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 March 31, 2015

or

¨

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

Commission file number 001-35560

 

ImmunoCellular Therapeutics, Ltd.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

93-1301885

(State or other jurisdiction of

incorporation or organization)

 

(IRS Employer

Identification No.)

 

23622 Calabasas Road, Suite 300

Calabasas, California

 

91302

(Address of principal executive offices)

 

(Zip code)

(818) 264-2300

(Registrant’s telephone number, including area code)

 

 

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

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes   x     No   ¨

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

 

Large accelerated filer

¨

  

Accelerated Filer

x

 

 

 

 

 

Non-accelerated filer (Do not check if a smaller reporting company)

¨

  

Smaller reporting company

¨

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

The Issuer had 90,254,823 shares of its common stock outstanding as of April 30, 2015.

 

 

 

 

 

 

 


ImmunoCellular Therapeutics, Ltd.

FORM 10-Q

Table of Contents

 

 

Page

PART 1

 

FINANCIAL INFORMATION

3

 

Item 1: Condensed Consolidated Financial Statements

3

 

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

18

 

Item 3: Quantitative and Qualitative Disclosures About Market Risk

21

 

Item 4: Controls and Procedures

22

 

PART II

 

 

OTHER INFORMATION

23

 

Item 1: Legal Proceedings

23

 

Item 1A: Risk Factors

23

 

Item 2: Unregistered Sales of Equity Securities and Use of Proceeds

23

 

Item 3: Defaults Upon Senior Securities

23

 

Item 4: Mine Safety Disclosures

23

 

Item 5: Other Information

23

 

Item 6: Exhibits

24

 

SIGNATURES

25

 

EXHIBIT INDEX

26

 

 

 

2


PART 1

FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements

ImmunoCellular Therapeutics, Ltd.

Condensed Consolidated Balance Sheets

 

 

March 31, 2015

 

 

December 31, 2014

 

 

(unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

34,771,179

 

 

$

23,222,296

 

Other assets

 

1,610,391

 

 

 

1,219,873

 

Total current assets

 

36,381,570

 

 

 

24,442,169

 

Property and equipment, net

 

42,430

 

 

 

47,365

 

Deferred financing costs

 

-

 

 

 

105,563

 

Other assets

 

553,805

 

 

 

583,464

 

Total assets

$

36,977,805

 

 

$

25,178,561

 

Liabilities and Shareholders’ Equity

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

$

492,615

 

 

$

322,002

 

Accrued compensation and benefits

 

147,576

 

 

 

334,527

 

Accrued liabilities

 

846,222

 

 

 

632,670

 

Total current liabilities

 

1,486,413

 

 

 

1,289,199

 

Warrant liability

 

3,122,077

 

 

 

597,719

 

Commitments and contingencies (Note 5)

 

 

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

 

 

Common stock, $0.0001 par value; 149,000,000 shares authorized;

   90,254,823  and 63,604,823 shares  issued and outstanding as of

   March 31, 2015 and December 31, 2014, respectively

 

9,025

 

 

 

6,360

 

Additional paid-in capital

 

95,132,062

 

 

 

84,632,209

 

Accumulated deficit

 

(62,771,772

)

 

 

(61,346,926

)

Total shareholders’ equity

 

32,369,315

 

 

 

23,291,643

 

Total liabilities and shareholders’ equity

$

36,977,805

 

 

$

25,178,561

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

 

3


ImmunoCellular Therapeutics, Ltd.

Condensed Consolidated Statements of Operations

(unaudited)

 

 

March 31, 2015

 

 

March 31, 2014

 

 

Revenues

$

-

 

 

$

-

 

 

Expenses:

 

 

 

 

 

 

 

 

Research and development

 

1,998,619

 

 

 

1,699,760

 

 

Stock based compensation

 

205,829

 

 

 

184,102

 

 

General and administrative

 

896,672

 

 

 

865,402

 

 

Total expenses

 

3,101,120

 

 

 

2,749,264

 

 

Loss before other income (expense) and income taxes

 

(3,101,120

)

 

 

(2,749,264

)

 

Interest income

 

3,257

 

 

 

3,354

 

 

Financing expense

 

(88,939

)

 

 

 

 

Change in fair value of warrant liability

 

1,761,956

 

 

 

(416,067

)

 

Loss before income taxes

 

(1,424,846

)

 

 

(3,161,977

)

 

Income taxes

 

 

 

 

 

 

Net loss

$

(1,424,846

)

 

$

(3,161,977

)

 

Net loss per share, basic and diluted:

$

(0.02

)

 

$

(0.05

)

 

Weighted average number of shares basic and diluted:

 

77,818,157

 

 

 

57,552,664

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

 

4


ImmunoCellular Therapeutics, Ltd.

Condensed Consolidated Statements of Shareholders’ Equity (Deficit)

(unaudited)

 

 

Preferred Stock

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional Paid-in Capital

 

 

Accumulated Deficit

 

 

Total

 

Balance at December 31, 2014

 

 

 

$

-

 

 

 

63,604,823

 

 

$

6,360

 

 

$

84,632,209

 

 

$

(61,346,926

)

 

$

23,291,643

 

Common stock and warrants issued for cash during February 2015 at $0.60 per share, net of offering costs

 

 

 

 

 

 

 

 

 

26,650,000

 

 

 

2,665

 

 

 

10,294,024

 

 

 

-

 

 

 

10,296,689

 

Stock based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

205,829

 

 

 

 

 

 

 

205,829

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,424,846

)

 

 

(1,424,846

)

Balance at March 31, 2015

 

 

 

$

 

 

 

90,254,823

 

 

$

9,025

 

 

$

95,132,062

 

 

$

(62,771,772

)

 

$

32,369,315

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

 

5


ImmunoCellular Therapeutics, Ltd.

Condensed Consolidated Statements of Cash Flows

(unaudited)

 

 

March 31, 2015

 

 

March 31, 2014

 

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

$

(1,424,846

)

 

$

(3,161,977

)

 

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

 

 

 

 

 

 

 

 

Depreciation and amortization

 

6,693

 

 

 

12,634

 

 

(Gain) loss on disposal of assets

 

-

 

 

 

(4

)

 

Change in fair value of warrant liability

 

(1,761,956

)

 

 

416,067

 

 

Financing expense

 

88,939

 

 

 

 

 

Stock-based compensation

 

205,829

 

 

 

184,102

 

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

Other assets

 

(360,859

)

 

 

30,927

 

 

Accounts payable

 

170,613

 

 

 

(290,665

)

 

Accrued compensation and benefits

 

(186,951

)

 

 

(203,464

)

 

Accrued liabilities

 

213,552

 

 

 

398,622

 

 

Net cash used in operating activities

 

(3,048,986

)

 

 

(2,613,758

)

 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

(1,758

)

 

 

(3,600

)

 

Proceeds from the sale of property and equipment

 

-

 

 

 

400

 

 

Net cash used in investing activities

 

(1,758

)

 

 

(3,200

)

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock and warrants from underwritten public offering, net of offering costs

 

14,599,627

 

 

 

 

 

Net cash provided by financing activities

 

14,599,627

 

 

 

-

 

 

Increase (decrease) in cash and cash equivalents

 

11,548,883

 

 

 

(2,616,958

)

 

Cash and cash equivalents, beginning of period

 

23,222,296

 

 

 

27,646,351

 

 

Cash and cash equivalents, end of period

$

34,771,179

 

 

$

25,029,393

 

 

Supplemental cash flows disclosures:

 

 

 

 

 

 

 

 

Interest expense paid

$

 

 

$

 

 

Income taxes paid

$

 

 

$

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

 

6


ImmunoCellular Therapeutics, Ltd.

Notes to Unaudited Condensed Consolidated Financial Statements

 

 

1. Nature of Organization (Planned Principal Operations Have Not Commenced)

ImmunoCellular Therapeutics, Ltd. (the Company) is seeking to develop and commercialize new therapeutics to fight cancer using the immune system. These condensed consolidated financial statements include the Company’s wholly owned subsidiaries, ImmunoCellular Bermuda, Ltd. in Bermuda and ImmunoCellular Therapeutics (Ireland) Limited and ImmunoCellular Therapeutics (Europe) Limited in Ireland, that were formed during 2014.  

The Company has been primarily engaged in the acquisition of certain intellectual property, together with development of its vaccine product candidates and the recent clinical testing activities for one of its vaccine product candidates, and has not generated any recurring revenues. The Company’s lead product candidate, ICT-107, has recently begun start-up and planning activities for its Phase III trial. The Company has two other product candidates, ICT-140 and ICT-121, both with investigational new drug (IND) applications active at the US Food and Drug Administration (FDA). Currently, the Company has suspended development of ICT-140 until the Company has secured a partner or sufficient financial resources to commence the ICT107 Phase III program.  Additionally, the Company has acquired the rights to technology for the development of certain stem cell immunotherapies for the treatment of cancer.  The Company has incurred operating losses and, as of March 31, 2015, the Company had an accumulated deficit of $62,771,772. The Company expects to incur significant research, development and administrative expenses before any of its products can be launched and recurring revenues generated.

The Company's activities are subject to significant risks and uncertainties, including the failure of any of the Company's product candidates to achieve clinical success or to obtain regulatory approval.  Additionally, it is possible that other companies with competing products and technology might obtain regulatory approval ahead of the Company.  The Company will need significant amounts of additional funding in order to complete the development of any of its product candidates and the availability and terms of such funding cannot be assured.

Interim Results

The accompanying condensed consolidated financial statements as of March 31, 2015 and for the three month periods ended March 31, 2015 and 2014 are unaudited, but include all adjustments, consisting of normal recurring entries, which the Company’s management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2014 have been derived from the Company’s audited financial statements included in its Form 10-K for the year ended December 31, 2014 filed with the Securities and Exchange Commission (SEC) on March 10, 2015.

The condensed consolidated financial statements included herein have been prepared by the Company pursuant to the rules and regulations of the SEC. Certain information and note disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the U.S. (GAAP) have been condensed or omitted pursuant to such rules and regulations. The condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements in its Form 10-K for the year ended December 31, 2014. The Company’s operating results will fluctuate for the foreseeable future. Therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods.

 

2. Summary of Significant Accounting Policies

Liquidity – As of March 31, 2015, the Company had working capital of $34,895,157, compared to working capital of $23,152,970 as of December 31, 2014. The estimated cost of completing the development of any of our current vaccine product candidates, including our stem cell immunotherapies, and of obtaining all required regulatory approvals to market any of those product candidates is substantially greater than the amount of funds we currently have available. However, we believe that our existing cash balances are sufficient for our currently planned level of operations for at least the next twelve months, although there is no assurance that such proceeds will be sufficient for this purpose.

Principles of Consolidation - The condensed consolidated balance sheets include the accounts of the Company and its subsidiaries. The consolidated statements of operations include the Company’s accounts and the accounts of its subsidiaries from the date of acquisition. All intercompany transactions and balances have been eliminated in consolidation.

Cash and cash equivalents – The Company considers all highly liquid instruments with an original maturity of 90 days or less at acquisition to be cash equivalents. As of March 31, 2015 and December 31, 2014, the Company had $33,431,067 and $10,427,810, respectively, of certificates of deposit. The Company places its cash and cash equivalents with various banks in order to maintain FDIC insurance on all of its investments.

7


Property and Equipment – Property and equipment are stated at cost and depreciated using the straight-line method based on the estimated useful lives (generally three to five years) of the related assets. Computer and computer equipment are depreciated over three years. Management continuously monitors and evaluates the realizability of recorded long-lived assets to determine whether their carrying values have been impaired. The Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that the assets might be impaired and the nondiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. Any impairment loss is measured by comparing the fair value of the asset to its carrying amount. Repairs and maintenance costs are expensed as incurred.

Research and Development Costs – Research and development expenses consist of costs incurred for direct research and development and are expensed as incurred.

Stock Based Compensation – We have in effect an equity incentive plan under which stock options and awards have been granted to employees and non-employee members of the Board of Directors. We are required to estimate the fair value of share-based awards on the date of grant. The value of the award is principally recognized as expense ratably over the requisite service periods. We have estimated the fair value of stock options as of the date of grant using the Black-Scholes option pricing model. The Black-Scholes model considers, among other factors, the expected life of the award and the expected volatility of our stock price. We evaluate the assumptions used to value stock options on a quarterly basis. The fair values generated by the Black-Scholes model may not be indicative of the actual fair values of our equity awards, as they do not consider other factors important to those awards to employees, such as continued employment and periodic vesting.

Fair value was estimated at the date of grant using the following weighted average assumptions:

 

 

Three months
Ended
March 31, 2015

 

 

Three months
Ended
March 31, 2014

 

Risk-free interest rate

 

1.87

%

 

 

2.23

%

Expected dividend yield

 

None

 

 

 

None

 

Expected life

 

7.1 Years

 

 

 

6.0Years

 

Expected volatility

 

96.3

%

 

 

95.3

%

Expected forfeitures

 

0

%

 

 

0

%

 

The risk-free interest rate used is based on the implied yield currently available in U.S. Treasury securities at maturity with an equivalent term. The Company has not declared or paid any dividends and does not currently expect to do so in the future. The expected term of options represents the period that our stock-based awards are expected to be outstanding and was determined based on projected holding periods for the remaining unexercised shares. Consideration was given to the contractual terms of our stock-based awards, vesting schedules and expectations of future employee behavior. For the three months ended March 31, 2015 and 2014, the expected volatility is based upon the historical volatility of the Company’s common stock. Forfeitures have been estimated to be zero.

The Company’s stock price volatility and option lives involve management’s best estimates, both of which impact the fair value of the option calculated and, ultimately, the expense that will be recognized over the life of the option.

When options are exercised, our policy is to issue reserved but previously unissued shares of common stock to satisfy share option exercises. As of March 31, 2015, the Company had 10,469,540 shares of authorized and unissued common stock.

No tax benefits were attributed to the stock-based compensation expense because a valuation allowance was maintained for all net deferred tax assets.

8


Income Taxes – The Company accounts for federal and state income taxes under the liability method, with a deferred tax asset or liability determined based on the difference between the financial statement and tax basis of assets and liabilities, as measured by the enacted tax rates. The Company’s provision for income taxes represents the amount of taxes currently payable, if any, plus the change in the amount of net deferred tax assets or liabilities. A valuation allowance is provided against net deferred tax assets if recoverability is uncertain on a more likely than not basis. As of March 31, 2015 and December 31, 2014, the Company fully reserved its deferred tax assets. The Company recognizes in its financial statements the impact of an uncertain tax position if the position will more likely than not be sustained upon examination by a taxing authority, based on the technical merits of the position. The Company’s policy is to recognize interest related to unrecognized tax benefits as interest expense and penalties as operating expenses. As of March 31, 2015, the Company had no unrecognized tax benefits and as such, no liability, interest or penalties were required to be recorded.  The Company does not expect this to change significantly in the next twelve months.  The Company has determined that its main taxing jurisdictions are the United States of America and the State of California.  The Company is not currently under examination by any taxing authority nor has it been notified of a pending examination. The Company’s tax returns are generally no longer subject to examination for the years before December 31, 2010 for the state and December 31, 2011 for the federal taxing authority.

During 2014, the Company licensed the non-U.S. rights to a significant portion of its intellectual property to its Bermuda-based subsidiary for approximately $11.0 million. The fair value of the intellectual property rights was determined by an independent third party. The proceeds from this sale represented a gain for U.S. tax purposes and were offset by current year losses and net operating loss carryforwards. However, the Internal Revenue Service, or the IRS, or the California Franchise Tax Board, or the CFTB, could challenge the valuation of the intellectual property rights and assess a greater valuation, which would require the Company to utilize a larger portion, or all, of its available net operating losses. If an IRS or a CFTB valuation exceeds the available net operating losses, the Company would incur additional income taxes. The Company’s ability to use its net operating losses is subject to the limitations of IRS Section 382, as well as expiration of federal and state net operating loss carryforwards .

Fair Value of Financial Instruments – The carrying amounts reported in the balance sheets for cash, cash equivalents, and accounts payable approximate their fair values due to their quick turnover. The fair value of warrant derivative liability is estimated using the Binomial Lattice option valuation model.

Fair value for financial reporting is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.  The Company utilizes a fair value hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The three levels of inputs that may be used to measure fair value are as follows:

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

Level 2—quoted prices for similar assets and liabilities in active markets or inputs that are observable

Level 3—inputs that are unobservable (for example cash flow modeling inputs based on assumptions)

Warrant liabilities represent the only financial assets or liabilities recorded at fair value by the Company. The fair value of warrant liabilities are determined based on Level 3 inputs.

Use of Estimates – The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make certain estimates and assumptions about the future outcome of current transactions which may affect the reporting and disclosure of these transactions. Accordingly, actual results could differ from those estimates used in the preparation of these financial statements.

The following critical accounting policies affect the Company’s more significant judgments and estimates used in the preparation of these financial statements:

Stock-Based Compensation - Stock-based compensation expense is estimated as of the grant date based on the fair value of the award and is recognized as expense over the requisite service period, which generally equals the vesting period, based on the number of awards that are expected to vest. Estimating the fair value for stock options requires judgment, including the expected term of our stock options, volatility of the company’s stock, expected dividends, risk-free interest rates over the expected term of the options and the expected forfeiture rate. In connection with performance based programs, the company makes assumptions principally related to the number of awards that are expected to vest after assessing the probability that certain performance criteria will be met.

9


Income Taxes - The Company accounts for federal and state income taxes under the liability method, with a deferred tax asset or liability determined based on the difference between the financial statement and tax basis of assets and liabilities, as measured by the enacted tax rates. The Company’s provision for income taxes represents the amount of taxes currently payable, if any, plus the change in the amount of net deferred tax assets or liabilities. A valuation allowance is provided against net deferred tax assets if recoverability is uncertain on a more likely than not basis. The Company recognizes in its financial statements the impact of an uncertain tax position if the position will more likely than not be sustained upon examination by a taxing authority, based on the technical merits of the position. The Company’s policy is to recognize interest related to unrecognized tax benefits as interest expense and penalties as operating expenses. The Company is not currently under examination by any taxing authority nor has it been notified of an impending examination. The Company’s tax returns for the years ended December 31, 2009 to 2013, remain open for possible review.

Warrant Liability - The fair value of warrant liability is estimated using the Binomial Lattice option valuation model.  The use of the Binomial Lattice option valuation model requires estimates including the volatility of the Company’s stock, risk-free rates over the expected term of warrants and early exercise of the options.

Basic and Diluted Loss per Common Share – Basic and diluted loss per common share are computed based on the weighted average number of common shares outstanding. Common share equivalents (which consist of options and warrants) are excluded from the computation, since the effect would be antidilutive. Common share equivalents which could potentially dilute earnings per share, and which were excluded from the computation of diluted loss per share, totaled 40,160,947 shares and 20,551,398 shares at March 31, 2015 and 2014, respectively.

Recently Issued Accounting Standards In August 2014, the FASB issued ASU No. 2014-15, which applies to entities that have substantial doubt about their ability to continue as a going concern.  This update requires management to assess the probability about the entity’s ability to remain as a going concern for a period of one year from the date the financial statements are ready to be issued.  Depending on management’s conclusions about the entity’s ability to remain as a going concern, the entity must make certain disclosures in its financial statements.  This ASU is effective for annual periods beginning after December 15, 2016.  The adoption of this ASU is not expected to have a material impact on the Company’s consolidated results of operations, financial condition or liquidity.

In January 2015, the FASB issued ASU No. 2015-01, which eliminates the concept of extraordinary items for financial statement presentation purposes.  This ASU is effective for fiscal years beginning after December 15, 2015.  The adoption of this ASU is not expected to have a material impact on the Company’s consolidated results of operations, financial condition or liquidity.

Other recent accounting pronouncements issued by the FASB (including its Emerging Issues Task Force) and the Securities and Exchange Commission did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statements. 

 

3. Property and Equipment

Property and equipment consist of the following:

 

 

March 31, 2015

 

  

December 31, 2014

 

Computers

$

60,834

 

  

$

59,076

 

Research equipment

 

143,185

 

  

 

143,185

 

 

 

204,019

 

  

 

202,261

 

Accumulated depreciation

 

(161,589

)

  

 

(154,896

)

 

$

42,430

 

  

$

47,365

 

Depreciation expense was $6,693 and $12,634  for the three months ended March 31, 2015 and 2014, respectively.

 

4. Related-Party Transactions

Cedars-Sinai Medical Center License Agreement

Dr. John Yu, our Chief Scientific Officer and former interim Chief Executive Officer, is a neurosurgeon at Cedars-Sinai Medical Center (Cedars-Sinai). In November 2006, the Company entered into a license agreement with Cedars-Sinai under which the Company acquired an exclusive, worldwide license to its technology for use as cellular therapies, including dendritic cell-based vaccines for neurological disorders that include brain tumors and neurodegenerative disorders and other cancers. This technology is covered by a number of issued and pending U.S. and foreign patents and applications, and the term of the license will be until the last to expire of any patent claims that are issued covering this technology.

10


As an upfront licensing fee, the Company issued Cedars-Sinai 694,000 shares of its common stock and paid Cedars-Sinai $62,000.  Subsequently, the Company issued Cedars-Sinai an additional 100,000 shares of the Company’s common stock as an additional license fee.

The Company has also entered into various sponsored research agreements with Cedars-Sinai and has paid an aggregate of approximately $1.2 million.  The last agreement concluded on March 19, 2014 at an incremental cost of $126,237.  As of March 31, 2015, Cedars-Sinai is not performing any research activities on behalf of the Company.

 

5. Commitments and Contingencies

Sponsored Research Agreements

In an effort to expand the Company’s intellectual property portfolio to use antigens to create personalized vaccines, the Company has entered into various intellectual property and research agreements. Those agreements are long-term in nature and are discussed below.

ICON (formerly known as Aptiv Solutions)

The Company has contracted with ICON to provide certain services related to the Company’s ICT-107 Phase II trial. The original agreement was entered into in August of 2010.  On September 17, 2013, the Company entered into a Master Services Agreement with ICON to provide certain services related to the Company’s products under development.  Simultaneously, the Company and ICON entered into Project Agreement Number 1 for the ICT-140 Phase II trial that provides for payments of approximately $2.7 million until completion of the services described therein.  On May 6, 2014, the Company and ICON entered into Amendment #1 to Project Agreement Number 1 to amend the project schedule and provide additional services for an additional fee of $170,004.  On August 21, 2014, the Company and ICON entered into Amendment #2 to Project Agreement Number 1 to amend the project schedule and replace the aggregate budget.  The total aggregate fee pursuant to the original agreement and the two modifications is $3.5 million. Currently, the Company has suspended development of ICT-140 and, therefore, there is no ongoing commitment related to this program.  On July 17, 2014, the Company and ICON entered into Project Agreement CD-133 for the ICT-121 Phase I trial that provides for payments of approximately $2.3 million until completion of the services described therein.

As of March 31, 2015, the Company’s remaining obligation under the existing commitments is approximately $2.0 million.

The Johns Hopkins University Licensing Agreement

On February 23, 2012, the Company entered into an Exclusive License Agreement, effective as of February 16, 2012, with The Johns Hopkins University (JHU) under which it received an exclusive, worldwide license to JHU’s rights in and to certain intellectual property related to mesothelin-specific cancer immunotherapies. The Company is advancing a cancer vaccine program using JHU and other intellectual property according to commercially reasonable development timeline.  If successful and a product ultimately is registered, the Company will either sell the product directly or via a third-party partnership.

Pursuant to the License Agreement, the Company agreed to pay an upfront licensing fee in the low hundreds of thousands of dollars, payable half in cash and half in shares of its common stock in two tranches, within 30 days of the effective date of the License Agreement and upon issuance of the first U.S. patent covering the subject technology. Annual minimum royalties or maintenance fees increase over time and range from low tens of thousands to low hundreds of thousands of dollars. In addition, the Company has agreed to pay milestone license fees upon completion of specified milestones, totaling single digit millions of dollars if all milestones are met.  Royalties based on a low single digit percentage of net sales are also due on direct sales, while third party sublicensing payments will be shared at a low double digit percentage.

The Comp any and JHU each have termination rights that include termination for any reason and for reasons relating to specific performance or financial conditions.   Effective September 24, 2013, the Company entered into an Amendment No. 1 to the Exclusive License Agreement that updated certain milestones.

The University of Pittsburgh Patent License Agreement

On March 20, 2012, the Company entered into an Exclusive License Agreement with the University of Pittsburgh under which the Company has licensed intellectual property surrounding EphA2, a tyrosine kinase receptor that is highly expressed by ovarian cancer and other advanced and metastatic malignancies. The License Agreement grants a worldwide exclusive license to the intellectual property for ovarian and pancreatic cancers; and a worldwide non-exclusive license to the intellectual property for brain cancer.

11


Pursuant to the License Agreement, the Company agreed to pay an upfront nonrefundable and noncreditable licensing fee and nonrefundable and noncreditable maintenance fees due annually starting 12 months from the anniversary of the effective date of the License Agreement. In addition, the Company has agreed to make certain milestone payments upon completion of specified milestones and to pay customary royalties based on a specified percentage of net sales and sublicensing payments, as applicable.

In April 2015, the Company exercised its right to terminate this agreement effective October 12, 2015.

Torrey Pines

On October 1, 2012, the Company entered into a Contract Services Agreement with Torrey Pines under which the Company has engaged Torrey Pines to determine the immunogenicity of certain peptides that are used in conjunction with the Company’s ICT-107 Phase IIb trial and in the development of ICT-140. The Company agreed to pay an upfront nonrefundable and noncreditable fee and is obligated to pay the remainder at the conclusion of the contract. On April 1, 2013, the Company and Torrey Pines expanded the scope of work to be completed by Torrey Pines under an additional Contract Services Agreement. This supplemental agreement provided for the Company to pay an upfront fee and additional fees at the conclusion of the contract. On April 1, 2014, the Company and Torrey Pines   entered into an Amended and Restated Contract Services Agreement for Torrey Pines to perform certain additional services in connection with the Company’s vaccine technologies.

California Institute of Technology

On September 9, 2014, the Company entered into an Exclusive License Agreement with the California Institute of Technology (Caltech) under which the Company acquired exclusive rights to novel technology for the development of certain antigen specific T-cell immunotherapies for the treatment of cancers.

Pursuant to the License Agreement, the Company agreed to pay a one time license fee, a minimum annual royalty based on a low single digit percentage of net revenues and an annual maintenance fee in the low tens of thousands of dollars.  In addition, the Company has agreed to make certain milestone payments upon completion of specified milestones.

Cedars-Sinai Medical Center

In connection with the Cedars-Sinai Medical Center License Agreement and sponsored research agreement, the Company has certain commitments as described in Note 4.

Manufacturing

PharmaCell B.V.

In March 2015, the Company entered into an Agreement for GMP Manufacturing of ICT-107  with PharmaCell B.V. (PharmaCell), pursuant to which PharmaCell will provide contract manufacturing services for the European production of ICT-107, a dendritic cell vaccine for the treatment of newly diagnosed glioblastoma multiforme.

The Company will pay for manufacturing services performed by PharmaCell under the Agreement pursuant to statements of work entered into from time to time. The Company may unilaterally terminate the Agreement upon 90 days’ written notice to PharmaCell, or 30 days’ written notice in the event of a clinical hold or other suspension or early termination of a clinical trial. PharmaCell may terminate the Agreement in certain circumstances upon 90 days’ written notice to the Company. Either party may terminate the Agreement in the event of the other party’s insolvency or for the other party’s material breach of its obligations under the Agreement if such breach remains uncured after 30 days of receiving written notice of such breach. Absent early termination, the Agreement will continue until all services under applicable statements of work have been completed.

Employment Agreements

The Company has employment agreements with its management that provide for a base salary, bonus and stock option grants.  The aggregate annual base salary payable to this group is approximately $1.1 million and the potential bonus is approximately $400,000.  During the three months ended March 31, 2015, the Company issued an aggregate of 437,500 stock options to its management at a weighted average exercise price of $0.57 that vest over a period of 4 years.  Additionally, during the three months ended March 31, 2015, the Company issued 337,500 restricted shares of the Company’s common stock.  These shares will vest in March 2017.  

