UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 10-Q

 

 

 

(Mark One)

 

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

 

For the quarterly period ended June 30, 2019

 

OR

 

o TRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE EXCHANGE ACT OF 1934

 

From the transition period from               to               .

 

Commission File Number 001-35798

 

 

Humanigen, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   77-0557236
(State or other jurisdiction of   (IRS Employer
incorporation)   Identification No.)

 

533 Airport Boulevard, Suite 400 Burlingame, CA 94010

(Address of principal executive offices)

(Zip Code)

 

Registrant’s telephone number, including area code: (650) 243-3100

 

Title of each class Trading Symbol(s) Name of each exchange on with registered
     

 

 

 

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   o

 

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

 

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

 

Large accelerated filer   o   Accelerated filer o
     
Non-accelerated filer   x   Smaller reporting company   x
     
    Emerging growth company   o

 

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

 

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

 

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes  x  No  o

 

As of August 12, 2019, there were 112,776,857 shares of common stock of the issuer outstanding.

 

 

 

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Table of Contents  

 

TABLE OF CONTENTS

HUMANIGEN, INC.

FORM 10-Q

 

       
      Page
       
PART I. FINANCIAL INFORMATION 3
       
  Item 1. Financial Statements (unaudited) 3
       
    Condensed Consolidated Balance Sheets as of June 30, 2019 and December 31, 2018 3
       
   

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six
Months Ended June 30, 2019 and 2018

4
       
   

Condensed Consolidated Statements of Cash flows for the Six Months Ended June 30, 2019 and
2018

5
       
   

Condensed Consolidated Statements of Stockholders’ Deficit for the Six Months Ended June 30,
2019 and 2018

6
       
    Notes to Condensed Consolidated Financial Statements 7
       
  Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 19
       
  Item 4. Controls and Procedures 27
       
PART II. OTHER INFORMATION 29
       

 

Item 1. Legal Proceedings 29
       

 

Item 6. Exhibits 30
       
SIGNATURES   31

 

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PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

Humanigen, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share data)

(Unaudited)

 

    June 30,     December 31,  
    2019     2018  
Assets            
Current assets:            
Cash and cash equivalents   $ 1,091     $ 814  
Prepaid expenses and other current assets     425       485  
Total current assets     1,516       1,299  
                 
Restricted cash     71       71  
Total assets   $ 1,587     $ 1,370  
                 
Liabilities and stockholders’ deficit                
Current liabilities:                
Accounts payable   $ 3,573     $ 2,856  
Accrued expenses     3,527       3,129  
Advance notes     950       807  
Notes payable to vendors     1,546       1,471  
Total current liabilities     9,596       8,263  
Convertible notes     2,752       1,217  
Total liabilities     12,348       9,480  
                 
Stockholders’ deficit:                
Common stock, $0.001 par value: 225,000,000 shares authorized at                
June 30, 2019 and December 31, 2018; 112,741,563 and 109,897,526 shares issued and
outstanding at June 30, 2019 and December 31, 2018, respectively
    113       110  
Additional paid-in capital     269,606       266,381  
Accumulated deficit     (280,480 )     (274,601 )
Total stockholders’ deficit     (10,761 )     (8,110 )
Total liabilities and stockholders’ deficit   $ 1,587     $ 1,370  

 

See accompanying notes.

 

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Humanigen, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

(Unaudited)

 

    Three Months Ended June 30,     Six Months Ended June 30,  
    2019     2018     2019     2018  
Operating expenses:                        
Research and development   $ 1,234     $ 577     $ 1,593     $ 1,273  
General and administrative     1,746       2,032       3,625       5,989  
Total operating expenses     2,980       2,609       5,218       7,262  
                                 
Loss from operations     (2,980 )     (2,609 )     (5,218 )     (7,262 )
                                 
Other expense:                                
Interest expense     (358 )     (32 )     (660 )     (426 )
Other income (expense), net     -       2       (1 )     (1 )
Reorganization items, net     -       (29 )     -       (66 )
Net loss     (3,338 )     (2,668 )     (5,879 )     (7,755 )
Other comprehensive income     -       -       -       -  
Comprehensive loss   $ (3,338 )   $ (2,668 )   $ (5,879 )   $ (7,755 )
                                 
Basic and diluted net loss per common share   $ (0.03 )   $ (0.02 )     (0.05 )   $ (0.10 )
                                 
Weighted average common shares outstanding used to                                
calculate basic and diluted net loss per common share     111,110,926       109,377,584       110,560,662       79,517,510  

  

See accompanying notes.

 

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Humanigen, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)

 

    Six Months Ended June 30,
    2019   2018
Operating activities:        
Net loss   $ (5,879 )   $ (7,755 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation and amortization     -       19  
Noncash interest expense     651       422  
Stock based compensation expense     1,426       3,455  
Issuance of common stock for payment of  accrued compensation     90       -  
Issuance of common stock in exchange for services     68       51  
Changes in operating assets and liabilities:                
Prepaid expenses and other assets     60       149  
Accounts payable     717       (88 )
Accrued expenses     594       16  
Net cash used in operating activities     (2,273 )     (3,731 )
                 
Financing activities:                
Net proceeds from issuance of common stock     -       2,781  
Net proceeds from term loan     -       50  
Proceeds from exercise of stock options     325       -  
Net proceeds from issuance of convertible notes     1,275       -  
Net proceeds from issuance of advance notes     950       400  
Net cash provided by financing activities     2,550       3,231  
                 
Net increase (decrease) in cash, cash equivalents and restricted cash     277       (500 )
Cash, cash equivalents and restricted cash, beginning of period     885       838  
Cash, cash equivalents and restricted cash, end of period   $ 1,162     $ 338  
                 
Supplemental cash flow disclosure:                
Cash paid for interest   $ 8     $ 3  
Supplemental disclosure of non-cash investing and financing activities:                
Conversion of notes payable and related accrued interest and fees to common stock   $ 981     $ 18,432  
Beneficial conversion feature of Convertible notes   $ 142     $ -  
Issuance of stock options in lieu of cash compensation   $ 195     $ 303  
Issuance of common stock for payment of accrued compensation   $ 90     $ -  
Issuance of common stock in exchange for services   $ 68     $ 31  

 

See accompanying notes.

 

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Humanigen, Inc.

Condensed Consolidated Statements of Stockholders’ Deficit

(in thousands, except share data)

(Unaudited)

 

    Three and Six Months Ended June 30, 2019  
                Additional           Total  
    Common Stock     Paid-In     Accumulated     Stockholders’  
    Shares     Amount     Capital     Deficit     Deficit  
Balances at January 1, 2019     109,897,526     $ 110     $ 266,381     $ (274,601 )   $ (8,110 )
Issuance of stock options for payment of accrued compensation     -       -       195       -       195  
Issuance of common stock for payment of accrued compensation     93,358       -       90       -       90  
Issuance of common stock in exchange for services     82,432       -       68       -       68  
Exercise of common stock options     75,000       -       50       -       50  
Stock-based compensation expense     -       -       697       -       697  
Comprehensive loss     -       -       -       (2,541 )     (2,541 )
Balances at March 31, 2019     110,148,316       110       267,481       (277,142 )     (9,551 )
Issuance of common stock upon note conversions     2,179,622       2       979       -       981  
Convertible note beneficial conversion feature     -       -       143       -       143  
Exercise of common stock options     413,625       1       274       -       275  
Stock-based compensation expense     -       -       729       -       729  
Comprehensive loss     -       -       -       (3,338 )     (3,338 )
Balances at June 30, 2019     112,741,563     $ 113     $ 269,606     $ (280,480 )   $ (10,761 )

 

 

    Three and Six Months Ended June 30, 2018  
                Additional           Total  
    Common Stock     Paid-In     Accumulated     Stockholders’  
    Shares     Amount     Capital     Deficit     Deficit  
Balances at January 1, 2018     14,946,712     $ 15     $ 238,246     $ (262,597 )   $ (24,336 )
Conversion of notes payable and related accrued interest                                        
and fees to common stock     76,007,754       76       18,356       -       18,432  
Issuance of common stock     18,253,320       18       2,583       -       2,601  
Issuance of stock options for payment of accrued compensation     -       -       303       -       303  
Stock-based compensation expense     -       -       2,675       -       2,675  
Comprehensive loss     -       -       -       (5,087 )     (5,087 )
Balances at March 31, 2018     109,207,786       109       262,163       (267,684 )     (5,412 )
Issuance of common stock     400,000       1       179       -       180  
Issuance of common stock in exchange for services     88,333       -       51       -       51  
Stock-based compensation expense     -       -       780       -       780  
Comprehensive loss     -       -       -       (2,668 )     (2,668 )
Balances at June 30, 2018     109,696,119     $ 110     $ 263,173     $ (270,352 )   $ (7,069 )

   

See accompanying notes.

 

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Humanigen, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

1. Nature of Operations

 

Description of the Business

 

The Company was incorporated on March 15, 2000 in California and reincorporated as a Delaware corporation in September 2001 under the name KaloBios Pharmaceuticals, Inc. Effective August 7, 2017, the Company changed its legal name to Humanigen, Inc.

 

During February 2018, the Company completed the restructuring transactions announced in December 2017 and furthered its transformation into a biopharmaceutical company pursuing cutting-edge science to develop its proprietary monoclonal antibodies for various oncology indications and to enhance T-cell engaging therapies, potentially making these treatments safer, more effective and more efficiently administered.

 

The Company’s primary focus is on improving the efficacy and safety of approved and development stage chimeric antigen receptor T-cell therapy, also known as CAR-T, through the prophylactic administration of its proprietary Humaneered ® monoclonal antibody, lenzilumab, the Company’s lead product candidate. The prophylactic administration of lenzilumab in combination with CAR-T is in development to prevent the serious and potentially life-threatening side-effects associated with CAR-T while simultaneously making those therapies more effective, efficient and cost-effective. Identifying, treating and managing severe side-effects of CAR-T consumes significant hospital resources and additional costs that we believe have impeded the pace of adoption of these promising and highly effective treatments as the standard of care for certain hematologic cancers. These side-effects may also hamper the use of CAR-T in earlier stage treatment of hematologic cancers as well as the expansion of CAR-T into treatment of solid tumors, both of which represent significant growth drivers for the overall CAR-T marketplace.

 

There are currently no FDA-approved therapies available for the prevention of the serious side-effects associated with CAR-T. Pre-clinical data generated in partnership with the Mayo Clinic indicates that the use of lenzilumab may prevent or significantly minimize the onset of both CAR-T induced neurologic toxicities (NT) and cytokine release syndrome (CRS) while also enhancing the proliferation and effector functions of the CAR-T itself, thus simultaneously improving efficacy and potentially reducing relapse rates, a key issue with current CAR-T where approximately half the patients who initially respond have relapsed within a year of therapy. The Company continues to advance the development of lenzilumab through clinical trials that it expects will serve as the basis for registration in close collaboration with some of the leading and most experienced investigators in the CAR-T field. The Company is also exploring additional partnerships with established CAR-T companies as a potential means of accelerating the development and commercialization of lenzilumab in conjunction with their existing CAR-T offerings. The Company aims to position lenzilumab as an essential companion product to CAR-T and a necessary part of the standard pre-conditioning drug regimen that all patients treated with CAR-T currently receive.

 

Lenzilumab is a recombinant monoclonal antibody (mAb) that neutralizes soluble granulocyte-macrophage colony-stimulating factor (GM-CSF) a critical cytokine which is elevated early in the inflammatory cascade and where peak levels are associated with serious and potentially life-threatening CAR-T-related side-effects. GM-CSF is also implicated in the growth of certain hematologic malignancies, such as chronic myelomonocytic leukemia (CMML) and juvenile myelomonocytic leukemia (JMML), graft-versus-host-disease (GVHD) associated with hematopoietic stem cell transplant (HSCT), hemophagocytic lymphoproliferative disease (HLH), macrophage activation syndrome (MAS), certain solid tumors and other serious conditions, particularly a range of auto-immune conditions.

 

There is extensive published evidence from multiple academic and expert clinical centers linking early elevation of GM-CSF to serious and potentially life-threatening side-effects in CAR-T therapy. Following CAR-T administration GM-CSF initiates a signaling cascade of inflammation that results in the trafficking and recruitment of myeloid cells to the tumor site. These myeloid cells then produce key downstream cytokines known to be associated with development of NT and CRS, further perpetuating the inflammatory cascade.

 

Peer-reviewed publications in leading journals by well-recognized experts have shown that GM-CSF is a biomarker elevated in patients who suffer severe NT as a side-effect of CAR-T. Pre-clinical studies have demonstrated lenzilumab’s effectiveness in preventing CRS and significantly reducing NT associated with CAR-T. The data from these studies also shows an increase in CAR-T cell expansion when lenzilumab is administered prophylactically in combination with CAR-T.

 

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On May 30, 2019, the Company entered into a Clinical Collaboration Agreement (the “Collaboration Agreement) with Kite Pharma, Inc. (“Kite”), a wholly owned subsidiary of Gilead Sciences, Inc., pursuant to which the parties agreed to conduct a multi-center Phase 1b/2 study of lenzilumab with Kite’s Yescarta ® (axicabtagene ciloleucel) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (the “Study”). The primary objective of the Study is to determine the effect of lenzilumab on the safety of Yescarta. Various other important parameters, including efficacy and healthcare resource utilization, will also be measured. Kite will act as the sponsor of the Study and will be responsible for its conduct. 

 

On June 19, 2019 the Company entered into an exclusive worldwide license agreement (the “Mayo Agreement”) with the Mayo Foundation for Medical Education and Research (“Mayo”) for certain technologies used to create CAR-T cells lacking GM-CSF expression through various gene-editing tools including CRISPR-Cas9 (GM-CSF knock-out). The license covers various patent applications and know-how developed by Mayo in collaboration with the Company. These licensed technologies complement and broaden the Company’s position in the GM-CSF neutralization space and expand the Company’s discovery platform aimed at improving CAR-T to include gene-edited CAR-T cells.

 

On July 19, 2019 the Company entered into an exclusive worldwide license agreement (the “Zurich Agreement”) with the University of Zurich (“UZH”) for technology used to prevent Graft versus Host Disease (“GvHD”) through GM-CSF neutralization. The Zurich Agreement covers various patent applications filed by UZH which complement and broaden the Company’s position in the application of GM-CSF and expands the Company’s development platform to include improving allogeneic Hematopoietic Stem Cell Transplantation (“HSCT”).

 

Ifabotuzumab is an anti-Eph Type-A receptor 3 (EphA3) mAb that has the potential for treating solid tumors, hematologic malignancies and serious pulmonary conditions. Anti-EphA3 as a CAR-T construct, which utilizes certain sequences of ifabotuzumab to generate a specific type of CAR-T, may also be useful in the treatment of a range of cancers. The Company is collaborating with an expert CAR-T center to make a series of CAR constructs based on ifabotuzumab, of which initial constructs have been created, and plans to move to pre-clinical testing with these constructs for a range of cancer types. EphA3 is a tumor specific antigen expressed on the surface of a multitude of solid bulk tumor cells, tumor stroma cells and tumor vasculature in certain cancers. The Company completed the Phase I dose escalation portion of a Phase I/II clinical trial in ifabotuzumab in multiple hematologic malignancies for which the preliminary results were published in the journal Leukemia Research in 2016. A Phase I radio-labeled imaging trial of ifabotuzumab in recurrent glioblastoma multiforme, a particularly aggressive and deadly form of brain cancer, is currently enrolling at two centers in Australia, the Olivia-Newton John Cancer Research Institute (ONJCRI) in Melbourne and the Queensland Institute for Medical Research in Brisbane. The lead investigators at the ONJCI, are also evaluating an antibody-drug conjugate (ADC) comprising ifabotuzumab.  The current trial has enrolled eight patients to date, and is expected to complete enrollment with a total of twelve patients by year end and to report on the initial findings soon thereafter.   The Company continues to explore partnering opportunities to facilitate the further development of ifabotuzumab in a range of cancer types.

 

HGEN005 is a pre-clinical stage anti-human epidermal growth factor-like module containing mucin-like hormone receptor 1 (EMR1) mAb. EMR1 is a therapeutic target for eosinophilic disorders. Eosinophils are a type of white blood cell. If too many are produced in the body, chronic inflammation and tissue and organ damage may result. Analysis of blood and bone marrow shows that surface expression of EMR1 is restricted to mature eosinophils and correlated with eosinophilia. Tissue eosinophils also express EMR1. In pre-clinical work, the Company has demonstrated that eosinophil killing is enhanced in the presence of HGEN005 and immune effector cells. A major limitation of current eosinophil targeted therapies is incomplete depletion of tissue eosinophils and/or lack of cell selectivity, which may mean that HGEN005 could offer promise in a range of eosinophil-driven diseases, such as eosinophilic asthma, eosinophilic esophagitis and eosinophilic granulomatosis with polyangiitis. The Company is considering developing a series of CAR constructs based on HGEN005 and may take or partner these constructs, if developed, into pre-clinical testing. Importantly, and in contrast to other agents, HGEN005 appears to have an effect solely on eosinophils, without impacting other populations, such as mast cells.

 

The Company’s monoclonal antibody portfolio was developed with its proprietary, patent-protected Humaneered ® technology, which consists of methods for converting antibodies (typically murine) into engineered, high-affinity antibodies designed for human therapeutic use, with a focus on oncology and other serious, chronic conditions.

 

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Liquidity and Going Concern

 

The Company has incurred significant losses since its inception in March 2000 and had an accumulated deficit of $280.5 million as of June 30, 2019. At June 30, 2019, the Company had a working capital deficit of $8.1 million.  To date, none of the Company’s product candidates has been approved for sale and therefore the Company has not generated any revenue from product sales. Management expects operating losses to continue for the foreseeable future. The Company will require additional financing in order to meet its anticipated cash flow needs during the next twelve months. As a result, the Company will continue to require additional capital through equity offerings, debt financing and/or payments under new or existing licensing or collaboration agreements. If sufficient funds are not available on acceptable terms when needed, the Company could be required to significantly reduce its operating expenses and delay, reduce the scope of, or eliminate one or more of its development programs. The Company’s ability to access capital when needed is not assured and, if not achieved on a timely basis, could materially harm its business, financial condition and results of operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

 

The Condensed Consolidated Financial Statements for the three and six months ended June 30, 2019 were prepared on the basis of a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business. The ability of the Company to meet its total liabilities of $12.3 million at June 30, 2019 and to continue as a going concern is dependent upon the availability of future funding. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

 

Basis of Presentation

 

The accompanying interim unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and on a basis consistent with the annual consolidated financial statements and include all adjustments necessary for the presentation of the Company’s condensed consolidated financial position, results of operations and cash flows for the periods presented. The Condensed Consolidated Financial Statements include the accounts of the Company and its wholly owned subsidiaries. These financial statements have been prepared on a basis that assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The December 31, 2018 Condensed Consolidated Balance Sheet was derived from the audited financial statements but does not include all disclosures required by U.S. GAAP. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, 2019, or for any other future annual or interim period. The accompanying unaudited Condensed Consolidated Financial Statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s 2018 Form 10-K.

 

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the Condensed Consolidated Financial Statements and accompanying notes. Actual results could differ materially from those estimates. The Company believes judgment is involved in determining the valuation of the fair value-based measurement of stock-based compensation, accruals and warrant valuations. The Company evaluates its estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the Condensed Consolidated Financial Statements.

 

2. Chapter 11 Filing

 

On December 29, 2015, the Company filed a voluntary petition for bankruptcy protection under Chapter 11 of the U.S. Bankruptcy Code. The filing was made in the United States Bankruptcy Court for the District of Delaware (the “Bankruptcy Court”) (Case No. 15-12628 (LSS) (the “Bankruptcy Case”). The Company’s Plan of Reorganization filed with the Bankruptcy Court (the “Plan”) became effective June 30, 2016 and the Company emerged from its Chapter 11 bankruptcy proceedings.

 

The reconciliation of certain proofs of claim filed against the Company in the Bankruptcy Case, including certain General Unsecured Claims, Convenience Class Claims and Other Subordinated Claims, is complete.  As a result of its examination of the claims, the Company asked the Bankruptcy Court to disallow, reduce, reclassify, subordinate or otherwise adjudicate certain claims the Company believes are subject to objection or otherwise improper.  On July 11, 2018, the Company filed an objection to the remaining claims. By objection, the Company sought to disallow in their entirety the remaining claims totaling approximately $0.5 million. On September 17, 2018 the Bankruptcy Court issued a Final Decree and Order to close the Bankruptcy Case and terminate the remaining claims and noticing services.

 

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For the three and six months ended June 30, 2019 and 2018, Reorganization items, net consisted of the following charges related to the bankruptcy proceedings:

 

    Three Months Ended June 30,     Six Months Ended June 30,  
    2019     2018     2019     2018  
Legal fees   $ -     $ 23     $ -     $ 53  
Professional fees     -       6       -       13  
Total reorganization items, net   $ -     $ 29     $ -     $ 66  

 

There were no cash payments for reorganization for the three and six months ended June 30, 2019. Cash payments for reorganization items totaled $0.07 million and $0.09 million for the three and six months ended June 30, 2018, respectively.

 

3. Summary of Significant Accounting Policies

 

There have been no material changes in the Company’s significant accounting policies since those previously disclosed in the 2018 Form 10-K.

 

In November 2016, the FASB issued ASU 2016-18, “Statement of Cash Flows (Topic 230): Restricted Cash”. ASU 2016-18 requires the inclusion of restricted cash with cash and cash equivalents when reconciling the beginning-of-the period and end-of-period total amounts shown on the statement of cash flows. The Company adopted the standard effective January 1, 2018. As a result of the adoption, the Company will no longer present the change within restricted cash in the consolidated statements of cash flows. See below for the composition of cash, cash equivalents and restricted cash shown on the statements of cash flow:

 

    June 30,  
    2019     2018  
Cash and cash equivalents   $ 1,091     $ 267  
Restricted cash     71       71  
Total cash, cash equivalents and restricted cash as shown on statement of cash flows   $ 1,162     $ 338  

 

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. The FASB subsequently issued ASU No. 2018-10 and 2018-11 in July 2018, which provide clarifications and improvements to ASU 2016-02 (collectively, the “new lease standard”).

 

ASU No. 2018-11 provides the optional transition method which allows companies to apply the new lease standard at the adoption date instead of at the earliest comparative period presented and continue to apply the provisions of the previous lease standard in its annual disclosures for the comparative periods. The new lease standard requires lessees to present a right-of-use asset and a corresponding lease liability on the balance sheet. Additional footnote disclosures related to leases is also required.

 

On January 1, 2019, the Company adopted the new lease standard using the optional transition method and certain other practical expedients. Under the practical expedient package elected, the Company is not required to reassess whether expired or existing contracts are or contain a lease; and is not required to reassess the lease classifications or reassess the initial direct costs associated with expired or existing leases.

 

The new lease standard also provides practical expedients for an entity’s ongoing accounting. The Company elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, we will not recognize right of use assets or lease liabilities, and this includes not recognizing right of use assets or lease liabilities for existing short-term leases of those assets in transition. The Company elected the practical expedient to not separate lease and non-lease components for certain classes of assets. See Note 4 for a description of the Company’s current leases and their treatment under the new lease standard.

 

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4. Leases

 

The Company leases an office-space under a month-to-month lease for $1,000 per month. Management has determined the lease term to be less than 12 months, including renewals, and therefore has not recorded a right-of-use asset and corresponding liability under the short-term lease recognition exemption. Lease costs for the three and six months ended June 30, 2019 totaled $3,000 and $6,400, respectively and are included in the Consolidated Statements of Operations.

 

As described in Note 3, the Company has elected to adopt the transitional practical expedients, and was not required to reassess whether any existing or expired contracts contained embedded leases. The Company has not entered into any contracts during the 2019 fiscal year that contain an embedded lease.

 

5. Potentially Dilutive Securities

 

The Company’s potentially dilutive securities, which include stock options, restricted stock units and warrants, have been excluded from the computation of diluted net loss per common share as the effect of including those securities would be to reduce the net loss per common share and be antidilutive. Therefore, the denominator used to calculate both basic and diluted net loss per common share is the same in each period presented.

 

The following outstanding potentially dilutive securities have been excluded from the computations of diluted net loss per common share:

 

    As of June 30,  
    2019     2018  
Options to purchase common stock     15,139,374       15,651,023  
Warrants to purchase common stock     331,193       331,193  
      15,470,567       15,982,216  

 

6. Fair Value of Financial Instruments

 

Cash, accounts payable and accrued liabilities are carried at cost, which approximates fair value given their short-term nature. Marketable securities and cash equivalents are carried at fair value. The Company has money market funds of $71 at June 30, 2019 and December 31, 2018 that are reported as restricted cash on the balance sheet. The amortized cost of these funds equals their fair value as there were no unrealized gains or losses at June 30, 2019 or December 31, 2018.

 

The fair value of financial instruments reflects the amounts that would be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The fair value hierarchy is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable, and the third is considered unobservable, as follows:

 

Level 1 — Quoted prices in active markets for identical assets or liabilities.

 

Level 2 — Inputs other than those included in Level 1 that are directly or indirectly observable, such as quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

 

Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

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The Company measures the fair value of financial assets and liabilities using the highest level of inputs that are reasonably available as of the measurement date. The following tables summarize the fair value of financial assets that are measured at fair value and the classification by level of input within the fair value hierarchy:

 

    Fair Value Measurements as of  
    June 30, 2019  
(in thousands)   Level 1     Level 2     Level 3     Total  
Investments:                        
Money market funds   $ 71     $     $     $ 71  
Total assets measured at fair value   $ 71     $     $     $ 71  

 

    Fair Value Measurements as of  
    December 31, 2018  
(in thousands)   Level 1     Level 2     Level 3     Total  
Investments:                        
Money market funds   $ 71     $     $     $ 71  
Total assets measured at fair value   $ 71     $     $     $ 71  

 

7. Debt

 

Notes Payable to Vendors

 

On June 30, 2016, the Company issued promissory notes in an aggregate principal amount of approximately $1.2 million to certain claimants in accordance with the Plan. The notes are unsecured, bear interest at 10% per annum and became due and payable in full, including principal and accrued interest on June 30, 2019. As of June 30, 2019 and December 31, 2018, the Company has accrued $0.4 million and $0.3 million in interest related to these promissory notes, respectively. As June 30, 2019 fell on a Sunday, in July 2019 the Company used approximately $0.5 million of the proceeds from the 2019 Bridge Notes (described below) to retire a portion of these notes. (See below for a discussion of the 2019 Bridge Notes including proceeds received subsequent to June 30, 2019.) After giving effect to these payments in July, the aggregate principal amount and accrued but unpaid interest on these notes approximates $1.1 million. The outstanding principal amount and accrued but unpaid interest on these notes is currently payable to the respective holders without demand, notice or declaration, and the holders, without demand or notice of any kind, may exercise any and all other rights and remedies available to them under the notes, the Plan, at law or in equity. We do not have sufficient funds to repay the principal and accrued but unpaid interest on these notes in their entirety. See Part II, Item 1A. “Risk Factors” for more information.

 

Advance Notes

 

In June, July and August, 2018 the Company received an aggregate of $0.9 million of proceeds from advances made to the Company (the “Advance Notes”) by four different lenders including Dr. Cameron Durrant, the Company’s Chairman and Chief Executive Officer; Cheval Holdings, Ltd., an affiliate of Black Horse Capital, L.P., the Company’s controlling stockholder; and Ronald Barliant, a director of the Company (collectively the “Lenders”). The Advance Notes accrued interest at a rate of 7% per year, compounded annually.

