acquired In-process Research and Development Expenses . Acquired in-process research and development expenses for the three months ended June 30, 2016 and 2015 were $32.0 million and $0, respectively. Acquired in-process research and development expenses for the three months ended June 30, 2016 include costs associated with the purchase price of the license rights from Mabtech Limited and the purchase price of the license rights from the City of Hope.

General and Administrative Expenses . General and administrative expenses for the three months ended June 30, 2016 and 2015 were $4,220,000 and $3,072,000, respectively. General and administrative expenses consist primarily of salaries and personnel related expenses for executive, finance and administrative personnel, stock-based compensation expense, professional fees, infrastructure expenses, legal and accounting expenses and other general corporate expenses. The increase of $1,148,000 is primarily attributable to higher legal costs, higher salaries and related compensation expenses, consulting expenses and rent and facility expenses. We expect general and administrative expenses to increase in absolute dollars as we: (i) incur incremental expenses associated with expanded operations and development efforts, (ii) compliance with our public reporting obligations, (iii) increased infrastructure costs, and (iv) invest in our JV’s or other third party agreements.

Intangible Amortization . Intangible amortization for the three months ended June 30, 2016 and 2015 was $111,000 and $349,000, respectively. The decrease in the three months ended June 30, 2016 as compared to the same period in 2015 is due to license rights being amortized on a straight line basis through the date those assets were sold in 2015.

Income (loss) on equity investments .  Income on equity investments for the three months ended June 30, 2016 and 2015 was $470,000 and $0, respectively.  The increase in the three months ended June 30, 2016 as compared to the same period in 2015 is due to the recognition of our portion of the income from operations from our joint venture entities which did not exist during the same period in 2015.

Interest Expense . Interest expense for the three months ended June 30, 2016 and 2015 was $273,000 and $442,000, respectively. The decrease in interest expense resulted primarily from lower average borrowings under the amended loan and security agreement.

Interest Income . Interest income for the three months ended June 30, 2016 and 2015 was $45,000 and $0, respectively. We expect that continued low interest rates will significantly limit our interest income in the near term.

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Income tax benefit . Income tax provision for the three months ended June 30, 2016 and 2015 was $0 and a tax benefit of $17,000, respectively. The decrease in income tax benefit resulted mainly from the amortization and decrease of deferred tax liabilities and return to provision adjustments recorded for the three months ended June 30, 2015 .

Net Loss . Net loss for the three months ended June 30, 2016 and 2015 was $46.1 million and $11.0 million, respectively.  The increase in net loss resulted primarily from increased acquired in-process research and development expense, general and administrative expenses and research and development activities partially offset by the decrease in loss on equity investments.

Comparison of the Six Months Ended June 30, 2016 and 2015

Revenues . Revenues were $1,890,000 for the six months ended June 30, 2016, as compared to $2,150,000 for the six months ended June 30, 2015. The net decrease of $260,000 is primarily due to a decrease in sales and service revenues generated from the sale of customized reagents and providing contract development services partially offset by an increase in activities under our active grants for the six months ended June 30, 2016 compared to the corresponding period of 2015.

In June 2014, the National Institute of Allergy and Infectious Diseases, or NIAID, a division of the National Institutes of Health, or NIH awarded us a Phase II STTR grant to support the advanced preclinical development of human bispecific antibody therapeutics to prevent and treat Staphylococcus aureus ( S. aureus or Staph) infections, including methicillin-resistant S. aureus (MRSA), or the Staph Grant III award. The project period for this Phase II grant covers a two-year period which commenced in June 2014, with total funds available of approximately $1.0 million per year for up to 2 years. During the six months ended June 30, 2016 and 2015, we recorded $457,000 and $417,000 of revenue, respectively, associated with the Staph Grant III award.  

In June 2014, we were awarded a Phase I STTR grant entitled “Anti-Pseudomonas Immunotherapy and Targeted Drug Delivery” from the NIAID. This grant will support the preclinical development of novel anti- Pseudomonas aeruginosa mAb immunotherapy or an antibody-mediated targeted antibiotic delivery vehicle. Each modality may be an effective and safe stand-alone therapy and/or a component of a “cocktail” therapeutic option for prevention and treatment of P. aeruginosa infections. The project period for this Phase I grant covers a two-year period which commenced in July 2014, with total funds available of approximately $300,000 per year for up to 2 years.  During the six months ended June 30, 2016 and 2015, we recorded $224,000 and $93,000 of revenue, respectively, associated with the Phase I STTR grant award.

In July 2014, we were awarded a Phase I STTR grant from the National Cancer Institute (NCI), a division of the NIH, entitled “Targeting of Myc-Max Dimerization for the Treatment of Cancer”. This grant will support the preclinical development of the Myc inhibitor, which interferes with the protein-protein interaction (PPI) between Myc and its obligatory dimerization partner, Max, preventing sequence-specific binding to DNA and subsequent initiation of oncogenic transformation. The project period for this Phase I grant covers a one-year period which commenced in August 2014, with total funds available of approximately $225,000.  During the six months ended June 30, 2016 and 2015, we recorded $0 and $130,000 of revenue, respectively associated with the Phase I Myc grant award.

In August 2014, we were awarded a Phase I Small Business Technology Transfer (SBIR) grant from the National Heart, Lung, and Blood Institute (NHBLI), a division of the NIH, entitled “Human Anti-WISP-1 Antibodies for Treatment of Idiopathic Pulmonary Fibrosis”. This grant will advance the Company’s immunotherapy targeting WNT-1 Inducible Signaling Protein-1(WISP1) for the treatment of Idiopathic Pulmonary Fibrosis (IPF). WISP1 is a protein that has been shown to be upregulated in IPF, linked to key growth factors, cellular proliferation, hyperplasia and is correlated with late stage cancers. IPF is a fatal disease, which results in progressive loss of lung function due to fibrosis of the lungs. The project period for this Phase I grant covers a one-year period which commenced in August 2014, with total funds available of approximately $225,000.  During the six months ended June 30, 2016 and 2015, we recorded $52,000 and $31,000 of revenue, respectively, associated with the Phase I WISP1 grant award.

Revenues from a human immune-oncology anti PD-L1 license agreement for the six months ended June 30, 2016 and 2015, were $25,000 and $25,000, respectively.  We had no other revenue during the six months ended June 30, 2016 and 2015 as we have not yet developed any product candidates for commercialization or earned any licensing or royalty payments.

We expect that any revenue we generate will fluctuate from quarter to quarter as a result of the unpredictability of the demand for products and services offered as well as the timing and amount of grant awards, research and development reimbursements and other payments received under any strategic collaborations, if any.

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Cost of revenues . Cost of revenues for the six months ended June 30, 2016 and 2015 were $654,000 and $823,000, respectively, and relate to the sale of customized reagents and providing contract development services. The costs generally include employee-related expenses in cluding salary and benefits, direct materials and overhead costs including rent, depreciation, utilities, facility maintenance and insurance.

Research and Development Expenses . Research and development expenses for the six months ended June 30, 2016 and 2015 were $18,408,000 and $15,811,000, respectively. Research and development expenses include the costs to advance our CAR-T programs for solid tumors, our RTX program towards entering into future clinical trials, our biosimilar/biobetter antibodies development, costs to identify, isolate and advance human antibody drug candidates derived from our libraries as well as advancing our ADC preclinical drug candidates, preclinical testing expenses and the expenses associated with fulfilling our development obligations related to the NIH grant awards, collectively the NIH Grants. Such expenses consist primarily of salaries and personnel related expenses, stock-based compensation expense, clinical development expenses, preclinical testing, lab supplies, consulting costs, depreciation and other expenses. The increase of $2,597,000 is primarily attributable to increased salaries and personnel related expenses and lab supplies and other preclinical related expenses. We expect research and development expenses to increase in absolute dollars as we: (i) advance our CAR-T programs, (ii) advance RTX into clinical trials and pursue other potential indications, the cost of acquiring, developing and manufacturing clinical trial materials, and other regulatory operating activities, (iii) advance our biosimilar/biobetter antibodies clinical development program, (iv) incur incremental expenses associated with our efforts to further advance a number of potential product candidates into preclinical development activities, (v) continue to identify and advance a number of fully human therapeutic antibody and ADC preclinical product candidates, (vi) incur higher salary, lab supply and infrastructure costs incurred in connection with supporting all of our programs, and (vii) invest in our JV’s or other third party agreements.

Acquired In-process Research and Development Expenses . Acquired in-process research and development expenses for the six months ended June 30, 2016 and 2015 were $45.0 million and $0, respectively. Acquired in-process research and development expenses for the six months ended June 30, 2016 include costs associated with the purchase price of the license rights from Mabtech Limited and the purchase price of the license rights from the City of Hope.

General and Administrative Expenses . General and administrative expenses for the six months ended June 30, 2016 and 2015 were $8,715,000 and $5,291,000, respectively. General and administrative expenses consist primarily of salaries and personnel related expenses for executive, finance and administrative personnel, stock-based compensation expense, professional fees, infrastructure expenses, legal and accounting expenses and other general corporate expenses. The increase of $3,424,000 is primarily attributable to higher legal costs, higher salaries and related compensation expenses, consulting expenses and rent and facility expenses. We expect general and administrative expenses to increase in absolute dollars as we: (i) incur incremental expenses associated with expanded operations and development efforts, (ii) compliance with our public reporting obligations, (iii) increased infrastructure costs, and (iv) invest in our JV’s or other third party agreements.

Intangible Amortization . Intangible amortization for the six months ended June 30, 2016 and 2015 was $222,000 and $935,000, respectively. The decrease in the six months ended June 30, 2016 as compared to the same period in 2015 is due to license rights being amortized on a straight line basis through the date those assets were sold in 2015.

Gain on expiration of derivative liability .  Gain on expiration of the derivative liability for the six months ended June 30, 2016 and 2015 was $5,520,000 and $0, respectively.  The increase in the six months ended June 30, 2016 as compared to the same period in 2015 is due to the expiration of the unexercised derivative liability on March 31, 2016.

Income (loss) on equity investments .  Loss on equity investments for the six months ended June 30, 2016 and 2015 was $29,000 and $0, respectively.  The increase in the six months ended June 30, 2016 as compared to the same period in 2015 is due to the recognition of our portion of the loss from operations from our joint venture entities which did not exist during the same period in 2015.

Interest Expense . Interest expense for the six months ended June 30, 2016 and 2015 was $580,000 and $881,000, respectively. The decrease in interest expense resulted primarily from lower average borrowings under the amended loan and security agreement.

Interest Income . Interest income for the six months ended June 30, 2016 and 2015 was $58,000 and $0, respectively. We expect that continued low interest rates will significantly limit our interest income in the near term.

Income tax benefit . Income tax provision for the six months ended June 30, 2016 and 2015 was $0 and a tax benefit of $195,000, respectively. The decrease in income tax benefit resulted mainly from the amortization and decrease of deferred tax liabilities and return to provision adjustments recorded for the six months ended June 30, 2015 .

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Net Loss . Net loss for the six months ended June 30, 2016 and 2015 was $66.1 million and $21.4 million, respectively.  The increase in n et loss resulted primarily from increased acquired in-process research and development expense, increased loss on equity investments and general and administrative expenses partially offset by decreased research and development activities, interest expense and the gain on the expiration of derivative liability.

Liquidity and Capital Resources

As of June 30, 2016, we had $98.2 million in cash and cash equivalents attributable primarily to the net proceeds of $92.3 million from the sale of common stock and warrants under the private placements in 2016 and from $3.5 million in net proceeds from the sale of common stock through our ATM facility.  Our working capital as of June 30, 2016 was $85.2 million.

Cash Flows from Operating Activities . Net cash used for operating activities was $32.4 million for 2016 and is primarily attributable to our net loss of $66.1 million, partially offset by approximately $28.2 million in non-cash activities relating to stock-based compensation, an increase in acquired in-process research and development and gain on expiration of derivative liability and other non-cash activities. Net cash used for operating activities was $7.6 million for 2015 and primarily reflects a net loss of $21.4 million, which was partially offset by approximately $4.3 million in non-cash activities relating primarily to stock-based compensation and depreciation expense.

We expect to continue to incur substantial and increasing losses and negative net cash flows from operating activities as we expand and support our clinical and preclinical development and research activities and fund our JV’s and collaborations.

Cash Flows from Investing Activities . Net cash used by investing activities was $2.2 million for 2016 as compared to $12.0 million for 2015. The net cash used in 2016 related primarily to the equipment acquired for research and development activities. The net cash used in 2015 related primarily to investments in common stock.

We expect to increase our investment in equipment as we seek to expand and progress our research and development capabilities.

Cash Flows from Financing Activities . Net cash provided by financing activities was $93.7 million for 2016 which was primarily from the sale of common stock and warrants under the private placements in the second quarter of 2016, from the sale of common stock under our ATM facility and from the proceeds from option exercises, partially offset by the payment of principal payments under our amended and restated loan and security agreement as compared to cash used by financing activities of $651,000 in 2015 which related primarily to payment of deferred compensation partially offset by the proceeds from option exercises.

Future Liquidity Needs . We have principally financed our operations through underwritten public offerings, private equity financings and sales of common stock under our ATM facility, as we have not generated any product related revenue from our principal operations to date, and do not expect to generate significant revenue for several years, if ever. We will need to raise additional capital before we exhaust our current cash resources in order to continue to fund our research and development, including our plans for clinical and preclinical trials and new product development, as well as to fund operations generally. As and if necessary, we will seek to raise additional funds through various potential sources, such as equity and debt financings, or through corporate collaboration and license agreements. We can give no assurances that we will be able to secure such additional sources of funds to support our operations, or, if such funds are available to us, that such additional financing will be sufficient to meet our needs.

We anticipate that we will continue to incur net losses into the foreseeable future as we: (i) advance clinical stage product candidates such as biosimilar/biobetter antibodies, CAR-T programs and RTX in the clinic and potentially pursues other development, (ii) continue to identify a number of potential mAb and ADC drug candidates and further advance various preclinical and development activities, (iii) advance our product candidates into the clinic, (iv) invest in additional joint ventures or third party collaboration or acquisition agreements, and (v) expand corporate infrastructure, including the costs associated with being a NASDAQ listed public company. Based on currently available resources, we believe we have the ability to meet all obligations due over the course of the next twelve months.

We plan to continue to fund our operating losses and capital funding needs through public or private equity or debt financings, strategic collaborations, licensing arrangements, asset sales, government grants or other arrangements. We filed a universal shelf registration statement on Form S-3 with the Securities and Exchange Commission (“SEC”), which was declared effective by the SEC in July 2013 (the “2013 Shelf Registration Statement”). The 2013 Shelf Registration Statement provides us the ability to offer up to $100 million of securities, including equity and other securities as described in the registration statement. After the May 2014 underwritten offering, we have the ability to offer up to $36.6 million of additional securities under the 2013 Shelf Registration Statement. In November 2014, we filed an additional universal shelf registration statement on Form S-3 with the SEC, which was declared effective by the SEC in December 2014 (the “2014 Shelf Registration Statement”). The 2014 Shelf Registration Statement

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provides us with th e ability to offer up to $250 million of securities, including equity and other securities as described in the registration statement. Included in the 2014 Shelf Registration Statement is a sales agreement prospectus covering the offering, issuance and sal e by us of up to a maximum aggregate offering price of $50 million of our common stock that may be issued and sold under a sales agreement with MLV & Co. LLC (the “ATM Facility”).   During the six months ended June 30, 2016 we sold approximately $3.6 millio n under the ATM Facility.  After the first and second quarter 2016 sales activities we have the ability to offer up to $46.4 million of additional securities under the ATM Facility.  Pursuant to these Shelf Registration Statements, we may offer such securi ties from time to time and through one or more methods of distribution, subject to market conditions and our capital needs. Specific terms and prices will be determined at the time of each offering under a separate prospectus supplement, which will be file d with the SEC at the time of any offering. However, we cannot be sure that such additional funds will be available on reasonable terms, or at all. If we are unable to secure adequate additional funding, we may be forced to make reductions in spending, ext end payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. In addition, if we do not meet our payment obligations to third parties as they come due, we may be subject to litigation claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. Any of these actions could materially harm our business, results of operations, and future prospects .

If we raise additional funds by issuing equity securities, substantial dilution to existing stockholders would result. If we raise additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to operate our business.

Off-Balance Sheet Arrangements

Since our inception through June 30, 2016, we have not engaged in any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K.

New Accounting Pronouncements

Refer to Note 1, “Nature of Operations, Summary of Significant Accounting Polices and Business Activities,” in the accompanying notes to the consolidated financial statements for a discussion of recent accounting pronouncements.

 

I tem 3.

Quantitative and Qualitative Disclosures About Market Risk.  

Interest Rate Risk. Our exposure to market risk is confined to our cash and cash equivalents. We have cash and cash equivalents and invest primarily in high-quality money market funds, which we believe are subject to limited credit risk. Due to the low risk profile of our investments, an immediate 10% change in interest rates would not have a material effect on the fair market value of our portfolio. Our amended and restated loan and security agreement has a fixed interest rate of 7.95% per annum through the loan maturity. We do not believe that we have any material exposure to interest rate risk arising from our investments.

Capital Market Risk . We currently do not have significant revenues from grants or sales and services and we have no product revenues from our planned principal operations and therefore depend on funds raised through other sources. One source of funding is through future debt or equity offerings. Our ability to raise funds in this manner depends upon, among other things, capital market forces affecting our stock price.

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I tem 4.

Controls and Procedures.  

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

In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. As required by Rule 13a-15(b) promulgated by the SEC under the Exchange Act, we carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on the foregoing, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Quarterly Report on Form 10-Q.

Changes in Internal Control Over Financial Reporting

There has been no change in our internal control over financial reporting during the quarter ended June 30, 2016 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

 

 

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P ART II. OTHER INFORMATION

I tem 1.

Legal Proceedings.

To the best of our knowledge, we are not a party to any legal proceedings that, individually or in the aggregate, are deemed to be material to our financial condition or results of operations.  

In the normal course of business, the Company may be named as a defendant in one or more lawsuits. The Company is not a party to any outstanding material litigation and management is currently not aware of any legal proceedings that, individually or in the aggregate, are deemed to be material to its financial condition or results of operations.  

On April 25, 2016, Wildcat Liquid Alpha, LLC (“WLA”) filed a complaint in the Court of Chancery of the State of Delaware seeking an order compelling the Company to provide WLA with certain documents, books and records for inspection and copying pursuant to an April 11, 2016 demand made by WLA.  The Company believes that WLA’s April 11, 2016 demand for documents and the corresponding litigation are deficient and without merit, and will vigorously defend itself against both. The Company is unable to determine whether any loss will occur with respect to this matter or to estimate the range of such potential loss; therefore, no amount of loss has been accrued by the Company as of the date of filing of this Quarterly Report on Form 10-Q. Furthermore, there is no guarantee that the Company will prevail in this action or receive any relief if it does prevail.

On May 13, 2016, WLA filed a derivative action in the Court of Chancery of the State of Delaware against each of the members of the Board and against the Company as nominal defendant alleging, among other things: (1) breach of fiduciary duty with respect to the Company’s prior announcement of four transactions through which investors agreed to purchase up to $150 million of shares of our common stock and warrants; (2) breach of fiduciary duty with respect to the formation of, and certain options and warrants issued by, certain of the Company’s subsidiaries to Dr. Ji and members of the Board; (3) waste of corporate assets; (4) unjust enrichment; and (5) mismanagement, including questioning the Company’s decisions to make passive investments in other corporations (the “Derivative Action”). The Company believes that the Derivative Action is without merit, and will vigorously defend itself against the action. The Company is unable to determine whether any loss will occur with respect to the Derivative Action or to estimate the range of such potential loss; therefore, no amount of loss has been accrued by the Company as of the date of filing of this Quarterly Report on Form 10-Q. Furthermore, there is no guarantee that the Company will prevail in this suit or receive any damages or other relief if it does prevail.

I tem 1A.

Risk Factors.

Our Annual Report on Form 10-K for the year ended December 31, 2015, Part I –Item 1A, Risk Factors, describes important risk factors that could cause our business, financial condition, results of operations and growth prospects to differ materially from those indicated or suggested by forward-looking statements made in this Form 10-Q or presented elsewhere by management from time to time. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially and adversely affect our business.

There have been no material changes in our risk factors since the filing of our Annual Report on Form 10-K for the year ended December 31, 2015.

I tem 6.

Exhibits.

The exhibits listed in the Exhibit Index immediately preceding the exhibits are filed as part of this Quarterly Report on Form 10-Q and such Exhibit Index is incorporated herein by reference.

 

37


 

S IGNATURES

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

 

 

 

Sorrento Therapeutics, Inc.

 

 

 

 

 

Date: August 8, 2016

 

By:  

 

/s/ Henry Ji, PH.D. 

 

 

 

 

Henry Ji, Ph.D.

 

 

 

 

Director, Chief Executive Officer & President

 

 

 

 

(Principal Executive Officer)

 

 

 

 

 

Date: August 8, 2016

 

By:  

 

/s/ Kevin M. Herde 

 

 

 

 

Kevin M. Herde

 

 

 

 

Executive Vice President, Chief Financial Officer

 

 

 

 

(Principal Financial and Accounting Officer)

 

38


 

EXHIBIT INDEX

 

4.1

 

Form of Common Stock Purchase Warrant issued to investors pursuant to the Securities Purchase Agreement, dated as of April 3, 2016, by and among Sorrento Therapeutics, Inc., ABG SRNE Limited and Ally Bridge LB Healthcare Master Fund Limited (incorporated by reference to Exhibit 4.9 to the Registrant’s Registration Statement on Form S-3 filed with the SEC on June 29, 2016).

 

 

 

4.2

 

Form of Common Stock Purchase Warrant issued to investors pursuant to the Securities Purchase Agreement, dated as of April 3, 2016, by and between Sorrento Therapeutics, Inc. and FREJOY Investment Management Co., Ltd. and Securities Purchase Agreement, dated as of April 3, 2016, by and between Sorrento Therapeutics, Inc. and Beijing Shijilongxin Investment Co., Ltd. (incorporated by reference to Exhibit 4.10 to the Registrant’s Registration Statement on Form S-3 filed with the SEC on June 29, 2016).

 

 

 

4.3

 

Common Stock Purchase Warrant issued to Yuhan Corporation on April 29, 2016 (incorporated by reference to Exhibit 4.11 to the Registrant’s Registration Statement on Form S-3 filed with the SEC on June 29, 2016).

 

 

 

10.1

 

Securities Purchase Agreement, dated as of April 3, 2016, by and among Sorrento Therapeutics, Inc., ABG SRNE Limited and Ally Bridge LB Healthcare Master Fund Limited (incorporated by reference to Exhibit 4.5 to the Registrant’s Registration Statement on Form S-3 filed with the SEC on June 29, 2016).