12


Operating Lease

The Company entered into a lease for office space effective June 15, 2013 and continuing through August 31, 2016 at an initial monthly rental of $8,063. The monthly rental increases by 3% on each anniversary date of the lease. Rent for the months of August and September 2013 was abated.  Rent expense was approximately $25,000 and $24,000 for the three months ended March 31, 2015 and 2014, respectively.

Future minimum rentals under the operating lease are as follows:

 

Years ending December 31,

 

Amount

 

2015

 

 

75,990

 

2016

 

 

68,432

 

Total

 

$

144,422

 

 

6. Shareholders’ Equity

Underwritten Public Offering

In February 2015, the Company raised approximately $14,500,000 (after commissions and offering expenses) from the sale of 26,650,000 shares of common stock and warrants to purchase 18,655,000 shares of common stock at an exercise price of $0.66 per share, to various investors in an underwritten public offering.  Each unit was priced at $0.60.  The warrants have a term of 60 months from the date of issuance.  The warrants also provide for a weighted-average adjustment to the exercise price if we issue or are deemed to issue additional shares of our common stock at a price per share less than the then effective price of the warrants, subject to certain exceptions (see “Warrant Liability” below.)

Controlled Equity Offering

On April 18, 2013, the Company entered into a Controlled Equity Offering SM Sales Agreement (the Sales Agreement) with Cantor Fitzgerald & Co., as agent (Cantor), pursuant to which the Company may offer from time to time through Cantor, shares of our common stock having an aggregate offering price of up to $25.0 million (of which only $17.0 million is currently registered for offer and sale). Under the Sales Agreement, Cantor may sell shares by any method permitted by law and deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act, as amended, including sales made directly on the NYSE MKT, on any other existing trading market for our common stock or to or through a market maker. The Company may instruct Cantor not to sell shares if the sales cannot be effected at or above the price designated by us from time to time. The Company is not obligated to make any sales of the shares under the Sales Agreement. The offering of shares pursuant to the Sales Agreement will terminate upon the earlier of (a) the sale of all of the shares subject to the Sales Agreement or (b) the termination of the Sales Agreement by Cantor or the Company, as permitted therein. Cantor will receive a commission rate of 3.0% of the aggregate gross proceeds from each sale of shares and the Company has agreed to provide Cantor with customary indemnification and contribution rights. The Company will also reimburse Cantor for certain specified expenses in connection with entering into the Sales Agreement.  On April 22, 2013, NYSE MKT approved the listing of 10,593,220 shares of our common stock in connection with the Sales Agreement. Through March 31, 2015 , we sold 6,949,261 shares of our common stock under the Sales Agreement that resulted in proceeds to the Company of approximately $9,402,383.  As of March 31, 2015 , aggregate gross sales for additional common stock of approximately $7,081,494 remained available under the Sales Agreement .  No shares were sold during the three months ended March 31, 2015.

13


Stock Options

In February 2005, the Company adopted an Equity Incentive Plan (the Plan). Pursuant to the Plan, a committee appointed by the Board of Directors may grant, at its discretion, qualified or nonqualified stock options, stock appreciation rights and may grant or sell restricted stock to key individuals, including employees, nonemployee directors, consultants and advisors. Option prices for qualified incentive stock options (which may only be granted to employees) issued under the plan may not be less than 100% of the fair value of the common stock on the date the option is granted (unless the option is granted to a person who, at the time of grant, owns more than 10% of the total combined voting power of all classes of stock of the Company; in which case the option price may not be less than 110% of the fair value of the common stock on the date the option is granted). Option prices for nonqualified stock options issued under the Plan are at the discretion of the committee and may be equal to, greater or less than fair value of the common stock on the date the option is granted. The options vest over periods determined by the Board of Directors and are exercisable no later than ten years from date of grant (unless they are qualified incentive stock options granted to a person owning more than 10% of the total combined voting power of all classes of stock of the Company, in which case the options are exercisable no later than five years from date of grant). Initially, the Company reserved 6,000,000 shares of common stock for issuance under the Plan. On October 24, 2011, the Company’s shareholders voted to increase the number of authorized shares reserved for the Plan to 8,000,000 shares. On September 20, 2013, the Company’s shareholders voted to increase the number of authorized shares reserved for the Plan to 12,000,000 shares. Options to purchase 4,339,340 common shares have been granted under the Plan and are outstanding as of March 31, 2015. Additionally, 260,000 shares of restricted common stock have been granted under the Plan.  As of March 31, 2015, there were 4,467,731 options available for issuance under the Plan.

The following table summarizes stock option activity for the Company during the three months ended March 31, 2015 :

 

 

Options

 

  

Weighted
Average
Exercise
Price

 

  

Weighted
Average
Remaining
Contractual
Term

 

  

Aggregate
Intrinsic
Value

 

Outstanding December 31, 2014

9,314,765

 

  

$

1.19

  

  

 

0

  

  

 

0

  

Granted

1,193,000

 

  

$

0.58

  

  

 

0

  

  

 

0

  

Exercised

0

 

  

$

0

  

  

 

0

  

  

 

0

  

Forfeited or expired

(85,000

)

  

$

(2.25

)  

  

 

0

  

  

 

0

  

Outstanding March 31, 2015

10,422,765

 

  

$

1.24

  

  

 

3.52

  

  

$

11,000

  

Vested or expected to vest at March 31, 2015

8,027,189

 

  

$

1.20

  

  

 

2.23

  

  

$

11,000

  

 

As of March 31, 2015 , the total unrecognized compensation cost related to unvested stock options amounted to $3.0 million, which will be recognized over the weighted-average remaining requisite service period of approximately  17 months.

 

On March 20, 2015, the Company issued an aggregate of 260,000 shares of restricted common stock to certain members of management.  The shares will vest on March 19, 2017.  For accounting purposes, these shares were valued at $0.58, which was the stock price on the date of grant, and will be expensed over the service period of two years from the date of grant.

Warrants

In connection with the sale of Preferred Stock in May 2010, the Company issued warrants to purchase 1,350,000 shares of the Company’s common stock at an exercise price of $2.50. The warrants have a five-year term from the date of issuance. As of March 31, 2015, warrants to purchase 1,290,996 shares of the Company’s common stock at $2.50 remain outstanding related to this private placement. (See “Warrant Liability” below.)

14


In connection with the February 2011 common stock private placement, the Company issued to the investors warrants to purchase 2,609,898 shares of the Company’s common stock at $2.25 per share. The warrants have a five-year term from the date of issuance and contain a provision that provides for an adjustment to the exercise price in the event the Company completes an equity financing at a per share price of its common stock that is less than the adjusted exercise price. As a result of the January and October 2012 financings, the exercise price of the warrants was adjusted to $1.87 and the number of warrants was proportionately increased to 2,823,670 net of exercises. During the quarter ended June 30, 2014, the exercise price was further adjusted to $1.85 and the number of warrants outstanding was increased to 2,854,196 to reflect the issuances pursuant to the Company’s Controlled Equity Offering SM .  During the quarter ended September 30, 2014, the exercise price was further adjusted to $1.84 and the number of warrants outstanding was increased to 2,869,696 to reflect the issuances pursuant to the Company’s Controlled Equity Offering SM .  During the quarter ended December 31, 2014, the exercise price was further adjusted to $1.79 and the number of warrants outstanding was increased to 2,949,845 to reflect the issuances pursuant to the Company’s Controlled Equity Offering SM .  As a result of the February 2015 financing, the exercise price of the warrants was further adjusted to $1.44 and the number of warrants was proportionately increased to 3,666,836.  As of March 31, 2015 , warrants to purchase 3,666,836 shares of the Company’s common stock remain outstanding related to this private placement. (See “Warrant Liability” below.)

In connection with the January 2012 underwritten public offering, the Company issued to the investors warrants to purchase 4,744,718 shares of the Company’s common stock at $1.41 per share. The warrants have a five-year term from the date of issuance. These warrants qualify for equity treatment since they do not have any provisions that would require the Company to redeem them for cash or that would result in an adjustment to the number of warrants. As of March 31, 2015 , warrants to purchase 1,418,575 shares of the Company’s common stock remain outstanding relating to this public offering.

In connection with the October 2012 underwritten public offering, the Company issued to the investors warrants to purchase 4,500,000 shares of the Company’s common stock at $2.65 per share. The warrants have a five-year term from the date of issuance. These warrants qualify for equity treatment since they do not have any provisions that would require the Company to redeem them for cash or that would result in an adjustment to the number of warrants. As of March 31, 2015 , warrants to purchase 4,446,775 shares of the Company’s common stock remain outstanding relating to this public offering.

In connection with the February 2015 underwritten public offering, the Company issued to the investors warrants to purchase 18,655,000 shares of the Company’s common stock at $0.66 per share.  The warrants have a five-year term from the date of issuance and contain a provision that provides for an adjustment to the exercise price in the event the Company completes an equity financing at a per share price of its common stock that is less than the adjusted exercise price.  Accordingly, these warrants do not qualify for equity treatment.  As of March 31, 2015, warrants to purchase 18,655,000 shares of the Company’s common stock remain outstanding relating to this public offering. (See “Warrant Liability” below.)

Warrant Liability

The Company’s warrant liability is adjusted to fair value each reporting period and is influenced by several factors including the price of the Company’s common stock as of the balance sheet date. On March 31, 2015 , the price per share of Company’s common stock was $0.49 per share compared to $ 0.73 per share at December 31, 2014.

 

In connection with the sale of Preferred Stock in 2010, the Company issued to the investors warrants to purchase 1,350,000 shares of the Company’s common stock at an exercise price of $2.50 per share. Of the total proceeds from the May 2010 preferred stock sale, $5,710,500 was allocated to the freestanding warrants associated with the units based upon the fair value of these warrants determined under the Black Scholes option pricing model. The warrants contain a provision whereby the warrant may be settled for cash in connection with a change of control with a private company. Due to the potential variability of their exercise price, these warrants do not qualify for equity treatment, and therefore are recognized as a liability. The warrant liability is adjusted to fair value each reporting period and any change in value is recognized in the statement of operations. Prior to 2011, the Company concluded that the Black-Scholes method of valuing the price adjustment feature does not materially differ from the valuation of such warrants using the Monte Carlo or binomial lattice simulation models, and therefore, the use of the Black-Scholes valuation model was considered a reasonable method to value the warrants. The assumptions used in the Black Scholes model for determining the initial fair value of the warrants were as follows: (i) dividend yield of 0%; (ii) expected volatility of 102%, (iii) risk-free interest rate of 2.50%, and (iv) contractual life of 60 months. Effective January 1, 2011, the Company determined that it was more appropriate to value the warrants using a binomial lattice simulation model. For the three months ended March 31, 2014 , the Company recorded a charge to other expense of $125,227. As of March 31, 2015 , the Company revalued the warrants using the binomial lattice simulation model assuming (i) dividend yield of 0%; (ii) expected volatility of 46 %; (iii) risk free rate of 0.05% and (iv) expected term of 0.09 years. For the three months ended March 31, 2015, the Company recorded a credit to other income of $7,746.  As of March 31, 2015 , the carrying value of the warrant liability is $nil.

15


In connection with the February 2011 common stock private placement, the Company issued to the investors warrants to purchase 2,818,675 shares of the Company’s common stock at $2.25 per share. Of the total proceeds from the February 2011 common stock private placement, $2,476,790 was allocated to the freestanding warrants associated with the units based upon the fair value of the warrants determined under the Binomial lattice model. The warrants contain a provision whereby the warrant exercise price would be decreased in the event that certain future common stock issuances are made at a price less than $1.55. Due to the potential variability of their exercise price, these warrants do not qualify for equity treatment, and therefore are recognized as a liability. As a result of the January and October 2012 financings, the exercise price of the warrants was adjusted to $1.87 and the number of warrants was proportionately increased to 2,823,670 net of exercises. The Company recorded a charge to financing expense of $368,524 to reflect the issuance of the additional warrants. As of result of the Company’s Controlled Equity Offering during 2014, the exercise price of the warrants was adjusted to $ 1.79 and the number of warrants was proportionately increased to 2,949,867, net of exercises. The Company recorded a charge to financing expense of $62,683 to reflect the issuance of the additional warrants.   As of result of the Company’s February 2015 underwritten public offering, the exercise price of the warrants was adjusted to $ 1.44 and the number of warrants was proportionately increased to 3,666,836 . The warrant liability is adjusted to fair value each reporting period, and any change in value is recognized in the statement of operations. The Company initially valued these warrants using a binomial lattice simulation model assuming (i) dividend yield of 0%; (ii) expected volatility of 146%; (iii) risk free rate of 1.96% and (iv) expected term of 5 years. Based upon those calculations, the Company calculated the initial valuation of the warrants to be $2,476,790. For the three months ended March 31, 2014, the Company recorded a charge to other expense of $290,840.  As of March 31, 2015 , the Company revalued the warrants using the binomial lattice simulation model assuming (i) dividend yield of 0%; (ii) expected volatility of 74 %; (iii) risk free rate of 0.23.% and (iv) expected term of .89 years. For the three months ended March 31, 2015, the Company recorded a credit to other income of $634,910. As of March 31, 2015 , the carrying value of the warrant liability is $44,002.

In connection with the February 2015 underwritten public offering, the Company issued to the investors warrants to purchase 18,655,000 shares of the Company’s common stock at $0.66 per share.  The warrants contain a provision whereby the warrant exercise price would be decreased in the event that certain future common stock issuances are made at a price less than $0.66.  Due to the potential variability of their exercise price, these warrants do not qualify for equity treatment, and therefore are recognized as a liability.The Company initially valued these warrants using a binomial lattice simulation model assuming (i) dividend yield of 0%; (ii) expected volatility of 97.0%; (iii) risk free rate of 1.53% and (iv) expected term of 5 years.  Based upon these calculations, the Company calculated the initial valuation of the warrants to be $4,197,375.  As of March 31, 2015, the Company revalued the warrants using the binomial lattice simulation model assuming (i) dividend yield of 0%; (ii) expected volatility of 92.0%; (iii) risk free rate of 1.34% and (iv) expected term of 4.86 years.  For the three months ended March 31, 2015, the Company recorded a credit to other income of $1,119,300. As of March 31, 2015, the carrying value of the warrant liability is $3,078,075.

Volatility has been estimated using the historical volatility of the Company’s stock price. 

The following reconciliation of the beginning and ending balances for all warrant liabilities measured at fair market value on a recurring basis using significant unobservable inputs (level 3) during the period ended March 31, 2015 and 2014 :

 

 

March 31, 2015

 

 

March 31, 2014

 

Balance – January 1

$

597,719

 

 

$

1,064,810

 

Issuance of warrants and effect of repricing

 

4,286,314

 

 

 

0

 

Exercise of warrants

 

0

 

 

 

0

 

(Gain) or loss included in earnings

 

(1,761,956

)

 

 

416,067

 

Transfers in and out/or out of Level 3

 

0

 

 

 

0

 

Balance – March 31

$

3,122,077

 

 

$

1,480,877

 

 

Additionally , during the three months ended March 31, 2015, the Company recorded a charge to financing expense of $88,939 to reflect the issuance of the additional warrants .

 

7. 401(k) Profit Sharing Plan

During 2011, the Company adopted a Profit Sharing Plan that qualifies under Section 401(k) of the Internal Revenue Code. Contributions to the plan are at the Company’s discretion. The Company did not make any matching contributions during the three months ended March 31, 2015 or March 31, 2014.

 

8. Income Taxes

Deferred taxes represent the net tax effects of the temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes. Temporary differences result primarily from the recording of tax benefits of net operating loss carry forwards and stock-based compensation.

16


As of March 31, 2015, the Company has an insufficient history to support the likelihood of ultimate realization of the benefit associated with its deferred tax assets. Accordingly, a valuation allowance has been established for the full amount of the deferred tax assets.

The Company’s effective income tax rate differs from the amount computed by applying the federal statutory income tax rate to loss before income taxes as follows:

 

 

March 31, 2015

 

 

March 31, 2014

 

Income tax benefit at the federal statutory rate

 

-34

%

 

 

-34

%

State income tax benefit, net of federal tax benefit

 

-6

%

 

 

-6

%

Change in fair value of warrant liability

 

124

%

 

 

5

%

Change in valuation allowance for deferred tax assets

 

-84

%

 

 

35

%

Total

 

0

%

 

 

0

%

 

 

March 31, 2015

 

 

March 31, 2014

 

Net operating loss carryforwards

$

17,060,834

 

 

$

16,900,628

 

Stock-based compensation

 

2,315,228

 

 

 

2,094,628

 

Less valuation allowance

 

(19,376,062

)

 

 

(18,995,256

)

Net deferred tax asset

$

0

 

 

$

0

 

As of March 31, 2015 and December 31, 2014, the Company had federal and California income tax net operating loss carry forwards of approximately $42.7 million and $40.8 million respectively. These net operating losses will begin to expire in 2022 and 2016, respectively, unless previously utilized.

Section 382 of the Internal Revenue Code can limit the amount of net operating losses which may be utilized if certain changes to a company’s ownership occur. While the Company underwent an ownership change in 2012 as defined by Section 382 of the Internal Revenue Code, management estimated that the Company had not incurred any limitations on its ability to utilize its net operating losses under Section 382 of the Internal Revenue Code during 2012. The Company may incur limitations in the future if there is a change in ownership as computed under the prescribed method of the Internal Revenue Code.

During the fourth quarter of 2014, the Company licensed the non-U.S. rights to a significant portion of its intellectual property to its Bermuda-based subsidiary for approximately $11.0 million. The fair value of the intellectual property rights was determined by an independent third party. The proceeds from this sale represent a gain for U.S. tax purposes and are offset by current year losses and net operating loss carryforwards. However, the Internal Revenue Service, or the IRS, or the California Franchise Tax Board, or the CFTB, could challenge the valuation of the intellectual property rights and assess a greater valuation, which would require the Company to utilize a portion, or all, of its available net operating losses. If an IRS or a CFTB valuation exceeds the available net operating losses, the Company would incur additional income taxes. The Company’s ability to use its net operating losses is subject to the limitations of IRS Section 382, as well as expiration of federal and state net operating loss carryforwards.

 

 

17


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

Throughout this Quarterly Report on Form 10-Q, the terms “we,” “us,” “our,” and “our company” refer to ImmunoCellular Therapeutics, Ltd., a Delaware corporation and its subsidiaries.

Cautionary Statement Regarding Forward-Looking Statements

This Quarterly Report contains forward-looking statements, which reflect the views of our management with respect to future events and financial performance. These forward-looking statements are subject to a number of uncertainties and other factors that could cause actual results to differ materially from such statements. Forward-looking statements are identified by words such as “anticipates,” “believes,” “estimates,” “expects,” “plans,” “projects,” “targets” and similar expressions. Readers are cautioned not to place undue reliance on these forward-looking statements, which are based on the information available to management at this time and which speak only as of this date. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For a discussion of some of the factors that may cause actual results to differ materially from those suggested by the forward-looking statements, please read carefully the information under the heading “Risk Factors” in our Form 10-K for the year ended December 31, 2014. The identification in this Quarterly Report of factors that may affect future performance and the accuracy of forward-looking statements is meant to be illustrative and by no means exhaustive. All forward-looking statements should be evaluated with the understanding of their inherent uncertainty.

Overview

ImmunoCellular Therapeutics, Ltd. and its subsidiaries (the Company) is a biotechnology company that is seeking to develop and commercialize new therapeutics to fight cancer using the immune system.

The Company has been primarily engaged in the acquisition of certain intellectual property, together with development of its product candidates and the recent clinical testing for its vaccine product candidates, and has not generated any recurring revenues. The Company’s lead product candidate, ICT-107, completed Phase II testing in December 2013. The Company has two other product candidates, ICT-140 and ICT-121, both with investigational new drug (IND) applications active at the US Food and Drug Administration (FDA). The Company is holding the initiation of its ICT-140 trial until we can find a partner to share expenses or until we have secured sufficient financial resources to commence the ICT-107 Phase III program. Additionally, the Company has acquired the rights to technology for the development of certain stem cell immunotherapies for the treatment of cancer.  The Company has incurred operating losses and, as of March 31, 2015, the Company had an accumulated deficit of $62,771,772. The Company expects to incur significant research, development and administrative expenses before any of its products can be launched and recurring revenues generated.

Critical Accounting Policies

Management’s discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, including those related to impairment of long-lived assets, including finite lived intangible assets, accrued liabilities, fair value of warrant derivatives and certain expenses. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.

Our significant accounting policies are summarized in Note 2 of our condensed consolidated financial statements. We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our consolidated financial statements:

Research and Development Costs

Although we believe that our research and development activities and underlying technologies have continuing value, the amount of future benefits to be derived from them is uncertain. Research and development costs are expensed as incurred. During the three months ended March 31, 2015 and 2014, we recorded an expense of $1,998,619 and $1,699,760, respectively, related to research and development activities.

18


Stock-Based Compensation

Stock-based compensation expense is estimated as of the grant date based on the fair value of the award and is recognized as expense over the requisite service period, which generally equals the vesting period, based on the number of awards that are expected to vest. Estimating the fair value for stock options requires judgment, including the expected term of our stock options, volatility of our stock, expected dividends, risk-free interest rates over the expected term of the options and the expected forfeiture rate. In connection with our performance based programs, we make assumptions principally related to the number of awards that are expected to vest after assessing the probability that certain performance criteria will be met.

Income Taxes

The Company accounts for federal and state income taxes under the liability method, with a deferred tax asset or liability determined based on the difference between the financial statement and tax basis of assets and liabilities, as measured by the enacted tax rates. The Company’s provision for income taxes represents the amount of taxes currently payable, if any, plus the change in the amount of net deferred tax assets or liabilities. A valuation allowance is provided against net deferred tax assets if recoverability is uncertain on a more likely than not basis. The Company recognizes in its consolidated financial statements the impact of an uncertain tax position if the position will more likely than not be sustained upon examination by a taxing authority, based on the technical merits of the position. The Company’s policy is to recognize interest related to unrecognized tax benefits as interest expense and penalties as operating expenses. The Company is not currently under examination by any taxing authority nor has it been notified of an impending examination. The Company’s tax returns for the years ended December 31, 2011 to 2014, remain open for possible review.

Fair Value of Financial Instruments

The carrying amounts reported in the balance sheets for cash, cash equivalents, and accounts payable approximate their fair values due to their quick turnover. The fair value of warrant liability is estimated using the Binomial Lattice option valuation model.

Results of Operations

Three months ended March 31, 2015

Net Loss

We incurred a net loss of $1,424,846 and $3,161,977 for the three months ended March 31, 2015 and 2014, respectively. The decrease in the net loss is primarily due to a credit to earnings of $1,761,956 during the three months ended March 31, 2015 related to the revaluation of our warrant derivatives, compared to a charge of $416,067 during the same period in 2014.  This was partially offset by an increase in our research and development activities during the three months ended March 31, 2015 as we started our preparation for the Phase III trial of ICT-107.

Revenues

We did not have any revenue during the three months ended March 31, 2015 and 2014 and we do not expect to have any revenue in 2015.

Expenses

General and administrative expenses for the three months ended March 31, 2015 and 2014 were $896,672 and $865,402, respectively.

Research and development expenses for the three months ended March 31, 2015 and 2014 were $1,998,619 and $1,699,760, respectively. During the three months ended March 31, 2015 we incurred expenses related to the start-up and planning of our ICT-107 Phase 3 trial.  Additionally, we incurred certain expenses related to the development of certain stem cell immunotherapies for the treatment of cancer.  We expect these expenses to increase in future periods as we progress in the ICT-107 Phase 3 trial and as we develop our stem cell immunotherapies.  As of December 31, 2014, our ICT-140 ovarian cancer program was placed on hold.  As a result, we incurred minimal expenses related to this trial during the most recent quarter and we expect future expenses to continue to decline until such time as we obtain additional financing or find a partner for this trial.  

19


Liquidity and Capital Resources

As of March 31, 2015, we had working capital of $34,895,157, compared to working capital of $23,152,970 as of December 31, 2014. The estimated cost of completing the development of any of our current vaccine product candidates and of obtaining all required regulatory approvals to market either of those product candidates is substantially greater than the amount of funds we currently have available. However, we believe that our existing cash balances will be sufficient to fund our operations for at least the next twelve months from the date of filing this Quarterly report on Form 10-Q, although there is no assurance that such proceeds will be sufficient.

On February 12, 2015, we entered into an underwriting agreement with Roth Capital Partners, LLC, pursuant to we sold 26,650,000 shares of our common stock and warrants to purchase 18,655,000 shares of our common stock at a combined public offering price of $0.60 per share and accompanying warrant to purchase 0.70 of a share of our common stock. The resulting aggregate net proceeds from the offering was approximately $14.5 million, after deducting underwriting discounts and other offering expenses payable by us of approximately $1.5 million. The warrants have an exercise price of $0.66 per share and a term of 60 months from the date of issuance. The warrants provide for a weighted-average adjustment to the exercise price if we issue or are deemed to issue additional shares of our common stock at a price per share less than the then effective exercise price of the warrants, subject to certain exceptions.  Accordingly, these warrants have been accounted for as derivative liabilities and approximately $4.2 million of the net proceeds was allocated to the warrant derivative and the remaining $10.3 million was allocated to equity.  

On April 18, 2013, we entered into a Controlled Equity Offering SM Sales Agreement (the Sales Agreement) with Cantor Fitzgerald & Co., as agent (Cantor), pursuant to which we may offer and sell, from time to time through Cantor, shares of our common stock having an aggregate offering price of up to $25.0 million (of which only $17.0 million was initially registered for offer and sale). Under the Sales Agreement, Cantor may sell shares by any method permitted by law and deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act, as amended, including sales made directly on the NYSE MKT, on any other existing trading market for our common stock or to or through a market maker. We may instruct Cantor not to sell shares if the sales cannot be effected at or above the price designated by us from time to time. We are not obligated to make any sales of the shares under the Sales Agreement. The offering of shares pursuant to the Sales Agreement will terminate upon the earlier of (a) the sale of all of the shares subject to the Sales Agreement or (b) the termination of the Sales Agreement by Cantor or the Company, as permitted therein. We will pay Cantor a commission rate of 3.0% of the aggregate gross proceeds from each sale of shares and have agreed to provide Cantor with customary indemnification and contribution rights. We will also reimburse Cantor for certain specified expenses in connection with entering into the Sales Agreement. On April 22, 2013, NYSE MKT approved the listing of 10,593,220 shares of our common stock in connection with the Sales Agreement. Through March 31, 2015, we sold 6,949,261 shares of our common stock under the Sales Agreement that resulted in proceeds to the Company of approximately $9,402,383.  As of March 31, 2015, we had $7,081,494 available under the Sales Agreement.  See additional discussion in Notes 6 to the unaudited condensed consolidated financial statements which are included in Part 1 of this Form 10-Q.

We may in the future seek to obtain funding through strategic alliances with larger pharmaceutical or biomedical companies. We cannot be sure that we will be able to obtain any additional funding from either financings or alliances, or that the terms under which we may be able to obtain such funding will be beneficial to us. If we are unsuccessful or only partly successful in our efforts to secure additional financing, we may find it necessary to suspend or terminate some or all of our product development and other activities.

As of March 31, 2015, we had no long-term debt obligations or other similar long-term liabilities. We have various purchase commitments for sponsored research and license fees. We have no financial guarantees, debt or lease agreements or other arrangements that could trigger a requirement for an early payment or that could change the value of our assets, and we do not engage in trading activities involving non-exchange traded contracts. We do not have any bank credit lines.

Contractual Obligations

The following is a summary of our contractual obligations including those entered into subsequent to March 31, 2015.