 

 

In accordance with their terms, on May 30, 2019, in connection with the Company’s announcement of the Collaboration Agreement with Kite, the lenders converted the amounts due under the Advance Notes into the Company’s common stock at the conversion price of $0.45 per share. The Company issued a total of 2,179,622 shares of common stock in connection with the conversion.

 

2018 Convertible Notes

 

Commencing September 19, 2018, the Company delivered a series of convertible promissory notes (the “2018 Notes”) evidencing an aggregate of $2.5 million of loans made to the Company by six different lenders, including an affiliate of Black Horse Capital, L.P., the Company’s controlling stockholder. The 2018 Notes bear interest at a rate of 7% per annum and will mature on the earliest of (i) twenty-four months from the date the Notes were signed, (ii) the occurrence of any customary event of default, or (iii) the certain liquidation events including any dissolution or winding up of the Company or merger or sale by the Company of all or substantially all of its assets (in any case, a “Liquidation Event”). The Company used the proceeds from the Notes for working capital.

 

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The 2018 Notes are convertible into equity securities in the Company in three different scenarios:

 

If the Company sells its equity securities on or before the date of repayment of the 2018 Notes in any financing transaction that results in gross proceeds to the Company of at least $10 million (a “Qualified Financing”), the 2018 Notes will be converted into either (i) such equity securities as the noteholder would acquire if the principal and accrued but unpaid interest thereon (the “Conversion Amount”) were invested directly in the financing on the same terms and conditions as given to the financing investors in the Qualified Financing, or (ii) common stock at a conversion price equal to $0.45 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the Notes).

 

If the Company sells its equity securities on or before the date of repayment of the 2018 Notes in any financing transaction that results in gross proceeds to the Company of less than $10 million (a “Non-Qualified Financing”), the noteholders may convert their remaining 2018 Notes into either (i) such equity securities as the noteholder would acquire if the Conversion Amount were invested directly in the financing on the same terms and conditions as given to the financing investors in the Non-Qualified Financing, or (ii) common stock at a conversion price equal to $0.45 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the Notes).

 

The 2018 Notes may convert in the event the Company enters into or publicly announces its intention to consummate a Liquidation Event. Immediately prior to the completion of any such Liquidation Event, in lieu of receiving payment in cash, noteholders may convert the Conversion Amount into common stock at a conversion price equal to $0.45 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the Notes).

 

2019 Convertible Notes

 

Commencing on April 23, 2019, the Company delivered a series of convertible promissory notes (the “2019 Notes”) evidencing an aggregate of $1.3 million of loans made to the Company.

 

The 2019 Notes bear interest at a rate of 7.5% per annum and will mature on the earliest of (i) twenty-four months from the date the 2019 Notes are signed (the “Stated Maturity Date”), (ii) the occurrence of any customary event of default, or (iii) the certain liquidation events including any dissolution or winding up of the Company or merger or sale by the Company of all or substantially all of its assets (in any case, a “Liquidation Event”). The Company used the proceeds from the 2019 Notes for working capital.

 

The 2019 Notes are convertible into equity securities in the Company in four different scenarios:

 

If the Company sells its equity securities on or before the Stated Maturity Date in any financing transaction that results in gross proceeds to the Company of at least $10.0 million (a “Qualified Financing”) or the Company consummates a reverse merger or similar transaction, the 2019 Notes will be converted into either (i) (a) in the case of a Qualified Financing, such equity securities as the noteholder would acquire if the principal and accrued but unpaid interest thereon together with such additional amount of interest as would have been paid on the 2019 Notes if held to the Stated Maturity Date (the “Conversion Amount”) were invested directly in the financing on the same terms and conditions (including price) as given to the financing investors in the Qualified Financing or (b) in the case of a reverse merger, common stock at the same price per share paid by the buyer in such transaction (which in a stock for stock transaction, shall be based on the price per share used by the parties for purposes of setting the applicable exchange ration), or (ii) common stock at a conversion price equal to $1.25 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the 2019 Notes).

 

If the Company sells its equity securities on or before the date of repayment of the 2019 Notes in any financing transaction that results in gross proceeds to the Company of less than $ 10.0 million (a “Non-Qualified Financing”), the noteholders may convert their remaining Convertible Notes into either (i) such equity securities as the noteholder would acquire if the Conversion Amount were invested directly in the financing on the same terms and conditions (including price) as given to the financing investors in the Non-Qualified Financing, or (ii) common stock at a conversion price equal to $1.25 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the 2019 Notes).

 

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The 2019 Notes may convert in the event the Company enters into or publicly announces its intention to consummate a Liquidation Event. Immediately prior to the completion of any such Liquidation Event, in lieu of receiving payment in cash, noteholders may convert the Conversion Amount into common stock at a conversion price equal to $1.25 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the 2019 Notes).

 

In addition, upon the six-month anniversary of the date the 2019 Notes are signed or such earlier time as the Company publicly announces that it has entered into a definitive arrangement with an unaffiliated third party (a “Strategic Partner”) pursuant to which, among other things, such Strategic Partner may agree to collaborate with the Company in conducting a clinical study to assess the efficacy of the Company’s lenzilumab monoclonal antibody in reducing adverse effects from neurotoxicity and cytokine release syndrome when used as a companion therapy in certain CAR-T cell therapies, noteholders may convert any portion of the outstanding principal amount of the 2019 Notes, together with (a) any unpaid and accrued interest on such principal amount to the date the noteholder’s notice of the noteholder’s intention to convert is received by the Company (the “Notice Date”), and (b) such additional amount of interest as would have been paid on such principal amount from the Notice Date to the Stated Maturity Date, into common stock at a conversion price equal to $1.25 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the 2019 Notes). The Company’s announcement of the Collaboration Agreement with Kite satisfied this requirement and accordingly, the 2019 Notes are convertible into common stock on the above terms.

 

The Advance Notes, the 2018 Notes and the 2019 Notes have an optional voluntary conversion feature in which the holder could convert the notes in the Company’s common stock at maturity at a conversion rate of $0.45 per share for the Advance Notes and the 2018 Notes and at a conversion rate of $1.25 for the 2019 Notes. The intrinsic value of this beneficial conversion feature was $1.8 million upon the issuance of the Advance Notes, the 2018 Notes and the 2019 Notes and was recorded as additional paid-in capital and as a debt discount which is accreted to interest expense over the term of the Advance Notes and Notes. Interest expense includes debt discount amortization of $0.2 million and $0.4 million for the three and six month periods ended June 30, 2019.

 

The Company evaluated the embedded features within the Advance Notes, the 2018 Notes and the 2019 Notes to determine if the embedded features are required to be bifurcated and recognized as derivative instruments. The Company determined that the Advance Notes, the 2018 Notes and the 2019 Notes contain contingent beneficial conversion features (“CBCF”) that allow or require the holder to convert the Advance Notes, the 2018 Notes and the 2019 Notes, as applicable, to Company common stock at a conversion rate of $0.45 per share for the Advance Notes and the 2018 Notes and $1.25 for the 2019 Notes, but did not contain embedded features requiring bifurcation and recognition as derivative instruments. Upon the occurrence of a CBCF that results in conversion of the Advance Notes, the 2018 Notes or the 2019 Notes to Company common stock, the remaining unamortized discount will be charged to interest expense. Upon conversion of the Advance Notes on May 30, 2019, the remaining unamortized discount was charged to interest expense. The remaining debt discount will be amortized over 15 and 22 months for the 2018 Notes and the 2019 Notes, respectively.

 

2019 Bridge Notes

 

On June 28, 2019, the Company issued three short-term, secured bridge notes (the “2019 Bridge Notes”) evidencing an aggregate of $1.7 million of loans made to the Company by three parties: Cheval Holdings, Ltd., an affiliate of Black Horse Capital, L.P., the Company’s controlling stockholder, lent $750,000; Nomis Bay LTD, the Company’s second largest stockholder, lent $750,000; and Cameron Durrant, M.D., MBA, the Company’s Chief Executive Officer and Chairman of the Board of Directors, lent $200,000. The proceeds from the 2019 Bridge Notes were or will be used to satisfy a portion of the unsecured obligations incurred in connection with the Company’s emergence from bankruptcy in 2016 and for working capital and general corporate purposes. Of the $1.7 million in proceeds received, $950,000 was received on June 28, 2019 and was recorded as Advance notes in the Condensed Consolidated Balance Sheet as of June 30, 2019. The remaining proceeds of $750,000 were received July 1, 2019 and recorded accordingly.

 

The 2019 Bridge Notes bear interest at a rate of 7.0% per annum and will mature on October 1, 2019. The 2019 Bridge Notes may become due and payable at such earlier time as the Company raises more than $3,000,000 in a bona fide financing transaction or upon a change in control. The 2019 Bridge Notes are secured by liens of substantially all of the Company’s assets.

 

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Upon an event of default, which events include, but are not limited to, (1) the Company failing to timely pay any monetary obligation under the 2019 Bridge Notes; (2) the Company failing to pay its debts generally as they become due and (3) the Company commencing any proceeding relating to the Company under any bankruptcy reorganization, arrangement, insolvency, readjustment of debt, dissolution or liquidation or similar laws of any jurisdiction now or hereafter in effect, the interest payable on the 2019 Bridge Notes increases to 10.0% per annum. Further, upon certain events of default, all payments and obligations due and owed under the 2019 Bridge Notes shall immediately become due and payable without demand and without notice to the Company.

 

8. Commitments and Contingencies

 

Contractual Obligations and Commitments

 

As of June 30, 2019, other than the debt issuances described in Note 7 and the license agreement described in Note 10, there were no material changes to the Company’s contractual obligations from those set forth in the 2018 Form 10-K.

  

Guarantees and Indemnifications

 

The Company has certain agreements with service providers with which it does business that contain indemnification provisions pursuant to which the Company typically agrees to indemnify the party against certain types of third-party claims. The Company accrues for known indemnification issues when a loss is probable and can be reasonably estimated. The Company would also accrue for estimated incurred but unidentified indemnification issues based on historical activity. As the Company has not incurred any indemnification losses to date, there were no accruals for or expenses related to indemnification issues for any period presented.

 

9. Stockholders’ Equity

 

Restructuring Transactions

 

As further described in the Company’s Form 10-K for the year ended December 31, 2018, on February 27, 2018, the Company completed a comprehensive restructuring of its outstanding indebtedness of approximately $18.4 million under a series of term loans (the “Term Loans”) with two lender groups, including affiliates of Black Horse Capital, L.P. and raised incremental new capital from Cheval Holdings, Ltd. At the closing of the restructuring, the Company: (i) in exchange for the satisfaction and extinguishment of the entire balance of the Company’s Term Loans and related accrued interest totaling $18.4 million, (a) issued an aggregate of 59,786,848 shares of Common Stock (the “New Lender Shares”), and (b) transferred and assigned to a joint venture controlled by one of the term loan lenders, all of the assets of the Company related to benznidazole (the “Benz Assets”), the Company’s former drug candidate; and (ii) issued to Cheval an aggregate of 32,028,669 shares of Common Stock for total consideration of $3.0 million.

 

The conversion of the outstanding debt for Common Stock at closing of the restructuring was accounted for as a decrease to Long-term debt and an increase to Common stock and Additional paid-in capital in the amount of the liabilities outstanding at the time of conversion.

 

In connection with the transfer of the Benz Assets to the joint venture, the joint venture partner paid certain amounts incurred by the Company after December 21, 2017 and prior to February 27, 2018 in investigating certain causes of action and claims related to or in connection with the Benz Assets. In addition, upon exercise of its rights under the terms of the joint venture, the joint venture partner assumed certain legal fees and expenses owed by the Company to its litigation counsel totaling $0.3 million.

 

Since the Benz Assets had no carrying value on the Company’s Condensed Consolidated Balance Sheet, the Company’s initial investment in the joint venture was recorded at $0.

 

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Equity Financings

 

On March 12, 2018, the Company issued 2,445,557 shares of its common stock for total proceeds of $1.1 million to accredited investors.

 

On June 4, 2018, the Company issued 400,000 shares of its common stock for total proceeds of $0.2 million to an accredited investor.

 

2012 Equity Incentive Plan

 

Under the Company’s 2012 Equity Incentive Plan, the Company may grant shares, stock units, stock appreciation rights, performance cash awards and/or options to employees, directors, consultants, and other service providers. For options, the per share exercise price may not be less than the fair market value of a Company common share on the date of grant. Awards generally vest and become exercisable over three to four years and expire 10 years from the date of grant. Options generally become exercisable as they vest following the date of grant.

 

On March 9, 2018, the Board of Directors of the Company approved an amendment to the Company’s 2012 Equity Incentive Plan (the “Equity Plan”) to increase the number of shares of the Company’s common stock authorized for issuance under the Equity Plan by 16,050,000 shares, and to increase the annual maximum aggregate number of shares subject to stock option awards that may be granted to any one person under the Equity Plan during a calendar year to 7,500,000.

 

 

A summary of stock option activity for the six months ended June 30, 2019 under all of the Company’s options plans is as follows:

 

    Options     Weighted
Average
Exercise
Price
 
Outstanding at January 1, 2019     15,409,357     $ 0.95  
Granted     728,610       1.10  
Exercised     (488,625 )     0.67  
Cancelled (forfeited)     (509,923 )     0.62  
Cancelled (expired)     (45 )     9.68  
Outstanding at June 30, 2019     15,139,374     $ 0.97  

 

 

The weighted average fair value of options granted during the six months ended June 30, 2019 was $0.82 per share.

 

The Company valued the options granted using the Black-Scholes options pricing model and the following weighted-average assumption terms for the six months ended June 30 , 2019:

 

     

Six months ended

June 30, 2019

 
Exercise price      $0.84 - $1.30  
Market value      $0.84 - $1.30  
Risk-free rate     2.49% - 2.59%  
Expected term     6 years  
Expected volatility     99.1% - 99.3%  
Dividend yield     -  

 

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Stock-Based Compensation

 

The Company recorded stock-based compensation expense in the Condensed Consolidated Statements of Operations and Comprehensive Loss as follows:

 

    Three months ended June 30,     Six months ended June 30,  
    2019     2018     2019     2018  
General and administrative   $ 697     $ 780     $ 1,394     $ 3,254  
Research and development     32       -       32       201  
Total stock-based compensation   $ 729     $ 780     $ 1,426     $ 3,455  

 

At June 30, 2019, the Company had $1.7 million of total unrecognized stock-based compensation expense, net of estimated forfeitures, related to outstanding stock options that will be recognized over a weighted-average period of 1.4 years.

 

10. License Agreements

 

Mayo Agreement

 

On June 19, 2019 the Company entered into an exclusive worldwide license agreement (the “Mayo Agreement”) with the Mayo Foundation for Medical Education and Research (“Mayo”) for certain technologies used to create CAR-T cells lacking GM-CSF expression through various gene-editing tools including CRISPR-Cas9 (GM-CSF knock-out). The license covers various patent applications and know-how developed by Mayo in collaboration with the Company. These licensed technologies complement and broaden the Company’s position in the GM-CSF neutralization space and expand the Company’s discovery platform aimed at improving CAR-T to include gene-edited CAR-T cells.

 

Pursuant to the Mayo Agreement, the Company will pay $200,000 to Mayo within six months of the effective date, or upon completion of a qualified financing, whichever is earlier. The Mayo Agreement also requires the payment of milestones and royalties upon the achievement of certain regulatory and commercialization milestones. The Company accrued the initial payment in Accrued expenses in the accompanying Condensed Consolidated Balance Sheet as of June 30, 2019.

 

11. Savant Arrangements

 

On June 30, 2016 the Company and Savant Neglected Diseases, LLC (“Savant”) entered into an Agreement for the Manufacture, Development and Commercialization of Benznidazole for Human Use (the “MDC Agreement”), pursuant to which the Company acquired certain worldwide rights relating to benznidazole (the “Compound”).

 

In addition, on the Effective Date the Company and Savant also entered into a Security Agreement (the “Security Agreement”), pursuant to which the Company granted Savant a continuing senior security interest in the assets and rights acquired by the Company pursuant to the MDC Agreement and certain future assets developed from those acquired assets.

 

On the Effective Date, the Company issued to Savant a five year warrant (the “Warrant”) to purchase 200,000 shares of the Company’s Common Stock, at an exercise price of $2.25 per share, subject to adjustment. The Warrant is exercisable for 25% of the shares immediately and exercisable for the remaining shares upon reaching certain regulatory related milestones. As of June 30, 2019 the number of shares for which the Warrant is currently exercisable totals 100,000 shares at an exercise price of $2.25 per share.

 

As a result of the FDA granting accelerated and conditional approval of a benznidazole therapy manufactured by a competitor for the treatment of Chagas disease and awarding such competitor a neglected tropical disease PRV in August 2017, the Company ceased development of benznidazole and re-evaluated the final two vesting milestones and concluded that the probability of achievement of these milestones had decreased to 0%.

 

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In July 2017, the Company commenced litigation against Savant alleging that Savant breached the MDC Agreement and seeking a declaratory judgement. Savant has asserted counterclaims for breaches of contract under the MDC Agreement and the Security Agreement. The dispute primarily concerns the Company’s right under the MDC Agreement to offset certain costs incurred by the Company in excess of the agreed upon budget against payments due Savant. See Note 12, below, for more information regarding the Savant litigation. The aggregate cost overages as of June 30, 2017 that the Company asserts are Savant’s responsibility total approximately $3.4 million, net of a $0.5 million deductible. The Company asserts that it is entitled to offset $2.0 million in milestone payments due Savant against the cost overages, such that as of June 30, 2017, Savant owed the Company approximately $1.4 million. As of June 30, 2019, the cost overages totaled $4.1 million such that Savant owed the Company approximately $2.1 million in cost overages. Such cost overages have been charged to Research and development expense as incurred. Recovery of such cost overages, if any, will be recorded as a reduction of Research and development expense in the period received.

 

The $2.0 million in milestone payments due Savant are included in Accrued expenses in the accompanying Condensed Consolidated Balance Sheet as of June 30, 2019 and December 31, 2018.

 

12. Litigation

 

Savant Litigation

 

On July 10, 2017, the Company filed a complaint against Savant Neglected Diseases, LLC (“Savant”) in the Superior Court for the State of Delaware, New Castle County (the “Delaware Court”). KaloBios Pharmaceuticals, Inc. v. Savant Neglected Diseases, LLC , No. N17C-07-068 PRW-CCLD. The Company asserted breach of contract and declaratory judgment claims against Savant arising under the MDC Agreement. See Note 11 - “Savant Arrangements” for more information about the MDC Agreement. The Company alleges that Savant has breached its MDC Agreement obligations to pay cost overages that exceed a budgetary threshold as well as other related MDC Agreement representations and obligations. In the litigation, the Company has alleged that as of June 30, 2017, Savant was responsible for aggregate cost overages of approximately $3.4 million, net of a $0.5 million deductible under the MDC. The Company asserts that it is entitled to offset $2.0 million in milestone payments due Savant against the cost overages, such that as of June 30, 2017 Savant owed the Company approximately $1.4 million.

 

On July 12, 2017, Savant removed the case to the Bankruptcy Court, claiming that the action is related to or arises under the Bankruptcy Case from which we emerged in July 2016. On July 27, 2017, Savant filed an Answer and Counterclaims. Savant’s filing alleges breaches of contracts under the MDC Agreement and the Security Agreement, claiming that the Company breached its obligations to pay the milestone payments and other related representations and obligations.

 

On August 1, 2017, the Company moved to remand the case back to the Delaware Court (the “Motion to Remand”).

 

On August 2, 2017, Savant sent a foreclosure notice to the Company, demanding that it provide the Collateral as defined in the Security Agreement for inspection and possession on August 9, 2017, with a public sale to be held on September 1, 2017. The Company moved for a Temporary Restraining Order (the “TRO”) and Preliminary Injunction in the Bankruptcy Court on August 4, 2017. Savant responded on August 7, 2017. On August 7, 2017, the Bankruptcy Court granted the Company’s motion for a TRO, entering an order prohibiting Savant from collecting on or selling the Collateral, entering our premises, issuing any default notices to us, or attempting to exercise any other remedies under the MDC Agreement or the Security Agreement. The parties have stipulated to continue the provisions of the TRO in full force and effect until further order of the appropriate court.

 

On January 22, 2018, Savant wrote to the Bankruptcy Court requesting dissolution of the TRO. On January 29, 2018, the Bankruptcy Court granted the Motion to Remand and denied Savant’s request to dissolve the TRO, ordering that any request to dissolve the TRO be made to the Delaware Court.

 

On February 13, 2018 Savant made a letter request to the Delaware Superior Court to dissolve the TRO. Also on February 13, 2018, the Company filed its Answer and Affirmative defenses to Savant’s Counterclaims. On February 15, 2018 the Company filed a letter opposition to Savant’s request to dissolve the TRO and requesting a status conference. A hearing on Savant’s request to dissolve the TRO was held before the Delaware Superior Court on March 19, 2018. The Delaware Superior Court denied Savant’s request to dissolve the TRO and the TRO remains in effect.

 

On April 11, 2018, the Company advised the Delaware Superior Court that it would meet and confer with Savant regarding a proposed case management order and date for trial. On April 26, 2018 the Delaware Superior Court so-ordered a proposed case management order submitted by the Company and Savant. The schedule in the case management order was modified by stipulation on August 24, 2018.

 

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On April 8, 2019, the Company moved to compel Savant to produce documents in response to the Company’s document requests.  The parties thereafter agreed to a discovery schedule through June 30, 2019, which the Superior Court so-ordered, and the parties produced documents to each other. 

 

On June 4, 2019, Savant filed a complaint against the Company and Madison Joint Venture LLC (“Madison”) in the Delaware Court of Chancery (the “Chancery Action”) seeking to “recover as damages that amounts owed to it under the MDC Agreement, and to reclaim Savant’s intellectual property,” among other things.  Savant also requested leave to move to dismiss the Company’s complaint on the grounds that the Company’s transfer of assets to Madison was champertous.  On June 10, 2019, the Company requested by letter that the Superior Court hold a contempt hearing because the Chancery Action violated the TRO entered by the Bankruptcy Court, the terms of which have been extended by stipulation of the parties.  On June 18, 2019, the Superior Court held a telephonic status conference.  The parties agreed that the Chancery Action should be consolidated with the Superior Court action, after which the Superior Court would address the parties’ motions. 

 

On July 22, 2019, the Company moved for contempt against Savant.  Savant filed its opposition on July 29, 2019. 

 

On July 23, 2019, Savant moved for summary judgment on the issue of champerty.  The Company’s response is due August 27, 2019.

 

On July 25, 2019, Savant moved for a preliminary injunction hearing. The Company filed its response on August 1, 2019.

 

On July 26, 2019, the Company moved to modify the previously agreed-upon discovery schedule to extend discovery through December 31, 2019.

 

On July 30, 2019, the Company filed a motion to dismiss Savant’s Chancery Court complaint. The Company’s opening brief is due on September 6, 2019.

 

On August 12, 2019, the Superior Court denied the Company’s motion for contempt.

 

Savant’s motion for summary judgment and the Company’s motion to dismiss will be heard on October 7, 2019, after which the parties will meet and confer and agree on a joint scheduling order going forward.

 

13. Subsequent Events

 

On July 19, 2019 the Company entered into an exclusive worldwide license agreement (the “Zurich Agreement”) with the University of Zurich (“UZH”) for technology used to prevent Graft versus Host Disease (“GvHD”) through GM-CSF neutralization. The Zurich Agreement covers various patent applications filed by UZH which complement and broaden the Company’s position in the application of GM-CSF and expands the Company’s development platform to include improving allogeneic Hematopoietic Stem Cell Transplantation (“HSCT”).

 

Pursuant to the Zurich Agreement, the Company paid $100,000 to UZH in July 2019. The Zurich Agreement also requires the payment of milestones and royalties upon the achievement of certain regulatory and commercialization milestones.

 

 

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

 

You should read the following discussion and analysis together with our financial statements and the notes to those statements included elsewhere in this Quarterly Report on Form 10-Q and our 2018 Form 10-K for the fiscal year ended December 31, 2018. This Quarterly Report on Form 10-Q contains statements that discuss future events or expectations, projections of results of operations or financial condition, trends in our business, business prospects and strategies and other “forward-looking” information. In some cases, you can identify “forward-looking statements” by words like “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “intends,” “potential” or “continue” or the negative of those words and other comparable words. These statements may relate to, among other things, our expectations regarding the scope, progress, expansion, and costs of researching, developing and commercializing our product candidates; our opportunity to benefit from various regulatory incentives; expectations for our financial results, revenue, operating expenses and other financial measures in future periods; and the adequacy of our sources of liquidity to satisfy our working capital needs, capital expenditures, and other liquidity requirements. Actual events or results may differ materially due to known and unknown risks, uncertainties and other factors such as:

 

· our lack of revenues, history of operating losses, bankruptcy, limited cash reserves and ability to obtain additional capital to develop and commercialize our product candidates, including the additional capital which will be necessary to pursue the Kite collaboration and undertake the clinical trials that we plan to initiate, and continue as a going concern;

 

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· our ability to execute our strategy and business plan focused on developing our proprietary monoclonal antibody portfolio;

· our ability to preserve our stock quotation on the OTCQB Venture Market or, in the future, to list our common stock on a national securities exchange, whether through a new listing or by completing a reverse merger or other strategic transaction;
· our ability to successfully pursue the Kite collaboration;
· the success, progress, timing and costs of our efforts to evaluate or consummate various strategic alternatives if in the best interests of our stockholders;
· the timing of the initiation, enrollment and completion of planned clinical trials;

· our ability to timely source adequate supply of our development products from third-party manufacturers on which we depend;

· the potential, if any, for future development of any of our present or future products;

· increasing levels of market acceptance of CAR-T therapies and the development of a market for lenzilumab;

· our ability to successfully progress, partner or complete further development of our programs;

· our plans to research, develop and commercialize our product candidates;

· our ability to identify and develop additional uses for our products;

· our ability to attain market exclusivity and/or to protect our intellectual property and to operate our business without infringing on the intellectual property rights of others;

· our ability to attract and retain collaborators with development, regulatory and commercialization expertise;

· the outcome of pending or future litigation;

· the ability of our controlling stockholder to influence control over all matters put to a vote of our stockholders, including elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction;

· our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions,

· limitations, and/or warnings in the label of an approved product candidate;

· the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; and

· changes in the regulatory landscape that may prevent us from pursuing or realizing any of the expected benefits from the various regulatory incentives, or the imposition of regulations that affect our products.

   

These are only some of the factors that may affect the forward-looking statements contained in this Form 10-Q. For a discussion identifying additional important factors that could cause actual results to vary materially from those anticipated in the forward-looking statements, see “Risk Factors” in Item 1A of Part I of our 2018 Form 10-K. You should review these risk factors for a more complete understanding of the risks associated with an investment in our securities. However, we operate in a competitive and rapidly changing environment and new risks and uncertainties emerge, are identified or become apparent from time to time. It is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Form 10-Q. You should be aware that the forward-looking statements contained in this Form 10-Q are based on our current views and assumptions. We undertake no obligation to revise or update any forward-looking statements made in this Form 10-Q to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.

 

Overview

 

We were incorporated on March 15, 2000 in California and reincorporated as a Delaware corporation in September 2001 under the name KaloBios Pharmaceuticals, Inc. Effective August 7, 2017, we changed our legal name to Humanigen, Inc..