 

 

 

10.2

 

Securities Purchase Agreement, dated as of April 3, 2016, by and between Sorrento Therapeutics, Inc. and FREJOY Investment Management Co., Ltd. (incorporated by reference to Exhibit 4.6 to the Registrant’s Registration Statement on Form S-3 filed with the SEC on June 29, 2016).

 

 

 

10.3

 

Securities Purchase Agreement, dated as of April 3, 2016, by and between Sorrento Therapeutics, Inc. and Beijing Shijilongxin Investment Co., Ltd. (incorporated by reference to Exhibit 4.7 to the Registrant’s Registration Statement on Form S-3 filed with the SEC on June 29, 2016).

 

 

 

10.4

 

Securities Purchase Agreement, dated as of April 3, 2016, by and between Sorrento Therapeutics, Inc. and Yuhan Corporation (incorporated by reference to Exhibit 4.8 to the Registrant’s Registration Statement on Form S-3 filed with the SEC on June 29, 2016).

 

 

 

10.5

 

Voting Agreement, dated as of April 29, 2016, by and between Sorrento Therapeutics, Inc. and Yuhan Corporation (incorporated by reference to Exhibit 4.12 to the Registrant’s Registration Statement on Form S-3 filed with the SEC on June 29, 2016).

 

 

 

10.6

 

Letter Agreement , dated June 30, 2016, among Chan Soon-Shiong Family Foundation, Cambridge Equities, L.P. and Sorrento Therapeutics, Inc.

 

 

 

10.7*

 

License and Collaboration Agreement, dated July 6, 2016, among Les Laboratoires Servier, SAS, Institut de Recherches Internationales Servier and Sorrento Therapeutics, Inc.

* The Registrant has requested confidential treatment with respect to certain portions of the exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.

39


 

 

31.1

  

Certification of Henry Ji, Ph.D., Principal Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended.

 

 

 

31.2

  

Certification of Kevin M. Herde, Principal Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended.

 

 

 

32.1

  

Certification of Henry Ji, Ph.D., Principal Executive Officer, and Kevin M. Herde, Principal Financial Officer, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, as amended.

 

 

 

101.INS

  

XBRL Instance Document

 

 

 

101.SCH

  

XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL

  

XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

101.DEF

  

XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

101.LAB

  

XBRL Taxonomy Extension Label Linkbase Document

 

 

 

101.PRE

  

XBRL Taxonomy Extension Presentation Linkbase Document

 

*Portions of this exhibit were omitted and filed separately with the U.S. Securities and Exchange Commission pursuant to a request for confidential treatment.

**Sorrento hereby undertakes to furnish supplementally a copy of any omitted schedule or exhibit to such agreement to the U.S. Securities and Exchange Commission upon request .

+Management contract or compensatory plan.

 

40

 

Exhibit 10.6

 

June 30, 2016

 

Sorrento Therapeutics, Inc.

9380 Judicial Drive

San Diego, California 92121

 

Ladies and Gentlemen:

This letter agreement (this “ Agreement ”) sets forth the terms and conditions of a binding agreement among Sorrento Therapeutics, Inc., a Delaware corporation (“ Sorrento ”), the Chan Soon-Shiong Family Foundation, a Delaware exempt corporation (“ CSSFF ”), and Cambridge Equities, LP, a Delaware limited partnership (“ Cambridge ”), with reference to the following facts:

A. CSSFF owns, in the aggregate, 7,878,098 shares of common stock, par value $0.0001 per share of Sorrento (the “ Sorrento Shares ”).

B. Cambridge owns a Common Stock Purchase Warrant, dated December 22, 2014, to purchase 1,724,138 shares of Sorrento Common Stock at an exercise price of $5.80 per share (the “ Sorrento Warrant ”).

C. Sorrento owns, in the aggregate, 5,618,326 shares of common stock, par value $0.0001 per share of NantKwest, Inc. (“ NantKwest Shares ”).

1. Purchase and Sale of Sorrento Shares; Sorrento Warrant .   Subject to the terms and conditions of this Agreement, at the Closing, CSSFF will sell to Sorrento, and Sorrento will purchase from CSSFF, the Sorrento Shares.  Subject to the terms and conditions of this Agreement, at the Closing, Cambridge will surrender and forfeit its rights to acquire up to 500,000 shares of common stock, par value $0.0001 per share, of Sorrento (the “ Sorrento Common Stock ”) under the Sorrento Warrant (such that immediately following the Closing, the Sorrento Warrant will be exercisable by Cambridge for up to an aggregate of 1,224,138 shares of Sorrento Common Stock at an exercise price of $5.80 per share) (the “ Warrant Amendment ”).

2. Purchase and Sale of NantKwest Shares .   Subject to the terms and conditions of this Agreement, at the Closing, Sorrento will sell to CSSFF, and CSSFF will purchase from Sorrento, the NantKwest Shares.

3. Consideration .  In consideration of the purchase and sale of the Sorrento Shares and the NantKwest Shares and the Warrant Amendment, each as contemplated by Sections 1 and 2 above: (a)  CSSFF will convey, assign and transfer to Sorrento the Sorrento Shares; and (b) Sorrento will convey, assign and transfer to CSSFF the NantKwest Shares and wire transfer to CSSFF an aggregate of $15,639,071.95 pursuant to wire instructions delivered by CSSFF to Sorrento, which wire instructions will be delivered to Sorrento by July 1, 2016.

 


 

4. CSSFF Representations .  CSSFF represents and warrants to Sorrento that (a) CSSFF has full power and authority to execute and deliver, and to perform all of its obligations under, this Agreement; (b) the execution, delivery and performance by CSSFF of this Agreement have been approved by all requisite action on the part of CSSFF; (c) the execution, delivery and performance of this Agreement does not and will not: (i) violate or conflict with any law, rule, regulation, order, writ, judgment, injunction, decree, determination, award, contract, agreement or understanding presently in effect applicable to CSSFF (including the charter and governing documents of CSSFF) or (ii) require any authorization, consent, approval, license, exemption by or from, or filing or registration with, any court, executive or legislative body, governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign; (d) this Agreement constitutes a legal, valid and binding obligation of CSSFF enforceable against it in accordance with its terms; (e) CSSFF has good title to and is the sole owner of the Sorrento Shares, free and clear of all liens, charges and any encumbrances of any kind whatsoever (and at the Closing Sorrento will receive good title to the Sorrento Shares, free and clear of all liens, charges and any encumbrances of any kind whatsoever); (f) CSSFF is not a party to any voting, trust, proxy or other agreement or understanding with respect to the voting of such Sorrento Shares or any other capital stock of Sorrento; (g) CSSFF did not offer or sell such Sorrento Shares by any form of general solicitation or general advertising; (h) CSSFF is an “accredited investor” as that term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended; (i) CSSFF (i) is a sophisticated person with respect to the sale of such Sorrento Shares; (ii) has adequate information concerning the business and financial condition of Sorrento to make an informed decision regarding the sale of such Sorrento Shares; (iii) has independently and without reliance upon Sorrento or any of its officers or directors, and based on such information as CSSFF has deemed appropriate, made its own analysis and decision to enter into this Agreement; and (iv) acknowledges that arm’s-length negotiations between Sorrento and CSSFF resulted in CSSFF agreeing to the sufficiency of the consideration hereunder.  CSSFF acknowledges that Sorrento (and none of its officers, directors or representatives) has not given CSSFF any investment advice, credit information or opinion on whether the sale of the Sorrento Shares is prudent; and (j) Charles Kenworthy has authority to execute this Agreement on behalf of CSSFF.

5. Cambridge Representations .  Cambridge represents and warrants to Sorrento that (a) Cambridge has full power and authority to execute and deliver, and to perform all of its obligations under, this Agreement; (b) the execution, delivery and performance by Cambridge of this Agreement have been approved by all requisite action on the part of Cambridge; (c) the execution, delivery and performance of this Agreement does not and will not: (i) violate or conflict with any law, rule, regulation, order, writ, judgment, injunction, decree, determination, award, contract, agreement or understanding presently in effect applicable to Cambridge (including the charter and governing documents of Cambridge) or (ii) require any authorization, consent, approval, license, exemption by or from, or filing or registration with, any court, executive or legislative body, governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign; (d) this Agreement constitutes a legal, valid and binding obligation of Cambridge enforceable against it in accordance with its terms; (e) Cambridge has good title to and is the sole owner of the Sorrento Warrant, free and clear of all liens, charges and any encumbrances of any kind whatsoever; (f) Cambridge is an “accredited investor” as that term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended; (g) CSSFF (i) is a sophisticated person with respect to the Warrant Amendment; (ii) has adequate information concerning the business and financial condition of Sorrento to make an informed decision regarding the Warrant Amendment; (iii) has independently and without reliance upon Sorrento or any of its officers or directors, and based on such information as Cambridge has deemed appropriate, made its own analysis and decision to enter into this Agreement; and (iv) acknowledges that arm’s-length negotiations between Sorrento and Cambridge resulted in Cambridge agreeing to the sufficiency of the consideration hereunder.  Cambridge acknowledges that Sorrento (and none of its officers, directors or representatives) has not given Cambridge any investment advice, credit information or opinion on whether the Warrant Amendment is prudent; and (h) Charles Kenworthy has authority to execute this Agreement on behalf of Cambridge.

 


 

6. Sorrento Representations .  Sorrento represents and warrants to CSSFF that (a) Sorrento has full power and authority to execute and deliver, and to perform all of its obligations under, this Agreement; (b) the execution, delivery and performance by Sorrento of this Agreement have been approved by all requisite action on the part of Sorrento; (c) the execution, delivery and performance of this Agreement does not and will not: (i) violate or conflict with any law, rule, regulation, order, writ, judgment, injunction, decree, determination, award, contract, agreement or understanding presently in effect applicable to Sorrento (including the charter and governing documents of Sorrento) or (ii) require any authorization, consent, approval, license, exemption by or from, or filing or registration with, any court, executive or legislative body, governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign; (d) this Agreement constitutes a legal, valid and binding obligation of Sorrento enforceable against it in accordance with its terms; (e) Sorrento has good title to and is the sole owner of the NantKwest Shares, free and clear of all liens, charges and any encumbrances of any kind whatsoever (and at the Closing CSSFF will receive good title to such NantKwest Shares, free and clear of all liens, charges and any encumbrances of any kind whatsoever); (f) Sorrento is not a party to any voting, trust, proxy or other agreement or understanding with respect to the voting of such NantKwest Shares or any other capital stock of NantKwest; (g) Sorrento did not offer or sell such NantKwest Shares by any form of general solicitation or general advertising; (h) Sorrento is an “accredited investor” as that term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended; (i) Sorrento (i) is a sophisticated person with respect to the sale of such NantKwest Shares; (ii) has adequate information concerning the business and financial condition of NantKwest to make an informed decision regarding the sale of such NantKwest Shares; (iii) has independently and without reliance upon CSSFF or NantKwest or any of its officers or directors, and based on such information as Sorrento has deemed appropriate, made its own analysis and decision to enter into this Agreement; and (iv) acknowledges that arm’s-length negotiations between Sorrento and CSSFF resulted in Sorrento agreeing to the sufficiency of the consideration hereunder.  Sorrento acknowledges that none of CSSFF or NantKwest (and none of its officers, directors or representatives) has given Sorrento any investment advice, credit information or opinion on whether the sale of the NantKwest Shares is prudent; and (j) Henry Ji has authority to execute this Agreement on behalf of Sorrento.

7. Closing .  The closing of the sale and purchase of the Sorrento Shares and the NantKwest Shares (the “ Closing ”) shall occur on or before July 8, 2016 (such date to be mutually agreed between the parties).  At the Closing: (a)  CSSFF will convey, assign and transfer to Sorrento the Sorrento Shares ; (b)  Sorrento will convey, assign and transfer to CSSFF the NantKwest Shares; (c) Sorrento will wire transfer to CSSFF in immediately available funds the aggregate amount of $15,639,071.95 to the account designated by CSSFF by written notice delivered to Sorrento by July 1, 2016; and (d) Cambridge will surrender the original Sorrento Warrant to Sorrento for cancellation and Sorrento will issue to Cambridge a new warrant of like tenor representing the right to purchase up to an aggregate of 1,224,138 shares of Sorrento Common Stock at an exercise price of $5.80 per share.

8. CSSFF Acknowledgments . CSSFF acknowledges and understands: (a) Sorrento and its officers and directors may possess material nonpublic information not known to CSSFF that may impact the value of the Sorrento Shares, including without limitation, information concerning Sorrento’s business and financial results for the six months ended June 30, 2016; (b) the disadvantage to which CSSFF is subject due to the disparity of information between Sorrento and CSSFF; (c) notwithstanding such disparity of information, CSSFF has deemed it appropriate to sell the Sorrento Shares to Sorrento as contemplated hereunder (and if CSSFF were in possession of some or all of any such material nonpublic information, CSSFF might not sell the Sorrento Shares to Sorrento); (d) CSSFF has made its own decision to consummate the transaction contemplated hereunder based on its own independent review and consultations with such investment, legal, tax, accounting and other advisers as it deemed necessary, and without reliance on any representation or warranty of, or advice from, Sorrento; and (e) CSSFF hereby waives any right to rescind or invalidate the sale of the Sorrento Shares to Sorrento or to seek any damages or other remuneration from Sorrento or its officers or directors based on the possession of any such material nonpublic information by Sorrento or the lack of possession of any such material nonpublic information by CSSFF.  Without limiting the generality of the foregoing, CSSFF agrees that Sorrento and its officers, directors, stockholders, employees and agents shall have no liability to CSSFF or its beneficiaries whatsoever due to or in connection with Sorrento’s use or non-disclosure of any material nonpublic information or otherwise as a result of the transaction contemplated hereby, and CSSFF hereby irrevocably waives any claim that it might have based on the failure of Sorrento to disclose any material nonpublic information.

 


 

9. Cambridge Acknowledgments . Cambridge acknowledges and understands: (a) Sorrento and its officers and directors may possess material nonpublic information not known to Cambridge that may impact the value of the Sorrento Warrant, including without limitation, information concerning Sorrento’s business and financial results for the six months ended June 30, 2016; (b) the disadvantage to which Cambridge is subject due to the disparity of information between Sorrento and Cambridge; (c) notwithstanding such disparity of information, Cambridge has deemed it appropriate to agree to the Warrant Amendment as contemplated hereunder (and if Cambridge were in possession of some or all of any such material nonpublic information, Cambridge might not agree to the Warrant Amendment); (d) Cambridge has made its own decision to consummate the transaction contemplated hereunder based on its own independent review and consultations with such investment, legal, tax, accounting and other advisers as it deemed necessary, and without reliance on any representation or warranty of, or advice from, Sorrento; and (e) Cambridge hereby waives any right to rescind or invalidate the Warrant Amendment or to seek any damages or other remuneration from Sorrento or its officers or directors based on the possession of any such material nonpublic information by Sorrento or the lack of possession of any such material nonpublic information by Cambridge.  Without limiting the generality of the foregoing, Cambridge agrees that Sorrento and its officers, directors, stockholders, employees and agents shall have no liability to Cambridge or its beneficiaries whatsoever due to or in connection with Sorrento’s use or non-disclosure of any material nonpublic information or otherwise as a result of the transaction contemplated hereby, and Cambridge hereby irrevocably waives any claim that it might have based on the failure of Sorrento to disclose any material nonpublic information.

10. Sorrento Acknowledgments .  Sorrento acknowledges and understands: (a) CSSFF and its officers and directors may possess material nonpublic information not known to Sorrento that may impact the value of the NantKwest Shares, including without limitation, information concerning NantKwest’s business and financial results for the six months ended June 30, 2016; (b) the disadvantage to which Sorrento is subject due to the disparity of information between Sorrento and CSSFF; (c) notwithstanding such disparity of information, Sorrento has deemed it appropriate to sell the NantKwest Shares to CSSFF as contemplated hereunder (and if Sorrento were in possession of some or all of any such material nonpublic information, Sorrento might not sell the NantKwest Shares to CSSFF); (d) Sorrento has made its own decision to consummate the transaction contemplated hereunder based on its own independent review and consultations with such investment, legal, tax, accounting and other advisers as it deemed necessary, and without reliance on any representation or warranty of, or advice from, CSSFF or NantKwest; and (e) Sorrento hereby waives any right to rescind or invalidate the sale of the NantKwest Shares to CSSFF or to seek any damages or other remuneration from CSSFF or NantKwest or its officers or directors based on the possession of any such material nonpublic information by CSSFF or the lack of possession of any such material nonpublic information by Sorrento.  Without limiting the generality of the foregoing, Sorrento agrees that CSSFF and NantKwest and its officers, directors, stockholders, employees and agents shall have no liability to Sorrento or its beneficiaries whatsoever due to or in connection with CSSFF’s use or non-disclosure of any material nonpublic information or otherwise as a result of the transaction contemplated hereby, and Sorrento hereby irrevocably waives any claim that it might have based on the failure of CSSFF to disclose any material nonpublic information.

11. Further Assurances .  Each party shall do and perform, or cause to be done and performed, all such further acts and things, and shall execute and deliver all such other agreements, certificates, instruments and documents, including stock powers, as the other party may reasonably request in order to carry out the intent and accomplish the purposes of this Agreement and the consummation of the transactions contemplated hereby.

12. Arbitration .  Any and all disputes arising out of or related to this Agreement shall be resolved pursuant to binding arbitration held in the County of Los Angeles in the State of California and administered by the Judicial Arbitration and Mediation Services, Inc. pursuant to its Streamlined Arbitration Rules & Procedures then in effect. Each party shall bear its own attorneys’ fees and expenses in such arbitration.  The parties agree to abide by all decisions and awards rendered in such proceedings.  Such decisions and awards rendered by the arbitrator shall be final and conclusive.

13. Governing Law .  This Agreement and any matter or dispute relating hereto shall be governed by and construed in accordance with the laws of the State of California, without regard to principles of conflicts of law.

 


 

14. Counterparts . This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.  Any party may execute this Agreement by facsimile or .pdf signature and the other party shall be entitled to rely on such facsimile or .pdf signature as evidence that this Agreement has been duly executed by such party.

15. Voluntary Execution of Agreement .  This Agreement is executed voluntarily, without any duress or undue influence on the part of any party or on behalf of any party.  Each party acknowledges that (a) it has read and understands the terms and consequences of this Agreement; (b) it has been represented in the preparation, negotiation and execution of this Agreement by legal counsel of its own choice or that it has voluntarily declined to seek such counsel; and (c) it is fully aware of the legal and binding effect of this Agreement.

[Signature Page Follows]


 


 

Please kindly countersign this Agreement to confirm your agreement with the terms and conditions set forth herein.

 

Sincerely,

 

Chan Soon-Shiong Family Foundation

 

Cambridge Equities, LP

 

 

 

 

 

 

 

 

By:  MP13 Ventures, LLC, its general partner

 

 

 

 

 

By:

/s/ Charles Kentworthy

 

By:

/s/ Charles Kentworthy

Name: 

Charles Kenworthy

 

Name: 

Charles Kenworthy

Title:

Executive Vice President

 

Title:

Manager

 

ACKNOWLEDGED AND AGREED:

 

Sorrento Therapeutics, Inc.

 

By:

 

/s/ Henry Ji, Ph.D.

Name:

 

Henry Ji, Ph.D.

Title:

 

President & Chief Executive Officer

 

 

 

Exhibit 10.7

CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL TREATMENT AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION

LICENSE AND COLLABORATION AGREEMENT

BETWEEN

LES LABORATOIRES SERVIER

INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

AND

SORRENTO THERAPEUTICS, INC.

 

 

 

 


 

 

License and Collaboration Agreement

 

This License and Collaboration Agreement is entered into as of July 6, 2016 (subject to Section 11.5.3 , the “ Effective Date ”) by and between Les Laboratoires Servier, a corporation incorporated under the laws of France having a principal place of business at 50 Rue Carnot, 92284 Suresnes Cedex, France and Institut de Recherches Internationales Servier, a company duly organized and existing under the laws of France, having offices and principal place of business at 50 Rue Carnot, 92284 Suresnes Cedex, France (individually and collectively, “ Servier ”), and Sorrento Therapeutics, Inc., a Delaware corporation having its principal place of business at 9380 Judicial Drive, San Diego, CA 92121, U.S.A. (“ Sorrento ”). Servier and Sorrento are individually referred to herein as a “ Party ” and collectively, as the “ Parties ”.

RECITALS

WHEREAS , Sorrento is discovering and developing antibodies for use in immuno-oncology and other therapeutic areas, and owns certain patents, proprietary technology, know-how and information relating to such antibodies; and

WHEREAS , Servier and its Affiliates possess expertise in developing, manufacturing and commercializing pharmaceutical products and wishes to obtain a license to, and Sorrento wishes to license to Servier, certain patents and know-how, in order for Servier to Develop, Manufacture and Commercialize the Products in the Territory.

NOW, THEREFORE , in consideration of the promises and mutual covenants herein below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

ARTICLE 1. DEFINITIONS

Defined Terms . The following capitalized terms or derivatives thereof (verbs, nouns, singular, plural), when used in this Agreement, shall have the following meanings:

1.1 Accounting Standards ” means the International Financial Reporting Standards, the US Generally Accepted Accounting Principles, and any other internationally recognized accounting standards that may be adopted by a Party.

1.2 Acquiree ” has the meaning set forth in Section 11.6.2 .

1.3 Acquiror ” has the meaning set forth in Section 11.6.2 .

1.4 Acquisition Transaction ” has the meaning set forth in Section 11.6.2 .

1.5 Additional Anti-PD-1 Products ” means a Sorrento Additional Anti-PD-1 Product and/or a Servier Additional Anti-PD-1 Product.

 


 

1.6 Affiliates ” means with respect to a Party, any person or entity, which directly or indirectly controls, is controlled by, or is under common control with such Party. Solely as used in this definition, the term “control” means (a) the ownership, directly or indirectly, beneficially or legally, of at least fifty percent (50%) of the outstanding voting securities or capital stock (or such lesser percentage which is the maximum allowed to be owned by a person or entity in a particular jurisdiction) of such Party or other person or entity, as applicable, or such other comparable ownership interest with respect to any person or entity that is not a corporation; or (b) the power, direct or indirect, whether through ownership of voting securities or partnership or other ownership interests, by contract or otherwise of more than fifty percent (50%), to direct the management and policies of a Party or such other person or entity, as applicable.  

1.7 Agreement ” means this License and Collaboration Agreement together with the recitals and all exhibits, schedules and attachments hereto.