 

 

Total

 

 

Less than
1 year

 

 

1-3
years

 

 

3-5
years

 

 

More than
5 years

 

Unconditional purchase obligations

$

2,796,440

 

 

$

2,718,440

 

 

$

52,000

 

 

$

26,000

 

 

$

-

 

Operating lease obligation

 

238,516

 

 

 

101,652

 

 

 

136,864

 

 

 

-

 

 

 

-

 

 

$

3,034,956

 

 

$

2,820,092

 

 

$

188,864

 

 

$

26,000

 

 

$

-

 

20


Cash Flows

We used $3,048,986 of cash in our operations for the three months ended March 31, 2015, compared to $2,613,738 for the three months ended March 31, 2014. During the three months ended March 31, 2015 we incurred expenses related to the start-up and planning of our ICT-107 Phase III trial.  Additionally, we incurred certain expenses related to the development of certain stem cell immunotherapies for the treatment of cancer.  We expect these expenses to increase in future periods as we progress in the ICT-107 Phase III trial and as we develop our stem cell immunotherapies.  As of December 31, 2014, our ICT-140 ovarian cancer program was placed on hold.  As a result, we incurred minimal expenses related to this trial during the most recent quarter and we expect future expenses to continue to decline until such time as we obtain additional financing or find a partner for this trial.   During the three months ended March 31, 2014, we incurred certain pre-clinical expenses related to ICT-121 and ICT‑140 and certain ICT-107 expenses related to patient follow up and data analysis for the Phase II trial. Our general and administrative expenses remained consistent between periods.  We had $301,461 of non-cash expenses for the three months ended March 31, 2015, consisting of $88,939 of financing expense associated with the repricing of warrants resulting from the February 2015 financing, $205,829 of stock based compensation and $6,693 of depreciation expense.  We had $612,803 of non-cash expenses during the three months ended March 31, 2014, consisting of $416,067 related to the increase in our warrant liabilities, $184,102 of stock based compensation and $12,634 of depreciation expense. .

During the three months ended March 31, 2015, our investing cash flows used $1,758 to acquire certain computer equipment. During the three months ended March 31, 2014, our investing cash flows used $3,600 to acquire certain computer software.  

As described above, we completed an underwritten public offering during the three months ended March 31, 2015.  We received net proceeds of $14,599,627, excluding $105,563 of deferred offering costs that were previously advanced by the Company, from the issuance of common stock and warrants.  

During the three months ended March 31, 2015 and 2014, we did not receive any proceeds from the exercise of stock options, the exercise of warrants or from our controlled equity offering.

Inflation and changing prices have had no effect on our income or losses from operations over our two most recent fiscal years.

Off-Balance Sheet Arrangements

We are not party to any off-balance sheet arrangements that have, or are reasonably likely to have, a material current or future effect on our financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

During the three months ended March 31, 2015, there were no material changes to our market risk disclosures as set forth in Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” of our Annual Report on Form 10-K for the year ended December 31, 2014, filed on March 10,  2015 with the SEC.

 

21


  Item 4. Controls and Procedures

As of the end of the fiscal quarter covered by this report, we carried out an evaluation, under the supervision and with the participation of our principal executive officer and principal financial officer, regarding the effectiveness of the design and operation of our disclosure controls and procedures pursuant to SEC Rule 15d-15(b) of the Exchange Act. Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of March 31, 2015, (i) our disclosure controls and procedures were effective to ensure that information that is required to be disclosed by us in reports that we file under the Exchange Act is recorded, processed, summarized and reported or submitted within the time period specified in the rules and forms of the SEC and (ii) our disclosure controls and procedures were effective to provide reasonable assurance that material information required to be disclosed by us in the reports we file or submit under the Exchange Act was accumulated and communicated to our management as appropriate to allow timely decisions regarding required disclosure. There were no changes in our internal control over financial reporting that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

We do not expect that our disclosure controls and procedures and internal control over financial reporting will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. 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 our company have been detected. The design of any system of controls also is based in part upon assurance that any design will succeed in achieving its stated goals under all potential future conditions. However, controls may become inadequate because of changes in conditions or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

 

 

22


PART II

OTHER INFORMATION

 

Item 1. Legal Proceedings

None.

 

Item 1A. Risk Factors

You should read and consider the risk factors included under Item 1A. of our Annual Report on Form 10-K for the year ended December 31, 2014, filed on March 10, 2015 with the SEC.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

 

Item 3. Defaults Upon Senior Securities

None.

 

Item 4. Mine Safety Disclosures

Not applicable.

 

Item 5. Other Information

None.

 

 

 

23


  Item 6. Exhibits

 

Exhibit
No.

  

Description

 

4.1

 

 

Form of Warrant issued to participants in the February 12, 2015 underwritten public offering.

 

10.1

 

 

Employment Agreement dated January 30, 2015 between Steven J. Swanson and ImmunoCellular Therapeutics, Ltd.

 

10.2

 

 

Agreement for GMP Manufacturing of ICT-107 dated March 13, 2015 between PharmaCell B.V. and ImmunoCellular Therapeutics, Ltd.

 

31.1

  

 

Certification of the Registrant’s Principal Executive Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

31.2

  

 

Certification of the Registrant’s Principal Financial Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

32.1

  

 

Certification of the Registrant’s Principal Executive Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

32.2

  

 

Certification of the Registrant’s Principal Financial Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

101.INS

  

 

XBRL Instance Document

 

101.SCH

  

 

XBRL Taxonomy Extension Schema Document

 

101.CAL

  

 

XBRL Taxonomy Extension Calculation Linkbase Document

 

101.LAB

  

 

XBRL Taxonomy Extension Labels Linkbase Document

 

101.PRE

  

 

XBRL Taxonomy Extension Presentation Linkbase Document

 

101.DEF

  

 

XBRL Taxonomy Extension Definition Linkbase Document

Certain portions of the exhibit have been omitted based upon a request for confidential treatment filed by us with the Securities and Exchange Commission. The omitted portions of the exhibit have been separately filed by us with the Securities and Exchange Commission.

 

24


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.

 

Dated: May 11, 2015

 

IMMUNOCELLULAR THERAPEUTICS, LTD.

 

 

By:

 

/s/ Andrew Gengos

 

Name:

 

Andrew Gengos

 

Title:

 

President and Chief Executive Officer

(Principal Executive Officer)

 

 

By:

 

/s/ David Fractor

 

Name:

 

David Fractor

 

Title:

 

Principal Accounting Officer

(Principal Financial and Accounting Officer)

 

 

 

25


EXHIBIT INDEX

IMMUNOCELLULAR THERAPEUTICS, LTD.

FORM 10-Q FOR QUARTER ENDED MARCH 31, 2015

 

Exhibit
No.

  

Description

 

4.1

 

 

Form of Warrant issued to participants in the February 12, 2015 underwritten public offering.

 

10.1

 

 

Employment Agreement dated January 30, 2015 between Steven J. Swanson and ImmunoCellular Therapeutics, Ltd.

 

10.2

 

 

Agreement for GMP Manufacturing of ICT-107 dated March 13, 2015 between PharmaCell B.V. and ImmunoCellular Therapeutics, Ltd.

 

31.1

  

 

Certification of the Registrant’s Principal Executive Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

31.2

  

 

Certification of the Registrant’s Principal Financial Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

32.1

  

 

Certification of the Registrant’s Principal Executive Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

32.2

  

 

Certification of the Registrant’s Principal Financial Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

101.INS

  

 

XBRL Instance Document

 

101.SCH

  

 

XBRL Taxonomy Extension Schema Document

 

101.CAL

  

 

XBRL Taxonomy Extension Calculation Linkbase Document

 

101.LAB

  

 

XBRL Taxonomy Extension Labels Linkbase Document

 

101.PRE

  

 

XBRL Taxonomy Extension Presentation Linkbase Document

 

101.DEF

  

 

XBRL Taxonomy Extension Definition Linkbase Document

Certain portions of the exhibit have been omitted based upon a request for confidential treatment filed by us with the Securities and Exchange Commission. The omitted portions of the exhibit have been separately filed by us with the Securities and Exchange Commission.

 

26

 

 

Exhibit 4.1

COMMON STOCK PURCHASE WARRANT

 

immunocellular THERAPEUTICS, ltd.

Warrant No. : 02-2015-___

Warrant Shares: _______ Initi al Exercise Date: February 18, 2015

THIS COMMON STOCK PURCHASE WARRANT (the “ Warrant ”) certifies that, for value received, _____________ or its assigns (the “ Holder ”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date hereof (the “ Initial Exercise Date ”) and on or prior to the close of business on the five (5) year anniversary of the Initial Exercise Date (the “ Termination Date ”) but not thereafter, to subscribe for and purchase from ImmunoCellular Therapeutics, Ltd., a Delaware corporation (the “ Company ”), up to ______ shares (as subject to adjustment hereunder, the “ Warrant Shares ”) of Common Stock. The purchase price of one share of Common Stock under this Warrant shall be equal to the Exercise Price, as defined in Section 2(b).  This Warrant is issued pursuant to (i) the Underwriting Agreement, dated as of February 12, 2015, between the Company and Roth Capital Partners, LLC (the “ Underwriting Agreement ”) and (ii) the Company’s Registration Statement on Form S-1 (File No.: 333- 200874 ).

Section 1 . Definitions .  In addition to the terms defined elsewhere in this Warrant, the following terms have the meanings indicated in this Section 1:

Affiliate ” means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person, as such terms are used in and construed under Rule 405 under the Securities Act.

Approved Stock Plan ” means any employee benefit plan or other issuance, employment agreement or option grant or similar agreement which has been approved by the Board of Directors of the Company, pursuant to which the Company’s securities may be issued to any employee, consultant, officer or director for services provided to the Company.

Board of Directors ” means the board of directors of the Company.

Business Day ” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or any day on which banking institutions in the State of New York are authorized or required by law or other governmental action to close.

Commission ” means the United States Securities and Exchange Commission.

Common Stock ” means (i) the Company’s shares of Common Stock, par value $0.0001 per share, and (ii) any share capital into which such Common Stock shall have

1


 

been changed or any share capital resulting from a reclassification of such Common Stock.

 

Common Stock Equivalents ” means any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire at any time Common Stock, including, without limitation, any debt, preferred stock, right, option, warrant or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.

 

Exchange Act ” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

 

Liens ” means a lien, charge pledge, security interest, encumbrance, right of first refusal, preemptive right or other restriction.

Person ” means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.

Proceeding ” means an action, claim, suit, investigation or proceeding (including, without limitation, an informal investigation or partial proceeding, such as a deposition), whether commenced or threatened.

Securities Act ” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

Trading Day ” means a day on which the Common Stock is traded on a Trading Market.

Trading Market ” means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date in question: the NYSE MKT, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market, or the New York Stock Exchange (or any successors to any of the foregoing.

Transfer Agent ” means Computershare Trust Company, N.A., the current transfer agent of the Company, with a mailing address of 350 Indiana Street, Suite 750, Golden, Colorado 80401, and any successor transfer agent of the Company.

Section 2 . Exercise .

a) Exercise of the purchase rights represented by this Warrant may be made, in whole or in part, at any time or times on or after the Initial Exercise Date and on or before the Termination Date by delivery to the Company (or such other office or agency of the Company as it may designate by notice in writing to the registered Holder at the address of the Holder appearing on the books of the Company) of a duly executed facsimile copy (or e-mail attachment) of the Notice of Exercise in the form annexed hereto. Within three (3) Trading Days following the date of exercise as aforesaid, the Holder shall deliver the aggregate Exercise Price for the shares specified in the applicable

2


 

Notice of Exercise by wire transfer or cashier’s check drawn on a United States bank unless the cashless exercise procedure specified in Section 2(c) below is specified in the applicable Notice of Exercise. No ink-original Notice of Exercise shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Exercise form be required.  Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company until the Holder has purchased all of the Warrant Shares available hereunder and the Warrant has been exercised in full, in which case, the Holder shall surrender this Warrant to the Company for cancellation within three (3) Trading Days of the date the final Notice of Exercise is delivered to the Company. Partial exercises of this Warrant resulting in purchases of a portion of the total number of Warrant Shares available hereunder shall have the effect of lowering the outstanding number of Warrant Shares purchasable hereunder in an amount equal to the applicable number of Warrant Shares purchased.  The Holder and the Company shall maintain records showing the number of Warrant Shares purchased and the date of such purchases. The Company shall deliver any objection to any Notice of Exercise within one (1) Business Day of receipt of such notice.   The Holder and any assignee, by acceptance of this Warrant, acknowledge and agree that, by reason of the provisions of this paragraph, following the purchase of a portion of the Warrant Shares hereunder, the number of Warrant Shares available for purchase hereunder at any given time may be less than the amount stated on the face hereof.

b) Exercise Price .  The exercise price per share of the Common Stock under this Warrant shall be $0.66, subject to adjustment hereunder (the “ Exercise Price ”).

c) Cashless Exercise . If at the time of exercise hereof there is no effective registration statement registering, or the prospectus contained therein is not available for the issuance of the Warrant Shares to the Holder, then this Warrant may also be exercised, in whole or in part, at such time by means of a “cashless exercise” in which the Holder shall be entitled to receive a number of Warrant Shares equal to the quotient obtained by dividing [(A-B) (X)] by (A), where:

(A) = the VWAP on the Trading Day immediately preceding the date on which Holder elects to exercise this Warrant by means of a “cashless exercise,” as set forth in the applicable Notice of Exercise;

 

(B) = the Exercise Price of this Warrant, as adjusted hereunder; and

 

(X) = the number of Warrant Shares that would be issuable upon exercise of this Warrant in accordance with the terms of this Warrant if such exercise were by means of a cash exercise rather than a cashless exercise.

 

VWAP ” means, for any date, the price determined by the first of the following clauses that applies: (a) if the Common Stock is then listed or quoted on a Trading Market, the daily volume weighted average price of the Common Stock for such date (or the nearest preceding date) on the Trading Market on which the Common Stock is then listed or quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m.

3


 

(New York City time) to 4:02 p.m. (New York City time)), (b)  if the OTC Bulletin Board is not a Trading Market, the volume weighted average price of the Common Stock for such date (or the nearest preceding date) on the OTC Bulletin Board, (c) if the Common Stock is not then listed or quoted for trading on the OTC Bulletin Board and if prices for the Common Stock are then reported in the “Pink Sheets” published by Pink OTC Markets, Inc. (or a similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the Common Stock so reported, or (d) in all other cases, the fair market value of a share of Common Stock as determined by an independent appraiser selected in good faith by the Holders of a majority in interest of the Securities then outstanding and reasonably acceptable to the Company, the fees and expenses of which shall be paid by the Company.

Notwithstanding anything herein to the contrary, on the Termination Date, this Warrant shall be automatically exercised via cashless exercise pursuant to this Section 2(c).

 

d) Mechanics of Exercise .

i. Delivery of Warrant Shares Upon Exercise .  The Company shall cause the Warrant Shares purchased hereunder to be transmitted by the Transfer Agent to the Holder by crediting the account of the Holder’s or its designee’s balance account with The Depository Trust Company through its Deposit or Withdrawal at Custodian system (“ DWAC ”) if the Company is then a participant in such system and either (A) there is an effective registration statement permitting the issuance of the Warrant Shares to or resale of the Warrant Shares by Holder or (B) this Warrant is being exercised via cashless exercise, and otherwise by physical delivery of a certificate, registered in the Company’s share register in the name of the Holder or its designee, for the number of Warrant Shares to which the Holder is entitled pursuant to such exericse to the address specified by the Holder in the Notice of Exercise by the date that is one (1) Trading Day after the delivery to the Company of the Notice of Exercise (such date, the “ Warrant Share Delivery Date ”).   The Warrant Shares shall be deemed to have been issued, and Holder or any other person so designated to be named therein shall be deemed to have become a holder of record of such shares for all purposes, as of the date the Warrant has been exercised, with payment to the Company of the Exercise Price (or by cashless exercise, if permitted) and all taxes required to be paid by the Holder, if any, pursuant to Section 2(d)(vi) prior to the issuance of such shares, having been paid. If the Company fails for any reason to deliver to the Holder the Warrant Shares subject to a Notice of Exercise by the Warrant Share Delivery Date, the Company shall pay to the Holder, in cash, as liquidated damages and not as a penalty, for each $1,000 of Warrant Shares subject to such exercise (based on the VWAP of the Common Stock on the date of the applicable Notice of Exercise), $10 per Trading Day (increasing to $20 per Trading Day on the fifth Trading Day after such liquidated damages begin

4


 

to accrue) for each Trading Day after such Warrant Share Delivery Date until such Warrant Shares are delivered or Holder rescinds such exercise.

ii. Delivery of New Warrants Upon Exercise .  If this Warrant shall have been exercised in part, the Company shall, at the request of a Holder and upon surrender of this Warrant certificate, at the time of delivery of the Warrant Shares, deliver to the Holder a new Warrant evidencing the rights of the Holder to purchase the unpurchased Warrant Shares called for by this Warrant, which new Warrant shall in all other respects be identical with this Warrant.

iii. Rescission Rights .  If the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares pursuant to Section 2(d)(i) by the Warrant Share Delivery Date, then the Holder will have the right to rescind such exercise.

iv. Compensation for Buy-In on Failure to Timely Deliver Warrant Shares Upon Exercise .  In addition to any other rights available to the Holder, if the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares in accordance with the provisions of Section 2(d)(i) above pursuant to an exercise on or before the Warrant Share Delivery Date, and if after such date the Holder is required by its broker to purchase (in an open market transaction or otherwise) or the Holder’s brokerage firm otherwise purchases, shares of Common Stock to deliver in satisfaction of a sale by the Holder of the Warrant Shares which the Holder anticipated receiving upon such exercise (a “ Buy-In ”), then the Company shall (A) pay in cash to the Holder the amount, if any, by which (x) the Holder’s total purchase price (including brokerage commissions, if any) for the shares of Common Stock so purchased exceeds (y) the amount obtained by multiplying (1) the number of Warrant Shares that the Company was required to deliver to the Holder in connection with the exercise at issue times (2) the price at which the sell order giving rise to such purchase obligation was executed, and (B) at the option of the Holder, either reinstate the portion of the Warrant and equivalent number of Warrant Shares for which such exercise was not honored (in which case such exercise shall be deemed rescinded) or deliver to the Holder the number of shares of Common Stock that would have been issued had the Company timely complied with its exercise and delivery obligations hereunder.  For example, if the Holder purchases Common Stock having a total purchase price of $11,000 to cover a Buy-In with respect to an attempted exercise of shares of Common Stock with an aggregate sale price giving rise to such purchase obligation of $10,000, under clause (A) of the immediately preceding sentence the Company shall be required to pay the Holder $1,000. The Holder shall provide the Company written notice indicating the amounts payable to the Holder in respect of the Buy-In and, upon request of the Company, evidence of the amount of such loss.  Nothing herein shall limit a Holder’s right to pursue any other remedies

5


 

available to it hereunder, at law or in equity including, without limitation, a decree of specific performance and/or injunctive relief with respect to the Company’s failure to timely deliver shares of Common Stock upon exercise of the Warrant as required pursuant to the terms hereof.

v. No Fractional Shares or Scrip .  No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant.  As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such exercise, the Company shall, at its election, either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Exercise Price or round up to the next whole share.

vi. Charges, Taxes and Expenses .  Issuance of Warrant Shares shall be made without charge to the Holder for any issue or transfer tax or other incidental expense in respect of the issuance of such Warrant Shares, all of which taxes and expenses shall be paid by the Company, and such Warrant Shares shall be issued in the name of the Holder or in such name or names as may be directed by the Holder; provided , however , that in the event Warrant Shares are to be issued in a name other than the name of the Holder, this Warrant when surrendered for exercise shall be accompanied by the Assignment Form attached hereto duly executed by the Holder and the Company may require, as a condition thereto, the payment of a sum sufficient to reimburse it for any transfer tax incidental thereto.  The Company shall pay all Transfer Agent fees required for same-day processing of any Notice of Exercise and all fees to the Depository Trust Company (or another established clearing corporation performing similar functions) required for same-day electronic delivery of the Warrant Shares.

vii. Closing of Books .  The Company will not close its stockholder books or records in any manner which prevents the timely exercise of this Warrant, pursuant to the terms hereof.

e) Holder’s Exercise Limitations .  The Company shall not effect any exercise of this Warrant, and a Holder shall not have the right to exercise any portion of this Warrant, pursuant to Section 2 or otherwise, to the extent that after giving effect to such issuance after exercise as set forth on the applicable Notice of Exercise, the Holder (together with the Holder’s Affiliates, and any other Persons acting as a group together with the Holder or any of the Holder’s Affiliates), would beneficially own in excess of the Beneficial Ownership Limitation (as defined below).  For purposes of the foregoing sentence, the number of shares of Common Stock beneficially owned by the Holder and its Affiliates shall include the number of shares of Common Stock issuable upon exercise of this Warrant with respect to which such determination is being made, but shall exclude the number of shares of Common Stock which would be issuable upon (i) exercise of the remaining, nonexercised portion of this Warrant beneficially owned by the Holder or any of its Affiliates and (ii) exercise or conversion of the unexercised or nonconverted portion

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of any other securities of the Company (including, without limitation, any other  Common Stock Equivalents) subject to a limitation on conversion or exercise analogous to the limitation contained herein beneficially owned by the Holder or any of its Affiliates.  Except as set forth in the preceding sentence, for purposes of this Section 2(e), beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder, it being acknowledged by the Holder that the Company is not representing to the Holder that such calculation is in compliance with Section 13(d) of the Exchange Act and the Holder is solely responsible for any schedules required to be filed in accordance therewith.   To the extent that the limitation contained in this Section 2(e) applies, the determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates) and of which portion of this Warrant is exercisable shall be in the sole discretion of the Holder, and the submission of a Notice of Exercise shall be deemed to be the Holder’s determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates) and of which portion of this Warrant is exercisable, in each case subject to the Beneficial Ownership Limitation, and the Company shall have no obligation to verify or confirm the accuracy of such determination.   In addition, a determination as to any group status as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder.  For purposes of this Section 2(e), in determining the number of outstanding shares of Common Stock, a Holder may rely on the number of outstanding shares of Common Stock as reflected in (A) the Company’s most recent periodic or annual report filed with the Commission, as the case may be, (B) a more recent public announcement by the Company or (C) a more recent written notice by the Company or the Transfer Agent setting forth the number of shares of Common Stock outstanding.  Upon the written or oral request of a Holder, the Company shall within two Trading Days confirm orally and in writing to the Holder the number of shares of Common Stock then outstanding.  In any case, the number of outstanding shares of Common Stock shall be determined after giving effect to the conversion or exercise of securities of the Company, including this Warrant, by the Holder or its Affiliates since the date as of which such number of outstanding shares of Common Stock was reported.  The “ Beneficial Ownership Limitation ” shall be 4.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock issuable upon exercise of this Warrant.  The Holder, upon notice to the Company, may increase or decrease the Beneficial Ownership Limitation provisions of this Section 2(e), provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock upon exercise of this Warrant held by the Holder and the provisions of this Section 2(e) shall continue to apply.  Any increase in the Beneficial Ownership Limitation will not be effective until the 61 st day after such notice is delivered to the Company.  The provisions of this paragraph shall be construed and implemented in a manner otherwise than in strict conformity with the terms of this Section 2(e) to correct this paragraph (or any portion hereof) which may be defective or inconsistent with the intended Beneficial Ownership Limitation herein contained or to make changes or supplements necessary or desirable to

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properly give effect to such limitation. The limitations contained in this paragraph shall apply to a successor holder of this Warrant.  

Section 3 . Certain Adjustments .

a) Stock Dividends and Splits . If the Company, at any time while this Warrant is outstanding: (i) pays a stock dividend or otherwise makes a distribution or distributions on shares of its Common Stock or any other equity or equity equivalent securities payable in shares of Common Stock (which, for avoidance of doubt, shall not include any shares of Common Stock issued by the Company upon exercise of this Warrant), (ii) subdivides outstanding shares of Common Stock into a larger number of shares, (iii) combines (including by way of reverse stock split) outstanding shares of Common Stock into a smaller number of shares, or (iv) issues by reclassification of shares of the Common Stock any shares of capital stock of the Company, then in each case the Exercise Price shall be multiplied by a fraction of which the numerator shall be the number of shares of Common Stock (excluding treasury shares, if any) outstanding immediately before such event and of which the denominator shall be the number of shares of Common Stock outstanding immediately after such event, and the number of shares issuable upon exercise of this Warrant shall be proportionately adjusted such that the aggregate Exercise Price of this Warrant shall remain unchanged.  Any adjustment made pursuant to this Section 3(a) shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend or distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or re‑classification.

b) Adjustment upon Issuance of shares of Common Stock . If and whenever on or after the Issuance Date, the Company issues or sells, or in accordance with this Section 3(b) is deemed to have issued or sold, any shares of Common Stock (including the issuance or sale of shares of Common Stock owned or held by or for the account of the Company, but excluding shares of Common Stock deemed to have been issued by the Company in connection with any Excluded Securities (as defined below) (the “ Additional Shares ”) for a consideration per share (the “ New Issuance Price ”) less than a price (the “ Applicable Price ”) equal to the Exercise Price in effect immediately prior to such issue or sale or deemed issuance or sale (the foregoing a “ Dilutive Issuance ”), then immediately after such Dilutive Issuance, the Exercise Price then in effect shall be reduced to a price determined as follows:

 

Adjusted Exercise Price = (A x B) + D

A+C

where

 

“A” equals the number of shares of Common Stock outstanding, including the Additional Shares deemed to be issued hereunder, immediately preceding the Dilutive Issuance;

 

“B” equals the Exercise Price in effect immediately preceding such Dilutive Issuance;

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“C” equals the number of Additional Shares issued or deemed issued hereunder as a result of the Dilutive Issuance; and

 

“D” equals the aggregate consideration, if any, received or deemed to be received by the Company upon such Dilutive Issuance.