 

During February 2018, we completed the financial restructuring transactions announced in December 2017 and furthered our transformation into a biopharmaceutical company pursuing cutting-edge science to develop our proprietary monoclonal antibodies for various oncology indications and to enhance T-cell engaging therapies, potentially making these treatments safer, more effective and more efficiently administered.

 

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Our primary focus is on improving the efficacy and safety of approved and development stage chimeric antigen receptor T-cell therapy, also known as CAR-T, through the prophylactic administration of our proprietary Humaneered ® monoclonal antibody, lenzilumab, our lead product candidate. The prophylactic administration of lenzilumab in combination with CAR-T is in development to prevent the serious and potentially life-threatening side-effects associated with CAR-T, while simultaneously making those therapies more effective, efficient and cost-effective. Identifying, treating and managing severe side-effects of CAR-T consumes significant hospital resources and additional costs that we believe have impeded the pace of adoption of these promising and highly effective treatments as the standard of care for certain hematologic cancers. These side-effects may also hamper the use of CAR-T in earlier stage treatment of hematologic cancers and the utility of CAR-T in the treatment of solid tumors, both of which represent significant growth drivers for the overall CAR-T marketplace.

 

There are currently no FDA approved therapies available for the prevention of the serious side effects associated with CAR-T therapies. Pre-clinical data generated in partnership with the Mayo Clinic indicates that the use of lenzilumab may prevent or significantly minimize the onset of both CAR-T induced neurologic toxicities (NT) and cytokine release syndrome (CRS) while also enhancing the proliferation and effector functions of the CAR-T itself, thus simultaneously improving efficacy and potentially reducing relapse rates, a key issue with current CAR-T therapy where approximately half the patients who initially respond have relapsed within a year of therapy. We continue to advance the development of lenzilumab through clinical trials that we expect will serve as the basis for registration in close collaboration with some of the leading and most experienced investigators in the CAR-T field. We are also exploring additional partnerships with established CAR-T companies as a potential means of accelerating the development and commercialization of lenzilumab in conjunction with their existing CAR-T offerings. We aim to position lenzilumab as an essential companion product to CAR-T and a necessary part of the standard pre-conditioning drug regimen that all patients treated with CAR-T currently receive.

 

Lenzilumab is a recombinant monoclonal antibody (mAb) that neutralizes soluble granulocyte-macrophage colony-stimulating factor (GM-CSF) a critical cytokine which is elevated early in the inflammatory cascade and where peak levels are associated with serious and potentially life-threatening CAR-T-related side effects. GM-CSF is also implicated in the growth of certain hematologic malignancies, such as chronic myelomonocytic leukemia (CMML) and juvenile myelomonocytic lymphoproliferative disease (HLH), macrophage activation syndrome (MAS), certain solid tumors and other serious conditions, particularly a range of auto-immune conditions.

 

There is extensive published evidence from multiple academic and expert clinical centers linking early elevation of GM-CSF to serious and potentially life-threatening side-effects in CAR-T. Following CAR-T administration GM-CSF initiates a signaling cascade of inflammation that results in the trafficking and recruitment of myeloid cells to the tumor site. These myeloid cells then produce key downstream cytokines known to be associated with development of NT and CRS, further perpetuating the inflammatory cascade.

 

Peer-reviewed publications in leading journals by well-recognized experts have shown that GM-CSF is a biomarker elevated in patients who suffer severe NT as a side-effect of CAR-T. Pre-clinical studies have demonstrated lenzilumab’s effectiveness in preventing CRS and significantly reducing NT associated with CAR-T. The data from these studies also shows an increase in CAR-T cell expansion when lenzilumab is administered prophylactically in combination with CAR-T.

 

On May 30, 2019, we entered into the Collaboration Agreement with Kite pursuant to which the parties agreed to conduct a multi-center Phase 1b/2 study of lenzilumab with Kite’s Yescarta ® (axicabtagene ciloleucel) in patients with relapsed or refractory diffuse large B-cell lymphoma. The primary objective of the study is to determine the effect of lenzilumab on the safety of Yescarta. Various other important parameters, including efficacy and healthcare resource utilization will also be measured. Kite will act as the sponsor of the study and will be responsible for its conduct. 

 

On June 19, 2019 we entered into an exclusive worldwide license agreement (the “Mayo Agreement”) with the Mayo Foundation for Medical Education and Research (“Mayo”) for certain technologies used to create CAR-T cells lacking GM-CSF expression through various gene-editing tools including CRISPR-Cas9 (GM-CSF knock-out). The license covers various patent applications and know-how developed by Mayo in collaboration with us. These licensed technologies complement and broaden our position in the GM-CSF neutralization space and expand our discovery platform aimed at improving CAR-T to include gene-edited CAR-T cells.

 

On July 19, 2019 we entered into an exclusive worldwide license agreement (the “Zurich Agreement”) with the University of Zurich (“UZH”) for technology used to prevent Graft versus Host Disease (“GvHD”) through GM-CSF neutralization. The Zurich Agreement covers various patent applications filed by UZH which complement and broaden our position in the application of GM-CSF and expands our development platform to include improving allogeneic Hematopoietic Stem Cell Transplantation (“HSCT”).

 

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Ifabotuzumab is an anti-Eph Type-A receptor 3 (EphA3) mAb that has the potential for treating solid tumors, hematologic malignancies and serious pulmonary conditions. Anti-EphA3 as a CAR-T construct, which utilizes certain sequences of ifabotuzumab to generate a specific type of CAR-T, may also be useful in the treatment of a range of cancers. We are collaborating with an expert CAR-T center to make a series of CAR constructs based on ifabotuzumab, of which initial constructs have been created, and plan to move to clinical testing with these constructs for a range of cancer types. EphA3 is a tumor specific antigen expressed on the surface of a multitude of solid bulk tumor cells, tumor stroma cells and tumor vasculature in certain cancers. We have completed the Phase I dose escalation portion of a Phase I/II clinical trial in ifabotuzumab in multiple hematologic malignancies for which the preliminary results were published in the journal Leukemia Research in 2016. A Phase I radio-labeled imaging trial of ifabotuzumab in recurrent glioblastoma multiforme, a particularly aggressive and deadly form of brain cancer, is enrolling at two centers in Australia, the Olivia-Newton John Cancer Research Institute (ONJCRI) in Melbourne and the Queensland Institute for Medical Research in Brisbane. The lead investigators at the ONJCI, are also evaluating an ADC comprising ifabotuzumab.  The current trial has enrolled eight patients to date, and is expected to complete enrollment with a total of twelve patients by year end and to report on the initial findings soon thereafter. We continue to explore partnering opportunities to facilitate the development of ifabotuzumab in a ranges of cancer types.

 

HGEN005 is a pre-clinical stage anti-human epidermal growth factor-like module containing mucin-like hormone receptor 1 (EMR1) mAb. EMR1 is a therapeutic target for eosinophilic disorders. Eosinophils are a type of white blood cell. If too many are produced in the body, chronic inflammation and tissue and organ damage may result. Analysis of blood and bone marrow shows that surface expression of EMR1 is restricted to mature eosinophils and correlated with eosinophilia. Tissue eosinophils also express EMR1. In pre-clinical work, we have demonstrated that eosinophil killing is enhanced in the presence of HGEN005 and immune effector cells. A major limitation of current eosinophil targeted therapies is incomplete depletion of tissue eosinophils and/or lack of cell selectivity, which may mean that HGEN005 could offer promise in a range of eosinophil-driven diseases, such as eosinophilic asthma, eosinophilic esophagitis and eosinophilic granulomatosis with polyangiitis. We are considering developing a series of CAR constructs based on HGEN005 and may take or partner these constructs, if developed, into pre-clinical testing. Importantly, and in contrast to other agents, HGEN005 appears to have an effect solely on eosinophils without impacting other populations, such as mast cells.

 

Lenzilumab, ifabotuzumab and HGEN005 were each developed with our proprietary, patent-protected Humaneered technology, which consists of methods for converting antibodies (typically murine) into engineered, high-affinity antibodies designed for human therapeutic use, with a focus on oncology and other serious chronic conditions.

 

We have incurred significant losses and had an accumulated deficit of $280.5 million as of June 30, 2019. We expect to continue to incur net losses for the foreseeable future as we develop our drug candidates, expand clinical trials for our drug candidates currently in clinical development, expand our development activities and seek regulatory approvals. Significant capital is required to continue to develop and to launch a product and many expenses are incurred before revenue is received, if any. We are unable to predict the extent of any future losses or when we will receive revenue or become profitable, if at all.

 

We will require substantial additional capital to continue as a going concern and to support our business efforts, including obtaining regulatory approvals for our product candidates, clinical trials and other studies, and, if approved, the commercialization of our product candidates. We anticipate that we will seek additional financing from a number of sources, including, but not limited to, the sale of equity or debt securities, strategic collaborations, and licensing of our product candidates. Additional funding may not be available to us on a timely basis or at acceptable terms, if at all. Our ability to access capital when needed is not assured and, if not achieved on a timely basis, would materially harm our business, financial condition and results of operations. If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our development programs. We may also be required to sell or license to others our technologies, product candidates, or development programs that we would have preferred to develop and commercialize ourselves and on less than favorable terms, if at all. If in the best interests of our stockholders, we may also find it appropriate to enter into a strategic transaction that could result in, among other things, a sale, merger, consolidation or business combination.

 

If management is unsuccessful in efforts to raise additional capital, based on our current levels of operating expenses, our current capital is not expected to be sufficient to fund our operations for the next twelve months. These conditions raise substantial doubt about our ability to continue as a going concern.

 

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The condensed consolidated financial statements for the three and six months ended June 30, 2019 were prepared on the basis of a going concern, which contemplates that we will be able to realize our assets and discharge liabilities in the normal course of business. Our ability to meet our liabilities and to continue as a going concern is dependent upon the availability of future funding. The financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.

 

Critical Accounting Policies and Use of Estimates

 

Our management’s discussion and analysis of our financial condition and results of operations is based on our Condensed Consolidated Financial Statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of our financial statements in conformity with GAAP requires our management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. Our management believes judgment is involved in determining revenue recognition, valuation of financing derivative, the fair value-based measurement of stock-based compensation, accruals and warrant valuations. Our management evaluates estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the Condensed Consolidated Financial Statements. If our assumptions change, we may need to revise our estimates, or take other corrective actions, either of which may also have a material adverse effect on our statements of operations, liquidity and financial condition.

 

Until December 31, 2018, we qualified as an emerging growth company (“EGC”) under the JOBS Act. Emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We elected to avail ourselves of this exemption from new or revised accounting standards and, therefore, we may not be subject to the same new or revised accounting standards as other smaller reporting companies that are not emerging growth companies.

 

We ceased to be considered as an EGC as of December 31, 2018. Accordingly, we are required to adopt new accounting standards on the same timeline as other smaller companies.

 

There were no significant and material changes in our critical accounting policies and use of estimates during the three months ended March 31, 2019, as compared to those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Use of Estimates” in our 2018 Form 10-K, filed with the SEC on March 26, 2019.

 

Results of Operations

 

General

 

We have not generated net income from operations for any periods presented. At June 30, 2019, we had an accumulated deficit of $280.5 million primarily as a result of research and development and general and administrative expenses. While we may in the future generate revenue from a variety of sources, including license fees, milestone payments, and research and development payments in connection with strategic partnerships, our product candidates may never be successfully developed or commercialized and we may therefore never realize revenue from any product sales, particularly because most of our product candidates are at an early stage of development. Accordingly, we expect to continue to incur substantial losses from operations for the foreseeable future, and there can be no assurance that we will ever generate significant revenue or profits.

 

Research and Development Expenses

 

Conducting research and development is central to our business model. We expense both internal and external research and development costs as incurred. We track external research and development costs incurred by project for each of our clinical programs. Our external research and development costs consist primarily of:

 

· expenses incurred under agreements with contract research organizations, investigative sites, and consultants that conduct our clinical trials and a substantial portion of our pre-clinical activities;
· the cost of acquiring and manufacturing clinical trial and other materials; and
· other costs associated with development activities, including additional studies.

 

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Other research and development costs consist primarily of internal research and development costs such as salaries and related fringe benefit costs for our employees (such as workers compensation and health insurance premiums), stock-based compensation charges, travel costs, lab supplies, overhead expenses such as rent and utilities, and external costs not allocated to one of our clinical programs. Internal research and development costs generally benefit multiple projects and are not separately tracked per project.

 

The following table shows our total research and development expenses for the three and six months ended June 30, 2019 and 2018:

 

    Three Months Ended June 30,     Six Months Ended June 30,  
(in thousands)   2019     2018     2019     2018  
External Costs                                
   Lenzilumab   $ 1,068     $ 476     $ 1,279     $ 937  
   Ifabotuzumab     29       25       54       50  
Internal costs     137       76       260       286  
Total research and development   $ 1,234       577     $ 1,593     $ 1,273  

 

General and Administrative Expenses

 

General and administrative expenses consist principally of personnel-related costs, professional fees for legal, consulting, audit and tax services, rent and other general operating expenses not otherwise included in research and development.

 

Comparison of Three Months Ended June 30, 2019 and 2018

 

  Three Months Ended June 30,   Increase/ (Decrease)  
(in thousands)   2019     2018     Amount     %  
Operating expenses:                                
Research and development   $ 1,234     $ 577     $ 657       114  
General and administrative     1,746       2,032       (286 )     (14 )
Loss from operations     (2,980 )     (2,609 )     371       14  
Interest expense     (358 )     (32 )     326       1,019  
Other expense, net     -       2       2       100  
Reorganization items, net     -       (29 )     (29 )     (100 )
Net loss   $ (3,338 )   $ (2,668 )   $ 670       25  

   

Research and development expenses increased by $0.6 million, from $0.6 million for the three months ended June 30, 2018 to $1.2 million for the three months ended June 30, 2019. The increase is primarily due to higher spending on the development of lenzilumab.

 

General and administrative expenses decreased $0.3 million from $2.0 million for the three months ended June 30, 2018 to $1.7 million for the three months ended June 30, 2019. The decrease is primarily due to lower compensation expense, including stock-based compensation costs, lower facility lease costs and lower professional fees.

 

Interest expense increased $0.3 million from $0.0 million recognized for the three months ended June 30, 2018 to $0.3 million for the three months ended June 30, 2019. Interest expense for the three months ended June 30, 2019 primarily consisted of interest related to the Advance Notes, entered into in June, July and August 2018, the 2018 Notes, entered into in September 2018, the 2019 Notes entered into in April 2019 and the Notes payable to vendors related to our 2016 bankruptcy filing. Interest expense for the three months ended June 30, 2018 primarily consisted of interest on the Term Loans, which converted to common stock in February 2018 related to the Restructuring Transactions and the Notes payable to vendors related to our 2016 bankruptcy filing.

 

There were no reorganization costs incurred for the three months ended June 30, 2019. The bankruptcy was closed in September 2018 and, as a result, there were minimal costs for the three months ended June 30, 2018.

 

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Comparison of Six Months Ended June 30, 2019 and 2018

 

    Six Months Ended June 30,     Increase/ (Decrease)  
(in thousands)   2019     2018     Amount     %  
Operating expenses:                                
Research and development   $ 1,593     $ 1,273     $ 320       25  
General and administrative     3,625       5,989       (2,364 )     (39 )
Loss from operations     (5,218 )     (7,262 )     (2,044 )     (28 )
Interest expense     (660 )     (426 )     234       55  
Other expense, net     (1 )     (1 )     -       100  
Reorganization items, net     -       (66 )   $ (66 )     (100 )
Net loss   $ (5,879 )   $ (7,755 )   $ (1,876 )     (24 )

   

Research and development expenses increased by $0.3 million, from $1.3 million for the six months ended June 30, 2018 to $1.6 million for the six months ended June 30, 2019. The increase is primarily due to higher spending on the development of lenzilumab.

 

General and administrative expenses decreased $2.4 million from $6.0 million for the six months ended June 30, 2018 to $3.6 million for the six months ended June 30, 2019. The decrease is primarily due to a $1.9 million decrease in stock-based compensation expense related to the issuance of options to management, consultants and board members subsequent to the completion of the Restructuring Transactions in 2018, with no similar issuances in 2019, and a decrease of $0.4 million in professional fees.

 

 

Reorganization items, net, decreased $0.1 million for the six months ended June 30, 2019 versus the six months ended June 30, 2018. The decrease is related to the absence of reorganization expenses in the current six-month period.

 

Interest expense increased $0.2 million from $0.4 million recognized for the six months ended June 30, 2018 to $0.6 million for the six months ended June 30, 2019. Interest expense for the six months ended June 30, 2019 primarily consisted of interest related to the Advance Notes, entered into in June, July and August 2018, the 2018 Notes, entered into in September 2018, the 2019 Notes entered into in April 2019 and the Notes payable to vendors related to our 2016 bankruptcy filing. Interest expense for the six months ended June 30, 2018 primarily consisted of interest on the Term Loans, which converted to common stock in February 2018 related to the Restructuring Transactions and the Notes payable to vendors related to our 2016 bankruptcy filing.

 

Liquidity and Capital Resources

 

Since our inception, we have financed our operations primarily through proceeds from the public offerings of our common stock, private placements of our preferred stock, debt financings, interest income earned on cash, and cash equivalents, and marketable securities, and borrowings against lines of credit. At June 30, 2019, we had cash and cash equivalents of $1.1 million. As of August 12, 2019, we had cash and cash equivalents of approximately $500 thousand.

 

The following table sets forth the primary sources and uses of cash and cash equivalents for each of the periods presented below:

 

    Six Months Ended June 30,  
(In thousands)   2019     2018  
Net cash (used in) provided by:                
   Operating activities   $ (2,273 )   $ (3,731 )
   Financing activities     2,550       3,231  
Net increase (decrease) in cash and cash equivalents   $ 277     $ (500 )

 

Net cash used in operating activities was $2.3 million and $3.7 million for the six months ended June 30, 2019 and 2018, respectively. Cash used in operating activities of $2.3 million for the six months ended June 30, 2019 primarily related to our net loss of $5.9 million, adjusted for non-cash items, such as $1.4 million in stock-based compensation, $0.7 million in noncash interest expense, and net increases in working capital items of $1.4 million.

 

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 Cash used in operating activities of $3.7 million for the six months ended June 30, 2018 primarily related to our net loss of $7.8 million, adjusted for non-cash items, such as $3.5 million in stock-based compensation, $0.4 million in noncash interest expense, and net increases in working capital items of $0.1 million.

 

Net cash provided by financing activities was $2.6 million for the six months ended June 30, 2019 and was related to the issuance of debt and the exercise of stock options during the period. Net cash provided by financing activities was $3.2 million for the six months ended June 30, 2018. This amount consists primarily of $1.5 million received from Cheval related to the Restructuring Transactions (see “Restructuring Transactions” below), $1.1 million from the issuance of 2,445,557 shares of our common stock to accredited investors on March 12, 2018, $0.2 million received from the issuance of 400,000 shares of our common stock to an accredited investor on June 4, 2018 and $0.4 million received from the issuance of the Advance Notes on June 29, 2018.

 

On July 1, 2019, we received proceeds from one of the 2019 Bridge Notes in the amount of $750,000 which had not been received as of June 30, 2019. See Note 7 in the Notes to the Condensed Consolidated Financial Statements.

 

Restructuring Transactions

 

On February 27, 2018, we completed a comprehensive restructuring of our outstanding indebtedness of approximately $18.4 million under a series of term loans (the “Term Loans”) with two lender groups, including affiliates of Black Horse Capital, L.P. and raised incremental new capital from Cheval Holdings, Ltd.. At the closing of the restructuring, we: (i) in exchange for the satisfaction and extinguishment of the entire balance of the Term Loans, (a) issued an aggregate of 59,786,848 shares of Common Stock (the “New Lender Shares”), and (b) transferred and assigned to a joint venture controlled by one of the term loan lenders, all of our assets related to benznidazole (the “Benz Assets”), our former drug candidate; and (ii) issued to Cheval an aggregate of 32,028,669 shares of Common Stock for total consideration of $3.0 million.

 

In connection with the transfer of the Benz Assets to the joint venture, the joint venture partner paid certain amounts we incurred after December 21, 2017 and prior to February 27, 2018 in investigating certain causes of action and claims related to or in connection with the Benz Assets. In addition, upon exercise of its rights under the terms of the joint venture, the joint venture partner assumed certain legal fees and expenses owed us to our litigation counsel totaling $0.3 million.

 

Upon completion of the Restructuring Transactions, the Black Horse Entities collectively held 66,870,851 shares of our common stock, or approximately 62.6% of our outstanding common stock. Accordingly, the completion of the Restructuring Transactions resulted in a change in control of our company, as the Black Horse Entities and their affiliates owning more than a majority of our outstanding common stock. Dr. Dale Chappell, a member of our board of directors from June 30, 2016 until November 10, 2017, controls the Black Horse Entities and accordingly, will be able to exert control over matters of our company and will be able to determine all matters of our company requiring stockholder approval.

 

We will require substantial additional capital to continue as a going concern and to support our business efforts, including obtaining regulatory approvals for our product candidates, clinical trials and other studies, and, if approved, the commercialization of our product candidates. The amount of capital we will require and the timing of our need for additional capital will depend on many factors, including:

 

· the progress and timing of the Study we are pursuing with Kite, and related costs we are required to incur;

· the type, number, timing, progress, costs, and results of the other product candidate development programs that we are pursuing or may choose to pursue in the future;

· the scope, progress, expansion, costs, and results of our other pre-clinical and clinical trials;

· the timing of and costs involved in obtaining regulatory approvals;

· the success, progress, timing and costs of our efforts to evaluate or consummate various strategic alternatives if in the best interests of our stockholders;

· our ability to preserve our stock quotation on the OTCQB Venture Market or, in the future, to list our common stock on a national securities exchange, whether through a new listing or by completing a strategic transaction;

· our ability to establish and maintain development partnering arrangements and any associated funding;

· the emergence of competing products or technologies and other adverse market developments;

· the costs of maintaining, expanding, and protecting our intellectual property portfolio, including potential litigation costs and liabilities;

· the resources we devote to marketing, and, if approved, commercializing our product candidates;

 

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· the scope, progress, expansion and costs of manufacturing our product candidates; and

· the costs associated with being a public company.

 

We are pursuing efforts to raise additional capital from a number of sources, including, but not limited to, the sale of equity or debt securities and strategic collaborations. Additional funding may not be available to us on a timely basis or at acceptable terms, if at all. Our ability to access capital when needed is not assured and, if not achieved on a timely basis, would materially harm our business, financial condition and results of operations. Any financing we may obtain may be dilutive to existing stockholders. If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our development programs. We may also be required to sell or license to others our technologies, product candidates, or development programs that we would have preferred to develop and commercialize ourselves and on less than favorable terms, if at all. If in the best interests of our stockholders, we may also find it appropriate to enter into a strategic transaction that could result in, among other things, a sale, merger, consolidation or business combination.

 

If management is unsuccessful in efforts to raise additional capital, based on our current levels of operating expenses, our current capital will not be sufficient to fund our operations for the next twelve months. These conditions raise substantial doubt about our ability to continue as a going concern.

 

Our common stock currently trades on the OTCQB Venture Market under the ticker symbol “HGEN”. Although our common stock is listed for quotation on the OTCQB Venture Market, trading is limited and an active market for our common stock may never develop in the future, which could harm our ability to raise capital to continue to fund operations.

 

 

Off-Balance Sheet Arrangements

 

We currently have no off-balance sheet arrangements, such as structured finance, special purpose entities or variable interest entities.

 

Item 4. Controls and Procedures.

 

Management’s Evaluation of our Disclosure Controls and Procedures

 

“Disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

 

Disclosure controls and procedures include, without limitation, those designed to ensure that this information is accumulated and communicated to our management to allow timely decisions regarding required disclosure. Management, including our Chief Executive Officer, who is also acting as our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based upon the evaluation our Chief Executive Officer, who is also acting as our Chief Financial Officer, concluded that the disclosure controls and procedures were not effective as of June 30, 2019 to ensure that information required to be disclosed in the reports we file and submit under the Exchange Act is (i) recorded, processed, summarized and reported as and when required and (ii) accumulated and communicated to our management, including our Chief Executive Officer, who is also acting as our Chief Financial Officer, as appropriate to allow timely discussion regarding required disclosure.

 

Changes in Internal Control Over Financial Reporting

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act). On June 28, 2019, J. Greg Jester, our then Chief Financial Officer, died unexpectedly. Dr. Cameron Durrant, our Chief Executive Officer, is acting, on an interim basis, as the Company’s principal financial and accounting officer. Our Chief Executive Officer assessed the effectiveness of our internal control over financial reporting as of June 30, 2019. In making this assessment, our Chief Executive Officer used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in Internal Control—Integrated Framework . Based on that assessment and using the COSO criteria, our Chief Executive Officer has concluded that, as of June 30, 2019, our internal control over financial reporting was not effective because of the material weaknesses described below.

 

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

 

The ineffectiveness of our internal control over financial reporting at June 30, 2019, was due to an insufficient degree of segregation of duties among our accounting and financial reporting personnel.

 

During 2019, we intend to work to remediate the material weaknesses identified above, which could include the addition of accounting and financial reporting personnel and/or the engagement of accounting and personnel consultants on a limited-time basis until we add a sufficient number of personnel. However, our current financial position could make it difficult for us to add the necessary resources.

 

Inherent Limitations of Controls

 

Management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all error and all fraud. Controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost - benefit relationship of possible controls and procedures. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision - making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with the policies or procedures. Because of the inherent limitations in a cost - effective control system, misstatements due to error or fraud may occur and not be detected. 

 

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PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

Please see Note 12 to the Condensed Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q for a summary of legal proceedings and developments during the quarter ended June 30, 2019.

 

Item 1A. Risk Factors.

 

If we cannot obtain additional financing, we may not be able to pursue our collaboration with Kite or other business issues, or continue as a going concern.

 

As previously disclosed, we do not expect to recognize any revenues while we continue to pursue the development of lenzilumab and our other product candidates. As a result, we require substantial additional capital to support our business efforts, including our collaboration with Kite Pharma, Inc. (a Gilead company). Under our agreement with Kite, the parties have agreed to conduct a multi-center Phase 1/2 study of lenzilumab with Kite’s Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory B-cell lymphoma. The primary objective of the study is to determine the effect of lenzilumab on the safety of Yescarta, as well as to determine potential enhanced efficacy and healthcare resource utilization associated with the combination. We currently project we will be responsible for an aggregate of approximately $8 million in out-of-pocket costs assuming a total of 72 patients are enrolled in the study, of which $2 million will be required to be paid to Kite thirty days prior to the initiation of the study.

 

As of June 30, 2019, our current liabilities of approximately $12.1 million exceeded our current assets of approximately $1.5 million. Our cash position was insufficient for us to satisfy in full at maturity on June 30, 2019 all of the outstanding principal amount and accrued but unpaid interest on unsecured promissory notes we made to certain of our vendors upon our emergence from bankruptcy. We paid approximately $0.5 million to extinguish certain of these notes in July 2019. After giving effect to these payments in July, the aggregate principal amount and accrued but unpaid interest on these notes approximates $1.1 million. The outstanding principal amount and accrued but unpaid interest on these notes is currently payable to the respective holders without demand, notice or declaration, and the holders, without demand or notice of any kind, may exercise any and all other rights and remedies available to them under the notes, the Plan, at law or in equity. We do not have sufficient funds to repay the principal and accrued but unpaid interest on these notes in their entirety notes, as our available cash balance as of the date of this filing was approximately $500 thousand.