1.8 Alliance Manager ” has the meaning set forth in Section 3.5 .

1.9 Antibody ” means any purified monoclonal or polyclonal antibody, whether multiple or single chain, recombinant or naturally occurring, whole or fragment, and any variants, derivatives or constructs thereof, including but not limited to, antigen binding portions including Fab, Fab’, F(ab’)2, Fv, dAb and CDR fragments, single chain antibodies (scFv), chimeric antibodies, diabodies and polypeptides (including any humanized versions thereof) that contain at least a portion of an immunoglobulin that is sufficient to bind selectively to a  specific antigen.  For the avoidance of doubt, Antibody includes bispecific antibodies and antibody drug conjugates.

1.10 Associated Compound ” means any compound Controlled by Servier other than pursuant to the licenses granted by Sorrento under this Agreement or the R&D Agreement that is Developed in combination with a Product, provided that for purposes of ARTICLE 8 , all salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of such compound shall be deemed to be the same Associated Compound. Associated Compound shall not include any Product.

1.11 Arbitration ” has the meaning set forth in Section 14.2.1 .

1.12 Arbitration Request ” has the meaning set forth in Section 14.2.1 .

1.13 Audited Party ” has the meaning set forth in Section 8.10.2 .

1.14 Auditing Party ” has the meaning set forth in Section 8.10.2 .

1.15 Authorized Recipients ” has the meaning set forth in Section 10.2 .

1.16 Background IP ” has the meaning set forth in Section 9.1.1 .

1.17 Biosimilar ” means, with respect to a given Product in a given country of the Territory, any biological product that (a) is sold after the Effective Date by a Third Party that is not a Sublicensee of Servier and without the consent of Servier, under a

3


 

Marketing Approval granted by a Competent Authority to such Third Party; (b) is similar to such Product in terms of quality characteristics, biological activity, safety and efficacy, notwithstanding minor differences and considered in the United States under 42 USC §262(i)(2) or its foreign equivalent applicable Law, on a country-by-country basis where such Product is marketed, as a “biosimilar” product provided that such applicable Law exists; and (c) is approved in reliance in whole or in part, on (i) a prior Marketing Approval (or on any safety or efficacy data submitted in support of prior Marketing Approval) of such Product or reference to other publicly available clinical data with respect to such Product, or (ii) a demonstration of biosimilarity to or interchangeability with such Product.  

1.18 BGB ” means the German Civil Code ( Bürgerliches Gesetzbuch ).

1.19 Business Day ” means a day that is not a Saturday, Sunday or a day on which banking institutions in Paris, France or New York, United States of America, are authorized by applicable Law to remain closed.

1.20 Calendar Quarter ” means each three (3) consecutive calendar months ending on each March 31, June 30, September 30 and December 31.

1.21 Calendar Year ” means any period of time commencing on January 1 and ending on the next December 31.

1.22 “Capitalized Lease Obligation ” means that portion of the obligations under a Capital Lease that is required to be capitalized in accordance with GAAP.

1.23 Capital Lease ” means a lease that is required to be capitalized for financial reporting purposes in accordance with GAAP.

1.24 CDR ” means complementarity-determining region.

1.25 Claim ” means any charge, complaint, action, suit, proceeding, hearing, investigation, claim or demand, including without limitation any investigation by a Competent Authority.

1.26 Claim Notice ” has the meaning set forth in Section 12.3.1 .

1.27 Clinical Studies ” means a research study in humans that is (a) conducted in accordance with international ethical and scientific quality standards for designing, conducting, recording and reporting research studies involving investigational medicinal products for human use and that involve the participation of human subjects, which standards are established through Laws, and (b) designed to generate clinical data and results regarding a chemical compound or biological molecule in support of Marketing Approval, including any translational research studies. Clinical Studies include any Phase 1 Clinical Study(ies), any Phase 2 Clinical Study(ies), any Phase 3 Clinical Study(ies) or any Phase 4 Clinical Study(ies).

1.28 CMC ” means chemistry, manufacturing and controls.

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1.29 Commercialization ” means any and all activities of obtaining pricing and reimbursement strategy, marketing, promoting, distributing, importing, offering for sale, having sold, selling or conducting any other commercial exploitation activities relating to the Products in the Field in the Territory.  

1.30 Commercially Reasonable Efforts ” means the application by or on behalf of Servier of a level of resources and efforts to Develop, or Commercialize, as applicable, the Products, as would normally be exerted and employed by a pharmaceutical company similarly positioned as Servier consistent with the exercise of its prudent scientific and business judgment in pursuing the development or commercialization of its pharmaceutical products of a similar stage of product life, safety, efficacy, intellectual property profile (including the patent situation and the freedom to operate), commercial potential and all other relevant factors. For clarity, it is understood that “Commercially Reasonable Efforts” shall be evaluated as a whole and may change over time.

1.31 Committee ” has the meaning set forth in Section 3.2 .

1.32 Compassionate Use means the use of a Product as an investigational drug in accordance with applicable Law outside of a clinical trial to treat a patient with a serious or life-threatening disease or condition who has no comparable or satisfactory alternative treatment options.

1.33 Competing Product ” means any Antibody that (a) originates from Sorrento’s G-MAB library or is acquired by Sorrento or its Affiliates and (b) is directed against the Target. Competing Product shall not include the Products.

1.34 Competing Product ROFN Election Notice ” has the meaning set forth in Section 11.6.4 .

1.35 Competing Product ROFN Notice ” has the meaning set forth in Section 11.6.4 .

1.36 Competitive Program ” has the meaning set forth in Section 11.6.1 .

1.37 Competent Authority ” means any court, tribunal, regulatory agency of (a) any national, federal, state, provincial, county, city or other political subdivision government, including the FDA, or (b) any supranational body (including the EMA).

1.38 Confidential Information ” means any and all Know-How, information and Data of a confidential nature, whether financial, business, legal, technical or non-technical, oral, written, or in electronic form, including information and data related to the Product, a Party, or any concepts, discoveries, inventions, data, designs or formulae in relation to this Agreement, that is disclosed, supplied or otherwise made available by one Party or any of its Affiliates or Sublicensees (“ Disclosing Party ”) to the other Party or any of its Affiliates or Sublicensees (“ Receiving Party ”). All Confidential Information disclosed by a Party pursuant to the Confidential Agreement between the Parties dated July 8th, 2014, as amended effective as from July 8, 2015 (the “ Prior CDA ”) shall be deemed to be Confidential Information of such Party pursuant to this Agreement (with the mutual

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understanding and agreement that any use and disclosure thereof that is authorized under ARTICLE 10 shall not be restricted by, or be deemed a violation of, such Prior CDA).  

1.39 Consolidated Indebtedness ” means, as at any date of determination, the aggregate amount of, without duplication, the current and non-current portion of all indebtedness for borrowed money of Sorrento, determined on a consolidated basis in accordance with GAAP, which by its terms matures more than one year after the date of calculation, and any such indebtedness maturing within one (1) year from such date which is renewable or extendable at the option of Sorrento to a date more than one (1) year from such date, including, in any event, but without duplication, the amount of Sorrento’s Capitalized Lease Obligations.

1.40 Control ”, “ Controlled ” or “ Controlling ” means, with respect to a subject item and a Party, the ability of such Party or its Affiliates, whether arising by ownership, possession or pursuant to a license or sublicense, to grant licenses or sublicenses to the other Party with respect to such subject item, as provided in this Agreement, without  violating the terms of any agreement or other arrangement with any Third Party, provided that, without prejudice to Sorrento’s representations and warranties, with respect to the Know-How or Intellectual Property Rights that become Controlled by either Party after the Effective Date, such Know-How or Intellectual Property Rights shall be deemed not  Controlled if a payment has to be made to a Third Party in consideration of the grant of a license or sublicense pursuant to this Agreement unless the other Party agrees to make the portion of such payment corresponding to the grant of the license or sublicense and further provided that, notwithstanding the foregoing clause, Sorrento shall be deemed not to Control any license from *.

1.41 Coordination Committee ” or “ CC ” has the meaning set forth in Section 3.1.1 .

1.42 Copyrights ” means all copyrights, and all right, title and interests in all copyrights, copyright registrations and applications for copyright registration, certificates of copyright and copyrighted rights and interests throughout the world, and all right, title and interest in related applications and registrations throughout the world.

1.43 Cover ”, “ Covered ” or “ Covering ” means, with respect to any Product, as appropriate, and a Patent Right, that, in the absence of a (sub)license under, or ownership of, such Patent Right, the offering for sale, selling or importing of such a Product, as appropriate, with respect to a given country, would infringe a Valid Claim of such Patent Right.

1.44 Damages ” has the meaning set forth in Section 12.1 .

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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1.45 Data ” means any and all non-aggregated and aggregated research, pharmacology, medicinal chemistry, pre-clinical, clinical, commercial, marketing, process development, manufacturing and other data or information, including investigator brochures and reports (both preliminary and final), statistical analyses, expert opinions and reports, and safety data, in each case generated from, or related to, Clinical Studies or non-clinical studies, research or testing specifically related or directed to Product. For the avoidance of doubt, Data shall be deemed Confidential Information of the Disclosing Party for the purposes of the Agreement subject to ARTICLE 10 of this Agreement.  

1.46 Debt to Equity Ratio ” means, as of any date of determination, the ratio of (a)(i) the amount of Sorrento’s Consolidated Indebtedness as of such date minus (ii) cash, cash equivalents and marketable securities of Sorrento as of such date and the amount of any outstanding payments due from Servier to Sorrento hereunder as of such date, to (b) Sorrento’s Equity as of such date.

1.47 Derivative Antibody ” means any Antibody other than the Initial Antibody, which is (a) developed by or for Servier, its Affiliates or Sublicensee, (b) *, and (c) directed against the Target and, possibly, other targets selected by Servier. For sake of clarity, the Derivative Antibodies do not contain the Linker Technology, and therefore do not include any Additional Anti-PD1 Products.

1.48 Derivative Product ” means a pharmaceutical product that contains a Derivative Antibody.

1.49 Development ” means with respect to a Product, the activities performed to obtain and maintain the Marketing Approval for the relevant Product, including without limitation: research, test method development and stability testing, assay development, toxicology, pharmacology, formulation, quality assurance, quality development, statistical analysis, process development, and scale-up, pharmacokinetic studies, data collection and management, Clinical Studies (including research to design Clinical Studies and specifically excluding activities directed to obtaining pricing and reimbursement approvals), regulatory affairs (including submission of Data or other materials to a Competent Authority to obtain, maintain and/or expand Marketing Approval of a Product), project management, drug safety surveillance activities related to Clinical Studies, validation of methods and tests.

1.50 Development Milestone has the meaning set forth in Section 8.2 .

1.51 Disclosing Party ” has the meaning set forth in Section 1.38 .

1.52 Dispute ” has the meaning set forth in Section 14.2.1 .

1.53 DMF ” means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction for a Product submitted or to be submitted by a Party to Competent Authorities.

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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1.54 Dollars ” or “ USD ” or “ $ ” means U.S. dollars.  

1.55 Effective Date ” has the meaning set forth in the preamble.

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

1.57 European Union ” or “ EU ” means all countries of the European Union, as may be included from time to time.

1.58 Executive Officer ” means the President & CEO of Sorrento and the Vice President of Research and Development or the Vice President of Business Development & Licensing of Servier, or their duly authorized respective designees with equivalent decision-making authority with respect to matters under this Agreement.

1.59 FDA ” means the United States Food and Drug Administration or any successor entity thereto.

1.60 Field ” means any human use.

1.61 First Commercial Sale ” means the first sale to a Third Party of a Product by or under the authority of Servier or its Affiliates or Sublicensees, in a country after receipt of the applicable Marketing Approval, as desirable in such country, from the Competent Authorities in that country. For the avoidance of doubt, Compassionate Use shall not be considered a First Commercial Sale.

1.62 FPFV ” has the meaning set forth in Section 8.2.1 .

1.63 FTC ” has the meaning set forth in Section 11.5.3 .

1.64 GAAP ” means generally accepted accounting principles in the United States, as in effect from time to time.

1.65 “HSR” has the meaning set forth in Section 11.5.3 .

1.66 IND/IMPD ” means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, (b) the Investigational Medicinal Product Dossier in the European Territory, or (c) the equivalent application to the applicable Competent Authority in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

1.67 Indemnified Party ” has the meaning set forth in Section 12.3.1 .

1.68 Indemnifying Party ” has the meaning set forth in Section 12.3.1 .

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1.69 Initial Antibody ” means *. Notwithstanding the foregoing, Initial Antibody excludes any Antibody with modifications resulting from chemical reactions outside living organisms.  

1.70 Initial Product ” means a pharmaceutical product consisting of the Initial Antibody.

1.71 Insolvent Party has the meaning set forth in Section 13.4.4 .

1.72 Intellectual Property Rights ” means, collectively, Patent Rights, Copyrights, Trade Secrets, Trademarks, moral rights and all other intellectual property and proprietary rights.

1.73 Joint Inventions ” has the meaning set forth in Section 9.1.2 .

1.74 Joint Patents ” has the meaning set forth in Section 9.1.2 .

1.75 Joint Other Intellectual Property Rights ” has the meaning set forth in Section 9.1.2 .

1.76 Joint Intellectual Property Rights ” means collectively, Joint Patent and Joint Other Intellectual Property Rights (excluding Trademarks).

1.77 Know-How ” means any and all ideas, concepts, designs,  technical information, techniques, Data, database rights, discoveries, inventions, practices, methods, procedures, processes, methods, algorithm, knowledge, skill, experience, test data and any other information or technology, whether in written, electronic, graphic or any other form, including pharmaceutical, chemical, biological and biochemical compositions, formulations, assays, APIs, molecules, samples, cell lines, journals and laboratory notebooks.

1.78 Knowledge ” means only the current, actual knowledge and awareness including from conversations with other officers and employees of Sorrento and otherwise in the ordinary course of their duties (and shall not include any deemed or constructive knowledge or awareness) of Sorrento’s “officers” as of the Effective Date, as determined by Sorrento in accordance with Rule 16a-1(f) under the U.S. Securities Exchange Act of 1934, as amended, who include Henry Ji, George Ng, Jeffrey Su and Kevin Herde, and Gunnar Kaufmann.

1.79 LA Cell Technology ” means the unique cell-penetrating technology for use with antibody therapeutics and/or other small molecules and/or macro-molecules owned by LA Cell Inc., an Affiliate of Sorrento.

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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1.80 Laws ” shall mean any applicable national, supranational, federal, state, local or foreign law, statute, ordinance, principle of common law, or any rule, regulation, standard, judgment, order, writ, injunction, decree, arbitration award, agency requirement, license or permit of any Competent Authority, including any rules, regulations, guidelines, directives or other requirements of Competent Authorities, including good clinical practices, good laboratory practices and good manufacturing practices, as well as all anti-bribery or anti-corruption laws, as applicable.  

1.81 Linker Technology ” means Sorrento’s proprietary technology that is applied to chemically couple the Initial Antibody to another Antibody and referred to in the Sorrento Linker Patent Rights .

1.82 Licensed Other Intellectual Property Rights ” means Intellectual Property Rights Controlled by Sorrento, other than Patent Rights and Trademarks.

1.83 MAA ” means a Marketing Authorization Application, in relation to any Product, filed or to be filed with the EMA (or equivalent national agency), for authorization to place a medicinal product on the market in the European Union (or any other territory).

1.84 Manufacture ” means, with respect to a Product, any and all processes and activities conducted to manufacture preclinical, clinical and commercial quantities of such, in particular, the production, the manufacture, the processing, the filling, the packaging, the labeling, the inspection, the storage, the warehousing and the shipping of such Product. Manufacture shall also include the supply of any raw materials or packaging materials with respect thereto, or any intermediate of any of the foregoing, including process and cost optimization, process qualification and validation, commercial manufacture, stability and release testing, quality assurance and quality control. For clarity, “Manufacturing” has a correlative meaning.

1.85 Marketing Approval ” shall mean all approvals, licenses, registrations or authorizations of the Competent Authorities in a country, necessary for the marketing and sale of the Product in such country, including the approval of an MAA or an NDA.

1.86 NDA ” means a New Drug Application, including all supplements and amendments thereto, for the approval of the Product as a new drug by the FDA.

1.87 *

1.88 Non-Compete Period ” has the meaning set forth in Section 11.6.1 .

1.89 Owned Sorrento Contribution Patent Rights ” has the meaning set forth in Section 11.2.3 .

1.90 Patent Committee ” has the meaning set forth in Section 9.2.1 .

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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1.91 Party ” or “ Parties has the meaning set forth in the preamble.  

1.92 Patent Challenge ” has the meaning set forth in Section 13.3 .

1.93 Patent Rights ” means any and all patent rights and all right, title and interest in all patent applications and patents that issue from them, all letters patent or equivalent rights and applications in each case to the extent the same has not been held, by a court of competent jurisdiction, to be invalid or unenforceable in a decision from which no appeal can be taken or from which no appeal was taken within the time permitted for appeal.  Patent Rights include any extension, registration, confirmation, reissue, continuation, supplementary protection certificate, divisional, continuation-in-part, re-examination or renewal thereof or foreign counterparts of any of the foregoing.

1.94 Payee Party ” has the meaning set forth in Section 8.9.5 .

1.95 Paying Party ” has the meaning set forth in Section 8.9.5 .

1.96 Permitted Deductions ” has the meaning set forth in Section 1.87 .

1.97 Phase 1 Clinical Study ” means a clinical study of a product in human subjects which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

1.98 “Phase 1 Data” has the meaning set forth in Section 8.8.2 .

1.99 Phase 2 Clinical Study ” means a clinical study of a product that is designed to establish the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence pivotal clinical trials, as further defined in 21 C.F.R. § 312.21(b) (or the non-United States equivalent thereof).

1.100 Phase 3 Clinical Study ” means a pivotal clinical study of a product on sufficient numbers of patients that is designed to establish the efficacy and safety of a product, which is prospectively designed to demonstrate statistically whether such product is effective and safe for use in a particular indication in a manner sufficient to file an NDA to obtain Regulatory Approval to market the product, as further defined in 21 C.F.R. § 312.21(c) (or the non-United States equivalent thereof).

1.101 Product ” means the Initial Product, any Additional Anti-PD-1 Product(s) or Derivative Product(s) Developed under this Agreement.  

1.102 Product Trademarks ” has the meaning set forth in Section 9.5.1 .

1.103 Prior CDA ” has the meaning set forth in Section 1.38 .

1.104 Prosecuting Party ” has the meaning set forth in Section 9.2.4 .

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1.105 Quality Agreement ” has the meaning set forth in Section 6.2.2 .  

1.106 Receiving Party ” has the meaning set forth in Section 1.38 .

1.107 Regulatory Approval ” means any and all approvals, licenses, registrations or authorizations by a Competent Authority and necessary for the Development activities (including any IND/IMPD approval), Manufacturing activities or Commercialization activities (including any applicable Marketing Approval, pricing, final labeling and reimbursement approvals).

1.108 Regulatory Materials ” means regulatory applications, submissions, dossiers, notifications, registrations, case reports forms, trial master file, DMF, common technical documents, question and answers with Competent Authorities, Marketing Approvals or other filings or communications made to or with, or other approvals granted by, a Competent Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize a Product in a particular country or regulatory jurisdiction.

1.109 Responsible Party ” has the meaning set forth in Section 9.4.4 .

1.110 ROFN Election Notice ” has the meaning set forth in Section 2.7 .

1.111 ROFN Notice ” has the meaning set forth in Section 2.7 .

1.112 ROFN Products ” has the meaning set forth in Section 2.7 .

1.113 “Royalties” has the meaning set forth in Section 8.4 .

1.114 Royalty Bearing Net Sales ” means on a country-by-country and Product-by-Product basis, the Net Sales generated during the Royalty Term for such Product in such country.

1.115 Royalty Term ” means on a country-by-country and Product-by-Product basis, the period commencing on the First Commercial Sale of a Product and ending on the expiration of the last-to-expire Valid Claim of a Patent Right that Covers the composition of matter of such Product in such country.

1.116 “Rules” has the meaning set forth in Section 14.2.1 .

1.117 R&D Agreement ” means an agreement that may be entered into between the Parties with respect to the Development of Additional Anti-PD-1 Products.

1.118 Sales Milestones ” has the meaning set forth in Section 8.3 .

1.119 Scientific Committee ” or “ SC ” has the meaning set forth in Section 3.1.2 .

1.120 Seller ” has the meaning set forth in Section 1.87 .

1.121 Servier ” has the meaning set forth in the preamble.

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1.122 Servier Additional Anti-PD-1 Product ” means a pharmaceutical product that contains the Initial Antibody or * directed against the Target and, possibly, any other targets selected by Servier.  

1.123 Servier Indemnitees ” has the meaning set forth in Section 12.1 .

1.124 Servier IP ” means any and all Servier Patent Rights and Servier Know-How. For the avoidance of doubt, Servier IP shall include Servier’s interest in the Joint Intellectual Property.

1.125 Servier Know-How ” means all Know-How that is developed or Controlled by Servier and its Affiliates other than pursuant to the licenses granted by Sorrento under this Agreement or the R&D Agreement as of the Effective Date and thereafter during the Term and (a) that is used in connection with the Development, Manufacture, or Commercialization of the Products or (b) is reasonably necessary or useful for the Development, Manufacture, or Commercialization of a Product.

1.126 Servier Patent Right ” means all Patent Rights that are Controlled by Servier and its Affiliates as of the Effective Date and thereafter during the Term and that Cover, or is reasonably necessary or useful for, the Development, Manufacture or Commercialization of the Products (including its composition, formulation, combination, product by process, or method of use, manufacture, preparation or administration). Servier Patent Rights shall include Servier’s interest in Joint Patents that meet the above requirements.

1.127 Sole Invention ” has the meaning set forth in Section 9.1.2 .

1.128 Sorrento has the meaning set forth in the preamble.

1.129 Sorrento Additional Anti-PD-1 Product ” means a pharmaceutical product that contains the Initial Antibody * directed against the Target and any other targets the Parties mutually agree upon, as developed pursuant to the terms of an R&D Agreement.

1.130 Sorrento Anti-PD-1 Patent Rights ” means (a) the following patent applications: * and (b) any patent or patent application in the Territory, including any continuations, continuations-in-part (but solely with respect to those claims of such continuations-in-part that are fully supported by the specifications of the patent applications of clause (a) hereof), divisionals, and any and all reissues, extensions, registrations, reexaminations, or confirmations to the foregoing, in all cases that (i) claim priority to any of the patent applications of clause (a) hereof and (ii) disclose and claim invention(s) that are substantially the same as the invention(s) disclosed and claimed in the patent applications of clause (a) hereof.