 

i. Issuance of Options . If the Company in any manner grants any Options and the lowest price per share for which one share of Common Stock is issuable upon the exercise of any such Option or upon conversion, exercise or exchange of any Convertible Securities issuable upon exercise of any such Option is less than the Applicable Price, then such share of Common Stock shall be deemed to be outstanding and to have been issued and sold by the Company at the time of the granting or sale of such Option for such price per share. For purposes of this Section 3(b)(i), the “lowest price per share for which one share of Common Stock is issuable upon exercise of such Options or upon conversion, exercise or exchange of such Convertible Securities issuable upon exercise of any such Option” shall be equal to the sum of the lowest amounts of consideration (if any) received or receivable by the Company with respect to any one share of Common Stock upon the granting or sale of the Option, upon exercise of the Option and upon conversion, exercise or exchange of any Convertible Security issuable upon exercise of such Option less any consideration paid or payable by the Company with respect to such one share of Common Stock upon the granting or sale of such Option, upon exercise of such Option and upon conversion exercise or exchange of any Convertible Security issuable upon exercise of such Option. No further adjustment of the Exercise Price shall be made upon the actual issuance of such shares of Common Stock or of such Convertible Securities upon the exercise of such Options or upon the actual issuance of such shares of Common Stock upon conversion, exercise or exchange of such Convertible Securities.

ii. Issuance of Convertible Securities . If the Company in any manner issues or sells any Convertible Securities and the lowest price per share for which one share of Common Stock is issuable upon the conversion, exercise or exchange thereof is less than the Applicable Price, then such share of Common Stock shall be deemed to be outstanding and to have been issued and sold by the Company at the time of the issuance or sale of such Convertible Securities for such price per share. For the purposes of this Section 3(b)(ii), the “lowest price per share for which one share of Common Stock is issuable upon the conversion, exercise or exchange thereof” shall be equal to the sum of the lowest amounts of consideration (if any) received or receivable by the Company with respect to one share of Common Stock upon the issuance or sale of the Convertible Security and upon conversion, exercise or exchange of such Convertible Security less any consideration paid or payable by the Company with respect to

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such one share of Common Stock upon the issuance or sale of such Convertible Security and upon conversion, exercise or exchange of such Convertible Security. No further adjustment of the Exercise Price shall be made upon the actual issuance of such shares of Common Stock upon conversion, exercise or exchange of such Convertible Securities, and if any such issue or sale of such Convertible Securities is made upon exercise of any Options for which adjustment of this Warrant has been or is to be made pursuant to other provisions of this Section 3(b), no further adjustment of the Exercise Price shall be made by reason of such issue or sale.

iii. Change in Option Price or Rate of Conversion . If the purchase price provided for in any Options, the additional consideration, if any, payable upon the issue, conversion, exercise or exchange of any Convertible Securities, or the rate at which any Convertible Securities are convertible into or exercisable or exchangeable for shares of Common Stock increases or decreases at any time, the Exercise Price in effect at the time of such increase or decrease shall be adjusted to the Exercise Price which would have been in effect at such time had such Options or Convertible Securities provided for such increased or decreased purchase price, additional consideration or increased or decreased conversion rate, as the case may be, at the time initially granted, issued or sold. For purposes of this Section 3(b)(iii), if the terms of any Option or Convertible Security that was outstanding as of the date of issuance of this Warrant are increased or decreased in the manner described in the immediately preceding sentence, then such Option or Convertible Security and the shares of Common Stock deemed issuable upon exercise, conversion or exchange thereof shall be deemed to have been issued as of the date of such increase or decrease. No adjustment pursuant to this Section 3(b) shall be made if such adjustment would result in an increase of the Exercise Price then in effect.

iv. Calculation of Consideration Received . In case any Option is issued in connection with the issue or sale of other securities of the Company, together comprising one integrated transaction, (x) the Options will be deemed to have been issued for the Option Value of such Options and (y) the other securities issued or sold in such integrated transaction shall be deemed to have been issued for the difference of (I) the aggregate consideration received by the Company less any consideration paid or payable by the Company pursuant to the terms of such other securities of the Company, less (II) the Option Value. If any shares of Common Stock, Options or Convertible Securities are issued or sold or deemed to have been issued or sold for cash, the consideration received therefor will be deemed to be the net amount received by the Company therefor. If any shares of Common Stock, Options or Convertible Securities are issued or sold for a consideration other than cash, the amount of such consideration received by the Company will be the fair value of such consideration,

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except where such consideration consists of securities, in which case the amount of consideration received by the Company will be the Closing Sale Price of such security on the date of receipt. If any shares of Common Stock, Options or Convertible Securities are issued to the owners of the non-surviving entity in connection with any merger in which the Company is the surviving entity, the amount of consideration therefor will be deemed to be the fair value of such portion of the net assets and business of the non-surviving entity as is attributable to such shares of Common Stock, Options or Convertible Securities, as the case may be. The fair value of any consideration other than cash or securities will be determined jointly by the Company and the Holder. If such parties are unable to reach agreement within ten (10) days after the occurrence of an event requiring valuation (the “ Valuation Event ”), the fair value of such consideration will be determined within five (5) Trading Days after the tenth (10th) day following the Valuation Event by an independent, reputable appraiser jointly selected by the Company and the Holder. The determination of such appraiser shall be final and binding upon all parties absent manifest error and the fees and expenses of such appraiser shall be borne by the Company.

v. Record Date . If the Company takes a record of the holders of shares of Common Stock for the purpose of entitling them (A) to receive a dividend or other distribution payable in shares of Common Stock, Options or in Convertible Securities or (B) to subscribe for or purchase shares of Common Stock, Options or Convertible Securities, then such record date will be deemed to be the date of the issue or sale of the shares of Common Stock deemed to have been issued or sold upon the declaration of such dividend or the making of such other distribution or the date of the granting of such right of subscription or purchase, as the case may be.

vi. No Change in Warrant Shares .  No reduction in the Exercise Price pursuant to this Section 3(b) shall change the number of Warrant Shares for which this Warrant shall be exercisable.

For the purposes of this Section 3(b):

Convertible Securities ” means any stock or securities (other than Options) directly or indirectly convertible into or exercisable or exchangeable for shares of Common Stock.

Excluded Securities ” means: (i) capital stock, Options or Convertible Securities issued to directors, officers, employees or consultants of the Company in connection with their service as directors of the Company, their employment by the Company or their retention as consultants by the Company pursuant to an Approved Stock Plan, (ii) shares of Common Stock issued upon the conversion or exercise of Options or Convertible

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Securities that were issued and outstanding on the date immediately preceding the Initial Exercise Date, provided such securities are not amended after the Initial Exercise Date to increase the number of shares of Common Stock issuable thereunder or to lower the exercise or conversion price thereof, (iii) securities issued pursuant to the Underwriting Agreement and securities issued upon the exercise or conversion of those securities, (iv) shares of Common Stock issued or issuable by reason of a dividend, stock split or other distribution on shares of Common Stock (but only to the extent that such a dividend, split or distribution results in an adjustment in the Warrant Price pursuant to the other provisions of this Warrant), and (v) capital stock, Options or Convertible Securities issued as consideration for an acquisition or strategic transaction approved by a majority of the disinterested directors of the Company, provided that any such issuance shall only be a Person (or to the equityholders of a Person) which is, itself or through its subsidiaries, an operating company or an owner of an asset in a business synergistic with the business of the Company and shall provide to the Company additional benefits in addition to the investment of funds, but shall not, for the purposes of this clause (v), include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities.

Options ” means any rights, warrants or options to subscribe for or purchase shares of Common Stock or Convertible Securities.

Option Value ” means the value of an Option based on the Black and Scholes Option Pricing model obtained from the “OV” function on Bloomberg determined as of the day prior to the public announcement of the applicable Option for pricing purposes and reflecting (i) a risk-free interest rate corresponding to the U.S. Treasury rate for a period equal to the remaining term of the applicable Option as of the applicable date of determination, (ii) an expected volatility equal to the greater of (a) 100% and (b) the 100 day volatility obtained from the HVT function on Bloomberg as of the day immediately following the public announcement of the issuance of the applicable Option, (iii) the underlying price per share used in such calculation shall be the highest VWAP of the Common Stock during the period beginning on the day prior to the execution of definitive documentation relating to the issuance of the applicable Option and the public announcement of such issuance and (iv) a 360 day annualization factor.

c) Subsequent Rights Offerings .   In addition to any adjustments pursuant to Section 3(a) above, if at any time the Company grants, issues or sells any Common Stock Equivalents or rights to purchase stock, warrants, securities or other property pro rata to the record holders of any class of shares of Common Stock (the “ Purchase Rights ”), then the Holder will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which the Holder could have acquired if the Holder had

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held the number of shares of Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date on which a record is taken for the grant, issuance or sale of such Purchase Rights, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the grant, issue or sale of such Purchase Rights (provided, however, to the extent that the Holder’s right to participate in any such Purchase Right would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Purchase Right to such extent (or beneficial ownership of such shares of Common Stock as a result of such Purchase Right to such extent) and such Purchase Right to such extent shall be held in abeyance for the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation).

d) Pro Rata Distributions .  During such time as this Warrant is outstanding, if the Company shall declare or make any dividend or other distribution of its assets (or rights to acquire its assets) to holders of shares of Common Stock, by way of return of capital or otherwise (including, without limitation, any distribution of cash, stock or other securities, property or options by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement or other similar transaction) (a “ Distribution ”), at any time after the issuance of this Warrant, then, in each such case, the Holder shall be entitled to participate in such Distribution to the same extent that the Holder would have participated therein if the Holder had held the number of shares of Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date of which a record is taken for such Distribution, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the participation in such Distribution ( provided , however , to the extent that the Holder’s right to participate in any such Distribution would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Distribution to such extent (or in the beneficial ownership of any shares of Common Stock as a result of such Distribution to such extent) and the portion of such Distribution shall be held in abeyance for the benefit of the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation).  

e) Fundamental Transaction . If, at any time while this Warrant is outstanding, (i) the Company, directly or indirectly, in one or more related transactions effects any merger or consolidation of the Company with or into another Person, (ii) the Company, directly or indirectly, effects any sale, lease, license, assignment, transfer, conveyance or other disposition of all or substantially all of its assets in one or a series of related transactions, (iii) any, direct or indirect, purchase offer, tender offer or exchange offer (whether by the Company or another Person) is completed pursuant to which holders of Common Stock are permitted to sell, tender or exchange their shares for other securities, cash or property and has been accepted by the holders of 50% or more of the outstanding Common Stock, (iv) the Company, directly or indirectly, in one or more related transactions effects any reclassification, reorganization or recapitalization of the

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Common Stock or any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property, or (v) the Company, directly or indirectly, in one or more related transactions consummates a stock or share purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off or scheme of arrangement) with another Person or group of Persons whereby such other Person or group acquires more than 50% of the outstanding shares of Common Stock (not including any shares of Common Stock held by the other Person or other Persons making or party to, or associated or affiliated with the other Persons making or party to, such stock or share purchase agreement or other business combination) (each a “ Fundamental Transaction ”), then, upon any subsequent exercise of this Warrant, the Holder shall have the right to receive, for each Warrant Share that would have been issuable upon such exercise immediately prior to the occurrence of such Fundamental Transaction, at the option of the Holder (without regard to any limitation in Section 2(e) on the exercise of this Warrant), the number of shares of Common Stock of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration (the “ Alternate Consideration ”) receivable as a result of such Fundamental Transaction by a holder of the number of shares of Common Stock for which this Warrant is exercisable immediately prior to such Fundamental Transaction (without regard to any limitation in Section 2(e) on the exercise of this Warrant).   For purposes of any such exercise, the determination of the Exercise Price shall be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration issuable in respect of one share of Common Stock in such Fundamental Transaction, and the Company shall apportion the Exercise Price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration.  If holders of Common Stock are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Holder shall be given the same choice as to the Alternate Consideration it receives upon any exercise of this Warrant following such Fundamental Transaction.  Notwithstanding anything to the contrary, in the event of a Fundamental Transaction, the Company or any Successor Entity (as defined below) shall, at the Holder’s option, exercisable at any time concurrently with, or within 30 days after, the consummation of the Fundamental Transaction, purchase this Warrant from the Holder by paying to the Holder an amount of cash equal to the Black Scholes Value of the remaining unexercised portion of this Warrant on the date of the consummation of such Fundamental Transaction.  “Black Scholes Value” means the value of this Warrant based on the Black and Scholes Option Pricing Model obtained from the “OV” function on Bloomberg, L.P. (“Bloomberg”) determined as of the day of consummation of the applicable Fundamental Transaction for pricing purposes and reflecting (A) a risk-free interest rate corresponding to the U.S. Treasury rate for a period equal to the time between the date of the public announcement of the applicable Fundamental Transaction and the Termination Date, (B) an expected volatility equal to the greater of 100% and the 100 day volatility obtained from the HVT function on Bloomberg as of the Trading Day immediately following the public announcement of the applicable Fundamental Transaction, (C) the underlying price per share used in such calculation shall be the sum of the price per share being offered in cash, if any, plus the value of any non-cash consideration, if any, being offered in such Fundamental Transaction and (D) a remaining

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option time equal to the time between the date of the public announcement of the applicable Fundamental Transaction and the Termination Date.  The Company shall cause any successor entity in a Fundamental Transaction in which the Company is not the survivor (the “ Successor Entity ”) to assume in writing all of the obligations of the Company under this Warrant and the other Transaction Documents in accordance with the provisions of this Section 3(e) pursuant to written agreements in form and substance reasonably satisfactory to the Holder and approved by the Holder (without unreasonable delay) prior to such Fundamental Transaction and shall, at the option of the Holder, deliver to the Holder in exchange for this Warrant a security of the Successor Entity evidenced by a written instrument substantially similar in form and substance to this Warrant which is exercisable for a corresponding number of shares of capital stock of such Successor Entity (or its parent entity) equivalent to the shares of Common Stock acquirable and receivable upon exercise of this Warrant (without regard to any limitations on the exercise of this Warrant) prior to such Fundamental Transaction, and with an exercise price which applies the exercise price hereunder to such shares of capital stock (but taking into account the relative value of the shares of Common Stock pursuant to such Fundamental Transaction and the value of such shares of capital stock, such number of shares of capital stock and such exercise price being for the purpose of protecting the economic value of this Warrant immediately prior to the consummation of such Fundamental Transaction), and which is reasonably satisfactory in form and substance to the Holder. Upon the occurrence of any such Fundamental Transaction, the Successor Entity shall succeed to, and be substituted for (so that from and after the date of such Fundamental Transaction, the provisions of this Warrant and the other Transaction Documents referring to the “Company” shall refer instead to the Successor Entity), and may exercise every right and power of the Company and shall assume all of the obligations of the Company under this Warrant and the other Transaction Documents with the same effect as if such Successor Entity had been named as the Company herein.

f) Calculations . All calculations under this Section 3 shall be made to the nearest cent or the nearest 1/100th of a share, as the case may be. For purposes of this Section 3, the number of shares of Common Stock deemed to be issued and outstanding as of a given date shall be the sum of the number of shares of Common Stock (excluding treasury shares, if any) issued and outstanding.

g) Notice to Holder .  

i. Adjustment to Exercise Price . Whenever the Exercise Price is adjusted pursuant to any provision of this Section 3, the Company shall promptly mail to the Holder a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of Warrant Shares and setting forth a brief statement of the facts requiring such adjustment.

ii. Notice to Allow Exercise by Holder . If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Common Stock, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Common Stock, (C) the Company

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shall authorize the granting to all holders of the Common Stock rights or warrants to subscribe for or purchase any shares of capital stock of any class or of any rights, (D) the approval of any stockholders of the Company shall be required in connection with any reclassification of the Common Stock, any consolidation or merger to which the Company is a party, any sale or transfer of all or substantially all of the assets of the Company, or any compulsory share exchange whereby the Common Stock is converted into other securities, cash or property, or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company, then, in each case, the Company shall cause to be mailed to the Holder at its last address as it shall appear upon the Warrant Register of the Company, at least 20 calendar days prior to the applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of the Common Stock of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y) the date on which such reclassification, consolidation, merger, sale, transfer or share exchange is expected to become effective or close, and the date as of which it is expected that holders of the Common Stock of record shall be entitled to exchange their shares of the Common Stock for securities, cash or other property deliverable upon such reclassification, consolidation, merger, sale, transfer or share exchange; provided that the failure to mail such notice or any defect therein or in the mailing thereof shall not affect the validity of the corporate action required to be specified in such notice.  To the extent that any notice provided in this Warrant constitutes, or contains, material, non-public information regarding the Company or any of the Subsidiaries, the Company shall simultaneously file such notice with the Commission pursuant to a Current Report on Form 8-K.  The Holder shall remain entitled to exercise this Warrant during the period commencing on the date of such notice to the effective date of the event triggering such notice except as may otherwise be expressly set forth herein.

Section 4 . Transfer of Warrant .

a) Transferability .  This Warrant and all rights hereunder (including, without limitation, any registration rights) are transferable, in whole or in part, upon surrender of this Warrant at the principal office of the Company or its designated agent, together with a written assignment of this Warrant substantially in the form attached hereto duly executed by the Holder or its agent or attorney and funds sufficient to pay any transfer taxes payable upon the making of such transfer.  Upon such surrender and, if required, such payment, the Company shall execute and deliver a new Warrant or Warrants in the name of the assignee or assignees, as applicable, and in the denomination or denominations specified in such instrument of assignment, and shall issue to the assignor a new Warrant evidencing the portion of this Warrant not so assigned, and this Warrant shall promptly be cancelled.   Notwithstanding anything herein to the contrary, the Holder

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shall not be required to physically surrender this Warrant to the Company unless the Holder has assigned this Warrant in full, in which case, the Holder shall surrender this Warrant to the Company within three (3) Trading Days of the date the Holder delivers an assignment form to the Company assigning this Warrant full.   The Warrant, if properly assigned in accordance herewith, may be exercised by a new holder for the purchase of Warrant Shares without having a new Warrant issued.  

b) New Warrants . This Warrant may be divided or combined with other Warrants upon presentation hereof at the aforesaid office of the Company, together with a written notice specifying the names and denominations in which new Warrants are to be issued, signed by the Holder or its agent or attorney.  Subject to compliance with Section 4(a), as to any transfer which may be involved in such division or combination, the Company shall execute and deliver a new Warrant or Warrants in exchange for the Warrant or Warrants to be divided or combined in accordance with such notice. All Warrants issued on transfers or exchanges shall be dated the initial issuance date of this Warrant and shall be identical with this Warrant except as to the number of Warrant Shares issuable pursuant thereto.

c) Warrant Register . The Company shall register this Warrant, upon records to be maintained by the Company for that purpose (the “ Warrant Register ”), in the name of the record Holder hereof from time to time.  The Company may deem and treat the registered Holder of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other purposes, absent actual notice to the contrary.

Section 5 . Miscellaneous .

a) No Rights as Stockholder Until Exercise .  This Warrant does not entitle the Holder to any voting rights, dividends or other rights as a stockholder of the Company prior to the exercise hereof as set forth in Section 2(d)(i), except as expressly set forth in Section 3.  

b) Loss, Theft, Destruction or Mutilation of Warrant . The Company covenants that upon receipt by the Company of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant or any stock certificate relating to the Warrant Shares, and in case of loss, theft or destruction, of indemnity or security reasonably satisfactory to it (which, in the case of the Warrant, shall not include the posting of any bond), and upon surrender and cancellation of such Warrant or stock certificate, if mutilated, the Company will make and deliver a new Warrant or stock certificate of like tenor and dated as of such cancellation, in lieu of such Warrant or stock certificate.

c) Saturdays, Sundays, Holidays, etc .  If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall not be a Business Day, then, such action may be taken or such right may be exercised on the next succeeding Business Day.

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d) Authorized Shares .  

The Company covenants that, during the period the Warrant is outstanding, it will reserve from its authorized and unissued Common Stock a sufficient number of shares to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant.  The Company further covenants that its issuance of this Warrant shall constitute full authority to its officers who are charged with the duty of executing stock certificates to execute and issue the necessary Warrant Shares upon the exercise of the purchase rights under this Warrant.  The Company will take all such reasonable action as may be necessary to assure that such Warrant Shares may be issued as provided herein without violation of any applicable law or regulation, or of any requirements of the Trading Market upon which the Common Stock may be listed.  The Company covenants that all Warrant Shares which may be issued upon the exercise of the purchase rights represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant and payment for such Warrant Shares in accordance herewith, be duly authorized, validly issued, fully paid and nonassessable and free from all taxes, liens and charges created by the Company in respect of the issue thereof (other than taxes in respect of any transfer occurring contemporaneously with such issue).  

Except and to the extent as waived or consented to by the Holder, the Company shall not by any action, including, without limitation, amending its certificate of incorporation or through any reorganization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary or appropriate to protect the rights of Holder as set forth in this Warrant against impairment.  Without limiting the generality of the foregoing, the Company will (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise immediately prior to such increase in par value, (ii) take all such action as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and nonassessable Warrant Shares upon the exercise of this Warrant and (iii) use commercially reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction thereof, as may be, necessary to enable the Company to perform its obligations under this Warrant.

Before taking any action which would result in an adjustment in the number of Warrant Shares for which this Warrant is exercisable or in the Exercise Price, the Company shall obtain all such authorizations or exemptions thereof, or consents thereto, as may be necessary from any public regulatory body or bodies having jurisdiction thereof.

e) Jurisdiction . This Warrant shall be governed by, and construed in accordance with, the internal laws of the State of New York, without reference to the

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choice of law provisions thereof.  The Company and, by accepting this Warrant, the Holder, each irrevocably submits to the exclusive jurisdiction of the courts of the State of New York located in New York County and the United States District Court for the Southern District of New York for the purpose of any suit, action, proceeding or judgment relating to or arising out of this Warrant and the transactions contemplated hereby.  Service of process in connection with any such suit, action or proceeding may be served on each party hereto anywhere in the world by the same methods as are specified for the giving of notices under this Warrant.  The Company and, by accepting this Warrant, the Holder, each irrevocably consents to the jurisdiction of any such court in any such suit, action or proceeding and to the laying of venue in such court.  The Company and, by accepting this Warrant, the Holder, each irrevocably waives any objection to the laying of venue of any such suit, action or proceeding brought in such courts and irrevocably waives any claim that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum.   EACH OF THE COMPANY AND, BY ITS ACCEPTANCE HEREOF, THE HOLDER HEREBY WAIVES ANY RIGHT TO REQUEST A TRIAL BY JURY IN ANY LITIGATION WITH RESPECT TO THIS WARRANT AND REPRESENTS THAT COUNSEL HAS BEEN CONSULTED SPECIFICALLY AS TO THIS WAIVER .

f) Restrictions .  The Holder acknowledges that the Warrant Shares acquired upon the exercise of this Warrant, if not registered, and the Holder does not utilize cashless exercise, will have restrictions upon resale imposed by state and federal securities laws.

g) Nonwaiver and Expenses .  No course of dealing or any delay or failure to exercise any right hereunder on the part of Holder shall operate as a waiver of such right or otherwise prejudice the Holder’s rights, powers or remedies.  Without limiting any other provision of this Warrant, if the Company willfully and knowingly fails to comply with any provision of this Warrant, which results in any material damages to the Holder, the Company shall pay to the Holder such amounts as shall be sufficient to cover any costs and expenses including, but not limited to, reasonable attorneys’ fees, including those of appellate proceedings, incurred by the Holder in collecting any amounts due pursuant hereto or in otherwise enforcing any of its rights, powers or remedies hereunder.

h) Notices .  The Company shall provide Holder with prompt written notice of all actions taken pursuant to this Warrant. Whenever notice is required to be given under this Warrant, unless otherwise provided herein, such notice shall be given in writing, will be mailed (a) if within the domestic United States by first-class registered or certified airmail, or nationally recognized overnight express courier, postage prepaid, or by facsimile or (b) if delivered from outside the United States, by International Federal Express or facsimile, and (c) will be deemed given (i) if delivered by first-class registered or certified mail domestic, three (3) business days after so mailed, (ii) if delivered by nationally recognized overnight carrier, one (1) business day after so mailed, (iii) if delivered by International Federal Express, two (2) business days after so mailed and (iv) if delivered by facsimile, upon electronic confirmation of receipt, and will be delivered and addressed as follows:

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if to the Company, to:

 

ImmunoCellular Therapeutics, Ltd.

23622 Calabasas Road, Suite 300

Calabasas, California 91302

Attn: Andrew Gengos, President and Chief Executive Officer

Facsimile: (818) 224-5287

 

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

 

Cooley LLP

3175 Hanover Street

Palo Alto, California 94304

Attn: Glen Y. Sato

Facsimile: (650) 849-7400

 

if to the Holder, at the address of the Holder appearing on the books of the Company

i) Limitation of Liability .  No provision hereof, in the absence of any affirmative action by the Holder to exercise this Warrant to purchase Warrant Shares, and no enumeration herein of the rights or privileges of the Holder, shall give rise to any liability of the Holder for the purchase price of any Common Stock or as a stockholder of the Company, whether such liability is asserted by the Company or by creditors of the Company.

j) Remedies .  The Holder, in addition to being entitled to exercise all rights granted by law, including recovery of damages, will be entitled to specific performance of its rights under this Warrant.  The Company agrees that monetary damages would not be adequate compensation for any loss incurred by reason of a breach by it of the provisions of this Warrant and hereby agrees to waive and not to assert the defense in any action for specific performance that a remedy at law would be adequate.

k) Successors and Assigns .  Subject to applicable securities laws, this Warrant and the rights and obligations evidenced hereby shall inure to the benefit of and be binding upon the successors and permitted assigns of the Company and the successors and permitted assigns of Holder.  The provisions of this Warrant are intended to be for the benefit of any Holder from time to time of this Warrant and shall be enforceable by the Holder or holder of Warrant Shares.

l) Amendment .  This Warrant may be modified or amended or the provisions hereof waived with the written consent of the Company and the Holder .

m) Severability .  Wherever possible, each provision of this Warrant shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Warrant shall be prohibited by or invalid under applicable law, such

20


 

provision shall be ineffective to the extent of such prohibition or invalidity, without invalidating the remainder of such provisions or the remaining provisions of this Warrant.

n) Headings .  The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant.

 

********************

 

(Signature Page Follows)

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IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its officer thereunto duly authorized as of the date first above indicated.

 

 

 

 

IMMUNOCELLULAR THERAPEUTICS, LTD.

 

 

 

 

 

 

 

By:

 

 

 

 

Name:  

 

 

 

Title:  

 

 

 

22


 

NOTICE OF EXERCISE

 

To: ImmunoCellular Therapeutics, Ltd.

 

(1) The undersigned hereby elects to purchase ________ Warrant Shares of the Company pursuant to the terms of the attached Warrant (only if exercised in full), and tenders herewith payment of the exercise price in full, together with all applicable transfer taxes, if any.

(2) Payment shall take the form of (check applicable box):

[  ] in lawful money of the United States; or

[ ] [if permitted the cancellation of such number of Warrant Shares as is necessary, in accordance with the formula set forth in subsection 2(c), to exercise this Warrant with respect to the maximum number of Warrant Shares purchasable pursuant to the cashless exercise procedure set forth in subsection 2(c).

(3) Please issue said Warrant Shares in the name of the undersigned or in such other name as is specified below:

_______________________________

 

The Warrant Shares shall be delivered to the following DWAC Account Number:

 

_______________________________

_______________________________

_______________________________

 

 

[SIGNATURE OF HOLDER]

Name of Investing Entity: ________________________________________________________________________

Signature of Authorized Signatory of Investing Entity : _________________________________________________

Name of Authorized Signatory: ___________________________________________________________________

Title of Authorized Signatory: ____________________________________________________________________

Date: ________________________________________________________________________________________

 

 

 


 


 

EXHIBIT B

 

ASSIGNMENT FORM

(To assign the foregoing Warrant, execute this form and supply required information.  Do not use this form to purchase shares.)

FOR VALUE RECEIVED, the foregoing Warrant and all rights evidenced thereby are hereby assigned to

Name:

 

(Please Print)

Address:

 

(Please Print)

Dated: _______________ __, ______

 

Holder’s Signature:

 

Holder’s Address:

 

 

 

 

Exhibit 10.1

ImmunoCellular Therapeutics, Ltd.

EMPLOYMENT AGREEMENT

for

Steven J. Swanson

This Employment Agreement (the “ Agreement ”) is made between ImmunoCellular Therapeutics, Ltd. (the “ Company ”) and Steven J. Swanson (the “ Executive ”) (collectively, the “ Parties ”).

Whereas , the Company desires for Executive to provide services to the Company, and wishes to provide Executive with certain compensation and benefits in return for such employment services; and

Whereas , Executive wishes to be employed by the Company and to provide personal services to the Company in return for certain compensation and benefits;

Now, Therefore , in consideration of the mutual promises and covenants contained herein and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereto agree as follows:

1. Employment by the Company.

1.1 Position.   Starting on February 16, 2015, Executive shall serve as the Company’s Senior Vice President, Research.  During the term of Executive’s employment with the Company, Executive will devote Executive’s best efforts and substantially all of Executive’s business time and attention to the business of the Company, except for approved time off permitted by the Company’s general employment policies.  

1.2 Duties and Location.   Executive shall perform such duties as are required by the Company’s Chief Executive Officer, to whom Executive will report.  Executive’s primary office location will be the Company’s headquarters. The Company reserves the right to reasonably require Executive to perform Executive’s duties at places other than Executive’s primary office location from time to time, and to require reasonable business travel.  The Company may modify Executive’s job title and duties as it deems necessary and appropriate in light of the Company’s needs and interests from time to time.

1.3 Policies and Procedures.   The employment relationship between the Parties shall be governed by the general employment policies and practices of the Company, except that when the terms of this Agreement differ from or are in conflict with the Company’s general employment policies or practices, this Agreement shall control.

1.


 

2. Compensation.

2.1 Salary.   For services to be rendered hereunder, Executive shall receive a base salary at the rate of Two Hundred Eighty-Five Thousand Dollars ($285,000) per year (the “ Base Salary ”), subject to standard payroll deductions and withholdings and payable in accordance with the Company’s regular payroll schedule.

2.2 Stock Option Grant.   Subject to approval by the Board of Directors (the “Board” ), Executive shall be granted an option to purchase 250,000 shares of Common Stock in the Company at the fair market value on the date of grant (the “ Option ”).  The Option shall be governed in all respects by the terms of the governing equity plan documents and option agreement between Executive and the Company, and shall be subject to a vesting schedule whereby one-quarter (1/4) of the shares subject to the Option shall vest one year after grant, with the remaining shares vesting in equal monthly installments over the following three years thereafter, subject to Executive’s continuous service.