 

Accordingly, we are seeking financing from a number of sources, including, but not limited to, the sale of equity or debt securities, strategic collaborations, and licensing of our product candidates, to enable us to pursue the Kite collaboration and our other business initiatives. As disclosed in Note 7 to the accompanying unaudited condensed consolidated financial statements, since 2018, our capital-raising efforts have succeeded in raising a series of short-term bridge loans and convertible debt financings, most recently a short-term bridge financing advanced by our two largest stockholders which collectively control approximately 91% of our outstanding common stock, and our Chairman and Chief Executive Officer, Dr. Cameron Durrant. The bridge loans bear interest at 7% per year; are secured by liens on substantially all of our assets; and mature October 31, 2019 unless earlier repaid or extended. The interest on the bridge loans would increase to 10% per year upon any default of our obligations.

 

Additional funding may not be available to us on a timely basis or at acceptable terms, if at all. Our ability to access capital when needed is not assured and, if not achieved on a timely basis, would materially harm our business, financial condition and results of operations. In addition, the lenders under our bridge financing would be entitled to exercise all available remedies available to them, and we may not be able to continue as a going concern.

 

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Item 6. Exhibits.

 

Exhibit No.   Exhibit Description
2.1   Findings of Fact, Conclusions of Law, and Order Confirming Second Amended Chapter 11 Plan of Reorganization of the Registrant.
3.1   Amended and Restated Certificate of Incorporation of the Registrant.
3.2   Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Registrant.
3.3   Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Registrant, as amended.
3.4   Second Amended and Restated Bylaws of the Registrant.
10.1*   Form of 2019 Convertible Note.
10.2*   Clinical Collaboration Agreement, dated May 30, 2019 between the Registrant and Kite Pharma, Inc.
10.3*   Form of 2019 Bridge Note
31.1**   Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as amended.
31.2**   Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as amended.
32.1**   Certification of Chief Executive Officer pursuant to 18 U.S.C. §1350.
32.2**   Certification of Chief Financial Officer pursuant to 18 U.S.C. §1350.
     
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

____________________

 

* Filed herewith.

 

** The Certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Humanigen, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.

 

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SIGNATURES

 

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

 

    HUMANIGEN, INC.
       
Date: August 12, 2019   By:   /s/ Cameron Durrant
      Cameron Durrant
      Chief Executive Officer
      (Principal Executive Officer)
       
       
Date: August 12, 2019   By:   /s/ Cameron Durrant
      Cameron Durrant
      Acting Chief Financial Officer
      (Principal Financial and Accounting Officer)

 

 

31

 

 

 

 

 

Exhibit 10.1

 

THE SECURITIES REPRESENTED HEREBY (THE “SECURITIES”) HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR ANY STATE SECURITIES LAWS AND MAY NOT BE SOLD, ASSIGNED, TRANSFERRED, PLEDGED, ENCUMBERED, HYPOTHECATED, EXCHANGED OR OTHERWISE DISPOSED OF UNLESS REGISTERED UNDER THE SECURITIES ACT AND UNDER APPLICABLE STATE SECURITIES LAWS OR THE COMPANY SHALL HAVE RECEIVED AN OPINION OF COUNSEL FOR THE HOLDER, REASONABLY SATISFACTORY TO THE COMPANY AND ITS COUNSEL, THAT REGISTRATION OF SUCH SECURITIES UNDER THE SECURITIES ACT AND UNDER THE PROVISIONS OF APPLICABLE STATE SECURITIES LAWS IS NOT REQUIRED.

 

CONVERTIBLE PROMISSORY NOTE

 

$[NUMBER] [DATE]

 

 

For value received, Humanigen, Inc., a Delaware corporation (the “ Company ”), promises to pay to [HOLDER NAME] (the “ Holder ”) the principal sum of $[NUMBER] together with accrued and unpaid interest thereon, each due and payable on the date and in the manner set forth below.

 

This convertible promissory note (this “ Note ”) is issued as part of a series of similar convertible promissory notes (collectively, the “ Notes ”) pursuant to the terms of that certain Convertible Note Purchase Agreement dated as of [DATE] by and among the Company, Holder, and the other purchasers identified therein, as the same may be amended from time to time (the “ Agreement ”). Capitalized terms used but not otherwise defined herein shall have the meanings ascribed to them in the Agreement. This Note is an unsecured obligation of the Company.

 

1.        Repayment. Unless otherwise converted as provided herein, all unpaid principal together with the unpaid and accrued interest payable hereunder shall be due and payable on the date repayment is demanded by the Holder which may be any day on or after the earliest of (i) twenty-four months from the date of this Note (the “ Stated Maturity Date ”), (ii) the occurrence of an Event of Default (as described in Section 7 below), or (iii) the occurrence of a Liquidation Event (the earliest date of which being the “ Maturity Date ”). “ Liquidation Event ” means (i) any event pursuant to which (A) any Person or Persons acting as a group acquires all or substantially all of the assets of the Company by sale, exclusive license or otherwise, or (B) any Person or Persons acting as a group (other than the equity holders of the Company existing as of the date hereof), whether by merger, consolidation or otherwise, shall become the beneficial owner(s) of greater than an aggregate of 50% of the Company’s outstanding voting equity interests (other than in connection with a Qualified Financing (as defined below) or Non-Qualified Financing (as defined below)), or (ii) any dissolution or winding-up of the Company. This Note shall rank pari passu with each of the other Notes such that all Notes shall rank equally and no payment will be made under any Note unless a pro rata payment is simultaneously made under all Notes.

 

2.        Interest Rate. The Company promises to pay simple interest on the outstanding principal amount hereof from the date hereof until payment in full, which interest shall be payable at the rate of 7.5% per annum or the maximum rate permissible by law, whichever is less. Interest shall be due and payable on the Maturity Date and shall be calculated on the basis of a 365-day year for the actual number of days elapsed.

 

     
 

 

3.        Conversion.

 

(a)        Mandatory Conversion Upon Qualified Financing . If the Company issues and sells its Equity Securities (as defined below) to investors (the “ Qualified Financing Investors ”) on or before the Stated Maturity Date in any bona fide financing transaction that results in gross proceeds to the Company of at least $10,000,000 (excluding conversion of this Note and other indebtedness) (a “ Qualified Financing ”) or the Company consummates a reverse merger or similar transaction, then the Company will give the Holder at least ten days’ prior written notice of the anticipated closing date of such Qualified Financing or reverse merger, and the outstanding principal balance and any unpaid and accrued interest on this Note, together with such additional amount of interest as would have been paid on this Note if held to the Stated Maturity Date (the “ Conversion Amount ”), will automatically be converted, upon such closing date (and, in the case of a reverse merger, immediately prior to the consummation of such reverse merger), into either, at the Holder’s option, (x) (A) in the case of a Qualified Financing, such Equity Securities as the Holder would acquire if the Conversion Amount were invested directly in the Qualified Financing on the same terms and conditions (including price) as given to the Qualified Financing Investors or (B) in the case of a reverse merger, shares of Common Stock at the same price per share paid by the buyer in such transaction (which, in a stock for stock deal, shall be based on the price per share used by the parties for purposes of setting the applicable exchange ratio), or (y) Common Stock at a conversion price equal to $1.25 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of this Note), as each Holder shall elect and notify the Company at least five days prior to the anticipated closing date of such Qualified Financing. For purposes of this Note, “ Equity Securities ” shall mean Common Stock or any securities issued by the Company (other than convertible indebtedness) and conferring the right to purchase Common Stock or that are convertible into or exercisable or exchangeable for (with or without additional consideration) Common Stock, whether sold independently or as part of a unit of one or more securities issued by the Company.

 

(b)        Optional Conversion Upon Non-Qualified Financing . In the event that the Company issues and sells shares of its Equity Securities to investors (the “ Non-Qualified Financing Investors ”) on or before the date of the repayment in full of this Note in any bona fide financing transaction that is not a Qualified Financing (a “ Non - Qualified Financing ”), then the Company will give the Holder at least ten days’ prior written notice of the anticipated closing date of such Non-Qualified Financing and the Holder may elect to convert all, but not less than all, of the Conversion Amount of the Notes held by such Holder, upon such closing date, into either (x) such Equity Securities as the Holder would acquire if the Conversion Amount were invested directly in the Non-Qualified Financing on the same terms and conditions (including price) as given to the Non-Qualified Financing Investors, or (y) Common Stock at a conversion price equal to $1.25 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of this Note). In order to exercise the option to convert this Note pursuant to this Section 3(b), the Holder must notify the Company of the Holder’s election to so convert at least five days prior to the anticipated closing date of the Non-Qualified Financing.

 

(c)        Optional Conversion Upon Liquidation Event . In the event that the Company enters into any agreement providing for, or publicly announces the intention to consummate, a Liquidation Event prior to the conversion or repayment in full of this Note, (i) the Company will give the Holder at least ten days’ prior written notice of the anticipated closing date of such Liquidation Event, and (ii) the Holder may elect to convert, upon such closing date (and immediately prior to the consummation of such Liquidiation Event), all, but not less than all, of the Conversion Amount into Common Stock at a conversion price equal to $1.25 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of this Note). In order to exercise the option to convert the Notes pursuant to this Section 3(c), the Holder must notify the Company of the Holder’s election to so convert or require payment at least five days prior to the anticipated closing date of the Liquidation Event.

 

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(d)        Optional Conversion Upon Collaboration Or Expiry Of Holding Period . Commencing on the earlier of (x) such time as the Company publicly announces that it has entered into a definitive arrangement with an unaffiliated third party (a “ Strategic Partner ”) pursuant to which, among other things, such Strategic Partner may agree to collaborate with the Company in conducting a clinical study to assess the efficacy of the Company’s lenzilumab monoclonal antibody in reducing adverse effects from neurotoxicity and cytokine release syndrome when used as a companion therapy in certain CAR-T cell therapies, or (y) the six-month anniversary of the date of this Note, the Holder may elect to convert any portion of the outstanding principal amount of this Note, together with (i) any unpaid and accrued interest on such principal amount to the date the Holder’s notice of the Holder’s intention to convert is received by the Company (the “ Notice Date ”), and (ii) such additional amount of interest as would have been paid on such principal amount from the Notice Date to the Stated Maturity Date, into Common Stock at a conversion price equal to $1.25 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of this Note). In order to exercise the option to convert all or any portion of the principal amount of this Note pursuant to this Section 3(d), the Holder shall notify the Company of the Holder’s election to so convert in accordance with the provisions of Section 9 hereof, and shall specify in such notice the principal amount of this Note to be converted and the date on which such conversion shall be effected.

 

(e)       No fractional shares or units will be issued on conversion of this Note. If the Holder would otherwise be entitled to a fractional share or unit, the Holder shall receive in lieu thereof a cash payment equal to the applicable per share or per unit price of the Equity Securities or Common Stock into which the Conversion Amount is proposed to be converted, as applicable, multiplied by the fraction of the share or unit the Holder would otherwise be entitled to receive. If conversion of this Note occurs pursuant to Section 3(a) or Section 3(b), the Company shall use its commercially reasonable efforts to afford to the Holder the ability to become a party to any agreement pursuant to which an investor in a Qualified Financing or Non-Qualified Financing, as the case may be, may receive registration rights in respect of the Equity Securities issued by the Company in such transaction.

 

4.        Maturity. If this Note has not been previously converted pursuant to Section 3 above, then, effective upon the Stated Maturity Date, the Holder may elect to convert the Conversion Amount of the Notes into Common Stock at a conversion price equal to $1.25 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of this Note). Any election to convert the Notes pursuant to this paragraph must be made in writing and delivered to the Company at least five days prior to the Maturity Date. Unless this Note has been previously converted in accordance with the terms of Section 3 above or pursuant to the preceding sentences of this Section 4, the entire outstanding principal balance and all unpaid accrued interest shall become fully due and payable on the Stated Maturity Date.

 

5.        Expenses. In the event of any default hereunder, the Company shall pay all reasonable attorneys’ fees and court costs incurred by the Holder in enforcing and collecting this Note.

 

6.        Prepayment. The Company may not prepay this Note (including accrued interest), in whole or in part, prior to the Maturity Date without the consent of the Holder.

 

7.        Default. If there shall be any Event of Default (as defined below) hereunder, at the option and upon the declaration of the Holder and upon written notice to the Company (which election and notice shall not be required in the case of an Event of Default under Section 7(c), 7(d) or 7(e)), this Note shall accelerate and all principal and unpaid accrued interest shall become due and payable. The occurrence of any one or more of the following shall constitute an “ Event of Default ”:

 

    3  
 

 

(a)       The Company fails to pay timely any of the principal amount due under this Note on the date the same becomes due and payable or any accrued interest or other amounts due under this Note on the date the same becomes due and payable;

 

(b)       The Company shall default in its performance of any covenant under the Agreement or this Note, and such default is not cured by the Company within 30 days after written notice thereof is given to the Company by the Holder;

 

(c)       The Company files any petition or action for relief under any bankruptcy, reorganization, insolvency or moratorium law or any other law for the relief of, or relating to, debtors, now or hereafter in effect, or makes any assignment for the benefit of creditors or takes any corporate action in furtherance of any of the foregoing;

 

(d)       An involuntary petition is filed against the Company (unless such petition is dismissed or discharged within 60 days) under any bankruptcy statute now or hereafter in effect, or a custodian, receiver, trustee, assignee for the benefit of creditors (or other similar official) is appointed to take possession, custody or control of any property of the Company;

 

(e)       A liquidation, termination of existence or dissolution of the Company; or

 

(f)       Any representation, warranty or statement of fact made by the Company in the Agreement, or any other agreement, schedule, confirmatory assignment or otherwise in connection with the transactions contemplated hereby or thereby, shall when made or deemed made be false or misleading in any material respect; provided, however, that such failure shall not result in an Event of Default to the extent it is corrected by the Company within a period of 30 days after the Company’s receipt of written notice from the Holder specifying such failure.

 

8.        Waiver. The Company hereby waives demand, notice, presentment, protest and notice of dishonor.

 

9.        Notices. All notices, requests, demands, consents, instructions or other communications required or permitted hereunder shall be in writing and faxed, emailed, mailed or delivered to each party as follows: (i) if to the Holder, at the Holder’s address, email address or facsimile number set forth in the Agreement, or at such other address, email address or facsimile number as the Holder shall have furnished the Company in writing, or (ii) if to the Company, at the Company’s address, email address or facsimile number set forth on the signature page to the Agreement, or at such other address, email address or facsimile number as the Company shall have furnished to the Holder in writing. All such notices and communications will be deemed effectively given the earliest of (a) when received, (b) when delivered personally, (c) one business day after being delivered by facsimile or email (with receipt of appropriate confirmation), (d) one business day after being deposited with an overnight courier service of recognized standing or (e) three days after being deposited in the U.S. mail, first class with postage prepaid.

 

10.        Governing Law. This Note shall be governed by and construed under the internal laws of the State of New York, without giving effect to conflicts of laws principles.

 

11.        Modification; Waiver. Any term of this Note may be amended or waived with the written consent of the Company and the Holder. In the event that the Company amends or otherwise modifies any other of the Notes, the Company shall give notice thereof to the Holder and, upon request by the Holder, this Note shall be similarly amended or modified.

 

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12.        Powers and Remedies Cumulative; Delay or Omission Not Waiver of Default . No right or remedy herein conferred upon or reserved to the Holder is intended to be exclusive of any other right or remedy, and every right and remedy shall, to the extent permitted by law, be cumulative and in addition to every other right and remedy given hereunder or now or hereafter existing at law or in equity or otherwise. The assertion or employment of any right or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any other appropriate right or remedy. No delay or omission of the Holder to exercise any right or power accruing upon any Event of Default occurring and continuing as aforesaid shall impair any such right or power or shall be construed to be a waiver of any such Event of Default or an acquiescence therein; and every power and remedy given by this Note or by law may be exercised from time to time, and as often as shall be deemed expedient, by the Holder.

 

13.        Transfer Rights. The Holder may not transfer this Note to a third party without the prior written consent of the Company, not to be unreasonably withheld, conditioned or delayed; provided, however, that the Holder shall have the right to transfer and assign this Note without any consent of the Company to a Permitted Transferee (as defined below). Each new Note issued upon any transfer of this Note shall bear a legend as to the applicable restrictions on transferability to ensure compliance with the Act, unless in the opinion of counsel for the Company such legend is not required in order to ensure compliance with the Act. The Company may issue stop transfer instructions to its Transfer Agent, if any, in connection with such restrictions. Subject to the foregoing, transfers of this Note shall be registered upon registration books maintained for such purpose by or on behalf of the Company. Prior to presentation of this Note for registration of transfer, the Company shall treat the registered holder hereof as the owner and holder of this Note for the purpose of receiving all payments of principal and interest hereon and for all other purposes whatsoever, whether or not this Note shall be overdue and the Company shall not be affected by notice to the contrary. “ Permitted Transferee ” means, as to any Holder, any of the following: (i) if a natural person, his/her ancestors, descendants, siblings, or spouse, any executor or administrator of his/her estate, or to a custodian, trustee (including a trustee of a voting trust), executor, or other fiduciary primarily for the account of such Holder or his/her ancestors, descendants, siblings, or spouse, whether step, in-law or adopted, and, in the case of any such trust or fiduciary, to the Holder who transferred this Note to such trust or fiduciary, but only with respect to transfers made for bona fide estate planning purposes, either during his or her lifetime or on death by will or intestacy; (ii) with respect to any Holder which is an entity, (A) the then-existing members, shareholders or other investors in the Holder in connection with the dissolution or winding-up of the Holder, or (B) any Person in connection with any consolidation or reorganization of the Holder directly or indirectly with or into one or more other investment vehicles; (iii) any affiliate of the Holder (other than any investment portfolio company of the Holder that is an affiliate) which controls, is controlled by or is under common control with the Holder; or (iv) any fund or entity managed or advised by Soundview Capital Partners LP or any affiliate thereof.

 

14.        Most Favored Nation Amendment Provisions . Prior to the conversion or payment in full of the Note, if the Company issues any indebtedness which is convertible into the Company’s Equity Securities (“ Subsequent Convertible Securities ”), the Company will promptly provide Holder with written notice thereof, together with a copy of all documentation relating to such Subsequent Convertible Securities and, upon written request of Holder, any additional information related to such Subsequent Convertible Securities as may be reasonably requested by Holder. Within 30 days after the Holder’s receipt of such information, if the Holder determines that the terms of the Subsequent Convertible Securities are preferable to the terms of the Note, Holder will notify the Company in writing. Promptly after receipt of such written notice from the Holder, the Company agrees to amend and restate the Note to be identical to the instruments evidencing the Subsequent Convertible Securities and any purchase documents related thereto.

 

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15.        Assignment by the Issuer. Neither this Note nor any of the rights, interests or obligations hereunder may be assigned, in whole or in part, by the Company, without the prior written consent of the Holder.

 

16.        Successors and Assigns. Subject to the restrictions on transfer provided herein, the rights and obligations of the Company and the Holder shall be binding upon and benefit the respective successors, assigns, heirs, administrators and transferees of the Company or the Holder, as applicable.

 

ORAL AGREEMENTS OR COMMITMENTS TO LOAN MONEY, EXTEND CREDIT OR TO FORBEAR FROM ENFORCING REPAYMENT OF A DEBT INCLUDING PROMISES TO EXTEND OR RENEW SUCH DEBT ARE NOT ENFORCEABLE. TO PROTECT THE COMPANY AND THE HOLDER FROM MISUNDERSTANDING OR DISAPPOINTMENT, ANY AGREEMENTS WE REACH COVERING SUCH MATTERS ARE CONTAINED IN THIS WRITING, WHICH IS THE COMPLETE AND EXCLUSIVE STATEMENT OF THE AGREEMENT BETWEEN US, EXCEPT AS WE MAY LATER AGREE IN WRITING TO MODIFY IT.

 

[ Remainder of Page Intentionally Left Blank ]

 

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IN WITNESS WHEREOF, the Company has caused this Convertible Promissory Note to be issued as of the date first set forth above.

 

 

COMPANY:

 

HUMANIGEN, INC.

     
     
     
  By: _/s/ Cameron Durrant
   

Name: Dr. Cameron Durrant

Title: Chief Executive Officer 

 

 

 

[Signature Page to Convertible Promissory Note] 

 

 

 

 

Exhibit 10.2

 

 

 

 

 

 

CLINICAL COLLABORATION AGREEMENT

BY AND BETWEEN

HUMANIGEN, INC.

AND

KITE PHARMA, INC.

 

 

 

 

 

     
 

 

Table of Contents

 

Page

 

ARTICLE 1 DEFINITIONS 1
ARTICLE 2 CONDUCT OF THE STUDY; REGULATORY MATTERS 6
2.1 Overview 6
2.2 Sponsor 6
2.3 Collaboration IND; Protocol. 6
2.4 Enrollment 6
2.5 Project Participants 6
2.6 Regulatory Matters. 7
2.7 Adverse Experience Reporting. 7
2.8 Documentation, Updates and Final Study Report. 8
2.9 Costs 8
2.10 Additional Studies. 9
ARTICLE 3 GOVERNANCE 9
3.1 Joint Development Committee. 9
3.2 Data Review Committee. 11
3.3 Data Monitoring Committee 11
ARTICLE 4 SUPPLY OF STUDY DRUGS 11
4.1 Humanigen Investigational Product. 11
4.2 Insufficient Quantities 12
4.3 Quality Agreement 12
4.4 Mutual Obligations. 12
ARTICLE 5 STUDY DATA; SAMPLE ANALYSES AND SAMPLE DATA 13
5.1 Study Data 13
5.2 Samples and Sample Analyses. 13
5.3 Sample Data. 13
ARTICLE 6 INTELLECTUAL PROPERTY 14
6.1 Ownership and Use; Definitions. 14
6.2 Mutual Freedom to Operate . 15
6.3 Patent Prosecution and Maintenance of Collaboration Inventions 16
6.4 Third Party Infringement and Patent Enforcement or Defense. 17
ARTICLE 7 CONFIDENTIALITY 17
7.1 Ownership of Confidential Information. 17
7.2 Disclosure and Use of Confidential Information. 18
7.3 Authorized Disclosures 19

 

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7.4 Termination of Prior Agreement 19
ARTICLE 8 PUBLIC DISCLOSURES; USE OF NAMES 20
8.1 CLINICAL TRIALS REGISTRIES 20
8.2 Publications and Presentations. 20
8.3 Press Releases and Other Public Disclosures. 20
8.4 Use of Names 21
ARTICLE 9 HUMAN SUBJECTS 21
9.1 Informed Consent 21
9.2 IRB Approval 22
9.3 Patient Privacy and Data Protection 22
9.4 Financial Disclosures 22
9.5 Transparency 22
ARTICLE 10 SUBCONTRACTING; RECORDS 22
10.1 Subcontracting 22
10.2 Records. 23
ARTICLE 11 COMPLIANCE WITH LAWS 23
11.1 Compliance with Laws and Policies 23
11.2 Debarment 23
ARTICLE 12 TERM; TERMINATION 23
12.1 Term 23
12.2 Termination for Material Breach 23
12.3 Termination for Other Reasons 24
12.4 Effects of Termination or Expiration. 24
ARTICLE 13 REPRESENTATIONS AND WARRANTIES 24
13.1 Mutual Representations and Warranties 24
13.2 Disclaimers 25
ARTICLE 14 INDEMNIFICATION; LIMITATION ON LIABILITY; INSURANCE 25
14.1 Indemnification. 25
14.2 Limitation on Liability 26
14.3 Insurance. 26
ARTICLE 15 DISPUTE RESOLUTION 27
15.1 Internal Resolution 27
15.2 Dispute Resolution and Jurisdiction 27
ARTICLE 16 MISCELLANEOUS 27

 

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(continued)

 

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16.1 Notices 27
16.2 Assignment. 28
16.3 Force Majeure 28
16.4 Relationship of the Parties 28
16.5 Amendment; Waiver 28
16.6 Construction; Captions 28
16.7 Severability 29
16.8 Entire Agreement 29
16.9 Counterparts; Facsimiles 29

 

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CLINICAL COLLABORATION AGREEMENT

 

 

This Clinical Collaboration Agreement (“ Agreement ”) is made and entered into, effective as of May 30, 2019 (“ Effective Date ”), by and between Humanigen, Inc., a Delaware corporation, having a principal place of business at 533 Airport Boulevard, Suite 400, Burlingame, CA 94010 (“ Humanigen ”) and Kite Pharma, Inc. , a Delaware corporation, having a place of business at 2400 Broadway, Santa Monica, CA 90404 (“ Kite ”). Humanigen and Kite are each referred to herein individually as a “ Party ” and collectively as the “ Parties.

 

Recitals

 

A.        Humanigen is developing the anti-GMCSF antibody Humanigen Investigational Product (defined below) for the prevention of neurotoxicity and cytokine release syndrome related to CAR-T and potentially other therapies;

 

B.        Kite is developing the Kite Investigational Product (defined below) for the treatment of certain blood cancers;

 

C.        Based on a hypothesis that certain CAR-related neurologic events may be reduced after treatment of Kite Investigational Product and sequential prophylaxis with an anti-GMCSF antibody, Kite wishes to conduct a Phase I/II clinical study evaluating the incidence of neurologic events when Kite Investigational Product is used with Humanigen Investigational Product in patients with relapsed/refractory large B cell lymphoma; and

 

D.        Humanigen and Kite, consistent with the terms of this Agreement, desire to collaborate as more fully described herein, including by providing the Humanigen Investigational Product to Kite for the conduct of the Study described herein.

 

Agreement

 

Now, Therefore , for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Humanigen and Kite agree as follows:

 

Article 1

DEFINITIONS

 

Capitalized terms used in this Agreement shall have the meanings set forth below, unless otherwise specifically indicated.

 

1.1        Affiliate ” of a Party means any corporation or other business entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with such Party. For purposes of this definition, the term “ control ” (including, the correlative meanings, “ controlled by ” and “ under common control with ”) means (a) the direct or indirect ownership of more than fifty percent (50%) of the stock having the right to vote for directors thereof (or general partnership interests) or (b) the ability to otherwise control the decisions of the board of directors or equivalent governing body thereof.

 

1.2        Ancillary Agreements ” means the Supply Agreement, Quality Agreement, PV Agreement, and other operational agreements to be entered into by the Parties after the Effective Date, including without limitation, an agreement to track financial disclosures pursuant to Section 9.4

 

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1.3        Applicable Law ” means all (a) federal, state, local, national and regional statutes, laws, rules, regulations and directives applicable to a particular activity under this Agreement (including the performance of clinical trials and medical treatment) that may be in effect from time to time (including GCP, GLP, GMP and other laws promulgated by Regulatory Authorities); (b) applicable data protection and patient privacy laws and requirements (including those specified in the EU General Data Protection Regulation and the regulations issued under HIPAA); (c) export control and economic sanctions regulations that prohibit the shipment of United States-originated products and technology to certain restricted countries, entities and individuals; (d) anti-bribery and anti-corruption laws pertaining to interactions with government agents, officials and representatives (including the United States Foreign Corrupt Practices Act); (e) laws and regulations governing payments to healthcare providers; (f) laws and requirements governing ineligibility to participate in federal, state or other healthcare programs (including debarment under 21 USC § 335a, disqualification under 21 CFR §312.70 or § 812.119, sanctions by a Federal Health Care Program (as defined in 42 USC § 1320a-7b(f)), including the federal Medicare or a state Medicaid program); and (g) successor or replacement statutes, laws, rules, regulations and directives relating to the foregoing.