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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1.131 Sorrento Contributions ” means any of (a) the Initial Product, (b) the Initial Product including within it the Linker Technology and used as part of any Additional Anti-PD1 Product, and (c) *.     

1.132 Sorrento Contribution Patent Rights ” means (a) any Sorrento Anti-PD1 Patent Rights, provided that if divisionals are filed pursuant to Section 9.2.1 , only the divisionals Covering the Sorrento Contributions will be included in Sorrento Contribution Patent Rights and (b) any Patent Rights that are specifically related  to the Sorrento Contributions and that exclude Sorrento Linker Patent Rights.

1.133 Sorrento Core IP ” means all Sorrento Contribution Patent Rights filed in jurisdictions other than the U.S.

1.134 Sorrento Deliverables has the meaning set forth in Section 6.2.1 .

1.135 Sorrento’s Equity ” means, as of any date of determination, Sorrento’s stockholders’ equity determined on a consolidated basis in accordance with GAAP.

1.136 Sorrento Indemnitees ” has the meaning set forth in Section 12.2 .

1.137 Sorrento IP ” means any and all Sorrento Patent Rights and Licensed Other Intellectual Property Rights in the Sorrento Know-How. For the avoidance of doubt, Sorrento IP shall include Sorrento’s interest in the Joint Intellectual Property.

1.138 Sorrento Know-How ” means, subject to Section 10.4 , all Know-How that is Controlled by Sorrento as of the Effective Date and thereafter during the Term and is (a) relating to the Sorrento Contribution that is transferred or provided to Servier pursuant to Section 2.6 and Section 6.1.2 below and (i) used in connection with the Development, Manufacture, or Commercialization of the Products or (ii) reasonably necessary for the Development, Manufacture, or Commercialization of a Product.

1.139 Sorrento Linker Patent Rights ” means the following patent applications: * and any related Patent Rights.

1.140 Sorrento Patent Rights ” means any Patent Rights that are Controlled by Sorrento as of the Effective Date and thereafter during the Term, and that Cover the Development, Manufacture or Commercialization of any Sorrento Contribution pursuant to the terms of this Agreement. For the avoidance of doubt, Sorrento Patent Rights include Sorrento Anti-PD-1 Patent Rights, Sorrento Contribution Patent Rights and Sorrento Linker Patent Rights. Sorrento Patent Rights shall include Sorrento’s interest in Joint Patents that meet the above requirements.

1.141 SPV ” has the meaning set forth in Section 13.4.5 .

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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1.142 Sublicense Agreement ” has the meaning set forth in Section 2.4 .  

1.143 Sublicensees ” means a Third Party which is a sublicensee of the rights granted to Servier under this Agreement, on an arms’ length and bona fide basis, in accordance with the terms and conditions of this Agreement. For sake of clarity, Sublicensees do not include (a) wholesalers, distributors or similar entities performing similar functions, even if such Third Party is granted a limited right to promote and resell a Product sold to it and (b) Servier’s Affiliates.

1.144 Sublicensing Revenues ” shall mean *.

1.145 Subsequent Sublicensee ” has the meaning set forth in Section 2.4 .

1.146 Supply Agreement ” has the meaning set forth in Section 6.2.1 .

1.147 Target ” means human PD-1 (CD279).

1.148 Technology Transfer ” has the meaning set forth in Section 6.1.2 .

1.149 Term ” has the meaning set forth in Section 13.1 .

1.150 Territory ” means worldwide.

1.151 Third Party ” means any person or entity other than Sorrento, Servier and their respective Affiliates.

1.152 Third Party Claim ” has the meaning set forth in Section 12.1 .

1.153 Third Party IP Claim ” has the meaning set forth in Section 9.4.1 .

1.154 Third Party License ” has the meaning set forth in Section 8.5.2 .

1.155 Trademarks ” means all trademarks, service marks, trade names, rights in trade dress, logos, symbols, brand names and all trademark rights and interests throughout the world, and all right, title and interest in related applications and registrations throughout the world under common law, state law, federal law or laws of foreign countries.

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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1.156 Trade Secrets ” means all right, title and interest in all trade secrets and trade secret rights arising under common law, state law, federal law or laws of foreign countries, provided that any Trade Secret disclosed to the other Party both (a) without obtaining the other Party’s prior written consent and without being marked as “trade secret” or with a similar designation and (b) in a manner that a reasonable person would not regard as being provided under circumstances indicating that it is a trade secret shall not be deemed a Trade Secret pursuant to applicable Laws, but will be treated as Confidential Information of the disclosing Party.  

1.157 US Sublicense ” has the meaning set forth in Section 8.8 .

1.158 Valid Claim ” means (a) a claim of an issued and unexpired patent, which claim has not been revoked or held invalid or unenforceable by a court or other government agency of competent jurisdiction or has not been held or admitted to be invalid or unenforceable through re-examination or disclaimer, reissue, opposition procedure, nullity suit or otherwise or (b) a claim of a pending patent application that has not been abandoned, finally rejected or expired without the possibility of appeal or refiling; provided, however, that Valid Claim will exclude any such pending claim in an application that has not been granted within * years following the earliest priority filing date for such application.

1.159 Withholding Taxes ” has the meaning set forth in Section 8.9.5 .

ARTICLE 2. LICENSE GRANTS

Section 2.1 Sorrento License Grant . Subject to Sections 2.2 and 2.8 and other terms and conditions of this Agreement, Sorrento hereby grants to Servier a sublicensable (subject to Section 2.4 below), personal and non-transferable (except as set forth in Section 14.4 ), royalty-bearing right and license under the Sorrento IP to Develop, Manufacture or have Manufactured, use, sell, offer for sale, import, export or otherwise Commercialize the Products, in each case as a monotherapy or in combination with other therapies or products in the Field in the Territory. The foregoing license shall be exclusive (even as to Sorrento except to the extent set forth in Section 2.2 below) solely with respect to the Sorrento Contributions. For clarification, the foregoing license does not include LA Cell Technology and in no event shall Sorrento be obligated to transfer or otherwise provide the LA Cell Technology to Servier.

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

Section 2.2 Servier License Grant. Servier hereby grants to Sorrento a non-exclusive, non-sublicensable (except with Servier’s express prior written consent and agreement as to the terms of the sublicense), non-transferable (except as set forth in Section 14.4 ), royalty-free right and license under the Servier IP and Sorrento IP to conduct any activities expressly assigned to Sorrento pursuant to this Agreement or any applicable R&D Agreement. Notwithstanding the foregoing, Servier hereby approves a sublicense only for research and/or manufacturing, as applicable, for purposes of this Agreement under Sorrento IP and Servier IP to * and * and the

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respective sublicenses with each of the foregoing entities in the form that have been provided to Servier prior to the Effective Date. Further, Sorrento shall be excused from its performance under this Agreement to the extent that Servier’s failure or delay in providing its express prior written consent and agreement as to the terms of the sublicense prevents or otherwise adversely affects Sorrento’s performance under this Agreement.  

Section 2.3 Performance by Affiliates and Subcontractors .  Subject to the terms and conditions of this Agreement, Servier may, without Sorrento’s prior written consent, discharge any obligations and exercise any right hereunder through any of its Affiliates or Third Party, provided that, Servier shall cause or otherwise ensure that such Affiliate or Third Party subcontractor  comply with the terms and provisions that are applicable to the activities entrusted to such Affiliate or Third Party subcontractor including confidentiality provision in ARTICLE 10 . Servier shall remain primarily and fully liable for any acts or omissions of such Affiliate or Third Party subcontractor and any act or omission of such Affiliate or Third Party subcontractor shall be and shall be deemed to be an act or omission by Servier.

Section 2.4 Sublicense.   If Servier enters into a sublicense with a Sublicensee pursuant to ARTICLE 2 , Servier shall promptly inform Sorrento of such sublicense agreement (each, a “ Sublicense Agreement ”) and shall ensure that the Sublicense Agreement is consistent with and fully implements the relevant provisions of this Agreement including the audit provisions set forth in Section 8.10 and Sorrento’s rights under this Agreement. Each Sublicense Agreement shall protect Sorrento’s rights and interests in the Sorrento IP to at least the same extent as this Agreement, including without limitation containing provisions for the benefit of Sorrento substantially similar in language and scope to the license provisions set forth in ARTICLE 2 , the ownership provisions in Section 9.1 , and the confidentiality provisions set forth in ARTICLE 10 of this Agreement.  For the avoidance of doubt, the Sublicensee shall have no right of any type or kind to the Sorrento IP except to the extent of Servier’s right pursuant to ARTICLE 2 . Servier agrees to cause or otherwise ensure that each Sublicensee  comply with the terms and conditions of the Sublicense Agreement in connection with Sorrento IP. Servier shall be fully responsible and liable for any act or omission of such Sublicensee and any third party to whom sublicensing rights are transferred through a further sublicense by a Sublicensee (“ Subsequent Sublicensee ”) and any such act or omission shall be and shall be deemed to be an act or omission of Servier. Upon any expiration or termination of this Agreement for any reason, all Sublicense Agreements entered into pursuant to this Section 2.4 shall automatically terminate unless and to the extent Sorrento, in its sole discretion, agrees in writing to an assignment of any Sublicense Agreement to Sorrento or to enter into a direct agreement with any Sublicensee. In no event shall Sorrento have any obligation or liability to any Sublicense or any Subsequent Sublicensee and Servier shall fully and effectively disclaim the same in any such Sublicense Agreement. Any subsequent sublicenses granted by the Sublicensees shall be subject to the same requirement as set forth in this Section 2.4 .

Section 2.5 No Trademark License .  No right or license, express or implied, is granted to Servier to use any Trademarks, inlcuding without limitation any Trademarks owned or Controlled by Sorrento or any of its Affiliates.  No right or license, express or implied, is granted to Sorrento to use any Trademarks, including without limitation any Trademarks owned or Controlled by Servier.

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Section 2.6 Know How Transfer.  

2.6.1 Initial Transfer . As promptly as practicable following the Effective Date, and in any event no later than fifteen (15) days thereafter, Sorrento shall transfer to Servier all Regulatory Materials and sponsorships and deliver to Servier all communications with Competent Authorities and all other documents, reports (including with respect to technology transfer to *) and data, as applicable, in each case in Sorrento’s or its subcontractors’ possession and Controlled by Sorrento and regarding the Initial Antibody and any Initial Products, including one report for each study that has been conducted by or on behalf of Sorrento and the documents listed in Schedule 2.6.1, provided that, notwithstanding the requirement in this Section 2.6.1, Sorrento shall not be required to provide any information or other data that are not in its or its subcontractors’ possession and that are in a form or format other than the form or format in its or its subcontractors’ possession.

2.6.2 Ongoing Transfer . Thereafter following the initial transfer set forth in Section 2.6.1 , Sorrento shall, subject to applicable Laws regarding the export (including re-export) or import of certain information, materials or services, as soon as commercially reasonably deliver to Servier all information and documents,  specifically relating to any Sorrento Contributions as may become Controlled and possessed by Sorrento. For the avoidance of doubt, the foregoing shall not obligate Sorrento to attempt to obtain additional right or license from any Third Party for Servier’s exercise of its rights under this Agreement.

Section 2.7 Right of First Negotiation for ROFN Products. If at any time during the Term, Sorrento intends to start a process to sell, transfer, or grant any rights to a Third Party with respect to Sorrento’s anti-PD-1 or the mutually agreed upon clones for the following immune checkpoint inhibitors: * and any other immune checkpoint inhibitors specifically agreed upon by the Parties through the Coordination Committee and in the R&D Agreement (“ ROFN Products ”) or receives a written offer from a Third Party to enter into negotiations for the sale, transfer, or grant of any rights to an ROFN Product, then, in each case, Sorrento shall provide Servier with a written notice prior to commencing such processes or responding to such offer, as applicable (the “ ROFN Notice ”).

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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If Servier notifies Sorrento of its interest to license such ROFN Product following receipt of the ROFN Notice (“ ROFN Election Notice ”), Sorrento and Servier shall enter into good faith negotiations on an exclusive basis for a period of ninety (90) days to attempt to negotiate a ROFN Product Agreement for such ROFN Product. If either Servier does not provide such written notice within ten (10) days or the Parties fail execute a ROFN Product Agreement for such ROFN Product within ninety (90) days of the ROFN Election Notice, then Sorrento shall be free to enter into a partnering agreement with a Third Party and otherwise shall have no further obligation to Servier.

Section 2.8 Restrictions; No Other Licenses. Notwithstanding anything to the contrary in this Agreement or otherwise, the license granted to Servier under this Agreement is solely as specifically set forth in Section 2.1   and specifically excludes the Intellectual Property Rights and Know How covering: (a) the Linker Technology by itself and any other antibody, product or other item or material linked to, combined with or included in the Additional Anti-PD-1 Product and (b) * including any other portion of any antibody, product or other item or material linked to, combined with or included in the Derivative Antibody or Derivative Product.  In addition, neither Party grants to the other Party any rights, licenses or covenants in or to any Intellectual Property Rights, whether by implication, estoppel, vicariously, indirectly or otherwise, other than the license rights that are specifically and expressly granted under this Agreement. All rights not specifically and expressly granted by a licensing party under this Agreement are reserved by such licensing party and may be used or practiced by such licensing party for any purpose.

ARTICLE 3. GOVERNANCE

Section 3.1 Governance; Committees.

3.1.1 Coordination Committee .  Within thirty (30) days following the Effective Date, Sorrento and Servier shall establish a Coordination Committee (“ Coordination Committee ” or “ CC ”) to serve as a forum of exchange of information with respect to the Development and Commercialization of the Initial Products.

3.1.2 Scientific Committee .  If the Parties enter into a R&D Agreement, they may establish a scientific committee to oversee the activities under such R&D Agreement (“ Scientific Committee ” or “ SC ”).

Section 3.2 Committee Membership. The CC and SC (each, a “ Committee ”) shall each be composed of an equal number of representatives from each of Sorrento and Servier selected by such Party.  Unless the Parties otherwise agree, the exact number of representatives for each of Sorrento and Servier shall be three (3) representatives.  Either Party may replace its respective Committee representatives at any time with prior written notice to the other Party.

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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Section 3.3 Committee Meetings.   The CC shall meet at least twice each Calendar Year or more or less often as otherwise agreed to by the Parties.  The SC shall meet at the periodicity set forth in the applicable R&D Agreement. All Committee meetings may be conducted by telephone, video-conference or in person as determined by the applicable Committee.  Each Party shall bear its own personnel and travel costs and expenses relating to Committee meetings.  With the consent of the Parties (not to be withheld unreasonably), other employee representatives of the Parties may attend any Committee meeting as non-voting observers.  

Section 3.4 Limitation on Committee Responsibility. Unless otherwise agreed in any R&D Agreement with respect to the Development of any Additional Anti-PD-1 Product, the Committees shall not have any responsibility or authority, and shall not have any oversight or other rights, with respect to the Products, including further Development, use, manufacture, regulatory filings, other regulatory matters and Commercialization.

Section 3.5 Alliance Managers.   Within thirty (30) days following the Effective Date, each Party shall appoint an individual to act as alliance manager for such Party (each, an “ Alliance Manager ”).  Each Alliance Manager shall be a representative of the applicable Party on the CC. The Alliance Managers shall coordinate all contacts between the Parties regarding the activities contemplated by this Agreement, shall facilitate all such activities hereunder, and shall be responsible for progressing the alliance activities, otherwise facilitating communication and being the first line of dispute resolution.  The Alliance Managers shall attend all meetings of the CC and shall be responsible for assisting the CC in performing its oversight responsibilities.  The name and contact information for each Party’s Alliance Manager, as well as any replacement(s) chosen by such Party, in its sole discretion, from time to time. Each Party shall provide its Alliance Manager with sufficient resources for the Alliance Manager to perform his or her role under this Agreement.

Section 3.6 Scope of Governance.   Notwithstanding the creation of the Committees, each Party shall retain the rights, powers and discretion granted to it hereunder, and no Committee shall be delegated or vested with rights, powers or discretion unless such delegation or vesting is expressly provided herein, or the Parties expressly so agree in writing.  No Committee shall have the power to amend or modify this Agreement, and no decision of any Committee shall be in contravention of any terms and conditions of this Agreement.  The Alliance Managers shall not have any rights, powers or discretion except as expressly granted to the Alliance Managers hereunder and in no event shall the Alliance Managers have any right or power to modify or amend this Agreement. It is understood and agreed that issues to be formally decided by any of the Committees are only those specific issues that are expressly provided in this Agreement to be decided by such Committee.

ARTICLE 4. DEVELOPMENT

Section 4.1 Development Activities. Servier shall control, at its sole cost and expense, the Development of the Initial Product and shall regularly inform Sorrento of the status of such Development through the CC or otherwise.

Section 4.2 Diligence. Servier shall, itself or through its Affiliates or Sublicensees, use Commercially Reasonable Efforts to Develop at least one Product in the Field.

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Section 4.3 Sorrento’s Assistance. Sorrento shall provide reasonable assistance to Servier with respect to the use of the Linker Technology to enable the Development of Servier Additional Anti-PD-1 Products pursuant to the R&D Agreement and *. Sorrento shall provide reasonable assistance to Servier with respect to the Development of Sorrento Additional Anti-PD-1 Products in accordance with the applicable R&D Agreement.    

ARTICLE 5. REGULATORY MATTERS

Section 5.1 Regulatory Filings.

5.1.1 Responsibility . Following the Effective Date, and subject to Sorrento’s assistance obligation pursuant to Section 5.2 , Servier shall control, at its sole cost and expense, the preparation and filing all necessary Regulatory Materials for the Products with Competent Authorities.

5.1.2 Ownership . Subject to Sorrento’s ownership in and to the Sorrento Know-How, Servier shall own all Regulatory Materials and all correspondence with Competent Authorities for the Product in the Territory and Servier shall own and be the license holder for all Marketing Approvals, pricing and reimbursement approvals for the Product.

Section 5.2 Cooperation. Sorrento will, at its sole cost and expense, use commercially reasonable efforts to cooperate with Servier in providing technical regulatory expertise for assistance in developing the submission strategy for filing Regulatory Materials and defining technical content and will provide commercially reasonable support to Servier to ensure timely filing of Regulatory Materials, in each case for each Product Developed under this Agreement.  In particular, no later than *, Sorrento shall provide to Servier the IMPD/IND quality part of the CMC documentation as needed for Servier to file the IND/IMPD for the Initial Product. Additionally, Sorrento shall use commercially reasonable efforts to provide to Servier, as promptly as practicable following Servier’s reasonable request, such reasonable assistance, cooperation and input (including documents and data) Servier deems reasonably necessary for Servier to prepare Regulatory Materials and obtain Regulatory Approvals, including Marketing Approvals, pricing and reimbursement approvals, together with any post-Marketing Approval or post-reimbursement approval regulatory filings, in each case with respect to such Product.

ARTICLE 6. MANUFACTURING AND SUPPLY

Section 6.1 Manufacturing Roles. The Parties shall have responsibility for the following activities with respect to Manufacturing for the Products:

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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6.1.1 Prior to Technology Transfer. Until the Technology Transfer as set forth in Section 6.1.2 , Sorrento shall have Manufactured and supplied to Servier the mutually agreed upon quantity of pre-clinical samples of the Initial Product for the IND/IMPD submissions as set forth in Section 6.2.1 , for Development pursuant to this Agreement.  

6.1.2 Technology Transfer . Upon Servier’s reasonable request, Sorrento shall transfer to Servier its agreement with * and its other CMOs, as applicable, for the Manufacturing of the Product.  In addition, upon Servier’s reasonable request, Sorrento shall, and shall cause its Third Party subcontractors to, perform a technology transfer (including reasonable technical assistance) of the manufacturing process(es) owned or Controlled by Sorrento and in Sorrento’s or such Third Party subcontractors’ possession for the Initial Product (and the Sorrento Contribution portion of Additional Anti-PD1 Products, if developed pursuant to an R&D Agreement) to Servier or its Third Party subcontractor in accordance with the technology transfer provisions set forth in this Agreement  (the “ Technology Transfer ”). Sorrento will issue an invoice for the Technology Transfer and Servier shall pay the invoiced price pursuant to Section 8.9 in accordance with a budget to be agreed upon prior to the initiation of the Technology Transfer.

6.1.3 Following Technology Transfer . At the conclusion of the Technology Transfer, Servier shall be solely responsible for and have sole control, in each case by itself or through one or more CMOs, of the Manufacture and supply of the Products, at Servier’s sole cost and expense.

Section 6.2 Supply Obligations and Quality Agreement.

6.2.1 Supply Obligation . Sorrento shall supply Servier with the quantity of pre-clinical samples of the Initial Products for IND/IMPD submissions as set forth in Schedule 6.2.1(a) that meet the quality requirement described in such Schedule by *, and shall deliver a certificate of analysis within acceptability ranges defined by the qualification  methods and pursuant to the requirements set forth in Schedule 6.2.1(a), which certificate shall be duly signed by Sorrento and in a form reasonably acceptable by Servier’s quality assurance by *, provided that, Sorrento shall not be liable for any delay if such delay is caused by Servier’s failure to accept or delay in accepting the certificate of analysis pursuant to the foregoing requirements (such pre-clinical quantities and certificate, collectively, the “ Sorrento Deliverables ”). If Servier so requests, the Parties shall negotiate in good faith a supply agreement within sixty (60) days of such request (the “ Supply Agreement ”) pursuant to which, for a transition period mutually agreed upon by the Parties, Sorrento will use commercially reasonable efforts to timely deliver to Servier agreed upon quantities of Initial Product for clinical use pursuant to the terms and conditions to be set forth in such Supply Agreement. *.

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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For clarification, any supply of clinical samples of the Initial Products shall be in the amount, on the timing and the cost mutually agreed between the Parties pursuant to the Supply Agreement, provided that Servier shall assume Sorrento’s obligations under a license agreement with *, which are set forth in Schedule 6.2.1(b), or alternatively, Servier shall enter into its own arrangement with *.

6.2.2 Quality Agreement . In the event that the Parties enter into a Supply Agreement, Servier shall enter into a separate agreement with Sorrento or its CMO covering the quality control, quality assurance and validation of any Product delivered under the appropriate supply agreement (the “ Quality Agreement ”). The Quality Agreement may be updated as required, independent of this Agreement. The Quality Agreement shall contain customary terms and conditions that are consistent with this Agreement, and shall set forth the respective requirements, roles and responsibilities of the Parties.

ARTICLE 7. COMMERCIALIZATION

Section 7.1 General.   Servier be solely responsible for and have sole control of all aspects of the Commercialization of the Products in the Territory, including planning and implementation, distribution, booking of sales, pricing, reimbursement and costs.