2.3 Annual Cash Bonus.    Executive will be eligible for an annual discretionary cash bonus of up to thirty percent (30%) of Executive’s Base Salary (the “ Annual Bonus ”), to be prorated for 2015.  Whether Executive receives an Annual Bonus for any given year, and the amount of any such Annual Bonus, will be determined by the Board (or the Compensation Committee of the Board) in its sole discretion based upon the Company’s and Executive’s achievement of objectives and milestones to be determined on an annual basis.  Any Annual Bonus that is awarded will be paid within the first ninety (90) days of the calendar year following the applicable bonus year.   Executive will not be eligible for, and will not earn, any Annual Bonus (including a prorated bonus) if Executive’s employment terminates for any reason before the payment date.

3. Standard Company Benefits. Executive shall be entitled to participate in all employee benefit programs for which Executive is eligible under the terms and conditions of the benefit plans that may be in effect from time to time and provided by the Company to its employees.  The Company reserves the right to cancel or change the benefit plans or programs it offers to its employees at any time.  

4. Expenses.   The Company will reimburse Executive for reasonable travel, entertainment or other expenses incurred by Executive in furtherance or in connection with the performance of Executive’s duties hereunder, in accordance with the Company’s expense reimbursement policy as in effect from time to time.

5. Termination of Employment; Severance.

5.1 At-Will Employment.   Executive’s employment relationship is at-will.  Either Executive or the Company may terminate the employment relationship at any time, with or without Cause or advance notice.

2.


 

5.2 Termination Without Cause; Resignation for Good Reason.  

(i) The Company may terminate Executive’s employment with the Company at any time without Cause (as defined below).  Further, Executive may resign at any time for Good Reason (as defined below).

(ii) In the event Executive’s employment with the Company is terminated by the Company without Cause, or Executive resigns for Good Reason, then provided such termination constitutes a “separation from service” (as defined under Treasury Regulation Section 1.409A-1(h), without regard to any alternative definition thereunder, a “ Separation from Service ”), and provided that Executive remains in compliance with the terms of this Agreement, the Company shall provide Executive with the following severance benefits:

(a) The Company shall pay Executive, as severance, six (6) months of Executive’s base salary in effect as of the date of Executive’s employment termination, subject to standard payroll deductions and withholdings (the “ Severance ”).  The Severance will be paid in equal installments on the Company’s regular payroll schedule over the six (6) month period following Executive’s Separation from Service; provided, however, that no payments will be made prior to the 60th day following Executive’s Separation from Service.  On the 60th day following Executive’s Separation from Service, the Company will pay Executive in a lump sum the Severance that Executive would have received on or prior to such date under the standard payroll schedule but for the delay while waiting for the 60 th day in compliance with Code Section 409A, with the balance of the Severance being paid as originally scheduled.

(b) Provided Executive timely elects continued coverage under COBRA, the Company shall pay Executive’s COBRA premiums to continue Executive’s coverage (including coverage for eligible dependents, if applicable) (“ COBRA Premiums ”) through the period (the “ COBRA Premium Period ”) starting on Executive’s Separation from Service and ending on the earliest to occur of: (i) six (6) months following Executive’s Separation from Service; (ii) the date Executive becomes eligible for group health insurance coverage through a new employer; or (iii) the date Executive ceases to be eligible for COBRA continuation coverage for any reason, including plan termination. In the event Executive becomes covered under another employer's group health plan or otherwise cease to be eligible for COBRA during the COBRA Premium Period, Executive must immediately notify the Company of such event.  Notwithstanding the foregoing, if the Company determines, in its sole discretion, that it cannot pay the COBRA Premiums without a substantial risk of violating applicable law (including, without limitation, Section 2716 of the Public Health Service Act), the Company instead shall pay to Executive, on the first day of each calendar month, a fully taxable cash payment equal to the applicable COBRA premiums for that month (including premiums for Executive and Executive’s eligible dependents who have elected and remain enrolled in such COBRA coverage), subject to applicable tax withholdings (such amount, the “ Special Cash Payment ”), for the remainder of the COBRA Premium Period.  Executive may, but is not obligated to, use such Special Cash Payments toward the cost of COBRA premiums.  

3.


 

(c) The Company will accelerate the vesting of the Option, as well as any other equity interests granted to Executive, such that the shares that would have vested in the six (6) months following Executive’s Separation from Service shall be deemed vested and exercisable as of Executive’s last day of employment (the “Accelerated Vesting” ).  

(iii) If the Company terminates Executive’s employment with the Company without Cause, or Executive resigns for Good Reason, in either case within twelve (12) months following the closing of a Change in Control (as defined below), then in addition to the Severance and COBRA Premiums (or Special Cash Payments set forth above), the Company will accelerate the vesting of the Option, as well as any other equity interests granted to Executive, such that fifty percent (50%) of the then-unvested shares subject to the Option (or other equity interests) will be deemed vested and exercisable as of Executive’s last day of employment.

5.3 Termination for Cause; Resignation Without Good Reason; Death or Disability.

(i) The Company may terminate Executive’s employment with the Company at any time for Cause.  Further, Executive may resign at any time without Good Reason.  Executive’s employment with the Company may also be terminated due to Executive’s death or disability.  

(ii) If Executive resigns without Good Reason, or the Company terminates Executive’s employment for Cause, or upon Executive’s death or disability, then (i) Executive will no longer vest in the Option, (ii) all payments of compensation by the Company to Executive hereunder will terminate immediately (except as to amounts already earned), and (c) Executive will not be entitled to any severance benefits, including (without limitation) the Severance, COBRA Premiums, Special Cash Payments or Accelerated Vesting.  

6. Conditions to Receipt of Severance, COBRA Premiums, Special Cash Payments and Accelerated Vesting.   The receipt of the Severance, COBRA Premiums, Special Cash Payments and Accelerated Vesting will be subject to Executive signing and not revoking a separation agreement and release of claims in a form satisfactory to the Company (the “ Separation Agreement” ) within a time period specified by the Company.  No Severance, COBRA Premiums, Special Cash Payments or Accelerated Vesting will be paid or provided until the Separation Agreement becomes effective.  Executive shall also resign from all positions and terminate any relationships as an employee, advisor, officer or director with the Company and any of its affiliates, each effective on the date of termination.

7. Section 409A.   It is intended that all of the severance benefits and other payments payable under this Agreement satisfy, to the greatest extent possible, the exemptions from the application of Code Section 409A provided under Treasury Regulations 1.409A‑1(b)(4), 1.409A‑1(b)(5) and 1.409A‑1(b)(9), and this Agreement will be construed to the greatest extent possible as consistent with those provisions, and to the extent no so exempt, this Agreement (and any definitions hereunder) will be construed in a

4.


 

manner that complies with Section 409A.  For purposes of Code Section 409A (including, without limitation, for purposes of Treasury Regulation Section 1.409A‑2(b)(2)(iii)), Executive’s right to receive any installment payments under this Agreement (whether severance payments, reimbursements or otherwise) shall be treated as a right to receive a series of separate payments and, accordingly, each installment payment hereunder shall at all times be considered a separate and distinct payment.  Notwithstanding any provision to the contrary in this Agreement, if Executive is deemed by the Company at the time of Executive’s Separation from Service to be a “specified employee” for purposes of Code Section 409A(a)(2)(B)(i), and if any of the payments upon Separation from Service set forth herein and/or under any other agreement with the Company are deemed to be “deferred compensation”, then to the extent delayed commencement of any portion of such payments is required in order to avoid a prohibited distribution under Code Section 409A(a)(2)(B)(i) and the related adverse taxation under Section 409A, such payments shall not be provided to Executive prior to the earliest of (i) the expiration of the six-month period measured from the date of Executive’s Separation from Service with the Company, (ii) the date of Executive’s death or (iii) such earlier date as permitted under Section 409A without the imposition of adverse taxation.  Upon the first business day following the expiration of such applicable Code Section 409A(a)(2)(B)(i) period, all payments deferred pursuant to this Paragraph shall be paid in a lump sum to Executive, and any remaining payments due shall be paid as otherwise provided herein or in the applicable agreement. No interest shall be due on any amounts so deferred.

8. Definitions.   

(i) Cause.   For purposes of this Agreement, “Cause” for termination will mean:  (a) commission of any felony or crime involving dishonesty; (b) participation in any fraud against the Company; (c) material breach of Executive’s duties to the Company; (d) persistent unsatisfactory performance of job duties after written notice from the Board and a reasonable opportunity to cure (if deemed curable); (e) intentional damage to any property of the Company; (f) misconduct, or other violation of Company policy that causes harm; (g) breach of any written agreement with the Company; and
(h) conduct by Executive which in the good faith and reasonable determination of the Board demonstrates gross unfitness to serve.  

(ii) Good Reason.   For purposes of this Agreement, Executive shall have “ Good Reason ” for resignation from employment with the Company if any of the following actions are taken by the Company without Executive’s prior written consent:  (a) a material reduction in Executive’s base salary, which the parties agree is a reduction of at least 10% of Executive’s base salary (unless pursuant to a salary reduction program applicable generally to the Company’s similarly situated employees); or (b) a material reduction in Executive’s duties (including responsibilities and/or authorities), provided, however, that a change in job position shall not be deemed a “material reduction” in and of itself unless Executive’s new duties are materially reduced from the prior duties; or (c) relocation of Executive’s principal place of employment to a place that increases Executive’s one-way commute by more than sixty (60) miles as compared to Executive’s then-current principal place of employment immediately prior to such relocation.  In order to resign for Good Reason, Executive must provide written notice to the Company’s CEO

5.


 

within 30 days after the first occurrence of the event giving rise to Good Reason setting forth the basis for Executive’s resignation, allow the Company at least 30 days from receipt of such written notice to cure such event, and if such event is not reasonably cured within such period, Executive must resign from all positions Executive then holds with the Company not later than 90 days after the expiration of the cure period.

(iii) Change of Control.   For purposes of this Agreement, “Change of Control” shall mean:  (a) the acquisition of the Company by another entity by means of any transaction or series of related transactions to which the Company is party (including, without limitation, any stock acquisition, reorganization, merger or consolidation but excluding any sale of stock for capital raising purposes) other than a transaction or series of transactions in which the holders of the voting securities of the Company outstanding immediately prior to such transaction continue to retain (either by such voting securities remaining outstanding or by such voting securities being converted into voting securities of the surviving entity), as a result of shares in the Company held by such holders prior to such transaction, at least fifty percent (50%) of the total voting power represented by the voting securities of the Company or such surviving entity outstanding immediately after such transaction or series of transactions; (b) a sale, lease or other conveyance of all or substantially all of the assets of the Company; or (c) any liquidation, dissolution or winding up of the Company, whether voluntarily or involuntarily.

9. Proprietary Information Obligations.

9.1 Confidential Information Agreement.   As a condition of employment, Executive shall execute and abide by the Company’s standard form of At-Will Employment, Confidential Information, Invention Assignment, and Arbitration Agreement (the “ Confidentiality Agreement ”).

9.2 Third-Party Agreements and Information.   Executive represents and warrants that Executive’s employment by the Company does not conflict with any prior employment or consulting agreement or other agreement with any third party, and that Executive will perform Executive’s duties to the Company without violating any such agreement.  Executive represents and warrants that Executive does not possess confidential information arising out of prior employment, consulting, or other third party relationships, that would be used in connection with Executive’s employment by the Company, except as expressly authorized by that third party.  During Executive’s employment by the Company, Executive will use in the performance of Executive’s duties only information which is generally known and used by persons with training and experience comparable to Executive’s own, common knowledge in the industry, otherwise legally in the public domain, or obtained or developed by the Company or by Executive in the course of Executive’s work for the Company.  

10. Outside Activities During Employment.

10.1 Non-Company Business.   Except with the prior written consent of the Board, Executive will not during the term of Executive’s employment with the Company undertake or engage in any other employment, occupation or business enterprise, other than ones in which Executive is a passive investor.  Prior approval by the Board,

6.


 

which will not be unreasonably withheld, is required for advisory or other company board of director commitments proposed by Executive.  In any event, Executive may engage in civic and not-for-profit activities so long as such activities do not materially interfere with the performance of Executive’s duties hereunder.  

10.2 No Adverse Interests.   Executive agrees not to acquire, assume or participate in, directly or indirectly, any position, investment or interest known to be adverse or antagonistic to the Company, its business or prospects, financial or otherwise.

11. Non-Solicitation.   Executive agree that during the period of employment with the Company and for twelve (12) months after the date Executive’s employment is terminated for any reason, Executive will not, either directly or through others, solicit or encourage or attempt to solicit or encourage any employee, independent contractor, or consultant of the Company to terminate his or her relationship with the Company in order to become an employee, consultant or independent contractor to or for any other person or entity.

12. Dispute Resolution.   To ensure the timely and economical resolution of disputes that may arise in connection with Executive’s employment with the Company, Executive and the Company agree that any and all disputes, claims, or causes of action arising from or relating to the enforcement, breach, performance, negotiation, execution, or interpretation of this Agreement, Executive’s employment, or the termination of Executive’s employment, including but not limited to statutory claims, shall be resolved to the fullest extent permitted by law by final, binding and confidential arbitration, by a single arbitrator, in Los Angeles, California, conducted by JAMS, Inc. (“ JAMS ”) under the then applicable JAMS rules (which can be found at the following web address: MACROBUTTON HtmlResAnchor http://www.jamsadr.com/rulesclauses ) .  By agreeing to this arbitration procedure, both Executive and the Company waive the right to resolve any such dispute through a trial by jury or judge or administrative proceeding.  The Company acknowledges that Executive will have the right to be represented by legal counsel at any arbitration proceeding.  The arbitrator shall:  (a) have the authority to compel adequate discovery for the resolution of the dispute and to award such relief as would otherwise be permitted by law; and (b) issue a written arbitration decision, to include the arbitrator’s essential findings and conclusions and a statement of the award.  The arbitrator shall be authorized to award any or all remedies that Executive or the Company would be entitled to seek in a court of law.  The Company shall pay all JAMS’ arbitration fees in excess of the amount of court fees that would be required of the Executive if the dispute were decided in a court of law.  Nothing in this Agreement is intended to prevent either Executive or the Company from obtaining injunctive relief in court to prevent irreparable harm pending the conclusion of any such arbitration.  Any awards or orders in such arbitrations may be entered and enforced as judgments in the federal and state courts of any competent jurisdiction.

13. General Provisions.

13.1 Notices.   Any notices provided must be in writing and will be deemed effective upon the earlier of personal delivery (including personal delivery by fax) or the next day after sending by overnight carrier, to the Company at its primary office location and to Executive at the address as listed on the Company payroll.

7.


 

13.2 Severability.   Whenever possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be invalid, illegal or unenforceable in any respect under any applicable law or rule in any jurisdiction, such invalidity, illegality or unenforceability will not affect any other provision or any other jurisdiction, but this Agreement will be reformed, construed and enforced in such jurisdiction to the extent possible in keeping with the intent of the parties.

13.3 Waiver.   Any waiver of any breach of any provisions of this Agreement must be in writing to be effective, and it shall not thereby be deemed to have waived any preceding or succeeding breach of the same or any other provision of this Agreement.

13.4 Complete Agreement.   This Agreement, together with the Confidentiality Agreement, constitutes the entire agreement between Executive and the Company with regard to this subject matter and is the complete , final, and exclusive embodiment of the Parties’ agreement with regard to this subject matter.  This Agreement is entered into without reliance on any promise or representation, written or oral, other than those expressly contained herein, and it supersedes any other such promises, warranties or representations.  It is entered into without reliance on any promise or representation other than those expressly contained herein, and it cannot be modified or amended except in a writing signed by a duly authorized officer of the Company.

13.5 Counterparts.   This Agreement may be executed in separate counterparts, any one of which need not contain signatures of more than one party, but all of which taken together will constitute one and the same Agreement.

13.6 Headings.   The headings of the paragraphs hereof are inserted for convenience only and shall not be deemed to constitute a part hereof nor to affect the meaning thereof.

13.7 Successors and Assigns.   This Agreement is intended to bind and inure to the benefit of and be enforceable by Executive and the Company, and their respective successors, assigns, heirs, executors and administrators, except that Executive may not assign any of his duties hereunder and he may not assign any of his rights hereunder without the written consent of the Company, which shall not be withheld unreasonably.

13.8 Tax Withholding and Indemnification.   All payments and awards contemplated or made pursuant to this Agreement will be subject to withholdings of applicable taxes in compliance with all relevant laws and regulations of all appropriate government authorities.  Executive acknowledges and agrees that the Company has neither made any assurances nor any guarantees concerning the tax treatment of any payments or awards contemplated by or made pursuant to this Agreement.  Executive has had the opportunity to retain a tax and financial advisor and fully understands the tax and economic consequences of all payments and awards made pursuant to the Agreement.

8.


 

13.9 Choice of Law.   All questions concerning the construction, validity and interpretation of this Agreement will be governed by the laws of the State of California.  

In Witness Whereof , the Parties have executed this Agreement on the day and year written below.

 

 

ImmunoCellular Therapeutics, Ltd.

 

 

 

 

 

 

 

 

 

By:

/s/ Andrew Gengos

 

 

 

Andrew Gengos

 

 

 

Chief Executive Officer

 

 

 

 

 

 

Date:

1/29/2015

 

 

 

 

 

 

 

 

 

Executive

 

 

 

/s/ Steven J. Swanson

 

 

 

Steven J. Swanson

 

 

 

 

 

Date:

1/30/ 2015

9.

 

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

Exhibit 10.2

 

Agreement

 

for

 

GMP Manufacturing

 

of

 

ICT-107

 

 

 

 

Between

 

 

 

PharmaCell B.V.

 

 

 

and

 

 

 

ImmunoCellular Therapeutics Ltd.

 

 

 

____________________

 

March 2015

____________________

 

 


 

 

This Agreement is made on March 13 of 2015 (" Effective Date ")

 

 

Between:

 

(1)

PharmaCell B.V. , a corporation duly incorporated under the laws of The Netherlands and having its registered office at Oxfordlaan 70, 6201 BH Maastricht, The Netherlands (hereafter referred to as " PharmaCell "); and,

 

(2)

ImmunoCellular Therapeutics Ltd., having a business address at 23622 Calabasas Road, Suite 300, Calabasas CA 91302, USA (hereafter referred to as “ ImmunoCellular ”),

 

(PharmaCell and ImmunoCellular hereinafter individually a “ Party ” and together the “ Parties ”)

 

 

Purpose and Scope :

 

 

(A)

PharmaCell is in the business of providing biotechnology and cell therapy development services including without limitation process development, validation, scale up services, production and product manufacturing services, quality assurance, regulatory support, analytical development, fill and finish services and quality control analysis under cGMP conditions in respect of intermediate and final drug products.

 

(B)

ImmunoCellular is in the business of discovery, development, manufacturing and/or commercialization of pharmaceutical cell therapy products for human use.

 

(C)

ImmunoCellular, within the scope of the above mentioned activities, wishes to outsource parts of its production processes with respect to its product ICT-107 for use in human clinical trials. In preparation for the clinical trial(s) ImmunoCellular wishes to engage the services of PharmaCell for a transfer of know-how, technology and experience to PharmaCell’s facilities and for the conduct of a number of production validation runs of the medicinal product ICT-107 ( “Inbound Technology Transfer”) . Following the Inbound Technology Transfer ImmunoCellular wishes to engage and contract with PharmaCell for cGMP Processing of the Product for clinical trials, testing and Release of batches of the Product in PharmaCell’s cGMP facilities including required batch documentation ( “Production” or “cGMP Production”) .

 

(D)

PharmaCell has the capacity within the estimated timelines to produce Product for clinical trials, in the quantities required (in writing) by ImmunoCellular, and to carry out all other aspects of Production, and is willing to provide the Services pursuant to the Project to ImmunoCellular which ImmunoCellular is willing to accept on the terms and conditions set out in this Agreement.

 

 

Now in consideration of the foregoing and the covenants and promises contained in this Agreement, it is agreed as follows:

 

 

1

Definitions

 

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


 

For purposes of this Agreement, the terms defined in this article shall have the respective meanings set forth below:

 

1.1

“Affiliate” means any person, corporation, partnership, firm, joint venture or other entity which, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with, PharmaCell or ImmunoCellular, as the case may be. An entity will be regarded as in control of another entity for purposes of this definition if it owns or controls more than fifty per cent (50%) of the shares of the subject entity entitled to vote in the election of directors (or, in the case of an entity that is not a corporation, for the election of the corresponding managing authority) or otherwise possess the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of the outstanding voting securities or by contract or otherwise;

 

1.2

“Agreement” means this Agreement in its entirety including all Schedules ;

 

1.3

“Applicable Law” means the applicable supranational, national, federal, provincial, state and local including municipal, laws, rules, orders and regulations, including any rules, orders, regulations, guidelines, directives or other requirements of any governmental authority, agency or other Government Competent Authorities having jurisdiction over the activities of the Parties under this Agreement and the Quality Agreement, including without limitation cGMP, and any such laws, rules, orders and regulations, guidelines, directives or other requirements pertaining to environment, health and safety, patient privacy and data protection, and anti-bribery and anti-corruption, in each case that may be in effect from time to time during the Term hereof, and any amendments thereto.

 

1.4

“Audit” means the attendance by ImmunoCellular and/or its representatives, at PharmaCell's Facility to review, discuss, verify and inspect PharmaCell's Facility, its SOPs and to audit its records (including the right to make copies related to specific audit findings and to make copies of any records or other documents that are owned by ImmunoCellular, all of which shall be uploaded by PharmaCell to a Sharepoint drive that is accessible at all times by ImmunoCellular) and compliance with cGMP, Applicable Law and this Agreement and the Quality Agreement in the performance of the cGMP Services including cGMP Production;

 

1.5

“Batch” means a defined quantity of Product which has been produced during a defined cycle of manufacture, and which is identified by a unique production number.  “Batch Records” means the document created as and after each Batch is Processed that, when complete and accurate, reflects and incorporates all aspects of the Master Batch Record, and all related documents issued, with respect to such Batch.  “Master Batch Record” or “MBR” means the document containing the formula and complete manufacturing and control instructions reviewed and approved in writing by both Parties’ Quality Assurance.

 

1.6

"Business Day(s)" means any day which is not a Saturday, a Sunday or a Dutch public holiday and references to any time shall be to Dutch time (GMT+ one hour);

 

1.7

“Calendar Year” means a period of twelve (12) months commencing on 1 January and ending on 31 December;

 

1.8

"Certificate of Analysis" means a certificate executed by a Qualified Person confirming that at the time of issue of the certificate the Product has been Processed in accordance with the MBR and meets the Specification.  “Certificate of Compliance” means a certificate executed by a Qualified Person confirming that a Batch has been Processed in

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


 

accordance with cGMP.  The Certificate of Analysis and Certificate of Compliance shall be as set forth in Schedule 4;

 

1.9

“cGMP" means current Good Manufacturing Practices as promulgated in EU Commission Directive 2003/94/EC (EU GMP Guidelines) and 21 CFR 211 (US/FDA cGMP for Finished Pharmaceuticals), 610 (US/FDA General Biological Products standards), EU Commission Directive 2001/20/EC (Clinical Trials), EU Commission Directive 2004/23/EC (Quality and safety of human tissue and cells), EU Regulation EC 1394/2007 (Advanced Therapy Medicinal Products (ATMP)), EU Directive 2001/83/EC (Medicinal Products for Human Use), and national implementation of the foregoing, and applicable International Conference on Harmonisation guidelines as well as any applicable regulatory guidelines issued by Government Competent Authorities in particular relevant guidance on Good Manufacturing Practices contained in Volume 4 of the Rules Governing Medicinal Products in the European Union and the national implementations of these rules. For the avoidance of doubt, PharmaCell's operational quality standards are defined in internal GMP documents which shall always be consistent and compliant with and adequately reflect current international applicable cGMP guidelines and allow cGMP manufacturing of investigational biopharmaceutical products and products for cellular therapies (ATMP);

 

1.10

"Confidential Information" means all data, information or material in whatever form that has or could have commercial value or other utility in the business or prospective business of a Party's company or its subsidiaries or Affiliates, whether or not such information is identified as Confidential Information, and any and all copies and derivations thereof and improvements thereon.  Confidential Information of ImmunoCellular includes without limitation, the MBR and Batch Records, the Product, the Process (including Specification and methods including analytical and testing methods), ImmunoCellular Materials, ImmunoCellular Intellectual Property Rights, ImmunoCellular Inventions, Pre-Existing IP of ImmunoCellular and ImmunoCellular Know How.  

 

1.11

"Due Date" shall have the meaning as defined in Section 4.3;

 

1.12

“Equipment” shall mean any and all of the equipment used in the Processing of the Product, whether such Equipment is the property of PharmaCell or Dedicated Equipment that is the property of ImmunoCellular.  

 

1.13

"Effective Date" shall have the meaning as defined in Section 10.1;

 

1.14

“Facility” means PharmaCell’s manufacturing facility located at PharmaCell Cell Manufacturing Facility B.V., Urmonderbaan 20b, 6167 RD Geleen, The Netherlands;

 

1.15

"Government Competent Authorities" means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to manufacture, use, transport (including import and export) or storage of the ImmunoCellular Materials or Product or the provision of the Services in any country;

 

1.16

"Group" means the relevant party, its subsidiaries, Affiliates, its holding companies and their subsidiaries and Affiliates from time to time;

 

1.17

"Information" means any and all information of whatever nature and in any form relating to either Party and their business affairs and all such other information relating to their

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


 

products, plans and technology of whatever nature and application including, without limitation, all information relating to the Process and Product;

 

1.18

"Inspection” means inspections, audits or visits by Government Competent Authorities;

 

1.19

"Intellectual Property Rights" means all intellectual property rights, including (without limitation) patents, supplementary protection certificates, utility models, trademarks, database rights, rights in designs, copyrights and topography rights (whether or not any of these rights are registered, and including applications and the right to apply for registration of any such rights) and all ideas, discoveries, developments, improvements, enhancements, adaptations, derivations, modifications, refinements, inventions, know-how, trade secrets, techniques and confidential information and other proprietary knowledge and information, and all rights (including enforcement rights) and forms of protection of a similar nature or having equivalent or similar effect to any of these which may subsist anywhere in the world, in each case for their full term, and together with any continuations, continuations-in-part, divisionals, renewals, reissues, reexaminations, registrations or extensions;

 

1.20

"Permitted Recipients" means the directors, officers, employees, contractors (including consultants) or professional advisers of the relevant Party or its Affiliates who are required, on a strict need to know basis, in the course of their duties to receive and consider the Confidential Information for the purpose of enabling the relevant Party to perform its obligations or exercise its rights under this Agreement or the Quality Agreement provided that such persons are under written obligations of confidence no less onerous than those contained herein at Section 8 which are imposed on the Receiving Party;

 

1.21

"Pre-existing IP " shall have the meaning as defined in Section 9.1;

 

1.22

“Price” means the price for the Services as defined in Schedule 1 and in Schedule 2 ;

 

1.23

“Process” means the method of manufacture, processing, testing and packaging (including labelling) of the Product from the Raw Materials and Release of Product which, pursuant to the Services, is to be produced by PharmaCell for ImmunoCellular under this Agreement;

 

1.24

“Product” means ImmunoCellular autologous dendritic cell based cancer vaccine known as “ICT-107”;

 

1.25

“PharmaCell Intellectual Property Rights” means all Intellectual Property Rights owned or Controlled by PharmaCell related to the purpose of this Agreement;

 

1.26

"PharmaCell Inventions" has the meaning set out in Section 9.3;

 

1.27

“PharmaCell Know-How” means all technical and non-technical information known by PharmaCell and which at the time of its first disclosure by PharmaCell to ImmunoCellular or is used by PharmaCell in the provision of Services, was neither (i) known to ImmunoCellular as demonstrated by written records existing at the time of such disclosure or (ii) freely available in the public domain;

 

1.28

“Project” means the Services and deliverables described in the Schedules, the timelines therefor and the fees and costs thereof.