 

1.4        “Background IP” is defined in Section 6.2(d).

 

1.5        Biologics License Application ” or “ BLA ” means a biologics license application filed or to be filed with the FDA as described in 21 CFR Part 601, or the equivalent filing with a relevant Regulatory Authority in any jurisdiction (including a marketing authorization application filed or to be filed with the EMA or Health Canada), together with any amendments, supplements or other additions or deletions thereto.

 

1.6        Business Day ” means a day, other than a Saturday, Sunday or day on which commercial banks located in Santa Monica, California are authorized or required by law or regulation to close.

 

1.7        Case Report Form ” means the form (whether paper or electronic) for collecting certain data about each Subject, including the data collected for such Subject.

 

1.8        CFR ” means the United States Code of Federal Regulations.

 

1.9        Collaboration IND ” means the IND that includes the Protocol covering the Study.

 

1.10        Collaboration Invention ” is defined in Section 6.1(c).

 

1.11        Combination ” means the Humanigen Investigational Product and the Kite Investigational Product used in the combination or sequence as set forth in the Protocol, but not co-formulated, together.

 

1.12        Confidential Information ” means nonpublic information (including Know-How) (i) that is disclosed by or on behalf of one Party to the other or its designee in connection with this Agreement (whether orally, electronically, visually or in writing) and/or (ii) Joint Confidential Information as defined in Section 7.1(c).

 

1.13        CRO ” means a Third Party service provider (e.g., a person or organization) that assumes one or more obligations of the Sponsor, in accordance with Title 21 of the CFR, or the equivalent assumption of obligations in a jurisdiction other than the United States.

 

1.14        Database Lock ” means the database lock of the Study Data after Study Completion.

 

1.15        Data Review Committee ” or “ DRC ” is defined in Section 3.2(a).

 

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1.16        EMA ” means, collectively, the European Medicines Agency and the European Commission (with respect to its functions related to marketing authorizations for medicinal products), or any successor entity thereto performing similar functions.

 

1.17        FDA ” means the United States Food and Drug Administration, or any successor entity thereto performing similar functions.

 

1.18        Final Study Report ” is defined in Section 2.8(c).

 

1.19        GCP ” means, as to the United States and the European Union, applicable good clinical practices (for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected) in effect in the United States and the European Union, respectively, during the term of the Agreement and, with respect to any other jurisdiction, clinical practices equivalent to good clinical practices then in effect in the United States or the European Union.

 

1.20        GLP ” means, as to the United States and the European Union, applicable good laboratory practices in effect in the United States and the European Union, respectively, during the term of the Agreement and, with respect to any other jurisdiction, laboratory practices equivalent to good laboratory practices then in effect in the United States or the European Union.

 

1.21        GMP ” means, as to the United States and the European Union, applicable good manufacturing practices in effect in the United States and the European Union, respectively, during the term of the Agreement and, with respect to any other jurisdiction, manufacturing practices equivalent to good manufacturing practices then in effect in the United States or the European Union.

 

1.22        HIPAA ” means, collectively, the United States Health Insurance Portability and Accountability Act of 1996, and the regulations promulgated thereunder, as amended from time to time.

 

1.23        Humanigen Investigational Product ” means lenzilumab in final form for administration to Subjects in the Study.

 

1.24        Humanigen Owned Invention ” is defined in Section 6.1(b)(ii).

 

1.25        IND ” means an investigational new drug application filed or to be filed with the FDA as described in 21 CFR Part 312, or the equivalent filing with a relevant Regulatory Authority in any jurisdiction (including an investigational medicinal product dossier filed or to be filed with the EMA or a clinical trial application filed or to be filed with Health Canada), together with any amendments, supplements or other additions or deletions thereto.

 

1.26        “Invention” means any invention, discovery or creation (including materials and Know-How but excluding Study Data and Sample Data) that is first conceived, reduced to practice, discovered or otherwise created by a Party (directly or by a Third Party on its behalf) or jointly by the Parties, in each case, (i) in the course of, or as a result of, conducting and providing support for the Study; (ii) through use of the Study Data or the Sample Data; or (iii) through use of the Samples.

 

1.27        Investigational Products ” means the Humanigen Investigational Product and the Kite Investigational Product. An “ Investigational Product ” means either the Humanigen Investigational Product or the Kite Investigational Product, as applicable.

 

1.28        Investigator ” is defined in 21 CFR § 312.3(b) and, under this Agreement, means an individual who conducts the Study at a Participating Site in any jurisdiction.

 

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1.29        IRB ” means an institutional review board as described in 45 CFR Part 46, or the equivalent entity (such as an independent ethics committee) in any jurisdiction.

 

1.30        JDC Chair ” is defined in Section 3.1(a).

 

1.31        JDC Co-Leader ” is defined in Section 3.1(a).

 

1.32        Joint Development Committee ” or “ JDC ” is defined in Section 3.1(a).

 

1.33        Joint Patent ” is defined in Section 6.3(a).

 

1.34        Kite Investigational Product ” means axicabtagene ciloleucel (“axi-cel”) in final form for administration to Subjects in the Study.

 

1.35        Kite Owned Invention ” is defined in Section 6.1(b)(i).

 

1.36        Know-How ” means all information, unpatented inventions (whether or not patentable), improvements, practices, formula, trade secrets, techniques, methods, procedures, knowledge, results, test data (including pharmacological, toxicological, pharmacokinetic and pre-clinical and clinical information and test data, related reports, structure-activity relationship data and statistical analysis), analytical and quality control data, protocols, processes, models, designs, and other information regarding research, discovery, development, marketing, pricing, distribution, cost, sales and manufacturing. Know-How shall not include any Patents.

 

1.37        NDA ” means a new drug application filed or to be filed with the FDA as described in 21 CFR Part 314, or the equivalent filing with a relevant Regulatory Authority in any jurisdiction (including a marketing authorization application filed or to be filed with the EMA or Health Canada), together with any amendments, supplements or other additions or deletions thereto.

 

1.38        Participating Site ” means a hospital or other institution participating in the Study.

 

1.39        Patents ” means all patents and patent applications and any patents issuing therefrom or claiming priority thereto in any country, including any reissues, extensions, supplementary protection certificates, registrations, divisions, continuations, continuations-in-part, reexaminations, substitutions or renewals thereof.

 

1.40        Project Participants ” means Investigators, Subinvestigators, Participating Sites, CROs, drug distributors, vendors and subcontractors or agents of Kite (or its Affiliates), who conduct or assist in conducting the Study or provide related services.

 

1.41        Prosecution and Maintenance ” or “ Prosecute and Maintain ” with regard to a given Patent, means the preparation, filing, prosecution and maintenance of such Patent, as well as any ex parte and inter partes proceedings, including reexaminations, reissues, applications for patent term extensions, interferences, derivation proceedings, post-grant review proceedings, oppositions and other similar administrative proceedings with respect to such Patent.

 

1.42        Protocol ” means the protocol to be based on the Kite protocol synopsis attached hereto as Exhibit A , titled “ A Phase1/2 Open-Label, Multicenter Study Evaluating the Incidence of Neurologic Events after Axicabtagene Ciloleucel as a Combination Therapy with Lenzilumab in Subjects with Refractory Large B-Cell Lymphoma ” which shall be approved and may be amended by the JDC in accordance with this Agreement. The Kite protocol synopsis (Exhibit A), Protocol and Study design is Kite Confidential Information.

 

1.43        PV Agreement ” is defined in Section 2.7(a).

 

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1.44        Quality Agreement ” is defined in Section 4.3.

 

1.45        Regulatory Authority ” means (a) the FDA; (b) the EMA; or (c) any regulatory authority or body performing similar functions in any jurisdiction anywhere in the world.

 

1.46        Regulatory Documentation ” means any document submitted to a Regulatory Authority, including all INDs, NDAs, BLAs, drug master files, correspondence with Regulatory Authorities, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records.

 

1.47        Sample Analyses ” is defined in Section 5.2(b).

 

1.48        Sample Analysis Plan ” means the plan, attached as Exhibit C , that outlines the Sample Analyses to be performed by Kite or Humanigen and the priority for performing such Sample Analysis. The Sample Analysis Plan (Exhibit C) is Kite Confidential Information.

 

1.49        Sample Data ” is defined in Section 5.3(a).

 

1.50        Samples ” is defined in Section 5.2(a).

 

1.51        Specifications ” means, with respect to an Investigational Product, the set of requirements for such Investigational Product set forth in the Quality Agreement.

 

1.52        Sponsor ” is defined in 21 CFR § 312.3(b) and, under this Agreement, means the entity that takes responsibility for and initiates the Study in any jurisdiction.

 

1.53        Study ” means the Phase I/II clinical study to be sponsored and conducted by Kite as set forth in the Protocol. The principal purpose of the Study is to evaluate the incidence of neurologic events after treatment of Kite Investigational Product in Combination with Humanigen Investigational Product, consistent with the requirements further described in 21 CFR § 312.21(a) & (b) (as may be amended) or foreign counterpart thereto, or a similar clinical study in a country other than the United States.

 

1.54        Study Completion ” means the last Subject visit specified in the Protocol for primary endpoint evaluation.

 

1.55        Study Data ” means all data (including raw data), Case Report Forms, findings, conclusions and other results from the Study and the Final Study Report, including investigator reports (both preliminary and final), statistical analyses and expert opinions and reports. Study Data excludes Sample Data.

 

1.56        Subinvestigator ” is defined in 21 CFR § 312.3(b) and, in the event the Study is conducted by a team at a Participating Site, means an individual designated by the Investigator to be the responsible leader of such team.

 

1.57        Subject ” is defined in 21 CFR § 312.3(b) and, under this Agreement, means a human who participates in the Study in any jurisdiction.

 

1.58        Supply Agreement ” is defined in Section 4.1.

 

1.59        Third Party ” means any person or entity other than a Party or its Affiliates.

 

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Article 2

CONDUCT OF THE STUDY; REGULATORY MATTERS

 

2.1       Overview . Kite has the hypothesis that there may potentially be a reduction in the incidence of CAR-related inflammatory events, such as neurologic events, after treatment with axicabtagene ciloleucel (Kite Investigational Product) and sequenced prophylaxis with an anti-GMCSF antibody in subjects with relapsed/ refractory large B-cell lymphoma. Kite now wishes to evaluate the hypothesis by conducting the Study under this Agreement, with support from Humanigen as described herein.

 

2.2       Sponsor . Kite shall be the Sponsor of the Study. Kite shall use commercially reasonable efforts to conduct, and use commercially reasonable efforts to cause all Project Participants to conduct, the Study in accordance with this Agreement, the Protocol and Applicable Law. Kite shall be responsible for obtaining all approvals and clearances necessary to conduct the Study, including approvals from Regulatory Authorities, IRBs and customs clearances. In no event shall Humanigen be deemed a Sponsor of the Study.

 

2.3       Collaboration IND; Protocol .

 

(a)       Collaboration IND . Kite shall maintain the Collaboration IND and will likewise maintain, or prepare and file (as applicable) any investigational medicinal product dossier(s), clinical trial application(s), or similar applications, necessary for the approval of the Study outside the United States, subject to co-ownership rights to jointly owned Study Data, jointly owned Sample Data, and jointly owned Collaboration Inventions. Subject to the ownership provisions of Sections 2.6(c), 5.1, 5.3, and 6.1(c), Kite shall own all right, title and interest in and to the Collaboration IND, investigational medicinal product dossier(s) or clinical trial application(s) (as the case may be), and related Regulatory Documentation.

 

(b)       Protocol . The Protocol for such Collaboration IND is to be mutually agreed to by the JDC and based on the Kite protocol synopsis set forth in Exhibit A . Any amendments to the Protocol shall be reviewed and approved in accordance with Section 3.1. Subject to the terms of this Agreement, Kite shall be responsible for preparing and filing all necessary Regulatory Documentation for the Collaboration IND and the Study.

 

(c)       Investigator’s Brochure . Kite shall prepare an investigator’s brochure for the Kite Investigational Product. Humanigen shall provide to Kite an investigator’s brochure(s) (and shall immediately provide any updates) for the Humanigen Investigational Product that pertain to safety matters and other information that may be required to keep the investigator’s brochure(s) for the Humanigen Investigational Product up to date.

 

2.4       Enrollment . Commencing on or after the date the PV Agreement is executed by the Parties, Kite may begin enrolling Subjects in the Study in compliance with Applicable Law. Kite shall be responsible for tracking enrollment at Participating Sites which shall not exceed the maximum number of Subjects specified in the Protocol, unless such number is increased by an amendment to the Protocol.

 

2.5       Project Participants . Kite shall be solely responsible for the performance and conduct of the Project Participants, including monitoring the conduct of the Study at the Participating Sites. Kite shall be solely responsible for negotiating and executing the necessary agreements with all Project Participants. Kite shall reasonably determine that the compensation being paid to a Project Participant under its agreement with Kite for the Study constitutes the fair market value of the services to be provided. In no event shall any agreement with a Project Participant represent that Humanigen is a Sponsor of the Study.

 

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2.6       Regulatory Matters .

 

(a)       Generally . Kite shall comply with all lawful direction provided by Regulatory Authorities and IRBs with jurisdiction over the Study. Kite shall perform all regulatory obligations related to the Study, including preparation and submission of Regulatory Documentation for the Study, in accordance with the Protocol and Applicable Law.

 

(b)       Interactions with Regulatory Authorities . Kite shall promptly provide Humanigen with a copy of any material notice, inquiry or correspondence that Kite receives from a Regulatory Authority regarding the Study (“ Material Regulatory Notice ”), including any serious safety matter related to a Party’s Investigational Product or the Combination and any inspection or investigation by a Regulatory Authority. Humanigen shall have the right (but not the obligation) to provide comments to any response to such Material Regulatory Notice, to the extent such Material Regulatory Notice is related to either the Combination or the Humanigen Investigational Product, and to participate in any discussions with a Regulatory Authority relating to such Material Regulatory Notice, to the extent permitted by such Regulatory Authority. Notwithstanding the aforementioned, if a Material Regulatory Notice is directed at the Humanigen Investigational Product, then Humanigen will immediately review and respond to Kite with all necessary information to address the Material Regulatory Notice. Furthermore, without limiting Humanigen’s obligations under Section 2.6(c), Humanigen shall promptly provide Kite with a copy of any material notice, inquiry or correspondence that Humanigen or its Affiliate receives from a Regulatory Authority regarding the Humanigen Investigational Product that would reasonably have an impact on the conduct of the Study, including without limitation, any serious safety matter related to the Humanigen Investigational Product. In addition to Material Regulatory Notices, Kite may conduct other meetings with Regulatory Authorities relating to the Study, and at the JDC’s discretion, invite Humanigen to observe and/or contribute to Kite’s interactions with Regulatory Authorities. The Parties shall keep confidential the nature and substance of such Kite’s discussions with Regulatory Authorities, and any Confidential Information or Joint Confidential Information exchanged in such discussions shall at all times be subject to the terms of this Agreement.

 

(c)       Letter of Cross-Reference . Promptly, but no later than ten (10) business days, after the Effective Date, Humanigen shall provide to Kite a letter of cross-reference authorizing Kite to reference Humanigen INDs for the Humanigen Investigational Product as reasonably necessary to support the Study under the existing Collaboration IND maintained by Kite. Such letter of cross-reference shall remain in full force and effect until the end of the Term. In addition to Humanigen’s obligations to supply the Humanigen Investigational Product under Section 4.1, Humanigen shall, promptly following Kite’s request, provide and make available to Kite any necessary information about the Humanigen Investigational Product, including without limitation, any Humanigen Confidential Information, to support Kite in obtaining approval to conduct the Study from Regulatory Authorities and IRBs and in conducting the Study. Further, Humanigen shall provide reasonable assistance to Kite to support Kite’s interactions with Regulatory Authorities and IRBs in connection with the Study. Neither Party shall have any rights to use the other Party’s solely owned Confidential Information or Joint Confidential Information, except as otherwise expressly provided in this Agreement, including this Section 2.6(c), Section 5.1(b), Section 5.3(b), Article 7, and Article 8, and such permitted uses do not grant any right or license or transfer ownership to either Party under any of the other Party’s information (including without limitation Confidential Information). Notwithstanding the foregoing, while a Party may have rights to use solely owned Confidential Information or Joint Confidential Information as expressly set forth in this Agreement, in no event shall any Party disclose, disseminate or otherwise share the other Party’s solely owned Confidential Information or Joint Confidential Information with any Third Party except as expressly authorized in Articles 7 or 8, without the express written consent of such other Party.

 

2.7       Adverse Experience Reporting .

 

(a)        Within ninety (90) days of executing this Agreement, and in any event prior to the in the initiation of any clinical Study activities, including enrollment of the first Study subject, the Parties shall enter into a pharmacovigilance agreement setting forth the Parties’ responsibilities and obligations with respect to the procedures and timeframes for compliance with Applicable Law pertaining to safety reporting of the respective Investigational Products and the Combination (“ PV Agreement ”). Such PV Agreement will ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party to comply with Applicable Laws, including any local regulatory requirements. Kite will be responsible for fulfilling all regulatory reporting obligations with regard to the Study and the Collaboration IND and such requirements will be documented in the PV Agreement.

 

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(b)        Kite shall be responsible for reporting adverse events from the Study to Regulatory Authorities in accordance with Applicable Law, including 21 CFR § 312.32.

 

2.8       Documentation, Updates and Final Study Report .

 

(a)       Documentation . Each Party shall maintain reports and documentation arising in connection with the Study in a good scientific manner and in compliance with Applicable Law. Each Party shall provide to the other Party all such reports and documentation arising from the Study (including reports of interim analyses, if applicable) reasonably requested to enable each Party to comply with any of its legal, regulatory and/or contractual obligations, or in response to any request by a Regulatory Authority.

 

(b)       Updates . Kite shall provide written updates regarding the status of the Study (including enrollment status, project timelines, Humanigen Investigational Product inventory and Humanigen Investigational Product forecasting) to Humanigen on a quarterly basis within forty-five (45) days of the end of each calendar quarter. Following receipt of such written update, Humanigen may request that Kite make available Kite personnel responsible for the Study on a reasonable basis to address Humanigen’s questions regarding such written update, either in person or by telephone; provided, however, that Kite shall have no obligation to conduct any unplanned Study Data cuts to address any such Humanigen questions unless necessary and required to address a material safety concern. Humanigen shall provide a list of questions and/or topics for discussion in advance of such meeting.

 

(c)       Final Study Report . Kite shall complete the Study as outlined in the Protocol. Kite shall summarize the findings of the Study in a Final Study Report. Kite shall provide the Final Study Report to Humanigen within six (6) months after Database Lock, subject to complete payment of all Kite invoices by Humanigen. “ Final Study Report ” means a formal clinical study report documenting and summarizing the results and interpretation of the Study, including the trial design, trial objectives, patient assessment, data analysis, results, risk/benefit analysis, safety and effectiveness, in accordance with the requirements of then-existing Regulatory Authority rules, regulations and guidance on the structure and content of clinical study reports.

 

2.9       Costs . Each Party shall share equally (fifty percent (50%) each) in all out-of-pocket expenses actually incurred in conducting the Study, including but not limited to expenses for CROs, Third Party testing and analysis service providers and central labs, Sample Analysis, Participating Sites, patient screening, imaging and care, clinical data management, statistical analysis, data safety monitoring and advisory boards, investigator meetings, and shipping of patient materials to and from a manufacturing site, in accordance with the mutually agreed budget as set forth in Exhibit B attached hereto, as may be amended from time to time by the unanimous agreement of the JDC (as defined below). For clarity, such expenses shall not include any expenses incurred for the raw materials of an Investigational Product and for the manufacturing and processing of an Investigational Product by a Party or any of its contractors. Each Party shall perform its obligations under this Agreement and will be responsible for all other indirect costs at its own cost and expense, including internal FTE and overhead costs. Thirty (30) days prior to the initiation of the Study (with such date to be determined by the JDC), Humanigen shall pay to Kite an amount equal to Two Million Dollars (US$2,000,000), which is approximately equal to fifty percent (50%) of the out-of-pocket costs to be incurred in the conduct of the Study for eighteen (18) Subjects to be dosed. In the event the Study is terminated prior to 18 Subjects being dosed, Kite agrees to reconcile the funds received from Humanigen against the out-of-pocket costs and non-cancellable expenses actually incurred up to the date of Study termination, and refund Humanigen that amount. Once 18 Subjects have been dosed, within thirty (30) days prior to the first day of each subsequent calendar quarter thereafter until Study Completion, Kite shall invoice Humanigen an amount equal to fifty percent (50%) of the anticipated out-of-pocket costs to be incurred in conducting the Study for the upcoming calendar quarter, as reasonably forecasted by Kite, and Humanigen shall pay all such invoices within thirty (30) days of receipt of such invoice from Kite. Any excess amounts paid by Humanigen to Kite hereunder will be refunded to Humanigen within sixty (60) days of Study Completion.

 

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2.10       Additional Studies .

 

(a)       Using Combination . After completing the Study, if one Party (“ Proposing Party ”) wishes to conduct one or more additional studies that include the other Party’s Investigational Product (“ Additional Study(ies) ”), the Proposing Party will provide the other Party with a protocol summarizing the Additional Study(ies) (“ Additional Study Plan(s) ), and the opportunity to participate, at least six (6) months prior to initiating any Additional Studies. If the other Party decides to not participate in the Additional Study(ies), the Proposing Party may proceed alone on the Additional Study Plan(s) at its own expense, provided the Additional Studies are approved by regulatory authorities, and provided further that the non-Proposing Party will be under no obligation to provide any support, Investigational Products or materials to the Proposing Party for such Additional Study(ies). The Parties shall discuss providing supply of its respective Investigational Product for an Additional Study, provided that neither Party shall be obligated to supply its Investigational Product for any Additional Study.

 

(b)       Other Studies . Nothing in this Agreement shall (a) prohibit either Party from performing any additional studies relating to its own Investigational Product, either individually or in combination with any other compound or product, in any therapeutic area or (b) create an exclusive relationship between the Parties with respect to either Investigational Product.

 

Article 3

GOVERNANCE

 

3.1       Joint Development Committee .

 

(a)       Establishment of the JDC . Within thirty (30) days after the Effective Date, the Parties shall establish a Joint Development Committee (“ Joint Development Committee ” or “ JDC ”) to oversee the Study. The JDC shall be composed of at least two (2), but no more than three (3) representatives designated by each Party (and the Parties need not have the same number of representatives). The representatives shall be appropriate (in terms of their seniority, availability, function in their respective organizations, training and experience) for the activities then being undertaken. Each Party shall designate one of its representatives as its primary JDC contact for JDC matters (each, a Party’s “ JDC Co-Leader ”). Kite’s JDC Co-Leader shall chair the Joint Development Committee (“ JDC Chair ”), including scheduling JDC meetings and setting meeting agendas. A Party may replace any or all of its representatives (and designated JDC Co-Leader) at any time by informing the other Party’s JDC Co-Leader in advance, in writing (which may be by email). The JDC shall exist during the Term, unless otherwise mutually agreed by the Parties in writing.

 

(b)       Responsibilities of the JDC . The Joint Development Committee shall be responsible for the following activities:

 

(i)        reviewing and approving the Protocol and any subsequent amendments to the Protocol;

 

(ii)        reviewing and amending the budget as may be reasonably necessary to reflect changes in the Study;

 

(iii)        approving Participating Sites and Investigators;

 

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(iv)        reviewing the progress of the Study;

 

(v)        establishing the Data Review Committee (as described in Section 3.2) and deciding whether and how to address its recommendations;

 

(vi)        evaluating and determining how to address any safety matters related to the Combination;

 

(vii)        reviewing the progress of the Sample Analysis Plan, including determining the timing for Sample Analysis to be performed by a Party and the transfer of results to the other Party;

 

(viii)        coordinating the transfer of materials and information between the Parties, including the Study Data, the Final Study Report, the Samples and the Sample Data;

 

(ix)        addressing any issues that may arise in the event of a shortage of supply of Humanigen Investigational Product for the Study, subject to Section 4.1;

 

(x)        attempting to resolve any Disputes related to the Study; and

 

(xi)        performing such other functions as appropriate to further the purposes of the Study, or as otherwise specified in this Agreement.

 

(c)       Unanimous Decisions . Actions and decisions to be taken by the JDC shall be made only following a unanimous vote, with each Party’s representatives on the JDC having collectively one (1) vote, provided that, Kite’s JDC representatives shall have the final decision making authority with respect to (i) operational matters in conducting the Study, including selecting Participating Sites, Investigators and CROs, and (ii) amendments to the Protocol that do not directly relate to the Humanigen Investigational Product or the part of the Combination that consists of the Humanigen Investigational Product, in each case that does not result in an increase in the mutually agreed upon budget by fifteen percent (15%). For clarity, Kite’s JDC representatives shall not have final decision making authority with respect to matters directly related to the Humanigen Investigational Product or the part of the Combination that consists of the Humanigen Investigational Product, and Humanigen’s JDC representatives shall not have final decision making authority with respect to matters directly related to the Kite Investigational Product or the part of the Combination that consists of the Kite Investigational Product. If the JDC cannot reach unanimous agreement within fifteen (15) Business Days of a matter being brought to a vote not otherwise addressed by this Section 3.1(c), either Party may refer the dispute to the Parties’ executives for resolution in accordance with Section 15.1. The JDC has no authority to amend, or to waive compliance with, any provisions of this Agreement.

 

(d)       Meetings; Attendees; Decisions . Once established, the Joint Development Committee shall meet at least once each calendar quarter. The JDC may meet in person or via teleconference, video conference or the like, provided that at least one (1) meeting per calendar year shall be held in person (unless otherwise agreed by the Parties). Each Party shall bear the expense of its respective representatives’ participation in JDC meetings. If a Party’s representative is unable to attend a given meeting, such Party may designate a knowledgeable alternate to attend such meeting and perform the functions of such representative. Each Party may invite a reasonable number of non-voting employees, consultants or scientific advisors to attend JDC meetings, provided that such invitees are bound by appropriate confidentiality obligations. The JDC shall maintain written minutes of each JDC meeting, including all decisions made, action items assigned or completed and other appropriate matters. The JDC Chair shall prepare the initial draft minutes and provide the Humanigen Co-Leader with ten (10) business days for Humanigen to review and approve such minutes.

 

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(e)       Sub-Teams; Designees . From time to time, the Joint Development Committee may establish sub-teams to oversee particular projects or activities, and such sub-teams will be constituted and operate as determined by the JDC. From time to time, the JDC may designate individuals (by name or function) to oversee activities, and such designees will perform such activities as determined by the JDC. The JDC also reserves the right to discontinue sub-teams.

 

3.2       Data Review Committee .

 

(a)       Establishment of the DRC; Meetings . Under the direction of the Joint Development Committee, the Parties may establish a Data Review Committee (“ Data Review Committee ” or “ DRC ”) to monitor the safety of the Investigational Products being used in the Study. The DRC shall be composed of (i) at least one clinician designated by Humanigen familiar with the therapeutic profile of the Humanigen Investigational Product; (ii) at least one clinician designated by Kite familiar with the therapeutic profile of the Kite Investigational Product; and (iii) if the Parties agree to include one or more Third Party clinicians, such individuals shall be acceptable to both Parties, and shall be bound by appropriate confidentiality and invention assignment obligations. The DRC shall meet at least once each calendar quarter or at such other times as deemed appropriate by the Parties and on an ad hoc basis as necessary during the Study.