Section 7.2 Diligence. Servier shall itself, or through its Affiliates or Sublicensees, use Commercially Reasonable Efforts to Commercialize at least one Product in the Field.

ARTICLE 8. PAYMENTS AND MILESTONES

Section 8.1 Upfront Fee.   In consideration for the rights granted under this Agreement, Servier shall pay Sorrento a one-time, non-refundable and non-creditable lump sum payment of: (a) Twenty-Five Million Euros (EUR 25,000,000€), within ten (10) days of the Effective Date and receipt of the corresponding invoice from Sorrento and (b) * (EUR *€) within ten (10) days of the first IND/IMPD submission by Servier, if any, and receipt of the corresponding invoice from Sorrento.  

Section 8.2 Development and Regulatory Milestones. Subject to Section 8.8 , in consideration for the rights granted under this Agreement, in each case upon initial achievement of the applicable milestone with respect to Clinical Studies conducted by or on behalf of Servier or its Sublicensees for the Initial Product or Regulatory Filings made by or on behalf of Servier or its Sublicensees for the Initial Product, Servier will pay Sorrento the one-time, non-refundable and non-creditable lump sum payments set forth below (each, a “ Development Milestone ”).

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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8.2.1 *  

Development Milestone Event

Milestone Payment Amount

*

*  

 

 

8.2.2 *

Development Milestone Event

Milestone Payment Amount

*

*

*

*

*

*

*

*

 

 

8.2.3 *

Development Milestone Event

Milestone Payment Amount

*

*

*

*

*

*

*

*

 

 

8.2.4 *

Development Milestone Event

Milestone Payment Amount

*

*

*

*

*

*

*

*

 

 

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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*

Section 8.3 Sales Milestones.   Subject to Section 8.8 , as partial consideration for the rights granted hereunder, Servier shall make the non-refundable, non-creditable, one-time sales milestone payments to Sorrento based upon achievement of the first instance of cumulative Net Sales of the Initial Product in the Territory over a Calendar Year as set forth below (each, a “ Sales Milestone ”).

Net Sales Milestone of the Initial Product over a Calendar Year

Milestone payment (in €)

€*

€*

€*

€*

€*

€*

€*

€*

€*

€*

€*

€*

€*

€*

€*

€*

 

 

Section 8.4 Royalties . Subject to Section 8.8 as partial consideration for the rights granted hereunder, Servier shall pay Sorrento royalties equal to the following percentages of Royalty Bearing Net Sales of the Initial Product over a Calendar Year, subject to adjustment as set forth in Section 8.5 (“ Royalties ”):

Royalty Bearing Net Sales of the Initial Product over a Calendar Year

Royalty Rate

For the portion that is less than or equal to €*

*%

For the portion that is greater than €* but less than or equal to €*

*%

For the portion that is greater than €*  but less than or equal to €*

*%

For the portion that is greater than €* but less than or equal to €*

*%

For the portion that is greater than €*  but less than or equal to €*

*%

For the portion that is greater than €* but less than or equal to (€*

*%

For the portion that is greater than €*

*%

 

 

Section 8.5 Royalty Adjustments.

Biosimilar Drug Competition. Notwithstanding the foregoing, as soon as there is any Biosimilar version of a Product commercialized in any given country, the Royalties payable to Sorrento for such Product in such country shall be reduced by * percent (*%) of the amount otherwise payable hereunder, provided that, in such case, no further Royalties shall be due for such Product after ten (10) years from the First Commercial Sale of the Product in such country.  Further, if total sales of any Biosimilar of a Product in any country reaches more than * percent (*%) of the total sales in such country, then, no further Royalties shall be due for such Product in such country.

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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8.5.1 Third Party Licenses.   If it is reasonably necessary for Servier (including as evidenced by an opinion of internationally recognized outside counsel) to license one or more Patent Rights from one or more Third Parties in order to Develop, Manufacture, Commercialize or use any Product, whether directly or through any Affiliate or Sublicensee, in the Territory, then Servier may negotiate and obtain a license under such Patent Right(s) (each such Third Party license referred to herein as a “ Third Party License ”).  Without prejudice to the provisions of Section 11.2 and Section 12.1 , if any payments are due to a Third Party pursuant to a Third Party License or in the context of proceedings brought by any Third Party alleging that one or more Patent Rights of such Third Party is infringed by the Development, Manufacture, Commercialization or use any Product, then Servier may deduct such payment(s) from the Royalties associated to such Product otherwise payable under Section 8.4 , *.  

8.5.2 For the avoidance of doubt, Sorrento shall be solely responsible for all license payments, milestones and royalties owed by Sorrento to a Third Party with respect to any Sorrento Contribution pursuant to a license agreement with a Third Party, on Intellectual Property Rights or Know How that is owned or licensed by Sorrento relating to any Sorrento Contribution on or prior to the Effective Date, provided that, notwithstanding the foregoing and except with respect to the Sorrento Deliverables, Sorrento shall not be responsible for any additional license payments, milestones and royalties to * for Servier’s exercise of its rights under this Agreement.

Section 8.6 Additional Anti-PD-1 Products. In the event that Servier elects to Develop and Commercialize any Additional Anti-PD-1 Products, Servier shall make the following payments to Sorrento, in lieu of its payments to Sorrento pursuant to Section 8.2 and Section 8.3 above, in consideration of the rights granted to it under this Agreement.

8.6.1 Servier Additional Anti-PD-1 Products.

8.6.1.(a) Development and Regulatory Milestones. Upon initial achievement of the applicable Development Milestone Events set forth in the table of Section 8.2 for the first Servier Additional Anti-PD-1 Product, Servier will pay Sorrento non-refundable and non-creditable payments equal to * of the applicable payment amounts set forth in Section 8.2 .  For clarity, such payments shall be made only once irrespective of the number of Servier Additional Anti-PD-1 Products that are developed and only to the extent they have not been paid for the Initial Product.

8.6.1.(b) Sales Milestones. For each Servier Additional Anti-PD-1 Product Developed under this Agreement, Servier shall pay Sorrento non-refundable and non-creditable payments in an amount equal to those set forth in * upon the achievement of the milestones set forth therein on a Servier Additional Anti-PD-1 Product-by- Servier Additional Anti-PD-1 Product basis.

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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8.6.1.(c) Royalties.   For each Servier Additional Anti-PD-1 Product Developed under this Agreement, Servier shall pay Sorrento the royalty amounts set forth in * on Royalty Bearing Net Sales of such Servier Additional Anti-PD-1 Product.  

8.6.2 Sorrento Additional Anti-PD-1 Products.

8.6.2.(a) Development and Regulatory Milestones. Upon achievement of the applicable Development Milestone Events set forth in the table of Section 8.2 for any Sorrento Additional Anti-PD-1 Product, Servier will pay Sorrento non-refundable and non-creditable payments equal to the applicable payment amounts set forth in *, provided, however, that such payments shall be due only if Sorrento has borne the costs of characterizing any Antibody Controlled by Sorrento that may be included in any such Sorrento Additional Anti-PD-1 Product and performing the studies needed for the IND, which studies are substantially similar to the studies conducted by Sorrento for the Initial Antibody.

8.6.2.(b) Sales Milestones. For each Sorrento Additional Anti-PD-1 Product Developed under this Agreement, Servier shall pay Sorrento non-refundable and non-creditable payments in an amount equal to those set forth in * upon the achievement of the milestones set forth therein on a Sorrento Additional Anti-PD-1 Product-by- Sorrento Additional Anti-PD-1 Product basis.

8.6.2.(c) Royalties .  For each Sorrento Additional Anti-PD-1 Product Developed under this Agreement, Servier shall pay Sorrento the royalty amounts set forth in * on the Royalty Bearing Net Sales of such Sorrento Additional Anti-PD-1 Product.

Section 8.7 Payments for Derivative Products. For each Derivative Product developed under this Agreement and Covered by a Valid Claim of a Sorrento Patent Right, Servier shall pay Sorrento an amount equal to *.

Section 8.8 * :

8.8.1 *

8.8.2 *

8.8.3 *.

*.

Section 8.9 Payment Terms

8.9.1 Payment. All payments made by Servier pursuant to this ARTICLE 8 shall be made in immediately available funds by wire transfer to such bank and account of Sorrento as may be designated from time to time by Sorrento.

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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8.9.2 Terms. Except as otherwise set forth herein, all other payments due hereunder will be paid within forty-five (45) days following receipt of an invoice requesting such payment.  

8.9.3 Invoices . All invoices provided to Servier hereunder should include Sorrento’s bank details, the contact name for issue resolution and will be marked for the attention of the Alliance Manager.

8.9.4 Late Payment.   Interest shall accrue on any late payment of fees owed to Sorrento not made on the date such payment is due, at an annual interest rate equal to the lesser of (a) the Euribor one month with respect to payments in Euros or (b) the highest rate permissible by Law, with such interest accruing from the date the payment was originally due to Sorrento.

8.9.5 Taxes and Withholding. All payments under this Agreement shall be made without any deduction or withholding for or on account of any tax, except as set forth in this Section 8.9.5 .  The Parties agree to cooperate with one another and use reasonable efforts to minimize under applicable Law obligations for any and all income or other taxes required by applicable Law to be withheld or deducted from any of the royalty and other payments made by or on behalf of a Party hereunder (“ Withholding Taxes ”). The applicable paying Party under this Agreement (the “ Paying Party ”) shall, if required by applicable Law, deduct from any amounts that it is required to pay to the recipient Party hereunder (the “ Payee Party ”) an amount equal to such Withholding Taxes.  Such Withholding Taxes shall be paid to the proper taxing authority for the Payee Party’s account and, if available, evidence of such payment shall be secured and sent to Payee Party within thirty (30) days of such payment.  The Paying Party shall, at the Payee Party’s sole cost and expense, as mutually agreed by the Parties, do all such lawful acts and things and sign all such lawful deeds and documents as the Payee Party may reasonably request to enable the Paying Party to avail itself of any applicable legal provision or any double taxation treaties with the goal of paying the sums due to the Payee Party hereunder without deducting any Withholding Taxes.

8.9.6 Conversions. With respect to amounts required to be converted into another currency for calculation of the Net Sales amount, the milestones and the Royalty payments, such amount shall be converted using a rate of exchange which corresponds to the average quarterly rate published by the European Central Bank as used by Servier for conversion between the relative currencies for its reporting period in its books and records that are maintained in accordance with Accounting Standards, as applicable, for its external reporting.

Section 8.10 Reports and Audits.

8.10.1 Sales Payment Reports. After the First Commercial Sale by the Seller of a Product requiring the payments due to Sorrento pursuant to Section 8.3 or Section 8.4 and ending, on a Product-by-Product basis, following the last to expire Royalty Term with respect to such Product, Servier shall send to Sorrento a written report within thirty (30) days following the beginning of each Calendar Quarter. Such report shall state, for the previous Calendar Quarter the description of each Product sold, by country, the corresponding Net Sales and the calculation of any milestones fees and Royalties due.

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8.10.2 Records; Inspection.   Each Party shall keep complete, true and accurate books of account and records for the purpose of determining the amounts payable under this Agreement. Such books and records shall be kept at the principal place of business of each Party, as the case may be, for at least three (3) years following the end of the six (6) month period to which they pertain.  Each Party (the “ Audited Party ”) shall make such account and records available, on reasonable notice sent by the other Party (the “ Auditing Party ”), for inspection during business hours, with not less than thirty (30) Business Days’ advance written notice, by an independent auditor nominated by such and reasonably acceptable for the Audited Party, for the purpose of verifying the accuracy of any statement or report given by the Audited Party. Such auditor shall advise the Parties simultaneously promptly upon its completion of its audit whether or not the payments due hereunder have been accurately recorded, calculated and reported, and, if not, then the amount of such discrepancy. A Party’s financial records with respect to a given period of time shall only be subject to one (1) audit, except in the case of fraud.  The Auditing Party’s right to perform an audit pertaining to any Calendar Year shall expire three (3) years after the end of such Calendar Year. The auditor shall be required to keep confidential all information learnt during any such inspection, and to disclose to the Auditing Party only such details as may be necessary to report the accuracy of the Audited Party’s statement or report. The Auditing Party shall be responsible for the auditor’s costs, unless the auditor certifies that there was a variation or error producing an increase exceeding five percent (5%) of the royalty amount stated for any period covered by the inspection, then all reasonable costs relating to the inspection for such period and any unpaid amounts that are discovered shall be paid promptly by the Audited Party.  

Section 8.11 No Guarantee of Success. Servier makes no representation, warranty or covenant, either express or implied, that (a) it will successfully Develop, Manufacture, Commercialize or continue to Develop, Manufacture or Commercialize any Product in any country, or (b) if Commercialized, that any Product will achieve any particular sales level, whether in any individual country or cumulatively throughout the Territory .

ARTICLE 9. INTELLECTUAL PROPERTY AND PATENT RIGHTS

Section 9.1 Ownership.

9.1.1 Background IP. With respect to all Know-How and Intellectual Property Rights Controlled by a Party prior to the Effective Date or developed separate and apart from this Agreement (“ Background IP ”), as between the Parties, such Background IP shall be deemed owned by the Party Controlling such Know-How and Intellectual Property Rights.

9.1.2 Inventions. Subject to the provisions of the subsequent sentence, any invention invented or Know How generated solely by employees, agents, or independent contractors of a Party or its Affiliates in the course of performing activities under this Agreement, together with all Intellectual Property Rights therein, shall be owned by such Party (“ Sole Invention ”).  Any invention made or Know How (a) generated jointly by at least one (1) employee, agent, or independent contractor of each Party or such Party’s Affiliate  in the course of performing activities under this Agreement or (b) invented or generated solely by employees, agents, or independent contractors of a Party or its Affiliates in the course of performing activities under this Agreement or an R&D Agreement but financed by the other Party pursuant to this

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Agreement or an R&D Agreement (except as and to the extent otherwise provided in the applicable R&D Agreement), together with all Intellectual Property Rights therein (“ Joint Inventions ”, and all Patents covering such Joint Inventions, hereinafter, “ Joint Patents ” and any other Intellectual Property Rights (excluding Trademarks) in and to such Joint Inventions, hereinafter “ Joint Other Intellectual Property Rights ”), shall be owned jointly by the Parties in accordance with joint ownership interests of co-inventors or their respective contributions. Each Party shall promptly disclose to the other Party in writing any inventions and any written invention disclosures, or other similar documents, submitted to it by its employees, agents, or independent contractors describing each and every invention that may be either a Sole Invention or a Joint Invention, and all Know-How relating to such invention.  

9.1.3 Joint IP. Subject to and except as otherwise provided in this Agreement including with respect to the exclusive licenses granted to Servier hereunder with respect to the Products and the non-compete obligation in Section 11.6 , each Party shall have the right to freely sell, assign, license, encumber and otherwise exploit Joint Inventions, Joint Patents and Joint Other Intellectual Property Rights without notice or accounting to the other Party.

Section 9.2 Patent Right Prosecution.

9.2.1 Patent Committee. Within fifteen (15) days of the Effective Date, the Parties shall establish a patent committee comprised of an equal number of representatives of Sorrento and Servier (the “ Patent Committee ”). The Patent Committee shall define the proposed strategy, review and validate the proposed claims and review all significant matters relating to the prosecution and defense of the Sorrento Contribution Patent Rights, and Joint Patents relating to the Sorrento Contributions. In addition, the Parties acknowledge and agree that *. This strategy shall be handled in close coordination with Servier through the Patent Committee. Sorrento shall have the final decision making with respect to the Sorrento Contribution Patent Rights including the Sorrento Anti-PD-1 Patent Rights as long as it is established that such decision does not adversely impact Servier’s rights under this Agreement and, unless otherwise agreed in the relevant R&D Agreement, Servier shall have the final decision making with respect to the Joint Patent Rights as long as it is established that such decision does not adversely impact Sorrento’s rights under this Agreement including Section 13.4.1(e).

9.2.2 Sorrento Patent Rights. Except as and to the extent expressly and specifically provided in this ARTICLE 9 , Sorrento shall have the right and authority to control the preparation, filing, prosecution and maintenance of the Sorrento Patent Rights on a worldwide basis in its sole discretion and control. Sorrento shall be responsible, at its sole cost and expense, for filing, prosecuting and maintaining all such Sorrento Patent Rights on a worldwide basis.

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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9.2.2.(a) Sorrento Contribution Patent Rights . Sorrento shall provide Servier with a copy of all material communications from patent authorities in the Territory regarding the Sorrento  Contribution  Patent Rights, and shall provide drafts of any material filings or responses to be made to such patent authorities with respect to such Sorrento Contribution Patent Rights in a timely manner and shall take into account any reasonable comments from Servier, provided that Sorrento shall follow Servier’s reasonable instructions with respect to the opt-out procedure for Unitary/European patents, and Servier’s reasonable instructions with respect to the order of review of the claims by the patent offices as applicable, the correction of any possible issue identified by Servier from time to time and the territories. Notwithstanding the foregoing, if Sorrento determines in its sole discretion to abandon or not maintain any Sorrento  Contribution Patent Rights, Sorrento shall provide Servier with at least forty-five (45) days prior written notice of such determination and, if Servier so requests, shall provide Servier with the opportunity to prosecute and maintain such Sorrento Contribution Patent Rights in the name of Servier, at Servier’s sole cost and expense; in which case, such Patent shall be assigned to Servier and shall cease to be a Sorrento Patent Right.    

9.2.3 Servier Patent Rights. Subject to Section 9.2.1 above, Servier shall have the right and authority to control the preparation, filing, prosecution and maintenance of the Servier Patent Rights on a worldwide basis in its sole discretion and shall be responsible, at its sole cost and expense, for filing, prosecuting and maintaining all such Servier Patent Rights.

9.2.4 Joint Patents. In the event the Parties conceive or generate any Joint Patents, Servier shall be responsible for such filing, prosecution and enforcement of Joint Patents to the extent they are specifically related to the Initial Products and, unless otherwise agreed in the relevant R&D Agreement, the Additional Anti-PD1 Products. If the Joint Patents are not specifically related to the Initial Products and, unless otherwise agreed in the relevant R&D Agreement, the Additional Anti-PD1 Products, the Patent Committee will promptly meet to discuss whether to seek patent protection thereon and if patent applications are to be filed, the Parties’ rights and responsibilities regarding filing, prosecution and enforcement. All costs and expenses of filing, prosecuting and maintaining a Joint Patent shall be shared equally by the Parties. The Party that prosecutes a given Joint Patent (the “ Prosecuting Party ”) shall provide the other Party the opportunity to review and comment on any and all such prosecution efforts regarding the applicable Joint Patent, and such other Party shall provide the Prosecuting Party reasonable assistance in such efforts; provided that the Prosecuting Party shall have final control over such prosecution efforts after reasonably considering the other Party’s comments, if any in good faith. The Prosecuting Party shall provide the other Party with a copy of all material communications from any Patent authority in the applicable jurisdictions regarding the Joint Patent being prosecuted by such Party, and shall provide drafts of any material filings or responses to be made to such Patent authorities a reasonable amount of time, but in no event less than forty (40) days, in advance of submitting such filings or responses. In particular, each Party agrees to provide the other Party with all information necessary or desirable to enable the other Party to comply with any duty of candor or duty of disclosure requirements of any Patent authority.

9.2.5 Cooperation in Prosecution.   Each Party shall provide the other Party all reasonable assistance and cooperation in the Patent prosecution efforts described above in this Section 9.2 , including providing any necessary powers of attorney and executing any other required documents or instruments for such prosecution.

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Section 9.3 Patent Term Extensions. Servier will have the sole right but not the obligation to apply for and obtain any patent term extension, supplementary protection certificates or similar extension of rights, for any Sorrento  Contribution  Patent Rights and any Joint Patents specifically related to the Sorrento Contributions, provided that Servier will consult with Sorrento before applying for or obtaining any such extensions with respect to any Sorrento Contribution Patent Rights and any Joint Patents specifically related to the Sorrento Contributions.  Sorrento will provide reasonable assistance in connection with obtaining any such extensions including, to the extent reasonably and legally required in a particular country or region, making available a copy of the necessary documentation to enable Servier to obtain the extension in such country.  

Section 9.4 Intellectual Property Litigation. Except as and to the extent expressly provided in this Section 9.4 , Sorrento shall have the right, but not the obligation, to bring or defend an infringement action with respect to Sorrento Patent Rights at its own expense, in its own name and entirely under its sole discretion and control.

9.4.1 Notice and Cooperation.   Sorrento shall promptly notify Servier, to the extent Sorrento becomes aware (a) of any suspected or threatened infringement of any Sorrento Contribution Patent Rights (including any “patent certification” filed in the United States under 21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) or similar provisions in other jurisdictions or of any declaratory judgment, or similar action alleging the invalidity, unenforceability or non-infringement of any Sorrento Contribution Patent Rights or any administrative challenge to any Sorrento Contribution Patent Rights under Chapters 31 and 32 of Title 35, USC or similar provisions in other jurisdictions alleging the unpatentability of any Intellectual Property) in the Field, (b) of any claim that the exercise of the rights granted hereunder under the Sorrento Contribution Patent Rights infringes any Intellectual Property Rights (excluding Trademarks) of a Third Party in the Field, (c) of any claims of alleged patent infringement with respect to the Development, Manufacture or Commercialization of the Sorrento Contributions in the Field and (d) of any suspected or actual misappropriation of the Sorrento Know-How required to be transferred to Servier under this Agreement in the Field (each, a “ Third Party IP Claim ”).

9.4.2 Servier’s First Right. Servier may in its sole discretion, but shall not be required to, bring legal action against any Third Party or defend a Third Party IP Claim, at its own cost and expense.  Prior to bringing or defending a legal action, Servier shall discuss its intention with Sorrento (subject to Sorrento entering into a common interest agreement if requested by Servier and without disclosing any information that would compromise attorney-client privilege or similar privileges), and shall take Commercially Reasonable Efforts to consider Sorrento’s input in good faith. If Servier decides to bring or defend a legal action and Sorrento is required to join as a necessary party to such action and the Third Party brings a counterclaim against Sorrento, Servier shall defend, indemnify and hold harmless any Sorrento Indemnitees from and against any and all Damages to the extent incurred as a result of or arising out of any such counterclaim brought against one or more of Sorrento Indemnitees.

9.4.3 Sorrento’s Second Right. If Servier decides that it will not bring legal action or defend a Third Party IP Claim under Section 9.4.2 , then it shall promptly notify Sorrento.  Upon receipt of such notice of intent to decline action, Sorrento, may, but shall not be required to, bring legal action or defend against any an Exclusive Third Party IP Claim, in its own name and at its own cost, provided that Sorrento shall not be entitled to bring such action if in Servier’s reasonable judgment such action may adversely impact the Development or Commercialization of any Product.