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


 

 

1.29

“Project Leader” means the designated representative from each Party who will be responsible for management of the overall Project timelines and deliverables of the Project.  Each Party will designate one person as a Project Leader to the other Party in writing. Each Party shall be entitled to change their respective designated Project Leader at any time and shall promptly give written notice of the change to the other Party including the new contact details of the new representative(s) in any event no less than seven (7) Business Days after the change has been implemented;

 

1.30

“Qualified Person” means the person (in accordance with Article 48 of Directive 2001/83/EC and with Article 13(2) of Directive 2001/20/EC), qualified to perform batch release of Product from the Facility;

 

1.31

“Raw Materials” means materials, components and devices received by PharmaCell from ImmunoCellular (including ImmunoCellular Materials) or ImmunoCellular’s suppliers, or purchased directly by PharmaCell from its own qualified suppliers, in each case accompanied by a certificate of analysis, for the purpose of Processing such material into Product. Applicable donor material will be obtained by ImmunoCellular in compliance with EU Commission Directive 2004/23/EC (Quality and safety of human tissue and cells);

 

1.32

“Regulatory Approval” means any and all permits, approvals, licenses, registrations, or authorizations of any Government Competent Authority necessary for PharmaCell to provide the Services;

 

1.33

“Release” means when a Qualified Person has completed the review of all necessary testing results and certified that the Batch of Product has been manufactured in accordance with the relevant Specification, cGMP and all other Applicable Law. The Qualified Person shall Release the batch of Product to ImmunoCellular or it designees before or as soon as possible after delivery of the Product to ImmunoCellular or its designees and “Released” shall be construed accordingly;

 

1.34

“ImmunoCellular Intellectual Property Rights” means all Intellectual Property Rights owned or Controlled by ImmunoCellular that are necessary for the performance of the Services in accordance with this Agreement. "Controlled" with respect to an Intellectual Property Right matter, shall mean the legal authority or right of a Party or its Affiliate to grant a license or sublicense of Intellectual Property Rights to the other Party hereto, or to otherwise disclose proprietary or trade secrets information to the other Party, without breaching the terms of any agreement with a Third Party, or infringing upon the Intellectual Property Rights of a Third Party, or misappropriating the proprietary or trade secret information of a Third Party;

 

1.35

"ImmunoCellular Inventions" has the meaning set out in Section 9.6;

 

1.36

“ImmunoCellular Know-How” means all technical and non-technical information provided by or on behalf of ImmunoCellular to PharmaCell that at the time of first disclosure by or on behalf of ImmunoCellular to PharmaCell was neither (i) known to PharmaCell as demonstrated by written records existing at the time of such disclosure nor (ii) freely available in the public domain;

 

1.37

“ImmunoCellular Materials” means Raw Materials and all materials and equipment provided by ImmunoCellular, its Affiliates, contractors (including vendors and suppliers) or agents to PharmaCell as described in Schedule 3 . With respect to biological materials,

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


 

reference to ImmunoCellular Materials shall include any portions, strains progeny and derivatives of such biological materials generated by or on behalf of PharmaCell;

 

1.38

“Schedule” means the schedule (or schedules as appropriate) to this Agreement which specify the Services, payment terms and other relevant details referred to under this Agreement, any and all of which are incorporated herein by reference and made a part hereof;

 

1.39

“Services” means any or all parts of the service to be performed under this Agreement in pursuance of the Project including without limitation cGMP Services and cGMP Production as more fully described in Schedule 1 and in Schedule 2 and any supplement to such Services agreed pursuant to Section 3.3;

 

1.40

“Specification” means the specification of the Product as described in Schedule 4 ;

 

1.41

"Stage" means a particular activity or series of activities that constitute a main step in the performance of the Services and which is more clearly identified in Schedule 1 by the breakdown of the Services into separate stages;

 

1.42

"Steering Committee" means the body organised in accordance with and pursuant to the rules under Section 5 of this Agreement;

 

1.43

"Inbound Technology Transfer" means the process of making available to PharmaCell all ImmunoCellular Materials, Pre-Existing IP of ImmunoCellular and other resources necessary for PharmaCell to manufacture the Product as described more fully in Section 2.  “Outbound Technology Transfer” means the process of transferring and making available to ImmunoCellular and/or its designees all data, information and resources, including without limitation the Process and PharmaCell Pre-Existing IP, PharmaCell Know How, PharmaCell Intellectual Property Rights, and PharmaCell Inventions, necessary or useful for ImmunoCellular and/or such designee(s) to manufacture the Product, or other products using the Process or improvements to the Process, as described more fully in Section 2.10;

 

1.44

"Term" shall have the meaning as defined in Section 10.1;

 

1.45

"Termination" means 'opzegging ' under Dutch law; provided, however, that termination shall not give a Party the rights or and remedies related to or arising from dissolution of this Agreement under Dutch law and the Parties expressly exclude such right of dissolution under Dutch law and waive and disavow such rights and remedies.    

 

1.46

"Third Party” shall mean any person or entity, which is not a Party or an Affiliate of any Party to this Agreement;

 

1.47

"Third Party Contractors" means any Third Party instructed by PharmaCell and pre-approved in writing by ImmunoCellular pursuant to the provisions of Section 2.4 to carry out tests or provide any other services regarding the Process, ImmunoCellular Materials or the Product for the performance of the Services under this Agreement;

 

1.48

“Third Party Costs” shall have the meaning assigned to such term in Section 4.1.2;

 

1.49

"Warrant" (' garanderen ') means that the warranting party accepts liability towards the other party for the (damage incurred by) the absence of occurrences, acts or facts explicitly warranted in this Agreement.

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


 

 

 

 

2

Provision Of Services

 

2.1

PharmaCell will perform the Services diligently using its professional skill and care through scientists reasonably skilled in the manufacturing and production of cell culture-based therapeutics and in accordance with professional standards, this Agreement and the Quality Agreement. PharmaCell will use all commercially reasonable efforts to meet the estimated timelines for the Inbound Technology Transfer and pending completion of the Inbound Technology Transfer the required product quality set out in the relevant Schedules for the Services related to the Inbound Technology Transfer. If such timelines or product quality cannot be met PharmaCell will promptly inform ImmunoCellular in writing as soon as possible about the (i) estimated term of the delay and (ii) the reasons for the delay.

 

If both Parties are of the view that the Inbound Technology Transfer and other agreed activities before start of the clinical trial program have been completed, this will be confirmed in writing. Following such notification, ImmunoCellular shall have the right to conduct a review of PharmaCell’s processes in all aspects in ImmunoCellular’s sole discretion, including without limitation an inspection of PharmaCell’s facilities, provided that Section 5.4 shall apply with respect to the number of employees and/or representatives allowed to access PharmaCell’s premises. PharmaCell shall provide all support reasonably required for ImmunoCellular to perform such review, including without limitation access to its facilities, SOPs and personnel as well as providing copies of relevant documentation.

 

2.2

Following the successful completion of the Inbound Technology Transfer as provided in Section 2.1 , PharmaCell will, at ImmunoCellular’s written request at the times and in the quantities ordered by ImmunoCellular subject to PharmaCell's acceptance thereof (which will not be unreasonably withheld or delayed), manufacture Product for clinical trial(s) for ImmunoCellular in accordance with the Specification, its SOPs, terms and conditions of this Agreement, the Quality Agreement, cGMP and other Applicable Law as well as the stipulations set forth in Schedule 1 and in Schedule 2 . If PharmaCell becomes aware that it will not be able to deliver Product in accordance with any such request, PharmaCell will immediately inform ImmunoCellular in writing.

 

2.3

Where stipulated in this Agreement or in any Schedule , the relevant part of the Services will comply with cGMP. New and/or changing interpretations of any cGMP requirements will be discussed and recorded in writing by the Parties as soon as one or both of the Parties becomes aware of any such new and/or changing interpretation, making whatever modifications to the Services as may be required therewith. PharmaCell is required to ensure that new cGMP requirements are brought to the attention of ImmunoCellular and will outline their impact on the Product manufacturing Process. Any modifications to the Services as may be required therewith will be amendments in terms of Section 2.5 .

 

2.4

In the performance of the Services PharmaCell may subcontract certain part(s) of the Services to Third Party Contractors after having obtained written consent of the ImmunoCellular Project Leader in each individual case, provided that PharmaCell has obliged the Third Party in writing to comply with all obligations under this Agreement which are relevant and appropriate to the Services to be provided by the Third Party Contractor so as to protect ImmunoCellular, and PharmaCell hereby agrees to be fully

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


 

and solely responsible and liable for the acts and omissions, and the performance and non-performance, of such Third Party Contractors however limited to their carrying out (or failure to carry out) of the delegated or subcontracted parts of the Services.  Other than as provided for herein, PharmaCell shall not delegate or subcontract to any third party the performance of the any of the Services hereunder without the prior written consent of ImmunoCellular.

 

2.5

The Services (including the Price thereof) as described in Schedule 1 and in Schedule 2 may be amended and/or supplemented from time to time if agreed between the Parties in writing in accordance with the provisions of Section 13.1 or if otherwise agreed in writing by the Steering Committee. Any modifications or changes to the Services required as a result of changes to regulatory requirements imposed by Government Competent Authorities will be referred to the Steering Committee for discussion as to how to modify the Services and timelines and if such modifications or changes require additional and unforeseen expenditure by PharmaCell (whether or not unforeseen), PharmaCell shall be fully and solely responsible at its own cost and expense for coming into compliance and making such changes or modifications. If, however, such modifications or changes have been requested in writing by ImmunoCellular, or are solely and specifically pertaining to, and only necessary for, the Product or Services for the Product, then the Parties will in good faith discuss a revision to the Price as a result of PharmaCell coming into compliance as a result of making such changes or modifications. Notwithstanding the foregoing, ImmunoCellular shall not be obligated to pay for any fees or costs that exceed the fees and costs set forth in a Schedule, and PharmaCell shall not be required to perform activities which would result in fees or costs exceeding those set forth in a Schedule, in each case without the prior written agreement of the Parties to amend such Schedule.   If ImmunoCellular wishes to change or add to the scope of Services, PharmaCell shall promptly provide ImmunoCellular with a proposed amendment to the Schedule and the fees and costs for such work.  If ImmunoCellular approves in writing such amended Schedule and the fees and costs associated therewith, PharmaCell shall perform such work in accordance with the amended Schedule and this Agreement and the Quality Agreement.

 

2.6

ImmunoCellular acknowledges and accepts that development activities may be included in the Services. ImmunoCellular acknowledges and accepts that such development activities are dependent upon living systems and that they may be experimental in nature.  Accordingly, the Parties agree that the timelines and anticipated results expected for such development parts of the Services are estimated only and will be adapted and mutually agreed upon in writing on a regular basis and, provided that PharmaCell has complied with its obligations under Section 2, it will not be in breach for the failure to achieve any target results, milestones or timelines or completing the development parts of such Services. The development parts of the Services are identified as such in Schedule 1 and any future amendments.

 

2.7

ImmunoCellular acknowledges that PharmaCell has the obligation to maintain its cGMP infrastructure and systems on a regular basis in order to secure continuity of operation for ImmunoCellular and other clients and to maintain its licenses. ImmunoCellular thus acknowledges that PharmaCell may schedule temporary shut-downs of its operation to perform such maintenance. Shut downs may take place from one to maximum two weeks at a time and may be scheduled up to two times a year (once during summer, once most likely during the Christmas period). ImmunoCellular and PharmaCell will schedule their activities taking these maintenance periods into account, and PharmaCell will notify ImmunoCellular in writing at least three (3) months in advance of its intent to schedule a shut down.

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


 

 

2.8

Prior to the supply of cGMP Product ImmunoCellular and PharmaCell shall enter into a quality agreement which further details the quality assurance obligations and responsibilities of the Parties with respect to the provision of Services (the “ Quality Agreement ”). The Quality Agreement shall include terms and conditions that are reasonably customary for agreements of that type taking into account each Party’s obligations under this Agreement and the requirements of Applicable Law.  

 

2.9

Equipment.   A list of Dedicated Equipment owned by ImmunoCellular is set forth in Schedule 3.  If additional Dedicated Equipment is required in order for PharmaCell to perform the Services, such items shall be added to Schedule 3 by mutual written agreement of the Parties and shall be delivered to PharmaCell on an agreed date. Dedicated Equipment shall be used by PharmaCell solely in performance of Services under this Agreement and for no other purpose.  PharmaCell will be solely responsible for the servicing, maintenance and repair of all Dedicated Equipment, and ImmunoCellular will reimburse PharmaCell for its reasonable documented expenses and hours of employees and Third Party Contractors in performing such activities unless the repair of Dedicated Equipment is due to PharmaCell’s misuse, abuse or neglect of the Dedicated Equipment.  The Dedicated Equipment will not be transferred to any other location or Third Party without ImmunoCellular’s prior written consent.  PharmaCell will identify the Dedicated Equipment as being owned by ImmunoCellular, and will keep the Dedicated Equipment free and clear of all claims, demands, security interests, liens and encumbrances and will remove the same at its sole expense.  PharmaCell shall make any filings necessary in The Netherlands to secure and evidence ImmunoCellular’s ownership of the Dedicated Equipment as and when requested by ImmunoCellular.  PharmaCell shall (i) restrict use of the Dedicated Equipment to those of its employees, agents and contractors for whom such use is required in order for it to perform Services under this Agreement, and (ii) deliver the Dedicated Equipment to ImmunoCellular or its designee(s)  on the expiration or termination of this Agreement, or as otherwise requested by ImmunoCellular, and the costs thereof shall be borne by ImmunoCellular (such that ImmunoCellular shall reimburse PharmaCell’s reasonable, documented out of pocket third party expenses), except where the termination is by PharmaCell under Section 10.3 or by ImmunoCellular under Section 10.2.1, in which case the costs and expenses thereof shall be borne by PharmaCell.  PharmaCell is solely responsible at its expense for all other Equipment, non-dedicated capital expenses and Facility improvements in support of the Services and Production hereunder. PharmaCell is also responsible for all installation, qualification and validation activities necessary to operate all other Equipment and Facility improvements in accordance with Applicable Law, and for the costs associated with such activities.

 

2.10

Outbound Technology Transfer.   In the event of the expiration or any termination of this Agreement for any reason, or if ImmunoCellular decides to establish an additional source of Product or have other products using the Process or improvements to the Process manufactured by a Third Party, then if and as requested by ImmunoCellular in writing, PharmaCell shall cooperate with ImmunoCellular to transfer to ImmunoCellular or its designees the Process including improvements thereto, and all PharmaCell Pre-Existing IP, PharmaCell Know How, PharmaCell Inventions, ImmunoCellular Inventions and PharmaCell Intellectual Property Rights that are necessary or useful for ImmunoCellular or its designees to manufacture or have manufactured the Product or any other products using the Process or improvements to the Process (“Outbound Technology Transfer”).  To facilitate an orderly transfer of the manufacture of the Product to an alternate site in the event any of the circumstances described in this Section 2.10, PharmaCell shall provide

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


 

the alternate site with reasonable assistance in the form of reasonable consulting services and training on the Processing of the Product, to be provided by PharmaCell personnel at the alternate location.  The consulting services provided under this Section 2.10 shall relate to the Processing, quality control, quality assurance, and the CMC (chemistry, manufacturing and control) part of the Product registration process.  Without limiting the foregoing, PharmaCell shall also transfer Dedicated Equipment to such alternate site if requested by ImmunoCellular. In the event the Outbound Technology Transfer is pursuant to ImmunoCellular’s termination of this Agreement under Section 10.2.1, or PharmaCell’s termination of this Agreement under Section 10.3, PharmaCell shall bear its own costs in connection with such Outbound Technology Transfer.  In all other cases, ImmunoCellular shall pay PharmaCell for its time at its then-current hourly rates, and reimburse PharmaCell’s reasonable, documented out of pocket Third Party Costs incurred to carry out the Outbound Technology Transfer. Notwithstanding the foregoing or anything to the contrary herein, if requested by ImmunoCellular in writing, PharmaCell shall continue to manufacture and supply Product until regulatory approval to manufacture Product at an alternate site has been obtained, or twenty four (24) months following any notice of termination, whichever is sooner, unless the Parties agree in writing to a different schedule.  In relation to any Outbound Technology Transfer, if requested in writing by ImmunoCellular, PharmaCell shall transfer any remaining inventory of ImmunoCellular Materials and/or Product to ImmunoCellular or its designees in accordance with ImmunoCellular’s instructions and at ImmunoCellular’s expense.

 

 

 

3

Deliverables

 

3.1

To enable PharmaCell to start the Services on the Effective Date and to continue and carry out the Services in accordance with this Agreement, including the timelines, ImmunoCellular shall supply to PharmaCell a list of ImmunoCellular Materials, as specified in Schedule 3, to carry out the Services, for use solely by PharmaCell and/or its Third Party Contractors to conduct the Services in accordance with the terms and conditions of this Agreement. Quantities of such ImmunoCellular Materials may, to the extent reasonable, be ordered from ImmunoCellular by PharmaCell during the performance of the Services for use by PharmaCell solely to conduct the Services. Further details such as volumes used, desired safety stock and forecast proceedings may be set forth in the Schedules . For the avoidance of doubt, other materials required to carry out the Services shall be ordered by PharmaCell directly from Third Party suppliers as set forth in the Quality Agreement. PharmaCell shall carry out the incoming inspection and testing of all ImmunoCellular Materials in accordance with cGMP requirements, as set forth in the Quality Agreement, shall promptly notify ImmunoCellular in writing if PharmaCell believes that any such materials are not suitable for use in the Production of Product and ImmunoCellular shall instruct PharmaCell as to what to do with such materials and, in ImmunoCellular’s discretion, ImmunoCellular shall replace or have PharmaCell replace such materials at ImmunoCellular’s expense.  PharmaCell shall be fully responsible for the suitability of, and for any loss or destruction of or damage to, any ImmunoCellular Materials when such materials are in PharmaCell’s or its Third Party Contractors’ possession, control or custody.   At all times, all of the ImmunoCellular Materials are and shall remain the sole and exclusive property of ImmunoCellular, and none of the ImmunoCellular Materials shall be transferred to any other location or third party without ImmunoCellular’s prior written consent.  PharmaCell shall handle and store ImmunoCellular Materials in accordance with their specifications so as to maintain the integrity of such materials and their continued conformance to their specifications.  PharmaCell will keep the materials free and clear of all claims, demands, liens, security

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


 

interests and encumbrances and will remove the same at its sole expense.  PharmaCell shall not allow any samples of the ImmunoCellular Materials to be used or tested by any party not under its direct supervisory control for any purpose, and shall perform only such tests and analyses as it deems necessary in order to satisfy its obligations under this Agreement and the Quality Agreement.  PharmaCell shall treat such test results as Confidential Information of ImmunoCellular.

 

3.2

When reasonably required by PharmaCell or where stipulated in any Schedule , ImmunoCellular shall, at its own cost and expense, make available to PharmaCell suitably skilled, educated employees or representatives with knowledge of the Project, Process, Product and ImmunoCellular Materials for the purpose of facilitating and discussing the progress of the Project to enable PharmaCell to perform the Services hereunder. To the extent such employees or representatives have access to PharmaCell’s facilities, ImmunoCellular shall ensure that such employees or representatives will (i) be subject to enforceable obligations of confidentiality preventing them from using any information of PharmaCell of a confidential nature which they acquire during such visit other than as permitted by this Agreement; and (ii) obey the rules at PharmaCell's facility with regard to health and safety, cGMP, customer confidentiality, provided that PharmaCell has provided ImmunoCellular’s employees and representatives the current rules of PharmaCell and with necessary instructions in advance in writing.

 

3.3

Subject to Section 2.5, ImmunoCellular shall be entitled to request supplements to the Services to the extent not otherwise provided in any Schedule hereto (for example, additional validation work to be performed on existing assays or equipment, additional analytical or process development work, ordering additional batches of ICT-107), provided that additional payment will be made to PharmaCell at PharmaCell’s then-current rates and provided that PharmaCell has the required capacities. Any such request should, if possible, be made four (4) weeks in advance of commencement of the Services, to which PharmaCell will respond within two (2) weeks of such request. Any such request shall be made in writing and approved in writing by the Parties together with the applicable prices and, in relation to a batch of cGMP Product, the delivery date for such batch by the respective Project Leaders of ImmunoCellular and PharmaCell prior to commencement of such additional Services. If after such approval, ImmunoCellular requests an alternative delivery date for cGMP Product, PharmaCell shall use reasonable efforts to deliver the applicable batch of cGMP Product on the date requested by ImmunoCellular. ImmunoCellular shall reimburse all reasonable, documented additional costs caused by its request.

 

3.4

PharmaCell will package and label the Product and/or any other material which is the result of the performance of the Services in accordance with the Schedules, ImmunoCellular’s instructions and Applicable Law before delivering the Product to ImmunoCellular or its designee. PharmaCell will deliver the Product and/or any other material being a result of the performance of the Services to ImmunoCellular or, at ImmunoCellular's discretion, to one or more Third Parties, both Ex Works the Facility (Incoterms 2010 as supplemented by this Agreement) on the delivery date agreed pursuant to Schedules 1 and 2 in accordance with ImmunoCellular’s instructions. PharmaCell shall store the Product after its Release for a maximum period of three (3) months at no charge, and subsequently in accordance with a separate written storage agreement between the Parties, until ImmunoCellular instructs PharmaCell in writing to ship Product to clinical trial sites, which will then be organised by PharmaCell, however without prejudice to the agreed delivery condition, i.e. following delivery Ex Works the Facility, at ImmunoCellular's cost and risk.  

 

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


 

3.5

PharmaCell shall prepare shipment only of Product that is Processed in accordance with this Agreement, the Quality Agreement and Applicable Law and meets Specification.  Unless agreed by ImmunoCellular in writing, PharmaCell shall not have any Product shipped prior to its Release and ImmunoCellular’s written authorization.  PharmaCell shall at ImmunoCellular's prior written authorization and instructions, ship Product in accordance with the terms of ImmunoCellular’s Purchase Orders to such locations as requested by ImmunoCellular in writing and at the cost of ImmunoCellular.  ImmunoCellular or its designees may select the freight carrier used by PharmaCell to ship Product and may monitor PharmaCell’s shipping/freight practices as they pertain to this Agreement. The shipping labels for each shipment shall contain information as specified in writing by ImmunoCellular.  PharmaCell shall ensure that shipping documentation complies with all Applicable Law.  In addition, at a minimum, PharmaCell shall electronically send to ImmunoCellular, at least five (5) days prior to each shipment of a Batch of Product, a copy of the Certificate of Analysis, and Certificate of Compliance for that Batch. At the time of delivery to the freight carrier, PharmaCell shall verify that the transport vehicle meets the prescribed Product storage conditions prior to the loading of the Product onto the transport vehicle.

 

3.6

PharmaCell shall perform quality controls in connection with its manufacturing of the Product in accordance with the quality control and testing procedures specified by ImmunoCellular, the Quality Agreement and Applicable Law. Each Product that is delivered to ImmunoCellular or its designee shall be Released by the Qualified Person of PharmaCell before or as soon as possible after delivery of the Product to ImmunoCellular or its designee, and PharmaCell shall provide ImmunoCellular in writing with a Certificate of Analysis, Certificate of Compliance, copy of the completed Batch Record and QC testing results and such other documents as may be required pursuant to the Quality Agreement.

 

3.7

In addition to PharmaCell’s other obligations, PharmaCell’s obligations in relation to the apheresis product shall be set forth in the Quality Agreement.

 

 

 

 

Defective Products

 

3.8

Non-Conformity of Product

 

If PharmaCell determines that a Batch of cGMP Product cannot be Released by the Qualified Person of PharmaCell as the Product supplied by PharmaCell does not conform to the Specification and/or such Product is not otherwise in conformity with this Agreement or the Quality Agreement, or if ImmunoCellular identifies a Product not conforming to the Specification or the Batch Records and/or such Product is not otherwise in conformity with this Agreement (including any warranties hereunder) or the Quality Agreement (each a “ Defective Product ”), then PharmaCell shall promptly give ImmunoCellular notice thereof in writing, or ImmunoCellular shall promptly give PharmaCell notice thereof in writing (as applicable).

 

Remedies for Defective Product

 

If PharmaCell manufactures a Defective Product for which the cause is attributable to (“toerekenbaar aan”) PharmaCell, PharmaCell shall, at ImmunoCellular’s option and at PharmaCell’s sole expense, either:

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


 

 

(a)

As promptly as possible, supply ImmunoCellular with a conforming (quantity of) Product at PharmaCell’s expense; or

(b)

reimburse ImmunoCellular for the Price paid by ImmunoCellular with respect to such Defective Product (if already paid) or, if ImmunoCellular has not already paid, issue a credit note against the appropriate invoice for the relevant Defective Product; and

(c)

in either case, reimburse ImmunoCellular for the costs (including costs of shipment) of any ImmunoCellular Materials used in the Production of Defective Product with a maximum of the total cost of ImmunoCellular Materials as set forth in Schedule 3.

 

Subject to PharmaCell’s obligations under Section 7.3, the obligations of PharmaCell mentioned in this Section 3.8 constitute PharmaCell's full liability in case of a Defective Product.

 

4

Price and Payment Terms

 

4.1

ImmunoCellular shall, pay to PharmaCell on invoice basis the following:

 

4.1.1

the Price as specified in Schedule 1 or in Schedule 2 ;

 

4.1.2

the raw material, logistics, external testing and equipment costs (including a handling charge as set forth in the Schedules , where applicable but excluding any costs for ImmunoCellular Materials supplied by ImmunoCellular) (“ Third Party Costs ”); and

 

Value Added Tax, excise duties and similar taxes imposed by or under the authority of any government or public authority on the provision of the Services (other than taxes on PharmaCell's income), if applicable. The payment of Third Party Costs will be subject to the quantity used or ordered on behalf of or for ImmunoCellular and any documented changes in market price during the Term. Third Party Costs will be invoiced monthly as they are incurred by PharmaCell plus an agreed handling charge as specified in the applicable Schedule. If ImmunoCellular does not agree to meet these costs then PharmaCell shall not be liable or in breach of this Agreement for its failure to continue with or perform those parts of the Services dependent, directly or indirectly, on such materials and external resources provided that PharmaCell notifies ImmunoCellular in writing of its decision to discontinue or not perform those parts of the Services.

 

4.2

All Prices are in Euro and all invoices will be raised in Euro and will be paid in Euro. The Price for the Services shall be as set forth in the Schedules provided that PharmaCell may, from time to time (but not effective before January 1 st , 2017) decide to adjust its Prices charged for Services performed under this Agreement. Such Price adjustments shall not exceed the increase in price level index of the CPI (consumer price index, as determined by the Central Bureau for Statistics in The Netherlands on their website www.cbs.nl , table: “Consumentenprijzen”) (the “Index”) since the last Price adjustment. In the event that, instead of making an adjustment in the Price of any part of the Services that is based on the Index, PharmaCell wishes to implement a Price adjustment, for a part of the Services that exceeds the aforementioned Index, which is based on extraordinary increases in direct costs of operations (e.g., labour and/or energy) since the last Price adjustment, such Price adjustment will be communicated in writing to ImmunoCellular three (3) months in advance, including a justification for such Price increase based on such underlying direct cost increases (evidenced by supporting documentation) that affect

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


 

the overall Price of such part of the Services. If ImmunoCellular agrees to a Price adjustment based on such direct cost increases, then the overall Price of the part of the Services affected by such direct cost increases shall be adjusted by a percentage that reflects the percentage increase in the overall Price of the part of the Services affected by such direct cost increases.  If ImmunoCellular does not agree to such Price adjustment, ImmunoCellular shall have the option to terminate the Agreement pursuant to 10.4 starting at the time of the intended Price adjustment; provided, however, that if requested by ImmunoCellular with its notice of termination, PharmaCell shall continue to manufacture and supply Product under the terms of this Agreement and the Quality Agreement for a period of up to six (6) months after the end of the ninety (90) day period provided for in Section 10.4. In any case, Price adjustments (whether based on increases in the Index or increases in direct costs of operations) cannot take place more often than once every twelve (12) months.  

 

4.3

All invoices to be issued by PharmaCell shall be issued according to the payment schedule as described in Schedule 1 and Schedule 2 . All invoices issued are net, which ImmunoCellular will pay, if undisputed, within thirty (30) days of receipt of invoice (" Due Date "). In case that PharmaCell has not fulfilled the Services in accordance with this Agreement and the Quality Agreement, including with the professional skill and care, the required product quality and within the estimated timelines as required by the terms set out in this Agreement including its Schedules, ImmunoCellular is entitled pursuant to this Section 4.3 to hold back the respective payments exclusively in such reasonably estimated amounts as related to the disputed activities until determination of any such dispute. Any other right of ImmunoCellular, to suspend, deduct or set-off in the course of payments is excluded. In the event that the estimated timeline has been exceeded, ImmunoCellular shall pay the corresponding amount as soon as the (part of the) Service has been successfully/properly fulfilled.