 

(b)       Responsibilities of the DRC . The Data Review Committee shall be responsible for performing the following functions:

 

(i)        evaluating suspected dose-limiting toxicities (using criteria defined in the Protocol, if applicable) and adjudicating treatment related adverse events, based on clinical experience with the Investigational Products;

 

(ii)        making recommendations to the JDC to hold dosing or enrollment, if safety data require further evaluation;

 

(iii)        making recommendations to the JDC to end dosing or enrollment; and

 

(iv)        performing such other functions as directed by the JDC.

 

(c)       Advisory Body . The Data Review Committee shall be solely an advisory body to the JDC and shall not have any power to make decisions that bind either Party.

 

3.3       Data Monitoring Committee . The Parties may establish a data monitoring committee, of independent clinician(s) agreed to by the Parties, to make safety recommendations about the safety of the Study to the JDC.

 

Article 4

SUPPLY OF STUDY DRUGS

 

4.1       Humanigen Investigational Product .

 

(a)       Manufacture and Supply . Promptly following the Effective Date, but in no event later than sixty (60) days following the Effective Date, Humanigen and Kite will enter into a supply agreement (the “ Supply Agreement ”) which will set out the quantities of the Humanigen Investigational Product that Humanigen will supply, or cause to be supplied (including setting aside a reserve of Humanigen Investigational Product in case of unanticipated or unforeseen shortages, or in the event of dissolution or insolvency), and the timelines for such supply, in each case, for use in the Study, including any extensions thereto. Humanigen shall supply Humanigen Investigational Product for use in the Study, at its expense, and in the quantities specified in the Supply Agreement. Humanigen represents and warrants to Kite that: (i) Humanigen shall supply Humanigen Investigational Product to reach Study Completion; (ii) such Humanigen Investigational Product shall be manufactured in compliance with: the Specifications for the Humanigen Investigational Product, Applicable Law and the Quality Agreement. Humanigen or its designee will deliver Humanigen Investigational Product to (i) Kite or (ii) a Project Participant as designated by Kite or the Joint Development Committee (for purposes of Section 4.1(b), “ Delivery Locations ”).

 

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(b)       Delivery . Humanigen shall deliver the Humanigen Investigational Product to the Delivery Locations in accordance with the Quality Agreement and the timelines specified in the Supply Agreement or determined by the Joint Development Committee.

 

(c)       Remaining Investigational Product . Upon completion or termination of the Study, Kite shall use commercially reasonable efforts to have all unused quantities of Humanigen Investigational Product, as well as all used vials and bottles containing the Humanigen Investigational Product, returned to Humanigen or destroyed (as directed by Humanigen, and at Humanigen’s cost) and documented accordingly.

 

(d)       Use of Humanigen Investigational Product . From the Effective Date until the first to occur of Study Completion or any earlier termination of the Study, Kite has the right to use the Humanigen Investigational Product for the purpose of conducting the Study, including without limitation, to perform any analytical methods validation transfer, if required, and shall use the Humanigen Investigational Product solely for such purpose. Kite shall use, store, transport, handle and dispose of the Humanigen Investigational Product in compliance with Applicable Law, the Quality Agreement and all reasonable instructions from Humanigen. Kite shall not use the Humanigen Investigational Product for any research, development or commercial purpose, other than for the Study; Kite shall not attempt to derive or reverse engineer the composition or underlying information or structure of the Humanigen Investigational Product, and in particular shall not analyze the Humanigen Investigational Product by physical, biological, chemical or biochemical means, except as necessary to perform its obligations under the Quality Agreement.

 

4.2       Insufficient Quantities . In the event that Humanigen determines that there are insufficient quantities of the Humanigen Investigational Product to reach Study Completion, Humanigen shall promptly provide written notice to Kite, including what quantities or manufacturing capacity of its Humanigen Investigational Product, if any, are available for the Study. The JDC will promptly discuss how to address the shortage and allocate the available amounts of Humanigen Investigational Product manufacturing capacity.

 

4.3       Quality Agreement . Within sixty (60) days of executing this Agreement, the Parties shall enter into a quality agreement establishing the quality requirements for Humanigen Investigational Product (“ Quality Agreement ”). In the event of a conflict between the Quality Agreement and this Agreement, this Agreement shall govern and control, unless otherwise expressly provided in the Quality Agreement.

 

4.4       Mutual Obligations .

 

(a)        Each Party shall (directly or through its subcontractor, subject to Section 10.1) obtain and maintain all regulatory approvals (including facility licenses) required to manufacture its respective Investigational Product in compliance with Applicable Law.

 

(b)        Each Party shall notify the other Party as promptly as possible in the event any manufacturing delay (or other event) is likely to adversely affect its ability to fulfill its obligations to supply its Investigational Product under this Agreement.

 

(c)        For clarity, this Agreement does not create any obligation on the part of either Party to provide its Investigational Product for any activities or purposes other than to conduct the Study.

 

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Article 5

STUDY DATA; SAMPLE ANALYSES AND SAMPLE DATA

 

5.1       Study Data .

 

(a)       Database; Analysis . Kite shall maintain all Study Data in its database in accordance with Applicable Law. Prior to Study Completion, Kite shall provide Study Data summaries and interim clinical study reports to Humanigen in accordance with the timelines to be determined by the JDC. Following Study Completion, Kite shall lead and coordinate the analysis of Study Data, with Humanigen support and involvement. Kite shall provide such Study Data to Humanigen via electronic data transfer, in SAS format or as otherwise agreed by the Parties, in conjunction with the Final Study Report.

 

(b)       Ownership and Use of Study Data . Kite shall solely own all Study Data that relate solely to the Kite Investigational Product. Humanigen shall solely own all Study Data that relate solely to the Humanigen Investigational Product. Except to the extent otherwise agreed in writing by an authorized representative of each Party, each Party shall use the other Party’s Study Data only for the purposes of: (i) seeking regulatory approval for the use of its Investigational Product in the Combination, and (ii) filing and Prosecuting Patent applications for Collaboration Inventions and enforcing any resulting Patents in accordance with Article 6. The Parties shall jointly own Study Data that relate solely to the Combination, and not solely to an Investigational Product. Such jointly owned Study Data shall be deemed Joint Confidential Information. Each Party has the right to use the jointly owned Study Data for any lawful purpose; provided, however , each Party’s use of the jointly owned Study Data is subject to: (i) Section 6.3(e), (ii) the limitations on disclosure of the other Party’s Confidential Information in Section 2.6(c) and Article 7, (iii) the limitations on disclosure of Joint Confidential Information in Section 2.6(c) and Article 7; (iv) Article 8; and (v) providing written notice to the other Party of such Party’s anticipated use of the jointly owned Study Data in a timely manner prior to such anticipated use.

 

5.2       Samples and Sample Analyses .

 

(a)       Samples . During the Study, Kite will direct the collection of certain biologic samples from Subjects (“ Samples ”), as set forth in the Protocol.

 

(b)       Sample Analysis . Kite shall provide to Humanigen the Samples necessary for Humanigen to perform the Sample Analysis for which Humanigen is responsible, pursuant to the Sample Analysis Plan. Each Party, at its own expense, shall perform (directly or through an Affiliate or Third Party acting on its behalf) the testing procedures and analyses of the Samples (together “ Sample Analysis/es ”) pursuant to the sample analysis plan attached hereto as Exhibit C (“ Sample Analysis Plan ”), which shall be set forth in the Protocol. The Sample Analyses shall be performed by a Party in accordance with the timeline set forth in the Sample Analysis Plan or otherwise determined by the JDC.

 

(c)        Neither Party shall use the Samples for any purpose other than to perform the Sample Analyses for which it is responsible, without the prior written consent of the other Party. Humanigen shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the Kite Investigational Product, and in particular, shall not analyze the Kite Investigational Product by physical, chemical or biochemical means.

 

5.3       Sample Data .

 

(a)        Each Party will be responsible for conducting the Sample Analysis for its own Investigational Product; the Party responsible for conducting Sample Analysis for the Combination will be set forth in the Sample Analysis Plan. Kite and Humanigen will each generate data (including raw data), findings, conclusions and other results in conducting such Sample Analyses for Samples obtained from the Study (“ Sample Data ”). Each Party shall provide to the other Party the results and/or analysis generated in the course of performing Sample Analyses for the Study via electronic data transfer or other format/media determined by the JDC. Such results shall be provided to the other Party within thirty (30) days of completion of the analysis or as otherwise set forth in the Sample Analysis Plan or otherwise agreed by the JDC.

 

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(b)        Kite shall solely own all Sample Data that relate solely to the Kite Investigational Product. Humanigen shall solely own all Sample Data that relate solely to the Humanigen Investigational Product. Except to the extent otherwise agreed in writing by an authorized representative of each Party, each Party shall use the other Party’s Sample Data only for the purposes of (i) seeking regulatory approval for the use of its Investigational Product in the Combination, and (ii) filing and Prosecuting Patent applications for Collaboration Inventions and enforcing any resulting Patents in accordance with Article 6. Further, Kite shall have the right to access and use Humanigen Sample Data for the purpose of performing correlative analysis(es) with the Kite Sample Data. The Parties shall jointly own Sample Data that relate solely to the Combination, and not solely to an Investigational Product. Such jointly owned Sample Data shall be deemed Joint Confidential Information. For clarity, and by way of example, the results of the correlative analysis(es) to be performed by Kite with use of the Humanigen Sample Data and Kite Sample Data relates solely to the Combination, shall be jointly owned by the Parties, and shall be deemed jointly owned Sample Data and Joint Confidential Information. Each Party has the right to use the jointly owned Sample Data for any lawful purpose; provided, however , each Party’s use of the jointly owned Sample Data is subject to: (i) Section 6.3(e); (ii) the limitations on disclosure of the other Party’s Confidential Information in Section 2.6(c) and Article 7; (iii) the limitations on disclosure of Joint Confidential Information in Section 2.6(c) and Article 7; (iv) Article 8; and (v) providing written notice to the other Party of such Party’s anticipated use of the jointly owned Sample Data in a timely manner prior to such anticipated use.

 

Article 6

INTELLECTUAL PROPERTY

 

6.1       Ownership and Use; Definitions .

 

(a)       Ownership of other Inventions. Ownership of any Invention that is not a Kite Owned Invention, Humanigen Owned Invention, or Collaboration Invention will be determined in accordance with U.S. patent law.

 

(b)       Sole Ownership and Use of Investigational Product-Specific Inventions

 

(i)        All Inventions that relate solely to (A) the Kite Investigational Product and uses thereof, methods of making, and modifications thereof, including improvements thereto, or (B) the Study Data and Sample Data that is solely owned by Kite (collectively, a “ Kite Owned Invention ”) , and all right, title and interest therein, shall be the sole and exclusive property of Kite. For the avoidance of doubt, any Collaboration Invention that generically encompasses the Kite Investigational Product (and not the Humanigen Investigational Product) within its scope, even where the Kite Investigational Product is not disclosed per se, is a Kite Owned Invention. Kite shall solely own all right, title and interest in and to any Kite Owned Invention. Kite shall have the sole right (but not the obligation), at its sole expense, to file, Prosecute, Maintain, and enforce Patents on the Kite Owned Inventions, including the right to use Study Data and Sample Data in such Prosecution and Maintenance subject to the obligations in Articles 5, 6 and 7.

 

(ii)        All Inventions that relate solely to (A) the Humanigen Investigational Product and uses thereof, methods of making, and modifications thereof, including any improvements thereto, or (B) the Study Data and Sample Data that is solely owned by Humanigen (“collectively, “ Humanigen Owned Inventions” ”), and all right, title and interest therein, shall be the sole and exclusive property of Humanigen. For the avoidance of doubt, any Collaboration Invention that generically encompasses the Humanigen Investigational Product (and not the Kite Investigational Product) within its scope, even where the Humanigen Investigational Product is not disclosed per se, is a Humanigen Owned Invention. Humanigen shall solely own all right, title and interest in and to any Humanigen Owned Invention. Humanigen shall have the sole right (but not the obligation), at its sole expense, to file, Prosecute, Maintain, and enforce Patents on the Humanigen Owned Inventions, including the right to use Study Data and Sample Data in such Prosecution and Maintenance subject to the obligations in Articles 5, 6 and 7.

 

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(c)       Joint Ownership of Collaboration Inventions . All rights to all Inventions relating to, or covering the Combination that are not Kite Owned Inventions or Humanigen Owned Inventions (“ Collaboration Inventions ”), and all right, title and interest thereto, shall be jointly owned by Kite and Humanigen. Each Party shall promptly disclose to the other Party any Invention they reasonably believe to be a Collaboration Invention. For those countries where a specific license is required for a joint owner of a Collaboration Invention to practice such Collaboration Invention in such countries, (i) Humanigen hereby grants to Kite a perpetual, irrevocable, non-exclusive, worldwide, royalty-free, fully paid-up license, transferable and sublicensable, under Humanigen’s right, title and interest in and to all Collaboration Inventions to use such Inventions for any use, and (ii) Kite hereby grants to Humanigen a perpetual, irrevocable, non-exclusive, worldwide, royalty-free, fully paid-up license, transferable and sublicensable, under Kite’s right, title and interest in and to all Collaboration Inventions to use such Inventions for any use, in each case subject to the obligations in Articles 5, 6 and 7. For clarity, the terms of this Agreement do not provide either Party with any rights, title or interest or any license to the other Party’s intellectual property except as necessary to conduct the Study, and as expressly provided under this Agreement, including as set forth in Section 6.3(e), below.

 

(d)       Assignments and Cooperation . Each Party hereby assigns to the other Party any joint or sole ownership interest in the Inventions as necessary to effectuate ownership of the Inventions as set forth in Sections 6.1(b) and 6.1(c). Each Party shall require its employees and Third Parties acting on a Party’s behalf to assign to such Party any Inventions conceived, reduced to practice or otherwise created by such employees or Third Parties, and to cooperate with such Party in connection with obtaining patent protection therefor. The Parties agree to cooperate with each other to effectuate ownership of the Inventions as set forth in Sections 6.1(b) and 6.1(c), including by executing and recording documents.

 

6.2       Mutual Freedom to Operate for Collaboration Inventions .

 

(a)       License to Kite . Humanigen hereby grants to Kite a non-exclusive, worldwide, fully paid, perpetual, sublicensable (as described in Section 6.2(c)) license, under Humanigen’s right, title and interest in and to the Humanigen Owned Inventions, solely for the purpose of performing of the Study with the Kite Investigational Product for use in the Combination.

 

(b)       License to Humanigen . Kite hereby grants to Humanigen a non-exclusive, worldwide, fully paid, perpetual, sublicensable (as described in Section 6.2(c)) license, under Kite’s right, title and interest in and to the Kite Owned Inventions, solely for the purpose of performing the Study with the Humanigen Investigational Product for use in the Combination.

 

(c)       Sublicenses; Exercise of Licensed Rights by Third Parties . Each Party may sublicense the rights granted to such Party under this Section 6.2, and any rights under such sublicense may be further sublicensed to multiple tiers of sublicensees. Further, the rights under such licenses may be exercised by an Affiliate or Third Party on behalf of such Party (or a sublicensee) without the grant of a sublicense of such rights.

 

(d)       No Implied Licenses; Background IP . Except as otherwise expressly provided in this Agreement, this Agreement does not grant any right or license to either Party under any of the other Party’s intellectual property rights (including pre-existing intellectual property rights owned or controlled by either Party prior to the Effective Date or intellectual property rights developed by such Party independently from the activities contemplated under this Agreement ( “Background IP ”)), and no other right or license is to be implied or inferred from any provision of this Agreement or by the conduct of the Parties, provided, however, that (i) Humanigen hereby covenants and agrees not to assert that the use of any Collaboration Invention, or the Study Data, or the Sample Data by Kite or its Affiliates has infringed any Background IP of Humanigen and (ii) Kite hereby covenants and agrees not to assert that the use of any Collaboration Invention, or the Study Data, or the Sample Data by Humanigen or its Affiliates has infringed any Background IP of Kite. For clarity, the terms of this Agreement do not provide Kite or Humanigen any rights to use or commercialize the other Party’s Investigational Products, alone or in combination with that Party’s Investigational Products.

 

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(e)       Termination. Any and all licenses granted under this Section 6.2 shall terminate upon the latest of (i) termination of this Agreement, and (ii) Study Completion.

 

6.3       Patent Prosecution and Maintenance of Collaboration Inventions .

 

(a)       Prosecution and Maintenance of Joint Patents . Kite will control the Prosecution and Maintenance of any Patent covering the Collaboration Invention (“ Joint Patent” ) , including deciding on (i) the content of the application; (ii) the countries in which Prosecution and Maintenance should be conducted, subject to Section 6.3(d); and (iii) the timing for filing of any provisional or regular Patent application. Kite will consult Humanigen in a timely manner and consider Humanigen’s comments in good faith. In the event of conflicting comments to Prosecution and Maintenance, Kite will make the final decision. Kite will provide copies of all Joint Patent applications filed and all related Prosecution and Maintenance documents to Humanigen.

 

(b)       Cooperation . Humanigen shall cooperate with and assist Kite in the Prosecution and Maintenance of any Joint Patent, including (i) consulting with Kite after receiving any substantial action or development in the Prosecution and Maintenance of such Patent and (i) making its relevant scientists and scientific records reasonably available.

 

(c)       Costs . Except as provided in Sections 6.3(a) and 6.3(d), the Parties shall equally share the out-of-pocket costs for all Joint Patents, with each Party contributing up to US$250,000 per annum unless jointly agreed in writing by the Parties.

 

(d)       Assignment to One Party . In the event that one Party (for purposes of this Section, the “ Filing Party ”) wishes to file a Patent application for a given Collaboration Invention and the other Party (for purposes of this Section, the “ Non-Filing Party ”) does not wish to file such Patent application in any countries or in particular countries, the Non-Filing Party shall execute such documents and perform such acts, at the Filing Party’s expense, as may be reasonably necessary to effect an assignment of such Collaboration Invention (including applicable Patent applications) to the Filing Party in all applicable countries, in a timely manner, to allow the Filing Party to Prosecute and Maintain such Patent applications, at the Filing Party’s expense. Likewise, if a Party (for purposes of this Section, the “ Opting-Out Party ”) wishes to discontinue the Prosecution and Maintenance of a Patent application for a given Collaboration Invention in any countries or in particular countries, the other Party, at its sole option (for purposes of this Section, the “ Continuing Party ”), may continue such Prosecution and Maintenance. In such event, the Opting-Out Party shall execute such documents and perform such acts, at the Continuing Party’s expense, as may be reasonably necessary to effect an assignment of such Collaboration Invention (including applicable Patent applications) to the Continuing Party in all applicable countries, in a timely manner, to allow the Continuing Party to Prosecute and Maintain such Patent applications, at the Continuing Party’s expense. The Non-Filing Party and the Opting-Out Party (as applicable) shall be entitled to receive copies of all Patent applications filed and all related Prosecution and Maintenance documents. Any Collaboration Invention (including applicable Patent applications) so assigned shall thereafter be owned solely by the Filing Party or Continuing Party (as applicable), provided however, that the Non-Filing Party or Opting-out Party as applicable (including its successors and assigns) shall retain a perpetual, irrevocable, non-exclusive, worldwide, royalty-free, sublicensable, transferable, and fully paid-up license for all purposes under any Patent claims arising from such Collaboration Invention or Joint Patent in any applicable countries with respect to a product discovered, developed, or commercialized by the Non-Filing Party or Opting-out Party.

 

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(e)       Limitations on Patent Prosecution . Notwithstanding anything to the contrary in Section 5.1(b) and Section 5.3(b), and except as expressly provided in Section 6.1(d) and Section 6.3(a), without the prior written consent of the other Party:

 

(i)        neither Humanigen nor Kite shall file or Prosecute any Patent application covering the subject matter of a Collaboration Invention or otherwise disclosing the other Party’s Confidential Information or, the Protocol, any jointly owned or solely owned Study Data or Sample Data, either relating to the Combination of the Kite Investigational Product and the Humanigen Investigational Product or any relating to the other Party’s Investigational Product, to the extent such information has not been previously published;

 

(ii)        Humanigen shall not file or Prosecute any Patent application covering the subject matter of a Kite Owned Invention;

 

(iii)        Kite shall not file or Prosecute any Patent application covering the subject matter of a Humanigen Owned Invention; and

 

(iv)        neither Humanigen nor Kite shall (A) provide assistance to any Third Party for any patent application covering subject matter that such Party is restricted from filing or prosecuting under clauses 6.3(e)(i) – 6.3(e)(iii) or (B) grant the right to any Third Party to disclose the Study Data or the Sample Data in the filing or prosecution of any patent application, regardless of which Party(ies) own such data, except in the case of clause (B), if such Third Party is an Affiliate of such Party.

 

(f)       Joint Research Agreement . This Agreement shall be deemed a joint research agreement under 35 U.S.C. §102(c) and any foreign counterparts entered into for the purpose of developing the combination of Kite Investigational Product and Humanigen Investigational Product.

 

6.4       Third Party Infringement and Patent Enforcement or Defense .

 

(a)       Notice . Each Party shall promptly provide the other Party with written notice reasonably detailing any known or alleged infringement by a Third Party of any Joint Patent, including Third Party submissions and post-grant reviews, unenforceability, or non-infringement of any such Joint Patent (collectively “ Third-Party Infringement ”). Within fifteen (15) days after receipt of such notice, the Parties shall consult with each other to determine the response to any Third Party Infringement.

 

(b)       Enforcement or Defense . Kite will have the sole right, at its sole discretion and expense, for enforcing and defending any Patents on Kite Owned Inventions and any Joint Patents assigned to Kite under Section 6.3(d). Humanigen will have the sole right, at its sole discretion and expense, for enforcing and defending any Patents on Humanigen Owned Inventions and any Joint Patents assigned to Humanigen under Section 6.3(d). The Parties shall jointly decide on a strategy for the enforcement and defense of any Joint Patent that is jointly owned and on each Party’s rights and obligations in connection therewith.

 

Article 7

CONFIDENTIALITY

 

7.1       Ownership of Confidential Information.

 

(a)        Except as otherwise expressly provided in the Agreement, Study Data, Sample Data, Inventions and other intellectual property, shall be the Confidential Information of the Party(ies) that own such Study Data, Sample Data, Inventions and other intellectual property.

 

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(b)        Data and other information (including Study Data, Sample Data and Inventions) specifically and solely related to the Kite Investigational Product or to the Humanigen Investigational Product shall be the Confidential Information solely of Kite or solely of Humanigen, respectively. Such information includes protocol synopses, investigators’ brochures (and portions thereof), biomarker data, pharmacokinetic and pharmacodynamic data and product storage, handling, expiry, administration and in use handling information.

 

(c)        Data and other information (including Study Data, Sample Data and Collaboration Inventions) generated in conduct of the Study and not solely related to only one of the Investigational Products, shall be Confidential Information of both Kite and Humanigen (“ Joint Confidential Information ”).

 

7.2       Disclosure and Use of Confidential Information .

 

(a)       Kite Confidential Information and Humanigen Confidential Information . Except to the extent expressly authorized by this Agreement or otherwise agreed to in writing, each Party (the “ Receiving Party ”) in possession of the Confidential Information of the other Party (the “ Disclosing Party ”) shall: (i) hold in confidence and not disclose the Disclosing Party’s Confidential Information to any Third Party (including without limitation, any future or potential Third Party collaborators), (ii) take all reasonable precautions to protect the Confidential Information of the other Party (including all precautions a Party employs with respect to its own confidential information of a similar nature and taking reasonable precautions to assure that no unauthorized use or disclosure is made by others to whom access to the Confidential Information of the Party is granted) and (iii) only use the Disclosing Party’s Confidential Information in connection with activities contemplated by, the exercise of rights permitted by or in order to further the purposes of this Agreement.

 

(b)       Exceptions . The foregoing obligations under Section 7.2(a) of the Receiving Party shall not apply to the Disclosing Party’s Confidential Information, to the extent that the Receiving Party establishes by written evidence that such Confidential Information:

 

(i)        was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of its disclosure by the Disclosing Party;

 

(ii)        was generally available to the public or otherwise part of the public domain at the time of its disclosure by the Disclosing Party;

 

(iii)        became generally available to the public or otherwise part of the public domain, other than through any act or omission of the Receiving Party in breach of this Agreement, after its disclosure by the Disclosing Party;

 

(iv)        was disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others;

 

(v)        was subsequently developed by or on behalf of the Receiving Party without use of the Disclosing Party’s Confidential Information or Joint Confidential Information, as the case may be; or

 

(vi)        is no longer subject to the provisions of Section 7.2 by the prior written consent of the Disclosing Party.

 

(c)       Joint Confidential Information . Except to the extent expressly authorized by this Agreement or otherwise agreed to in writing, or to the extent Study results have been published in accordance with Section 8.2 , each Party shall, with regard to Joint Confidential Information, (i) hold in confidence and not disclose Joint Confidential Information to any Third Party (including without limitation, any future or potential Third Party collaborators), (ii) take all reasonable precautions to protect Joint Confidential Information (including all precautions a Party employs with respect to its own confidential information of a similar nature and taking reasonable precautions to assure that no unauthorized use or disclosure is made by others to whom access to the Confidential Information of the Party is granted) and (iii) only use Joint Confidential Information in connection with activities contemplated by, the exercise of rights permitted by or in order to further the purposes of this Agreement.

 

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7.3       Authorized Disclosures .

 

(a)       Legal Compliance . A Party may disclose the other Party’s Confidential Information or Joint Confidential Information, as the case may be, if such disclosure is required by law, rule or regulation (including to comply with the order of a court or governmental regulations, disclosure by sponsor on any clinical trial registries, if applicable, and any disclosure requirements of the Securities and Exchange Commission or the securities exchange or other stock market on which such Party’s securities are traded), but only to the extent such disclosure is reasonably necessary for such compliance; and further provided, that such Party shall where practicable provide prompt notice of such disclosure requirement to the other Party and provide reasonable assistance to enable such other Party to seek a protective order or otherwise prevent such disclosure (in each case, to the extent it is legally permitted to do so).

 

(b)       Regulatory Authorities . A Party may disclose Joint Confidential Information to Regulatory Authorities to the extent such disclosure is required to comply with applicable governmental regulations or is in connection with such Party’s filings, submissions and communications with Regulatory Authorities regarding such Party’s Investigational Product; provided, however, such Party shall provide written notice to the other Party of such Party’s anticipated use of the Joint Confidential Information in a timely manner prior to such anticipated use.

 

(c)       Subcontractors . A Party may disclose the other Party’s Confidential Information or Joint Confidential Information, as the case may be, to subcontractors to the extent such disclosure is required to conduct the Study or perform the Sample Analysis; provided that any such subcontractors are contractually bound in writing by obligations reasonably similar to those set forth in Section 7.2.

 

(d)       Affiliates; Professional Advisors; Other Third Parties . Except for Exhibit A (Kite protocol synopsis) and Exhibit C (Sample Analysis Plan), which is Kite Confidential Information, for the purposes of this Section 7.3(d) , the terms of this Agreement shall be deemed to be Joint Confidential Information. A Party may disclose the terms of this Agreement (or a summary thereof) or the other Party’s Confidential Information or Joint Confidential Information, as the case may be, on a confidential basis and to the extent reasonably necessary, to its Affiliates, board members, accountants, attorneys, auditors or other professional advisors; provided that any such board members, accountants, attorneys, auditors or other professional advisors are legally bound by obligations reasonably similar to those set forth in Section 7.2. A Party may disclose the terms of this Agreement (or a summary thereof) or any Joint Confidential Information, to the extent reasonably necessary, to any bona fide (as evidenced by a written offer or term sheet) potential or actual investors, acquirers or merger partners for the sole purpose of evaluating an actual or potential investment, acquisition or merger; provided, however any such permitted disclosees must be contractually bound in writing by obligations reasonably similar to those set forth in Section 7.2.