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9.4.4 Cooperation and Settlement.   During the pendency of such action with respect to any Third Party IP Claim, at the other Party’s request, the Party responsible for defending or enforcing any such action (the “ Responsible Party ”) shall provide the other Party with all information reasonably requested regarding the status of such action (subject to the other Party entering into a common interest agreement if requested by the Responsible Party, and without disclosing any information that would compromise attorney-client privilege or similar privileges).  All materials provided by the Responsible Party to the other Party shall be treated as the Responsible Party’s Confidential Information. In any action or defense initiated by the Responsible Party, the other Party shall be entitled to, and if legally required shall, join the action so long as the Responsible Party retains at all times the sole right to direct and control the action (including the choice of its own counsel). The other Party is entitled to be independently represented by counsel of its choice, at its expense.  When either Party is bringing or defending an action with respect to any Third Party IP Claim, then (a) upon request by the Responsible Party, the other Party will assist in the defense against or enforcement of such action at the other Party’s costs, including if required or desirable to bring, maintain or prove damages in such action, furnishing a power of attorney, furnishing documents and information, cooperating in discovery, providing access to witnesses (including inventors) and executing all necessary documents as such Party may request, and (b) neither Party shall settle, consent to judgment or otherwise voluntarily dispose of the suit or action without the prior written consent of the other Party, which consent shall not be unreasonably delayed, conditioned, or withheld if such settlement, consent to judgment or other voluntary disposition does not impose any liability on the other Party (other than liability that is fully satisfied by the settling Party on behalf of the other Party) and does not impose any restrictions on the other Party.  

9.4.5 Allocation of Proceeds. The proceeds recovered from any Third Party IP Claims described in this Section 9.4 shall be first allocated to the reimbursement of the reasonable attorneys’ fees and out-of-pocket costs incurred by the Party who exercises its enforcement rights with respect to the Third Party IP Claims under this Section 9.4 (excluding the Damages paid in accordance with the last sentence of Section 9.4.2 ). If such recovery is insufficient to cover all such costs and expenses of both Parties, it shall be shared between the Parties, with the Party who exercises its enforcement rights under this Section 9.4 and recovers damages retaining seventy percent (70%) and the other Party retaining thirty percent (30%) of such funds. The remaining portion of proceeds shall be allocated to Servier and treated as Royalty Bearing Net Sales for the payment of Royalty and Sales Milestones to Sorrento.

Section 9.5 Trademarks and Domain Names

9.5.1 Servier shall select one or more product trademarks (including backup trademarks) for the Products for use by Servier in the Territory (including backup trademarks) that are not confusingly similar to or otherwise infringes Sorrento’s Trademarks (the “ Product Trademarks ”).  Servier (or its local Affiliates, as appropriate) shall own and retain all rights to Product Trademarks, together with all goodwill associated therewith, worldwide, and all e-brands, trade dress, service marks, domain names, designs and copyrights for the Product in the Territory.

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9.5.2 Servier shall be responsible for filing and registering Product Trademarks at Servier’s expense and in its own name. Servier may, at its own discretion, select for the Product Trademark a trademark which was already filed or registered in Servier’s portfolio. Servier shall have the right but not the obligation to use a single global product trademark in the Territory. Servier shall have the right to affix any logo or trade name of its choice on the Product in the Territory.  

9.5.3 Servier may also select domain names including or close to Product Trademarks. Servier shall be responsible for filing and registering these domain names at Servier’s expense and in its own name.

9.5.4 Sorrento does not have and shall not acquire any interest, title or right in any of the Product Trademarks or other Servier’s trademarks, trade dress, logos, trade names and designs. Sorrento shall not directly or indirectly seek through judicial or administrative process, to invalidate, oppose or challenge the validity, enforceability or scope of any Product Trademarks or other trade dress, logos, trade names and designs used in connection with The Products. During the term of this Agreement and thereafter, Sorrento undertakes not to take any actions and not to assist in any such actions to acquire any property rights in and to the Product Trademarks and any trade dress, logos, trade names, and designs used in connection with the Products, in particular not to register nor attempt to register in its name any trademark, trade name, trade or designs, identical or similar to the Product Trademarks and any trade dress, logos, trade names, and designs used in connection with the Products. Sorrento shall not register nor use directly or indirectly any domain name including a name identical to or similar to the Product Trademarks or Servier’s trade names.

9.5.5 Any and all use by Sorrento or its Affiliates of the Product Trademarks or and any trade dress, logos, trade names, and designs used in connection with the Products shall be submitted to Servier’s prior express written approval.

9.5.6 Sorrento shall maintain vigilance in the Territory and shall promptly notify Servier of any infringements or possible infringements of the Product Trademarks and any trade dress, logos, trade names, and designs used in connection with the Products of which it becomes aware.

9.5.7 Servier may, but shall not be required to, bring legal action against any such infringement or threatened infringement of which it is aware or which is brought to its attention by Sorrento  or others. In bringing any such action, Servier shall act in its own name. Sorrento shall refrain from instituting any action against any such infringement of the Product Trademarks and any trade dress, logos, trade names, and designs used in connection with the Products.

ARTICLE 10. CONFIDENTIAL INFORMATION

Section 10.1 Confidentiality. Except to the extent expressly authorized by this Agreement or agreed in writing by the Parties, during the Term and for a period of five (5) years after its termination or expiration, the Parties agree that the Receiving Party shall: (a) keep the Disclosing Party’s Confidential Information confidential; (b) not disclose, or permit the disclosure of, the Disclosing Party’s Confidential Information; and (c) not use, or permit to be used, the Disclosing Party’s Confidential Information for any purpose other than as expressly permitted under the terms of this Agreement.

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Section 10.2 Authorized Disclosure. The Receiving Party shall only be entitled to disclose, on a need to know basis for the purpose of the performance of the Agreement, Confidential Information of the Disclosing Party to its directors, employees, Affiliates, consultants, advisors, Sublicensees (or potential Sublicensees solely to the extent necessary for the evaluation of a potential sublicense), or Third Party subcontractors (collectively the “ Authorized Recipients ”); provided that such Authorized Recipients are bound by confidentiality and restricted use obligations or professional standards of confidentiality with respect to such Confidential Information that are at least as stringent as those set forth in this Agreement. The Receiving Party shall be responsible towards the Disclosing Party for any breach by its Authorized Recipients of any such confidentiality and restricted use obligations.  

Section 10.3 Disclosure to Third Parties. Notwithstanding the foregoing provisions of Section 10.1 , each Party may disclose Confidential Information of the Disclosing Party to the extent such disclosure is reasonably necessary:

10.3.1 to Competent Authorities (a) to the extent desirable to obtain or maintain Regulatory Approvals for any Product within the Territory, and (b) in order to respond to inquiries, requests or investigations relating to Products or this Agreement;

10.3.2 in connection with filing or prosecuting Patent Rights or trademark rights, in each case relating to Products, as permitted by this Agreement;

10.3.3 in connection with prosecuting or defending litigation as permitted by this Agreement;

10.3.4 subject to the provisions of Section 10.8 , in connection with or included in scientific presentations and publications relating to Products, including abstracts, posters, journal articles and the like, and posting results of and other information about clinical trials to clincialtrials.gov or similar websites; and

10.3.5 to the extent necessary in order to enforce its rights under this Agreement.

If a Party deems it reasonably necessary to disclose Confidential Information belonging to the other Party pursuant to this Section 10.3 , then the former Party shall, if available, use commercially reasonable effort to obtain a protective order, confidential treatment or other similar measures narrowing the scope of such use and public or other disclosure of such Confidential Information and otherwise take such measures to ensure confidential treatment of such information as is reasonably required. For clarification, any such limited disclosure shall not cause any such information to cease to be Confidential Information.

Section 10.4 Excluded Information. Notwithstanding Section 10.1 , the Confidential Information of the Disclosing Party shall not include information or materials that:

10.4.1 at the time of disclosure to, or acquisition by, the Receiving Party or its Affiliates is generally available to the public, or after the time of disclosure or acquisition is generally available to the public through no wrongful act or omission of the Receiving Party or its Authorized Recipients in breach of this Agreement;

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10.4.2 was in the lawful possession and at the free disposal of the Receiving Party prior to disclosure by the Disclosing Party, as evidenced by written records then in the possession of the Receiving Party;  

10.4.3 is rightfully made available to the Receiving Party by Third Parties not bound by confidentiality or restricted use obligations; or

10.4.4 is independently discovered or developed by the Receiving Party without use of the Confidential Information of the Disclosing Party, as evidenced by written records then in the possession of the Receiving Party.

Section 10.5 Legally Required Disclosures. The obligations set forth in this ARTICLE 10 will not apply to Confidential Information of the Disclosing Party that is disclosed by the Receiving Party in order to comply with the requirements of applicable Law, provided that the Receiving Party shall to the extent possible give reasonable advance written notice of such disclosure to the Disclosing Party and will cooperate with the Disclosing Party in protecting against any such disclosure and/or obtaining a protective order, confidential treatment or other similar measures narrowing the scope of such use and public or other disclosure of such Confidential Information and otherwise taking such measures to ensure confidential treatment of such information as is reasonably required. Any such compelled disclosure will be to the minimum extent permissible as required by applicable Law. For clarification, any such limited disclosure shall not cause any such information to cease to be Confidential Information.

Section 10.6 Agreement Termination. Upon termination of this Agreement, at the Disclosing Party’s request,  subject to Section 13.4.3 the Receiving Party will return or destroy all documents or other media containing Confidential Information of the Disclosing Party, provided however that the Receiving Party may retain one (1) copy for archival and compliance purposes, and as required by applicable Law or regulatory requirement.

Section 10.7 Remedies. The Parties agree that money damages may not be an adequate remedy if this ARTICLE 10 is breached and, therefore, either Party may, in addition to any other legal or equitable remedies, seek an injunction or other equitable relief against such breach or threatened breach without the necessity of posting any bond or surety.

Section 10.8 Scientific Publications or Communications. As between the Parties and except as otherwise agreed in an R&D Agreement, Servier and its designees shall have the exclusive right to make scientific publications or communications with respect to the Products, and to disclose Data in clinical trial registries.

ARTICLE 11. REPRESENTATIONS, WARRANTIES & COVENANTS; NON-COMPETE

Section 11.1 Representations and Warranties of Both Parties. Each Party represents and warrants to the other Party, at the Effective Date, that:

11.1.1 such Party is duly incorporated, validly existing and in good standing under the Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;

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11.1.2 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid and binding obligation, enforceable against it in accordance with the terms hereof; and  

11.1.3 the execution and delivery of this Agreement by such Party do not, and the performance of this Agreement by such Party, including the grant of rights to the other Party pursuant to this Agreement, will not: (a) conflict with, or result in any violation of or default under, any agreement, instrument or understanding, oral or written, to which it or any Affiliate is a party or by which it or any Affiliate is bound; (b) conflict with any rights granted by such Party to any other Third Party or breach any obligation that such Party has undertaken to any Third Party; or (c) violate any provision of any applicable Law.

Section 11.2 Representations and Warranties of Sorrento. *, Sorrento hereby represents to Servier that, at the Effective Date:

11.2.1 Sorrento has the right to grant the rights granted to Servier under this Agreement, and no rights granted to Servier pursuant to this Agreement are in violation of any agreement between Sorrento or any of its Affiliates and any Third Party;

11.2.2 None of Sorrento or its Affiliates, or any Third Party acting by or on behalf of Sorrento or any of its Affiliates in connection with the research, development or manufacture of the Product has been debarred or is subject to debarment;

11.2.3 Sorrento is the owner of and Controls the Sorrento Contribution Patent Rights listed in Schedule 11.2.3 (a) (“ Owned Sorrento Contribution Patent Rights ”). Each of the Owned Sorrento Contribution Patent Rights has been filed in good faith, has been prosecuted in accordance with any applicable duty of candor and has been maintained in a manner consistent with Sorrento’s standard practice, in each case in each applicable jurisdiction in which such Sorrento Contribution Patent Rights have been filed, and no official final deadlines with respect to prosecution thereof have been missed and all applicable fees have been paid on or before the due date for payment;   

11.2.4 All inventors of all Owned Sorrento Contribution Patent Rights have been identified as such in the filings with the relevant patent offices;

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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11.2.5 Sorrento does not Control other Patent Rights Covering Sorrento Contributions than the Owned Sorrento Contribution Patent Rights listed in Schedule 11.2.3;  

11.2.6 Neither Sorrento nor any of its Affiliates has granted any right or license, or agreed to grant any right or license, to any Third Party other than * (the right of which are not conflicting with those granted to Servier under this Agreement), to any of Sorrento Contribution Patent Rights;

11.2.7 All of Sorrento’s and its Affiliates’ officers, employees, independent contractors, consultants, and agents performing activities under this Agreement have executed agreements requiring assignment or licensing to Sorrento of all inventions patented under as an Owned Sorrento Contribution Patent Right made during the course of and as a result of their association with Sorrento or its Affiliate, as applicable, and obligating the individual to maintain as confidential the confidential information of Sorrento or its Affiliate, as applicable;

11.2.8 There are no agreements to which Sorrento or any of its Affiliates is a party under which Sorrento or any of its Affiliates obtains or has obtained a license or other right to Sorrento Contributions (for avoidance of doubt, not including the research tools, diagnostics or equipment used in connection with the Development and Manufacture of the Initial Product) from a Third Party other than * to Develop, file, use, manufacture or Commercialize the Sorrento Contributions in the Field in the Territory;

11.2.9 There is no pending or, threatened in writing claim, suit, action, litigation or other proceeding brought by a Third Party against Sorrento or any of its Affiliates (a) challenging the validity or enforceability of any of Sorrento Contribution Patent Rights in any portion of the Territory, (b) claiming that the Development, filing, use, manufacture or Commercialization of any of the Sorrento Contributions in the Territory constitutes or would constitute infringement of such Third Party’s Intellectual Property Right(s), or (c) seeking to subject any of Sorrento Contribution Patent Rights to interference, reexamination, reissue, revocation, opposition, appeal or other administrative proceedings, and, in each case of clauses (a), (b) and (c), to Sorrento’s Knowledge, there is no Third Party Intellectual Property Right that would reasonably be expected to give rise to any such claim, suit, action, demand or other proceeding;

11.2.10 Neither Sorrento nor any of its Affiliates has received any written communications alleging that it has infringed, misappropriated or otherwise violated, or that it would infringe, misappropriate or otherwise violate, through the manufacture, use, import, export, sale, or offer for sale of any of the Products in the Territory or any portion thereof, any Intellectual Property Rights or Know How Controlled by any Third Party. To Sorrento’s Knowledge, the Development, manufacture, use or Commercialization of the Sorrento Contributions as contemplated in accordance with this Agreement does not infringe the Intellectual Property Rights or misappropriate the Know How of any Third Party;  

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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11.2.11 Sorrento has taken reasonable precautions to preserve the confidentiality of the Sorrento Know-How required to be transferred to Servier under this Agreement;  

11.2.12 Sorrento has disclosed or made available to Servier in writing, complete and correct copies of: (a) any material data from studies of the Initial Product in its possession, and (b) all material regulatory filings and correspondence between Sorrento and its Affiliates, on the one hand, and any Competent Authority in the Territory on the other hand, relating to the Initial Product;

11.2.13 All studies conducted specifically for the Initial Antibody or Initial Product that have been conducted by Sorrento or any of its subcontractors, and in accordance with applicable Laws by persons with appropriate education, knowledge and experience;

11.2.14 The documents containing Data and Sorrento Know-How disclosed or made available to Servier in the context of the negotiation of this Agreement are true and accurate copies of what they purport to be;

11.2.15 No information or materials provided by Sorrento to Servier (whether prepared by Sorrento or any subcontractor) contain any materially untrue or, to Sorrento’s Knowledge, materially misleading statement of a material fact or omit to state a material fact, with respect to the efficacy, side effects or preclinical or clinical testing of the Initial Product; and

11.2.16 Sorrento has completed an effective transfer of all technology necessary to Manufacture the Initial product to *.

*

Section 11.3 Exclusions.

11.3.1 The representations and warranties in Section 11.2 shall not include any representations or warranties regarding the research tools, diagnostics or equipment used in connection with the Development and Manufacture of the Initial Product.

11.3.2 Changes in Legislation. Sorrento shall not be liable for breach of the representations and warranties in Section 11.2 to the extent that such liability would not have occurred but for the passing of, or change in, any law, statute, ordinance, rule, regulation, or administrative practice of any governmental or regulatory body (including any change of tax legislation or the increase in the rates of taxes) after the date of this Agreement.

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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11.3.3 Changes Attributable to Servier. Sorrento shall not be liable for breach of the representations and warranties in Section 11.2 in respect of any Damages  to the extent resulting from, or increased by any voluntary act or voluntary omission of Servier, or their respective directors, officers, employees, agents or other representatives, after the date of this Agreement including Servier’s exercise of its rights other than as permitted under this Agreement or Servier’s failure to comply with its obligations under this Agreement.  

11.3.4 Non-Compliance by Servier. Sorrento shall not be liable for breach of the representations and warranties in Section 11.2 in respect of any Damages to the extent that Servier has violated its obligation to mitigate damages under sec. 254 BGB.   

Section 11.4 Disclaimer.   EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES (AND EACH PARTY EXPRESSLY DISCLAIMS) ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND, WHETHER WRITTEN, ORAL, EXPRESS, IMPLIED STATUTORY OR OTHERWISE, INCLUDING ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY WARRANTIES THAT MAY ARISE FROM A COURSE OF PERFORMANCE, COURSE OF DEALING OR USAGE OR TRADE WITH RESPECT TO ANY INTELLECTUAL PROPERTY RIGHTS, TECHNOLOGY OR CONFIDENTIAL INFORMATION OF A PARTY OR ANY LICENSE GRANTED BY A PARTY UNDER THIS AGREEMENT. IN PARTICULAR, THE PARTIES AGREE AND EXPLICITLY CONFIRM THAT NONE OF THE REPRESENTATIONS AND WARRANTIES UNDER THIS AGREEMENT SHALL BE CONSTRUED AS A GUARANTEE BY A PARTY WITHIN THE MEANING OF SEC. 433 AND 444 GERMAN CIVIL CODE ( BÜRGERLICHES GESETZBUCH , “ BGB ”) ( GARANTIE FÜR DIE BESCHAFFENHEIT DER SACHE ). IN THE EVENT OF ANY REPRESENTATIONS AND WARRANTIES UNDER THIS AGREEMENT BEING INCORRECT IN WHOLE OR IN PART THE PROVISIONS SET FORTH IN THIS AGREEMENT SHALL APPLY INSTEAD AND TO THE EXCLUSION OF ANY AND ALL REMEDIES THAT WOULD OTHERWISE BE AVAILABLE TO A PARTY UNDER THE LAW IN THE EVENT OF A BREACH, EXCEPT IN CASE OF FRAUD, WILLFUL MISCONDUCT OR GROSS NEGLIGENCE. ANY FURTHER LIABILITY OF THE BREACHING PARTY AND OF THE BREACHING PARTY'S REPRESENTATIVES, AGENTS AND/OR ADVISORS AND ANY DIFFERING OR FURTHER RIGHTS OR CLAIMS OF THE NON-BREACHING PARTY EXCEPT AS OTHERWISE EXPLICITLY PROVIDED FOR IN THIS AGREEMENT OR IN CASE OF FRAUD, WILLFUL MISCONDUCT OR GROSS NEGLIGENCE, IRRESPECTIVE OF THEIR NATURE OR LEGAL BASIS, INCLUDING ANY RIGHT TO RESCIND ( ANFECHTEN ) OR TO WITHDRAW FROM ( ZURÜCKTRETEN ) THIS AGREEMENT, TO CLAIM REMEDIATION ( NACHERFÜLLUNG ), TO REDUCE PRICES UNDER THIS AGREEMENT AND/OR TO CLAIM DAMAGES ( SCHADENSERSATZ ) OR REIMBURSEMENT OF FUTILE EXPENDITURE ( ERSATZ VERGEBLICHER AUFWENDUNGEN ) ARE HEREBY EXPRESSLY EXCLUDED AND WAIVED.  

Section 11.5 Mutual Covenants. Each Party hereby covenants throughout the Term as set forth below.

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11.5.1 Such Party will not, and will cause its Affiliates not to, employ or use any contractor or agent that employs any individual or entity (a) that has been debarred by a Competent Authority under applicable Laws or convicted of a crime for which such Person could be so debarred, or (b) that is the subject of a debarment investigation or proceeding of a Competent Authority under applicable Laws, in each case of clauses (a) and (b), in the conduct of such Party’s or its Affiliates’ activities under this Agreement; and  

11.5.2 Such Party shall not, and shall cause its Affiliates not to, enter into any agreement or other arrangement with a Third Party that conflicts with the rights granted to the other Party under this Agreement.

11.5.3 If either Party determines in good faith that the licenses under this Agreement are required to be filed with the Federal Trade Commission (“ FTC ”) under the US’s Hart-Scott-Rodino Antitrust Improvements Act of 1976 (15 U.S.C. §18a) (“ HSR ”) or with equivalent foreign Governmental Authorities under any similar foreign Law, then each Party will promptly prepare and submit any necessary filings and will use commercially reasonable efforts to obtain such approvals and the Effective Date shall occur upon all such HSR or other governmental clearances have been obtained. Each Party will be responsible for its own costs; provided that Servier will pay all filing fee(s) required in the event of an HSR filing or filing for other governmental clearance.  Both Parties will use all commercially reasonable efforts to cause the clearance to be obtained as quickly as possible. However, neither Party will be required to adversely affect its legal position (e.g., agree to divestitures or product restrictions) in the interest of expediting such clearance.

Section 11.6 Non-Compete.

11.6.1 Covenant and Non-Compete. As partial consideration for Sorrento’s rights and Servier’s obligations set forth in this Agreement, Sorrento covenants and agrees that, for a period commencing on the Effective Date and continuing until the * anniversary of the Effective Date (the “ Non-Compete Period ”), it shall not, and it shall cause its Affiliates not to, directly or indirectly, through licensing to or assisting a Third Party or otherwise, Develop, Manufacture or Commercialize any Competing Products (such activities, a “ Competitive Program ”) without the prior written consent of Servier. *.