 

4.4

In the event that PharmaCell does not receive the full payment on the Due Date, without ImmunoCellular having disputed the related activities, it may, at its discretion, and without prejudice to its other statutory rights and remedies, charge statutory commercial interest (‘ wettelijke handelsrente’ ) as yearly published in the Dutch Bulletin of Acts and Decrees (‘ Staatsblad’) on the outstanding amount of the invoice until payment is received in full. Interest shall not accrue until ten (10) days following the forwarding by PharmaCell to ImmunoCellular of written notice of late payment .

 

4.5

PharmaCell shall maintain and retain records of all fees and other costs (including Third Party Costs) and expenses for which ImmunoCellular is obligated to pay or reimburse PharmaCell hereunder (including without limitation any costs relating to the purchase, maintenance, servicing or repair of any Dedicated Equipment for which ImmunoCellular reimburses PharmaCell, if applicable).  Such records shall be subject to audit by or on behalf of ImmunoCellular during the Term of this Agreement and for a period of three (3) years after its termination or expiration, on reasonable advance notice to PharmaCell and during regular business hours.  If any overpayment by ImmunoCellular is revealed by any such audit, PharmaCell shall promptly refund any overpaid amounts to ImmunoCellular.

 

 

5

Project Organisation

 

5.1

Steering Committee and Representatives

 

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


 

The Parties shall form the Steering Committee which shall comprise a minimum of two but an equal number of representatives (“ Representatives ”) from each of PharmaCell and ImmunoCellular and each Party shall notify the other of its elected Representatives. In general, each Representative shall carry an equal vote and proxy votes may be granted by Representatives to their fellow Representative(s) if they are unable to attend meetings. Each Party, irrespective of the number of Representatives attending each relevant meeting, shall have an equal vote.  

 

Each Party shall be entitled to change their respective nominated Representatives at any time and shall promptly give written notice of the change to the other Party including the new contact details of the new Representative(s) in any event no less than seven (7) Business Days after the change has been implemented.  

 

5.2

Function of the Steering Committee

 

The primary function of the Steering Committee is to ensure the ongoing communication between the Parties and discuss and resolve any operational issues arising under the Project. The Parties agree that their Representatives will endeavour to attend each meeting and both the Representatives and each Party shall discuss events in good faith with the aim of furthering and successfully concluding the Project. In addition to the primary function described above the Steering Committee shall also take on the following responsibilities:

5.2.1

Discuss and seek resolution of issues around management of the Project;

5.2.2

Agree and monitor deadlines and milestones for the Project;

5.2.3

Agree and discuss any changes to the Services.

 

In case that the Steering Committee is unable to reach an agreement on any issue, the CEO of PharmaCell and the CEO of ImmunoCellular, shall try to solve this issue in good faith by amicable discussion to seek a decision mutually acceptable for both Parties.

 

Notwithstanding anything to the contrary herein, the Steering Committee shall not have the authority to amend this Agreement or the Quality Agreement.

 

5.3

Meetings of Steering Committee

 

The Representatives of the Steering Committee shall meet in person or by telephone as often as required but at least once per calendar quarter with advance written notice of not less than ten (10) Business Days at the request of ImmunoCellular or PharmaCell. The Steering Committee must meet in a setting that allows the committee to make valid and enforceable decisions at least every three (3) months or immediately upon the request of one Party. The Steering Committee shall only be able to make valid and enforceable decisions if no less than two (2) Representatives of each Party are present at and attend the meeting. In the event that either Party does not send at least two Representatives to the meeting of the Steering Committee, the Steering Committee can also make valid and enforceable decisions with the attendance of one Representative of each Party.

 

5.4

Technical Meetings

 

Each week during the Term at a fixed date (for example each Monday) or as often as the Parties deem necessary and to be agreed between the Parties or with advance written notice of not less than three (3) Business Days at request of ImmunoCellular or PharmaCell, ImmunoCellular's and PharmaCell's respective employees or Representatives can meet (in person or by telephone) to follow-up with scientific and/or

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


 

technical issues of the Services (" Technical Meetings "). These Technical Meetings can take the form of weekly one-hour conference calls between PharmaCell and ImmunoCellular and will be arranged with the core team to give a short update of the Project, discuss problems and to bring about necessary decisions. The weekly one-hour conference calls with the core team are included in the Price.

 

In addition to the Technical Meetings and separate from Audits, PharmaCell shall permit ImmunoCellular upon no less than five (5) Business Days' notice and during reasonable times, a maximum of three (3) named qualified employees or representatives of ImmunoCellular (ImmunoCellular shall be responsible for ensuring that each such person adheres to the confidentiality obligations imposed on ImmunoCellular pursuant to Section 8 ) to enter those areas of PharmaCell's premises concerned with the Services, except for B cleanroom areas, for the sole purpose of observing and inspecting the performance of the Services, SOPs and those records of PharmaCell specific to the Services subject to the employees and representatives obeying and adhering to the rules and regulations in place at PharmaCell concerning health and safety, cGMP and customer confidentiality. PharmaCell shall in advance notify in writing or instruct ImmunoCellular employees and representatives about the current rules and regulations of PharmaCell's facility.

 

5.5

Exchange of Know-How

 

Parties will disclose to each other their Pre-Existing IP and their respective know-how (ImmunoCellular Know-How or PharmaCell Know-How, as the case may be) to the extent necessary for the performance of the Services by exchange of documentation and exchange of experience in the Technical Meetings.

 

5.6

Documentation and reporting

 

The Project documentation comprises the documents agreed between the Parties in the information exchange phase of the Inbound Technology Transfer. Unless specifically agreed otherwise, all Project documentation will be prepared in the English language and will be solely owned by ImmunoCellular and will be part of the Confidential Information of ImmunoCellular. PharmaCell agrees to provide ImmunoCellular upon request with any documentation relevant to and produced for the Services. All documentation relating to cGMP Services shall comply with the applicable cGMP requirements, the Quality Agreement and all other Applicable Law. A copy of each document finally signed or approved by PharmaCell in relation to the Services shall be sent to ImmunoCellular upon request.

 

5.7

Audits

 

The maximum number of Audits by ImmunoCellular (which shall be subject to the inspection terms set out in Section 5.4) shall be limited to one (1) in each Calendar Year, lasting no more than two (2) Business Days for two (2) auditors (and additional subject matter experts may attend but may not ask questions) and, in respect of these Audits, PharmaCell shall not make a charge. An Audit should be arranged on no less than thirty (30) Business Days' advance notice. In addition to the foregoing, ImmunoCellular and/or its representatives shall have the right to perform “For Cause” Audits at any time upon reasonable advance notice and during regular business hours. If a For Cause Audit confirms that PharmaCell did not comply with its obligations under this Agreement or the Quality Agreement or Applicable Law, then the For Cause Audit shall be at no charge to ImmunoCellular. In all other cases, PharmaCell’s standard hourly rates for For Cause Audits apply.  

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


 

 

Following any Audits, ImmunoCellular shall discuss its observations and conclusions with PharmaCell and PharmaCell shall at its expense promptly implement those critical corrective actions (i.e. those that are necessary to move forward in order to comply with Applicable Law, cGMP or the Quality Agreement) as may be reasonably determined by ImmunoCellular within thirty (30) days after notification thereof by ImmunoCellular.

5.8

Inspections and Regulatory Support

 

To the extent that Inspections are required, PharmaCell will give such Government Competent Authorities the possibility to conduct such Inspections under Applicable Law. PharmaCell is entitled to reasonable documented fees and reimbursement of documented costs, on a pass-through basis, in connection with any Inspections, which solely and specifically relate to the manufacture of the Product.

 

PharmaCell shall notify ImmunoCellular promptly but in any event by telephone within one (1) Business Day, and in writing within three (3) Business Days, after becoming aware of any proposed or unannounced Inspection of the Facility by any Government Competent Authorities, and if such Inspection relates to or could affect the Product, the Process or the provision of Services, shall permit ImmunoCellular or its agents and representatives (with a maximum of three persons) to be present and participate in such Inspection. Within three (3) Business Days of any contact with, or after receipt of any communication from, any Government Competent Authorities relating to or which could affect the Product, the Process, the Services, or any equipment used in connection with the provision of Services, PharmaCell shall forward a copy or description of the same to ImmunoCellular and respond to all inquiries by ImmunoCellular relating thereto. Further, PharmaCell shall consult with ImmunoCellular concerning the response of PharmaCell to each such communication. PharmaCell shall provide ImmunoCellular with a copy of all draft responses for comment as soon as possible and shall consider any of ImmunoCellular’s comments in good faith. PharmaCell shall also provide ImmunoCellular with a copy of all final responses for review and approval, which shall not be unreasonably withheld or delayed, at least two (2) Business Days prior to submission thereof. Following any Inspections, PharmaCell shall at its sole cost and expense, promptly implement those corrective actions as required by any Government Competent Authorities however only insofar as such actions are specifically related to, or the failure to take them could have direct consequences for, the Product, the Process or the Services.

 

Further, ImmunoCellular will be responsible for application for any and all clinical trial and marketing authorizations from any Government Competent Authorities throughout the world in respect of the Product. PharmaCell shall, subject to the confidentiality obligations herein, provide reasonable assistance in respect of these applications as is customary in respect of a product-specific regulatory approval application, by providing samples and reasonable copies, meaning in principle one (1) set, of data, documentation and information. In complying with ImmunoCellular’s requests PharmaCell will be entitled to its then-current customary fees and reasonable, documented cost reimbursements.

 

5.9

Records Retention

 

For the longer of (a)  three (3) years from the date of Product expiry or (b) the time required by all Applicable Law (the “ Retention Period ”), PharmaCell shall keep and maintain records sufficient to substantiate and verify its duties and obligations relating to Processing in respect of each Batch of Product including Batch Records, records of

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


 

Purchase Orders received, certificates of analysis from vendors for ImmunoCellular Materials, Product Processed, work-in-process, analyses of ImmunoCellular Materials and Product, and retain samples.  PharmaCell shall also retain for the Retention Period any records relating to regulatory compliance, environmental, health or safety and quality assurance and quality control of the Product.  PharmaCell shall make all such records available for inspection and copying by ImmunoCellular and/or its representatives during the Term hereof and the Retention Period thereafter, including during any Audit. At least ninety (90) days before the end of the Retention Period, PharmaCell shall notify ImmunoCellular in writing of its intention to destroy any records so retained and ImmunoCellular shall have to right to take possession of such records at its own expense.

 

6

Warranties

 

6.1

ImmunoCellular Warrants to PharmaCell that:

6.1.1

it is legally incorporated and in good standing in its country of incorporation and that it has the right to enter into this Agreement it is solvent and financially in good standing and able to pay its debts when due;

6.1.2

it has the right during the Term to supply PharmaCell with ImmunoCellular Materials and during the Term the right to license and disclose to PharmaCell, to the extent necessary for the performance of the Services by PharmaCell in accordance with this Agreement, the ImmunoCellular Intellectual Property Rights, ImmunoCellular Know-How (including without limitation know-how and confidential information relating to the Process) to PharmaCell;

6.1.3

during the Term, the Raw Material delivered by ImmunoCellular or by a Third Party instructed by ImmunoCellular to the Facility for the performance of the Services, will as of the date of delivery comply with the certificate of analysis delivered with such Raw Material which certificate shall verify the Raw Material to comply with cGMP–requirements and EU Commission Directive 2004/23/EC (Quality and safety of human tissue and cells);

6.1.4

where ImmunoCellular has provided PharmaCell with or directed or stipulated in writing that PharmaCell use the Raw Material, it is lawfully entitled to use the Raw Material for the performance of the Services under this Agreement;

6.1.5

to the best of its knowledge as of the Effective Date, no Intellectual Property Rights of a Third Party are or shall be infringed by the use of (i) ImmunoCellular Know-How (ii) ImmunoCellular Materials supplied by ImmunoCellular and (iii) ImmunoCellular Intellectual Property Rights by PharmaCell in accordance with this Agreement.

6.1.6

it will promptly inform PharmaCell if it receives notice of any claim or potential claim relating to infringement or alleged infringement of any Third Party Intellectual Property Rights by virtue of ImmunoCellular's or PharmaCell's use of the ImmunoCellular Materials, the Process, ImmunoCellular Know-How, Confidential Information of ImmunoCellular or ImmunoCellular Intellectual Property Rights or the manufacture of Product pursuant to the terms of this Agreement;

6.1.7

it does not and will not misuse, sell or unlawfully disclose to a Third Party PharmaCell's Pre-Existing IP or PharmaCell's Intellectual Property Rights, including PharmaCell's Know-How and PharmaCell's Confidential Information, nor assist another to do so;

6.1.8

to the best of its knowledge, the Raw Material and the Process are from a scientific point of view at the Effective Date suitable and adequate for the performance of the Services;

6.1.9

it will only allow Product to be used for application in humans if it has been issued with a Certificate of Analysis; and

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


 

6.1.10

PharmaCell does not require from ImmunoCellular, for the performance of the Services, any additional ImmunoCellular Intellectual Property Rights other than those provided or licensed by ImmunoCellular to PharmaCell under the terms of this Agreement.

 

 

6.2

PharmaCell Warrants to ImmunoCellular that:

6.2.1

it is legally incorporated and in good standing in its country of incorporation and that it has the right to enter into this Agreement it is solvent and financially in good standing and able to pay its debts when due, and it is not aware of any impediment that would inhibit its ability to perform the Services or any of its other obligations hereunder ;

6.2.2

to the best of PharmaCell's knowledge, it has at the Effective Date and based on information regarding the Services provided to PharmaCell by ImmunoCellular at the Effective Date, the resources reasonably necessary to perform the Services and will not, subject to ImmunoCellular's compliance under this Agreement, restrict such resources for the Term of this Agreement in such a way that PharmaCell can no longer render the Services within the estimated and/or agreed timelines. To the best of PharmaCell's knowledge from an internal corporate compliance and scientific point of view based on current information available to PharmaCell at the Effective Date, PharmaCell is able to perform the Services;

6.2.3

it has at the time of the conclusion of this Agreement the necessary permits, approvals, consents, licences, authorizations, registrations and permissions for the performance of its obligations under this Agreement, including permits for work in a cGMP environment and will maintain the same during the Term. It has or will establish facilities and technically qualified employees that are required for the performance of the Services;

6.2.4

it is not aware of any Intellectual Property Rights of a Third Party that are or would be infringed or misappropriated by the use of PharmaCell Intellectual Property Rights, PharmaCell Inventions, PharmaCell Pre-Existing IP and PharmaCell Know-How and/or the performance of the Services including the Process;

6.2.5

in respect of its creation of new technology to be developed under this Agreement for the purpose of the Services, it will not intentionally or with an act of gross negligence ( 'grove schuld ') infringe or misuse or misappropriate a Third Party's Intellectual Property Rights in its performance of the Services including the Process ;

6.2.6

it does not and will not misuse, sell, license, lease or unlawfully disclose or make available to a Third Party, any Confidential Information of ImmunoCellular, Pre-existing IP of ImmunoCellular, ImmunoCellular Inventions, ImmunoCellular's Intellectual Property Rights, including ImmunoCellular's Know-How, nor assist another to do so.  It shall not transfer, supply or sell to a Third Party in whole or part any of the ImmunoCellular Materials or the Product provided that it may, in accordance with ImmunoCellular's written instructions, transfer Raw Materials to Third Party Contractors (accepted and confirmed in writing by ImmunoCellular) in accordance with the terms of this Agreement ;

6.2.7

it will carry out any and all of its obligations under this Agreement and the Quality Agreement including the performance of the Services in accordance with the Applicable Law, including but not limited to mandatory provisions regarding (the processing, storage, transportation, handling, disposal, recycling and use of) waste (hazardous and non-hazardous), the protection of the environment and health and safety of employees, agents and contractors, privacy, labour, tax and competition law.

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


 

6.2.8

it will promptly inform ImmunoCellular in writing if it receives notice of any claim or potential claim relating to infringement or misappropriation or alleged infringement or misappropriation of any Third Party Intellectual Property Rights or other rights by virtue of its use of Pre-Existing ImmunoCellular IP, ImmunoCellular Know-How, ImmunoCellular Materials, ImmunoCellular Intellectual Property Rights, ImmunoCellular Inventions, Pre-Existing PharmaCell IP, PharmaCell Know-How or PharmaCell Intellectual Property Rights, PharmaCell Inventions  or its performance of the Services including the Process;

6.2.9

Product will: (i) be manufactured in accordance with this Agreement, the Quality Agreement and PharmaCell’s standard operating procedures (SOPs); (ii) meet Specification and cGMP and, at the time of shipment, will conform with the Certificate of Analysis and Certificate of Compliance; (ii) not be adulterated or misbranded within the meaning of the European equivalents of the United States Federal Food, Drug, and Cosmetic Act, as amended (the “ Act ”) and similar provisions of any Applicable Law in which the definitions of adulteration and misbranding are substantially the same as those contained in the Act, as the Act and such Applicable Law are constituted and effective at the time of delivery and will not be an article which may not under the provisions of Sections 404 and 505 of the Act be introduced into interstate commerce ; and (iii) title to Product will pass to ImmunoCellular or its designee(s) as provided herein free and clear of any claims, demands, security interests, liens or other encumbrances; and

6.2.10

each of its employees, agents and contractors has unconditionally and irrevocably assigned all of his/her right, title, and interest in and to any inventions (and all Intellectual Property Rights therein) to PharmaCell, has agreed to promptly disclose such inventions in writing to PharmaCell, and has entered into other contracts with PharmaCell, including without limitation confidentiality agreements, necessary for PharmaCell to comply with the terms and conditions of this Agreement and the Quality Agreement.

 

6.3

In consideration of the express Warranties set out above under this Section 6 and without prejudice to each Party’s liability under Section 7, to the maximum extent permitted by Applicable Law (save for those express Warranties set out above), neither Party makes or gives any other express or implied Warranties in relation to its respective obligations, duties or activities owed or performed under this Agreement and hereby excludes all such Warranties.  WITHOUT LIMITING THE FOREGOING, OTHER THAN AS EXPRESSLY PROVIDED FOR IN SECTION 6.1, IMMUNOCELLULAR PROVIDES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND WHATSOEVER, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR PURPOSE OR USE OR NON-INFRINGEMENT, AND HEREBY DISCLAIMS ANY AND ALL OTHER WARRANTIES.

 

6.4

PharmaCell certifies that it is not, and does not use the services of any persons or entities, debarred or threatened with debarment or suspended under 21 U.S.C. § 335a (a) or (b) or foreign equivalents in any capacity associated with or related to the Processing of Product or any other Services or activities under this Agreement.  

 

 

7

Liability and Indemnifications

 

Indemnification

 

7.1

In case that any circumstances arise which give either Party a right to claim indemnification from the other Party pursuant to Section 7.2 or 7.3 below, ImmunoCellular

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


 

and PharmaCell shall in good faith discuss whether the respective situation can be solved.  With respect to infringement of Third Party Intellectual Property Rights in the meaning of Section 7.2.1 or 7.3.1 the respective Indemnitor shall have the right to demand suspension of the infringing activity of the Services in order to solve or minimise the liability of the respective dispute with the Third Party at its own discretion and may explore the possibility of and enter into a license agreement with a Third Party under its own Intellectual Property Rights, or find a means to circumvent the Third Party Intellectual Property Right to overcome the infringement. The right to suspend the infringing activity does include the right to terminate any licenses granted to the other Party under this Agreement to the extent that this specific part of the license infringes the Third Party Intellectual Property Rights. However, the Indemnitor is not permitted to negotiate or conclude any settlement agreements or to acknowledge any claims of the Third Party against the Indemnitee on behalf of the Indemnitee or consent to an adverse judgment or agreement that adversely affects the rights of the Indemnitee under this Agreement without the Indemnitee's prior written consent (such consent not to be unreasonably withheld). However, in case that Indemnitor requests Indemnitee to stop the infringing activities where the indemnity covers losses or damages caused by such cessation but Indemnitee continues to conduct such activities, Indemnitee loses its right to claim indemnification from Indemnitor in respect of those activities from the date of request, provided however, that the direct damages incurred by the Indemnitee as a result of agreeing to Indemnitor’s request to stop the infringing activities are in itself considered damages that are subject to indemnification by the Indemnitor.

 

7.2

Without prejudice to ImmunoCellular's liability for breaches of its Warranties set forth in Section 6.1 and breaches of its other obligations under this Agreement (in which cases, for the avoidance of doubt, Sections 7.5 to 7.7 will apply), ImmunoCellular shall defend, indemnify and hold harmless PharmaCell, its Affiliates, directors, officers, employees, agents and contractors, licensors and licensees, successors and assigns, and PharmaCell's  Third Party Contractors (“PharmaCell Indemnitees”), against any and all Third Party losses, demands, claims, actions, liabilities, damages, costs and expenses (including but not limited to reasonable court costs, costs of investigation, litigation and settlement and documented and reasonable attorney’s fees and expenses together with any applicable taxes thereon, regardless of outcome) incurred by the PharmaCell Indemnitees to the extent resulting from any of the following:

 

(i)

a claim brought by a Third Party with respect to any infringement of or alleged infringement of any Third Party Intellectual Property Rights in the performance of the Services by PharmaCell as directed by ImmunoCellular in writing, save to the extent such infringement, alleged infringement, misappropriation or breach of Third Party Intellectual Property Rights is caused or alleged to be caused by PharmaCell's use of PharmaCell Intellectual Property Rights, Pre-Existing IP of PharmaCell, PharmaCell Know-How or PharmaCell Inventions;

(ii)

a claim brought by a Third Party with respect to any product liability claims relating to the Product or ImmunoCellular Materials, any conjugated form or formulation of the same, save to the extent such liability has arisen due to PharmaCell’s or a Third Party Contractor’s negligence, misconduct or breach of or non-compliance with this Agreement or the Quality Agreement or results from Defective Product; or

(iii)

any contamination of PharmaCell's facility or damage to PharmaCell caused by any ImmunoCellular personnel or representative (during a Technical Meeting or an Audit or otherwise) save to the extent that such person was acting in accordance with PharmaCell’s instructions, policies or procedures.

 

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


 

7.3

Without prejudice to PharmaCell's  liability for breaches of its Warranties set forth in Section 6.2 and breaches of its other obligations under this Agreement or the Quality Agreement (in which cases, for the avoidance of doubt, Sections 7.5 to 7.7 will apply), PharmaCell shall defend, indemnify and hold harmless ImmunoCellular and its Affiliates and its and their directors, officers, employees, agents and contractors, licensors and licensees, successors and assigns (“ImmunoCellular Indemnitees”), against any and all Third Party losses, demands, claims, actions, liabilities, damages, costs and expenses (including but not limited to reasonable court costs, costs of investigation, litigation and settlement and documented and reasonable attorney’s fees and expenses together with any applicable taxes thereon, regardless of outcome) incurred by the ImmunoCellular Indemnitees to the extent resulting from any of the following:

 

(i)

a claim brought by a Third Party with respect to any infringement or misappropriation of or alleged infringement or misappropriation of any Third Party Intellectual Property Rights in the performance of the Services by PharmaCell to the extent such infringement, alleged infringement, misappropriation or breach of Third Party Intellectual Property Rights is caused or alleged to be caused by PharmaCell's use of PharmaCell Intellectual Property Rights, Pre-Existing IP of PharmaCell, PharmaCell Know-How or PharmaCell Inventions;

(ii)

a claim brought by a Third Party with respect to any product liability claims relating to the Product or ImmunoCellular Materials, or any conjugated form or formulation of the same, to the extent such liability has arisen due to PharmaCell’s or a Third Party Contractor’s negligence, misconduct or breach of or non-compliance with this Agreement or the Quality Agreement or results from Defective Product; Or ,

(iii)

a claim brought by a Third Party with respect to any violation of Applicable Law committed by PharmaCell or a Third Party Contractor in the performance of this Agreement or the Quality Agreement.

 

Indemnification Procedure

 

7.4

The party (the " Indemnitee ”) that intends to claim indemnification under this Section 7 shall:

 

7.4.1

promptly, and in any event within ten (10) Business Days of it receiving notice of the claim, demand, threat or action, provide the other Party (the " Indemnitor ”) with a copy of such notice which has or has the potential to give rise to the Indemnitee seeking to rely on and claim the benefit of the indemnification together with notification of the Indemnitee's intention to rely on such indemnity, provided however, that failure to give such notice shall not relieve the Indemnitor of its indemnification obligations except and only to the extent such failure actually and materially prejudices the ability of the Indemnitor to defend against such claims;

7.4.2

not prejudice any defence to any claim or attempt to or settle or compromise such claim without the prior written consent of Indemnitor (which consent shall not unreasonably be withheld) otherwise the Indemnitee shall lose its right to claim the indemnity against the Indemnitor with respect to such claim;

7.4.3

subject to its other rights and obligations and compliance with the procedures set out in this Section 7 permit the Indemnitor to have overall control of the conduct of the negotiations and the proceedings including any counterclaim and/or settlement;

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


 

7.4.4

cooperate as reasonably requested by the Indemnitor, at the Indemnitor's expense, in the conduct of such claim (and any counterclaim) and/or settlement; and

7.4.5

have the right to instruct independent counsel and participate in all proceedings and negotiations whether named or not as a party in the claim or proceedings at its own expense.

 

Limitation of Liability

 

7.5

The Parties represent and acknowledge that they have negotiated the terms of this Agreement and have reached agreement on the terms based on their own assessment of their own risks, liabilities and rewards in connection with this Agreement and the Product, in addition to having had the benefit of professional legal advice and, accordingly, the Parties agree that subject to the terms of Section 7.6 and 7.7, and subject to each Party’s obligations to defend, indemnify and hold harmless under Sections 7.2 and 7.3, respectively,  either Party’s aggregate liability to the other for any loss or damage as a result of breach of this Agreement or of any other liability (including but not limited to claims under tort law ( 'onrechtmatige daad ') shall not exceed [ * ].

 

7.6

Subject to Section 7.7, neither Party shall have any liability to the other Party or its Affiliates or any Third Party, for any loss of profits, loss of use, business, business opportunities or revenue (whether direct or indirect) or indirect, incidental or consequential losses, or for any punitive, special or exemplary damages, other than to the extent such liabilities arise under such Party's obligation of indemnification pursuant to Sections 7.2 and 7.3, respectively, or such Party’s breach of its confidentiality obligations under Section 8, even if a Party knew or should have known of the possibility of such losses or damages.

 

7.7

Nothing in this Agreement shall purport or attempt or serve to exclude or restrict any liability of either Party for (i) fraud or fraudulent misrepresentation (‘ bedrog ’), (ii) breach of implied undertakings which cannot be excluded or limited by contract such as, and without limitation, warranties as to title; or (iii) gross negligence or wilful misconduct or deliberate wrongful acts ( 'grove schuld of opzetttelijk handelen/nalaten ') of that Party or its directors, officers, Affiliates, employees and/or sub-contractors.

 

8

Confidential Information and Data Protection  

 

8.1

The Parties acknowledge that there may be disclosure of each other's I nformation to the other. Each Party (the “ Receiving Party ”) shall treat any and all Confidential Information that it receives from the other Party (the “ Disclosing Party ”) under this Agreement as strictly confidential and shall not disclose the same to any Third Party or use it except in connection with the purpose of performing its obligations or exercising its rights under this Agreement without the prior written co nsent of the Disclosing Party. Each Party solely owns its Confidential Information.  In consideration of the Disclosing Party making available Confidential Information to the Receiving Party, the Receiving Party undertakes that it shall, and shall procure that each of its Permitted Recipients, shall:

8.1.1

treat and safeguard as private and confidential all the Confidential Information;

8.1.2

use the Confidential Information only for those purposes reasonably required or anticipated under this Agreement and without prejudice to the generality of the foregoing, not use any Confidential Information to obtain any commercial advantage over the Disclosing Party or to use the Confidential Information to compete with Disclosing Party in any way, and shall not use any of the

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


 

Disclosing Party’s Confidential Information to apply for, secure or perfect any Intellectual Property Rights;

8.1.3

ensure the proper and secure storage of all Confidential Information applying standards of due care reasonably expected and no less stringent than standards applied to protection of Receiving  Party's own Confidential Information;

8.1.4

not at any time without the Disclosing Party’s prior written consent disclose or reveal, whether directly or indirectly any of the Confidential Information to any person whatsoever save its Permitted Recipients, and then on a limited need to know basis, who shall be informed by it of the confidential nature of the Confidential Information and who shall be subject to and bound by substantially similar written obligations of confidentiality as those provided for in this Agreement, and for whom it hereby accepts full responsibility in the event that any such person shall breach the duty of confidence imposed upon them; and

8.1.5

not at any time have any discussion, correspondence or contact with any Third Party concerning the Confidential Information without the prior written consent of the Disclosing Party.