 

7.4       Termination of Prior Agreements . As of the Effective Date, this Agreement supersedes the Non-Disclosure Agreement between Kite and Humanigen, Inc. effective as of June 4, 2018. All “ Information ” (as defined in such non-disclosure agreement) exchanged between the Parties thereunder shall be deemed Confidential Information of the Disclosing Party hereunder and shall be subject to the provisions of Article 7.

 

Article 8

PUBLIC DISCLOSURES; USE OF NAMES

 

8.1       Clinical Trials Registries . Kite agrees that it is the “responsible party” as that term is used in Title VIII Section 801 of the Food Drug Administration Amendments Act 2007 (known as FDAAA 801) and, as such, agrees to timely post the required Study information on ClinicalTrials.gov, and on other clinical trials registries as required by Applicable Law.

 

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8.2       Publications and Presentations .

 

(a)        Kite is committed to timely publication of the final results following Study Completion, after taking appropriate action to secure intellectual property rights (if any) arising from the Study. Kite shall have the right to first publish or present any interim results and the final results of the Study (in accordance with this Section 8.2); provided that Kite gives Humanigen an opportunity to review and provide comments in accordance with subsection (b), with such comments to be included at Kite’s sole discretion. Humanigen agrees not to publish any results of the Study or Sample Data (including any interim Study results or Sample Data) prior to the timely publication of such Study results by Kite.

 

(b)        Each Party shall use reasonable efforts to publish or present scientific papers dealing with the Study in accordance with accepted scientific practice. The Parties agree that prior to submission of the Study results for publication or presentation or any other dissemination of results, including oral presentations, the publishing Party shall invite the other to comment on the content of the material to be published or presented according to the following procedure:

 

(i)        At least forty-five (45) days prior to submission for publication of any paper, letter or any other publication, or thirty (30) days prior to submission for presentation of any abstract, poster, talk or any other presentation, the publishing Party shall provide to the other Party the full details of the proposed publication or presentation in an electronic version. Upon written request from the other Party, the publishing Party agrees not to submit data for publication/presentation for an additional ninety (90) days in order to allow for actions to be taken to preserve rights for patent protection.

 

(ii)        The publishing Party shall give reasonable consideration to any request by the other Party made within the periods set forth in subsection (i) above to modify the publication and the Parties shall work in good faith and in a timely manner to resolve any issue regarding the content for publication.

 

(iii)        The publishing Party shall remove all Confidential Information of the other Party as requested by such other Party before finalizing the publication.

 

(iv)        Acknowledgements. Each Party agrees to identify and acknowledge the other Party’s support in any press release and any other publication or presentation of the results of the Study.

 

8.3       Press Releases and Other Public Disclosures .

 

(a)       Generally . For purposes of Section 8.3, a “ Disclosure ” means a press release or other public disclosure (including without limitation, investor calls) concerning this Agreement or the subject matter hereof, including the terms and conditions of this Agreement and the Protocol. The provisions of Section 8.3 are in addition to the provisions of Article 7.

 

(b)       Review and Approval . Each Party agrees that the other Party shall have no less than five (5) Business Days (before the date of a proposed Disclosure) to review and provide comments regarding any proposed Disclosure (subject to Section 8.3(d)), unless a shorter review time is agreed to by both Parties; provided that if such proposed Disclosure contains patentable subject matter owned solely or jointly by the reviewing party, the disclosing party will delay such proposed Disclosure, for ninety (90) days, to permit the reviewing party to prepare and file a patent application. Except for Disclosures covered by other provisions of Section 8.3, if a Party desires to make a Disclosure, it shall obtain the other Party’s prior written approval for the proposed Disclosure. Disclosures include public communications that contain previously disclosed information; provided, however , neither Party shall be required to obtain the other Party’s approval to repeat any information regarding the terms of this Agreement that has already been publicly disclosed by such Party, or by the other Party, in accordance with Section 8.3, provided such information remains accurate at such time.

 

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(c)       Joint Press Release by Kite . Promptly after the Effective Date, the Parties shall issue the joint press release in the form set forth in Exhibit D .

 

(d)       Disclosure Required by Law . In the event that one Party reasonably concludes, based on the opinion of legal counsel, that a Disclosure is required by law, rule or regulation (including the disclosure requirements of the Securities and Exchange Commission or the securities exchange or other stock market on which such Party’s securities are traded (for purposes of Section 8.3, collectively, an “ Exchange ”)), such Party shall provide the other Party with such advance notice of this Disclosure as it reasonably can, but shall not be required to obtain approval therefor. Each Party agrees that it shall obtain its own legal advice with regard to its compliance with securities laws, rules and regulations, and will not rely on any statements made by the other Party relating to such securities laws, rules and regulations.

 

(e)       Filing of Agreement . The Parties acknowledge that either or both Parties may be obligated under the disclosure requirements of an Exchange to file a copy of this Agreement with such Exchange. Each Party shall be entitled to make such a required filing, provided that it uses reasonable efforts to request confidential treatment of the commercial terms and sensitive technical terms of this Agreement, to the extent such confidential treatment is reasonably available to such Party. The filing Party shall provide to the other Party a copy of this Agreement marked to show the provisions for which the filing Party intends to seek confidential treatment no less than five (5) Business Days before the date of the proposed filing, for such other Party’s review and comment, and shall thereafter provide reasonable advance notice and opportunity for comment on any subsequent changes to the proposed redactions.

 

8.4       Use of Names . Each Party agrees to identify the other Party and acknowledge its support in any press release and any publication or presentation of the Study Data or Sample Data (which shall be in accordance with other provisions of this Agreement, including Section 8.2). Except as otherwise expressly provided in this Agreement, no right, express or implied, is granted by the Agreement to use in any manner the name of “ Kite, ” “ Gilead, ” “ Humanigen ” or any other trade name or trademark of the other Party (or its Affiliates) in any public statement or for commercial, marketing or other promotional purpose, without the other Party’s prior written consent.

 

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Article 9

HUMAN SUBJECTS

 

9.1       Informed Consent . Kite shall prepare the patient informed consent form for the Study (which shall include any required consent for the Sample Analysis) in consultation with Humanigen (it being understood and agreed that the portion of the informed consent form relating to the Humanigen Investigational Product will be provided to Kite by Humanigen and shall include risks and discomforts associated with the Humanigen Investigational Product substantially similar to those identified in the safety information made available to Kite by Humanigen). Any changes to such form that relate to the Humanigen Investigational Product shall be subject to Humanigen’s review and prior written consent. Kite shall obtain the informed written consent of all Subjects participating in the Study, in accordance with Applicable Law. The informed consent form: (a) shall not represent that Humanigen is a Sponsor; (b) shall not represent that Humanigen agrees to compensate Subjects for Study-related injuries; and (c) shall not represent that Humanigen shall provide the Humanigen Investigational Product to Subjects after Study Completion or early termination of the Study. Kite shall provide copies of the forms of informed written consents upon Humanigen’s request. To the extent consents are validly obtained, and in a form approved by Kite, Kite further represents and warrants that the Samples may be used as contemplated in this Agreement without any obligation to the Subjects or Project Participants, including any obligations of compensation to such Subjects or Project Participants or any other Third Party for the intellectual property associated with such Samples or Sample Data.

 

9.2       IRB Approval . Kite shall obtain IRB review and approval of the Protocol and the informed consent form to be used in the Study in accordance with Applicable Law.

 

9.3       Patient Privacy and Data Protection . Each Party shall comply with Applicable Law relating to patient privacy and data protection. Each Party agrees that it shall not disclose in any publication, information that would reveal the identity of a Subject (such as name, social security number, telephone number or address), without the written consent of such Subject.

 

9.4       Financial Disclosures. Within a reasonable time after the Effective Date, the Parties shall enter into an agreement related to the collection of financial disclosure information from “clinical investigators” involved in the Study and the certification and/or disclosure of the same in accordance with all Applicable Law, including, but not limited to, Part 54 of Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA Guidance Documents. Among other things, such agreement will provide (a) for Kite to track and collect from all “clinical investigators” involved in the Study either separate certification and/or disclosure forms for each of Kite and Humanigen or one (1) “combined” certification and/or disclosure form for both Kite and Humanigen and (b) that Kite will be responsible for preparing and submitting the Financial Disclosure Module 1.3.4 components to the FDA for any Regulatory Documentation in connection with the Study. For purposes of this Section 9.4, the term “clinical investigators” shall have the meaning set forth in Part 54.2(d) of Title 21 of the United States Code of Federal Regulations.

 

9.5       Transparency. To the extent required by Applicable Law, Kite will be responsible for reporting payments and other transfers of value made to health care professionals (e.g. investigators, steering committee members, data monitoring committee members, consultants, etc.) in connection with the Study in accordance with reporting requirements under Applicable Law (including the Physician Payment Sunshine Act and state gift laws, and the European Federation of Pharmaceutical Industries and Associations Disclosure Code) and Kite policies. Humanigen shall provide all information required for such reporting regarding the value of the Humanigen Investigational Product provided for use in the Study. Such information shall be provided to the point of contact within Kite’s Global Clinical Supplies group who is identified to Humanigen in writing upon the execution of the Agreement and thereafter promptly following any change to such point of contact. Humanigen shall provide the necessary information regarding the value of the Humanigen Investigational Product within fifteen (15) business days following the execution of this Agreement. In the event that, at any time during the term of this Agreement, the value of the Humanigen Investigational Product provided under this Agreement changes, Humanigen shall notify Kite of such revised value, and the effective date of such revised value, within fifteen (15) business days following such change in value.

 

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Article 10

SUBCONTRACTING; RECORDS

 

10.1       Subcontracting . Each Party shall have the right to delegate any portion of its obligations under this Agreement to a subcontractor, provided that such Party shall remain solely and fully liable for the performance of such subcontractors. Each Party shall ensure that each of its subcontractors performs its obligations pursuant to the terms of this Agreement, including the Exhibits. Each Party shall use reasonable efforts to obtain and maintain copies of documents relating to the obligations performed by such subcontractors that are held by or under the control of such subcontractors and that are required to be provided to the other Party under this Agreement.

 

10.2       Records .

 

(a)        Each Party shall maintain complete and accurate records of its activities under this Agreement, including without limitation, records relating to its Sample Analysis, and the manufacture and supply of the Investigational Product in accordance with Applicable Law, including GCP, GLP, and GMP. Humanigen shall make its manufacturing and supply records with respect to the Humanigen Investigational Product available to review, audit and inspect by Kite in accordance with the Quality Agreement and PV Agreements, as applicable, or upon request by Kite at reasonable times during normal business hours. Kite shall make such records which are related to use of funds by Kite to conduct the Study, for review, audit and inspection by Humanigen, once a year, with at least fifteen (15) days advance notice by Humanigen, and such audit and inspection will occur during normal business hours.

 

(b)        Each Party shall maintain such records for at least the period of time required by Applicable Law, but for no less than ten (10) years following the completion or termination of the Study.

 

Article 11

COMPLIANCE WITH LAWS

 

11.1       Compliance with Laws and Policies . Each Party shall perform activities under this Agreement in compliance with Applicable Law and in accordance with good scientific and business ethics and the ethics and other corporate policies applicable to such Party. Specifically, each Party covenants that it, its directors, employees, officers, and anyone acting on its behalf, shall not, in connection with the performance of this Agreement, directly or indirectly, make, promise, authorize, ratify or offer to make, or take any act in furtherance of any payment or transfer of anything of value for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an improper advantage; or improperly assisting it in obtaining or retaining business for it or the other Party, or in any way with the purpose or effect of public or commercial bribery. Other provisions of the Agreement require compliance with specified areas of Applicable Law and such other provisions do not limit the scope of compliance required of the Parties under this Section.

 

11.2       Debarment . Kite shall require each Project Participant to represent and warrant that neither the Project Participant nor anyone employed by such Project Participant has been debarred under 21 USC § 335a, disqualified under 21 CFR § 312.70 or § 812.119, sanctioned by a Federal Health Care Program (as defined in 42 USC § 1320a-7b(f)), including the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar regional, national, federal or state agency or program. If a Project Participant receives notice of debarment, suspension, sanction, exclusion, ineligibility or disqualification under the foregoing-referenced statutes, Kite shall promptly notify Humanigen, and the Parties shall agree upon appropriate action to address the matter.

 

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Article 12

TERM; TERMINATION

 

12.1       Term . Unless sooner terminated as provided in Article 12, this Agreement shall expire on the one year anniversary of the date that Kite provides the Final Study Report to Humanigen or termination of the Study (in either case, “ Term ”).

 

12.2       Termination for Material Breach . Either Party may terminate this Agreement, by notice to the other Party, for any material breach of this Agreement by the other Party, if such breach is not cured within thirty (30) days after the allegedly breaching Party receives notice of such breach from the non-breaching Party; provided, however , if such breach is not capable of being cured within such thirty (30) day period, the cure period shall be extended for such amount of time that the Parties agree to in writing is reasonably necessary to cure such breach, so long as the allegedly breaching Party is using diligent efforts to do so.

 

12.3       Termination for Other Reasons . Kite may immediately suspend or terminate the Study by notice to Humanigen. Either Party may terminate this Agreement immediately, by notice to the other Party, if: (a) based on a review of Study Data or other Study-related information, such Party determines that the Study may unreasonably affect patient safety; (b) any Regulatory Authority or IRB withdraws the authorization and/or approval to conduct the Study; (c) any Regulatory Authority takes any action, or raises any objection, that prevents such Party from supplying its Investigational Product for purposes of the Study; or (d) the other Party breaches the representation and warranty under Section 13.1(c). Either Party may terminate this Agreement with thirty (30) days’ notice to the other Party, if such Party determines, in its sole discretion, to discontinue all development of its Investigational Product, for medical, scientific, business or legal reasons; provided, however that if Humanigen is the terminating Party pursuant to this provision, it shall fulfill its supply obligations under Section 4.1 after such termination.

 

12.4       Effects of Termination or Expiration .

 

(a)       Study Wind-Down . Following termination of this Agreement under Section 12.2 or Section 12.3, the Parties shall cooperate to ensure the orderly wind-down of Study activities, taking into consideration the safety and welfare of Subjects.

 

(b)       Accrued Rights and Obligations . Except as otherwise expressly provided in this Agreement, termination of this Agreement shall not affect the rights and obligations of the Parties that accrued prior to the effective date of such termination. Any right that a Party has to terminate this Agreement, and any rights that such Party has under Article 12, shall be in addition to and not in lieu of all other rights or remedies that such Party may have at law or in equity or otherwise.

 

(c)       Survival . Except as otherwise expressly provided in this Agreement, the following shall survive this Agreement’s expiration or termination for any reason: Article 1 (Definitions), Section 2.6 (Regulatory Matters), Section 2.8(a) (Documentation), Section 2.10 (Additional Studies), Section 5.1(b) (Ownership of Study Data), Section 5.3(b) (Sample Data), Article 6 (Intellectual Property and Licenses), Article 7 (Confidentiality), Article 8 (Public Disclosures; Use of Names), Section 9.3 (Patient Privacy and Data Protection), Section 10.2 (Records), Section 12.4 (Effects of Termination), Section 13.2 (Disclaimers), Section 14.1 (Indemnification), Section 14.2 (Limitation on Liability), Article 15 (Dispute Resolution) and Article 16 (Miscellaneous). To the extent applicable to a Section or Article that survives the expiration or termination of this Agreement, any other Sections and Articles that are (directly or indirectly) referenced in, or refer to, such surviving Section or Article shall survive.

 

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Article 13

REPRESENTATIONS AND WARRANTIES

 

13.1       Mutual Representations and Warranties . Each Party represents and warrants to the other Party the following:

 

(a)        Such Party has the full right, power and authority, and has obtained all approvals, permits or consents necessary, to enter into this Agreement, to perform all of its obligations hereunder.

 

(b)        Such Party has not entered into prior to the Effective Date, and shall not enter into during the Term, any agreement that conflicts with a Party’s obligations hereunder.

 

(c)        Neither Party nor anyone employed by it has been debarred under 21 USC § 335a, disqualified under 21 USC § 312.70 or § 812.119, sanctioned by a Federal Health Care Program (as defined in 42 USC § 1320a-7b(f)), including the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar regional, national, federal or state agency or program. If such Party receives notice of debarment, suspension, sanction, exclusion, ineligibility or disqualification under the foregoing-referenced statutes, such Party shall promptly notify the other Party, and the Parties shall agree upon appropriate action to address the matter.

 

13.2       Disclaimers . NEITHER PARTY REPRESENTS OR WARRANTS THAT THE STUDY WILL BE SUCCESSFUL OR LEAD TO ANY PARTICULAR RESULT. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO ITS RESPECTIVE INVESTIGATIONAL PRODUCT, MATERIALS OR INFORMATION SUPPLIED BY IT TO THE OTHER PARTY HEREUNDER, AND EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.

 

Article 14

INDEMNIFICATION; LIMITATION ON LIABILITY; INSURANCE

 

14.1       Indemnification .

 

(a)       Definitions . The following definitions are for purposes of Section 14.1:

 

(i)        Claims ” means claims, suits, actions, demands or other proceedings by any Third Party arising out of this Agreement or the Study, including product liability claims.

 

(ii)        Indemnitee ” means, as applicable, a Kite Indemnitee (as defined in Section 14.1(b)) or a Humanigen Indemnitee (as defined in Section 14.1(c)).

 

(iii)        Losses ” means any and all liabilities, damages, settlements, penalties, fines, reasonable costs and expenses (including, reasonable attorneys’ fees and other expenses of litigation).

 

(b)       Indemnification by Humanigen . Humanigen hereby agrees to indemnify, defend (if requested by Kite) and hold harmless each of Kite, its Affiliates and its and their officers, directors, employees, subcontractors and agents (for purposes of Section 14.1, each, a “ Kite Indemnitee ”) from and against Losses incurred in connection with Claims, to the extent such Losses (A) arise out of or in connection with: (1) the negligence or willful misconduct of any Humanigen Indemnitees; (2) Humanigen’s breach of any of its representations, warranties, covenants or obligations under this Agreement; or (3) Humanigen’s breach of any Applicable Law pertaining to activities it performs under this Agreement; or (B) are directly caused by the Humanigen Investigational Product, except to the extent to Losses arise out of or in connection with (1) the negligence or willful misconduct of any Kite Indemnitees; (2) Kite’s breach of any of its representations, warranties, covenants or obligations under this Agreement; or (3) Kite’s breach of any Applicable Law pertaining to activities it performs under this Agreement.

 

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(c)       Indemnification by Kite . Kite hereby agrees to indemnify, defend (if requested by Humanigen) and hold harmless each of Humanigen, its Affiliates and its and their officers, directors, employees, subcontractors and agents (for purposes of Section 14.1, each, a “ Humanigen Indemnitee ”) from and against Losses incurred in connection with Claims, to the extent such Losses (A) arise out of or in connection with: (1) the negligence or willful misconduct of any Kite Indemnitees; (2) Kite’s breach of any of its representations, warranties, covenants or obligations under this Agreement; or (3) Kite’s breach of any Applicable Law pertaining to activities it performs under this Agreement; or (B) are directly caused by the Kite Investigational Product, except to the extent any Losses arise out of or in connection with (1) the negligence or willful misconduct of any Humanigen Indemnitees; (2) Humanigen’s breach of any of its representations, warranties, covenants or obligations under this Agreement; or (3) Humanigen’s breach of any Applicable Law pertaining to activities it performs under this Agreement.

 

(d)        Each Party’s respective obligations under Section 14.1(b) and 14.1(c) are conditioned upon the Party seeking indemnification (the “ Indemnitee ”) delivering written notice to the other Party (the “ Indemnitor ”) of any potential Losses subject to indemnification hereunder promptly after the Indemnitee becomes aware of such potential Losses. The Indemnitor will have no indemnification obligations hereunder to the extent materially prejudiced by any delay by the Indemnitee in providing such notice. The Indemnitor will have the sole right to defend or settle (subject to the remainder of the paragraph) any Claim (using counsel reasonably satisfactory to the Indemnitee). The Indemnitee will cooperate fully with Indemnitor in connection therewith, at the Indemnitor’s expense. The Indemnitee may participate in (but not control) the defense thereof at its sole cost and expense. The Indemnitor shall keep the Indemnitee advised of the status of such action, suit, proceeding or claim and the defense thereof and shall reasonably consider recommendations made by the Indemnitee with respect thereto. The Indemnitee shall not agree to any settlement of such action, suit, proceeding or claim without the prior written consent of the Indemnitor, which shall not be unreasonably withheld, delayed or conditioned. The Indemnitor shall not agree to any settlement of such action, suit, proceeding or claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnitee from all liability with respect thereto or that imposes any liability or obligation on the Indemnitee without the prior written consent of the Indemnitee, which shall not be unreasonably withheld, delayed or conditioned.

 

(e)       Study Subjects . Kite shall not offer compensation on behalf of Humanigen to any Subject or bind Humanigen to any indemnification obligations in favor of any Subject. The Parties shall share equally all Losses arising out of any Claims, other than those described in paragraphs 14.1(b) or 14.1(c) above, to the extent such Losses arise out of the Study after both Parties’ respective Investigational Products have been administered (i.e., such Losses would not have occurred but for the Combination).

 

14.2       Limitation on Liability . IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL, PUNITIVE OR EXEMPLARY DAMAGES, HOWEVER CAUSED; PROVIDED HOWEVER, NOTHING IN THIS SECTION 14.2 IS INTENDED TO LIMIT THE RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER SECTION 14.1 OR FOR DAMAGES ARISING OUT OF A BREACH OF ARTICLES 6 OR 7.

 

14.3       Insurance .

 

(a)       General . Each Party shall maintain insurance coverage as set forth in Section 14.3(b); provided, however , that both Parties have the right, in their sole discretion, to self-insure, in part or in whole, for any such coverage. Insurance coverage shall be primary insurance with respect to each Party’s own participation under this Agreement and shall be maintained with an insurance company or companies having an A.M. Best’s rating (or its equivalent) of A-VII or better. On request, each Party shall provide to the other Party certificates of insurance evidencing the insurance coverage required under Section 14.3. Each Party shall provide to the other Party written notice of any cancellation, nonrenewal or adverse material change in any of the required insurance coverages in accordance with policy provisions. The limits of any required insurance coverage shall not limit the Parties’ liability under the indemnification provisions of this Agreement.

 

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(b)       Coverage . Each Party shall maintain in full force and effect through the term of this Agreement, sufficient insurance, including (i) commercial general liability (including contractual liability) insurance covering bodily injury and property damage arising out of such Party’s obligations under this Agreement, for limits no less than one million dollars ($1,000,000) per occurrence and two million dollars ($2,000,000) in the aggregate; (ii) clinical trial liability insurance with limits not less than $10,000,000 per occurrence; and (iii) product liability insurance relating to such Party’s Investigational Product, for limits of no less than one million dollars ($1,000,000) per occurrence and two million dollars ($2,000,000) in the aggregate. For claims-made type coverage, product liability insurance and clinical trial liability insurance shall be maintained for a minimum of three (3) years after the last Subject receives treatment in connection with the Study (which may be achieved, without limitation, by way of an extended reporting period endorsement), including any treatment received after Study Completion, but not less than the statute of limitations in any state or location where the Study is being conducted. Each Party shall ensure prior to the enrollment of any Subjects that the insurance policies required by this Section cover injuries that may arise in connection with the Study.

 

Article 15

DISPUTE RESOLUTION

 

15.1       Internal Resolution . Kite and Humanigen recognize that a dispute, controversy or claim of any nature whatsoever arising out of or relating to this Agreement (each, a “ Dispute ”) may from time to time arise during the Term. In the event of the occurrence of such a Dispute, the Parties shall first refer such Dispute to the JDC pursuant to Section 3.1(c). If the JDC cannot resolve such Dispute, the Party bringing the Dispute shall provide written notice, including a description of the Dispute and the steps taken to resolve such Dispute, to the other Party. Upon receipt of such notice, the Dispute shall be referred to Humanigen’s Chief Executive Officer and Kite’s Vice President, Clinical Development, for resolution, prior to proceeding under the other provisions of Article 15.

 

15.2       Dispute Resolution and Jurisdiction. The Parties shall attempt in good faith to settle all Disputes in an amicable manner. Any Dispute arising out of or relating to this Agreement, including the breach, termination or validity hereof or thereof, shall be governed by and construed in accordance with the substantive laws of the State of California, without giving effect to its choice of law principles that would direct the application of the substantive law of any other jurisdiction. The Parties hereby exclude from this Agreement the application of the United Nations Convention on Contracts for the International Sale of Goods. Nothing contained in this Agreement shall deny either Party the right to seek injunctive or other equitable relief from a court of competent jurisdiction in the context of a bona fide emergency or prospective irreparable harm, and such an action may be filed or maintained notwithstanding any ongoing discussions between the Parties.

 

Article 16

MISCELLANEOUS

 

16.1       Notices . Except as otherwise expressly provided in this Agreement, any notice required under this Agreement shall be in writing, shall specifically refer to this Agreement and shall be sent in accordance with the provisions of this Section 16.1. Notices shall be sent via one of the following means and will be effective (a) on the date of delivery, if delivered in person; (b) on the date of receipt, if sent by a facsimile or email (with delivery confirmed); or (c) on the date of receipt, if sent by private express courier or by first class certified mail, return receipt requested (or its equivalent). Any notice sent via facsimile or email shall be followed by a copy of such notice by private express courier or by first class mail. Notices shall be sent to the other Party at the addresses set forth below. Either Party may change its addresses for purposes of this Section 16.1 by sending written notice to the other Party.

 

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  If to Kite:  

Kite Pharma, Inc.

2225 Colorado Avenue

Santa Monica, CA 90404

Attn: Corporate Counsel

Telephone: 310-824-9999

Email: legal@kitepharma.com

       
  If to Humanigen:   Humanigen, Inc.

533 Airport Blvd, Suite 400

Burlingame, CA 94010

Attn: Cameron Durrant

Email: cdurrant@humanigen.com

  

16.2       Assignment .

 

(a)       General . Except as otherwise expressly provided in this Agreement, neither Party may assign any of its rights or delegate any of its obligations under this Agreement without the prior written consent of the other Party, such consent not to be unreasonably withheld. Subject to the other provisions of Section 16.2, either Party may assign this Agreement, in part or in its entirety, to (a) an Affiliate; (b) an acquirer of all its capital stock (by reverse triangular merger or otherwise) or all or substantially all its assets; or (c) an acquirer (whether by license or acquisition) of all of the assigning Party’s rights with respect to its Investigational Product, including rights to research, develop, manufacture and commercialize the Investigational Product (for purposes of Section 16.2, any of the foregoing, a “ Change of Control ”), provided that in the event of any Change of Control, the Third Party to which this Agreement is assigned expressly agrees in writing to assume and be bound by the obligations of the assigning Party under this Agreement. A copy of such writing shall be provided to the non-assigning Party within thirty (30) days of the assignment. Subject to the foregoing and other applicable provisions of Section 16.2 this Agreement will inure to the benefit of and bind the Parties’ successors and assigns. Any assignment or delegation in contravention of any such applicable provisions shall be null and void. Notwithstanding any other provision of Section 16.2, this Agreement may only be assigned together with the Ancillary Agreements.