11.6.2 Notwithstanding Section 11.6.1 , the Parties acknowledge that Sorrento may be acquired or merge with a Third Party or acquire a Third Party during the Term of this Agreement (such transaction, the “ Acquisition Transaction ”, and such Third Party, the “ Acquiror ” or “ Acquiree ”).  In such event, if the Acquiror or Acquiree was conducting a Competitive Program prior to the closing of such Acquisition Transaction, Sorrento shall not be deemed in breach of Section 11.6.1:

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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11.6.2.(a) If no Sorrento Know-How required to be provided to Servier under this Agreement shall be used by or on behalf of or shared with the Acquiror or Acquiree in connection with the subsequent development and commercialization of such Competing Product, (b) no employees, subcontractors, or other personnel of Sorrento that previously conducted activities in connection with the Competing Product may consult in any manner on any subsequent development and commercialization of any Competing Product and (c) Sorrento shall implement and maintain a firewall or clean room procedures that meet the industry standard in order to protect the Parties’ respective Confidential Information;  

11.6.2.(b) If Sorrento or the Acquiror sell or exclusively license to a Third Party or discontinue the Competing Product within twelve (12) months after the closing of Acquisition Transaction;

11.6.2.(c) If Acquiror or Acquiree exclusively licensed the Competing Product prior to or in conjunction with the closing of the Acquisition Transaction; or

11.6.2.(d) If Sorrento or the Acquiror agree to license the Competing Product to Servier on the same terms as the Initial Product under this Agreement.    

11.6.3 Notwithstanding Section 11.6.1 , Sorrento shall be entitled to perform development activities with respect to any Competing Product in collaboration with Servier pursuant to the R&D Agreement.

11.6.4 Notwithstanding the provisions of Section 11.6 or otherwise in this Agreement and subject to Section 11.6.2 and Section 11.6.3 above, Sorrento shall be entitled to perform research activities (but excluding any Clinical Studies or Commercialization activities) on a Competing Product provided that: (a) Sorrento shall not sell, transfer, or grant to any rights such Competing Product prior to the expiration of the Non-Compete Period;  and (b) following the expiration of the Non-Compete Period, if Sorrento intends to start a process to sell, transfer, or grant any rights to such Competing Product or receives a written offer from a Third Party to enter into negotiations for the sale, transfer, or grant of any rights to such Competing Product, then, in each case, Sorrento shall provide Servier with a written notice including a sufficient data package prior to commencing such processes or responding to such offer, as applicable (the “ Competing Product ROFN Notice ”). If Servier notifies to Sorrento of its interest to license such Competing Product within thirty (30) days following receipt of the Competing Product ROFN Notice (“ Competing Product ROFN Election Notice ”), Sorrento and Servier shall enter into good faith negotiations on an exclusive basis for a period of one hundred and twenty (120) days to attempt to negotiate an Agreement for such Competing Product. If either Servier does not provide such written notice within thirty (30) days or the Parties fail execute an Agreement for such Competing Product within one hundred and twenty (120) days of the Competing Product ROFN Election Notice, then Sorrento shall be free to enter into a partnering agreement with a Third Party, provided that such partnering agreement shall not be at economic terms less favorable to Sorrento than the latest terms offered by Servier.

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ARTICLE 12. INDEMNIFICATION; INSURANCE  

Section 12.1 Sorrento Indemnity.   Sorrento shall defend, indemnify and hold harmless Servier and its Affiliates and their respective directors, officers, agents, representatives, successors, permitted assignees and employees (collectively, the “ Servier Indemnitees ”) from and against any and all liabilities, losses, costs, damages and expenses, including reasonable attorneys’ fees (collectively, “ Damages ”), incurred as a result of or arising out of any claim, suit, action, demand or other proceeding made or brought by a Third Party (each, a “ Third Party Claim ”) against one or more Servier Indemnitees to the extent resulting from (a) the negligence, recklessness, or intentional wrongful acts or omissions of Sorrento or its Affiliates or their respective agents, representatives, consultants or independent contractors, in connection with the performance by or on behalf of Sorrento of Sorrento’s obligations or exercise of Sorrento’s rights under this Agreement,  (b) any breach by Sorrento of any representation or warranty, set forth in ARTICLE 11 of this Agreement, or (c) the research, discovery, Development, use, manufacture, handling, storage, transfer of the Sorrento Contribution by Sorrento or any of its Affiliates or any of the foregoing’s respective agents, representatives, consultants and independent contractors prior to the Effective Date; except, in any such case, to the extent such Damages are reasonably primarily attributable to any negligence, recklessness, willful misconduct or breach of this Agreement by Servier or a Servier Indemnitee (other than any breach by Servier or a Servier Indemnitee that primarily resulted from Sorrento’s or its Affiliates’ or their respective agents’, representatives’, consultants’ or independent contractors’ breach of this Agreement).  

Section 12.2 Servier Indemnit y. Servier shall defend, indemnify and hold harmless Sorrento and its Affiliates and their respective directors, officers, agents, representatives, permitted successors, permitted assignees and employees (collectively, the “ Sorrento Indemnitees ”) from and against any and all Damages incurred as a result of or arising out of any Third Party Claim made or brought against one or more Sorrento Indemnitees to the extent resulting from (a) the negligence, recklessness, or intentional wrongful acts or omissions of Servier or its Affiliates or their respective agents, representatives, consultants or independent contractors, in connection with the performance by or on behalf of Servier of Servier’s obligations or exercise of Servier’s rights under this Agreement, (b) any breach by Servier or its Affiliates or their respective agents, representatives, consultants or independent contractors of any representation or warranty set forth in ARTICLE 11 of this Agreement, or (c) use, Development, Manufacturing, Commercialization, handling, storage, labeling or transfer of any Product by Servier or any of its Affiliates or Sublicensees or any of the foregoing’s respective agents, representatives, consultants, and independent contractors, or Servier’s customers; except, in any such case, to the extent such Damages are reasonably primarily attributable to any negligence, recklessness, willful misconduct or breach of this Agreement by Sorrento or a Sorrento Indemnitee (other than any breach by Sorrento or a Sorrento Indemnitee that primarily resulted from Servier’s or its Affiliates’ or their respective agents’, representatives’, consultants’ or independent contractors’ breach of this Agreement).

Section 12.3 Indemnification and Defense Procedures.

12.3.1 Notice of Claim.   All claims for indemnification or defense by a Party as provided herein shall be made solely by the Party seeking indemnification or defense of a Third Party Claim or remedies for any Damages (the “ Indemnified Party ”).  The Indemnified Party shall

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give written notice of the same to the other Party (the “ Indemnifying Party ”) reasonably promptly after the assertion against the Indemnified Party of any Third Party Claim or fact in respect of which the Indemnified Party intends to base a claim for indemnification hereunder (a “ Claim Notice ”), provided, however, that failure or delay to provide such Claim Notice shall not affect the Indemnifying Party’s indemnification or defense obligations, except to the extent such failure materially and adversely affects the ability to defend such claim.  Each Claim Notice must contain a description of the Third Party Claim and the nature and amount of any Damages (to the extent that the nature and amount of such Damages is known at such time).  The Indemnified Party shall furnish promptly to the Indemnifying Party copies of all notices, papers, correspondence, communications and official documents (including court papers) previously received or sent and thereafter that the Indemnified Party continues to receive or send in respect of any such Third Party Claim.  

12.3.2 Assumption of Defense. To the extent permitted by Laws, the Indemnifying Party shall assume the defense and handling of such Third Party Claim, at the Indemnifying Party’s sole expense in accordance to Section 12.3.3 .

12.3.3 Indemnification Procedure.   In assuming the defense of any Third Party Claim, the Indemnifying Party: (a) shall act diligently and in good faith with respect to all matters relating to the defense, settlement or disposition of such Third Party Claim as the defense, settlement or disposition relates to the Indemnified Party; (b) may, at its own cost, appoint as counsel in connection with conducting the defense and handling of such Third Party Claim any law firm or counsel reasonably selected by the Indemnifying Party and reasonably acceptable to the Indemnified Party; (c) keep the Indemnified Party informed of the status of such Third Party Claim; (d) shall have the right to settle the Claim on any terms the Indemnifying Party chooses, subject to prior notification to the Indemnified Party; provided that the Indemnifying Party shall not settle or otherwise resolve any Third Party Claim which could lead to liability or create any financial or other obligation on the part of the Indemnified Party for which the Indemnified Party is not entitled to indemnification hereunder or which admits any wrongdoing or responsibility for the claim on behalf of the Indemnified Party, without prior written consent of the Indemnified Party, which may not be unreasonably withheld or delayed.  The Indemnified Party shall reasonably cooperate with the Indemnifying Party in its defense of any Third Party Claim for which the Indemnifying Party has assumed the defense in accordance with this Section 12.3.3 , and shall have the right (at its own expense) to be present in person or through counsel at all legal proceedings giving rise to the right of indemnification.

12.3.4 Indemnified Party Right to Participate. If the Indemnifying Party fails to conduct the defense and handling of any Third Party Claim in good faith or if the Third Party Claim seeks non-monetary relief, (a) the Indemnified Party may at the Indemnifying Party’s expense, select counsel reasonably acceptable to the Indemnifying Party in connection with conducting the defense and handling of such Third Party Claim and defend against, and consent to the entry of any judgment or enter into any settlement with respect to the Third Party Claim in any manner the Indemnified Party may deem reasonably appropriate (and the Indemnified Party shall regularly inform the Indemnifying Party of the status of such Claim and consult with the Indemnifying Party but shall have no obligation hereunder to obtain any consent from, the Indemnifying Party in connection therewith, except that the Indemnified Party shall not settle such Third Party Claim without the prior written consent of the Indemnifying Party, which consent shall

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not be unreasonably withheld or delayed); and (b) the Indemnifying Party shall remain responsible to indemnify the Indemnified Party as provided in this Section 12.3.4 .  If the Indemnified Party elects to defend or handle such Third Party Claim in accordance with this Section 12.3.4 , the Indemnifying Party shall cooperate with the Indemnified Party, at the Indemnified Party’s request but at no expense to the Indemnified Party, and shall be entitled to participate in the defense and handling of such Third Party Claim with its own counsel and at its own expense.  

Section 12.4 Insurance.   During the Term and thereafter for a period of five (5) years, each Party shall procure and maintain adequate insurance coverage with international reputable company or a program of self-insurance (which shall be of types and amounts sufficient to cover the liabilities hereunder, contingent or otherwise of such Party and its Affiliates). It is understood that such insurances shall not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this Section 12.4.  Each Party shall provide the other Party with written evidence of such insurance upon request.  Each Party shall provide the other Party with written notice at least thirty (30) days prior to the cancellation, non-renewal or material change in the insurance coverage.

Section 12.5 Disclaimer of Liability.  IN NO EVENT SHALL EITHER PARTY OR ANY OF ITS RESPECTIVE AFFILIATES AND THEIR RESPECTIVE OFFICERS, DIRECTORS AND EMPLOYEES BE LIABLE UNDER THIS AGREEMENT FOR SPECIAL, INDIRECT, PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING INDIRECT LOST PROFIT AND INDIRECT LOST OPPORTUNITIES) SUFFERED BY THE OTHER PARTY UNDER THIS AGREEMENT, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE OR OTHERWISE, OTHER THAN IF SUCH DAMAGES ARE PAYABLE TO A THIRD PARTY AND INDEMNIFIABLE BY A PARTY PURSUANT TO THIS AGREEMENT. NOTWITHSTANDING THE FOREGOING, THIS DISCLAIMER DOES NOT APPLY TO (A) STRICT LIABILITY OR DAMAGES CAUSED BY INTENTIONAL ACTS WHEREVER THE RESTRICTION OF LIABILITY IS EXCLUDED MANDATORY GERMAN LAW, (B) THE INDEMNIFICATION OBLIGATIONS OF A PARTY UNDER ARTICLE 12 OR (C) LIABILITY OR DAMAGES RESULTING FROM A BREACH OF CONFIDENTIALITY OBLIGATIONS OF A PARTY UNDER ARTICLE 10 .  

ARTICLE 13. TERM AND TERMINATION

Section 13.1 Term. The term of this Agreement (the “ Term ”) will commence on the Effective Date and will extend, unless this Agreement is terminated earlier in accordance with Section 13.2 , on a Product-by-Product and country-by-country basis, until such time as the Royalty Term with respect to the sale of such Product in such country expires.  Upon expiration of the Royalty Term with respect to a Product and country, the licenses granted by Sorrento to Servier under this Agreement with respect to such Product shall remain in effect as granted in accordance with this Agreement, shall become irrevocable, fully paid-up and royalty-free licenses and shall last as long as Servier intends to Develop or Commercialize a Product.

Section 13.2 Termination.   Notwithstanding anything in this Agreement or elsewhere to the contrary, this Agreement may be terminated as follows:

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13.2.1 Termination for Material Breach.   Either Party shall have the right to terminate this Agreement in the event the other Party has materially breached or defaulted in the performance of any of its material obligations hereunder which breach or default is material in the overall context of the Agreement, and such breach has continued for  * days after written notice thereof was provided to the breaching Party by the non-breaching Party which clearly describes the remedies that the non-breaching Party intends to apply should the breach remain uncured. Any such termination shall become effective at the end of such * day period if, prior to the expiration of the * day period, (a) the breaching Party has not cured any such breach or default or (b) with respect to a breach of Commercially Reasonable Efforts obligations to Develop or Commercialize the Product, has not communicated to the non-breaching Party a remediation plan reasonably designed to cure such breach or default within a reasonable period of time.  If the allegedly breaching Party disputes the breach and provides written notice of that dispute to the other Party, the matter shall be addressed under the dispute resolution provisions in Section 14.2.1 , and the notifying Party may not terminate this Agreement until it has been finally determined under Section 14.2.1 that the Agreement was materially breached as described above and the breaching Party does not cure the breach within * days of the arbitration award under Section 14.2.1 below.  

13.2.2 Termination by Mutual Consent. This Agreement may be terminated by the mutual written consent of the Parties.

13.2.3 Termination by Servier for Convenience. Servier may terminate this Agreement (a) in its entirety or (b) with respect to one or more Products on a country-by-country basis, in each case by providing * days’ prior written notice to Sorrento, specifying in such notice which Product or countries the termination applies to, with such termination being effective upon the end of such * notice period.

13.2.4 Termination for Insolvency. Either Party may terminate this Agreement if, at any time, the other Party will file in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for the appointment of a receiver or trustee of the Party or of substantially all of its assets, or if the other Party proposes a written agreement of composition or extension of substantially all of its debts, or if the other Party will be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition will not be dismissed within * days after the filing thereof, or if the other Party will propose or be a party to any dissolution or liquidation, or if the other Party will make an assignment of substantially all of its assets for the benefit of creditors.  Upon the bankruptcy of any Party, the non-bankrupt Party will further be entitled to a complete duplicate of, or complete access to, any such intellectual property, and such, if not already in its possession, will be promptly delivered to the non-bankrupt Party, unless the bankrupt Party elects to continue, and continues, to perform all of its obligations under this Agreement.

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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13.2.5 Termination by Servier for Safety. Servier may terminate this Agreement (a) in its entirety or (b) with respect to one or more Products on a country-by-country basis, immediately upon written notice to Sorrento, such Product shows significant safety issue in humans. For purposes of this Section 13.2.5 , “safety issue” means it is Servier’s reasonable and good faith belief, that there is an unacceptable risk for harm in humans based upon: (i) pre-clinical safety data, including data from animal toxicology studies; or (ii) the observation of a serious adverse effect in humans after a Product has been administered to or taken by humans, such as during a clinical trial or after the launch of such Product.  

Section 13.3 License Termination. If, during the Term, Servier or its Affiliate institutes or actively participates as an adverse party in any action, suit or other proceeding in the relevant Territory to invalidate or limit the scope of any Sorrento Contribution Patent Rights claim or obtain a ruling that any Sorrento Contribution Patent Rights claim is unenforceable or not patentable or that any Products would not, but for the licenses granted hereunder, infringe one or more claims of any Sorrento Contribution Patent Rights (a “ Patent Challenge ”), Sorrento has the right to immediately terminate this Agreement with notice to Servier. Servier shall include similar provisions in all sublicenses permitted under Section 2.4 referring to the termination of such sublicenses in case of Patent Challenge by a Sublicensee.

Section 13.4 Effects of Termination.

13.4.1 In the event of any termination of this Agreement in its entirety or with respect to any given Product (a) by Sorrento pursuant to Section 13.2.1 (Material Breach by Servier), Section 13.3 (License Termination), or Section 13.2.4 (Servier Insolvency), (b) by Servier for convenience pursuant to Section 13.2.3 or for safety pursuant to Section 13.2.5 or (c) by the Parties pursuant to Section 13.2.2 (Mutual Agreement):

13.4.1.(a) at Sorrento’s request, Servier will return to Sorrento or destroy (and certify such destruction to Sorrento), at Sorrento’s option, all Sorrento’s Confidential Information related to the terminated Product and Sorrento Know-How (provided that Servier shall be entitled to retain one (1) copy for archival and compliance purposes, and as required by applicable Law or regulatory requirement);

13.4.1.(b) Sorrento shall have the right to acquire some or all of the inventory of the terminated Product, as requested by Sorrento, in the possession of Servier and its Affiliates as of the date of such termination, provided that, if Sorrento so acquires any or all such inventory, Sorrento shall reimburse Servier the cost incurred by Servier for such inventory;

13.4.1.(c) except in case of termination for safety issue pursuant to Section 13.2.5 , the Parties shall cooperate to promptly transfer ownership of all regulatory filings and Regulatory Approvals (including any such filings and approvals related to manufacturing) to the extent permitted by applicable Laws, and responsibility for regulatory communication held by Servier to Sorrento.  Unless otherwise required by any applicable Law or regulation or requested by Sorrento, the foregoing assignment (or availability) shall be made within * days after the effective date of any termination;

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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13.4.1.(d) all licenses and sublicenses granted by Sorrento to Servier hereunder shall terminate, provided however that they will continue solely to enable Servier to (i) complete sales of Products for any purchase orders that were in place prior to the effective date of termination and (ii) sell off any existing inventory of Products that Sorrento does not purchase pursuant to subsection 13.4.1.(b) ;  

13.4.1.(e) if the terminated Product is the Initial Product or a Sorrento Additional Anti-PD-1 Product, to the extent requested by Sorrento and except in case of termination for safety pursuant to Section 13.2.5 , if requested by Sorrento, Servier shall enter into an exclusive license agreement whereby Servier grants to Sorrento a royalty bearing license based on * of net sales of the terminated Product, with the right to sublicense, under Servier IP that is necessary to further Develop, Manufacture and Commercialize the terminated Products, at terms and conditions, including financial terms and adequate indemnities to be agreed upon.  Alternatively, Servier may elect in its sole discretion to assign all or part of such Servier IP to Sorrento at a price payable by Sorrento, equal to * of Net Sales of the terminated Product; and

13.4.1.(f) the Parties will discuss in good faith the wind-down or transfer to Sorrento of any ongoing Clinical Trials or any ongoing pre-clinical studies for the terminated Products currently being conducted by or on behalf of Servier or its Affiliates at the time of termination; provided that Servier shall have no obligation to continue such activities following the termination effective date and if the continuation of any Clinical Trials is required after the termination effective date, Servier may continue them at Sorrento’s costs.

13.4.2 In the event of any termination of this Agreement in its entirety or with respect to any given Product by Servier pursuant to Section 13.2.1 (Material Breach by Sorrento), without prejudice to any other remedies available to Servier, all licenses and sublicenses granted by Sorrento to Servier hereunder shall become irrevocable and shall last as long as Servier intends to Develop or Commercialize such Product and all payments obligations set forth in ARTICLE 8 will survive for the term contemplated therein but will be reduced by *.  All other obligations under this Agreement with regard to such Product shall cease upon termination, subject to the survival provision set forth in Section 13.5.2 .  

13.4.3 Transition. In the event of termination in accordance with Section 13.2.1 or Section 13.2.2 , the non-terminating Party shall use diligent efforts to cooperate with the terminating Party or its subcontractors at the terminating Party’s cost (except in case of termination by either Party for breach by the other Party pursuant to Section 13.2.1 ) to effect a smooth and orderly transition of the information and materials necessary to enable the development and commercialization of the terminated Product in accordance with the terms set forth in this Section 13.4 .

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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13.4.4 Rights in Bankruptcy.   All licenses granted under this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the U.S. Bankruptcy Code.  Each Party, as licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the United States Bankruptcy Code.  In the event of the commencement of a bankruptcy proceeding by or against a Party under the United States Bankruptcy Code (the “ Insolvent Party ”), the other Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) certain Know-How licensed to it under this Agreement and all embodiments of such  Know-How, provided that, Sorrento shall not be required to provide any duplicate copies and embodiments of Sorrento Know-How to Servier so long as Sorrento has already provided Sorrento Know-How it is required to provide to Servier under this Agreement, and, if not already in its possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon its written request therefore, unless the Insolvent Party continues to perform all of its obligations under this Agreement, or (b) if not delivered or granted under (a) above, following the rejection of this Agreement by or on behalf of the Insolvent Party upon written request therefore by the other Party.  

13.4.5 SPV. If Sorrento’s Debt to Equity Ratio for any Calendar Quarter during the Term exceeds * as of the last day of any such Calendar Quarter, then, within * after the last day of such Calendar Quarter and each Calendar Quarter thereafter, Sorrento shall deliver a report to Servier setting forth the calculation of its Debt to Equity Ratio in the form attached hereto as Schedule 13.4.5(a) as of the last day of the applicable Calendar Quarter and then, * until Sorrento’s Debt to Equity Ratio becomes less than or equal to * or Sorrento transfers the Sorrento Core IP to the SPV pursuant to this Section 13.4.5 in a form satisfactory to Servier. If * after Sorrento delivers the first report to Servier pursuant to the foregoing sentence, the Debt to Equity Ratio still exceeds *, Sorrento will transfer all Sorrento Core IP to a newly formed entity (the “ SPV ”) within * thereafter. The SPV shall comply with the conditions set forth in Schedule 13.4.5(b), and Sorrento shall cause the SPV to enter into a license to Servier with the same rights and obligations as those of this Agreement, which shall enter into effect upon transfer of the Sorrento Core IP to the SPV. Sorrento shall represent that the SPV has no activity or liability other than as permitted in Schedule 13.4.5(b) and otherwise satisfies the conditions stated therein. If and until Sorrento fails to satisfy its transfer obligation pursuant to this Section 13.4.5 , Servier shall be entitled to suspend all payments otherwise due to Sorrento pursuant to this Agreement.  

Accrued Payment Pending Termination and Survival

13.5.1

Payment Obligations. The termination or expiration of this Agreement shall not affect any payment of any debts or obligations accruing prior to such date of termination or expiration.  For the avoidance of doubt, payment of any Development Milestones or Sales Milestone Payments by Servier as set forth in Section 8.2 and Section 8.3 will be due on milestones achieved during the period between any notice of termination under Section 13.2 and Section 13.3 the effective date of termination, as accrued.

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.