 

8.2

The obligations in this Agreement do not apply to Information:

8.2.1

which, at the time of its disclosure by the Disclosing Party, is available to the public;

8.2.2

which becomes generally available to the public after such disclosure otherwise than by reason of a breach of any of the undertakings in this Agreement or any breaches of confidence by the Receiving Party or any Permitted Recipients;

8.2.3

which is, at the time of such first disclosure and as evidenced by the Receiving Party's written records, lawfully already within its possession without any breach of any confidentiality undertaking;

8.2.4

which is provided to a Receiving Party by a Third Party which is lawfully in possession of such Information without any breach of any confidentiality undertakings, as evidenced by Receiving Party’s written records, or

8.2.5

which is developed by or on behalf of the Receiving Party independently of the Disclosing Party’s Confidential Information as evidenced by the Receiving Party's written records.

 

8.3

A Receiving Party may disclose that portion of the Confidential Information of the Disclosing Party to the extent that the Receiving Party (or any of its Permitted Recipients) is compelled to disclose such Confidential Information by law, rule, regulation, court of competent jurisdiction or by any stock exchange or other regulatory authority having jurisdiction over it or them (but, for the avoidance of doubt, only to that extent); provided that prior to making such compelled disclosure, the Receiving Party notifies the Disclosing Party in advance in writing and gives the Disclosing Party an opportunity to challenge, limit or seek to obtain a protective order and/or confidential treatment of such compelled disclosure.

 

8.4

Other than the limited and restricted rights of use set out in this Section 8 nothing in this Agreement intends to or has the effect of granting any right, title, licence or interest in or to the Receiving Party in respect of the Disclosing Party's Confidential Information or Intellectual Property Rights – except for the assignment of rights and grants of licenses under Section 9 of this Agreement.

 

8.5

Except as otherwise provided for in this Agreement or otherwise required by law or administrative authorities, neither ImmunoCellular nor PharmaCell shall disclose any terms or conditions of the Agreement to any Third Party without the prior written consent of the other Party other than, on a strictly need to know basis, for the purpose of obtaining

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


 

financing or other major corporate transaction, or in the case of ImmunoCellular, in connection with entering into or fulfilling obligations under any licence or agreement relating to the exploitation of Product, to the extent required in connection with such transaction or purpose.  Without limiting the foregoing, upon prior written notice to PharmaCell, ImmunoCellular shall also have the right to disclose Confidential Information of PharmaCell to patent offices in order for ImmunoCellular to exercise its rights under Section 9, and to Government Competent Authorities.  

 

8.6

Upon termination of this Agreement or at the request of the Disclosing Party, each Party shall promptly return to the other, at the other’s request, any and all Confidential Information of the other (including copies of documents, computer records and records on all other media) then in its possession or under its control except where such Confidential Information is covered under surviving assignments and licence rights between the Parties.  Each Party may retain one (1) copy of the other Party’s Confidential Information in a secure location for the sole purposes of legal and regulatory compliance and to monitor its ongoing obligations hereunder.

 

8.7

PharmaCell shall comply with all applicable data protection and privacy laws when performing its Services under this Agreement. In particular, PharmaCell shall adequately protect any patient data that may become accessible to PharmaCell against disclosure to any Third Party and shall use such data only for the provision of its Services hereunder and for no other purpose. All personal data that is no longer required for PharmaCell’s performance of its obligations under this Agreement shall be deleted or returned to ImmunoCellular, as requested by ImmunoCellular. PharmaCell shall immediately report any violation of data protection or privacy laws identified by PharmaCell to ImmunoCellular .

 

 

9

Intellectual Property Rights

 

9.1

The Parties acknowledge and agree that any Intellectual Property Rights owned by or licensed by a Third Party to either Party and in existence as at the date of this Agreement or before commencement of the Services (whichever is the earlier) shall remain the sole and absolute property of that Party who owned or was licensed to use such rights and that unless otherwise expressly granted herein nothing in this Agreement shall act as any grant of a licence or transfer of such rights to the other Party (hereinafter the               " Pre-Existing IP ").

 

9.2

In respect of the Pre-Existing IP which may be or is reasonably necessary for the performance of the Services hereunder, and without additional consideration, each Party hereby grants to the other for the Term of this Agreement a non-exclusive, worldwide, revocable, non-transferable, non-assignable (other than as permitted under Section 13.3) non-sublicensable (other than to Third Party Contractors approved in writing by ImmunoCellular for the performance of that specific part of the Services pursuant to Section 2.4, and to licensees of ImmunoCellular), fully  paid up, royalty free licence to use such Intellectual Property Rights solely to the extent the same are required by the other for the performance of the Services or the use of Product as contemplated by this Agreement hereunder and provided that the granting of such licence does not infringe any contractual obligations of the licensor or violates Applicable Law. Except as otherwise expressly provided for in this Agreement, this license shall automatically terminate upon the expiration or termination of this Agreement and all rights shall automatically revert in their entirety to the licensor.

 

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


 

9.3

Any Intellectual Property Rights developed solely by PharmaCell in the performance of the Services that solely constitute an improvement of Pre-Existing IP of PharmaCell and that (i) do not involve any use of Pre-Existing IP of ImmunoCellular or ImmunoCellular Know‑How (or other Confidential Information of ImmunoCellular) or ImmunoCellular Intellectual Property Rights and (ii) are not related to the Services, the Process or the Product, (the "PharmaCell Inventions ") shall be exclusively owned by PharmaCell.

 

9.4

Without additional consideration, PharmaCell hereby grants ImmunoCellular a non-exclusive, perpetual, irrevocable, royalty-free, fully paid up, non-transferable, fully sublicensable through multiple tiers, worldwide licence to PharmaCell Intellectual Property Rights, PharmaCell Inventions and to Pre-Existing IP of PharmaCell and PharmaCell Know How, to the extent strictly necessary for the manufacturing, sale, offer for sale, marketing, distribution, import, export and the use of the Product and any product using the Process or any improvement to the Process, and/or the use, practice or exploitation of ImmunoCellular Inventions. For the avoidance of doubt, this license includes without limitation the right of ImmunoCellular to sub-license these rights at any time to Third Parties for the manufacture of the Product or any product using the Process or any improvement to the Process, pursuant to an Outbound Technology Transfer.

 

9.5

ImmunoCellular grants PharmaCell for the Term of this Agreement a non-exclusive, royalty-free, non-transferable, non-assignable, non-sublicensable (other than to Third Party Contractors approved in writing by ImmunoCellular for the performance of that specific part of the Services pursuant to Section 2.4) and revocable right to the ImmunoCellular-Inventions to the extent reasonably necessary for the performance of the Services in accordance with this Agreement.  

 

9.6

Any Intellectual Property Rights developed solely by PharmaCell or jointly by PharmaCell and others including ImmunoCellular, as a result of the performance of the Services, that involve any use of Pre-Existing IP of ImmunoCellular or ImmunoCellular Know‑How (or other Confidential Information of ImmunoCellular) or ImmunoCellular Intellectual Property Rights or that relate to the Product or the Process (the "ImmunoCellular Inventions ") shall be exclusively owned by ImmunoCellular.  PharmaCell shall promptly notify ImmunoCellular in writing of any and all ImmunoCellular Inventions.  Accordingly and without additional consideration, PharmaCell hereby transfers and assigns to ImmunoCellular, PharmaCell’s entire right, title and interest in and to ImmunoCellular Inventions and related Intellectual Property Rights, and shall cause its employees, agents and Third Party Contractors to do the same.    

 

9.7

Each Party may file patent protection on any Intellectual Property Rights it owns or, as set forth above, subsequently owns under this Agreement and the other Party shall promptly upon request co-operate, at the requesting Party's reasonable expense, with any requests to assist or enable the Party's protection including but not limited to signing and delivering documents and other information necessary for the valid assignment, application and prosecution and enforcement of any such patent.

 

9.8

PharmaCell shall not sell, lease, license, attempt to reverse-engineer, copy, distribute, deconstruct, disassemble, modify, adapt or create derivatives of any ImmunoCellular Materials or the Product, or any Confidential Information of ImmunoCellular, or attempt to determine the structure or composition of any of the foregoing other than as may be required in performing its Services under this Agreement, nor shall it allow any Third Party to do so.

 

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


 

9.9

Notwithstanding anything to the contrary under Dutch law, the assignments of rights and grants of licenses by PharmaCell to ImmunoCellular under this section 9 shall not be revoked, rescinded or terminated by operation of law or otherwise and shall survive the expiration or termination of this Agreement for any reason.

 

9.10

Except to the extent expressly provided for herein, nothing contained in this Agreement shall be construed as a grant of right or of license, whether express or implied, by ImmunoCellular to PharmaCell, with respect to the Product, the Process, ImmunoCellular Materials, ImmunoCellular Inventions or any Confidential Information of ImmunoCellular, or to any patent, copyright, trademark, trade secrets or any other Intellectual Property Rights of ImmunoCellular.

 

 

10

Term and Termination, Remedies for Breach

 

10.1

This Agreement shall commence on and become effective on its signing by both Parties (hereinafter the " Effective Date ") provided that it has been lawfully executed by all Parties and will expire when the Services have been completed or this Agreement is terminated in accordance with this Section 10 (the " Term "). In respect of any part(s) of the Services which have been performed before the Effective Date, the Parties agree that the performance of those part(s) shall be deemed to have been performed during the Term and governed by the terms of this Agreement.  

 

Events of Termination

 

10.2

Notwithstanding Section 10.1, either Party (" Non-Defaulting Party ") may terminate this Agreement before expiry of the Term with immediate effect upon written notice to the other Party (" Defaulting Party ") if:

10.2.1

the Defaulting Party commits a material breach of its obligations under this Agreement and, if the breach is capable of remedy, fails to remedy it during the period of thirty (30) days starting on the date of receipt of notice from the Non-Defaulting Party identifying the breach and requiring it to be remedied; if in a particular case the Defaulting Party can prove that it reasonably needs more time to remedy a breach, and it is endeavouring in good faith to remedy such breach, then the Parties will in good faith agree on an extension of this thirty (30) day period unless such extension would  harm objective business interests of the Non-Defaulting Party.

10.2.2

the Defaulting Party is deemed unable to pay its debts within the meaning of the relevant Sections of the Dutch Insolvency Act, meaning the other Party receives suspension of payment or, whether voluntarily or involuntarily, is declared bankrupt or if such Party becomes permanently unable to perform its obligations hereunder for reasons other than suspension of payment or bankruptcy, such as, for example, liquidation, dissolution or winding-up.

 

10.3

Notwithstanding Section 10.1 PharmaCell may terminate (i) the Agreement (or any part) at any Stage during the Services up to but before commencement of the first batch cGMP Product (“Batch I”) as described in Schedule 1 and in Schedule 2 on 90 days' advance written notice subject to the following:

10.3.1

PharmaCell may only invoke termination under this Section 10.3 in respect of those Services or Stages for which notice is served if for unexpected technical or scientific reasons beyond PharmaCell's reasonable control, it:

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


 

(a)

becomes technically or scientifically impossible or unworkable or unfeasible to deliver such Services or Stages based on the current technologies fairly known and available to PharmaCell at the time such obstacles arise. Such assessment, if disputed by ImmunoCellular, will be resolved by the Parties by the appointment of a mutually acceptable independent expert in the field who will be appointed within 30 days of PharmaCell’s notice and will provide a written conclusion, including an action plan for resolving the technical obstacles, within 60 days from the appointment.  If the parties fail to appoint an expert within such period, the parties shall require the CEDR, London to select an expert ; or,

(b)

requires the application, purchase or use of technology, skills and/or materials beyond that reasonably contemplated by the Parties at the Effective Date and the application, purchase or use of which will result in a material and adverse change to the financial returns to PharmaCell under this Agreement and ImmunoCellular proves unwilling or unable to compensate PharmaCell fully for such adverse change to the financial returns;

 

provided that PharmaCell shall notify ImmunoCellular of such circumstances in writing within 10 Business Days of becoming aware of such circumstances.

 

10.3.2

During the 90 day notice period:

(a)

PharmaCell shall (subject to Section 10.3.3), unless Parties agree otherwise in writing, continue to perform all other Stages of the Services in accordance with this Agreement which are not dependent upon those Stages identified in PharmaCell's notice; and

(b)

the P arties shall in good faith discuss the difficulties and scientific and technical hurdles in an attempt to resolve such problems. If the P arties agree during such discussions that the Services can be delivered then the notice to terminate shall expire and this Agreement (or the part(s) of the Services as the case may be) shall continue in full force and effect. If agreement cannot be reached the Agreement or part(s) of the Services shall terminate on expiry of the 90 days' notice period . If only certain part(s) of the Services have been terminated, ImmunoCellular is entitled to terminate the whole Agreement with immediate effect.   

 

10.3.3

Upon service of the notice PharmaCell shall take all reasonable steps to mitigate and avoid incurring expenses, commitments and costs that it would otherwise seek to recover from ImmunoCellular pursuant to Section 10.3.4 of this Agreement.

 

10.3.4

In respect of termination under this Section 10.3 ImmunoCellular shall pay PharmaCell in full for all the successfully completed Stages of the Services performed up to the date of termination in accordance with this Agreement and the Quality Agreement, and shall pay a pro rata amount of the Price for those Stages of the Services that have been commenced but not completed at the date of termination.  ImmunoCellular shall also pay PharmaCell all other reasonable documented expenses that have been incurred by or to which PharmaCell is committed in accordance with the Schedules (and which cannot be refunded or used for any other projects or customers) in pursuance of the Services including the cost of commitments made to T hird P arties, including Raw M aterials, as a result of this Agreement and which have been approved in writing by ImmunoCellular in advance . For the avoidance of doubt, any payments made

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


 

under this Section 10.3 shall not exceed the total Price of the applicable stage of the Services.

 

10.4

ImmunoCellular may terminate this Agreement or any Stage of the Services at any time for any reason or no reason before completion of the Services or Stage thereof by giving no less than ninety (90) days advance notice in writing to PharmaCell (thirty (30) days in the event of a clinical hold or other suspension or early termination of a clinical trial on specific instruction of a Government Competent Authority in any case as demonstrated in writing to PharmaCell) detailing which Stage(s) of the Services are to be terminated. In the event ImmunoCellular elects to terminate this Agreement either in whole or a material and significant portion of the Services to be performed under the Agreement in accordance with this Section 10.4 it shall pay to PharmaCell the sums specified pursuant to Section 10.5.

 

10.5

In the event that this Agreement or any Stage of the Services is terminated, neither Party shall incur any future liability towards the other Party other than:

10.5.1

in respect of any accrued rights and liabilities; and

10.5.2

the payment by ImmunoCellular to PharmaCell of sums due in respect to those Stages that have been successfully completed in accordance with this Agreement and the Quality Agreement, or have been irreversibly committed by ImmunoCellular (i.e. the reservation fees in case these are agreed) in accordance with this Agreement (and its Schedules) at the date of termination and a pro-rata Price for those Stages (fairly determined having regard to man hours, materials, profit element) and further irreversible commitments incurred by PharmaCell which, at the date of termination, have not been completed but have been started per request of ImmunoCellular and are being prepared, started and performed in accordance with this Agreement and the Quality Agreement including all Raw Materials and other non-cancellable external costs incurred by PharmaCell in performance of the Services (and which cannot be refunded or used for any other projects or customers); and,

10.5.3

where ImmunoCellular terminates this Agreement (however: not if ImmunoCellular terminates pursuant to Section 10.2.1 or 10.4 for reason of a clinical hold or other suspension or early termination of a clinical trial on specific instruction of a Government Competent Authority), ImmunoCellular shall pay to PharmaCell, in addition to any other sums payable under this Section 10 due to the termination, an early termination sum in the amount of [ * ] of the price for the remaining Services (i.e. the proportion of the price of the Services related to the Technology Transfer or of other Services, other than those Services set forth in Schedule 2, that have been agreed in writing, and which Services are not being cGMP Production to which the reservation fees in section 10.5.2 apply) to be completed as of the effective date of the termination.

 

10.6

Termination of this Agreement for whatever reason shall not affect the accrued rights and liabilities of either PharmaCell or ImmunoCellular arising under or out of this Agreement. Upon termination and provided ImmunoCellular has paid all sums according to Section 4, PharmaCell will deliver the Product and/or any material arising out of the performance of the Services and any ImmunoCellular Materials then held by PharmaCell as well as all reports, records, data, information and documentation in connection with such Services to the extent that such material, reports, records, data, information and documentation refer to the Services up to and including the date of termination of this Agreement. All provisions which are expressed to survive this Agreement and the provisions of Sections 2.4, 2.10, 3.8, 5.7, 5.8, 5.9, 6, 7, 8, 9, 10, 12 and 13 shall survive termination or expiry of this Agreement and remain in full force and effect. T ermination of

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


 

this Agreement is not an exclusive remedy and the Parties shall have the rights and remedies available to them in equity and at law.

 

10.7

Each Party hereby waives its right to rescind ( ‘vernietigen’ ) or dissolve ( ‘ontbinden’ ) this Agreement in whole or in part, except in the event of fraud ( ‘bedrog’ ). The applicability of clauses 6:228 and 6:265 of the Dutch Civil Code is excluded.

 

11

Force Majeure

 

11.1

Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached the Agreement for failure or delay in fulfilling or performing any term of the Agreement or the Services to the extent, and for so long as, such failure or delay is caused by or results from causes beyond the reasonable control of the relevant Party in accordance with clause 6:75 of the Dutch Civil Code, including but not limited to earthquakes, floods, embargoes, wars, acts of war (whether war is declared or not), terrorist acts, insurrections, riots, civil commotion, acts of God or other acts, omissions or delays in acting by any  administrative authority or other party (" Force Majeure Event ").

 

11.2

The Party affected by the Force Majeure event shall promptly notify in writing the other Party of the Force Majeure Event, which prevents that Party from performing its obligations hereunder. In the event a Force Majeure Event continues for more than thirty (30) days after such notice is served, and it is adversely affecting the performance of this Agreement, then the Party that is not experiencing the Force Majeure Event will have the right, on written notice not to expire before the end of the thirty (30) days period, to terminate this Agreement. In the case of such termination (i) ImmunoCellular will not have a right to reimbursement for any sums paid under this Agreement or any claim for damages as a result of the termination of the Agreement or non-performance of the Services but shall account to PharmaCell for any sums due under this Agreement in respect of Services performed in accordance with this Agreement and the Quality Agreement up to and including the day of the Force Majeure Event and (ii) PharmaCell will not have any right to any claim for damages or losses as a result of the termination of the Agreement or non-performance of the Services.

 

 

12

Applicable Law, Jurisdiction and Dispute Resolution

 

Applicable Law and Jurisdiction

 

This Agreement, including the construction, validity and performance of this Agreement shall be governed by the laws of the Netherlands, regardless of its or any other jurisdiction’s choice of law principles.

 

In the event of any controversy or claim arising out of or relating to this Agreement, the Parties shall consult and negotiate with each other and, recognizing their mutual interests, attempt to reach an amicable solution satisfactory to both Parties. If they do not reach settlement within a period of 60 days, then either Party may, by notice to the other Party and to the International Centre for Dispute Resolution of the American Arbitration Association ("ICDR"), demand mediation under the International Mediation Procedures of the ICDR. If settlement is not reached within 60 days after service of a written demand for mediation, any unresolved controversy or claim arising out of or related to this Agreement shall be finally settled by binding arbitration in accordance with

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


 

the International Arbitration Rules of the International Centre for Dispute Resolution of the ICDR.

 

The ICDR shall appoint one arbitrator having knowledge of Dutch law. The arbitrator shall award to the prevailing Party, its reasonable documented fees (including attorneys fees) and costs incurred in connection with the arbitration.  The place of arbitration shall be New York City, New York (USA) and the language shall be English.  A prevailing Party may have the arbitration award enforced in any court of competent jurisdiction.

 

Either Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any interim or provisional relief (including injunctive relief and specific performance) that is necessary to protect the rights or property of that Party (irrespective of whether mediation or arbitration proceedings are pending) without having to prove actual damages or post a bond.

 

 

 

13

Miscellaneous

 

Amendment and Non-Waiver

 

13.1

No modification, extension or variation of this Agreement (or any document entered into pursuant to or in connection with this Agreement including any Schedule) shall be valid unless it is in writing (excluding email) and signed by or on behalf of each of the Parties to this Agreement. This is also true for a potential waiver to the requirement of written form. The failure to enforce any right or provision herein shall not constitute a waiver of that right or provision.

 

Insurance

 

13.2

Each Party undertakes to maintain appropriate levels of insurance in commercially reasonable amounts with financially capable carriers and/or through self-insurance programs as is customary in the pharmaceutical industry for the programs and activities to be conducted by it and/or as a result of the Services and shall maintain adequate levels of insurance to satisfy its respective obligations under this Agreement. Each Party shall provide the other Party with a certificate of insurance upon request and shall notify the other Party in writing no less than thirty (30) days before the cancellation, non-renewal, or material change in its insurance.

 

Assignment

 

13.3

PharmaCell may not assign its (or parts of) its rights under this Agreement to any third party without the prior written consent of ImmunoCellular. ImmunoCellular may assign this Agreement to an Affiliate or to a Third Party that acquires all or substantially all of the business or assets to which this Agreement pertains, or to a licensee of the Product, in each case without the consent of PharmaCell; provided, however, that ImmunoCellular demonstrates to PharmaCell’s reasonable satisfaction that a non-Affiliated assignee is not a competitor of PharmaCell, is financially solvent and agrees to assume and be bound by all of ImmunoCellular’s obligations hereunder.

 

Entire Agreement

 

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


 

13.4

This Agreement, and the Schedules and documents referred to in it and the Quality Agreement executed separately but annexed at the time of completion as Schedule 5 , constitutes the entire Agreement and understanding of the Parties and supersedes any previous or contemporaneous agreement between the Parties relating to the subject matter of this Agreement. The Nondisclosure Agreement between the Parties dated [ * ] (the “NDA”) is hereby terminated and superseded by this Agreement and the Confidential Information under the NDA shall be deemed and treated as Confidential Information of ImmunoCellular under this Agreement and subject to and governed by Section 8 hereof. If there is any conflict, overlap or ambiguity between the operative provisions of this Agreement and the Quality Agreement, then the relevant operative provisions of the Quality Agreement shall to the extent relating to regulatory or quality issues prevail to the exclusion of the relevant provisions in this Agreement. If there is any conflict, overlap or ambiguity between the provisions of the body of this Agreement and any of its Schedules , other than the Quality Agreement set forth in Schedule 5 , then the relevant provisions of the body of this Agreement shall prevail unless the provision of the Schedule makes an explicit reference to the provision of the body of this Agreement that shall be amended.

 

Severability

 

13.5

If any provision of this Agreement shall be found invalid or unenforceable, such invalidity or unenforceability shall not affect the other provisions of this Agreement which shall remain in full force and effect. The Parties agree, in the circumstances referred to in this Section 13.5 to attempt to substitute for any invalid or unenforceable provision a valid or enforceable provision which achieves to the greatest extent possible the same effect as would have been achieved by the invalid or unenforceable provision.

 

No Partnership

 

13.6

Nothing in this Agreement is intended to or shall operate to create a partnership or joint venture of any kind between the Parties or to authorise either party to act as agent for the other, and no party shall have authority to act in the name or on behalf of or otherwise to bind the other in any way (including but not limited to the making of any representation or warranty, the assumption of any obligation or liability and the exercise of any right or power).

 

Use of Name; Press and News Releases

 

13.7

Each Party agrees not to use the name, emblem, logo or marks of the other Party to this Agreement in any advertising, press or news release, or other publication or public statement, without the prior written consent of the other Party, except as required by law or regulation. ImmunoCellular will agree to the issuance of a joint press release or a separate press release by PharmaCell related to the Parties business relationship at an appropriate date within three (3) months following the Effective Date, provided ImmunoCellular has reviewed and approved in writing the language and timing of such release.  Following such release, PharmaCell shall have the right to use ImmunoCellular as a reference on its website and other corporate communication materials, provided such communication is consistent with the previously issued press release and such use is approved in writing by ImmunoCellular.

 

Language

 

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


 

13.8

In the event of an inconsistency between any terms of this Agreement or the Quality Agreement and any translations thereof into another language, the English language meaning shall control.

 


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


 

 

THIS AGREEMENT has been executed by or on behalf of the Parties as of the Effective Date

 

Signed on behalf of

PharmaCell B.V.

by

 

Name : /s/ Alexander Vos                                 

 

Position : Chief Executive Officer

                 13 MAR 2015

 

 

)

)

)

)

)

)

)

)

)

 

 

Signed on behalf of

ImmunoCellular Therapeutics Ltd.

by

 

Name : /s/ Andrew Gengos

 

Position : President & CEO

                 16 MARCH 2015

 

)

)

)

)

)

)

)

)

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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


 

 

 

 

 

 

 

 

 

Schedule 1

to Master Services Agreement

dated March  13, 2015

 

Project Description and Project Fees

 

 

     ––

 

 

Technology Transfer and Validation of ICT-107 for ImmunoCellular Therapeutics Ltd.

 

 

 

 

 

 

 

 

Project #

 

Date : March    13, 2015

 

 

[ * ]


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

 


 

 

 

 

 

Schedule 2

to Master Services Agreement

dated March 13, 2015

 

 

Project Description and Project Fees

 

 

     ––

 

 

GMP Manufacturing of ICT-107 for

 

ImmunoCellular Therapeutics Ltd.

 

 

 

 

 

 

 

 

 

Project #

 

Rev. March 13, 2015

[ * ]

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

 

Exhibit 31.1

Certification of the Principal Executive Officer Under Section 302 of the Sarbanes-Oxley Act

I, Andrew Gengos, certify that:

1.

I have reviewed this Form 10-Q of ImmunoCellular Therapeutics, Ltd.;

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: May 11, 2015

By:

/s/ Andrew Gengos 

 

 

Name:

Andrew Gengos

 

 

Title:

President and Chief Executive Officer

 

Exhibit 31.2

Certification of the Principal Financial Officer Under Section 302 of the Sarbanes-Oxley Act

I, David Fractor, certify that:

1.

I have reviewed this Form 10-Q of ImmunoCellular Therapeutics, Ltd.;

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: May 11, 2015

By:

/s/ David Fractor  

 

 

Name:

David Fractor

 

 

Title:

Principal Financial and Accounting Officer

 

Exhibit 32.1

CERTIFICATION OF THE PRINCIPAL EXECUTIVE OFFICER

Pursuant to the requirement set forth in Rule 13a -14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350), the undersigned officer of ImmunoCellular Therapeutics, Ltd. (the “Company”) hereby certifies that, to the best of his knowledge:

1.

The Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2015 (“Periodic Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and

2.

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

 

Date:  May 11, 2015

By:

/s/ Andrew Gengos  

 

 

Name:

Andrew Gengos

 

 

Title:

President and Chief Executive Officer

 

Exhibit 32.2

CERTIFICATION OF THE PRINCIPAL FINANCIAL OFFICER

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350), the undersigned officer of ImmunoCellular Therapeutics, Ltd. (the “Company”) hereby certifies that, to the best of his knowledge:

1.

The Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2015 (“Periodic Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and

2.

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

 

Date: May 11, 2015

By:

/s/ David Fractor  

 

 

Name:

David Fractor

 

 

Title:

Principal Financial and Accounting Officer