 

(b)       Acquisitions . If Humanigen or its Affiliates acquires, or is acquired by, a Third Party that has an active program researching, developing or commercializing a chimeric antigen receptor designed to target the antigen CD19 (any or all of which such programs are a “ Kite Competitive Program ”), Humanigen shall (i) adopt reasonable procedures to prevent any disclosure and/or use of Confidential Information of Kite or Joint Confidential Information, as the case may be, in any Kite Competitive Program, and (ii) provide notice to Kite describing such procedures as soon as practicable.

 

16.3       Force Majeure . Neither Party shall be deemed to have breached this Agreement for failure to perform its obligations under this Agreement to the extent such failure results from causes beyond the reasonable control of the affected Party, such causes including acts of God, earthquakes, fires, floods, embargoes, wars, acts of terrorism, insurrections, riots, civil commotions, omissions or delays in action by any governmental authority, acts of a government or agency thereof and judicial orders or decrees. If a force majeure event occurs, the Party unable to perform shall promptly notify the other Party of the occurrence of such event, and the Parties shall meet (in person or telephonically) promptly thereafter to discuss the circumstances relating thereto. The Party unable to perform shall (a) provide reasonable status updates to the other Party from time to time; (b) use commercially reasonable efforts to mitigate any adverse consequences arising out of its failure to perform; and (c) resume performance as promptly as possible.

 

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16.4       Relationship of the Parties . The Parties to this Agreement are independent contractors, and nothing contained in this Agreement shall be deemed or construed to create a partnership, joint venture, employment, franchise, agency or fiduciary relationship between the Parties.

 

16.5       Amendment; Waiver . Except as otherwise expressly provided in this Agreement, no amendment to this Agreement shall be effective unless made in writing and executed by an authorized representative of each Party. A Party’s failure to exercise, or delay in exercising, any right, power, privilege or remedy under this Agreement shall not (a) operate as a waiver thereof or (b) operate as a waiver of any other right, power, privilege or remedy. A waiver will be effective only upon the written consent of the Party granting such waiver.

 

16.6       Construction; Captions . Each Party acknowledges that it participated in the negotiation and preparation of this Agreement and that it had the opportunity to consult with an attorney of its choice in connection therewith. Ambiguities, if any, in this Agreement shall not be construed against either Party, irrespective of which Party may be deemed to have drafted the Agreement or authorized the ambiguous provision. Capitalized terms defined in the singular shall include the plural and vice versa. The terms “ includes ” and “ including ” mean “ includes, without limitation, ” and “ including, without limitation, ” respectively. Titles, headings and other captions are for convenience only and shall not affect the meaning or interpretation of this Agreement.

 

16.7       Severability . If any of the provisions of this Agreement are held to be illegal, invalid or unenforceable, such illegal, invalid or unenforceable provisions shall be replaced by legal, valid and enforceable provisions that will achieve to the maximum extent possible the intent of the Parties, and the other provisions of this Agreement shall remain in full force and effect.

 

16.8       Entire Agreement . This Agreement, together with the Ancillary Agreements and the Exhibits hereto, contains the entire understanding between the Parties with respect to the subject matter hereof and thereof and supersedes and terminates all prior agreements, understandings and arrangements between the Parties with respect to such subject matter, whether written or oral.

 

16.9       Counterparts; Facsimiles . This Agreement may be executed in two (2) or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. A facsimile (including a PDF image delivered via email) of this Agreement, including the signature pages hereto, will be deemed to be an original. Notwithstanding the foregoing, the Parties shall deliver original execution copies of this Agreement to one another as soon as practicable following execution thereof.

 

[Signature page follows]

 

    29  
 

 

In Witness Whereof , the Parties have caused this Agreement to be executed by their respective duly authorized representatives as set forth below.

 

 

 

Kite Pharma, Inc.  

 

 

 

Humanigen, Inc.

 

 

/s/ J.G. McHutchison   /s/ Cameron Durrant
Signature   Signature
     
Name: J.G. McHutchison

Title: CSO

Date: May 30, 2019
  Name: Cameron Durrant

Title: CEO

Date: May 30, 2019

  

    30  
 

  

Exhibit A

 

Kite Protocol Synopsis 

 

    31  
 

 

Exhibit B

 

Study Budget  

 

    32  
 

  

Exhibit C

 

Sample Analysis Plan

 

    33  
 

 

Exhibit D

 

Press Release

 

This press release was filed as Exhibit 99.1 to the Current Report on Form 8-K of Humanigen, Inc. with the Securities and Exchange Commission on May 31, 2019.

 

 

 

 

 

 

 

Exhibit 10.3

 

SECURED BRIDGE NOTE

 

 

$[NUMBER] June 28, 2019

 

For value received, the undersigned, Humanigen, Inc., a Delaware corporation (“ Borrower ”), promises to pay to the order of [HOLDER NAME], and its successors and assigns (together with its successors and assigns, “ Lender ”), in lawful money of the United States of America, the principal sum of $[NUMBER] with interest thereon to be computed from the date of disbursement under this promissory note (the “ Note ”) at the rate of 7% (the “ Interest Rate ”).

 

Borrower shall pay all outstanding principal and accrued interest at the Interest Rate and all other amounts owed pursuant to this Note and the other Credit Documents on October 1, 2019 (the “ Maturity Date ”), unless earlier accelerated pursuant to the terms of this Note or any other Credit Document.

 

Borrower shall make all payments payable in cash under this Note in lawful money of the United States. All payments paid by Borrower to Lender under this Note and under the other Credit Documents shall be applied in the following order of priority: (i) to amounts, other than principal and interest, due to Lender pursuant to this Note or the other Credit Documents; (ii) to accrued but unpaid interest on this Note; and (iii) to the unpaid principal balance of this Note. Borrower irrevocably waives the right to direct the application of any and all payments at any time hereafter received by Lender from or on behalf of Borrower, and Borrower irrevocably agrees that Lender shall have the continuing exclusive right to apply any and all such payments against the then due and owing obligations of Borrower in such order of priority as Lender may deem advisable. If Borrower makes any payment of principal, interest or other amounts upon the indebtedness by check, draft, or other remittance, Lender shall not be deemed to have received such payment until Lender actually receives the payment instrument.

 

1.       Interest. Interest shall accrue at the Interest Rate on the outstanding principal balance at the end of each day on which any amount is outstanding under this Note. Interest shall be calculated on a daily basis (computed on the actual number of days elapsed over a year of 360 days), commencing on the date of this Note, and shall be based upon the outstanding principal balance at the end of each day.

 

2.       Default Interest. Upon the occurrence of an Event of Default (as hereinafter defined), including the failure of Borrower to make full payment on the Maturity Date, Lender shall be entitled to receive, and Borrower shall pay, interest on the then outstanding principal balance due and payable under this Note at the rate of 3.0% per annum above the Interest Rate (“ Default Rate ”) but in no event greater than the maximum rate permitted by applicable law. Interest shall accrue and be payable at the Default Rate from the occurrence of an Event of Default until all Events of Default have been fully cured. Such accrued interest shall be secured by the Liens (as hereinafter defined) in favor of Lender under the Credit Documents (as hereinafter defined). Borrower agrees that Lender’s right to collect interest at the Default Rate is given for the purpose of compensating Lender at reasonable amounts for Lender’s added costs and expenses that occur as a result of Borrower’s default and that are difficult to predict in amount, such as increased general overhead, concentration of management resources on problem loans, and increased cost of funds. Lender and Borrower agree that Lender’s collection of interest at the Default Rate is not a fine or penalty, but is intended to be and shall be deemed to be reasonable compensation to Lender for increased costs and expenses that Lender will incur if an Event of Default occurs hereunder. Collection of interest at the Default Rate shall not be construed as an agreement or privilege to extend the Maturity Date or to limit or impair any rights and remedies of Lender under any Credit Document. If judgment is entered on this Note, interest shall continue to accrue post-judgment at the greater of (a) the Default Rate or (b) the applicable statutory judgment rate.

 

   
 

 

3.             Security; Definitions; and Construction.

 

(a)       This Note is and shall be secured by, and Lender is entitled to the benefits of, the Liens granted by Borrower to Agent under the Credit Documents and all other related filings, instruments, agreements and documents providing Collateral for the Loan and the other Obligations (as hereinafter defined), whether now or hereafter in existence.

 

(b)       When used herein, the following terms shall have the following meanings (terms defined in the singular to have the same meaning when used in the plural and vice versa):

 

Agent ” means Black Horse Capital Master Fund Ltd., in its capacity as agent for the Lender and the other Holders, and any successors or assigns thereof in such capacity.

 

Change in Control ” means (i) any reorganization, merger or consolidation of Borrower, other than a transaction or series of related transactions in which the holders of the voting securities of Borrower outstanding immediately prior to such transaction or series of related transactions retain, immediately after such transaction or series of related transactions, at least a majority of the total voting power represented by the outstanding voting securities of Borrower or such other surviving or resulting entity or (ii) a sale, lease or other disposition of all or substantially all of the assets of Borrower.

 

Code ” means the Uniform Commercial Code as in effect in the State of Delaware from time to time.

 

Collateral means all personal and real property with respect to which a Lien has been granted to or for the benefit of Agent pursuant to the Credit Documents, or which otherwise secures the payment or performance of any Obligation.

 

Credit Documents ” means, collectively, the Security Agreement, this Note, and any and all guaranties, security agreements, pledge agreements, and other instruments, agreements and documents delivered to Agent from time to time that evidence, secure or otherwise relate to any of the transactions described in or contemplated thereby, and any amendments, renewals, restatements, replacements or other modifications of the foregoing from time to time.

 

Financing ” means a bona fide transaction or series of related transactions with the principal purpose of raising capital, pursuant to which Borrower raises aggregate gross proceeds of not less than THREE MILLION DOLLARS ($3,000,000.00).

 

Holders ” has the meaning ascribed to such term in the Security Agreement.

 

Lien ” means any mortgage, deed of trust, pledge, security interest, hypothecation, assignment, deposit arrangement, lien (statutory or other), or preference, priority, or other security agreement or preferential arrangement, charge or encumbrance of any kind or nature whatsoever (including any conditional sale or other title retention agreement, any financing lease having substantially the same economic effect as any of the foregoing, and the filing of any financing statement under the Code or comparable law of any jurisdiction to evidence any of the foregoing).

 

Loan ” means the loan evidenced by this Note.

 

Loan Parties ” means, collectively, Borrower and any other party who may from time to time be obligated under this Note.

 

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Obligations ” means this Loan and all other term loans and revolving credit loans and all other advances, debts, liabilities, obligations, covenants and duties owing, arising, due or payable from Borrower to Lender of any kind or nature, existing or future, whether or not evidenced by any note, letter of credit, reimbursement agreement, guaranty or other instrument or document, whether arising under or issued pursuant to this Note, the Credit Documents or otherwise and whether direct or indirect (including those acquired by assignment), absolute or contingent, primary or secondary, due or to become due, existing on or after the date hereof and however acquired or extended, and whether or not of the same kind or quality or that relate to the same transactions or series of transactions, and all amendments, renewals, restatements, replacements, consolidations or other modifications of the foregoing from time to time. The term includes all principal, interest, fees, expenses and any other amounts chargeable to Borrower or any other person or entity under any of the Credit Documents.

 

Security Agreement means the Security Agreement dated as of the date hereof by and between Agent, as agent for the Holders, and Borrower, as it may be amended, modified, supplemented, or replaced from time to time.

 

Usury Law ” means any law or regulation of any governmental authority having jurisdiction, limiting the amount of interest that may be paid for the loan, use or detention of money.

 

(c)           The terms “include”, “including” and similar terms shall be construed as if followed by the phrase “without being limited to.” The term “or” has, except where otherwise indicated, the inclusive meaning represented by the phrase “or.” Words of masculine, feminine or neuter gender shall mean and include the correlative words of the other genders, and words importing the singular number shall mean and include the plural number, and vice versa. All article, section, schedule, and exhibit captions are used for convenient reference only and in no way define, limit or describe the scope or intent of, or in any way affect, any such article, section, schedule, or exhibit. Unless the context of this Note clearly requires otherwise, references to the plural include the singular, references to the singular include the plural. Any reference in this Note or in the Credit Documents to this Note or to any of the Credit Documents shall include all alterations, amendments, changes, extensions, modifications, renewals, replacements, substitutions, and supplements thereto and thereof, as applicable.

 

(d)          An Event of Default shall “continue” or be “continuing” until such Event of Default has been waived in writing by Lender.

 

4.             Usury. All agreements contained in the Credit Documents are expressly limited so that in no event whatsoever, whether by reason of the making of advances on account of the Loan, or under any of the Credit Documents, or acceleration of maturity of the unpaid principal balance of the Loan or otherwise, shall the amount paid or agreed to be paid by or on behalf of Borrower to Lender for the use, forbearance or detention of money exceed the highest lawful rate permissible under any applicable Usury Law. If, from any circumstances whatsoever, compliance with any of the Credit Documents, at the time performance thereunder shall be due, shall involve transcending the limit of validity prescribed by law which a court of competent jurisdiction may deem applicable thereto, then, ipso facto , the obligations to be fulfilled shall be reduced to the limit of such validity. If from any circumstance, Lender shall ever receive as interest an amount which would exceed the highest lawful rate, such amount which would be excessive interest shall be applied to the reduction of the unpaid principal balance due hereunder and not to the payment of interest. This provision shall control every other provision of all agreements between any Borrower and Lender; provided , however , that there shall be no automatic reduction of such payments or obligations as to any party barred by law from availing itself in any action or proceeding of the defense of usury, or any party barred or exempted from the operation of any Usury Law, or in the event and to the extent the Loan, because of its amount or purpose or for any other reason, is exempt from the operation of the Usury Law.

 

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5.             Prepayment.

 

(a)       This Note may be prepaid in whole or in part at any time after the date hereof.

 

(b)       This Note shall be prepaid in whole concurrently with the completion of a Financing or upon a Change in Control.

 

(c)       Any prepayment of principal shall be accompanied by a payment of interest accrued to date thereon.

 

6.             Default.

 

6.1          Events of Default. Any one or more of the following events shall constitute an event of default (each, an “ Event of Default ”) under this Note:

 

(a)       Borrower fails to timely pay any monetary obligation under this Note in accordance with the terms hereof; or

 

(b)       Borrower fails or neglects to timely perform, keep, or observe any other term, provision, condition, covenant, or agreement contained in this Note and such failure or neglect continues more than fifteen (15) days after Agent sends written notice to Borrower of such failure or neglect (provided that Borrower shall not be entitled to a cure period hereunder if Agent determines in good faith that such failure or neglect is not capable of being cured or is not capable of being cured within such 15-day period); or

 

(c)       any Loan Party fails to timely pay any monetary obligation or fails or neglects to timely perform, keep, or observe any term, provision, condition, covenant or agreement under any other Credit Document in accordance with the terms thereof and such failure or neglect continues beyond any applicable notice and cure period provided in such Credit Document; or

 

(d)       an “Event of Default” under any other Credit Document shall have occurred; or

 

(e)       Borrower is unable to pay its debts generally as they become due, makes an assignment for the benefit of creditors, or an order, judgment, decree or injunction is entered adjudicating Borrower bankrupt or insolvent or requiring the dissolution or split up of Borrower or preventing Borrower from conducting all or any part of its business; or any order for relief with respect to Borrower is entered under the Federal Bankruptcy Code; or Borrower petitions or applies to any tribunal for the appointment of a custodian, trustee, receiver or liquidator of Borrower, or of any substantial part of the assets of Borrower, or commences any proceeding relating to Borrower under any bankruptcy reorganization, arrangement, insolvency, readjustment of debt, dissolution or liquidation or similar laws of any jurisdiction now or hereafter in effect; or any such petition or application is filed, or any such proceeding is commenced, against Borrower and either (i) Borrower by any act indicates its approval thereof, consent thereto or acquiescence therein or (ii) such petition, application or proceeding is not dismissed within sixty (60) days.

 

6.2          Acceleration upon Event of Default. Upon the occurrence of any Event of Default (whether or not Lender has knowledge that such Event of Default exists), then the Loan and all other Obligations of Borrower and the other Loan Parties to Lender under this Note and the other Credit Documents shall, (a) at the option of Agent, or (b) upon an Event of Default under Section 6.1(e) above, and notwithstanding any cure period allowed in any other Credit Document, immediately become due and payable without demand and without notice to Borrower, any other Loan Party, or any other person or entity.

 

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7.            Agent’s Rights and Remedies.

 

7.1       Rights and Remedies. Upon the occurrence, and during the continuation, of an Event of Default: (a) Agent shall have all rights and remedies available to it at law or equity for collection of the amounts due under this Note; (b) Agent shall have all rights, powers and remedies set forth in the other Credit Documents relating to the Collateral as security for the Loan and the other Obligations, as well as any and all rights and remedies available to it under any applicable law or as otherwise provided at law or in equity; (c) Borrower shall pay to Agent, in addition to the sums stated above, the reasonable costs of collection, regardless of whether litigation is commenced, including any reasonable attorneys’ (and any other consultants’ or experts’) fees, expenses and other costs, to the extent not prohibited by law; and (d) notwithstanding any other provision of this Note, during the period of existence of such Event of Default, interest on the Loan evidenced by this Note shall accrue and be paid at the Default Rate.

 

7.2       Remedies Cumulative. Agent’s rights and remedies under this Note, the Credit Documents and all other agreements related to the transactions described in the Credit Documents shall be cumulative. Agent shall have all other rights and remedies not inconsistent herewith as provided under the Code, by law or in equity. No exercise by Agent of one right or remedy shall be deemed an election, and no waiver by Agent of any Event of Default shall be deemed a continuing waiver. No delay by Agent shall constitute a waiver, election, or acquiescence by it.

 

7.3          Borrower’s Approvals, Ratifications, and Waivers.

 

(a)       Except as expressly set forth herein, to the fullest extent permitted by applicable law, Borrower, for itself, and its successors and assigns, expressly waives presentment, demand, protest, notice of dishonor, protest, notice of protest, notice of intent to accelerate, notice of acceleration, and any and all other notices, demands and consents in connection with the delivery, acceptance, performance, default or enforcement of this Note, and hereby further waives stay of execution and all suretyship defenses to payment generally. No release of any security held for the payment of this Note, or extension of any time periods for any payments due hereunder, or release of Collateral that may be granted by Agent from time to time, and no alteration, amendment or waiver of any provision of this Note or of any of the other Credit Documents, shall modify, waive, extend, change, discharge, terminate or affect the liability of Borrower or any other Loan Party under this Note or the other Credit Documents.

 

(b)       No failure or delay of Agent in exercising any right or remedy hereunder will operate as a waiver thereof, nor will any single or partial exercise of any such right or power, or any abandonment or discontinuance of steps to enforce such right or power, or any course of conduct, preclude any other or further exercise thereof or the exercise of any other right or power, or operate as, or be construed to constitute, a waiver of any subsequent breach of the same or other provision hereof.

 

(c)       Borrower covenants and agrees that it is liable with respect to all of the Obligations, including the Loan. Upon the occurrence of any Event of Default and at any time thereafter, Borrower covenants and agrees that Agent may, in its sole and absolute discretion, proceed directly against Borrower, any other Loan Party, or any other person or entity liable for the payment or performance of the Obligations, or any or all of the Collateral, or other security for the Obligations, or any combination of the foregoing, in one or more claims, actions or proceedings, whether or not any such claims, actions or proceedings are instituted simultaneously or at different times.

 

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8.       Authority. Borrower warrants and represents that the persons or officers who are executing this Note and the other Credit Documents on behalf of Borrower have full right, power and authority to do so, and that this Note and the other Credit Documents constitute valid and binding documents, enforceable against Borrower in accordance with their terms, and that no other person, entity, or party is required to sign, approve, or consent to, this Note.

 

9.       Governing Law. The laws of the State of Delaware shall govern all questions concerning the construction, validity, interpretation and enforceability of this Note, and the performance of the obligations imposed by this Note, without giving effect to any choice of law or conflict of law rules or provisions (whether of the State of Delaware or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of Delaware.

 

10.        Notices . All notices, demands and other communications required or permitted to be given hereunder shall be in writing and may be delivered by hand, by email in .pdf format or similar format, by nationally recognized private courier, or by United States mail. Notices delivered by mail shall be deemed given three business days after being deposited in the United States mail, postage prepaid, registered or certified mail, return receipt requested. Notices delivered by hand shall be deemed delivered when actually delivered. Notices given by nationally recognized private courier shall be deemed delivered on the date delivery is promised by the courier. Notices given by email with a confirmation or acknowledgment of transmission (including any response to such transmission) shall be deemed given when transmitted. Notices, demands and communications to each Party shall be sent to the following address and other information applicable for the method of notice used:

 

If to Borrower:

Humanigen, Inc.

533 Airport Blvd., #400

Burlingame, CA 94010

Attn: Dr. Cameron Durrant

E-mail: cdurrant@humanigen.com

 

   
If to Lender:

[NAME]

[ADDRESS LINE 1]

[ADDRESS LINE 2]

Attn:

E-mail:

 

or to such other respective addresses or fax numbers as each Party may designate by notice given in accordance with the foregoing provisions of this Section 10 .

 

11.       WAIVER OF JURY TRIAL AND COUNTERCLAIMS. TO THE FULLEST EXTENT PERMITTED BY LAW, AND AS SEPARATELY BARGAINED-FOR CONSIDERATION TO LENDER, BORROWER HEREBY WAIVES ANY RIGHT TO TRIAL BY JURY (WHICH LENDER ALSO WAIVES) IN ANY ACTION, SUIT, PROCEEDING OR COUNTERCLAIM OF ANY KIND ARISING OUT OF OR OTHERWISE RELATING TO ANY OF THE CREDIT DOCUMENTS, THE OBLIGATIONS, THE COLLATERAL, OR LENDER’S CONDUCT IN RESPECT OF ANY OF THE FOREGOING. TO EFFECTUATE THE FOREGOING, AGENT IS HEREBY GRANTED AN IRREVOCABLE POWER OF ATTORNEY TO FILE, AS ATTORNEY-IN-FACT FOR BORROWER, A COPY OF THIS NOTE IN ANY DELAWARE COURT, AND THE COPY OF THIS NOTE SO FILED SHALL CONCLUSIVELY BE DEEMED TO CONSTITUTE BORROWER’S WAIVER OF TRIAL BY JURY IN ANY PROCEEDING ARISING OUT OF OR OTHERWISE RELATING TO ANY OF THE CREDIT DOCUMENTS, THE OBLIGATIONS, THE COLLATERAL OR LENDER’S CONDUCT IN RESPECT OF ANY OF THE FOREGOING.

 

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12.          Appointment of Agent . The Lender hereby designates the Agent to act as the contractual representative for the Lender with respect to this Note and the Security Agreement. The Lender hereby authorizes the Agent to take such action on its behalf under the provisions of this Note and the Security Agreement, and to exercise such powers and perform such duties hereunder and thereunder as are specifically delegated to it hereunder or under the Security Agreement or required of the Agent by the terms hereof or thereof, together with such other powers as are reasonably incidental thereto.

 

13.          Miscellaneous.

 

(a)       Time is of the essence in this Note.

 

(b)       The provisions of this Note shall be deemed severable and if any portion shall be held invalid, illegal or unenforceable for any reason, the remainder of this Note shall be effective and binding upon the Parties, and interpreted in a manner consistent with the parties’ original intent prior to the severance of this Note, to the extent reasonably practicable.

 

(c)       This Note and the other Credit Documents collectively: (i) constitute the final expression of the agreement between Borrower and Lender concerning the Loan; (ii) contain the entire agreement between Borrower and Lender respecting the matters set forth herein and in such other Credit Documents; and (iii) may not be contradicted by evidence of any prior or contemporaneous oral agreements or understandings between Borrower and Lender. Neither this Note nor any of the terms hereof may be terminated, amended, supplemented, waived or modified orally, but only by an instrument in writing executed by the party against which enforcement of the termination, amendment, supplement, waiver or modification is sought.

 

(d)       If there is a conflict between or among the terms, covenants, conditions or provisions of this Note and the other Credit Documents, any term, covenant, condition or provision that Lender may elect to enforce from time to time so as to enlarge the interest of Lender in its security for the Obligations, afford Lender the maximum financial benefits or security for the Obligations, or provide Lender the maximum assurance of payment of the Loan and the Obligations in full shall control. BORROWER ACKNOWLEDGES AND AGREES THAT IT HAS BEEN PROVIDED WITH SUFFICIENT AND NECESSARY TIME AND OPPORTUNITY TO REVIEW THE TERMS OF THIS NOTE AND EACH OF THE CREDIT DOCUMENTS WITH ANY AND ALL COUNSEL IT DEEMS APPROPRIATE, AND THAT NO INFERENCE IN FAVOR OF, OR AGAINST, LENDER OR BORROWER SHALL BE DRAWN FROM THE FACT THAT EITHER SUCH PARTY HAS DRAFTED ANY PORTION OF THIS NOTE OR ANY OF THE CREDIT DOCUMENTS.

 

 

[ Remainder of page intentionally left blank; signature page follows ]

 

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IN WITNESS WHEREOF, Borrower has executed and delivered this Note to Lender and Lender has accepted this Note from Borrower as of the day and year first above written.

 

 

  Humanigen, Inc. ,
  a Delaware corporation
     
     
     
  By: /s/ Greg Jester
  Name: Greg Jester
  Title: Chief Financial Officer

 

 

[SIGNATURE PAGE TO SECURED PROMISSORY NOTE]

 

 

 

 

 

Exhibit 31.1

 

CERTIFICATION PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

CERTIFICATIONS

 

I, Cameron Durrant, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of Humanigen, 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(s) 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(s) 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 12, 2019    
  /s/ Cameron Durrant  
  Cameron Durrant,  
  Chief Executive Officer  
  (Principal Executive Officer)  

 

 

 

 

 

 

 

Exhibit 31.2

 

CERTIFICATION PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

CERTIFICATIONS

 

I, Cameron Durrant, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of Humanigen, 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(s) 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(s) 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 12, 2019    
  /s/ Cameron Durrant  
  Cameron Durrant  
  Chief Executive Officer  
  (Interim Principal Financial and Accounting Officer)  

 

 

 

 

 

 

 

Exhibit 32.1

 

CERTIFICATION OF

PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

 

 

I, Cameron Durrant, certify, to the best of my knowledge, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report on Form 10-Q of Humanigen, Inc. for the quarter ended June 30, 2019 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that information contained in such Quarterly Report on Form 10-Q fairly presents in all material respects the financial condition and results of operations of Humanigen, Inc.

 

Date:  August 12, 2019      
  By: /s/ Cameron Durrant  
  Name:   Cameron Durrant  
  Title: Chief Executive Officer  
    (Principal Executive Officer)  

 

 

 

 

 

 

Exhibit 32.2

 

CERTIFICATION OF

PRINCIPAL FINANCIAL OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

 

 

I, Cameron Durrant, certify, to the best of my knowledge, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report on Form 10-Q of Humanigen, Inc. for the quarter ended June 30, 2019 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that information contained in such Quarterly Report on Form 10-Q fairly presents in all material respects the financial condition and results of operations of Humanigen, Inc.

 

Date:  August 12, 2019      
  By: /s/ Cameron Durrant  
  Name: Cameron Durrant  
  Title: Chief Executive Officer  
   

(Interim Principal Financial and
Accounting Officer)