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13.5.2 Survival. The provisions of ARTICLE 1, Section 2.4 (last four sentences), Section 2.5, Section 2.8, ARTICLE 8, Section 9.1, Section 9.2.2 (first two sentences), Section 9.2.3, Section 9.4 (first sentence), ARTICLE 10, Section 11.2 (last sentence), Section 11.3, Section 11.4, ARTICLE 12, Section 13.4 (except for Section 13.4.5), Section 13.5, and ARTICLE 14 will survive the expiration or any termination of this Agreement for any reason, in accordance with their respective terms and conditions, and for the respective duration stated therein, and where no duration is stated, will survive indefinitely.  In addition, any Section that is referred to in the above listed Sections shall survive solely for the interpretation or enforcement of the latters.  

ARTICLE 14. MISCELLANEOUS

Section 14.1 Public Announcements. Except where otherwise expressly permitted hereunder, neither Party will make any public announcement of any information regarding this Agreement or any activities under this Agreement without the prior written approval of the other Party, which approval will not be unreasonably withheld or delayed.  Each Party will submit to the other Party any proposed announcements at least thirty (30) days prior to the intended date of publication of such announcement to permit review and approval.

Section 14.2 Dispute Resolution.

14.2.1 Arbitration.   In the event a dispute arises (each, a “ Dispute ”), the Alliance Managers will attempt in good faith to resolve such Dispute, failing which either Party may cause such Dispute to be referred to the Executive Officers for resolution.  The Executive Officers shall attempt in good faith to resolve such Dispute by unanimous consent.  If the Executive Officers cannot resolve such Dispute within thirty (30) days of the matter being referred to them, then either Party may submit such Dispute to arbitration for final resolution by arbitration request (the “ Arbitration Request ”) under the Rules of Arbitration of the International Chamber of Commerce (the “ Rules ”) by three (3) arbitrators appointed in accordance with the said Rules (each such arbitration, an “ Arbitration ”).  Each Arbitration will be conducted in English and all foreign language documents shall be submitted in the original language and, if so requested by any arbitrator or Party, shall also be accompanied by a translation into English.  The place of arbitration shall be Geneva, Switzerland.  The arbitrators in any Arbitration shall enforce and not modify the terms of this Agreement.  The award of the arbitrators shall be final and binding on each Party and its respective successors and assigns.  All costs and expenses of any Arbitration, including reasonable attorneys’ fees and expenses and the administrative and arbitrator fees and expenses, shall be borne by the Parties as determined by the arbitrators.

14.2.2 Confidentiality. Except to the limited extent necessary to comply with applicable Law, legal process, or a court order or to enforce a final settlement agreement or secure enforcement or vacatur of the arbitrators’ award, the Parties agree that the existence, terms and content of any Arbitration, all information and documents disclosed in any Arbitration or evidencing any arbitration results, award, judgment or settlement, or the performance thereof, and any allegations, statements and admissions made or positions taken by either Party in any Arbitration shall be treated and maintained in confidence and are not intended to be used or disclosed for any other purpose or in any other forum.

14.2.3 Communications with Internal Counsel. In the course of the negotiation and implementation of this Agreement and the resolution of any disputes, investigations, administrative or other proceedings relating thereto, each Party will call upon the members of its

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internal legal department to provide advice to such Party and its directors, employees and agents on legal matters.  Notwithstanding any rights to the contrary under applicable procedural or substantive rules of law, each Party agrees not to request, produce or otherwise use any such communications between members of its legal department and directors, employees or agents in connection with any such disputes, investigations, administrative or other proceedings, to the extent such communications, if they had been exchanged between such Party and external attorneys, would have been covered by legal privilege and not disclosable.  

Section 14.3 Governing Law. This Agreement and any dispute arising from the performance or breach hereof will be governed by and construed and enforced in accordance with the Laws of Germany, excluding its rules of conflict of laws.

Section 14.4 Assignment. This Agreement will not be assignable by either Party to any Third Party without the written consent of the other Party hereto. Notwithstanding the foregoing, each Party may assign this Agreement, without the consent of the other Party, to an Affiliate or to a Third Party in connection with the sale of transfer of all or substantially all of the assets to which this Agreement pertains. Any assignment in violation of this provision is void and without effect.

Section 14.5 Binding Agreement. This Agreement, and the terms and conditions hereof, will be binding upon and will inure to the benefit of the Parties and their respective successors, heirs, administrators and permitted assigns.

Section 14.6 Force Majeure. Except for payment obligations under this Agreement, no Party will be held liable or responsible to the other Party nor be deemed to be in default under, or in breach of any provision of, this Agreement for failure or delay in fulfilling or performing any obligation of this Agreement when such failure or delay is due to force majeure, and without the fault or negligence of the Party so failing or delaying. For purposes of this Agreement, “force majeure” is defined as causes beyond the control of the Party, including, without limitation, acts of God; Laws of any government; war; civil commotion; destruction of production facilities or materials by fire, flood, earthquake, explosion or storm; labor disturbances; epidemic; and failure of public utilities or common carriers. In the event of force majeure, Sorrento or Servier, as the case may be, will immediately notify the other Party of such inability and of the period for which such inability is expected to continue. The Party giving such notice will thereupon be excused from such of its obligations under this Agreement as it is thereby disabled from performing for so long as such Party is so disabled, up to a maximum of ninety (90) days, after which time the Party not affected by the force majeure may terminate this Agreement. To the extent possible, each Party will use reasonable efforts to minimize the duration of any force majeure.

Section 14.7 Notices. Any notice or request required or permitted to be given under or in connection with this Agreement will be deemed to have been sufficiently given if in writing and personally delivered or sent by certified mail (return receipt requested), facsimile transmission (receipt verified), email or overnight express courier service (signature required), prepaid, to the Party for which such notice is intended, at the address set forth for such Party below:

If to Sorrento:

Sorrento Therapeutics, Inc.

9380 Judicial Drive

51


 

San Diego, CA 92121

Attention: CEO

Facsimile: +1 858 210 3759

E-Mail: hji@sorrentotherapeutics.com

 

With a copy to:

Sorrento Therapeutics, Inc.

9380 Judicial Drive

San Diego, CA 92121

Attention: Legal Department

Facsimile: +1 858 210 3759

E-Mail: legal@sorrentotherapeutics.com

 

With copies to:

If to Servier :

Les Laboratoires Servier

50 rue Carnot

92284 Suresnes Cedex

France

Attention: Alliance Management Director & US Licenses

Facsimile: +33 1 55 72 54 66

Email: mail.alliance.management@Servier.com

 

With a copy to:

Attention: Director Contract Department

Les Laboratoires Servier

50 rue Carnot

92284 Suresnes Cedex

France

 

or to such other address for such Party as it will have specified by like notice to the other Parties, provided that notices of a change of address will be effective only upon receipt thereof. If delivered personally or by facsimile transmission, the date of delivery will be deemed to be the date on which such notice or request was given. If sent by overnight express courier service, the date of delivery will be deemed to be the next business day after such notice or request was deposited with such service. If sent by certified mail, the date of delivery will be deemed to be the third (3rd) day after such notice or request was deposited with the postal service. If sent by email, the date of delivery will be deemed to be the day that the Party giving notice receives electronic confirmation of sending from its email provider.

52


 

Section 14.8 Waiver. Neither Party may waive or release any of its rights or interests in this Agreement except in writing. The failure of either Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement will not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition. No waiver by either Party of any condition or term in any one or more instances will be construed as a continuing waiver of such condition or term or of another condition or term.  

Section 14.9 Severability. If any provision hereof should be held invalid, illegal or unenforceable in any jurisdiction, the Parties will negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other provisions hereof will remain in full force and effect in such jurisdiction and will be liberally construed in order to carry out the intentions of the Parties hereto as nearly as may be possible. Such invalidity, illegality or unenforceability will not affect the validity, legality or enforceability of such provision in any other jurisdiction.

Section 14.10 Entire Agreement. This Agreement, including the schedules and exhibits hereto, sets forth all the covenants, promises, agreements, appendices, warranties, representations, conditions and understandings between the Parties hereto and supersedes and terminates all prior agreements and understandings between the Parties relating to the subject matter hereof. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties relating to the subject matter hereof other than as set forth herein and therein. No subsequent alteration, amendment, change or addition to this Agreement will be binding upon the Parties hereto unless reduced to writing and signed by the respective authorized officers of the Parties. To the extent of any conflict between the terms of this Agreement and the R&D Agreement, the terms of this Agreement shall govern.

Section 14.11 Independent Contractors. Nothing herein will be construed to create any relationship of employer and employee, agent and principal, partnership or joint venture between the Parties. Each Party is an independent contractor. Neither Party will assume, either directly or indirectly, any liability of or for the other Party. Neither Party will have the authority to bind or obligate the other Party nor will either Party represent that it has such authority.

Section 14.12 Headings. Headings used herein are for convenience only and will not in any way affect the construction of or be taken into consideration in interpreting this Agreement.

Section 14.13 Construction of Agreement. The terms and provisions of this Agreement represent the results of negotiations between the Parties and their representatives, each of which has been represented by counsel of its own choosing, and neither of which has acted under duress or compulsion, whether legal, economic or otherwise. Accordingly, the terms and provisions of this Agreement will be interpreted and construed in accordance with their usual and customary meanings, and each of the Parties hereto hereby waives the application in connection with the interpretation and construction of this Agreement of any rule of Law to the effect that ambiguous or conflicting terms or provisions contained in this Agreement will be interpreted or construed against the Party whose attorney prepared the executed draft or any earlier draft of this Agreement.  The definitions of the terms herein shall apply equally to the singular and plural forms of the terms defined.  Whenever the context may require, any pronoun shall include the corresponding masculine, feminine and neuter forms. The Parties each acknowledge that they have had the advice

53


 

of counsel with respect to this Agreement, that this Agreement has been jointly drafted, and that no rule of strict construction shall be applied in the interpretation hereof.  Unless the context requires otherwise: (a) the words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation”; (b) any reference to any applicable Law herein shall be construed as referring to such applicable Law as from time to time enacted, repealed or amended; (c) any reference herein to any person shall be construed to include the person’s permitted successors and assigns; (d) the words “herein”, “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof; (e) all references herein to Articles, Sections, or Schedules, unless otherwise specifically provided, shall be construed to refer to Articles, Sections or Schedules of this Agreement; (f) provisions that require that a Party, the Parties or any Committee hereunder “agree”, “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, electronic mail, letter, approved minutes or otherwise (but excluding instant messaging); (g)  the term “or” shall be interpreted in the inclusive sense commonly associated with the term “and/or” and (h) the words “will” and “shall” will have the same meaning in this Agreement. This Agreement has been executed in English, and the English version of this Agreement shall control.  

Section 14.14 Compliance with Applicable Law. Each Party’s obligations under this Agreement shall be subject to such Party’s compliance with Law applicable to its performance and its other obligations under the Agreement (including any anti-corruption, export control, environmental, hazardous substance, and data privacy and security Laws).

Section 14.15 Counterparts. This Agreement may be signed in counterparts, each and every one of which will be deemed an original, notwithstanding variations in format or file designation which may result from the electronic transmission, storage and printing of copies of this Agreement from separate computers or printers. Facsimile signatures will be treated as original signatures.


54


 

IN WITNESS WHEREOF, the Parties have caused this License and Collaboration Agreement to be executed by their duly authorized representatives.

 

For Sorrento Therapeutics, Inc.

 

For Les Laboratoires Servier

 

 

 

 

 

By:

 

 

By:

 

Name: 

Henry Ji

 

Name: 

Christian Bazantay

Title:

President and CEO

 

Title:

Proxy

 

 

 

By:

 

 

 

 

Name:

Eric Falcand

 

 

Title:

Proxy

 

 

 

 

 

For Institut de Recherches Internationales Servier

 

 

 

 

 

 

 

 

By:

 

 

 

 

Name:

Emmanuel Canet

 

 

 

Title:

Proxy

 

 

 

 

 

 

55


 

Schedule 2.6.1: Documents Subject to the Initial Transfer

*

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.


 


 

 

Schedule 6.2.1(a): Sorrento Deliverables

Supply Obligation for Pre-clinical studies

 

 

1/ Pre-clinical samples of the Initial Products for the 4 weeks toxicology study:

 

*

 

2/ Certificates of analysis

 

At Initial Product delivery (target: *) to start the 4 week study:

 

*

 

3/*

 

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.


 


 

 

 

Schedule 6.2.1(b): *Terms and Conditions

Clinical Supply Terms For GS Xceed™ Gene Expression System

 

 

The GS Xceed™ System Commercial License Terms

 

Commercial license is required per product before start of clinical trials

 

Commercial terms linked to manufacturing source:

 

 

·

* manufactures

 

a.

No license fees

 

b.

*% royalty on net sales

 

 

·

Customer or Strategic Partner manufactures

 

a.

*k per annum upon Phase 1 OR *k per annum due from Phase 2

 

b.

*% royalty on net sales

 

 

·

3rd Party CMO manufactures

 

a.

*k per annum and

 

b.

*% royalty on net sales

 

Term

 

·

Royalties to patent expiry then *% reduction for know-how

 

*

 

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.


 


 

Schedule 11.2: *

*

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.


 


 

Schedule 11.2.3(a): Owned Sorrento Contribution Patent Rights

 

The following patent applications:  

*

 

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.


 


 

Schedule 13.4.5(a) – Form of Report Setting Forth the Calculation of Debt to Equity Ratio

 

Quarter End Balance Sheet Date                                             

A)

Calculation of Debt

Sorrento’s total current liabilities                                             

+

 

Sorrento’s long term debt                                             

=

Total Debt                                             

A)

Total Debt                                             

B)

Total stockholder’s equity                                             

Debt to Equity Ratio = A / B =                                             

Requirement  - Less than or equal to *

In compliance:   Yes  /  No

CFO Signature                                             

 

[*]  Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission.  Confidential treatment has been requested with respect to the omitted portion.


 


 

 

Schedule 13.4.5(b) – SPV Conditions

The organizational documents of the SPV (the “ Charter Documents ”) shall contain the following provisions:

1.

The SPV’s sole business and activity shall be to hold the Sorrento Core IP and to perform its obligations and exercise its rights under the License and Collaboration Agreement among  Les Laboratoires Servier SAS, Institut de Recherches Internationales Servier and Sorrento Therapeutics, Inc. entered into as of the Effective Date  (the “License Agreement”);

2.

The SPV shall not transfer or otherwise license any assets of the SPV that are exclusively licensed under the License Agreement and not otherwise excepted under the License Agreement except as and to the extent contemplated under the License Agreement;

3.

The SPV shall not, to the fullest extent permitted by Law, engage in any dissolution, liquidation, consolidation, merger, asset sale or transfer of ownership interests other than any asset sale or transfer of ownership interests in the ordinary course of its business;

4.

The SPV shall not (a) make loans, borrow money and issue evidences of indebtedness or secure the same by mortgage, pledge, letter of credit, or other lien on any assets of the SPV, unless the creditor or holder thereof expressly agrees that upon the exercise of any of its rights or remedies all rights and remedies of Sorrento under the License Agreement will be unaffected and that such holder will not institute a bankruptcy proceeding against the SPV or join in any petition seeking the same or (b) grant any guarantee, become obligated for or pay the debts of any person or hold the credit of the SPV out as being available to satisfy the obligations of any other person (nor indemnify any person for losses resulting therefrom), nor have any of its obligations guaranteed by any other person or hold the SPV out as responsible for the debts of any other person or for the decisions or actions with respect to the business and affairs of any other person, nor seek or obtain credit or incur any obligation to any third party based upon the creditworthiness or assets of any other person (i.e., other than based on the creditworthiness or assets of the SPV) nor allow any person to do such things based on the credit of the SPV;

5.

The SPV shall at all times remain solvent and pay its debts and liabilities from its assets as the same shall become due;

6.

The SPV shall not form, or cause to be formed, any subsidiaries;

7.

The SPV shall not commingle funds with any other entity;

8.

The SPV shall maintain accurate records, books of account and financial statements disclosing that its assets are not available to pay creditors of any of its affiliates;

9.

The SPV shall file its own tax returns, if any, as may be required under applicable law, to the extent (1) not part of a consolidated group filing a consolidated return or returns or (2) not treated as a division for tax purposes of another taxpayer, and shall pay any taxes so required to be paid under applicable Law.

 


 

10.

The directors shall hold appropriate meetings to authorize all of the SPV’s corporate actions, which meetings may be held by telephone conference call;  

11.

The SPV shall pay its own liabilities and expenses out of its own funds as the same shall become due;

12.

The SPV shall hold itself out as a separate legal entity;

13.

The SPV shall maintain its valid existence as a limited liability company under the laws of the Nevada;

14.

The SPV shall have its own directors, including an Independent Director at all times who will be appointed by Sorrento as a member of the Board of Directors of the SPV. The Independent Director can only be removed or replaced by Sorrento.  In addition, the SPV shall create a special membership interest and issue such interest (the “Special Interest”) to Sorrento.  The Special Interest shall not be redeemable, but shall have no economic, informational, voting or other rights, except for the voting rights specified below;

15.

The SPV shall act solely in its corporate name and through its duly authorized directors, officers or agents in the conduct of its business, and shall conduct its business so as not to mislead others as to the identity of the entity or assets with which they are concerned.  Without limiting the generality of the foregoing, all written and oral communications, including without limitation letters, invoices, purchase orders, contracts, statements and loan applications, shall be made solely in the SPV’s own name;

16.

The SPV shall direct creditors of the SPV to send invoices and other statements of account of the SPV directly to the SPV and not to any affiliate and cause the affiliates to direct their creditors not to send invoices and other statements of accounts of such affiliate to the SPV;

17.

The SPV shall pay from its own bank accounts for accounting and payroll services, rent, lease and other expenses (or the SPV’s allocable share of any such amounts provided by one or more other affiliates) and not have such operating expenses (or the SPV’s allocable share thereof) paid by any affiliate;

18.

The SPV’s resolutions, agreements and other instruments shall be maintained by it as official records, separately identified and held apart from the records of any affiliate;

19.

The SPV shall grant a first priority lien on the Sorrento Anti-PD-1 Patent  Rights that it holds in order to secure Sorrento’s damages in the event that the License Agreement is terminated other than for Sorrento’s breach and Sorrento’s rights and licenses under such Sorrento Anti-PD-1 Patent Rights are not maintained.

20.

Notwithstanding any other provision that otherwise so empowers the SPV, any member of the SPV (other than the Special Member), the Board, any Officer or any other Person, neither the members nor the Board nor any Officer nor any other Person shall be authorized or empowered, nor shall they permit the SPV, without the prior unanimous written consent of the Special Member and the Board (including the Independent Director), to take any Material Action, provided, however, that the Board may not vote on, or authorize the taking of, any

 


 

Material Action, unless there is the Independent Director then serving in such capacity and it has given such Independent Director and the Special Member at least 30 days prior notice thereof.  For purposes of the foregoing, “ Material Action ” means to consolidate or merge the SPV with or into any Person, or sell all or substantially all of the assets of the SPV (other than to a Qualifying Person), or to institute proceedings to have the SPV be adjudicated bankrupt or insolvent, or consent to the institution of bankruptcy or insolvency proceedings against the SPV or file a petition seeking, or consent to, reorganization or relief with respect to the SPV under any applicable federal or state law relating to bankruptcy, or consent to the appointment of a receiver, liquidator, assignee, trustee, sequestrator (or other similar official) of the SPV or a substantial part of its property, or make any assignment for the benefit of creditors of the SPV, or admit in writing the SPV’s inability to pay its debts generally as they become due, or take action in furtherance of any such action, or, to the fullest extent permitted by Law,  dissolve or liquidate the SPV.  For the purposes hereof, a “ Qualifying Person ” means any Person that has expressly affirmed all of Sorrento and its sublicensees’ right under the License Agreement and that has instituted, with respect to the Sorrento Anti-PD-1 Patent Rights the procedures specified herein prior to any merger with or transfer to such person and any pharmaceutical company with gross revenue in excess of $500,000,000.  

The Independent Director shall not have any fiduciary duties to the members, any Director or any other Person; provided, however, the foregoing shall not eliminate the implied contractual covenant of good faith and fair dealing.  To the fullest extent permitted by Law,  the Independent Director shall not be liable to the SPV, the members or any other Person bound by the Charter Documents for breach of contract or breach of duties (including fiduciary duties), unless the Independent Director acted in bad faith or engaged in willful misconduct.  All right, power and authority of the Independent Director shall be limited to the extent necessary to exercise those rights and perform those duties specifically set forth herein.  No Independent Director shall at any time serve as trustee in bankruptcy for any Affiliate of the SPV.  Notwithstanding any other provision of this Agreement, the bankruptcy of a member shall not cause such member to cease to be a member of the SPV and upon the occurrence of such an event, the SPV shall continue without dissolution.

For the purposes hereof, a “ Person ” means an individual, a limited liability company, a partnership, a joint venture, a corporation, a trust, an unincorporated organization, association, or any other entity.

All capitalized terms used herein but not defined herein shall have the meanings assigned to such terms under the License Agreement.

 

Exhibit 31.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

I, Henry Ji, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Sorrento Therapeutics, 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 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 functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 8, 2016

By: 

/s/ Henry Ji, Ph.D.

 

 

Henry Ji, Ph.D.

 

 

Director, Chief Executive Officer and President

 

 

(Principal Executive Officer)

 

Exhibit 31.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

I, Kevin M. Herde, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Sorrento Therapeutics, 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 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 functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 8, 2016

By: 

/s/ Kevin M. Herde

 

 

Kevin M. Herde

 

 

Executive Vice President, Chief Financial Officer

 

 

(Principal Financial and Accounting Officer)

 

Exhibit 32.1

CERTIFICATIONS OF

PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER

PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

I, Henry Ji, Principal executive officer of Sorrento Therapeutics, Inc. (the “Company”), certify, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350, that to my knowledge:

1. The Quarterly Report on Form 10-Q of the Company for the period ended June 30, 2016 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: August 8, 2016

By: 

/s/ Henry Ji, Ph.D.

 

 

Henry Ji, Ph.D.

 

 

Director, Chief Executive Officer and President

 

 

(Principal Executive Officer)

I, Kevin M. Herde, Principal financial and accounting officer of Sorrento Therapeutics, Inc. (the “Company”), certify, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350, that to my knowledge:

1. The Quarterly Report on Form 10-Q of the Company for the period ended June 30, 2016 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: August 8, 2016

By: 

/s/ Kevin M. Herde

 

 

Kevin M. Herde

 

 

Executive Vice President, Chief Financial Officer

 

 

(Principal Financial and Accounting Officer)

A signed original of these certifications has been provided to Sorrento Therapeutics, Inc. and will be retained by Sorrento Therapeutics, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of Sorrento Therapeutics, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.